## Protocol Section
### Identification Module
**NCT ID:** NCT03698279

**Acronym:** QHD04

**Brief Title:** Safety and Immunogenicity of Different Dosages of High-Dose Quadrivalent Influenza Vaccine in Children 6 Months to 17 Years of Age

**Official Title:** Safety and Immunogenicity of Different Dosages of High-Dose Quadrivalent Influenza Vaccine in Children 6 Months to 17 Years of Age

#### Organization Study ID Info
**ID:** QHD04
#### Organization
**Class:** INDUSTRY
**Full Name:** Sanofi
#### Secondary ID Infos
**Domain:** WHO
**ID:** U1111-1189-3713
**Type:** OTHER
**ID:** 2018-005026-39
**Type:** EUDRACT_NUMBER
### Status Module
#### Completion Date
**Date:** 2019-10-16

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-04-04

**Type:** ACTUAL

**Last Update Submit Date:** 2022-03-24

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-10-16

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2020-06-01

**Type:** ACTUAL

**Results First Submit Date:** 2020-05-14

**Results First Submit QC Date:** 2020-05-14

#### Start Date
**Date:** 2018-10-09

**Type:** ACTUAL

**Status Verified Date:** 2022-03

#### Study First Post Date
**Date:** 2018-10-05
**Type:** ACTUAL
**Study First Submit Date:** 2018-10-04
**Study First Submit QC Date:** 2018-10-04
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Sanofi Pasteur, a Sanofi Company

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The objectives of this study were:

* To describe the safety of each dosage of high-dose quadrivalent influenza vaccine (QIV-HD) used in the study during the 28 days following each vaccination, and serious adverse events (including adverse events of special interest throughout the study).
* To describe the antibody response induced by each dosage of QIV-HD used in the study compared with unadjuvanted standard-dose quadrivalent influenza vaccine (QIV-SD) by hemagglutination inhibition (HAI) measurement method.
* To describe the antibody response induced by each dosage of QIV-HD used in the study compared with unadjuvanted QIV-SD by virus seroneutralization (SN) measurement method.
* To describe the antibody response induced by the highest acceptable dosage of QIV-HD compared with adjuvanted trivalent influenza vaccine (TIV) by HAI and virus SN measurement methods.

**Detailed Description:** Study duration per participant was approximately 180 days for participants who received one dose of vaccine and 208 days for participants who received two doses of vaccine.

### Conditions Module

**Conditions:**

- Influenza

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** SEQUENTIAL

**Intervention Model Description:** The study was divided into 13 groups and enrolled participants in 4 stages. The study used a stepwise age de-escalation and dose ascension design for children 6 months to less than (\<) 5 years of age.

##### Masking Info

**Masking:** TRIPLE

**Masking Description:** Modified double-blind: the participant's parent / legally acceptable representative, the Investigator, and other study personnel remained unaware of the treatment assignments throughout the trial. An unblinded vaccine administrator administered the appropriate vaccine but was not involved in safety data collection.

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 665

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants from United States (US) (aged 6 months to 17 years) received single injection of 30 microgram (μg) QIV-HD, intramuscularly (IM) at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.

**Intervention Names:**

- Biological: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) 30 μg (split-virion, inactivated)

**Label:** Group 1: QIV-HD 30 μg (US: 6 months to 17 years)

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Participants from US (aged 6 months to 17 years) received single injection of 45 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.

**Intervention Names:**

- Biological: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) 45 μg, (split-virion, inactivated)

**Label:** Group 2: QIV-HD 45 μg (US: 6 months to 17 years)

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Participants from US (aged 6 months to 17 years) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.

**Intervention Names:**

- Biological: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) 60 µg (split-virion, inactivated)

**Label:** Group 3: QIV-HD, 60 μg (US: 6 months to 17 years)

**Type:** EXPERIMENTAL

#### Arm Group 4

**Description:** Pooled arm consisted of participants who were from US aged 6 months to 17 years, randomized to Groups 1, 2 and 3 and received single injection of 15 μg QIV-SD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.

**Intervention Names:**

- Biological: Fluarix Quadrivalent Influenza vaccine (Unadjuvanted QIV-SD) (Inactivated)

**Label:** Group 4: Pooled QIV-SD, 15 μg (US: 6 months to 17 years)

**Type:** ACTIVE_COMPARATOR

#### Arm Group 5

**Description:** Participants from Canada (aged 6 to less than \[\<\] 24 months) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.

**Intervention Names:**

- Biological: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) 60 µg (split-virion, inactivated)

**Label:** Group 5: QIV-HD, 60 μg (Canada: 6 to <24 months)

**Type:** EXPERIMENTAL

#### Arm Group 6

**Description:** Participants from Canada (aged 6 to \<24 months) received single injection of 7.5 μg adjuvanted TIV, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.

**Intervention Names:**

- Biological: FLUAD Pediatric (adjuvanted TIV) (Surface Antigen, Inactivated)

**Label:** Group 6: Adjuvanted TIV (Canada: 6 to <24 months)

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group 1: QIV-HD 30 μg (US: 6 months to 17 years)

**Description:** Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM

**Name:** High-Dose Quadrivalent Influenza Vaccine (QIV-HD) 30 μg (split-virion, inactivated)

**Type:** BIOLOGICAL

#### Intervention 2

**Arm Group Labels:**

- Group 2: QIV-HD 45 μg (US: 6 months to 17 years)

**Description:** Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM

**Name:** High-Dose Quadrivalent Influenza Vaccine (QIV-HD) 45 μg, (split-virion, inactivated)

**Type:** BIOLOGICAL

#### Intervention 3

**Arm Group Labels:**

- Group 3: QIV-HD, 60 μg (US: 6 months to 17 years)

- Group 5: QIV-HD, 60 μg (Canada: 6 to <24 months)

**Description:** Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM

**Name:** High-Dose Quadrivalent Influenza Vaccine (QIV-HD) 60 µg (split-virion, inactivated)

**Type:** BIOLOGICAL

#### Intervention 4

**Arm Group Labels:**

- Group 4: Pooled QIV-SD, 15 μg (US: 6 months to 17 years)

**Description:** Pharmaceutical form: Solution for injection Route of administration: IM

**Name:** Fluarix Quadrivalent Influenza vaccine (Unadjuvanted QIV-SD) (Inactivated)

**Type:** BIOLOGICAL

#### Intervention 5

**Arm Group Labels:**

- Group 6: Adjuvanted TIV (Canada: 6 to <24 months)

**Description:** Pharmaceutical form: Solution for injection Route of administration: IM

**Name:** FLUAD Pediatric (adjuvanted TIV) (Surface Antigen, Inactivated)

**Type:** BIOLOGICAL

### Outcomes Module

#### Primary Outcomes

**Description:** An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. Unsolicited AEs includes both serious (SAEs) and non-serious unsolicited AEs. An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. All participants were observed for 30 minutes after vaccination, and any unsolicited systemic AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB.

**Measure:** Number of Participants With Immediate Unsolicited Adverse Events (AEs) After Any Vaccination

**Time Frame:** Within 30 minutes after any vaccination

**Description:** An unsolicited AE was an observed AE that does not fulfill the conditions prelisted in the CRB in terms of diagnosis and/or onset window post-vaccination. Unsolicited AEs included both serious and non-serious unsolicited AEs. An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. Adverse reactions (ARs) were AEs related to vaccination. An injection site reaction was an AR at and around the injection site. Systemic AEs were all AEs that were not injection or administration site reactions.

**Measure:** Number of Participants With Unsolicited Adverse Events After Any Vaccination

**Time Frame:** Within 28 days after any vaccination

**Description:** An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. An SAE which caused death of the participant was considered as fatal SAE. Adverse events of special interest (AESIs) were defined as SAEs which included new onset of Guillain-Barré syndrome, encephalitis/myelitis (including transverse myelitis), Bell's palsy, convulsions, optic neuritis, and brachial neuritis.

**Measure:** Number of Participants With Serious Adverse Events (SAEs) After Any Vaccination

**Time Frame:** From Day 0 up to 6 months (i.e. 180 days) post last vaccination

**Description:** Anti-influenza antibodies were measured by hemagglutination inhibition (HAI) assay for strains A/H1N1, A/H3N2, B/Victoria and B/Yamagata lineage. Seroconversion: defined as either HAI titer \<10(1/dilution) at Day 0 and post-vaccination titer greater than or equal to (\>=)40(1/dilution) at Day 28, or HAI titer \>=10(1/dilution) at Day 0 and \>=4-fold increase in HAI titer (1/dilution) at Day 28. Data for this Outcome Measure (OM) was planned to be collected and reported for dose level (QIV-HD 30μg and 45μg) matched separate groups for QIV-SD (Groups 4a, 4b and 4c), instead of pooled QIV-SD arm. Due to complex study design and analysis of doses and age groups, QIV-SD group participants, who matched to participants in QIV-HD 30μg and 45μg dose formulations groups (who were 9 through 17 years old and shared matching age group with QIV-SD control group), included in Groups 4a, 4b and 4c in this OM might be counted in more than once in QIV-SD arms for different dose levels, as applicable.

**Measure:** Number of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine

**Time Frame:** Day 28 post any vaccination

**Description:** GMTs of anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage. Data for this OM was planned to be collected and reported for dose level (QIV-HD 30 μg and QIV-HD 45 μg) matched separate groups for QIV-SD (Groups 4a, 4b and 4c), instead of pooled QIV-SD arm. Due to the complex study design and analysis of the dose formulation and age groups in the study, QIV-SD group participants, who matched to participants in the QIV-HD 30 μg and QIV-HD 45 μg dose formulations groups (who were 9 through 17 years old and shared a matching age group with QIV-SD control group), included in Groups 4a, 4b and 4c in this OM might be counted in more than once in QIV-SD arms for different dose levels, as applicable.

**Measure:** Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine

**Time Frame:** Day 28 post any vaccination

**Description:** GMTs of anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage. GMTRs were calculated as the ratio of GMTs post-vaccination and pre-vaccination.

**Measure:** Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine

**Time Frame:** Day 0 (pre-vaccination), Day 28 (post any vaccination)

**Description:** GMT was measured for each influenza strain using HAI assay method for 4 strains: A/H1N1, A/H3N2, B/Victoria lineage, and B/Yamagata lineage.

**Measure:** Number of Participants With Neutralization Antibody Titers >= 40 (1/Dilution) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine

**Time Frame:** Day 28 post any vaccination

**Description:** GMT was measured for each influenza strain using SN assay method for 4 strains: A/H1N1, A/H3N2, B/Victoria lineage, and B/Yamagata lineage.

**Measure:** Geometric Mean Titers of Influenza Antibodies (Measured by Seroneutralization [SN] Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine

**Time Frame:** Day 28 post any vaccination

**Description:** GMTRs of anti-influenza antibodies were measured using SN assay method for 4 strains: A/H1N1, A/H3N2, B/Victoria lineage and B/Yamagata lineage. GMTRs were calculated as the ratio of GMTs post vaccination and pre-vaccination.

**Measure:** Geometric Mean Titers Ratio of Influenza Antibodies (Measured by Seroneutralization Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine

**Time Frame:** Day 0 (pre-vaccination), Day 28 (post any vaccination)

**Description:** Neutralizing Antibody titer was measured for each influenza strain with SN assay method for 4 strains: A/H1N1, A/H3N2, B/Victoria lineage, and B/Yamagata lineage at pre-defined thresholds of \>=20, \>=40 and \>=80 (1/dilution).

**Measure:** Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds

**Time Frame:** Day 28 post any vaccination

**Description:** Neutralizing Antibody titer was measured for each influenza strain with SN method for 4 strains: A/H1N1, A/H3N2, B/Victoria lineage, and B/Yamagata lineage. 2-fold and 4-fold rise was defined as the computed value = post-vaccination computed value / pre-vaccination computed value.

**Measure:** Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer

**Time Frame:** Day 28 post any vaccination

**Description:** A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRB and considered as related to the administered vaccination. Solicited injection site reactions included tenderness/pain, erythema, swelling, induration and bruising.

**Measure:** Number of Participants With Solicited Injection Site Reactions

**Time Frame:** Within 7 days after any vaccination

**Description:** A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRB and considered as related to the administered vaccination. Solicited systemic reactions included fever, vomiting, crying abnormal, drowsiness, appetite loss and irritability. Fever was planned to be evaluated for the whole population where as, the other events (vomiting, crying abnormal, drowsiness, appetite lost, and irritability) were planned to be evaluated only in the participants aged 6 months to \<36 months.

**Measure:** Number of Participants With Solicited Systemic Reactions After Any Vaccination

**Time Frame:** Within 7 days after any vaccination

**Description:** A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRB and considered as related to the administered vaccination. Solicited systemic reactions included: headache, malaise, myalgia and shivering.

**Measure:** Number of Participants With Solicited Systemic Reactions After Any Vaccination: Participants Aged >36 Months

**Time Frame:** Within 7 days after any vaccination

### Eligibility Module

**Eligibility Criteria:** Inclusion criteria :

* Aged 6 months to 17 years on the day of inclusion.
* Assent form was signed and dated by the participant (7 to 17 years of age) and informed consent form was signed and dated by the parent(s) or guardian(s) and by an independent witness, if required by local regulations.
* Participant and parent/guardian were able to attend all scheduled visits and complied with all study procedures.
* For participants aged \<24 months: Born at full term of pregnancy (greater than or equal to \[\>=\] 37 weeks) and/or with a birth weight \>=2.5 kilogram.

Exclusion criteria:

* Participant was pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination. To be considered of non-childbearing potential, a female must be pre-menarche.
* Participation at the time of study enrollment (or in the 4 weeks preceding the first study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
* Receipt of any vaccine in the 30 days preceding the first study vaccination, or planned receipt of any vaccine before Visit 3 for participants receiving 1 dose of influenza vaccine or Visit 5 for participants receiving 2 doses of influenza vaccine.
* For previously influenza vaccinated participants: Previous vaccination against influenza in the preceding 6 months with either the study vaccine or another vaccine.
* For previously influenza unvaccinated participants: Any influenza vaccination (from birth to the day of inclusion) with either the study vaccine or another influenza vaccine.
* For previously influenza unvaccinated participants: Any previous laboratory confirmed influenza infection (from birth to the day of inclusion)
* Receipt of immune globulins, blood or blood-derived products in the past 3 months.
* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
* Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances.
* Thrombocytopenia or bleeding disorder, contraindicating IM vaccination based on Investigator's judgement.
* Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
* Current alcohol abuse or drug addiction.
* Chronic illness that, in the opinion of the investigator, was at a stage where it might interfere with study conduct or completion.
* Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature \>=38.0°Celsius \[\>=100.4°Fahrenheit\]). A prospective participant should not be included in the study until the condition had resolved or the febrile event had subsided.
* Identified as an immediate family member (i.e., spouse, natural or adopted child, grandchild, nephew, or niece) of the Investigator or employee with direct involvement in the proposed study.
* Personal history of Guillain-Barré syndrome.
* Any condition that in the opinion of the Investigator would pose a health risk to the participant if enrolled or could interfere with the evaluation of the vaccine
* Personal history of clinically significant development delay (at the discretion of the Investigator), neurologic disorder, or seizure disorder.
* Known seropositivity for hepatitis B or hepatitis C.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

**Healthy Volunteers:** True

**Maximum Age:** 17 Years

**Minimum Age:** 6 Months

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** San Diego

**Country:** United States

**Facility:** Investigational Site Number 8400004

**State:** California

**Zip:** 92123-1881

**Location 2:**

**City:** Miami

**Country:** United States

**Facility:** Investigational Site Number 8400001

**State:** Florida

**Zip:** 33186

**Location 3:**

**City:** Atlanta

**Country:** United States

**Facility:** Investigational Site Number 8400002

**State:** Georgia

**Zip:** 30322

**Location 4:**

**City:** El Dorado

**Country:** United States

**Facility:** Investigational Site Number 8400013

**State:** Kansas

**Zip:** 67042

**Location 5:**

**City:** Newton

**Country:** United States

**Facility:** Investigational Site Number 8400015

**State:** Kansas

**Zip:** 67114

**Location 6:**

**City:** Wichita

**Country:** United States

**Facility:** Investigational Site Number 8400009

**State:** Kansas

**Zip:** 67207

**Location 7:**

**City:** Metairie

**Country:** United States

**Facility:** Investigational Site Number 8400007

**State:** Louisiana

**Zip:** 70006

**Location 8:**

**City:** Las Vegas

**Country:** United States

**Facility:** Investigational Site Number 8400010

**State:** Nevada

**Zip:** 89104

**Location 9:**

**City:** Warwick

**Country:** United States

**Facility:** Investigational Site Number 8400011

**State:** Rhode Island

**Zip:** 02886

**Location 10:**

**City:** Salt Lake City

**Country:** United States

**Facility:** Investigational Site Number 8400003

**State:** Utah

**Zip:** 84107

**Location 11:**

**City:** Salt Lake City

**Country:** United States

**Facility:** Investigational Site Number 8400012

**State:** Utah

**Zip:** 84109

**Location 12:**

**City:** Salt Lake City

**Country:** United States

**Facility:** Investigational Site Number 8400005

**State:** Utah

**Zip:** 84121

**Location 13:**

**City:** West Jordan

**Country:** United States

**Facility:** Investigational Site Number 8400014

**State:** Utah

**Zip:** 84088-8865

**Location 14:**

**City:** Montreal

**Country:** Canada

**Facility:** Investigational Site Number 1241003

**Zip:** H3T 1C5

**Location 15:**

**City:** Pierrefonds

**Country:** Canada

**Facility:** Investigational Site Number 1241002

**Zip:** H9H 4Y6

**Location 16:**

**City:** Quebec

**Country:** Canada

**Facility:** Investigational Site Number 1241001

**Zip:** G1E 7G9

#### Overall Officials

**Official 1:**

**Affiliation:** Sanofi Pasteur, a Sanofi Company

**Name:** Clinical Sciences & Operations

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**Description:** Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

**IPD Sharing:** YES

### References Module

#### References

**Citation:** Chang LJ, Anderson EJ, Jeanfreau R, He Y, Hicks B, Shrestha A, Pandey A, Landolfi V, DeBruijn I; QHD04 Study Group. Safety and immunogenicity of high doses of quadrivalent influenza vaccine in children 6 months through <18 years of age: A randomized controlled phase II dose-finding trial. Vaccine. 2021 Mar 12;39(11):1572-1582. doi: 10.1016/j.vaccine.2021.02.014. Epub 2021 Feb 18.

**PMID:** 33610374

## Document Section

### Large Document Module

#### Large Docs

- Date: 2019-02-25

- Filename: Prot_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: False

- Label: Study Protocol

- Size: 2040806

- Type Abbrev: Prot

- Upload Date: 2020-05-14T12:01

- Date: 2019-07-04

- Filename: SAP_001.pdf

- Has ICF: False

- Has Protocol: False

- Has SAP: True

- Label: Statistical Analysis Plan

- Size: 1174192

- Type Abbrev: SAP

- Upload Date: 2020-05-14T12:01

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012141

- Term: Respiratory Tract Infections

- ID: D000007239

- Term: Infections

- ID: D000009976

- Term: Orthomyxoviridae Infections

- ID: D000012327

- Term: RNA Virus Infections

- ID: D000014777

- Term: Virus Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M10295

- Name: Influenza, Human

- Relevance: HIGH

- As Found: Influenza

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14978

- Name: Respiratory Tract Infections

- Relevance: LOW

- As Found: Unknown

- ID: M12902

- Name: Orthomyxoviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007251

- Term: Influenza, Human

### Intervention Browse Module - Ancestors

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

### Intervention Browse Module - Browse Leaves

- ID: M17360

- Name: Vaccines

- Relevance: HIGH

- As Found: Other

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000014612

- Term: Vaccines

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** An SR was an AE that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. Analysis was performed on SafAS population.

#### Event Groups

**Group ID:** EG000

**Title:** Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years)

**Deaths Num At Risk:** 122

**Description:** Participants from US (aged 6 months to 17 years) received single injection of 30 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.

**ID:** EG000

**Other Num Affected:** 101

**Other Num at Risk:** 122

**Serious Number At Risk:** 122

**Title:** Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years)

**Group ID:** EG001

**Title:** Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years)

**Deaths Num At Risk:** 121

**Description:** Participants from US (aged 6 months to 17 years) received single injection of 45 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.

**ID:** EG001

**Other Num Affected:** 100

**Other Num at Risk:** 121

**Serious Number At Risk:** 121

**Title:** Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years)

**Group ID:** EG002

**Title:** Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years)

**Deaths Num At Risk:** 158

**Description:** Participants from US (aged 6 months to 17 years) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.

**ID:** EG002

**Other Num Affected:** 118

**Other Num at Risk:** 158

**Serious Number Affected:** 2

**Serious Number At Risk:** 158

**Title:** Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years)

**Group ID:** EG003

**Title:** Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years)

**Deaths Num At Risk:** 234

**Description:** Pooled arm consisted of participants who were from US aged 6 months to 17 years, randomized to Groups 1, 2 and 3 and received single injection of 15 μg unadjuvanted QIV-SD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.

**ID:** EG003

**Other Num Affected:** 165

**Other Num at Risk:** 234

**Serious Number At Risk:** 234

**Title:** Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years)

**Group ID:** EG004

**Title:** Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months)

**Deaths Num At Risk:** 13

**Description:** Participants from Canada (aged 6 to \<24 months) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.

**ID:** EG004

**Other Num Affected:** 13

**Other Num at Risk:** 13

**Serious Number At Risk:** 13

**Title:** Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months)

**Group ID:** EG005

**Title:** Group 6: Adjuvanted TIV (Canada: 6 to <24 Months)

**Deaths Num At Risk:** 13

**Description:** Participants from Canada (aged 6 to \<24 months) received single injection of 7.5 μg adjuvanted TIV, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.

**ID:** EG005

**Other Num Affected:** 13

**Other Num at Risk:** 13

**Serious Number Affected:** 1

**Serious Number At Risk:** 13

**Title:** Group 6: Adjuvanted TIV (Canada: 6 to <24 Months)

**Frequency Threshold:** 5

#### Other Events

**Term:** Anaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA-22.0

**Term:** Ear Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Ear and labyrinth disorders

**Source Vocabulary:** MedDRA-22.0

**Term:** Abdominal Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA-22.0

**Term:** Diarrhoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA-22.0

**Term:** Oral Mucosal Eruption

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA-22.0

**Term:** Teething

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA-22.0

**Term:** Vomiting

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA-22.0

**Term:** Chills

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA-22.0

**Term:** Crying

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA-22.0

**Term:** Influenza Like Illness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA-22.0

**Term:** Injection Site Bruising

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA-22.0

**Term:** Injection Site Erythema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA-22.0

**Term:** Injection Site Induration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA-22.0

**Term:** Injection Site Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA-22.0

**Term:** Injection Site Swelling

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA-22.0

**Term:** Injection Site Warmth

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA-22.0

**Term:** Malaise

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA-22.0

**Term:** Pyrexia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA-22.0

**Term:** Bronchiolitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA-22.0

**Term:** Bronchitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA-22.0

**Term:** Conjunctivitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA-22.0

**Term:** Ear Infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA-22.0

**Term:** Gastroenteritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA-22.0

**Term:** Nasopharyngitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA-22.0

**Term:** Otitis Media

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA-22.0

**Term:** Pharyngitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA-22.0

**Term:** Sinusitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA-22.0

**Term:** Upper Respiratory Tract Infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA-22.0

**Term:** Tongue Injury

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA-22.0

**Term:** Decreased Appetite

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA-22.0

**Term:** Myalgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA-22.0

**Term:** Aphonia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA-22.0

**Term:** Headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA-22.0

**Term:** Somnolence

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA-22.0

**Term:** Insomnia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA-22.0

**Term:** Irritability

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA-22.0

**Term:** Sleep Terror

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA-22.0

**Term:** Cough

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA-22.0

**Term:** Nasal Congestion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA-22.0

**Term:** Rhinorrhoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA-22.0

**Term:** Dermatitis Diaper

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA-22.0

**Term:** Erythema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA-22.0

**Term:** Petechiae

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA-22.0

**Term:** Rash

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA-22.0

#### Serious Events

**Term:** Ear Infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA-22.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 122

**Group ID:** EG001

**Num At Risk:** 121

**Group ID:** EG002

**Num At Risk:** 158

**Group ID:** EG003

**Num At Risk:** 234

**Group ID:** EG004

**Num At Risk:** 13

**Group ID:** EG005

**Num Affected:** 1

**Num At Risk:** 13

**Num Events:** 1

**Term:** Respiratory Syncytial Virus Infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA-22.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 122

**Group ID:** EG001

**Num At Risk:** 121

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 158

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 234

**Group ID:** EG004

**Num At Risk:** 13

**Group ID:** EG005

**Num At Risk:** 13

**Term:** Febrile Convulsion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA-22.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 122

**Group ID:** EG001

**Num At Risk:** 121

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 158

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 234

**Group ID:** EG004

**Num At Risk:** 13

**Group ID:** EG005

**Num At Risk:** 13

**Time Frame:** AEs were collected from Day 0 (post-vaccination) up to 28 days after last vaccination. Solicited Reaction (SR) data were collected up to Day 7 after any vaccination. SAE data were collected throughout the study (up to 180 days after last vaccination).

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 124

**Group ID:** BG001

**Value:** 122

**Group ID:** BG002

**Value:** 159

**Group ID:** BG003

**Value:** 234

**Group ID:** BG004

**Value:** 13

**Group ID:** BG005

**Value:** 13

**Group ID:** BG006

**Value:** 665

**Units:** Participants

### Group

**ID:** BG000

**Title:** Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years)

**Description:** Participants from US (aged 6 months to 17 years) received single injection of 30 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.

### Group

**ID:** BG001

**Title:** Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years)

**Description:** Participants from US (aged 6 months to 17 years) received single injection of 45 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.

### Group

**ID:** BG002

**Title:** Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years)

**Description:** Participants from US (aged 6 months to 17 years) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.

### Group

**ID:** BG003

**Title:** Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years)

**Description:** Pooled arm consisted of participants who were from US aged 6 months to 17 years, randomized to Groups 1, 2 and 3 and received single injection of 15 μg unadjuvanted QIV-SD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.

### Group

**ID:** BG004

**Title:** Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months)

**Description:** Participants from Canada (aged 6 to \<24 months) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.

### Group

**ID:** BG005

**Title:** Group 6: Adjuvanted TIV (Canada: 6 to <24 Months)

**Description:** Participants from Canada (aged 6 to \<24 months) received single injection of 7.5 μg adjuvanted TIV, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.

### Group

**ID:** BG006

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 3.91

**Value:** 5.8

#### Measurement

**Group ID:** BG001

**Spread:** 4.30

**Value:** 6.1

#### Measurement

**Group ID:** BG002

**Spread:** 4.22

**Value:** 5.2

#### Measurement

**Group ID:** BG003

**Spread:** 4.02

**Value:** 5.1

#### Measurement

**Group ID:** BG004

**Spread:** 0.19

**Value:** 0.8

#### Measurement

**Group ID:** BG005

**Spread:** 0.28

**Value:** 1.0

#### Measurement

**Group ID:** BG006

**Spread:** 4.13

**Value:** 5.3

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

#### Measurement

**Group ID:** BG004

**Value:** 13

#### Measurement

**Group ID:** BG005

**Value:** 13

#### Measurement

**Group ID:** BG006

**Value:** 26

**Class Title:** 6 - < 24 months

#### Measurement

**Group ID:** BG000

**Value:** 29

#### Measurement

**Group ID:** BG001

**Value:** 30

#### Measurement

**Group ID:** BG002

**Value:** 54

#### Measurement

**Group ID:** BG003

**Value:** 75

#### Measurement

**Group ID:** BG004

**Value:** 0

#### Measurement

**Group ID:** BG005

**Value:** 0

#### Measurement

**Group ID:** BG006

**Value:** 188

**Class Title:** 6 - < 36 months

#### Measurement

**Group ID:** BG000

**Value:** 34

#### Measurement

**Group ID:** BG001

**Value:** 30

#### Measurement

**Group ID:** BG002

**Value:** 44

#### Measurement

**Group ID:** BG003

**Value:** 68

#### Measurement

**Group ID:** BG004

**Value:** 0

#### Measurement

**Group ID:** BG005

**Value:** 0

#### Measurement

**Group ID:** BG006

**Value:** 176

**Class Title:** 36 months - < 5 years

#### Measurement

**Group ID:** BG000

**Value:** 32

#### Measurement

**Group ID:** BG001

**Value:** 32

#### Measurement

**Group ID:** BG002

**Value:** 31

#### Measurement

**Group ID:** BG003

**Value:** 49

#### Measurement

**Group ID:** BG004

**Value:** 0

#### Measurement

**Group ID:** BG005

**Value:** 0

#### Measurement

**Group ID:** BG006

**Value:** 144

**Class Title:** 5 - 8 years

#### Measurement

**Group ID:** BG000

**Value:** 29

#### Measurement

**Group ID:** BG001

**Value:** 30

#### Measurement

**Group ID:** BG002

**Value:** 30

#### Measurement

**Group ID:** BG003

**Value:** 42

#### Measurement

**Group ID:** BG004

**Value:** 0

#### Measurement

**Group ID:** BG005

**Value:** 0

#### Measurement

**Group ID:** BG006

**Value:** 131

**Class Title:** 9 - 17 years

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 51

#### Measurement

**Group ID:** BG001

**Value:** 61

#### Measurement

**Group ID:** BG002

**Value:** 82

#### Measurement

**Group ID:** BG003

**Value:** 114

#### Measurement

**Group ID:** BG004

**Value:** 4

#### Measurement

**Group ID:** BG005

**Value:** 6

#### Measurement

**Group ID:** BG006

**Value:** 318

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 73

#### Measurement

**Group ID:** BG001

**Value:** 61

#### Measurement

**Group ID:** BG002

**Value:** 77

#### Measurement

**Group ID:** BG003

**Value:** 120

#### Measurement

**Group ID:** BG004

**Value:** 9

#### Measurement

**Group ID:** BG005

**Value:** 7

#### Measurement

**Group ID:** BG006

**Value:** 347

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 2

#### Measurement

**Group ID:** BG004

**Value:** 0

#### Measurement

**Group ID:** BG005

**Value:** 0

#### Measurement

**Group ID:** BG006

**Value:** 4

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 3

#### Measurement

**Group ID:** BG004

**Value:** 0

#### Measurement

**Group ID:** BG005

**Value:** 0

#### Measurement

**Group ID:** BG006

**Value:** 6

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 3

#### Measurement

**Group ID:** BG002

**Value:** 2

#### Measurement

**Group ID:** BG003

**Value:** 5

#### Measurement

**Group ID:** BG004

**Value:** 0

#### Measurement

**Group ID:** BG005

**Value:** 1

#### Measurement

**Group ID:** BG006

**Value:** 11

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 22

#### Measurement

**Group ID:** BG001

**Value:** 28

#### Measurement

**Group ID:** BG002

**Value:** 40

#### Measurement

**Group ID:** BG003

**Value:** 58

#### Measurement

**Group ID:** BG004

**Value:** 2

#### Measurement

**Group ID:** BG005

**Value:** 0

#### Measurement

**Group ID:** BG006

**Value:** 150

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 92

#### Measurement

**Group ID:** BG001

**Value:** 81

#### Measurement

**Group ID:** BG002

**Value:** 108

#### Measurement

**Group ID:** BG003

**Value:** 157

#### Measurement

**Group ID:** BG004

**Value:** 9

#### Measurement

**Group ID:** BG005

**Value:** 11

#### Measurement

**Group ID:** BG006

**Value:** 458

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 4

#### Measurement

**Group ID:** BG001

**Value:** 3

#### Measurement

**Group ID:** BG002

**Value:** 8

#### Measurement

**Group ID:** BG003

**Value:** 7

#### Measurement

**Group ID:** BG004

**Value:** 2

#### Measurement

**Group ID:** BG005

**Value:** 1

#### Measurement

**Group ID:** BG006

**Value:** 25

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 5

#### Measurement

**Group ID:** BG002

**Value:** 1

#### Measurement

**Group ID:** BG003

**Value:** 2

#### Measurement

**Group ID:** BG004

**Value:** 0

#### Measurement

**Group ID:** BG005

**Value:** 0

#### Measurement

**Group ID:** BG006

**Value:** 11

**Category Title:** Unknown or Not Reported

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Customized
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
**Population Description:** Analysis was performed on the randomized participants.
## Results Section - More Information Module
### Certain Agreement
**Other Details:** The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable participant matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Point of Contact
**Email:** Contact-US@sanofi.com
**Organization:** Sanofi Pasteur
**Phone:** 800-633-1610
**Phone Extension:** 1#
**Title:** Trial Transparency Team
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
### Outcome Measure 7
### Outcome Measure 8
### Outcome Measure 9
### Outcome Measure 10
### Outcome Measure 11
### Outcome Measure 12
### Outcome Measure 13
### Outcome Measure 14
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 46
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 46
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 53
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 80
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 12
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 8
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 8
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 10
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 46
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 45
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 52
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 80
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 12
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 8
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 10
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 72
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 71
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 107
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 26
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 24
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 98
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 8
- **Comment:** 
- **Group ID:** OG007
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 110
- **Group ID:** OG001
- **Value:** 112
- **Group ID:** OG002
- **Value:** 141
- **Group ID:** OG003
- **Value:** 39
- **Group ID:** OG004
- **Value:** 41
- **Group ID:** OG005
- **Value:** 148
- **Group ID:** OG006
- **Value:** 11
- **Group ID:** OG007
- **Value:** 12
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 63
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 79
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 102
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 18
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 20
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 71
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 8
- **Comment:** 
- **Group ID:** OG007
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 12
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 109
- **Group ID:** OG001
- **Value:** 111
- **Group ID:** OG002
- **Value:** 140
- **Group ID:** OG003
- **Value:** 38
- **Group ID:** OG004
- **Value:** 41
- **Group ID:** OG005
- **Value:** 146
- **Group ID:** OG006
- **Value:** 11
- **Group ID:** OG007
- **Value:** 12
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 84
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 94
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 117
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 28
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 30
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 111
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6
- **Comment:** 
- **Group ID:** OG007
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 12
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 110
- **Group ID:** OG001
- **Value:** 111
- **Group ID:** OG002
- **Value:** 141
- **Group ID:** OG003
- **Value:** 39
- **Group ID:** OG004
- **Value:** 41
- **Group ID:** OG005
- **Value:** 148
- **Group ID:** OG006
- **Value:** 11
- **Group ID:** OG007
- **Value:** 12
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 79
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 85
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 120
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 26
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 31
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 117
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 8
- **Comment:** 
- **Group ID:** OG007
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 110
- **Group ID:** OG001
- **Value:** 109
- **Group ID:** OG002
- **Value:** 141
- **Group ID:** OG003
- **Value:** 38
- **Group ID:** OG004
- **Value:** 41
- **Group ID:** OG005
- **Value:** 147
- **Group ID:** OG006
- **Value:** 11
- **Group ID:** OG007
- **Value:** 12
**Units:** Participants
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 525
- **Spread:** 
- **Upper Limit:** 863
- **Value:** 673
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 524
- **Spread:** 
- **Upper Limit:** 873
- **Value:** 676
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 674
- **Spread:** 
- **Upper Limit:** 1033
- **Value:** 834
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 419
- **Spread:** 
- **Upper Limit:** 1161
- **Value:** 698
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 480
- **Spread:** 
- **Upper Limit:** 1303
- **Value:** 791
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 461
- **Spread:** 
- **Upper Limit:** 830
- **Value:** 618
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 27.0
- **Spread:** 
- **Upper Limit:** 132
- **Value:** 59.7
- **Comment:** 
- **Group ID:** OG007
- **Lower Limit:** 261
- **Spread:** 
- **Upper Limit:** 1398
- **Value:** 604
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 116
- **Group ID:** OG001
- **Value:** 114
- **Group ID:** OG002
- **Value:** 145
- **Group ID:** OG003
- **Value:** 40
- **Group ID:** OG004
- **Value:** 41
- **Group ID:** OG005
- **Value:** 151
- **Group ID:** OG006
- **Value:** 13
- **Group ID:** OG007
- **Value:** 12
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 399
- **Spread:** 
- **Upper Limit:** 671
- **Value:** 518
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 600
- **Spread:** 
- **Upper Limit:** 1017
- **Value:** 781
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 604
- **Spread:** 
- **Upper Limit:** 982
- **Value:** 770
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 184
- **Spread:** 
- **Upper Limit:** 538
- **Value:** 314
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 264
- **Spread:** 
- **Upper Limit:** 738
- **Value:** 441
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 239
- **Spread:** 
- **Upper Limit:** 395
- **Value:** 307
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 33.0
- **Spread:** 
- **Upper Limit:** 133
- **Value:** 66.4
- **Comment:** 
- **Group ID:** OG007
- **Lower Limit:** 386
- **Spread:** 
- **Upper Limit:** 946
- **Value:** 604
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 116
- **Group ID:** OG001
- **Value:** 113
- **Group ID:** OG002
- **Value:** 144
- **Group ID:** OG003
- **Value:** 39
- **Group ID:** OG004
- **Value:** 41
- **Group ID:** OG005
- **Value:** 151
- **Group ID:** OG006
- **Value:** 13
- **Group ID:** OG007
- **Value:** 12
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 296
- **Spread:** 
- **Upper Limit:** 483
- **Value:** 378
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 334
- **Spread:** 
- **Upper Limit:** 560
- **Value:** 432
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 400
- **Spread:** 
- **Upper Limit:** 612
- **Value:** 494
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 194
- **Spread:** 
- **Upper Limit:** 452
- **Value:** 296
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 302
- **Spread:** 
- **Upper Limit:** 726
- **Value:** 468
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 246
- **Spread:** 
- **Upper Limit:** 390
- **Value:** 310
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 26.2
- **Spread:** 
- **Upper Limit:** 122
- **Value:** 56.6
- **Comment:** 
- **Group ID:** OG007
- **Lower Limit:** 767
- **Spread:** 
- **Upper Limit:** 2016
- **Value:** 1244
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 116
- **Group ID:** OG001
- **Value:** 113
- **Group ID:** OG002
- **Value:** 145
- **Group ID:** OG003
- **Value:** 40
- **Group ID:** OG004
- **Value:** 41
- **Group ID:** OG005
- **Value:** 151
- **Group ID:** OG006
- **Value:** 13
- **Group ID:** OG007
- **Value:** 12
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 582
- **Spread:** 
- **Upper Limit:** 899
- **Value:** 723
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 556
- **Spread:** 
- **Upper Limit:** 932
- **Value:** 720
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 722
- **Spread:** 
- **Upper Limit:** 1066
- **Value:** 877
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 474
- **Spread:** 
- **Upper Limit:** 1050
- **Value:** 706
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 501
- **Spread:** 
- **Upper Limit:** 1054
- **Value:** 727
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 466
- **Spread:** 
- **Upper Limit:** 721
- **Value:** 580
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 38.9
- **Spread:** 
- **Upper Limit:** 148
- **Value:** 75.8
- **Comment:** 
- **Group ID:** OG007
- **Lower Limit:** 12.3
- **Spread:** 
- **Upper Limit:** 38.6
- **Value:** 21.8
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 116
- **Group ID:** OG001
- **Value:** 112
- **Group ID:** OG002
- **Value:** 144
- **Group ID:** OG003
- **Value:** 39
- **Group ID:** OG004
- **Value:** 41
- **Group ID:** OG005
- **Value:** 151
- **Group ID:** OG006
- **Value:** 13
- **Group ID:** OG007
- **Value:** 12
**Units:** Participants
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 6.39
- **Spread:** 
- **Upper Limit:** 11.4
- **Value:** 8.55
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 7.31
- **Spread:** 
- **Upper Limit:** 13.7
- **Value:** 10.0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 12.1
- **Spread:** 
- **Upper Limit:** 22.0
- **Value:** 16.3
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 8.07
- **Spread:** 
- **Upper Limit:** 12.8
- **Value:** 10.1
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 0.878
- **Spread:** 
- **Upper Limit:** 2.28
- **Value:** 1.41
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 2.72
- **Spread:** 
- **Upper Limit:** 8.32
- **Value:** 4.76
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 110
- **Group ID:** OG001
- **Value:** 112
- **Group ID:** OG002
- **Value:** 141
- **Group ID:** OG003
- **Value:** 217
- **Group ID:** OG004
- **Value:** 11
- **Group ID:** OG005
- **Value:** 12
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 4.95
- **Spread:** 
- **Upper Limit:** 8.34
- **Value:** 6.42
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 7.15
- **Spread:** 
- **Upper Limit:** 12.2
- **Value:** 9.35
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 8.09
- **Spread:** 
- **Upper Limit:** 13.0
- **Value:** 10.3
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 3.90
- **Spread:** 
- **Upper Limit:** 5.45
- **Value:** 4.61
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 1.00
- **Spread:** 
- **Upper Limit:** 2.00
- **Value:** 1.41
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 8.89
- **Spread:** 
- **Upper Limit:** 27.2
- **Value:** 15.5
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 109
- **Group ID:** OG001
- **Value:** 111
- **Group ID:** OG002
- **Value:** 140
- **Group ID:** OG003
- **Value:** 214
- **Group ID:** OG004
- **Value:** 11
- **Group ID:** OG005
- **Value:** 12
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 8.31
- **Spread:** 
- **Upper Limit:** 13.7
- **Value:** 10.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 9.30
- **Spread:** 
- **Upper Limit:** 14.7
- **Value:** 11.7
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 13.2
- **Spread:** 
- **Upper Limit:** 21.0
- **Value:** 16.7
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 9.24
- **Spread:** 
- **Upper Limit:** 13.2
- **Value:** 11.0
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 0.949
- **Spread:** 
- **Upper Limit:** 1.98
- **Value:** 1.37
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 6.28
- **Spread:** 
- **Upper Limit:** 19.2
- **Value:** 11.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 110
- **Group ID:** OG001
- **Value:** 111
- **Group ID:** OG002
- **Value:** 141
- **Group ID:** OG003
- **Value:** 217
- **Group ID:** OG004
- **Value:** 11
- **Group ID:** OG005
- **Value:** 12
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 7.10
- **Spread:** 
- **Upper Limit:** 12.1
- **Value:** 9.28
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 8.83
- **Spread:** 
- **Upper Limit:** 14.7
- **Value:** 11.4
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 13.9
- **Spread:** 
- **Upper Limit:** 23.6
- **Value:** 18.1
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 8.15
- **Spread:** 
- **Upper Limit:** 11.7
- **Value:** 9.77
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 1.07
- **Spread:** 
- **Upper Limit:** 2.73
- **Value:** 1.71
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 0.785
- **Spread:** 
- **Upper Limit:** 1.13
- **Value:** 0.944
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 110
- **Group ID:** OG001
- **Value:** 109
- **Group ID:** OG002
- **Value:** 141
- **Group ID:** OG003
- **Value:** 215
- **Group ID:** OG004
- **Value:** 11
- **Group ID:** OG005
- **Value:** 12
**Units:** Participants
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 113
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 110
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 142
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 198
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 116
- **Group ID:** OG001
- **Value:** 114
- **Group ID:** OG002
- **Value:** 145
- **Group ID:** OG003
- **Value:** 221
- **Group ID:** OG004
- **Value:** 13
- **Group ID:** OG005
- **Value:** 12
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 111
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 110
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 139
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 198
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 9
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 116
- **Group ID:** OG001
- **Value:** 113
- **Group ID:** OG002
- **Value:** 144
- **Group ID:** OG003
- **Value:** 220
- **Group ID:** OG004
- **Value:** 13
- **Group ID:** OG005
- **Value:** 12
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 112
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 108
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 140
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 202
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 9
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 116
- **Group ID:** OG001
- **Value:** 113
- **Group ID:** OG002
- **Value:** 145
- **Group ID:** OG003
- **Value:** 221
- **Group ID:** OG004
- **Value:** 13
- **Group ID:** OG005
- **Value:** 12
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 115
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 109
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 142
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 215
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 116
- **Group ID:** OG001
- **Value:** 112
- **Group ID:** OG002
- **Value:** 144
- **Group ID:** OG003
- **Value:** 220
- **Group ID:** OG004
- **Value:** 13
- **Group ID:** OG005
- **Value:** 12
**Units:** Participants
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 4959
- **Spread:** 
- **Upper Limit:** 8754
- **Value:** 6589
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 4672
- **Spread:** 
- **Upper Limit:** 8264
- **Value:** 6213
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 5514
- **Spread:** 
- **Upper Limit:** 9001
- **Value:** 7045
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 3676
- **Spread:** 
- **Upper Limit:** 6659
- **Value:** 4948
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 14.8
- **Spread:** 
- **Upper Limit:** 76.9
- **Value:** 33.8
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 32.0
- **Spread:** 
- **Upper Limit:** 1708
- **Value:** 234
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 112
- **Group ID:** OG001
- **Value:** 112
- **Group ID:** OG002
- **Value:** 147
- **Group ID:** OG003
- **Value:** 216
- **Group ID:** OG004
- **Value:** 12
- **Group ID:** OG005
- **Value:** 11
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 515
- **Spread:** 
- **Upper Limit:** 798
- **Value:** 641
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 718
- **Spread:** 
- **Upper Limit:** 1181
- **Value:** 921
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 717
- **Spread:** 
- **Upper Limit:** 1091
- **Value:** 884
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 347
- **Spread:** 
- **Upper Limit:** 487
- **Value:** 411
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 35.3
- **Spread:** 
- **Upper Limit:** 83.9
- **Value:** 54.4
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 119
- **Spread:** 
- **Upper Limit:** 298
- **Value:** 188
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 113
- **Group ID:** OG001
- **Value:** 111
- **Group ID:** OG002
- **Value:** 142
- **Group ID:** OG003
- **Value:** 215
- **Group ID:** OG004
- **Value:** 11
- **Group ID:** OG005
- **Value:** 11
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 375
- **Spread:** 
- **Upper Limit:** 667
- **Value:** 500
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 444
- **Spread:** 
- **Upper Limit:** 825
- **Value:** 605
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 484
- **Spread:** 
- **Upper Limit:** 815
- **Value:** 628
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 302
- **Spread:** 
- **Upper Limit:** 472
- **Value:** 378
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 4.54
- **Spread:** 
- **Upper Limit:** 8.07
- **Value:** 6.05
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 39.5
- **Spread:** 
- **Upper Limit:** 84.9
- **Value:** 57.9
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 113
- **Group ID:** OG001
- **Value:** 112
- **Group ID:** OG002
- **Value:** 146
- **Group ID:** OG003
- **Value:** 216
- **Group ID:** OG004
- **Value:** 12
- **Group ID:** OG005
- **Value:** 11
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 893
- **Spread:** 
- **Upper Limit:** 1474
- **Value:** 1147
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 865
- **Spread:** 
- **Upper Limit:** 1552
- **Value:** 1159
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 1015
- **Spread:** 
- **Upper Limit:** 1549
- **Value:** 1254
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 698
- **Spread:** 
- **Upper Limit:** 1026
- **Value:** 846
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 11.1
- **Spread:** 
- **Upper Limit:** 27.8
- **Value:** 17.6
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 9.86
- **Spread:** 
- **Upper Limit:** 30.6
- **Value:** 17.4
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 112
- **Group ID:** OG001
- **Value:** 112
- **Group ID:** OG002
- **Value:** 146
- **Group ID:** OG003
- **Value:** 214
- **Group ID:** OG004
- **Value:** 12
- **Group ID:** OG005
- **Value:** 11
**Units:** Participants
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 7.67
- **Spread:** 
- **Upper Limit:** 16.7
- **Value:** 11.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 12.1
- **Spread:** 
- **Upper Limit:** 29.4
- **Value:** 18.8
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 19.6
- **Spread:** 
- **Upper Limit:** 43.2
- **Value:** 29.1
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 11.0
- **Spread:** 
- **Upper Limit:** 19.0
- **Value:** 14.5
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 0.663
- **Spread:** 
- **Upper Limit:** 8.53
- **Value:** 2.38
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 3.00
- **Spread:** 
- **Upper Limit:** 16.9
- **Value:** 7.12
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 103
- **Group ID:** OG001
- **Value:** 105
- **Group ID:** OG002
- **Value:** 138
- **Group ID:** OG003
- **Value:** 206
- **Group ID:** OG004
- **Value:** 10
- **Group ID:** OG005
- **Value:** 11
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2.98
- **Spread:** 
- **Upper Limit:** 4.34
- **Value:** 3.60
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 4.11
- **Spread:** 
- **Upper Limit:** 6.59
- **Value:** 5.20
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 4.58
- **Spread:** 
- **Upper Limit:** 6.70
- **Value:** 5.54
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 2.34
- **Spread:** 
- **Upper Limit:** 3.04
- **Value:** 2.66
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 0.629
- **Spread:** 
- **Upper Limit:** 1.72
- **Value:** 1.04
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 1.65
- **Spread:** 
- **Upper Limit:** 4.78
- **Value:** 2.81
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 101
- **Group ID:** OG001
- **Value:** 101
- **Group ID:** OG002
- **Value:** 134
- **Group ID:** OG003
- **Value:** 206
- **Group ID:** OG004
- **Value:** 10
- **Group ID:** OG005
- **Value:** 11
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 9.51
- **Spread:** 
- **Upper Limit:** 16.2
- **Value:** 12.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 11.9
- **Spread:** 
- **Upper Limit:** 20.0
- **Value:** 15.4
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 15.1
- **Spread:** 
- **Upper Limit:** 26.3
- **Value:** 19.9
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 10.4
- **Spread:** 
- **Upper Limit:** 15.4
- **Value:** 12.7
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 0.612
- **Spread:** 
- **Upper Limit:** 1.74
- **Value:** 1.03
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 6.73
- **Spread:** 
- **Upper Limit:** 16.3
- **Value:** 10.5
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 102
- **Group ID:** OG001
- **Value:** 105
- **Group ID:** OG002
- **Value:** 137
- **Group ID:** OG003
- **Value:** 205
- **Group ID:** OG004
- **Value:** 10
- **Group ID:** OG005
- **Value:** 11
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 7.50
- **Spread:** 
- **Upper Limit:** 12.7
- **Value:** 9.75
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 9.06
- **Spread:** 
- **Upper Limit:** 14.7
- **Value:** 11.5
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 11.1
- **Spread:** 
- **Upper Limit:** 17.8
- **Value:** 14.1
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 7.18
- **Spread:** 
- **Upper Limit:** 10.0
- **Value:** 8.49
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 0.604
- **Spread:** 
- **Upper Limit:** 2.24
- **Value:** 1.16
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 0.760
- **Spread:** 
- **Upper Limit:** 1.61
- **Value:** 1.10
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 101
- **Group ID:** OG001
- **Value:** 103
- **Group ID:** OG002
- **Value:** 137
- **Group ID:** OG003
- **Value:** 204
- **Group ID:** OG004
- **Value:** 10
- **Group ID:** OG005
- **Value:** 11
**Units:** Participants
#### Outcome Measure 10
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 112
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 112
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 147
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 208
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 13
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 112
- **Group ID:** OG001
- **Value:** 112
- **Group ID:** OG002
- **Value:** 147
- **Group ID:** OG003
- **Value:** 216
- **Group ID:** OG004
- **Value:** 13
- **Group ID:** OG005
- **Value:** 11
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 112
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 112
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 147
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 202
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 12
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 112
- **Group ID:** OG001
- **Value:** 112
- **Group ID:** OG002
- **Value:** 147
- **Group ID:** OG003
- **Value:** 216
- **Group ID:** OG004
- **Value:** 13
- **Group ID:** OG005
- **Value:** 11
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 111
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 111
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 146
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 201
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 112
- **Group ID:** OG001
- **Value:** 112
- **Group ID:** OG002
- **Value:** 147
- **Group ID:** OG003
- **Value:** 216
- **Group ID:** OG004
- **Value:** 13
- **Group ID:** OG005
- **Value:** 11
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 113
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 111
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 142
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 214
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 13
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 113
- **Group ID:** OG001
- **Value:** 111
- **Group ID:** OG002
- **Value:** 142
- **Group ID:** OG003
- **Value:** 215
- **Group ID:** OG004
- **Value:** 13
- **Group ID:** OG005
- **Value:** 11
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 111
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 111
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 141
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 208
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 13
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 113
- **Group ID:** OG001
- **Value:** 111
- **Group ID:** OG002
- **Value:** 142
- **Group ID:** OG003
- **Value:** 215
- **Group ID:** OG004
- **Value:** 13
- **Group ID:** OG005
- **Value:** 11
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 107
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 107
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 138
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 190
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 113
- **Group ID:** OG001
- **Value:** 111
- **Group ID:** OG002
- **Value:** 142
- **Group ID:** OG003
- **Value:** 215
- **Group ID:** OG004
- **Value:** 13
- **Group ID:** OG005
- **Value:** 11
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 110
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 108
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 143
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 201
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 9
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 113
- **Group ID:** OG001
- **Value:** 112
- **Group ID:** OG002
- **Value:** 146
- **Group ID:** OG003
- **Value:** 216
- **Group ID:** OG004
- **Value:** 13
- **Group ID:** OG005
- **Value:** 11
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 108
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 104
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 136
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 195
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 8
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 113
- **Group ID:** OG001
- **Value:** 112
- **Group ID:** OG002
- **Value:** 146
- **Group ID:** OG003
- **Value:** 216
- **Group ID:** OG004
- **Value:** 13
- **Group ID:** OG005
- **Value:** 11
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 99
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 99
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 128
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 181
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 113
- **Group ID:** OG001
- **Value:** 112
- **Group ID:** OG002
- **Value:** 146
- **Group ID:** OG003
- **Value:** 216
- **Group ID:** OG004
- **Value:** 13
- **Group ID:** OG005
- **Value:** 11
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 111
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 112
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 146
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 213
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 13
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 10
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 112
- **Group ID:** OG001
- **Value:** 112
- **Group ID:** OG002
- **Value:** 146
- **Group ID:** OG003
- **Value:** 214
- **Group ID:** OG004
- **Value:** 13
- **Group ID:** OG005
- **Value:** 11
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 111
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 108
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 145
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 208
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 9
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 112
- **Group ID:** OG001
- **Value:** 112
- **Group ID:** OG002
- **Value:** 146
- **Group ID:** OG003
- **Value:** 214
- **Group ID:** OG004
- **Value:** 13
- **Group ID:** OG005
- **Value:** 11
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 110
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 103
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 140
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 201
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 112
- **Group ID:** OG001
- **Value:** 112
- **Group ID:** OG002
- **Value:** 146
- **Group ID:** OG003
- **Value:** 214
- **Group ID:** OG004
- **Value:** 13
- **Group ID:** OG005
- **Value:** 11
**Units:** Participants
#### Outcome Measure 11
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 80
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 83
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 118
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 168
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 10
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 103
- **Group ID:** OG001
- **Value:** 105
- **Group ID:** OG002
- **Value:** 138
- **Group ID:** OG003
- **Value:** 206
- **Group ID:** OG004
- **Value:** 10
- **Group ID:** OG005
- **Value:** 11
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 65
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 70
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 104
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 141
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 9
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 103
- **Group ID:** OG001
- **Value:** 105
- **Group ID:** OG002
- **Value:** 138
- **Group ID:** OG003
- **Value:** 206
- **Group ID:** OG004
- **Value:** 10
- **Group ID:** OG005
- **Value:** 11
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 69
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 77
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 110
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 111
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 101
- **Group ID:** OG001
- **Value:** 101
- **Group ID:** OG002
- **Value:** 134
- **Group ID:** OG003
- **Value:** 206
- **Group ID:** OG004
- **Value:** 10
- **Group ID:** OG005
- **Value:** 11
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 44
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 51
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 72
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 61
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 101
- **Group ID:** OG001
- **Value:** 101
- **Group ID:** OG002
- **Value:** 134
- **Group ID:** OG003
- **Value:** 206
- **Group ID:** OG004
- **Value:** 10
- **Group ID:** OG005
- **Value:** 11
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 95
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 99
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 131
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 185
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 102
- **Group ID:** OG001
- **Value:** 105
- **Group ID:** OG002
- **Value:** 137
- **Group ID:** OG003
- **Value:** 205
- **Group ID:** OG004
- **Value:** 10
- **Group ID:** OG005
- **Value:** 11
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 80
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 88
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 113
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 158
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 10
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 102
- **Group ID:** OG001
- **Value:** 105
- **Group ID:** OG002
- **Value:** 137
- **Group ID:** OG003
- **Value:** 205
- **Group ID:** OG004
- **Value:** 10
- **Group ID:** OG005
- **Value:** 11
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 84
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 95
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 127
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 187
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 101
- **Group ID:** OG001
- **Value:** 103
- **Group ID:** OG002
- **Value:** 137
- **Group ID:** OG003
- **Value:** 204
- **Group ID:** OG004
- **Value:** 10
- **Group ID:** OG005
- **Value:** 11
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 71
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 81
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 109
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 142
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 101
- **Group ID:** OG001
- **Value:** 103
- **Group ID:** OG002
- **Value:** 137
- **Group ID:** OG003
- **Value:** 204
- **Group ID:** OG004
- **Value:** 10
- **Group ID:** OG005
- **Value:** 11
**Units:** Participants
#### Outcome Measure 12
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 81
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 84
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 100
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 116
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 31
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 30
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 40
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 48
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 17
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 15
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 34
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 23
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 21
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 18
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 26
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 22
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 10
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 10
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 13
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 16
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
#### Outcome Measure 13
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 15
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 122
- **Group ID:** OG001
- **Value:** 120
- **Group ID:** OG002
- **Value:** 158
- **Group ID:** OG003
- **Value:** 231
- **Group ID:** OG004
- **Value:** 13
- **Group ID:** OG005
- **Value:** 13
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 29
- **Group ID:** OG001
- **Value:** 30
- **Group ID:** OG002
- **Value:** 54
- **Group ID:** OG003
- **Value:** 74
- **Group ID:** OG004
- **Value:** 13
- **Group ID:** OG005
- **Value:** 13
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 9
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 10
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 20
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 9
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 29
- **Group ID:** OG001
- **Value:** 30
- **Group ID:** OG002
- **Value:** 54
- **Group ID:** OG003
- **Value:** 74
- **Group ID:** OG004
- **Value:** 13
- **Group ID:** OG005
- **Value:** 13
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 14
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 12
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 17
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 29
- **Group ID:** OG001
- **Value:** 30
- **Group ID:** OG002
- **Value:** 54
- **Group ID:** OG003
- **Value:** 74
- **Group ID:** OG004
- **Value:** 13
- **Group ID:** OG005
- **Value:** 13
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 10
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 15
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 20
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 29
- **Group ID:** OG001
- **Value:** 30
- **Group ID:** OG002
- **Value:** 54
- **Group ID:** OG003
- **Value:** 74
- **Group ID:** OG004
- **Value:** 13
- **Group ID:** OG005
- **Value:** 13
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 14
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 13
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 18
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 23
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 12
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 29
- **Group ID:** OG001
- **Value:** 30
- **Group ID:** OG002
- **Value:** 54
- **Group ID:** OG003
- **Value:** 74
- **Group ID:** OG004
- **Value:** 13
- **Group ID:** OG005
- **Value:** 13
**Units:** Participants
#### Outcome Measure 14
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 18
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 18
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 22
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 21
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 16
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 28
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 27
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 32
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 29
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 30
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 32
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 42
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 8
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 8
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. Unsolicited AEs includes both serious (SAEs) and non-serious unsolicited AEs. An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. All participants were observed for 30 minutes after vaccination, and any unsolicited systemic AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Analysis was performed on SafAS population which included participants who had received at least one dose of the study vaccines.
**Reporting Status:** POSTED
**Time Frame:** Within 30 minutes after any vaccination
**Title:** Number of Participants With Immediate Unsolicited Adverse Events (AEs) After Any Vaccination
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants from US (aged 6 months to 17 years) received single injection of 30 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG000
**Title:** Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years)
##### Group
**Description:** Participants from US (aged 6 months to 17 years) received single injection of 45 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG001
**Title:** Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years)
##### Group
**Description:** Participants from US (aged 6 months to 17 years) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG002
**Title:** Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years)
##### Group
**Description:** Pooled arm consisted of participants who were from US aged 6 months to 17 years, randomized to Groups 1, 2 and 3 and received single injection of 15 μg unadjuvanted QIV-SD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG003
**Title:** Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years)
##### Group
**Description:** Participants from Canada (aged 6 to \<24 months) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG004
**Title:** Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months)
##### Group
**Description:** Participants from Canada (aged 6 to \<24 months) received single injection of 7.5 μg adjuvanted TIV, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG005
**Title:** Group 6: Adjuvanted TIV (Canada: 6 to <24 Months)
#### Outcome Measure 2
**Description:** An unsolicited AE was an observed AE that does not fulfill the conditions prelisted in the CRB in terms of diagnosis and/or onset window post-vaccination. Unsolicited AEs included both serious and non-serious unsolicited AEs. An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. Adverse reactions (ARs) were AEs related to vaccination. An injection site reaction was an AR at and around the injection site. Systemic AEs were all AEs that were not injection or administration site reactions.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Analysis was performed on the SafAS population.
**Reporting Status:** POSTED
**Time Frame:** Within 28 days after any vaccination
**Title:** Number of Participants With Unsolicited Adverse Events After Any Vaccination
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants from US (aged 6 months to 17 years) received single injection of 30 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG000
**Title:** Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years)
##### Group
**Description:** Participants from US (aged 6 months to 17 years) received single injection of 45 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG001
**Title:** Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years)
##### Group
**Description:** Participants from US (aged 6 months to 17 years) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG002
**Title:** Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years)
##### Group
**Description:** Pooled arm consisted of participants who were from US aged 6 months to 17 years, randomized to Groups 1, 2 and 3 and received single injection of 15 μg unadjuvanted QIV-SD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG003
**Title:** Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years)
##### Group
**Description:** Participants from Canada (aged 6 to \<24 months) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG004
**Title:** Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months)
##### Group
**Description:** Participants from Canada (aged 6 to \<24 months) received single injection of 7.5 μg adjuvanted TIV, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG005
**Title:** Group 6: Adjuvanted TIV (Canada: 6 to <24 Months)
#### Outcome Measure 3
**Description:** An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. An SAE which caused death of the participant was considered as fatal SAE. Adverse events of special interest (AESIs) were defined as SAEs which included new onset of Guillain-Barré syndrome, encephalitis/myelitis (including transverse myelitis), Bell's palsy, convulsions, optic neuritis, and brachial neuritis.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Analysis was performed on the SafAS population.
**Reporting Status:** POSTED
**Time Frame:** From Day 0 up to 6 months (i.e. 180 days) post last vaccination
**Title:** Number of Participants With Serious Adverse Events (SAEs) After Any Vaccination
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants from US (aged 6 months to 17 years) received single injection of 30 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG000
**Title:** Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years)
##### Group
**Description:** Participants from US (aged 6 months to 17 years) received single injection of 45 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG001
**Title:** Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years)
##### Group
**Description:** Participants from US (aged 6 months to 17 years) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG002
**Title:** Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years)
##### Group
**Description:** Pooled arm consisted of participants who were from US aged 6 months to 17 years, randomized to Groups 1, 2 and 3 and received single injection of 15 μg unadjuvanted QIV-SD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG003
**Title:** Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years)
##### Group
**Description:** Participants from Canada (aged 6 to \<24 months) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG004
**Title:** Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months)
##### Group
**Description:** Participants from Canada (aged 6 to \<24 months) received single injection of 7.5 μg adjuvanted TIV, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG005
**Title:** Group 6: Adjuvanted TIV (Canada: 6 to <24 Months)
#### Outcome Measure 4
**Description:** Anti-influenza antibodies were measured by hemagglutination inhibition (HAI) assay for strains A/H1N1, A/H3N2, B/Victoria and B/Yamagata lineage. Seroconversion: defined as either HAI titer \<10(1/dilution) at Day 0 and post-vaccination titer greater than or equal to (\>=)40(1/dilution) at Day 28, or HAI titer \>=10(1/dilution) at Day 0 and \>=4-fold increase in HAI titer (1/dilution) at Day 28. Data for this Outcome Measure (OM) was planned to be collected and reported for dose level (QIV-HD 30μg and 45μg) matched separate groups for QIV-SD (Groups 4a, 4b and 4c), instead of pooled QIV-SD arm. Due to complex study design and analysis of doses and age groups, QIV-SD group participants, who matched to participants in QIV-HD 30μg and 45μg dose formulations groups (who were 9 through 17 years old and shared matching age group with QIV-SD control group), included in Groups 4a, 4b and 4c in this OM might be counted in more than once in QIV-SD arms for different dose levels, as applicable.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Analysis was performed on immunogenicity analysis set (IAS) population which included randomized participants who received 1 dose or 2 doses of study vaccine and had a post-vaccination blood sample. Here, 'number analyzed' = number of participants with available data for each specified category.
**Reporting Status:** POSTED
**Time Frame:** Day 28 post any vaccination
**Title:** Number of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants from US (aged 6 months to 17 years) received single injection of 30 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG000
**Title:** Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years)
##### Group
**Description:** Participants from US (aged 6 months to 17 years) received single injection of 45 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG001
**Title:** Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years)
##### Group
**Description:** Participants from US (aged 6 months to 17 years) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG002
**Title:** Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years)
##### Group
**Description:** Participants from US (aged 6 months to 17 years) received 15 μg QIV-SD, IM and were restricted for comparison to relevant experimental study group QIV-HD 30 μg.
**ID:** OG003
**Title:** Group 4a: QIV-SD, 15 μg, (US: 6 Months to 17 Years)
##### Group
**Description:** Participants from US (aged 6 months to 17 years) received 15 μg QIV-SD, IM and were restricted for comparison to relevant experimental study group QIV-HD 45 μg.
**ID:** OG004
**Title:** Group 4b: QIV-SD, 15 μg, (US: 6 Months to 17 Years)
##### Group
**Description:** Participants from US (aged 6 months to 17 years) received 15 μg QIV-SD, IM and were restricted for comparison to relevant experimental study group QIV-HD 60 μg.
**ID:** OG005
**Title:** Group 4c: QIV-SD, 15 μg, (US: 6 Months to 17 Years)
##### Group
**Description:** Participants from Canada (aged 6 to \<24 months) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG006
**Title:** Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months)
##### Group
**Description:** Participants from Canada (aged 6 to \<24 months) received single injection of 7.5 μg adjuvanted TIV, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG007
**Title:** Group 6: Adjuvanted TIV (Canada: 6 to <24 Months)
#### Outcome Measure 5
**Description:** GMTs of anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage. Data for this OM was planned to be collected and reported for dose level (QIV-HD 30 μg and QIV-HD 45 μg) matched separate groups for QIV-SD (Groups 4a, 4b and 4c), instead of pooled QIV-SD arm. Due to the complex study design and analysis of the dose formulation and age groups in the study, QIV-SD group participants, who matched to participants in the QIV-HD 30 μg and QIV-HD 45 μg dose formulations groups (who were 9 through 17 years old and shared a matching age group with QIV-SD control group), included in Groups 4a, 4b and 4c in this OM might be counted in more than once in QIV-SD arms for different dose levels, as applicable.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** GEOMETRIC_MEAN
**Population Description:** Analysis was performed on IAS population. Here, 'number analyzed' = number of participants with available data for each specified category.
**Reporting Status:** POSTED
**Time Frame:** Day 28 post any vaccination
**Title:** Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine
**Type:** PRIMARY
**Unit of Measure:** titers (1/dilution)
##### Group
**Description:** Participants from US (aged 6 months to 17 years) received single injection of 30 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG000
**Title:** Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years)
##### Group
**Description:** Participants from US (aged 6 months to 17 years) received single injection of 45 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG001
**Title:** Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years)
##### Group
**Description:** Participants from US (aged 6 months to 17 years) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG002
**Title:** Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years)
##### Group
**Description:** Participants from US (aged 6 months to 17 years) received 15 μg QIV-SD, IM and were restricted for comparison to relevant experimental study group QIV-HD 30 μg.
**ID:** OG003
**Title:** Group 4a: QIV-SD, 15 μg, (US: 6 Months to 17 Years)
##### Group
**Description:** Participants from US (aged 6 months to 17 years) received 15 μg QIV-SD, IM and were restricted for comparison to relevant experimental study group QIV-HD 45 μg.
**ID:** OG004
**Title:** Group 4b: QIV-SD, 15 μg, (US: 6 Months to 17 Years)
##### Group
**Description:** Participants from US (aged 6 months to 17 years) received 15 μg QIV-SD, IM and were restricted for comparison to relevant experimental study group QIV-HD 60 μg.
**ID:** OG005
**Title:** Group 4c: QIV-SD, 15 μg, (US: 6 Months to 17 Years)
##### Group
**Description:** Participants from Canada (aged 6 to \<24 months) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG006
**Title:** Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months)
##### Group
**Description:** Participants from Canada (aged 6 to \<24 months) received single injection of 7.5 μg adjuvanted TIV, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG007
**Title:** Group 6: Adjuvanted TIV (Canada: 6 to <24 Months)
#### Outcome Measure 6
**Description:** GMTs of anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage. GMTRs were calculated as the ratio of GMTs post-vaccination and pre-vaccination.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** GEOMETRIC_MEAN
**Population Description:** Analysis was performed on IAS population. Here, 'number analyzed' = number of participants with available data for each specified category.
**Reporting Status:** POSTED
**Time Frame:** Day 0 (pre-vaccination), Day 28 (post any vaccination)
**Title:** Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine
**Type:** PRIMARY
**Unit of Measure:** ratio
##### Group
**Description:** Participants from US (aged 6 months to 17 years) received single injection of 30 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG000
**Title:** Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years)
##### Group
**Description:** Participants from US (aged 6 months to 17 years) received single injection of 45 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG001
**Title:** Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years)
##### Group
**Description:** Participants from US (aged 6 months to 17 years) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG002
**Title:** Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years)
##### Group
**Description:** Pooled arm consisted of participants who were from US aged 6 months to 17 years, randomized to Groups 1, 2 and 3 and received single injection of 15 μg unadjuvanted QIV-SD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG003
**Title:** Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years)
##### Group
**Description:** Participants from Canada (aged 6 to \<24 months) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG004
**Title:** Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months)
##### Group
**Description:** Participants from Canada (aged 6 to \<24 months) received single injection of 7.5 μg adjuvanted TIV, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG005
**Title:** Group 6: Adjuvanted TIV (Canada: 6 to <24 Months)
#### Outcome Measure 7
**Description:** GMT was measured for each influenza strain using HAI assay method for 4 strains: A/H1N1, A/H3N2, B/Victoria lineage, and B/Yamagata lineage.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Analysis was performed on the IAS population. Here, 'number analyzed' = number of participants with available data for each specified category.
**Reporting Status:** POSTED
**Time Frame:** Day 28 post any vaccination
**Title:** Number of Participants With Neutralization Antibody Titers >= 40 (1/Dilution) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants from US (aged 6 months to 17 years) received single injection of 30 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG000
**Title:** Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years)
##### Group
**Description:** Participants from US (aged 6 months to 17 years) received single injection of 45 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG001
**Title:** Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years)
##### Group
**Description:** Participants from US (aged 6 months to 17 years) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG002
**Title:** Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years)
##### Group
**Description:** Pooled arm consisted of participants who were from US aged 6 months to 17 years, randomized to Groups 1, 2 and 3 and received single injection of 15 μg unadjuvanted QIV-SD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG003
**Title:** Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years)
##### Group
**Description:** Participants from Canada (aged 6 to \<24 months) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG004
**Title:** Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months)
##### Group
**Description:** Participants from Canada (aged 6 to \<24 months) received single injection of 7.5 μg adjuvanted TIV, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG005
**Title:** Group 6: Adjuvanted TIV (Canada: 6 to <24 Months)
#### Outcome Measure 8
**Description:** GMT was measured for each influenza strain using SN assay method for 4 strains: A/H1N1, A/H3N2, B/Victoria lineage, and B/Yamagata lineage.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** GEOMETRIC_MEAN
**Population Description:** Analysis was performed on the IAS population. Here, 'number analyzed' = number of participants with available data for each specified category.
**Reporting Status:** POSTED
**Time Frame:** Day 28 post any vaccination
**Title:** Geometric Mean Titers of Influenza Antibodies (Measured by Seroneutralization [SN] Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine
**Type:** PRIMARY
**Unit of Measure:** titers (1/dilution)
##### Group
**Description:** Participants from US (aged 6 months to 17 years) received single injection of 30 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG000
**Title:** Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years)
##### Group
**Description:** Participants from US (aged 6 months to 17 years) received single injection of 45 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG001
**Title:** Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years)
##### Group
**Description:** Participants from US (aged 6 months to 17 years) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG002
**Title:** Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years)
##### Group
**Description:** Pooled arm consisted of participants who were from US aged 6 months to 17 years, randomized to Groups 1, 2 and 3 and received single injection of 15 μg unadjuvanted QIV-SD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG003
**Title:** Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years)
##### Group
**Description:** Participants from Canada (aged 6 to \<24 months) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG004
**Title:** Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months)
##### Group
**Description:** Participants from Canada (aged 6 to \<24 months) received single injection of 7.5 μg adjuvanted TIV, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG005
**Title:** Group 6: Adjuvanted TIV (Canada: 6 to <24 Months)
#### Outcome Measure 9
**Description:** GMTRs of anti-influenza antibodies were measured using SN assay method for 4 strains: A/H1N1, A/H3N2, B/Victoria lineage and B/Yamagata lineage. GMTRs were calculated as the ratio of GMTs post vaccination and pre-vaccination.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** GEOMETRIC_MEAN
**Population Description:** Analysis was performed on IAS population. Here, 'number analyzed' = number of participants with available data for each specified category.
**Reporting Status:** POSTED
**Time Frame:** Day 0 (pre-vaccination), Day 28 (post any vaccination)
**Title:** Geometric Mean Titers Ratio of Influenza Antibodies (Measured by Seroneutralization Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine
**Type:** PRIMARY
**Unit of Measure:** ratio
##### Group
**Description:** Participants from US (aged 6 months to 17 years) received single injection of 30 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG000
**Title:** Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years)
##### Group
**Description:** Participants from US (aged 6 months to 17 years) received single injection of 45 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG001
**Title:** Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years)
##### Group
**Description:** Participants from US (aged 6 months to 17 years) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG002
**Title:** Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years)
##### Group
**Description:** Pooled arm consisted of participants who were from US aged 6 months to 17 years, randomized to Groups 1, 2 and 3 and received single injection of 15 μg unadjuvanted QIV-SD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG003
**Title:** Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years)
##### Group
**Description:** Participants from Canada (aged 6 to \<24 months) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG004
**Title:** Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months)
##### Group
**Description:** Participants from Canada (aged 6 to \<24 months) received single injection of 7.5 μg adjuvanted TIV, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG005
**Title:** Group 6: Adjuvanted TIV (Canada: 6 to <24 Months)
#### Outcome Measure 10
**Description:** Neutralizing Antibody titer was measured for each influenza strain with SN assay method for 4 strains: A/H1N1, A/H3N2, B/Victoria lineage, and B/Yamagata lineage at pre-defined thresholds of \>=20, \>=40 and \>=80 (1/dilution).
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Analysis was performed on the IAS population. Here, 'number analyzed' = number of participants with available data for each specified category.
**Reporting Status:** POSTED
**Time Frame:** Day 28 post any vaccination
**Title:** Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants from US (aged 6 months to 17 years) received single injection of 30 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG000
**Title:** Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years)
##### Group
**Description:** Participants from US (aged 6 months to 17 years) received single injection of 45 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG001
**Title:** Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years)
##### Group
**Description:** Participants from US (aged 6 months to 17 years) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG002
**Title:** Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years)
##### Group
**Description:** Pooled arm consisted of participants who were from US aged 6 months to 17 years, randomized to Groups 1, 2 and 3 and received single injection of 15 μg unadjuvanted QIV-SD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG003
**Title:** Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years)
##### Group
**Description:** Participants from Canada (aged 6 to \<24 months) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG004
**Title:** Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months)
##### Group
**Description:** Participants from Canada (aged 6 to \<24 months) received single injection of 7.5 μg adjuvanted TIV, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG005
**Title:** Group 6: Adjuvanted TIV (Canada: 6 to <24 Months)
#### Outcome Measure 11
**Description:** Neutralizing Antibody titer was measured for each influenza strain with SN method for 4 strains: A/H1N1, A/H3N2, B/Victoria lineage, and B/Yamagata lineage. 2-fold and 4-fold rise was defined as the computed value = post-vaccination computed value / pre-vaccination computed value.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Analysis was performed on the IAS population. Here, 'number analyzed' = number of participants with available data for each specified category.
**Reporting Status:** POSTED
**Time Frame:** Day 28 post any vaccination
**Title:** Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants from US (aged 6 months to 17 years) received single injection of 30 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG000
**Title:** Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years)
##### Group
**Description:** Participants from US (aged 6 months to 17 years) received single injection of 45 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG001
**Title:** Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years)
##### Group
**Description:** Participants from US (aged 6 months to 17 years) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG002
**Title:** Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years)
##### Group
**Description:** Pooled arm consisted of participants who were from US aged 6 months to 17 years, randomized to Groups 1, 2 and 3 and received single injection of 15 μg unadjuvanted QIV-SD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG003
**Title:** Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years)
##### Group
**Description:** Participants from Canada (aged 6 to \<24 months) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG004
**Title:** Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months)
##### Group
**Description:** Participants from Canada (aged 6 to \<24 months) received single injection of 7.5 μg adjuvanted TIV, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG005
**Title:** Group 6: Adjuvanted TIV (Canada: 6 to <24 Months)
#### Outcome Measure 12
**Description:** A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRB and considered as related to the administered vaccination. Solicited injection site reactions included tenderness/pain, erythema, swelling, induration and bruising.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Analysis was performed on the SafAS population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
**Reporting Status:** POSTED
**Time Frame:** Within 7 days after any vaccination
**Title:** Number of Participants With Solicited Injection Site Reactions
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants from US (aged 6 months to 17 years) received single injection of 30 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG000
**Title:** Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years)
##### Group
**Description:** Participants from US (aged 6 months to 17 years) received single injection of 45 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG001
**Title:** Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years)
##### Group
**Description:** Participants from US (aged 6 months to 17 years) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG002
**Title:** Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years)
##### Group
**Description:** Pooled arm consisted of participants who were from US aged 6 months to 17 years, randomized to Groups 1, 2 and 3 and received single injection of 15 μg unadjuvanted QIV-SD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG003
**Title:** Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years)
##### Group
**Description:** Participants from Canada (aged 6 to \<24 months) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG004
**Title:** Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months)
##### Group
**Description:** Participants from Canada (aged 6 to \<24 months) received single injection of 7.5 μg adjuvanted TIV, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG005
**Title:** Group 6: Adjuvanted TIV (Canada: 6 to <24 Months)
#### Outcome Measure 13
**Description:** A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRB and considered as related to the administered vaccination. Solicited systemic reactions included fever, vomiting, crying abnormal, drowsiness, appetite loss and irritability. Fever was planned to be evaluated for the whole population where as, the other events (vomiting, crying abnormal, drowsiness, appetite lost, and irritability) were planned to be evaluated only in the participants aged 6 months to \<36 months.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Analysis was performed on the SafAS population. Here, 'number analyzed' = number of participants with available data for each specified category.
**Reporting Status:** POSTED
**Time Frame:** Within 7 days after any vaccination
**Title:** Number of Participants With Solicited Systemic Reactions After Any Vaccination
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants from US (aged 6 months to 17 years) received single injection of 30 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG000
**Title:** Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years)
##### Group
**Description:** Participants from US (aged 6 months to 17 years) received single injection of 45 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG001
**Title:** Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years)
##### Group
**Description:** Participants from US (aged 6 months to 17 years) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG002
**Title:** Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years)
##### Group
**Description:** Pooled arm consisted of participants who were from US aged 6 months to 17 years, randomized to Groups 1, 2 and 3 and received single injection of 15 μg unadjuvanted QIV-SD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG003
**Title:** Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years)
##### Group
**Description:** Participants from Canada (aged 6 to \<24 months) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG004
**Title:** Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months)
##### Group
**Description:** Participants from Canada (aged 6 to \<24 months) received single injection of 7.5 μg adjuvanted TIV, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG005
**Title:** Group 6: Adjuvanted TIV (Canada: 6 to <24 Months)
#### Outcome Measure 14
**Description:** A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRB and considered as related to the administered vaccination. Solicited systemic reactions included: headache, malaise, myalgia and shivering.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Analysis was performed on the SafAS population. Here, "overall number of participants analyzed"= participants evaluable for this outcome measure. Data not collected and reported for Groups 5 and 6 because none of the participants in both groups lies in the age group of \>36 months.
**Reporting Status:** POSTED
**Time Frame:** Within 7 days after any vaccination
**Title:** Number of Participants With Solicited Systemic Reactions After Any Vaccination: Participants Aged >36 Months
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants from US (aged 6 months to 17 years) received single injection of 30 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG000
**Title:** Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years)
##### Group
**Description:** Participants from US (aged 6 months to 17 years) received single injection of 45 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG001
**Title:** Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years)
##### Group
**Description:** Participants from US (aged 6 months to 17 years) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG002
**Title:** Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years)
##### Group
**Description:** Pooled arm consisted of participants who were from US aged 6 months to 17 years, randomized to Groups 1, 2 and 3 and received single injection of 15 μg unadjuvanted QIV-SD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** OG003
**Title:** Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years)
### Participant Flow Module
#### Group
**Description:** Participants from US (aged 6 months to 17 years) received single injection of 30 microgram (μg) high-dose quadrivalent influenza vaccine (QIV-HD), intramuscularly (IM) at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** FG000
**Title:** Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years)
#### Group
**Description:** Participants from US (aged 6 months to 17 years) received single injection of 45 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** FG001
**Title:** Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years)
#### Group
**Description:** Participants from US (aged 6 months to 17 years) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** FG002
**Title:** Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years)
#### Group
**Description:** Pooled arm consisted of participants who were from US aged 6 months to 17 years, randomized to Groups 1, 2 and 3 and received single injection of 15 μg unadjuvanted standard-dose quadrivalent influenza vaccine (QIV-SD), IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** FG003
**Title:** Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years)
#### Group
**Description:** Participants from Canada (aged 6 to less than \[\<\] 24 months) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** FG004
**Title:** Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months)
#### Group
**Description:** Participants from Canada (aged 6 to \<24 months) received single injection of 7.5 μg adjuvanted trivalent influenza vaccine (TIV), IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
**ID:** FG005
**Title:** Group 6: Adjuvanted TIV (Canada: 6 to <24 Months)
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Withdrawal by parent/guardian
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
###### Reason
**Group ID:** FG002
**Number of Subjects:** 1
###### Reason
**Group ID:** FG003
**Number of Subjects:** 1
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
###### Reason
**Group ID:** FG005
**Number of Subjects:** 0
##### Withdraw
**Type:** Protocol deviation
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 1
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
###### Reason
**Group ID:** FG005
**Number of Subjects:** 0
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 1
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
###### Reason
**Group ID:** FG005
**Number of Subjects:** 0
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 3
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
###### Reason
**Group ID:** FG002
**Number of Subjects:** 4
###### Reason
**Group ID:** FG003
**Number of Subjects:** 5
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
###### Reason
**Group ID:** FG005
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 124
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 122
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 159
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 234
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 13
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 13
##### Milestone
**Type:** Safety Analysis Set Population (SafAS)
**Comment:** SafAS: Included participants who had received at least one dose of the study vaccines.
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 122
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 121
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 158
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 234
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 13
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 13
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 119
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 120
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 152
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 228
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 13
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 13
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 5
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 2
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 7
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 6
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 0
**Pre-Assignment Details:** A total of 665 participants were enrolled in the study.
**Recruitment Details:** The study was conducted at 16 centers in United States (US) and Canada from 09 October 2018 to 16 October 2019.
**Has Results:** True