## Protocol Section
### Identification Module
**NCT ID:** NCT02255279

**Brief Title:** Safety and Immunogenicity of an Adjuvanted Trivalent Influenza Vaccine in Children 6 to <72 Months of Age in Mexico.

**Official Title:** A Phase 3, Observed-Blind, Randomized, Multi-center Study to Evaluate Safety and Immunogenicity of an Adjuvanted Trivalent Influenza Vaccine in Children 6 to <72 Months of Age in Mexico.

#### Organization Study ID Info
**ID:** V70_50
#### Organization
**Class:** INDUSTRY
**Full Name:** Novartis
### Status Module
#### Completion Date
**Date:** 2015-05

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-01-27

**Type:** ESTIMATED

**Last Update Submit Date:** 2016-11-30

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2015-05

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2016-02-03

**Type:** ESTIMATED

**Results First Submit Date:** 2016-01-04

**Results First Submit QC Date:** 2016-01-04

#### Start Date
**Date:** 2014-10

**Status Verified Date:** 2016-01

#### Study First Post Date
**Date:** 2014-10-02
**Type:** ESTIMATED
**Study First Submit Date:** 2014-09-30
**Study First Submit QC Date:** 2014-09-30
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Novartis Vaccines

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The administration of adjuvanted Trivalent Influenza Vaccine (aTIV) has come to result in a more immunogenic and effective response compared with conventional influenza vaccines in elderly and adults.

The aim of this study is to evaluate safety and immunogenicity of Novartis aTIV in children 6 to \<72 months of age, Mexican population, in comparison to Fluzone, a non-adjuvanted trivalent influenza vaccine (TIV).

### Conditions Module

**Conditions:**

- Influenza

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 287

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** aTIV is a trivalent influenza virus vaccine, adjuvanted with MF59C.

**Intervention Names:**

- Biological: Adjuvanted Trivalent Influenza Vaccine, 1 dose for non-naive subjects (day 1), two doses for naive subjects (day 1 and day 29)

**Label:** aTIV

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** TIV is trivalent influenza vaccine licensed in Mexico.

**Intervention Names:**

- Biological: Non-adjuvanted Trivalent Influenza Vaccine, 1 dose for non-naive subjects (day 1), two doses for naive subjects (day 1 and day 29).

**Label:** TIV

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- aTIV

**Description:** A 0.25 mL (for children 6 to \<36 months old) and 0.5 mL (for children ≥36 months to \< 72 months old) dose of aTIV, a trivalent (surface antigen, formaldehyde-inactivated) influenza virus vaccine, adjuvanted with MF59C.1, administered at day 1 (for all subjects) and day 29 (for naïve subjects).

**Name:** Adjuvanted Trivalent Influenza Vaccine, 1 dose for non-naive subjects (day 1), two doses for naive subjects (day 1 and day 29)

**Type:** BIOLOGICAL

#### Intervention 2

**Arm Group Labels:**

- TIV

**Description:** A 0.25 mL (for children 6 to \<36 months old) and 0.5 mL (for children ≥36 months to \< 72 months old) dose of TIV , an egg-derived trivalent split influenza vaccine licensed in Mexico, administered at day 1 (for all subjects) and day 29 (for naïve subjects)

**Name:** Non-adjuvanted Trivalent Influenza Vaccine, 1 dose for non-naive subjects (day 1), two doses for naive subjects (day 1 and day 29).

**Type:** BIOLOGICAL

### Outcomes Module

#### Primary Outcomes

**Description:** Number of naive subjects 6 to \< 36 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after first vaccination and from Day 29 to Day 35 after second vaccination.

**Measure:** Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination.

**Time Frame:** From Day 1 to Day 7 by vaccination

**Description:** Number of non-naive subjects 6 to \< 36 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after vaccination.

**Measure:** Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination.

**Time Frame:** From Day 1 to Day 7

**Description:** Number of naive subjects ≥ 36 months to \< 72 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after first vaccination and from Day 29 to Day 35 after second vaccination.

**Measure:** Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination.

**Time Frame:** From Day 1 to Day 7 by vaccination

**Description:** Number of non-naive subjects ≥36 months to \< 72 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after vaccination.

**Measure:** Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination.

**Time Frame:** From Day 1 to Day 7

**Description:** Number of naive subjects aged 6 to \< 72 months reporting all unsolicited AEs, medically attended AEs, AE leading to study withdrawal and serious AEs (SAEs) from Day 1 to Day 50.

**Measure:** Number of Naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 50.

**Time Frame:** From Day 1 to Day 50

**Description:** Number of non-naive subjects aged 6 to \< 72 months reporting all unsolicited AEs, medically attended AEs, AE leading to study withdrawal and SAEs from Day 1 to Day 22.

**Measure:** Number of Non-naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 22

**Time Frame:** From Day 1 to Day 22

**Description:** Antibody response was assessed in terms of GMTs in all three homologous virus strains, 21 days after last immunization, in subjects 6 to \<72 months of age.

The study is considered a success if the 21 days after last immunization GMT ratios of aTIV relative to TIV demonstrate as non-inferior with the lower limit (LL) of the two sided 95% confidence interval (CI) above 0.67 (-0.176 on log10 scale) for each vaccine strain (Center for Biologics Evaluation and Research {CBER} Guideline on Seasonal Vaccines May 2007).

**Measure:** Geometric Mean Titers (GMTs), in All Three Homologous Virus Strains in Subjects 6 to < 72 Months of Age.

**Time Frame:** Day 1 and Day 22 (vaccine non-naïve subjects) or Day 50 (vaccine naïve subjects) post vaccination

#### Secondary Outcomes

**Description:** Percentages of subjects with seroconversion in all three homologous virus strains, 21 days after last immunization, in subjects 6 to \<72 months of age, defined as: HI ≥ 40 subject with a pre-vaccination HI titer \<10; a minimum 4-fold increase HI titer for subjects with a prevaccination HI titer ≥10, on Day 22 (non-naive subjects) or Day 50 (naive subjects), as applicable.

**Measure:** Percentages of Subjects Achieving Seroconversion in Hemagglutination Inhibition (HI) Titers and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects.

**Time Frame:** Day 1 and Day 22 (vaccine non-naive subjects) or Day 50 (vaccine naive subjects) post vaccination

**Description:** GMRs of HI, day 22/day 1 (non-naive subjects) or day 50/day 1 (naive subjects) in all three homologous virus strains, 21 days after last immunization, in subjects 6 to \<72 months of age. As the non-inferiority of aTIV to TIV has been established, GMT ratio of aTIV relative to TIV in all three homologous virus strains, 21 days after last immunization in subjects 6 to \<72 months of age was evaluated using margins greater than the non-inferiority cut-off of 0.67.

**Measure:** Geometric Mean Ratios (GMRs) of HI and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects.

**Time Frame:** Day 1 and Day 22 (vaccine non-naive subjects) or Day 50 (vaccine naive subjects) post vaccination

**Description:** Percentage of subjects with a HI titer ≥ 40, ≥110 and ≥330 on Day 1, Day 22 (non naïve subjects) or Day 50 (naïve subjects), in all three homologous virus strains, 21 days after last immunization, in subjects 6 to \<72 months of age.

**Measure:** Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects.

**Time Frame:** Day 1 and Day 22 (vaccine non-naive subjects) or Day 50 (vaccine naive subjects) post vaccination

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Individuals of \>6 months through \<72 months of age on the day of informed consent.
* Individuals whose parent(s)/legal guardian(s) have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
* Individuals who can comply with study procedures.
* Willingness to allow for serum samples to be stored beyond the study period, for potential additional future testing to better characterize immune response.

Exclusion Criteria:

* Progressive, unstable or uncontrolled clinical conditions.
* Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study.
* History of progressive or severe neurologic disorder, seizure disorder or Guillain-Barré syndrome.
* Surgery planned during the study period that in the Investigator's opinion would interfere with the study visits schedule.
* Known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
* Any fatal prognosis of an underlying medical condition (\<12 month life expectancy).
* Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
* Abnormal function of the immune system resulting from:

  1. Clinical conditions.
  2. Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days within 90 days prior to informed consent.
  3. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent.
* Received immunoglobulins or any blood products within 180 days prior to informed consent.
* Received an investigational or non-registered medicinal product within 30 days prior to informed consent.
* Study personnel as an immediate family or household member.
* Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study.
* Received any influenza vaccine (licensed or investigational) or with laboratory confirmed influenza within 6 months prior enrollment.
* Received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrolment in this study or who are planning to receive any vaccine within 28 days from the study vaccines.

**Healthy Volunteers:** True

**Maximum Age:** 71 Months

**Minimum Age:** 6 Months

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Colonia Chamilpa, Cuernavaca

**Country:** Mexico

**Facility:** 03, Centro Médico Universitario

**State:** Morelos

**Location 2:**

**City:** Mérida

**Country:** Mexico

**Facility:** 02, Unidad de Atencion Medica E Investigacion En Salud S.C (Unamis)

**State:** Yucatán

**Location 3:**

**City:** Mérida

**Country:** Mexico

**Facility:** 04, Medical Care and Research S.A. de C.V.

**State:** Yucatán

### References Module

#### References

**Citation:** Cruz-Valdez A, Valdez-Zapata G, Patel SS, Castelli FV, Garcia MG, Jansen WT, Arora AK, Heijnen E. MF59-adjuvanted influenza vaccine (FLUAD(R)) elicits higher immune responses than a non-adjuvanted influenza vaccine (Fluzone(R)): A randomized, multicenter, Phase III pediatric trial in Mexico. Hum Vaccin Immunother. 2018 Feb 1;14(2):386-395. doi: 10.1080/21645515.2017.1373227. Epub 2018 Jan 3.

**PMID:** 28925801

## 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: Infe

- Name: Anti-Infective Agents

### Intervention Browse Module - Browse Leaves

- ID: M17360

- Name: Vaccines

- Relevance: HIGH

- As Found: Other

- ID: M8681

- Name: Formaldehyde

- Relevance: LOW

- As Found: Unknown

- ID: M35911

- Name: MF59 oil emulsion

- 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:** Solicited AEs were collected by the subject parent(s)/legal guardian(s) for 7 days from the day of vaccination/s (Day 1 \& Day 29 for naive; Day 1 for non-naive). Unsolicited AEs were collected from Day 1 to Day 50 for naive, from Day 1 to Day 22 for non-naive.

All AEs were monitored until resolution or the investigator assesses them as stable.

#### Event Groups

**Group ID:** EG000

**Title:** Naive_aTIV (6 Months to < 72 Months)

**Description:** A 0.25 mL (for children 6 to \<36 months old) and 0.5 mL (for children ≥36 months to \< 72 months old) dose of aTIV to be administered (Naive).

**ID:** EG000

**Other Num Affected:** 58

**Other Num at Risk:** 77

**Serious Number At Risk:** 77

**Title:** Naive_aTIV (6 Months to < 72 Months)

**Group ID:** EG001

**Title:** Naive_TIV (6 Months to < 72 Months)

**Description:** A 0.25 mL (for children 6 to \<36 months old) and 0.5 mL (for children ≥36 months to \< 72 months old) dose of TIV to be administered (Naive).

Enrolled subjects- 79 Exposed subjects- 78 Reason for discrepancy- Before vaccination one subject was withdrawn from study because of the suspected egg allergy.

**ID:** EG001

**Other Num Affected:** 52

**Other Num at Risk:** 78

**Serious Number At Risk:** 78

**Title:** Naive_TIV (6 Months to < 72 Months)

**Group ID:** EG002

**Title:** Non-naive_aTIV (6 Months to < 72 Months)

**Description:** A 0.25 mL (for children 6 to \<36 months old) and 0.5 mL (for children ≥36 months to \< 72 months old) dose of aTIV to be administered (Non-naive).

**ID:** EG002

**Other Num Affected:** 35

**Other Num at Risk:** 67

**Serious Number At Risk:** 67

**Title:** Non-naive_aTIV (6 Months to < 72 Months)

**Group ID:** EG003

**Title:** Non-naive_TIV (6 Months to < 72 Months)

**Description:** A 0.25 mL (for children 6 to \<36 months old) and 0.5 mL (for children ≥36 months to \< 72 months old) dose of TIV to be administered (Non-naive).

**ID:** EG003

**Other Num Affected:** 31

**Other Num at Risk:** 64

**Serious Number At Risk:** 64

**Title:** Non-naive_TIV (6 Months to < 72 Months)

**Frequency Threshold:** 5

#### Other Events

**Term:** Diarrhoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Vomiting

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Crying

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Fatigue

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Injection site erythema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Injection site induration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Injection site pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Injection site swelling

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Pyrexia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Conjunctivitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (19.0)

**Term:** Gastroenteritis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (19.0)

**Term:** Nasopharyngitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (19.0)

**Term:** Pharyngitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (19.0)

**Term:** Myalgia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (19.0)

**Term:** Somnolence

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Eating disorder

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Irritability

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Cough

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (19.0)

**Term:** Rhinorrhoea

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (19.0)

**Term:** Arthralgia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (19.0)

**Time Frame:** Throughout the study; Day 1 - Day 50 (naive subjects) and Day 1 - Day 22 (non-naive subjects).

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 144

**Group ID:** BG001

**Value:** 143

**Group ID:** BG002

**Value:** 287

**Units:** Participants

### Group

**ID:** BG000

**Title:** aTIV (6 Months to < 72 Months)

**Description:** A 0.25 mL (for children 6 to \<36 months old) and 0.5 mL (for children ≥36 months to \< 72 months old) dose of aTIV to be administered.

### Group

**ID:** BG001

**Title:** TIV (6 Months to < 72 Months)

**Description:** A 0.25 mL (for children 6 to \<36 months old) and 0.5 mL (for children ≥36 months to \< 72 months old) dose of TIV to be administered.

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 18.2

**Value:** 29.5

#### Measurement

**Group ID:** BG001

**Spread:** 19.1

**Value:** 30.1

#### Measurement

**Group ID:** BG002

**Spread:** 18.6

**Value:** 29.8

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 68

#### Measurement

**Group ID:** BG001

**Value:** 72

#### Measurement

**Group ID:** BG002

**Value:** 140

**Category Title:** FEMALE

#### Measurement

**Group ID:** BG000

**Value:** 76

#### Measurement

**Group ID:** BG001

**Value:** 71

#### Measurement

**Group ID:** BG002

**Value:** 147

**Category Title:** MALE

**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:** Months
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Gender
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
**Other Details:** The terms and conditions of Novartis' agreement with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publications of the pooled data (i.e., data from all sites) in the clinical trial.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Point of Contact
**Email:** RegistryContactVaccinesUS@novartis.com
**Organization:** Novartis Vaccines
**Title:** Posting Director
## 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
#### Analysis
**CI Lower Limit:** 3.00
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 5.51
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Geometric mean titers (GMTs), in H1N1 strain of all the tree strains in Subjects 6 to \< 72 months of Age.
**Non-Inferiority Comment:** Hypothesis: Demonstrate non-inferiority (NI) of aTIV to TIV:

H0 : μAi - μBi ≤ -0.176 (Null) H1 : μAi - μBi \>-0.176 (alternative) (i= H1N1, H3N2, B) μA and μB are means of log10-transformed titers 21 days after last vaccination of the aTIV \& TIV vaccine groups respectively. NI is claimed if LL of 95% CI for GMT ratios is \>0.67.

Significance level is α = 2.5% (1-sided), which needs no further adjustment for multiplicity as to reach NI, above hypothesis needs to be rejected for all 3 strains.
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Ratio of GMTs
**Parameter Value:** 4.06
**Statistical Comment:** 
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** True
#### Analysis
**CI Lower Limit:** 2.05
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 3.25
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Geometric mean titers (GMTs), in H3N2 strain of all three homologous virus strains in Subjects 6 to \< 72 months of Age.
**Non-Inferiority Comment:** Hypothesis: Demonstrate non-inferiority (NI) of aTIV to TIV:

H0 : μAi - μBi ≤ -0.176 (Null) H1 : μAi - μBi \>-0.176 (alternative) (i= H1N1, H3N2, B) μA and μB are means of log10-transformed titers 21 days after last vaccination of the aTIV \& TIV vaccine groups respectively. NI is claimed if LL of 95% CI for GMT ratios is \>0.67.

Significance level is α = 2.5% (1-sided), which needs no further adjustment for multiplicity as to reach NI, above hypothesis needs to be rejected for all 3 strains.
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Ratio of GMTs
**Parameter Value:** 2.58
**Statistical Comment:** 
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** True
#### Analysis
**CI Lower Limit:** 3.52
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 6.20
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Geometric mean titers (GMTs), in B strain of all three homologous virus strains in Subjects 6 to \< 72 months of Age.
**Non-Inferiority Comment:** Hypothesis: Demonstrate non-inferiority (NI) of aTIV to TIV:

H0 : μAi - μBi ≤ -0.176 (Null) H1 : μAi - μBi \>-0.176 (alternative) (i= H1N1, H3N2, B) μA and μB are means of log10-transformed titers 21 days after last vaccination of the aTIV \& TIV vaccine groups respectively. NI is claimed if LL of 95% CI for GMT ratios is \>0.67.

Significance level is α = 2.5% (1-sided), which needs no further adjustment for multiplicity as to reach NI, above hypothesis needs to be rejected for all 3 strains.
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Ratio of GMTs
**Parameter Value:** 4.67
**Statistical Comment:** 
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** True
### Outcome Measure 8
#### Analysis
**CI Lower Limit:** 8.1
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 26.3
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Percentage of subjects achieving seroconversion in H1N1 strain after last vaccination with aTIV or TIV in naïve and non-naive subjects.
**Non-Inferiority Comment:** The following hypotheses should be tested to demonstrate non-inferiority of aTIV to TIV:

H0i: πi1 \> πi2-0.1 vs. H1i: πi1 \> πi2- 0.1 where H0i and H1i represent the null and the alternative hypothesis (respectively) of the non- inferiority objective and πi1 and πi2 represent the seroresponse rates 21 days after last immunization of the aTIV and TIV vaccine groups respectively in the i-th strain (H1N1, H3N2, B). The non-inferiority criterion is -0.1 (i.e., -10%).
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Vaccine Group Differences
**Parameter Value:** 17
**Statistical Comment:** Binary data were analyzed using loglinear models with a qualitative factor for vaccine group (αik, i = A, B) and center (δlk, k=1).
**Statistical Method:** Loglinear model
**Tested Non-Inferiority:** True
#### Analysis
**CI Lower Limit:** -1.8
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 21
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Percentage of subjects achieving seroconversion in H3N2 strain after last vaccination with aTIV or TIV in naive and non-naive subjects.
**Non-Inferiority Comment:** The following hypotheses should be tested to demonstrate non-inferiority of aTIV to TIV:

H0i: πi1 \> πi2-0.1 vs. H1i: πi1 \> πi2- 0.1 where H0i and H1i represent the null and the alternative hypothesis (respectively) of the non- inferiority objective and πi1 and πi2 represent the seroresponse rates 21 days after last immunization of the aTIV and TIV vaccine groups respectively in the i-th strain (H1N1, H3N2, B). The non-inferiority criterion is -0.1 (i.e., -10%).
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Vaccine Group Differences
**Parameter Value:** 10
**Statistical Comment:** Binary data were analyzed using loglinear models with a qualitative factor for vaccine group (αik, i = A, B) and center (δlk, k=1).
**Statistical Method:** Loglinear model
**Tested Non-Inferiority:** True
#### Analysis
**CI Lower Limit:** 47.5
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 68.5
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Percentage of subjects achieving seroconversion in B strains after last vaccination with aTIV or TIV in naïve and non naive subjects.
**Non-Inferiority Comment:** The following hypotheses should be tested to demonstrate non-inferiority of aTIV to TIV:

H0i: πi1 \> πi2-0.1 vs. H1i: πi1 \> πi2- 0.1 where H0i and H1i represent the null and the alternative hypothesis (respectively) of the non- inferiority objective and πi1 and πi2 represent the seroresponse rates 21 days after last immunization of the aTIV and TIV vaccine groups respectively in the i-th strain (H1N1, H3N2, B). The non-inferiority criterion is -0.1 (i.e., -10%).
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Vaccine Group Differences
**Parameter Value:** 58
**Statistical Comment:** Binary data were analyzed using loglinear models with a qualitative factor for vaccine group (αik, i = A, B) and center (δlk, k=1).
**Statistical Method:** Loglinear model
**Tested Non-Inferiority:** True
### Outcome Measure 9
### Outcome Measure 10
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 35
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 20
**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:** 15
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**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:** 1
**Title:** 
**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
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 26
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 16
**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:** 13
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 34
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 27
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 27
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 22
**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
**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
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 14
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 15
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 15
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 18
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 13
**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:** 9
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 15
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11
**Title:** 
**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
**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:** 11
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 9
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7
**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:** 2
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 10
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7
**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:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**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:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7
**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
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**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:** 3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6
**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:** 3
**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:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**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:** 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
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**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:** 2
**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
**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
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **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
**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:** 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
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**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:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**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:** 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
**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
**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:** 1
**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:** 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
**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
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**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:** 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
**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
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **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
**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
**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
**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
**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
**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:** 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
**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
**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
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 17
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 20
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
**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:** 3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 14
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 16
**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
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 15
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**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:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**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
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
**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:** 3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **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
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 33
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 28
**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:** 4
**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
**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
**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
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 26
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 25
**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
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **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
**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
**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
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
**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
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 11
- **Spread:** 
- **Upper Limit:** 19
- **Value:** 14
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 11
- **Spread:** 
- **Upper Limit:** 20
- **Value:** 15
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 536
- **Spread:** 
- **Upper Limit:** 849
- **Value:** 675
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 132
- **Spread:** 
- **Upper Limit:** 208
- **Value:** 166
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 40
- **Spread:** 
- **Upper Limit:** 86
- **Value:** 59
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 38
- **Spread:** 
- **Upper Limit:** 81
- **Value:** 55
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1077
- **Spread:** 
- **Upper Limit:** 1521
- **Value:** 1280
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 417
- **Spread:** 
- **Upper Limit:** 588
- **Value:** 495
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 6.41
- **Spread:** 
- **Upper Limit:** 8.71
- **Value:** 7.47
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 5.95
- **Spread:** 
- **Upper Limit:** 8.06
- **Value:** 6.92
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 61
- **Spread:** 
- **Upper Limit:** 93
- **Value:** 76
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 13
- **Spread:** 
- **Upper Limit:** 20
- **Value:** 16
**Title:** 
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 83.2
- **Spread:** 
- **Upper Limit:** 95
- **Value:** 90
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 65.9
- **Spread:** 
- **Upper Limit:** 82.7
- **Value:** 75
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 68.4
- **Spread:** 
- **Upper Limit:** 84.5
- **Value:** 77
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 57.4
- **Spread:** 
- **Upper Limit:** 75.6
- **Value:** 67
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 69.4
- **Spread:** 
- **Upper Limit:** 85.3
- **Value:** 78
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 15
- **Spread:** 
- **Upper Limit:** 31.2
- **Value:** 22
**Title:** 
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 34
- **Spread:** 
- **Upper Limit:** 62
- **Value:** 46
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 8.12
- **Spread:** 
- **Upper Limit:** 15
- **Value:** 11
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 16
- **Spread:** 
- **Upper Limit:** 28
- **Value:** 21
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 6.26
- **Spread:** 
- **Upper Limit:** 11
- **Value:** 8.39
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 8.25
- **Spread:** 
- **Upper Limit:** 13
- **Value:** 10
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 1.84
- **Spread:** 
- **Upper Limit:** 2.87
- **Value:** 2.30
**Title:** 
#### Outcome Measure 10
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 23.4
- **Spread:** 
- **Upper Limit:** 41.3
- **Value:** 32
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 24.4
- **Spread:** 
- **Upper Limit:** 42.6
- **Value:** 33
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 95.2
- **Spread:** 
- **Upper Limit:** 99.98
- **Value:** 99
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 81
- **Spread:** 
- **Upper Limit:** 93.7
- **Value:** 88
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 11.9
- **Spread:** 
- **Upper Limit:** 27
- **Value:** 19
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 12.7
- **Spread:** 
- **Upper Limit:** 28.2
- **Value:** 20
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 90.1
- **Spread:** 
- **Upper Limit:** 98.6
- **Value:** 96
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 58.4
- **Spread:** 
- **Upper Limit:** 76.4
- **Value:** 68
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1.5
- **Spread:** 
- **Upper Limit:** 10
- **Value:** 4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 3.1
- **Spread:** 
- **Upper Limit:** 13.6
- **Value:** 7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 69.4
- **Spread:** 
- **Upper Limit:** 85.3
- **Value:** 78
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 27.7
- **Spread:** 
- **Upper Limit:** 46.2
- **Value:** 37
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 46.5
- **Spread:** 
- **Upper Limit:** 65.4
- **Value:** 56
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 48.3
- **Spread:** 
- **Upper Limit:** 67.3
- **Value:** 58
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 96.8
- **Spread:** 
- **Upper Limit:** 100
- **Value:** 100
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 92.4
- **Spread:** 
- **Upper Limit:** 99.4
- **Value:** 97
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 34.6
- **Spread:** 
- **Upper Limit:** 53.5
- **Value:** 44
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 34.4
- **Spread:** 
- **Upper Limit:** 53.4
- **Value:** 44
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 95.2
- **Spread:** 
- **Upper Limit:** 99.98
- **Value:** 99
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 75.8
- **Spread:** 
- **Upper Limit:** 90.2
- **Value:** 84
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 24.8
- **Spread:** 
- **Upper Limit:** 42.8
- **Value:** 33
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 22
- **Spread:** 
- **Upper Limit:** 39.8
- **Value:** 30
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 78.2
- **Spread:** 
- **Upper Limit:** 91.8
- **Value:** 86
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 51
- **Spread:** 
- **Upper Limit:** 69.8
- **Value:** 61
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 4.3
- **Spread:** 
- **Upper Limit:** 15.5
- **Value:** 9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 4.4
- **Spread:** 
- **Upper Limit:** 15.8
- **Value:** 9
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 76.2
- **Spread:** 
- **Upper Limit:** 90.4
- **Value:** 84
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 23.6
- **Spread:** 
- **Upper Limit:** 41.6
- **Value:** 32
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.21
- **Spread:** 
- **Upper Limit:** 6.2
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.02
- **Spread:** 
- **Upper Limit:** 4.9
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 33.7
- **Spread:** 
- **Upper Limit:** 52.6
- **Value:** 43
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 2.5
- **Spread:** 
- **Upper Limit:** 12.5
- **Value:** 6
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 3.2
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 3.2
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 3.7
- **Spread:** 
- **Upper Limit:** 14.5
- **Value:** 8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 3.2
- **Value:** 0
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Number of naive subjects 6 to \< 36 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after first vaccination and from Day 29 to Day 35 after second vaccination.
**Parameter Type:** NUMBER
**Population Description:** Analysis performed on the Solicited Safety Set.
**Reporting Status:** POSTED
**Time Frame:** From Day 1 to Day 7 by vaccination
**Title:** Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination.
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** A 0.25 mL (for children 6 to \<36 months old) dose of aTIV to be administered.
**ID:** OG000
**Title:** Naive_aTIV (6 to <36 Months)
##### Group
**Description:** A 0.25 mL (for children 6 to \<36 months old) dose of TIV to be administered.
**ID:** OG001
**Title:** Naive_TIV (6 to <36 Months)
#### Outcome Measure 2
**Description:** Number of non-naive subjects 6 to \< 36 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after vaccination.
**Parameter Type:** NUMBER
**Population Description:** Analysis performed on the Solicited Safety Set.
**Reporting Status:** POSTED
**Time Frame:** From Day 1 to Day 7
**Title:** Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination.
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** A 0.25 mL (for children 6 to \<36 months old) dose of aTIV to be administered.
**ID:** OG000
**Title:** Non-naive_aTIV (6 to <36 Months)
##### Group
**Description:** A 0.25 mL (for children 6 to \<36 months old) dose of TIV to be administered.
**ID:** OG001
**Title:** Non-naive_TIV (6 to <36 Months)
#### Outcome Measure 3
**Description:** Number of naive subjects ≥ 36 months to \< 72 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after first vaccination and from Day 29 to Day 35 after second vaccination.
**Parameter Type:** NUMBER
**Population Description:** Analysis performed on the Solicited Safety Set.
**Reporting Status:** POSTED
**Time Frame:** From Day 1 to Day 7 by vaccination
**Title:** Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination.
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** A 0.5 mL (for children ≥36 months to \< 72 months old) dose of aTIV to be administered.
**ID:** OG000
**Title:** Naive_aTIV (≥36 Months to < 72 Months)
##### Group
**Description:** A 0.5 mL (for children ≥36 months to \< 72 months old) dose of TIV to be administered.
**ID:** OG001
**Title:** Naive_TIV (≥36 Months to < 72 Months)
#### Outcome Measure 4
**Description:** Number of non-naive subjects ≥36 months to \< 72 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after vaccination.
**Parameter Type:** NUMBER
**Population Description:** Analysis performed on the Solicited Safety Set.
**Reporting Status:** POSTED
**Time Frame:** From Day 1 to Day 7
**Title:** Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination.
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** A 0.5 mL (for children ≥36 months to \< 72 months old) dose of aTIV to be administered.
**ID:** OG000
**Title:** Non-naive_aTIV (≥36 Months to < 72 Months)
##### Group
**Description:** A 0.5 mL (for children ≥36 months to \< 72 months old) dose of TIV to be administered.
**ID:** OG001
**Title:** Non-naive_TIV (≥36 Months to < 72 Months)
#### Outcome Measure 5
**Description:** Number of naive subjects aged 6 to \< 72 months reporting all unsolicited AEs, medically attended AEs, AE leading to study withdrawal and serious AEs (SAEs) from Day 1 to Day 50.
**Parameter Type:** NUMBER
**Population Description:** Analysis performed on the Unsolicited Safety Set.
**Reporting Status:** POSTED
**Time Frame:** From Day 1 to Day 50
**Title:** Number of Naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 50.
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** A 0.25 mL (for children 6 to \<36 months old) and 0.5 mL (for children ≥36 months to \< 72 months old) dose of aTIV to be administered.
**ID:** OG000
**Title:** Naive_aTIV (6 Months to < 72 Months)
##### Group
**Description:** A 0.25 mL (for children 6 to \<36 months old) and 0.5 mL (for children ≥36 months to \< 72 months old) dose of TIV to be administered.
**ID:** OG001
**Title:** Naive_TIV (6 Months to < 72 Months)
#### Outcome Measure 6
**Description:** Number of non-naive subjects aged 6 to \< 72 months reporting all unsolicited AEs, medically attended AEs, AE leading to study withdrawal and SAEs from Day 1 to Day 22.
**Parameter Type:** NUMBER
**Population Description:** Analysis performed on the Unsolicited Safety Set.
**Reporting Status:** POSTED
**Time Frame:** From Day 1 to Day 22
**Title:** Number of Non-naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 22
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** A 0.25 mL (for children 6 to \<36 months old) and 0.5 mL (for children ≥36 months to \< 72 months old) dose of aTIV to be administered.
**ID:** OG000
**Title:** Non naive_aTIV (6 Months to < 72 Months)
##### Group
**Description:** A 0.25 mL (for children 6 to \<36 months old) and 0.5 mL (for children ≥36 months to \< 72 months old) dose of TIV to be administered.
**ID:** OG001
**Title:** Non naive_TIV (6 Months to < 72 Months)
#### Outcome Measure 7
**Description:** Antibody response was assessed in terms of GMTs in all three homologous virus strains, 21 days after last immunization, in subjects 6 to \<72 months of age.

The study is considered a success if the 21 days after last immunization GMT ratios of aTIV relative to TIV demonstrate as non-inferior with the lower limit (LL) of the two sided 95% confidence interval (CI) above 0.67 (-0.176 on log10 scale) for each vaccine strain (Center for Biologics Evaluation and Research {CBER} Guideline on Seasonal Vaccines May 2007).
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** GEOMETRIC_MEAN
**Population Description:** Analysis performed on the Per Protocol Set.
**Reporting Status:** POSTED
**Time Frame:** Day 1 and Day 22 (vaccine non-naïve subjects) or Day 50 (vaccine naïve subjects) post vaccination
**Title:** Geometric Mean Titers (GMTs), in All Three Homologous Virus Strains in Subjects 6 to < 72 Months of Age.
**Type:** PRIMARY
**Unit of Measure:** Titers
##### Group
**Description:** A 0.25 mL (for children 6 to \<36 months old) and 0.5 mL (for children ≥36 months to \< 72 months old) dose of aTIV to be administered.
**ID:** OG000
**Title:** aTIV (6 Months to < 72 Months)
##### Group
**Description:** A 0.25 mL (for children 6 to \<36 months old) and 0.5 mL (for children ≥36 months to \< 72 months old) dose of TIV to be administered.
**ID:** OG001
**Title:** TIV (6 Months to < 72 Months)
#### Outcome Measure 8
**Description:** Percentages of subjects with seroconversion in all three homologous virus strains, 21 days after last immunization, in subjects 6 to \<72 months of age, defined as: HI ≥ 40 subject with a pre-vaccination HI titer \<10; a minimum 4-fold increase HI titer for subjects with a prevaccination HI titer ≥10, on Day 22 (non-naive subjects) or Day 50 (naive subjects), as applicable.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** Analysis performed on the Per Protocol Set.
**Reporting Status:** POSTED
**Time Frame:** Day 1 and Day 22 (vaccine non-naive subjects) or Day 50 (vaccine naive subjects) post vaccination
**Title:** Percentages of Subjects Achieving Seroconversion in Hemagglutination Inhibition (HI) Titers and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects.
**Type:** SECONDARY
**Unit of Measure:** Percentages of subjects
##### Group
**Description:** A 0.25 mL (for children 6 to \<36 months old) and 0.5 mL (for children ≥36 months to \< 72 months old) dose of aTIV to be administered.
**ID:** OG000
**Title:** aTIV (6 Months to < 72 Months)
##### Group
**Description:** A 0.25 mL (for children 6 to \<36 months old) and 0.5 mL (for children ≥36 months to \< 72 months old) dose of TIV to be administered.
**ID:** OG001
**Title:** TIV (6 Months to < 72 Months)
#### Outcome Measure 9
**Description:** GMRs of HI, day 22/day 1 (non-naive subjects) or day 50/day 1 (naive subjects) in all three homologous virus strains, 21 days after last immunization, in subjects 6 to \<72 months of age. As the non-inferiority of aTIV to TIV has been established, GMT ratio of aTIV relative to TIV in all three homologous virus strains, 21 days after last immunization in subjects 6 to \<72 months of age was evaluated using margins greater than the non-inferiority cut-off of 0.67.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** GEOMETRIC_MEAN
**Population Description:** Analysis performed on the Per Protocol Set.
**Reporting Status:** POSTED
**Time Frame:** Day 1 and Day 22 (vaccine non-naive subjects) or Day 50 (vaccine naive subjects) post vaccination
**Title:** Geometric Mean Ratios (GMRs) of HI and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects.
**Type:** SECONDARY
**Unit of Measure:** Ratios
##### Group
**Description:** A 0.25 mL (for children 6 to \<36 months old) and 0.5 mL (for children ≥36 months to \< 72 months old) dose of aTIV to be administered.
**ID:** OG000
**Title:** aTIV (6 Months to < 72 Months)
##### Group
**Description:** A 0.25 mL (for children 6 to \<36 months old) and 0.5 mL (for children ≥36 months to \< 72 months old) dose of TIV to be administered.
**ID:** OG001
**Title:** TIV (6 Months to < 72 Months)
#### Outcome Measure 10
**Description:** Percentage of subjects with a HI titer ≥ 40, ≥110 and ≥330 on Day 1, Day 22 (non naïve subjects) or Day 50 (naïve subjects), in all three homologous virus strains, 21 days after last immunization, in subjects 6 to \<72 months of age.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** Analysis performed on the Per Protocol Set.
**Reporting Status:** POSTED
**Time Frame:** Day 1 and Day 22 (vaccine non-naive subjects) or Day 50 (vaccine naive subjects) post vaccination
**Title:** Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects.
**Type:** SECONDARY
**Unit of Measure:** Percentage of subjects
##### Group
**Description:** A 0.25 mL (for children 6 to \<36 months old) and 0.5 mL (for children ≥36 months to \< 72 months old) dose of aTIV to be administered.
**ID:** OG000
**Title:** aTIV (6 Months to < 72 Months)
##### Group
**Description:** A 0.25 mL (for children 6 to \<36 months old) and 0.5 mL (for children ≥36 months to \< 72 months old) dose of TIV to be administered.
**ID:** OG001
**Title:** TIV (6 Months to < 72 Months)
### Participant Flow Module
#### Group
**Description:** A 0.25 mL (for children 6 to \<36 months old) and 0.5 mL (for children ≥36 months to \< 72 months old) dose of aTIV to be administered.
**ID:** FG000
**Title:** aTIV (6 Months to < 72 Months)
#### Group
**Description:** A 0.25 mL (for children 6 to \<36 months old) and 0.5 mL (for children ≥36 months to \< 72 months old) dose of TIV to be administered.
**ID:** FG001
**Title:** TIV (6 Months to < 72 Months)
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
##### Withdraw
**Type:** Protocol Violation
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 3
###### Reason
**Group ID:** FG001
**Number of Subjects:** 6
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 144
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 143
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 139
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 134
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 5
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 9
**Pre-Assignment Details:** All enrolled subjects were included in study.
**Recruitment Details:** Subjects were enrolled from 3 study centers in Mexico.
**Has Results:** True