## Protocol Section
### Identification Module
**NCT ID:** NCT01553279

**Brief Title:** Immunogenicity and Safety of V419 (PR51) in Combination With MCC in Infants and Toddlers (V419-011)

**Official Title:** A Phase III Open-label Randomised Study, to Evaluate the Immunogenicity and Safety of the Concomitant Administration of V419 (PR5I) Given at 2, 3 and 4 Months of Age With Two Types of Meningococcal Serogroup C Conjugate (MCC) Vaccines Given at 3 and 4 Months of Age, and Followed by the Administration at 12 Months of Age of a Combined Haemophilus Influenzae Type b-MCC Vaccine

#### Organization Study ID Info
**ID:** V419-011
#### Organization
**Class:** INDUSTRY
**Full Name:** MCM Vaccines B.V.
#### Secondary ID Infos
**ID:** 2011-002413-11
**Type:** EUDRACT_NUMBER
**Domain:** MCMVaccBV Protocol ID
**ID:** PRI01C
**Type:** OTHER
**Domain:** Merck Protocol Number
**ID:** V419-011
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2013-09-27

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-03-28

**Type:** ACTUAL

**Last Update Submit Date:** 2019-03-06

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2013-09-27

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2019-03-28

**Type:** ACTUAL

**Results First Submit Date:** 2019-01-30

**Results First Submit QC Date:** 2019-03-06

#### Start Date
**Date:** 2012-03-30

**Type:** ACTUAL

**Status Verified Date:** 2019-03

#### Study First Post Date
**Date:** 2012-03-14
**Type:** ESTIMATED
**Study First Submit Date:** 2012-03-07
**Study First Submit QC Date:** 2012-03-09
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** MCM Vaccines B.V.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The primary objectives of this study are to evaluate the immunogenicity and safety of concomitant administration of V419 (PR51) with 2 types of meningococcal serogroup C conjugate (MCC) vaccines to healthy infants at 3 and 4 months of age in terms of antibody seroprotection rate (SPR) to MCC. Participants also received a Haemophilus influenza type B (Hib)-MCC vaccination at 12 months of age. It was hypothesized that the SPR to MCC at 1 month post-dose 2 of either tetanus toxoid conjugated Meningo C (MCC-TT) or CRM197 conjugated Meningo C (MCC-CRM) vaccines would be acceptable when administered concomitantly with V419.

### Conditions Module

**Conditions:**

- Neisseria Meningitidis

- Bacterial Infections

- Virus Diseases

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 284

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age), followed by a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of a measles, mumps, and rubella (MMR) vaccine (at 12 months of age).

**Intervention Names:**

- Biological: V419

- Biological: PREVNAR 13®

- Biological: MCC-TT

- Biological: Hib-MCC

- Biological: MMR Vaccine

**Label:** V419 and MCC-TT

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age), followed by a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).

**Intervention Names:**

- Biological: V419

- Biological: PREVNAR 13®

- Biological: MCC-CRM

- Biological: Hib-MCC

- Biological: MMR Vaccine

**Label:** V419 and MCC-CRM

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- V419 and MCC-CRM

- V419 and MCC-TT

**Description:** Diphtheria and Tetanus toxoids and acellular Pertussis adsorbed, inactivated Poliovirus, Haemophilus b conjugate \[meningococcal outer membrane protein complex\], and Hepatitis B \[recombinant\] vaccine administered via 0.5 mL intramuscular injection.

**Name:** V419

**Other Names:**

- PR51, VAXELIS®

**Type:** BIOLOGICAL

#### Intervention 2

**Arm Group Labels:**

- V419 and MCC-CRM

- V419 and MCC-TT

**Description:** Pneumococcal conjugate vaccine (13-valent, adsorbed) administered via 0.5 mL intramuscular injection (routine vaccination).

**Name:** PREVNAR 13®

**Type:** BIOLOGICAL

#### Intervention 3

**Arm Group Labels:**

- V419 and MCC-TT

**Description:** Meningococcal Group C polysaccharide conjugate vaccine to tetanus toxoid adsorbed 0.5 mL intramuscular injection at 3 and 4 months of age

**Name:** MCC-TT

**Other Names:**

- NEISVAC-C®

**Type:** BIOLOGICAL

#### Intervention 4

**Arm Group Labels:**

- V419 and MCC-CRM

**Description:** Meningococcal Group C conjugate vaccine to CRM-197 adsorbed 0.5 mL intramuscular injection at 3 and 4 months of age

**Name:** MCC-CRM

**Other Names:**

- MENJUGATE®

**Type:** BIOLOGICAL

#### Intervention 5

**Arm Group Labels:**

- V419 and MCC-CRM

- V419 and MCC-TT

**Description:** Haemophilus type b and meningococcal Group C conjugate vaccine administered via 0.5 mL intramuscular injection.

**Name:** Hib-MCC

**Other Names:**

- MENITORIX®

**Type:** BIOLOGICAL

#### Intervention 6

**Arm Group Labels:**

- V419 and MCC-CRM

- V419 and MCC-TT

**Description:** Measles, mumps, and rubella vaccine (live) given via 0.5 mL intramuscular injection (routine vaccination).

**Name:** MMR Vaccine

**Other Names:**

- M-M-RVAXPRO®

**Type:** BIOLOGICAL

### Outcomes Module

#### Primary Outcomes

**Description:** The acceptability (i.e., percentage of participants with anti-MCC Ab titre ≥1:8 dil) of the seroprotection rate (SPR) to MCC was determined 1 month after MCC-TT or MCC-CRM Dose 2. The SPR was considered acceptable if the lower bound of the 2-sided 95% CI was \>90%. Serum Ab levels were assayed using the Meningo C rabbit complement serum bactericidal Ab (rSBA) assay.

**Measure:** Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8 Dil One Month After MCC-TT or MCC-CRM (Part 1)

**Time Frame:** Month 5 (1 month after MCC-TT/MCC-CRM Dose 2)

#### Secondary Outcomes

**Description:** The acceptability (i.e., percentage of participants with anti-PRP Ab titre ≥0.15 µg/mL) of the seroprotection rate (SPR) to Haemophilus influenza type b (Hib) was determined 1 month after the third dose of V419 in participants also treated with MCC-TT or MCC-CRM. The pooled (i.e., all V419-treated participants) SPR was considered acceptable if the lower bound of the 2-sided 95% CI was \>80%. Serum Ab levels were determined with radioimmunoassay (RIA).

**Measure:** Percentage of Participants With Anti-Polyribosylribitol Phosphate (Anti-PRP) Antibody (Ab) Titre ≥0.15 µg/mL One Month After V419 Dose 3 (Part 1)

**Time Frame:** Month 5 (1 month after V419 Dose 3)

**Description:** The percentage of participants with anti-MCC Ab titres ≥1:8 dil and ≥1:128 dil 1 month after MCC-TT or MCC-CRM Doses 1 and 2 was determined in participants also treated with V419. Serum Ab levels were assayed using the Meningo C rabbit complement serum bactericidal Ab (rSBA) assay.

**Measure:** Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8 Dil and ≥1:128 Dil One Month After MCC-TT or MCC-CRM Doses 1 and 2 (Part 1)

**Time Frame:** Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2)

**Description:** Anti-MCC antibody GMTs were determined 1 month after MCC-TT or MCC-CRM Doses 1 and 2 in participants also treated with V419. Serum antibody levels were assayed using the Meningo C rabbit complement serum bactericidal antibody (rSBA) assay.

**Measure:** Geometric Mean Titres (GMTs) for Meningococcal Serogroup C (MCC) One Month After MCC-TT or MCC-CRM Doses 1 and 2 (Part 1)

**Time Frame:** Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2)

**Description:** The percentage of participants meeting Ab response rates for V14 antigens was determined after V114 Dose 3. Antibody response rate criteria for Haemophilus influenza Type B (PRP); hepatitis B (HBsAg); diphtheria; tetanus; and polio types 1, 2, and 3 are shown in the rows below. The percentage of seroresponders to pertussis seroresponders (pertussis toxoid \[PT\]; filamentous haemagglutinin (FHA); fimbrae types 2 and 3 \[FIM\]; and pertactin \[PRN\]) was determined as 1) if pre-vaccination Ab concentration \<lower limit of quantification (LLoQ) but post-vaccination Ab concentration ≥LLoQ; or 2) if pre-vaccination Ab concentration was ≥LLoQ but post-vaccination Ab concentration was ≥pre-immunization levels. Antibody titres were measured by RIA for PRP, enhanced chemiluminescence assay (ECi) for HBsAg, micrometabolic inhibition test (MIT) for diphtheria and poliovirus, and enzyme-linked immunosorbent assay (ELISA) for tetanus, PT, FHA, FIM, and PRN.

**Measure:** Antibody (Ab) Response Rates for V114 Antigens One Month After V114 Dose 3 (Part 1)

**Time Frame:** Month 5 (1 month after V419 Dose 3)

**Description:** The GMTs for PRP Ab titres were determined for each arm. Antibody titres for PRP were measured by radioimmunoassay (RIA).

**Measure:** Antibody (Ab) Geometic Mean Titres (GMTs) for Haemophilus Influenza Type B (Polyribosylribitol Phosphate [PRP]) One Month After V114 Dose 3 (Part 2)

**Time Frame:** Month 5 (1 month after V419 Dose 3)

**Description:** The GMTs for HBsAg Ab titres were determined for each arm. Antibody titres for HBsAg were measured by enhanced chemiluminescence (ECi) assay.

**Measure:** Antibody (Ab) Geometic Mean Titres (GMTs) for Hepatitis B Surface Antigen (HBsAg) One Month After V114 Dose 3 (Part 2)

**Time Frame:** Month 5 (1 month after V419 Dose 3)

**Description:** The GMTs for diphtheria Ab titres were determined for each arm. Antibody titres for diptheria were measured by enhanced micrometabolic inhibition test (MIT).

**Measure:** Antibody (Ab) Geometic Mean Titres (GMTs) for Diptheria One Month After V114 Dose 3 (Part 2)

**Time Frame:** Month 5 (1 month after V419 Dose 3)

**Description:** The GMTs for tetanus Ab titres were determined for each arm. Antibody titres for tetanus were determined with enzyme-linked immunosorbent assay (ELISA).

**Measure:** Antibody (Ab) Geometic Mean Titres (GMTs) for Tetanus One Month After V114 Dose 3 (Part 2)

**Time Frame:** Month 5 (1 month after V419 Dose 3)

**Description:** The GMTs for PT Ab titres were determined for each arm. Antibody titres for PT were measured with enzyme-linked immunosorbent assay (ELISA).

**Measure:** Antibody (Ab) Geometic Mean Titres (GMTs) for Pertussis Toxoid (PT) One Month After V114 Dose 3 (Part 2)

**Time Frame:** Month 5 (1 month after V419 Dose 3)

**Description:** The GMTs for FHA were determined for each arm. Antibody titres for FHA were measured by enhanced chemiluminescence (ECi) assay.

**Measure:** Antibody (Ab) Geometic Mean Titres (GMTs) for Filamentous Haemagglutinin (FHA) One Month After V114 Dose 3 (Part 2)

**Time Frame:** Month 5 (1 month after V419 Dose 3)

**Description:** The GMTs for PRN were determined for each arm. Antibody titres for PRN were measured by enhanced chemiluminescence (ECi) assay.

**Measure:** Antibody (Ab) Geometic Mean Titres (GMTs) for Pertactin (PRN) One Month After V114 Dose 3 (Part 2)

**Time Frame:** Month 5 (1 month after V419 Dose 3)

**Description:** The GMTs for FIM were determined for each arm. Antibody titres for FIM were measured by enhanced chemiluminescence (ECi) assay.

**Measure:** Antibody (Ab) Geometic Mean Titres (GMTs) for Fimbrae Types 2 and 3 (FIM) One Month After V114 Dose 3 (Part 2)

**Time Frame:** Month 5 (1 month after V419 Dose 3)

**Description:** The GMTs for polio types 1, 2, and 3 were determined for each arm. Antibody titres for polio types 1, 2, and 3 were measured by micrometabolic inhibition test (MIT).

**Measure:** Antibody (Ab) Geometic Mean Titres (GMTs) for Polio Types 1, 2, and 3 One Month After V114 Dose 3 (Part 2)

**Time Frame:** Month 5 (1 month after V419 Dose 3)

**Description:** The percentage of participants with anti-Hib Ab titres ≥1:8 (1/dil) and ≥1:28 (1/dil) were determined prior to, and 1 month after, administration of the single HiB-MCC vaccine at 12 months of age. Serum Ab levels were assayed using the Meningo C rabbit complement serum bactericidal Ab (rSBA) assay.

**Measure:** Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8(1/Dil) and Titre ≥1:28 (1/Dil) One Month After Anti-Haemophilus Influenzae Type B (Anti-Hib) Vaccination (Part 2)

**Time Frame:** Month 12 and Month 13 (Prior to anti-Hib MCC and 1 month after anti-HiB MCC)

**Description:** Antibody GMTs were were determined prior to, and 1 month after, administration of the single HiB-MCC vaccine at 12 months of age. Serum Ab levels were assayed using the Meningo C rabbit complement serum bactericidal Ab (rSBA) assay.

**Measure:** Antibody (Ab) Geometric Mean Titres (GMTs) for Meningococcal Serogroup C (MCC) One Month After Anti-Haemophilus Influenzae Type B (Anti-Hib) Meningococcal Serogroup C (MCC) Vaccination (Part 2)

**Time Frame:** Month 12 and Month 13 (Prior to anti-Hib MCC and 1 month after anti-HiB MCC)

**Description:** The percentage of participants with anti-PRP Ab titres ≥0.15 µg/mL and ≥1.0 µg/mL was determined prior to, and 1 month after, administration of the anti-Hib vaccination at Month 12. Anti-PRP Ab titres were measured with radioimmunoassay (RIA).

**Measure:** Percentage of Participants With Anti-Polyribosylribitol Phosphate (PRP) Antibody (Ab) Titres ≥0.15 µg/mL and ≥1.0 µg/mL One Month After Anti-Haemophilus Influenzae Type B MCC Vaccination (Part 2)

**Time Frame:** Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2)

**Description:** Anti-PRP Ab GMTs were determined prior to, and 1 month after, administration of the anti-Hib vaccination at Month 12. Anti-PRP Ab titres were measured with radioimmunoassay (RIA) and are expressed as µg/mL..

**Measure:** Geometric Mean Titres (GMTs) for Anti-Polyribosylribitol Phosphate (PRP) Antibody (Ab) One Month After Anti-Haemophilus Influenzae Type B (HiB) MCC Vaccination (Part 2)

**Time Frame:** Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2)

**Description:** An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the investigational product, whether or not considered related to the use of the product.

**Measure:** Percentage of Participants Experiencing an Adverse Event (AE) [Part 1]

**Time Frame:** Up to 4.5 months (up to 15 days after the final Part 1 vaccination)

**Description:** An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the investigational product, whether or not considered related to the use of the product. As per protocol, all injection site AEs were considered vaccine-related.

**Measure:** Percentage of Participants Experiencing an Injection Site (Vaccine-Related) Systemic Adverse Event (AE) [Part 1]

**Time Frame:** Up to 4.5 months (up to 15 days after the final Part 1 vaccination)

**Description:** The percentage of participants with solicited ISRs was determined for each arm. Solicited ISRs consisted of injection site pain, erythema, and swelling.

**Measure:** Percentage of Participants Experiencing a Solicited Injection Site Reaction (ISR) at the V419 Injection Site (Part 1)

**Time Frame:** Up to 4.5 months (up to 15 days after the final Part 1 vaccination)

**Description:** The percentage of participants with unsolicited ISRs was determined for each arm. Unsolicited ISRs were any injection-site ISRs not considered solicited.

**Measure:** Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the V419 Injection Site (Part 1)

**Time Frame:** Up to 4.5 months (up to 15 days after the final Part 1 vaccination)

**Description:** The percentage of participants with solicited ISRs was determined for each arm. Solicited ISRs consisted of injection site pain, erythema, and swelling.

**Measure:** Percentage of Participants Experiencing a Solicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1)

**Time Frame:** Up to 4.5 months (up to 15 days after the final Part 1 vaccination)

**Description:** The percentage of participants with unsolicited ISRs was determined for each arm. Unsolicited ISRs consisted of bruising, dermatitis, erythema, induration, mass, pain, rash, and warmth.

**Measure:** Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1)

**Time Frame:** Up to 4.5 months (up to 15 days after the final Part 1 vaccination)

**Description:** The percentage of participants with solicited systemic AEs was determined for each arm. Solicited systemic AEs consisted of crying, decreased appetite, irritability, pyrexia, somnolence, and vomiting.

**Measure:** Percentage of Participants Experiencing a Solicited Systemic Adverse Event (AE) [Part 1]

**Time Frame:** Up to 4.5 months (up to 15 days after the final Part 1 vaccination)

**Description:** The percentage of participants experiencing temperatures ≥38.0° Celsius (C), \>38.5° C, and \>39.5° C following any Part 1 vaccination was determined.

**Measure:** Percentage of Participants Experiencing Increased Temperature [Part 1]

**Time Frame:** Up to 4.5 months (up to 15 days after the final Part 1 vaccination)

**Description:** An SAE is an event that results in death; is life-threatening; results in or prolongs hospitalization; is a congenital anomaly/birth defect; is a cancer; is an overdose; or is another important medical event that may jeopardize the participant.

**Measure:** Percentage of Participants Experiencing a Serious Adverse Event (SAE) [Part 1]

**Time Frame:** Up to 4.5 months (up to 15 days after the final Part 1 vaccination)

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Healthy infant 46 to 74 days of age (both inclusive)
* Parent(s)/legal representative able to comply will the study procedures

Exclusion Criteria:

* Is participating in a study with an investigational compound or device since birth
* Has a history of congenital or acquired immunodeficiency
* Has a history of leukemia, lymphoma, malignant melanoma or myeloproliferative disorder
* Has a chronic illness that could interfere with study conduct or completion
* Has hypersensitivity to any of the vaccines components or history of a life-threatening reaction to a vaccine containing the same substances as the study vaccines or contraindication to any of the study vaccines
* Has a history, or mother has a history, of hepatitis B virus surface antigen (HBsAg) seropositivity
* Has a coagulation disorder that contraindicate intramuscular injection
* Has a history of vaccination with a hepatitis B, Haemophilus influenzae type b conjugate, diphtheria, tetanus, pertussis (acellular or whole-cell), poliovirus, pneumococcal conjugate or polysaccharide, meningococcal serogroup C conjugate, measles, mumps, or rubella containing vaccine(s)
* Has a history of hepatitis B, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, poliomyelitis, invasive pneumococcal, meningococcal serogroup C, measles, mumps or rubella infection
* Has received immune globulin, blood or blood-derived products, immunosuppressive agents systemic corticosteroids since birth
* Has received vaccination with an inactivated (except influenza vaccine) or conjugated or live vaccine in the last 30 days or vaccination with an inactivated influenza vaccine in the last 14 days
* Has received antipyretic, analgesic and non-steroidal anti-inflammatory medications in the last 48 hours
* Has a febrile illness or body temperature ≥38.0°C in the last 24 hours

**Healthy Volunteers:** True

**Maximum Age:** 74 Days

**Minimum Age:** 46 Days

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** Merck Sharp & Dohme LLC

**Name:** Medical Director

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**Description:** http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

**IPD Sharing:** YES

**URL:** http://engagezone.msd.com/ds_documentation.php

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001423

- Term: Bacterial Infections and Mycoses

- ID: D000007239

- Term: Infections

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4722

- Name: Bacterial Infections

- Relevance: HIGH

- As Found: Bacterial Infections

- ID: M10295

- Name: Influenza, Human

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: HIGH

- As Found: Virus Disease

- ID: M12136

- Name: Mycoses

- Relevance: LOW

- As Found: Unknown

- ID: M4721

- Name: Bacterial Infections and Mycoses

- Relevance: LOW

- As Found: Unknown

- ID: T2646

- Name: Haemophilus Influenzae

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001424

- Term: Bacterial Infections

- ID: D000014777

- Term: Virus Diseases

### 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

### Intervention Browse Module - Browse Leaves

- ID: M17360

- Name: Vaccines

- Relevance: LOW

- As Found: Unknown

- ID: M412

- Name: Heptavalent Pneumococcal Conjugate Vaccine

- Relevance: HIGH

- As Found: Impedance

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000069443

- Term: Heptavalent Pneumococcal Conjugate Vaccine

### Misc Info Module

#### Removed Countries

- Country: United Kingdom

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** All participants who received ≥1 dose of study medication are included.

#### Event Groups

**Group ID:** EG000

**Title:** V419 and MCC-TT

**Deaths Num At Risk:** 142

**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).

**ID:** EG000

**Other Num Affected:** 140

**Other Num at Risk:** 142

**Serious Number Affected:** 6

**Serious Number At Risk:** 142

**Title:** V419 and MCC-TT

**Group ID:** EG001

**Title:** V419 and MCC-CRM

**Deaths Num At Risk:** 142

**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).

**ID:** EG001

**Other Num Affected:** 137

**Other Num at Risk:** 142

**Serious Number Affected:** 4

**Serious Number At Risk:** 142

**Title:** V419 and MCC-CRM

**Frequency Threshold:** 2

#### Other Events

**Term:** Constipation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 16.1

**Term:** Diarrhoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 16.1

**Term:** Teething

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 16.1

**Term:** Vomiting

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 16.1

**Term:** Crying

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 16.1

**Term:** Injection site bruising

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 16.1

**Term:** Injection site erythema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 16.1

**Term:** Injection site mass

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 16.1

**Term:** Injection site pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 16.1

**Term:** Injection site swelling

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 16.1

**Term:** Injection site warmth

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 16.1

**Term:** Irritability

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 16.1

**Term:** Pyrexia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 16.1

**Term:** Nasopharyngitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

**Term:** Rhinitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

**Term:** Contusion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 16.1

**Term:** Decreased appetite

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 16.1

**Term:** Somnolence

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 16.1

**Term:** Insomnia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 16.1

**Term:** Cough

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 16.1

**Term:** Nasal congestion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 16.1

**Term:** Rhinorrhoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 16.1

**Term:** Rash

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 16.1

#### Serious Events

**Term:** Abdominal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 142

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 142

**Num Events:** 1

**Term:** Crying

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 142

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 142

**Num Events:** 1

**Term:** Hypothermia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 142

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 142

**Term:** Croup infectious

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 142

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 142

**Term:** Gastroenteritis salmonella

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 142

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 142

**Num Events:** 1

**Term:** Gastroenteritis viral

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 142

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 142

**Num Events:** 1

**Term:** Respiratory syncytial virus bronchiolitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 142

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 142

**Term:** Sepsis neonatal

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 142

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 142

**Term:** Urinary tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 142

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 142

**Term:** Weight gain poor

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 142

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 142

**Term:** Choking

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 142

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 142

**Num Events:** 1

**Time Frame:** Up to 12.5 months (up to 14 days after the final dose of study medication)

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 142

**Group ID:** BG001

**Value:** 142

**Group ID:** BG002

**Value:** 284

**Units:** Participants

### Group

**ID:** BG000

**Title:** V419 and MCC-TT

**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).

### Group

**ID:** BG001

**Title:** V419 and MCC-CRM

**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 6.7

**Value:** 62.6

#### Measurement

**Group ID:** BG001

**Spread:** 7.2

**Value:** 61.6

#### Measurement

**Group ID:** BG002

**Spread:** 7.0

**Value:** 62.1

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 62

#### Measurement

**Group ID:** BG001

**Value:** 67

#### Measurement

**Group ID:** BG002

**Value:** 129

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 80

#### Measurement

**Group ID:** BG001

**Value:** 75

#### Measurement

**Group ID:** BG002

**Value:** 155

**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:** Days
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Email:** ClinicalTrialsDisclosure@merck.com
**Organization:** Merck Sharp & Dohme Corp.
**Phone:** 1-800-672-6372
**Title:** Senior Vice President, Global Clinical Development
## 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
### Outcome Measure 15
### Outcome Measure 16
### Outcome Measure 17
### Outcome Measure 18
### Outcome Measure 19
### Outcome Measure 20
### Outcome Measure 21
### Outcome Measure 22
### Outcome Measure 23
### Outcome Measure 24
### Outcome Measure 25
### Outcome Measure 26
### Outcome Measure 27
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 97.0
- **Spread:** 
- **Upper Limit:** 100.0
- **Value:** 100.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 95.0
- **Spread:** 
- **Upper Limit:** 100.0
- **Value:** 99.1
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 95.9
- **Spread:** 
- **Upper Limit:** 99.9
- **Value:** 98.9
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 96.4
- **Spread:** 
- **Upper Limit:** 100.0
- **Value:** 100.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 89.9
- **Spread:** 
- **Upper Limit:** 99.3
- **Value:** 96.4
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 102
- **Group ID:** OG001
- **Value:** 84
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 93.1
- **Spread:** 
- **Upper Limit:** 99.8
- **Value:** 98.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 75.0
- **Spread:** 
- **Upper Limit:** 91.5
- **Value:** 84.5
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 102
- **Group ID:** OG001
- **Value:** 84
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 97.0
- **Spread:** 
- **Upper Limit:** 100.0
- **Value:** 100.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 95.0
- **Spread:** 
- **Upper Limit:** 100.0
- **Value:** 99.1
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 121
- **Group ID:** OG001
- **Value:** 109
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 95.5
- **Spread:** 
- **Upper Limit:** 100.0
- **Value:** 99.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 95.0
- **Spread:** 
- **Upper Limit:** 100.0
- **Value:** 99.1
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 121
- **Group ID:** OG001
- **Value:** 109
**Units:** Participants
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1058.4
- **Spread:** 
- **Upper Limit:** 1729.6
- **Value:** 1353
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 201.5
- **Spread:** 
- **Upper Limit:** 403.1
- **Value:** 285.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1689.8
- **Spread:** 
- **Upper Limit:** 2425.9
- **Value:** 2024.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 847.5
- **Spread:** 
- **Upper Limit:** 1369.8
- **Value:** 1077.4
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 92.4
- **Spread:** 
- **Upper Limit:** 99.7
- **Value:** 97.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 95.6
- **Spread:** 
- **Upper Limit:** 100.0
- **Value:** 100.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 93
- **Group ID:** OG001
- **Value:** 82
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 90.9
- **Spread:** 
- **Upper Limit:** 99.3
- **Value:** 96.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 89.7
- **Spread:** 
- **Upper Limit:** 99.2
- **Value:** 96.3
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 93
- **Group ID:** OG001
- **Value:** 82
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 97.1
- **Spread:** 
- **Upper Limit:** 100.0
- **Value:** 100.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 96.5
- **Spread:** 
- **Upper Limit:** 100.0
- **Value:** 100.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 125
- **Group ID:** OG001
- **Value:** 104
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 59.1
- **Spread:** 
- **Upper Limit:** 76.1
- **Value:** 68.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 64.5
- **Spread:** 
- **Upper Limit:** 82.1
- **Value:** 74.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 125
- **Group ID:** OG001
- **Value:** 104
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 97.0
- **Spread:** 
- **Upper Limit:** 100.0
- **Value:** 100.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 96.5
- **Spread:** 
- **Upper Limit:** 100.0
- **Value:** 100.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 122
- **Group ID:** OG001
- **Value:** 105
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 97.0
- **Spread:** 
- **Upper Limit:** 100.0
- **Value:** 100.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 96.5
- **Spread:** 
- **Upper Limit:** 100.0
- **Value:** 100.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 122
- **Group ID:** OG001
- **Value:** 105
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 94.6
- **Spread:** 
- **Upper Limit:** 100.0
- **Value:** 99.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 95.2
- **Spread:** 
- **Upper Limit:** 100.0
- **Value:** 100.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 100
- **Group ID:** OG001
- **Value:** 75
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 83.6
- **Spread:** 
- **Upper Limit:** 95.8
- **Value:** 91.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 81.5
- **Spread:** 
- **Upper Limit:** 96.1
- **Value:** 90.5
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 100
- **Group ID:** OG001
- **Value:** 74
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 88.7
- **Spread:** 
- **Upper Limit:** 98.4
- **Value:** 95.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 81.2
- **Spread:** 
- **Upper Limit:** 96.1
- **Value:** 90.4
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 100
- **Group ID:** OG001
- **Value:** 73
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 90.1
- **Spread:** 
- **Upper Limit:** 98.9
- **Value:** 96.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 88.8
- **Spread:** 
- **Upper Limit:** 99.2
- **Value:** 96.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 100
- **Group ID:** OG001
- **Value:** 75
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 96.8
- **Spread:** 
- **Upper Limit:** 100.0
- **Value:** 100.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 96.2
- **Spread:** 
- **Upper Limit:** 100.0
- **Value:** 100.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 114
- **Group ID:** OG001
- **Value:** 95
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 96.6
- **Spread:** 
- **Upper Limit:** 100.0
- **Value:** 100.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 95.9
- **Spread:** 
- **Upper Limit:** 100.0
- **Value:** 100.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 106
- **Group ID:** OG001
- **Value:** 89
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 96.0
- **Spread:** 
- **Upper Limit:** 100.0
- **Value:** 100.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 95.1
- **Spread:** 
- **Upper Limit:** 100.0
- **Value:** 100.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 90
- **Group ID:** OG001
- **Value:** 74
**Units:** Participants
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 4.7
- **Spread:** 
- **Upper Limit:** 8.83
- **Value:** 6.44
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 6.08
- **Spread:** 
- **Upper Limit:** 11.09
- **Value:** 8.21
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 150.7
- **Spread:** 
- **Upper Limit:** 252.7
- **Value:** 195.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 186.3
- **Spread:** 
- **Upper Limit:** 329.3
- **Value:** 247.7
**Title:** 
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.165
- **Spread:** 
- **Upper Limit:** 0.237
- **Value:** 0.198
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.181
- **Spread:** 
- **Upper Limit:** 0.268
- **Value:** 0.22
**Title:** 
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.9
- **Spread:** 
- **Upper Limit:** 1.17
- **Value:** 1.03
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.82
- **Spread:** 
- **Upper Limit:** 1.1
- **Value:** 0.95
**Title:** 
#### Outcome Measure 10
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 117.2
- **Spread:** 
- **Upper Limit:** 147.6
- **Value:** 131.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 118.3
- **Spread:** 
- **Upper Limit:** 150.2
- **Value:** 133.3
**Title:** 
#### Outcome Measure 11
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 44.8
- **Spread:** 
- **Upper Limit:** 56.6
- **Value:** 50.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 43.7
- **Spread:** 
- **Upper Limit:** 57.4
- **Value:** 50.1
**Title:** 
#### Outcome Measure 12
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 73.2
- **Spread:** 
- **Upper Limit:** 111.7
- **Value:** 90.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 83.7
- **Spread:** 
- **Upper Limit:** 136.3
- **Value:** 106.8
**Title:** 
#### Outcome Measure 13
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 339.4
- **Spread:** 
- **Upper Limit:** 475.5
- **Value:** 401.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 363.2
- **Spread:** 
- **Upper Limit:** 537.2
- **Value:** 441.7
**Title:** 
#### Outcome Measure 14
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 164.9
- **Spread:** 
- **Upper Limit:** 277.7
- **Value:** 214
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 193.8
- **Spread:** 
- **Upper Limit:** 343.1
- **Value:** 257.9
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 114
- **Group ID:** OG001
- **Value:** 95
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 288.2
- **Spread:** 
- **Upper Limit:** 514.9
- **Value:** 385.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 290.6
- **Spread:** 
- **Upper Limit:** 552.3
- **Value:** 400.6
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 106
- **Group ID:** OG001
- **Value:** 89
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 370.2
- **Spread:** 
- **Upper Limit:** 681.4
- **Value:** 502.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 284.9
- **Spread:** 
- **Upper Limit:** 576
- **Value:** 405.1
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 90
- **Group ID:** OG001
- **Value:** 74
**Units:** Participants
#### Outcome Measure 15
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 73.7
- **Spread:** 
- **Upper Limit:** 90.2
- **Value:** 83.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 30.4
- **Spread:** 
- **Upper Limit:** 51.0
- **Value:** 40.4
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 89
- **Group ID:** OG001
- **Value:** 94
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 30.2
- **Spread:** 
- **Upper Limit:** 51.4
- **Value:** 40.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 9.2
- **Spread:** 
- **Upper Limit:** 25.0
- **Value:** 16.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 89
- **Group ID:** OG001
- **Value:** 94
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 96.7
- **Spread:** 
- **Upper Limit:** 100.0
- **Value:** 100.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 92.2
- **Spread:** 
- **Upper Limit:** 99.4
- **Value:** 97.3
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 111
- **Group ID:** OG001
- **Value:** 111
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 95.0
- **Spread:** 
- **Upper Limit:** 100.0
- **Value:** 99.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 89.7
- **Spread:** 
- **Upper Limit:** 98.5
- **Value:** 95.5
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 111
- **Group ID:** OG001
- **Value:** 111
**Units:** Participants
#### Outcome Measure 16
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 34.4
- **Spread:** 
- **Upper Limit:** 73.4
- **Value:** 50.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 5.9
- **Spread:** 
- **Upper Limit:** 12.9
- **Value:** 8.7
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 89
- **Group ID:** OG001
- **Value:** 94
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2597.4
- **Spread:** 
- **Upper Limit:** 4086.3
- **Value:** 3257.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 432.7
- **Spread:** 
- **Upper Limit:** 779.5
- **Value:** 580.8
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 111
- **Group ID:** OG001
- **Value:** 111
**Units:** Participants
#### Outcome Measure 17
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 86.3
- **Spread:** 
- **Upper Limit:** 98.0
- **Value:** 93.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 88.6
- **Spread:** 
- **Upper Limit:** 98.7
- **Value:** 95.4
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 82
- **Group ID:** OG001
- **Value:** 87
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 43.5
- **Spread:** 
- **Upper Limit:** 65.9
- **Value:** 54.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 45.3
- **Spread:** 
- **Upper Limit:** 66.9
- **Value:** 56.3
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 82
- **Group ID:** OG001
- **Value:** 87
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 96.7
- **Spread:** 
- **Upper Limit:** 100.0
- **Value:** 100.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 96.6
- **Spread:** 
- **Upper Limit:** 100.0
- **Value:** 100.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 111
- **Group ID:** OG001
- **Value:** 111
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 95.0
- **Spread:** 
- **Upper Limit:** 100.0
- **Value:** 99.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 96.6
- **Spread:** 
- **Upper Limit:** 100.0
- **Value:** 100.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 111
- **Group ID:** OG001
- **Value:** 111
**Units:** Participants
#### Outcome Measure 18
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.81
- **Spread:** 
- **Upper Limit:** 1.45
- **Value:** 1.09
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.90
- **Spread:** 
- **Upper Limit:** 1.55
- **Value:** 1.18
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 82
- **Group ID:** OG001
- **Value:** 87
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 81.05
- **Spread:** 
- **Upper Limit:** 123.86
- **Value:** 100.19
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 101.11
- **Spread:** 
- **Upper Limit:** 144.80
- **Value:** 121.00
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 110
- **Group ID:** OG001
- **Value:** 106
**Units:** Participants
#### Outcome Measure 19
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 95.0
- **Spread:** 
- **Upper Limit:** 99.8
- **Value:** 98.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 92.9
- **Spread:** 
- **Upper Limit:** 99.2
- **Value:** 97.2
**Title:** 
#### Outcome Measure 20
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 95.0
- **Spread:** 
- **Upper Limit:** 99.8
- **Value:** 98.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 92.0
- **Spread:** 
- **Upper Limit:** 98.8
- **Value:** 96.5
**Title:** 
#### Outcome Measure 21
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 62.9
- **Spread:** 
- **Upper Limit:** 78.4
- **Value:** 71.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 56.3
- **Spread:** 
- **Upper Limit:** 72.6
- **Value:** 64.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 54.9
- **Spread:** 
- **Upper Limit:** 71.3
- **Value:** 63.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 57.8
- **Spread:** 
- **Upper Limit:** 73.9
- **Value:** 66.2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 42.9
- **Spread:** 
- **Upper Limit:** 59.9
- **Value:** 51.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 38.8
- **Spread:** 
- **Upper Limit:** 55.7
- **Value:** 47.2
**Title:** 
#### Outcome Measure 22
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2.9
- **Spread:** 
- **Upper Limit:** 11.7
- **Value:** 6.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 6.6
- **Spread:** 
- **Upper Limit:** 17.7
- **Value:** 11.3
**Title:** 
#### Outcome Measure 23
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 47.8
- **Spread:** 
- **Upper Limit:** 64.6
- **Value:** 56.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 37.4
- **Spread:** 
- **Upper Limit:** 54.3
- **Value:** 45.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 33.3
- **Spread:** 
- **Upper Limit:** 50.1
- **Value:** 41.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 37.4
- **Spread:** 
- **Upper Limit:** 54.3
- **Value:** 45.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 28.0
- **Spread:** 
- **Upper Limit:** 44.4
- **Value:** 35.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 20.9
- **Spread:** 
- **Upper Limit:** 36.3
- **Value:** 28.2
**Title:** 
#### Outcome Measure 24
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4.2
**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:** 0.7
**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:** 0.7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0.7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2.1
**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:** 0.7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0.7
**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:** 2.1
**Title:** 
#### Outcome Measure 25
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 85.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 81.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 63.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 64.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 88.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 81.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 10.6
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 81.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 78.9
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 40.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 49.3
**Title:** 
#### Outcome Measure 26
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 10.6
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2.1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0.0
**Title:** 
#### Outcome Measure 27
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1.6
- **Spread:** 
- **Upper Limit:** 9.0
- **Value:** 4.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.8
- **Spread:** 
- **Upper Limit:** 7.1
- **Value:** 2.8
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** The acceptability (i.e., percentage of participants with anti-MCC Ab titre ≥1:8 dil) of the seroprotection rate (SPR) to MCC was determined 1 month after MCC-TT or MCC-CRM Dose 2. The SPR was considered acceptable if the lower bound of the 2-sided 95% CI was \>90%. Serum Ab levels were assayed using the Meningo C rabbit complement serum bactericidal Ab (rSBA) assay.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.
**Reporting Status:** POSTED
**Time Frame:** Month 5 (1 month after MCC-TT/MCC-CRM Dose 2)
**Title:** Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8 Dil One Month After MCC-TT or MCC-CRM (Part 1)
**Type:** PRIMARY
**Unit of Measure:** Percentage of Participants
##### Group
**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
**ID:** OG000
**Title:** V419 and MCC-TT
##### Group
**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
**ID:** OG001
**Title:** V419 and MCC-CRM
#### Outcome Measure 2
**Description:** The acceptability (i.e., percentage of participants with anti-PRP Ab titre ≥0.15 µg/mL) of the seroprotection rate (SPR) to Haemophilus influenza type b (Hib) was determined 1 month after the third dose of V419 in participants also treated with MCC-TT or MCC-CRM. The pooled (i.e., all V419-treated participants) SPR was considered acceptable if the lower bound of the 2-sided 95% CI was \>80%. Serum Ab levels were determined with radioimmunoassay (RIA).
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.
**Reporting Status:** POSTED
**Time Frame:** Month 5 (1 month after V419 Dose 3)
**Title:** Percentage of Participants With Anti-Polyribosylribitol Phosphate (Anti-PRP) Antibody (Ab) Titre ≥0.15 µg/mL One Month After V419 Dose 3 (Part 1)
**Type:** SECONDARY
**Unit of Measure:** Percentage of Participants
##### Group
**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT or MCC-CRM (at 3 and 4 months of age).
**ID:** OG000
**Title:** V419 + MCC-TT/MCC-CRM
#### Outcome Measure 3
**Description:** The percentage of participants with anti-MCC Ab titres ≥1:8 dil and ≥1:128 dil 1 month after MCC-TT or MCC-CRM Doses 1 and 2 was determined in participants also treated with V419. Serum Ab levels were assayed using the Meningo C rabbit complement serum bactericidal Ab (rSBA) assay.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.
**Reporting Status:** POSTED
**Time Frame:** Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2)
**Title:** Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8 Dil and ≥1:128 Dil One Month After MCC-TT or MCC-CRM Doses 1 and 2 (Part 1)
**Type:** SECONDARY
**Unit of Measure:** Percentage of Participants
##### Group
**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
**ID:** OG000
**Title:** V419 and MCC-TT
##### Group
**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
**ID:** OG001
**Title:** V419 and MCC-CRM
#### Outcome Measure 4
**Description:** Anti-MCC antibody GMTs were determined 1 month after MCC-TT or MCC-CRM Doses 1 and 2 in participants also treated with V419. Serum antibody levels were assayed using the Meningo C rabbit complement serum bactericidal antibody (rSBA) assay.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** GEOMETRIC_MEAN
**Population Description:** All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.
**Reporting Status:** POSTED
**Time Frame:** Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2)
**Title:** Geometric Mean Titres (GMTs) for Meningococcal Serogroup C (MCC) One Month After MCC-TT or MCC-CRM Doses 1 and 2 (Part 1)
**Type:** SECONDARY
**Unit of Measure:** Titres
##### Group
**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
**ID:** OG000
**Title:** V419 and MCC-TT
##### Group
**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
**ID:** OG001
**Title:** V419 and MCC-CRM
#### Outcome Measure 5
**Description:** The percentage of participants meeting Ab response rates for V14 antigens was determined after V114 Dose 3. Antibody response rate criteria for Haemophilus influenza Type B (PRP); hepatitis B (HBsAg); diphtheria; tetanus; and polio types 1, 2, and 3 are shown in the rows below. The percentage of seroresponders to pertussis seroresponders (pertussis toxoid \[PT\]; filamentous haemagglutinin (FHA); fimbrae types 2 and 3 \[FIM\]; and pertactin \[PRN\]) was determined as 1) if pre-vaccination Ab concentration \<lower limit of quantification (LLoQ) but post-vaccination Ab concentration ≥LLoQ; or 2) if pre-vaccination Ab concentration was ≥LLoQ but post-vaccination Ab concentration was ≥pre-immunization levels. Antibody titres were measured by RIA for PRP, enhanced chemiluminescence assay (ECi) for HBsAg, micrometabolic inhibition test (MIT) for diphtheria and poliovirus, and enzyme-linked immunosorbent assay (ELISA) for tetanus, PT, FHA, FIM, and PRN.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.
**Reporting Status:** POSTED
**Time Frame:** Month 5 (1 month after V419 Dose 3)
**Title:** Antibody (Ab) Response Rates for V114 Antigens One Month After V114 Dose 3 (Part 1)
**Type:** SECONDARY
**Unit of Measure:** Percentage of Participants
##### Group
**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
**ID:** OG000
**Title:** V419 and MCC-TT
##### Group
**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
**ID:** OG001
**Title:** V419 and MCC-CRM
#### Outcome Measure 6
**Description:** The GMTs for PRP Ab titres were determined for each arm. Antibody titres for PRP were measured by radioimmunoassay (RIA).
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** GEOMETRIC_MEAN
**Population Description:** All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.
**Reporting Status:** POSTED
**Time Frame:** Month 5 (1 month after V419 Dose 3)
**Title:** Antibody (Ab) Geometic Mean Titres (GMTs) for Haemophilus Influenza Type B (Polyribosylribitol Phosphate [PRP]) One Month After V114 Dose 3 (Part 2)
**Type:** SECONDARY
**Unit of Measure:** µg/mL
##### Group
**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
**ID:** OG000
**Title:** V419 and MCC-TT
##### Group
**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
**ID:** OG001
**Title:** V419 and MCC-CRM
#### Outcome Measure 7
**Description:** The GMTs for HBsAg Ab titres were determined for each arm. Antibody titres for HBsAg were measured by enhanced chemiluminescence (ECi) assay.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** GEOMETRIC_MEAN
**Population Description:** All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.
**Reporting Status:** POSTED
**Time Frame:** Month 5 (1 month after V419 Dose 3)
**Title:** Antibody (Ab) Geometic Mean Titres (GMTs) for Hepatitis B Surface Antigen (HBsAg) One Month After V114 Dose 3 (Part 2)
**Type:** SECONDARY
**Unit of Measure:** mIU/mL
##### Group
**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
**ID:** OG000
**Title:** V419 and MCC-TT
##### Group
**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
**ID:** OG001
**Title:** V419 and MCC-CRM
#### Outcome Measure 8
**Description:** The GMTs for diphtheria Ab titres were determined for each arm. Antibody titres for diptheria were measured by enhanced micrometabolic inhibition test (MIT).
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** GEOMETRIC_MEAN
**Population Description:** All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.
**Reporting Status:** POSTED
**Time Frame:** Month 5 (1 month after V419 Dose 3)
**Title:** Antibody (Ab) Geometic Mean Titres (GMTs) for Diptheria One Month After V114 Dose 3 (Part 2)
**Type:** SECONDARY
**Unit of Measure:** IU/mL
##### Group
**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
**ID:** OG000
**Title:** V419 and MCC-TT
##### Group
**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
**ID:** OG001
**Title:** V419 and MCC-CRM
#### Outcome Measure 9
**Description:** The GMTs for tetanus Ab titres were determined for each arm. Antibody titres for tetanus were determined with enzyme-linked immunosorbent assay (ELISA).
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** GEOMETRIC_MEAN
**Population Description:** All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.
**Reporting Status:** POSTED
**Time Frame:** Month 5 (1 month after V419 Dose 3)
**Title:** Antibody (Ab) Geometic Mean Titres (GMTs) for Tetanus One Month After V114 Dose 3 (Part 2)
**Type:** SECONDARY
**Unit of Measure:** IU/mL
##### Group
**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
**ID:** OG000
**Title:** V419 and MCC-TT
##### Group
**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
**ID:** OG001
**Title:** V419 and MCC-CRM
#### Outcome Measure 10
**Description:** The GMTs for PT Ab titres were determined for each arm. Antibody titres for PT were measured with enzyme-linked immunosorbent assay (ELISA).
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** GEOMETRIC_MEAN
**Population Description:** All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.
**Reporting Status:** POSTED
**Time Frame:** Month 5 (1 month after V419 Dose 3)
**Title:** Antibody (Ab) Geometic Mean Titres (GMTs) for Pertussis Toxoid (PT) One Month After V114 Dose 3 (Part 2)
**Type:** SECONDARY
**Unit of Measure:** EU/mL
##### Group
**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
**ID:** OG000
**Title:** V419 and MCC-TT
##### Group
**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
**ID:** OG001
**Title:** V419 and MCC-CRM
#### Outcome Measure 11
**Description:** The GMTs for FHA were determined for each arm. Antibody titres for FHA were measured by enhanced chemiluminescence (ECi) assay.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** GEOMETRIC_MEAN
**Population Description:** All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.
**Reporting Status:** POSTED
**Time Frame:** Month 5 (1 month after V419 Dose 3)
**Title:** Antibody (Ab) Geometic Mean Titres (GMTs) for Filamentous Haemagglutinin (FHA) One Month After V114 Dose 3 (Part 2)
**Type:** SECONDARY
**Unit of Measure:** EU/mL
##### Group
**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
**ID:** OG000
**Title:** V419 and MCC-TT
##### Group
**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
**ID:** OG001
**Title:** V419 and MCC-CRM
#### Outcome Measure 12
**Description:** The GMTs for PRN were determined for each arm. Antibody titres for PRN were measured by enhanced chemiluminescence (ECi) assay.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** GEOMETRIC_MEAN
**Population Description:** All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.
**Reporting Status:** POSTED
**Time Frame:** Month 5 (1 month after V419 Dose 3)
**Title:** Antibody (Ab) Geometic Mean Titres (GMTs) for Pertactin (PRN) One Month After V114 Dose 3 (Part 2)
**Type:** SECONDARY
**Unit of Measure:** EU/mL
##### Group
**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
**ID:** OG000
**Title:** V419 and MCC-TT
##### Group
**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
**ID:** OG001
**Title:** V419 and MCC-CRM
#### Outcome Measure 13
**Description:** The GMTs for FIM were determined for each arm. Antibody titres for FIM were measured by enhanced chemiluminescence (ECi) assay.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** GEOMETRIC_MEAN
**Population Description:** All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.
**Reporting Status:** POSTED
**Time Frame:** Month 5 (1 month after V419 Dose 3)
**Title:** Antibody (Ab) Geometic Mean Titres (GMTs) for Fimbrae Types 2 and 3 (FIM) One Month After V114 Dose 3 (Part 2)
**Type:** SECONDARY
**Unit of Measure:** EU/mL
##### Group
**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
**ID:** OG000
**Title:** V419 and MCC-TT
##### Group
**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
**ID:** OG001
**Title:** V419 and MCC-CRM
#### Outcome Measure 14
**Description:** The GMTs for polio types 1, 2, and 3 were determined for each arm. Antibody titres for polio types 1, 2, and 3 were measured by micrometabolic inhibition test (MIT).
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** GEOMETRIC_MEAN
**Population Description:** All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.
**Reporting Status:** POSTED
**Time Frame:** Month 5 (1 month after V419 Dose 3)
**Title:** Antibody (Ab) Geometic Mean Titres (GMTs) for Polio Types 1, 2, and 3 One Month After V114 Dose 3 (Part 2)
**Type:** SECONDARY
**Unit of Measure:** titre (1/dil)
##### Group
**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
**ID:** OG000
**Title:** V419 and MCC-TT
##### Group
**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
**ID:** OG001
**Title:** V419 and MCC-CRM
#### Outcome Measure 15
**Description:** The percentage of participants with anti-Hib Ab titres ≥1:8 (1/dil) and ≥1:28 (1/dil) were determined prior to, and 1 month after, administration of the single HiB-MCC vaccine at 12 months of age. Serum Ab levels were assayed using the Meningo C rabbit complement serum bactericidal Ab (rSBA) assay.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** All randomized and treated participants with data available, who had no protocol violations that could interfere with results, and received all Part 1 vaccinations are included.
**Reporting Status:** POSTED
**Time Frame:** Month 12 and Month 13 (Prior to anti-Hib MCC and 1 month after anti-HiB MCC)
**Title:** Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8(1/Dil) and Titre ≥1:28 (1/Dil) One Month After Anti-Haemophilus Influenzae Type B (Anti-Hib) Vaccination (Part 2)
**Type:** SECONDARY
**Unit of Measure:** Percentage of Participants
##### Group
**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
**ID:** OG000
**Title:** V419 and MCC-TT
##### Group
**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
**ID:** OG001
**Title:** V419 and MCC-CRM
#### Outcome Measure 16
**Description:** Antibody GMTs were were determined prior to, and 1 month after, administration of the single HiB-MCC vaccine at 12 months of age. Serum Ab levels were assayed using the Meningo C rabbit complement serum bactericidal Ab (rSBA) assay.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** GEOMETRIC_MEAN
**Population Description:** All randomized and treated participants with data available, who had no protocol violations that could interfere with results, and received all Part 1 vaccinations are included.
**Reporting Status:** POSTED
**Time Frame:** Month 12 and Month 13 (Prior to anti-Hib MCC and 1 month after anti-HiB MCC)
**Title:** Antibody (Ab) Geometric Mean Titres (GMTs) for Meningococcal Serogroup C (MCC) One Month After Anti-Haemophilus Influenzae Type B (Anti-Hib) Meningococcal Serogroup C (MCC) Vaccination (Part 2)
**Type:** SECONDARY
**Unit of Measure:** tire (1/dil)
##### Group
**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
**ID:** OG000
**Title:** V419 and MCC-TT
##### Group
**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
**ID:** OG001
**Title:** V419 and MCC-CRM
#### Outcome Measure 17
**Description:** The percentage of participants with anti-PRP Ab titres ≥0.15 µg/mL and ≥1.0 µg/mL was determined prior to, and 1 month after, administration of the anti-Hib vaccination at Month 12. Anti-PRP Ab titres were measured with radioimmunoassay (RIA).
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.
**Reporting Status:** POSTED
**Time Frame:** Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2)
**Title:** Percentage of Participants With Anti-Polyribosylribitol Phosphate (PRP) Antibody (Ab) Titres ≥0.15 µg/mL and ≥1.0 µg/mL One Month After Anti-Haemophilus Influenzae Type B MCC Vaccination (Part 2)
**Type:** SECONDARY
**Unit of Measure:** Percentage of Participants
##### Group
**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
**ID:** OG000
**Title:** V419 and MCC-TT
##### Group
**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
**ID:** OG001
**Title:** V419 and MCC-CRM
#### Outcome Measure 18
**Description:** Anti-PRP Ab GMTs were determined prior to, and 1 month after, administration of the anti-Hib vaccination at Month 12. Anti-PRP Ab titres were measured with radioimmunoassay (RIA) and are expressed as µg/mL..
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** GEOMETRIC_MEAN
**Population Description:** All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.
**Reporting Status:** POSTED
**Time Frame:** Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2)
**Title:** Geometric Mean Titres (GMTs) for Anti-Polyribosylribitol Phosphate (PRP) Antibody (Ab) One Month After Anti-Haemophilus Influenzae Type B (HiB) MCC Vaccination (Part 2)
**Type:** SECONDARY
**Unit of Measure:** µg/mL
##### Group
**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
**ID:** OG000
**Title:** V419 and MCC-TT
##### Group
**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
**ID:** OG001
**Title:** V419 and MCC-CRM
#### Outcome Measure 19
**Description:** An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the investigational product, whether or not considered related to the use of the product.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** All randomized participants who received ≥1 dose of study medication in Part 1 are included.
**Reporting Status:** POSTED
**Time Frame:** Up to 4.5 months (up to 15 days after the final Part 1 vaccination)
**Title:** Percentage of Participants Experiencing an Adverse Event (AE) [Part 1]
**Type:** SECONDARY
**Unit of Measure:** Percentage of Participants
##### Group
**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
**ID:** OG000
**Title:** V419 and MCC-TT
##### Group
**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
**ID:** OG001
**Title:** V419 and MCC-CRM
#### Outcome Measure 20
**Description:** An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the investigational product, whether or not considered related to the use of the product. As per protocol, all injection site AEs were considered vaccine-related.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** All randomized participants who received ≥1 dose of study medication in Part 1 are included.
**Reporting Status:** POSTED
**Time Frame:** Up to 4.5 months (up to 15 days after the final Part 1 vaccination)
**Title:** Percentage of Participants Experiencing an Injection Site (Vaccine-Related) Systemic Adverse Event (AE) [Part 1]
**Type:** SECONDARY
**Unit of Measure:** Percentage of Participants
##### Group
**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
**ID:** OG000
**Title:** V419 and MCC-TT
##### Group
**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
**ID:** OG001
**Title:** V419 and MCC-CRM
#### Outcome Measure 21
**Description:** The percentage of participants with solicited ISRs was determined for each arm. Solicited ISRs consisted of injection site pain, erythema, and swelling.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** All randomized participants who received ≥1 dose of study medication in Part 1 are included.
**Reporting Status:** POSTED
**Time Frame:** Up to 4.5 months (up to 15 days after the final Part 1 vaccination)
**Title:** Percentage of Participants Experiencing a Solicited Injection Site Reaction (ISR) at the V419 Injection Site (Part 1)
**Type:** SECONDARY
**Unit of Measure:** Percentage of Participants
##### Group
**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
**ID:** OG000
**Title:** V419 and MCC-TT
##### Group
**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
**ID:** OG001
**Title:** V419 and MCC-CRM
#### Outcome Measure 22
**Description:** The percentage of participants with unsolicited ISRs was determined for each arm. Unsolicited ISRs were any injection-site ISRs not considered solicited.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** All randomized participants who received ≥1 dose of study medication in Part 1 are included.
**Reporting Status:** POSTED
**Time Frame:** Up to 4.5 months (up to 15 days after the final Part 1 vaccination)
**Title:** Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the V419 Injection Site (Part 1)
**Type:** SECONDARY
**Unit of Measure:** Percentage of Participants
##### Group
**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
**ID:** OG000
**Title:** V419 and MCC-TT
##### Group
**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
**ID:** OG001
**Title:** V419 and MCC-CRM
#### Outcome Measure 23
**Description:** The percentage of participants with solicited ISRs was determined for each arm. Solicited ISRs consisted of injection site pain, erythema, and swelling.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** All randomized participants who received ≥1 dose of study medication in Part 1 are included.
**Reporting Status:** POSTED
**Time Frame:** Up to 4.5 months (up to 15 days after the final Part 1 vaccination)
**Title:** Percentage of Participants Experiencing a Solicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1)
**Type:** SECONDARY
**Unit of Measure:** Percentage of Participants
##### Group
**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
**ID:** OG000
**Title:** V419 and MCC-TT
##### Group
**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
**ID:** OG001
**Title:** V419 and MCC-CRM
#### Outcome Measure 24
**Description:** The percentage of participants with unsolicited ISRs was determined for each arm. Unsolicited ISRs consisted of bruising, dermatitis, erythema, induration, mass, pain, rash, and warmth.
**Parameter Type:** NUMBER
**Population Description:** All randomized participants who received ≥1 dose of study medication in Part 1 are included.
**Reporting Status:** POSTED
**Time Frame:** Up to 4.5 months (up to 15 days after the final Part 1 vaccination)
**Title:** Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1)
**Type:** SECONDARY
**Unit of Measure:** Percentage of Participants
##### Group
**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
**ID:** OG000
**Title:** V419 and MCC-TT
##### Group
**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
**ID:** OG001
**Title:** V419 and MCC-CRM
#### Outcome Measure 25
**Description:** The percentage of participants with solicited systemic AEs was determined for each arm. Solicited systemic AEs consisted of crying, decreased appetite, irritability, pyrexia, somnolence, and vomiting.
**Parameter Type:** NUMBER
**Population Description:** All randomized participants who received ≥1 dose of study medication in Part 1 are included.
**Reporting Status:** POSTED
**Time Frame:** Up to 4.5 months (up to 15 days after the final Part 1 vaccination)
**Title:** Percentage of Participants Experiencing a Solicited Systemic Adverse Event (AE) [Part 1]
**Type:** SECONDARY
**Unit of Measure:** Percentage of Participants
##### Group
**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
**ID:** OG000
**Title:** V419 and MCC-TT
##### Group
**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
**ID:** OG001
**Title:** V419 and MCC-CRM
#### Outcome Measure 26
**Description:** The percentage of participants experiencing temperatures ≥38.0° Celsius (C), \>38.5° C, and \>39.5° C following any Part 1 vaccination was determined.
**Parameter Type:** NUMBER
**Population Description:** All randomized participants who received ≥1 dose of study medication in Part 1 are included.
**Reporting Status:** POSTED
**Time Frame:** Up to 4.5 months (up to 15 days after the final Part 1 vaccination)
**Title:** Percentage of Participants Experiencing Increased Temperature [Part 1]
**Type:** SECONDARY
**Unit of Measure:** Percentage of Participants
##### Group
**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
**ID:** OG000
**Title:** V419 and MCC-TT
##### Group
**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
**ID:** OG001
**Title:** V419 and MCC-CRM
#### Outcome Measure 27
**Description:** An SAE is an event that results in death; is life-threatening; results in or prolongs hospitalization; is a congenital anomaly/birth defect; is a cancer; is an overdose; or is another important medical event that may jeopardize the participant.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** All randomized participants who received ≥1 dose of study medication in Part 1 are included.
**Reporting Status:** POSTED
**Time Frame:** Up to 4.5 months (up to 15 days after the final Part 1 vaccination)
**Title:** Percentage of Participants Experiencing a Serious Adverse Event (SAE) [Part 1]
**Type:** SECONDARY
**Unit of Measure:** Percentage of Participants
##### Group
**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
**ID:** OG000
**Title:** V419 and MCC-TT
##### Group
**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
**ID:** OG001
**Title:** V419 and MCC-CRM
### Participant Flow Module
#### Group
**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
**ID:** FG000
**Title:** V419 and MCC-TT
#### Group
**Description:** In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
**ID:** FG001
**Title:** V419 and MCC-CRM
#### Period
**Title:** Part 1 (Infant Vaccinations)
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Milestone
**Type:** STARTED
**Comment:** Number Randomized
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 142
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 142
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 140
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 141
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 2
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 1
#### Period
**Title:** Interim Period
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 140
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 141
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 137
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 139
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 2
#### Period
**Title:** Period 2: Toddler Vaccinations
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 5
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 3
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 137
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 139
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 134
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 132
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 7
**Recruitment Details:** Infant participants were enrolled at 11 study sites in the United Kingdom.
**Has Results:** True