Trial Outcomes & Findings for Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine When Co-administered With Routine Pediatric Vaccines in Healthy Infants and Toddlers in Europe (NCT NCT03547271)

Last Updated: 2025-03-03

Results Overview

Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the serum bactericidal assay using human complement (hSBA).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1660 participants

Primary outcome timeframe

At 30 days post Dose 3 [12 to 18 months of age (MoA)]

Results posted on

2025-03-03

Participant Flow

This study was conducted at 33 investigational sites in 7 countries between 14 December 2018 to 24 May 2023.

A total of 1660 participants were enrolled in this study.

Participant milestones

Participant milestones
Measure	Group 1: MenACYW Participants received 3 doses of meningococcal polysaccharide (serogroups A, C, Y and W) tetanus toxoid \[MenACYW conjugate vaccine\] 0.5 milliliter (mL) as an intramuscular (IM) injection at dose 1: 2 months of age (MoA), dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and haemophilus influenzae type b conjugate vaccine \[DTaP-IPV-HB-Hib\], the pneumococcal vaccine (pneumococcal conjugate vaccine \[10-valent, adsorbed\] {PCV10} were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the measles, mumps, rubella (MMR) vaccine was administered at 12 to 18 MoA.	Group 2: Nimenrix Participants received 3 doses of Nimenrix® 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV10 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 3: MenACYW Participants received 3 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the pneumococcal conjugate vaccine (13-valent, adsorbed) \[PCV13\] were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 4: MenACYW Participants received 4 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 6 MoA and dose 4: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV13 were administered in a 2+1 regimen (concomitantly with the first and second doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and the toddler dose of MenACYW conjugate vaccine \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA. The third dose of MenACYW conjugate vaccine was administered alone, without any other routine pediatric vaccines.
Overall Study STARTED	714	726	112	108
Overall Study Safety Analysis Set (SafAS)	696	706	112	108
Overall Study COMPLETED	681	691	106	104
Overall Study NOT COMPLETED	33	35	6	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1: MenACYW Participants received 3 doses of meningococcal polysaccharide (serogroups A, C, Y and W) tetanus toxoid \[MenACYW conjugate vaccine\] 0.5 milliliter (mL) as an intramuscular (IM) injection at dose 1: 2 months of age (MoA), dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and haemophilus influenzae type b conjugate vaccine \[DTaP-IPV-HB-Hib\], the pneumococcal vaccine (pneumococcal conjugate vaccine \[10-valent, adsorbed\] {PCV10} were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the measles, mumps, rubella (MMR) vaccine was administered at 12 to 18 MoA.	Group 2: Nimenrix Participants received 3 doses of Nimenrix® 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV10 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 3: MenACYW Participants received 3 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the pneumococcal conjugate vaccine (13-valent, adsorbed) \[PCV13\] were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 4: MenACYW Participants received 4 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 6 MoA and dose 4: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV13 were administered in a 2+1 regimen (concomitantly with the first and second doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and the toddler dose of MenACYW conjugate vaccine \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA. The third dose of MenACYW conjugate vaccine was administered alone, without any other routine pediatric vaccines.
Overall Study Adverse Event	1	1	0	0
Overall Study Protocol deviation	5	7	3	0
Overall Study Withdrawal by Parent/Guardian	24	24	2	4
Overall Study Lost to Follow-up	3	3	1	0

Baseline Characteristics

Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine When Co-administered With Routine Pediatric Vaccines in Healthy Infants and Toddlers in Europe

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1: MenACYW n=714 Participants Participants received 3 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV10 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 2: Nimenrix n=726 Participants Participants received 3 doses of Nimenrix® 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV10 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 3: MenACYW n=112 Participants Participants received 3 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV13 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 4: MenACYW n=108 Participants Participants received 4 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 6 MoA and dose 4: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV13 were administered in a 2+1 regimen (concomitantly with the first and second doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and the toddler dose of MenACYW conjugate vaccine \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA. The third dose of MenACYW conjugate vaccine was administered alone, without any other routine pediatric vaccines.	Total n=1660 Participants Total of all reporting groups
Age, Continuous	72.6 Days STANDARD_DEVIATION 12.2 • n=5 Participants	72.4 Days STANDARD_DEVIATION 12.1 • n=7 Participants	62.5 Days STANDARD_DEVIATION 7.12 • n=5 Participants	63.3 Days STANDARD_DEVIATION 7.93 • n=4 Participants	71.2 Days STANDARD_DEVIATION 12.1 • n=21 Participants
Sex: Female, Male Female	355 Participants n=5 Participants	378 Participants n=7 Participants	45 Participants n=5 Participants	58 Participants n=4 Participants	836 Participants n=21 Participants
Sex: Female, Male Male	359 Participants n=5 Participants	348 Participants n=7 Participants	67 Participants n=5 Participants	50 Participants n=4 Participants	824 Participants n=21 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	9 Participants n=21 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	4 Participants n=21 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized White	693 Participants n=5 Participants	699 Participants n=7 Participants	106 Participants n=5 Participants	101 Participants n=4 Participants	1599 Participants n=21 Participants
Race/Ethnicity, Customized Not Reported	13 Participants n=5 Participants	16 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	30 Participants n=21 Participants
Race/Ethnicity, Customized Unknown	2 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	5 Participants n=21 Participants
Race/Ethnicity, Customized Multiple origin	4 Participants n=5 Participants	6 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	11 Participants n=21 Participants

PRIMARY outcome

Timeframe: At 30 days post Dose 3 [12 to 18 months of age (MoA)]

Population: Per-Protocol Analysis Set 2 (PPAS2) was a subset of Full Analysis Set 2 (FAS2). The FAS2 included the subset of randomized participants who received at least 1 dose of the study vaccine at booster vaccination and had a valid post-booster vaccination blood sample result. Only participants with data collected for each specific serogroup are reported.

Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the serum bactericidal assay using human complement (hSBA).

Outcome measures

Outcome measures
Measure	Group 1: MenACYW n=554 Participants Participants received 3 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV10 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 2: Nimenrix n=579 Participants Participants received 3 doses of Nimenrix® 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV10 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 3: MenACYW Participants received 3 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV13 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 4: MenACYW Participants received 4 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 6 MoA and dose 4: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV13 were administered in a 2+1 regimen (concomitantly with the first and second doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and the toddler dose of MenACYW conjugate vaccine \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA. The third dose of MenACYW conjugate vaccine was administered alone, without any other routine pediatric vaccines.
Groups 1 and 2: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y Serogroup A	131 Titer Interval 113.0 to 151.0	189 Titer Interval 165.0 to 218.0	—	—
Groups 1 and 2: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y Serogroup C	565 Titer Interval 505.0 to 632.0	120 Titer Interval 106.0 to 135.0	—	—
Groups 1 and 2: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y Serogroup W	423 Titer Interval 382.0 to 468.0	275 Titer Interval 247.0 to 305.0	—	—
Groups 1 and 2: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y Serogroup Y	285 Titer Interval 260.0 to 313.0	160 Titer Interval 145.0 to 177.0	—	—

SECONDARY outcome

Timeframe: At 30 days post Dose 2 (4 MoA)

Population: PPAS1 was a subset of FAS1. The FAS1 included the subset of randomized participants who received at least 1 dose of the study vaccine in the primary series and had a valid post-primary series vaccination blood sample result. Only participants with data collected for each specific serogroup are reported.

Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the hSBA. Percentages are rounded off to the tenth decimal place.

Outcome measures

Outcome measures
Measure	Group 1: MenACYW n=518 Participants Participants received 3 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV10 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 2: Nimenrix n=523 Participants Participants received 3 doses of Nimenrix® 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV10 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 3: MenACYW Participants received 3 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV13 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 4: MenACYW Participants received 4 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 6 MoA and dose 4: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV13 were administered in a 2+1 regimen (concomitantly with the first and second doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and the toddler dose of MenACYW conjugate vaccine \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA. The third dose of MenACYW conjugate vaccine was administered alone, without any other routine pediatric vaccines.
Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, W, and Y Serogroup A	63.6 Percentage of participants Interval 59.2 to 67.8	75.8 Percentage of participants Interval 71.8 to 79.5	—	—
Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, W, and Y Serogroup C	98.8 Percentage of participants Interval 97.5 to 99.6	91.9 Percentage of participants Interval 89.3 to 94.1	—	—
Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, W, and Y Serogroup W	96.5 Percentage of participants Interval 94.6 to 97.9	94.5 Percentage of participants Interval 92.1 to 96.3	—	—
Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, W, and Y Serogroup Y	96.5 Percentage of participants Interval 94.5 to 97.9	93.5 Percentage of participants Interval 91.0 to 95.5	—	—

SECONDARY outcome

Timeframe: Group 3: Day 0 before Dose 1 (2 MoA) and Dose 3 (12 to 18 MoA) and Day 30 Post Dose 2 (4 MoA) and Dose 3 (12 to 18 MoA); Group 4: Day 0 before Dose 1 (2 MoA) and Dose 4 (12 to 18 MoA) and Day 30 Post Dose 3 (6 MoA) and Dose 4 (12 to 18 MoA)

Population: PPAS1 was a subset of FAS1. FAS1: subset of randomized participants who received at least 1 dose of study vaccine in primary series and had valid post-primary series vaccination blood sample result. PPAS2 was a subset of FAS2. FAS2: subset of randomized participants who received at least 1 dose of study vaccine at booster vaccination and had valid post-booster vaccination blood sample result. Only participants with data collected for each specific serogroup at specified timepoints are reported.

Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the hSBA.

Outcome measures

Outcome measures
Measure	Group 1: MenACYW n=96 Participants Participants received 3 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV10 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 2: Nimenrix n=90 Participants Participants received 3 doses of Nimenrix® 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV10 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 3: MenACYW Participants received 3 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV13 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 4: MenACYW Participants received 4 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 6 MoA and dose 4: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV13 were administered in a 2+1 regimen (concomitantly with the first and second doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and the toddler dose of MenACYW conjugate vaccine \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA. The third dose of MenACYW conjugate vaccine was administered alone, without any other routine pediatric vaccines.
Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y PPAS1: Serogroup A: Day 0 before dose 1	3.00 Titer Interval 2.58 to 3.49	2.86 Titer Interval 2.49 to 3.28	—	—
Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y PPAS1: Serogroup A: Day 30 post dose 2	14.8 Titer Interval 10.6 to 20.8	—	—	—
Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y PPAS1: Serogroup A: Day 30 post dose 3	—	23.0 Titer Interval 17.1 to 30.9	—	—
Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y PPAS1: Serogroup C: Day 0 before dose 1	3.91 Titer Interval 3.16 to 4.84	3.88 Titer Interval 3.25 to 4.62	—	—
Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y PPAS1: Serogroup C: Day 30 post dose 2	309 Titer Interval 235.0 to 407.0	—	—	—
Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y PPAS1: Serogroup C: Day 30 post dose 3	—	481 Titer Interval 376.0 to 616.0	—	—
Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y PPAS1: Serogroup W: Day 0 before dose 1	2.67 Titer Interval 2.4 to 2.96	3.08 Titer Interval 2.63 to 3.6	—	—
Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y PPAS1: Serogroup W: Day 30 post dose 2	102 Titer Interval 79.7 to 131.0	—	—	—
Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y PPAS1: Serogroup W: Day 30 post dose 3	—	196 Titer Interval 156.0 to 245.0	—	—
Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y PPAS1: Serogroup Y: Day 0 before dose 1	2.85 Titer Interval 2.45 to 3.32	2.76 Titer Interval 2.36 to 3.23	—	—
Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y PPAS1: Serogroup Y: Day 30 post dose 2	73.4 Titer Interval 57.7 to 93.5	—	—	—
Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y PPAS1: Serogroup Y: Day 30 post dose 3	—	150 Titer Interval 116.0 to 195.0	—	—
Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y PPAS2: Serogroup A: Day 0 before dose 3	5.18 Titer Interval 4.22 to 6.37	—	—	—
Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y PPAS2: Serogroup A: Day 30 post dose 3	104 Titer Interval 67.9 to 161.0	—	—	—
Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y PPAS2: Serogroup A: Day 0 before dose 4	—	8.13 Titer Interval 6.33 to 10.4	—	—
Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y PPAS2: Serogroup A: Day 30 post dose 4	—	62.0 Titer Interval 39.9 to 96.4	—	—
Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y PPAS2: Serogroup C: Day 0 before dose 3	26.2 Titer Interval 18.7 to 36.8	—	—	—
Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y PPAS2: Serogroup C: Day 30 post dose 3	819 Titer Interval 622.0 to 1078.0	—	—	—
Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y PPAS2: Serogroup C: Day 0 before dose 4	—	56.9 Titer Interval 42.4 to 76.4	—	—
Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y PPAS2: Serogroup C: Day 30 post dose 4	—	791 Titer Interval 608.0 to 1029.0	—	—
Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y PPAS2: Serogroup W: Day 0 before dose 3	39.1 Titer Interval 29.6 to 51.8	—	—	—
Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y PPAS2: Serogroup W: Day 30 post dose 3	1049 Titer Interval 782.0 to 1406.0	—	—	—
Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y PPAS2: Serogroup W: Day 0 before dose 4	—	92.6 Titer Interval 74.3 to 115.0	—	—
Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y PPAS2: Serogroup W: Day 30 post dose 4	—	1024 Titer Interval 806.0 to 1301.0	—	—
Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y PPAS2: Serogroup Y: Day 0 before dose 3	33.0 Titer Interval 25.0 to 43.5	—	—	—
Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y PPAS2: Serogroup Y: Day 30 post dose 3	589 Titer Interval 470.0 to 737.0	—	—	—
Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y PPAS2: Serogroup Y: Day 0 before dose 4	—	85.8 Titer Interval 68.2 to 108.0	—	—
Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y PPAS2: Serogroup Y: Day 30 post dose 4	—	632 Titer Interval 512.0 to 780.0	—	—

SECONDARY outcome

Timeframe: Day 0 Before Dose 1 (2 MoA) and Day 30 Post Dose 2 (4 MoA); Day 0 Before Dose 3 (12 to 18 MoA) and Day 30 Post Dose 3 (12 to 18 MoA)

Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the hSBA. Percentages are rounded off to the tenth decimal place.

Outcome measures

Outcome measures
Measure	Group 1: MenACYW n=554 Participants Participants received 3 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV10 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 2: Nimenrix n=579 Participants Participants received 3 doses of Nimenrix® 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV10 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 3: MenACYW Participants received 3 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV13 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 4: MenACYW Participants received 4 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 6 MoA and dose 4: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV13 were administered in a 2+1 regimen (concomitantly with the first and second doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and the toddler dose of MenACYW conjugate vaccine \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA. The third dose of MenACYW conjugate vaccine was administered alone, without any other routine pediatric vaccines.
Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS1: Serogroup A: >=1:4: Day 0 before dose 1	31.1 Percentage of participants Interval 27.1 to 35.3	28.3 Percentage of participants Interval 24.5 to 32.4	—	—
Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS1: Serogroup A: >=1:8: Day 0 before dose 1	5.6 Percentage of participants Interval 3.8 to 7.9	6.4 Percentage of participants Interval 4.4 to 8.8	—	—
Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS1: Serogroup A: >=1:4: Day 30 post dose 2	77.2 Percentage of participants Interval 73.3 to 80.7	88.0 Percentage of participants Interval 84.8 to 90.7	—	—
Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS1: Serogroup A: >=1:8: Day 30 post dose 2	63.6 Percentage of participants Interval 59.2 to 67.8	75.8 Percentage of participants Interval 71.8 to 79.5	—	—
Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS1: Serogroup C: >=1:4: Day 0 before dose 1	14.3 Percentage of participants Interval 11.4 to 17.6	14.9 Percentage of participants Interval 11.9 to 18.3	—	—
Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS1: Serogroup C: >=1:8: Day 0 before dose 1	5.2 Percentage of participants Interval 3.5 to 7.5	5.2 Percentage of participants Interval 3.5 to 7.5	—	—
Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS1: Serogroup C: >=1:4: Day 30 post dose 2	99.0 Percentage of participants Interval 97.7 to 99.7	96.4 Percentage of participants Interval 94.4 to 97.8	—	—
Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS1: Serogroup C: >=1:8: Day 30 post dose 2	98.8 Percentage of participants Interval 97.5 to 99.6	91.9 Percentage of participants Interval 89.3 to 94.1	—	—
Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS1: Serogroup W: >=1:4: Day 0 before dose 1	11.7 Percentage of participants Interval 9.1 to 14.8	11.0 Percentage of participants Interval 8.4 to 14.0	—	—
Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS1: Serogroup W: >=1:8: Day 0 before dose 1	3.7 Percentage of participants Interval 2.2 to 5.6	3.5 Percentage of participants Interval 2.1 to 5.4	—	—
Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS1: Serogroup W: >=1:4: Day 30 post dose 2	98.6 Percentage of participants Interval 97.2 to 99.5	98.3 Percentage of participants Interval 96.8 to 99.2	—	—
Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS1: Serogroup W: >=1:8: Day 30 post dose 2	96.5 Percentage of participants Interval 94.6 to 97.9	94.5 Percentage of participants Interval 92.1 to 96.3	—	—
Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS1: Serogroup Y: >=1:4: Day 0 before dose 1	10.0 Percentage of participants Interval 7.6 to 12.9	9.8 Percentage of participants Interval 7.4 to 12.7	—	—
Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS1: Serogroup Y: >=1:8: Day 0 before dose 1	6.4 Percentage of participants Interval 4.4 to 8.8	5.6 Percentage of participants Interval 3.8 to 7.9	—	—
Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS1: Serogroup Y: >=1:4: Day 30 post dose 2	98.3 Percentage of participants Interval 96.7 to 99.2	97.3 Percentage of participants Interval 95.5 to 98.5	—	—
Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS1: Serogroup Y: >=1:8: Day 30 post dose 2	96.5 Percentage of participants Interval 94.5 to 97.9	93.5 Percentage of participants Interval 91.0 to 95.5	—	—
Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS2: Serogroup A: >=1:4: Day 0 before dose 3	69.1 Percentage of participants Interval 65.0 to 73.0	73.7 Percentage of participants Interval 69.9 to 77.3	—	—
Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS2: Serogroup A: >=1:8: Day 0 before dose 3	33.7 Percentage of participants Interval 29.7 to 37.9	46.2 Percentage of participants Interval 42.0 to 50.4	—	—
Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS2: Serogroup A: >=1:4: Day 30 post dose 3	98.2 Percentage of participants Interval 96.6 to 99.1	98.1 Percentage of participants Interval 96.6 to 99.0	—	—
Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS2: Serogroup A: >=1:8: Day 30 post dose 3	94.7 Percentage of participants Interval 92.4 to 96.4	96.5 Percentage of participants Interval 94.6 to 97.8	—	—
Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS2: Serogroup C: >=1:4: Day 0 before dose 3	92.5 Percentage of participants Interval 89.9 to 94.5	62.1 Percentage of participants Interval 57.9 to 66.1	—	—
Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS2: Serogroup C: >=1:8: Day 0 before dose 3	88.1 Percentage of participants Interval 85.1 to 90.7	41.6 Percentage of participants Interval 37.5 to 45.8	—	—
Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS2: Serogroup C: >=1:4: Day 30 post dose 3	99.8 Percentage of participants Interval 99.0 to 100.0	98.1 Percentage of participants Interval 96.6 to 99.0	—	—
Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS2: Serogroup C: >=1:8: Day 30 post dose 3	99.6 Percentage of participants Interval 98.7 to 100.0	95.5 Percentage of participants Interval 93.5 to 97.0	—	—
Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS2: Serogroup W: >=1:4: Day 0 before dose 3	96.7 Percentage of participants Interval 94.8 to 98.0	91.2 Percentage of participants Interval 88.5 to 93.4	—	—
Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS2: Serogroup W: >=1:8: Day 0 before dose 3	89.1 Percentage of participants Interval 86.2 to 91.6	77.6 Percentage of participants Interval 73.9 to 81.0	—	—
Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS2: Serogroup W: >=1:4: Day 30 post dose 3	100 Percentage of participants Interval 99.3 to 100.0	100 Percentage of participants Interval 99.4 to 100.0	—	—
Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS2: Serogroup W: >=1:8: Day 30 post dose 3	99.8 Percentage of participants Interval 99.0 to 100.0	99.5 Percentage of participants Interval 98.5 to 99.9	—	—
Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS2: Serogroup Y: >=1:4: Day 0 before dose 3	95.8 Percentage of participants Interval 93.7 to 97.3	85.7 Percentage of participants Interval 82.5 to 88.4	—	—
Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS2: Serogroup Y: >=1:8: Day 0 before dose 3	87.9 Percentage of participants Interval 84.9 to 90.5	69.6 Percentage of participants Interval 65.6 to 73.3	—	—
Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS2: Serogroup Y: >=1:4: Day 30 post dose 3	100 Percentage of participants Interval 99.3 to 100.0	100 Percentage of participants Interval 99.4 to 100.0	—	—
Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS2: Serogroup Y: >=1:8: Day 30 post dose 3	100 Percentage of participants Interval 99.3 to 100.0	99.8 Percentage of participants Interval 99.0 to 100.0	—	—

SECONDARY outcome

Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the hSBA. Percentages are rounded off to the tenth decimal place.

Outcome measures

Outcome measures
Measure	Group 1: MenACYW n=96 Participants Participants received 3 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV10 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 2: Nimenrix n=90 Participants Participants received 3 doses of Nimenrix® 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV10 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 3: MenACYW Participants received 3 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV13 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 4: MenACYW Participants received 4 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 6 MoA and dose 4: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV13 were administered in a 2+1 regimen (concomitantly with the first and second doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and the toddler dose of MenACYW conjugate vaccine \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA. The third dose of MenACYW conjugate vaccine was administered alone, without any other routine pediatric vaccines.
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS2: Serogroup Y: >=1:4: Day 0 before dose 4	—	100 Percentage of participants Interval 96.0 to 100.0	—	—
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS1: Serogroup A: >=1:4: Day 0 before dose 1	33.0 Percentage of participants Interval 23.6 to 43.4	32.6 Percentage of participants Interval 23.0 to 43.3	—	—
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS1: Serogroup A: >=1:8: Day 0 before dose 1	14.9 Percentage of participants Interval 8.4 to 23.7	11.2 Percentage of participants Interval 5.5 to 19.7	—	—
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS1: Serogroup A: >=1:4: Day 30 post dose 2	79.1 Percentage of participants Interval 69.3 to 86.9	—	—	—
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS1: Serogroup A: >=1:8: Day 30 post dose 2	63.7 Percentage of participants Interval 53.0 to 73.6	—	—	—
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS1: Serogroup A: >=1:4: Day 30 post dose 3	—	92.0 Percentage of participants Interval 84.3 to 96.7	—	—
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS1: Serogroup A: >=1:8: Day 30 post dose 3	—	81.8 Percentage of participants Interval 72.2 to 89.2	—	—
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS1: Serogroup C: >=1:4: Day 0 before dose 1	43.6 Percentage of participants Interval 33.4 to 54.2	48.9 Percentage of participants Interval 38.2 to 59.7	—	—
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS1: Serogroup C: >=1:8: Day 0 before dose 1	26.6 Percentage of participants Interval 18.0 to 36.7	32.2 Percentage of participants Interval 22.8 to 42.9	—	—
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS1: Serogroup C: >=1:4: Day 30 post dose 2	98.9 Percentage of participants Interval 94.3 to 100.0	—	—	—
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS1: Serogroup C: >=1:8: Day 30 post dose 2	98.9 Percentage of participants Interval 94.3 to 100.0	—	—	—
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS1: Serogroup C: >=1:4: Day 30 post dose 3	—	98.9 Percentage of participants Interval 94.0 to 100.0	—	—
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS1: Serogroup C: >=1:8: Day 30 post dose 3	—	98.9 Percentage of participants Interval 94.0 to 100.0	—	—
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS1: Serogroup W: >=1:4: Day 0 before dose 1	28.7 Percentage of participants Interval 19.9 to 39.0	35.6 Percentage of participants Interval 25.7 to 46.3	—	—
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS1: Serogroup W: >=1:8: Day 0 before dose 1	10.6 Percentage of participants Interval 5.2 to 18.7	16.7 Percentage of participants Interval 9.6 to 26.0	—	—
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS1: Serogroup W: >=1:4: Day 30 post dose 2	99.0 Percentage of participants Interval 94.3 to 100.0	—	—	—
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS1: Serogroup W: >=1:8: Day 30 post dose 2	96.9 Percentage of participants Interval 91.1 to 99.4	—	—	—
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS1: Serogroup W: >=1:4: Day 30 post dose 3	—	98.9 Percentage of participants Interval 94.0 to 100.0	—	—
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS1: Serogroup W: >=1:8: Day 30 post dose 3	—	98.9 Percentage of participants Interval 94.0 to 100.0	—	—
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS1: Serogroup Y: >=1:4: Day 0 before dose 1	26.6 Percentage of participants Interval 18.0 to 36.7	22.2 Percentage of participants Interval 14.1 to 32.2	—	—
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS1: Serogroup Y: >=1:8: Day 0 before dose 1	12.8 Percentage of participants Interval 6.8 to 21.2	12.2 Percentage of participants Interval 6.3 to 20.8	—	—
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS1: Serogroup Y: >=1:4: Day 30 post dose 2	99.0 Percentage of participants Interval 94.3 to 100.0	—	—	—
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS1: Serogroup Y: >=1:8: Day 30 post dose 2	95.8 Percentage of participants Interval 89.7 to 98.9	—	—	—
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS1: Serogroup Y: >=1:4: Day 30 post dose 3	—	98.9 Percentage of participants Interval 94.0 to 100.0	—	—
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS1: Serogroup Y: >=1:8: Day 30 post dose 3	—	98.9 Percentage of participants Interval 94.0 to 100.0	—	—
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS2: Serogroup A: >=1:4: Day 0 before dose 3	65.9 Percentage of participants Interval 55.3 to 75.5	—	—	—
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS2: Serogroup A: >=1:8: Day 0 before dose 3	37.4 Percentage of participants Interval 27.4 to 48.1	—	—	—
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS2: Serogroup A: >=1:4: Day 30 post dose 3	92.4 Percentage of participants Interval 84.9 to 96.9	—	—	—
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS2: Serogroup A: >=1:8: Day 30 post dose 3	89.1 Percentage of participants Interval 80.9 to 94.7	—	—	—
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS2: Serogroup A: >=1:4: Day 0 before dose 4	—	80.9 Percentage of participants Interval 71.2 to 88.5	—	—
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS2: Serogroup A: >=1:8: Day 0 before dose 4	—	52.8 Percentage of participants Interval 41.9 to 63.5	—	—
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS2: Serogroup A: >=1:4: Day 30 post dose 4	—	82.0 Percentage of participants Interval 72.5 to 89.4	—	—
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS2: Serogroup A: >=1:8: Day 30 post dose 4	—	82.0 Percentage of participants Interval 72.5 to 89.4	—	—
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS2: Serogroup C: >=1:4: Day 0 before dose 3	87.2 Percentage of participants Interval 78.8 to 93.2	—	—	—
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS2: Serogroup C: >=1:8: Day 0 before dose 3	79.8 Percentage of participants Interval 70.2 to 87.4	—	—	—
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS2: Serogroup C: >=1:4: Day 30 post dose 3	100 Percentage of participants Interval 96.1 to 100.0	—	—	—
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS2: Serogroup C: >=1:8: Day 30 post dose 3	100 Percentage of participants Interval 96.1 to 100.0	—	—	—
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS2: Serogroup C: >=1:4: Day 0 before dose 4	—	97.8 Percentage of participants Interval 92.1 to 99.7	—	—
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS2: Serogroup C: >=1:8: Day 0 before dose 4	—	92.1 Percentage of participants Interval 84.5 to 96.8	—	—
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS2: Serogroup C: >=1:4: Day 30 post dose 4	—	100 Percentage of participants Interval 95.8 to 100.0	—	—
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS2: Serogroup C: >=1:8: Day 30 post dose 4	—	100 Percentage of participants Interval 95.8 to 100.0	—	—
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS2: Serogroup W: >=1:4: Day 0 before dose 3	96.8 Percentage of participants Interval 90.9 to 99.3	—	—	—
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS2: Serogroup W: >=1:8: Day 0 before dose 3	92.5 Percentage of participants Interval 85.1 to 96.9	—	—	—
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS2: Serogroup W: >=1:4: Day 30 post dose 3	100 Percentage of participants Interval 95.8 to 100.0	—	—	—
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS2: Serogroup W: >=1:8: Day 30 post dose 3	100 Percentage of participants Interval 95.8 to 100.0	—	—	—
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS2: Serogroup W: >=1:4: Day 0 before dose 4	—	100 Percentage of participants Interval 96.0 to 100.0	—	—
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS2: Serogroup W: >=1:8: Day 0 before dose 4	—	100 Percentage of participants Interval 96.0 to 100.0	—	—
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS2: Serogroup W: >=1:4: Day 30 post dose 4	—	100 Percentage of participants Interval 95.8 to 100.0	—	—
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS2: Serogroup W: >=1:8: Day 30 post dose 4	—	100 Percentage of participants Interval 95.8 to 100.0	—	—
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS2: Serogroup Y: >=1:4: Day 0 before dose 3	94.7 Percentage of participants Interval 88.0 to 98.3	—	—	—
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS2: Serogroup Y: >=1:8: Day 0 before dose 3	89.4 Percentage of participants Interval 81.3 to 94.8	—	—	—
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS2: Serogroup Y: >=1:4: Day 30 post dose 3	100 Percentage of participants Interval 96.2 to 100.0	—	—	—
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS2: Serogroup Y: >=1:8: Day 30 post dose 3	100 Percentage of participants Interval 96.2 to 100.0	—	—	—
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS2: Serogroup Y: >=1:8: Day 0 before dose 4	—	100 Percentage of participants Interval 96.0 to 100.0	—	—
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS2: Serogroup Y: >=1:4: Day 30 post dose 4	—	100 Percentage of participants Interval 95.9 to 100.0	—	—
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 PPAS2: Serogroup Y: >=1:8: Day 30 post dose 4	—	100 Percentage of participants Interval 95.9 to 100.0	—	—

SECONDARY outcome

Timeframe: Day 30 Post Doses 2 and 3 (4 MoA and 12 to 18 MoA)

Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the hSBA. hSBA vaccine seroresponse was defined for a participant with a pre vaccination titer \<1:8, the post-vaccination titer must be \>=1:16 and for a participant with a pre vaccination titer \>=1:8, the post-vaccination titer must be at least 4-fold greater than the pre vaccination titer. Percentages are rounded off to the tenth decimal place.

Outcome measures

Outcome measures
Measure	Group 1: MenACYW n=551 Participants Participants received 3 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV10 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 2: Nimenrix n=575 Participants Participants received 3 doses of Nimenrix® 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV10 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 3: MenACYW Participants received 3 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV13 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 4: MenACYW Participants received 4 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 6 MoA and dose 4: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV13 were administered in a 2+1 regimen (concomitantly with the first and second doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and the toddler dose of MenACYW conjugate vaccine \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA. The third dose of MenACYW conjugate vaccine was administered alone, without any other routine pediatric vaccines.
Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse PPAS2: Serogroup A: Day 30 post dose 3	90.6 Percentage of participants Interval 87.8 to 92.9	91.7 Percentage of participants Interval 89.1 to 93.8	—	—
Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse PPAS2: Serogroup C: Day 30 post dose 3	98.7 Percentage of participants Interval 97.4 to 99.5	91.3 Percentage of participants Interval 88.7 to 93.5	—	—
Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse PPAS2: Serogroup W: Day 30 post dose 3	99.4 Percentage of participants Interval 98.4 to 99.9	98.4 Percentage of participants Interval 97.0 to 99.3	—	—
Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse PPAS2: Serogroup Y: Day 30 post dose 3	98.7 Percentage of participants Interval 97.4 to 99.5	96.9 Percentage of participants Interval 95.1 to 98.1	—	—
Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse PPAS1: Serogroup A: Day 30 post dose 2	46.7 Percentage of participants Interval 42.3 to 51.2	60.9 Percentage of participants Interval 56.5 to 65.2	—	—
Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse PPAS1: Serogroup C: Day 30 post dose 2	97.4 Percentage of participants Interval 95.7 to 98.6	86.8 Percentage of participants Interval 83.5 to 89.6	—	—
Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse PPAS1: Serogroup W: Day 30 post dose 2	92.6 Percentage of participants Interval 90.0 to 94.7	88.4 Percentage of participants Interval 85.4 to 91.1	—	—
Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse PPAS1: Serogroup Y: Day 30 post dose 2	87.1 Percentage of participants Interval 83.9 to 89.9	81.4 Percentage of participants Interval 77.8 to 84.7	—	—

SECONDARY outcome

Timeframe: Group 3: Day 30 Post Dose 2 (4 MoA), Day 30 Post Dose 3 (12 to 18 MoA); Group 4: D30 Post Dose 3 (6 MoA), Day 30 Post Dose 4 (12 to 18 MoA)

Population: PPAS1 was a subset of FAS1. FAS1 included subset of randomized participants who received at least 1 dose of study vaccine in primary series and had a valid post-primary series vaccination blood sample result. PPAS2 was a subset of FAS2. FAS2 included subset of randomized participants who received at least 1 dose of study vaccine at booster vaccination and had a valid post-booster vaccination blood sample result. Only participants with data collected for each specific serogroup are reported.

Outcome measures

Outcome measures
Measure	Group 1: MenACYW n=94 Participants Participants received 3 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV10 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 2: Nimenrix n=90 Participants Participants received 3 doses of Nimenrix® 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV10 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 3: MenACYW Participants received 3 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV13 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 4: MenACYW Participants received 4 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 6 MoA and dose 4: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV13 were administered in a 2+1 regimen (concomitantly with the first and second doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and the toddler dose of MenACYW conjugate vaccine \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA. The third dose of MenACYW conjugate vaccine was administered alone, without any other routine pediatric vaccines.
Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse PPAS1: Serogroup A: Day 30 post dose 2	51.7 Percentage of participants Interval 40.8 to 62.4	—	—	—
Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse PPAS1: Serogroup A: Day 30 post dose 3	—	65.5 Percentage of participants Interval 54.6 to 75.4	—	—
Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse PPAS1: Serogroup C: Day 30 post dose 2	92.5 Percentage of participants Interval 85.1 to 96.9	—	—	—
Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse PPAS1: Serogroup C: Day 30 post dose 3	—	96.7 Percentage of participants Interval 90.6 to 99.3	—	—
Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse PPAS1: Serogroup W: Day 30 post dose 2	94.7 Percentage of participants Interval 88.0 to 98.3	—	—	—
Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse PPAS1: Serogroup W: Day 30 post dose 3	—	95.6 Percentage of participants Interval 89.0 to 98.8	—	—
Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse PPAS1: Serogroup Y: Day 30 post dose 2	89.4 Percentage of participants Interval 81.3 to 94.8	—	—	—
Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse PPAS1: Serogroup Y: Day 30 post dose 3	—	94.4 Percentage of participants Interval 87.5 to 98.2	—	—
Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse PPAS2: Serogroup A: Day 30 post dose 3	77.8 Percentage of participants Interval 67.8 to 85.9	—	—	—
Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse PPAS2: Serogroup A: Day 30 post dose 4	—	63.6 Percentage of participants Interval 52.7 to 73.6	—	—
Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse PPAS2: Serogroup C: Day 30 post dose 3	97.8 Percentage of participants Interval 92.4 to 99.7	—	—	—
Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse PPAS2: Serogroup C: Day 30 post dose 4	—	95.3 Percentage of participants Interval 88.5 to 98.7	—	—
Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse PPAS2: Serogroup W: Day 30 post dose 3	97.7 Percentage of participants Interval 91.9 to 99.7	—	—	—
Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse PPAS2: Serogroup W: Day 30 post dose 4	—	89.5 Percentage of participants Interval 81.1 to 95.1	—	—
Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse PPAS2: Serogroup Y: Day 30 post dose 3	91.5 Percentage of participants Interval 83.9 to 96.3	—	—	—
Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse PPAS2: Serogroup Y: Day 30 post dose 4	—	80.9 Percentage of participants Interval 71.2 to 88.5	—	—

SECONDARY outcome

Timeframe: Groups 1, 2 and 3: Day 0 before Dose 1 (2 MoA); Group 4: Day 0 before Dose 4 (12 to 18 MoA)

GMCs of anti-pertussis antibodies (pertussis toxin \[PT\], filamentous hemagglutinin \[FHA\]) were measured by electrochemiluminescent (ECL) assay.

Outcome measures

Outcome measures
Measure	Group 1: MenACYW n=520 Participants Participants received 3 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV10 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 2: Nimenrix n=521 Participants Participants received 3 doses of Nimenrix® 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV10 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 3: MenACYW n=95 Participants Participants received 3 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV13 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 4: MenACYW n=90 Participants Participants received 4 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 6 MoA and dose 4: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV13 were administered in a 2+1 regimen (concomitantly with the first and second doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and the toddler dose of MenACYW conjugate vaccine \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA. The third dose of MenACYW conjugate vaccine was administered alone, without any other routine pediatric vaccines.
Geometric Mean Concentrations (GMCs) of Anti-Pertussis Antibodies PPAS1: Anti-PT: Day 0 before dose 1	2.97 Titer Interval 2.68 to 3.29	2.61 Titer Interval 2.38 to 2.87	11.0 Titer Interval 8.74 to 14.0	—
Geometric Mean Concentrations (GMCs) of Anti-Pertussis Antibodies PPAS1: Anti-FHA: Day 0 before dose 1	10.8 Titer Interval 9.73 to 12.1	10.1 Titer Interval 9.1 to 11.2	55.6 Titer Interval 42.4 to 73.0	—
Geometric Mean Concentrations (GMCs) of Anti-Pertussis Antibodies PPAS2: Anti-PT: Day 0 before dose 4	—	—	—	10.7 Titer Interval 8.82 to 13.1
Geometric Mean Concentrations (GMCs) of Anti-Pertussis Antibodies PPAS2: Anti-FHA: Day 0 before dose 4	—	—	—	30.3 Titer Interval 25.0 to 36.7

SECONDARY outcome

Timeframe: Groups 1, 2 and 3: Day 30 Post Doses 2 and 3 (4 MoA and 12 to 18 MoA); Day 0 Before Dose 3 (12 to 18 MoA); Group 4: Day 30 Post Dose 4 (12 to 18 MoA)

GMCs of hexavalent vaccines were measured as: anti-diphtheria, anti-tetanus, anti-pertussis antibodies (PT, FHA) by ECL assay, anti-hepatitis antibodies (anti-Hepatitis B surface antigen \[HBsAg\]) by the commercially available VITROS ECi/ECiQ, anti-poliovirus types 1, 2, and 3 by neutralization assay and anti-Haemophilus influenzae type b (anti-polyribosylribitol phosphate \[PRP\]) by Farr-type radioimmunoassay (RIA).

Outcome measures

Outcome measures
Measure	Group 1: MenACYW n=555 Participants Participants received 3 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV10 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 2: Nimenrix n=583 Participants Participants received 3 doses of Nimenrix® 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV10 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 3: MenACYW n=96 Participants Participants received 3 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV13 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 4: MenACYW n=90 Participants Participants received 4 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 6 MoA and dose 4: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV13 were administered in a 2+1 regimen (concomitantly with the first and second doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and the toddler dose of MenACYW conjugate vaccine \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA. The third dose of MenACYW conjugate vaccine was administered alone, without any other routine pediatric vaccines.
Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines PPAS2: Anti-polio 1: Day 30 after dose 3	1099 Titer Interval 980.0 to 1233.0	994 Titer Interval 883.0 to 1119.0	1538 Titer Interval 1212.0 to 1952.0	—
Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines PPAS1: Anti-diphtheria: Day 30 after dose 2	0.523 Titer Interval 0.474 to 0.578	0.489 Titer Interval 0.443 to 0.541	0.563 Titer Interval 0.458 to 0.691	—
Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines PPAS1: Anti-tetanus: Day 30 after dose 2	1.10 Titer Interval 1.02 to 1.18	1.13 Titer Interval 1.05 to 1.22	0.931 Titer Interval 0.788 to 1.1	—
Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines PPAS1: Anti-PT: Day 30 after dose 2	64.9 Titer Interval 61.4 to 68.7	68.1 Titer Interval 64.5 to 72.0	50.0 Titer Interval 43.2 to 58.0	—
Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines PPAS1: Anti-FHA: Day 30 after dose 2	92.4 Titer Interval 87.3 to 97.8	96.6 Titer Interval 90.8 to 103.0	125 Titer Interval 109.0 to 144.0	—
Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines PPAS1: Anti-HBsAg: Day 30 after dose 2	369 Titer Interval 323.0 to 421.0	345 Titer Interval 303.0 to 393.0	218 Titer Interval 147.0 to 322.0	—
Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines PPAS1: Anti-polio 1: Day 30 after dose 2	47.1 Titer Interval 40.1 to 55.3	43.5 Titer Interval 37.0 to 51.2	362 Titer Interval 260.0 to 504.0	—
Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines PPAS1: Anti-polio 2: Day 30 after dose 2	139 Titer Interval 117.0 to 167.0	143 Titer Interval 120.0 to 171.0	618 Titer Interval 429.0 to 890.0	—
Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines PPAS1: Anti-polio 3: Day 30 after dose 2	133 Titer Interval 112.0 to 157.0	145 Titer Interval 123.0 to 172.0	584 Titer Interval 419.0 to 814.0	—
Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines PPAS1: Anti-PRP: Day 30 after dose 2	0.376 Titer Interval 0.326 to 0.435	0.435 Titer Interval 0.379 to 0.499	0.725 Titer Interval 0.492 to 1.07	—
Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines PPAS2: Anti-diphtheria: Day 0 before dose 3	0.086 Titer Interval 0.079 to 0.095	0.080 Titer Interval 0.073 to 0.087	0.094 Titer Interval 0.076 to 0.116	—
Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines PPAS2: Anti-diphtheria: Day 30 after dose 3	1.82 Titer Interval 1.69 to 1.96	1.69 Titer Interval 1.57 to 1.81	2.71 Titer Interval 2.36 to 3.11	—
Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines PPAS2: Anti-diphtheria: Day 30 after dose 4	—	—	—	3.26 Titer Interval 2.88 to 3.69
Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines PPAS2: Anti-tetanus: Day 0 before dose 3	0.362 Titer Interval 0.336 to 0.391	0.424 Titer Interval 0.397 to 0.453	0.218 Titer Interval 0.18 to 0.264	—
Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines PPAS2: Anti-tetanus: Day 30 after dose 3	6.71 Titer Interval 6.33 to 7.12	8.59 Titer Interval 8.13 to 9.08	6.02 Titer Interval 5.06 to 7.16	—
Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines PPAS2: Anti-tetanus: Day 30 after dose 4	—	—	—	7.00 Titer Interval 5.99 to 8.18
Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines PPAS2: Anti-PT: Day 0 before dose 3	14.8 Titer Interval 13.8 to 15.8	14.6 Titer Interval 13.7 to 15.6	10.4 Titer Interval 8.99 to 12.0	—
Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines PPAS2: Anti-PT: Day 30 after dose 3	111 Titer Interval 105.0 to 118.0	109 Titer Interval 104.0 to 115.0	79.2 Titer Interval 66.2 to 94.6	—
Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines PPAS2: Anti-PT: Day 30 after dose 4	—	—	—	80.9 Titer Interval 68.2 to 95.9
Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines PPAS2: Anti-FHA: Day 0 before dose 3	38.4 Titer Interval 35.8 to 41.2	38.1 Titer Interval 35.5 to 40.8	30.6 Titer Interval 26.0 to 36.0	—
Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines PPAS2: Anti-FHA: Day 30 after dose 3	177 Titer Interval 167.0 to 187.0	184 Titer Interval 173.0 to 195.0	168 Titer Interval 142.0 to 200.0	—
Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines PPAS2: Anti-FHA: Day 30 after dose 4	—	—	—	181 Titer Interval 151.0 to 217.0
Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines PPAS2: Anti-HBsAg: Day 0 before dose 3	53.0 Titer Interval 45.5 to 61.8	48.8 Titer Interval 42.1 to 56.5	26.0 Titer Interval 17.6 to 38.2	—
Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines PPAS2: Anti-HBsAg: Day 30 after dose 3	2273 Titer Interval 1927.0 to 2681.0	2158 Titer Interval 1852.0 to 2515.0	1117 Titer Interval 666.0 to 1872.0	—
Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines PPAS2: Anti-HBsAg: Day 30 after dose 4	—	—	—	1144 Titer Interval 648.0 to 2020.0
Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines PPAS2: Anti-polio 1: Day 0 before dose 3	14.5 Titer Interval 12.7 to 16.5	13.6 Titer Interval 12.0 to 15.4	55.2 Titer Interval 40.8 to 74.6	—
Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines PPAS2: Anti-polio 1: Day 30 after dose 4	—	—	—	1625 Titer Interval 1291.0 to 2047.0
Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines PPAS2: Anti-polio 2: Day 0 before dose 3	33.2 Titer Interval 28.7 to 38.4	33.1 Titer Interval 28.8 to 37.9	85.3 Titer Interval 63.9 to 114.0	—
Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines PPAS2: Anti-polio 2: Day 30 after dose 3	2214 Titer Interval 1982.0 to 2472.0	2146 Titer Interval 1937.0 to 2379.0	3549 Titer Interval 2846.0 to 4425.0	—
Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines PPAS2: Anti-polio 2: Day 30 after dose 4	—	—	—	3858 Titer Interval 3001.0 to 4960.0
Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines PPAS2: Anti-polio 3: Day 0 before dose 3	19.7 Titer Interval 17.1 to 22.6	18.4 Titer Interval 16.0 to 21.1	37.7 Titer Interval 27.6 to 51.5	—
Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines PPAS2: Anti-polio 3: Day 30 after dose 3	1595 Titer Interval 1393.0 to 1827.0	1533 Titer Interval 1361.0 to 1728.0	2431 Titer Interval 1897.0 to 3115.0	—
Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines PPAS2: Anti-polio 3: Day 30 after dose 4	—	—	—	3397 Titer Interval 2567.0 to 4495.0
Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines PPAS2: Anti-PRP: Day 0 before dose 3	0.201 Titer Interval 0.176 to 0.23	0.224 Titer Interval 0.197 to 0.255	0.244 Titer Interval 0.174 to 0.343	—
Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines PPAS2: Anti-PRP: Day 30 after dose 3	9.42 Titer Interval 8.31 to 10.7	11.5 Titer Interval 10.3 to 12.9	16.1 Titer Interval 11.9 to 21.6	—
Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines PPAS2: Anti-PRP: Day 30 after dose 4	—	—	—	16.1 Titer Interval 12.1 to 21.6

SECONDARY outcome

Timeframe: Groups 1, 2 and 3: Day 30 Post Doses 2 and 3 (4 MoA and 12 to 18 MoA); Day 0 Before Dose 3 (12 to 18 MoA); Group 4: Day 30 Post Dose 4 (12 to 18 MoA)

GMCs of anti-diphtheria, anti-tetanus, anti-poliovirus types 1, 2, and 3, anti-haemophilus influenzae type b (anti-PRP) vaccines were measured as: anti-diphtheria, anti-tetanus by ECL assay, anti-poliovirus types 1, 2, and 3 by neutralization assay and anti-Haemophilus influenzae type b (anti-PRP) by Farr-type RIA. Response rate was defined as percentage of participants who achieved: anti diphtheria and anti-tetanus antibody concentrations \>=0.01 international units (IU)/milliliter (mL), \>=0.1 IU/mL and \>=1.0 IU/mL; anti-poliovirus types 1, 2, and 3 antibody titers \>=1:8; anti-PRP antibody concentrations \>=0.15 microgram (mcg)/mL and \>=1 mcg/mL. Percentages are rounded off to the tenth decimal place.

Outcome measures

Outcome measures
Measure	Group 1: MenACYW n=555 Participants Participants received 3 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV10 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 2: Nimenrix n=583 Participants Participants received 3 doses of Nimenrix® 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV10 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 3: MenACYW n=96 Participants Participants received 3 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV13 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 4: MenACYW n=90 Participants Participants received 4 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 6 MoA and dose 4: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV13 were administered in a 2+1 regimen (concomitantly with the first and second doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and the toddler dose of MenACYW conjugate vaccine \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA. The third dose of MenACYW conjugate vaccine was administered alone, without any other routine pediatric vaccines.
Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) PPAS1: Anti-diphtheria: >=1.0 IU/mL: Day 30 post dose 2	32.7 Percentage of participants Interval 28.6 to 36.9	32.5 Percentage of participants Interval 28.5 to 36.7	33.3 Percentage of participants Interval 23.9 to 43.9	—
Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) PPAS2: Anti-polio 3: >=1:8: Day 30 after dose 4	—	—	—	100 Percentage of participants Interval 95.8 to 100.0
Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) PPAS2: Anti-PRP: >=0.15 mcg/mL: Day 0 before dose 3	56.5 Percentage of participants Interval 52.2 to 60.7	60.4 Percentage of participants Interval 56.3 to 64.5	60.2 Percentage of participants Interval 49.5 to 70.2	—
Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) PPAS2: Anti-PRP: >=0.15 mcg/mL: Day 30 after dose 3	98.2 Percentage of participants Interval 96.7 to 99.1	98.8 Percentage of participants Interval 97.5 to 99.5	100 Percentage of participants Interval 96.0 to 100.0	—
Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) PPAS2: Anti-PRP: >=0.15 mcg/mL: Day 30 after dose 4	—	—	—	100 Percentage of participants Interval 96.0 to 100.0
Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) PPAS2: Anti-PRP: >=1 mcg/mL: Day 0 before dose 3	13.9 Percentage of participants Interval 11.1 to 17.1	14.9 Percentage of participants Interval 12.1 to 18.1	15.1 Percentage of participants Interval 8.5 to 24.0	—
Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) PPAS2: Anti-PRP: >=1 mcg/mL: Day 30 after dose 3	91.5 Percentage of participants Interval 88.9 to 93.7	94.9 Percentage of participants Interval 92.7 to 96.5	97.8 Percentage of participants Interval 92.3 to 99.7	—
Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) PPAS2: Anti-PRP: >=1 mcg/mL: Day 30 after dose 4	—	—	—	96.7 Percentage of participants Interval 90.6 to 99.3
Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) PPAS1: Anti-diphtheria: >=0.01 IU/mL: Day 30 post dose 2	100 Percentage of participants Interval 99.3 to 100.0	99.8 Percentage of participants Interval 98.9 to 100.0	100 Percentage of participants Interval 96.1 to 100.0	—
Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) PPAS1: Anti-diphtheria: >=0.1 IU/mL: Day 30 post dose 2	90.5 Percentage of participants Interval 87.6 to 92.9	89.6 Percentage of participants Interval 86.7 to 92.1	94.6 Percentage of participants Interval 87.9 to 98.2	—
Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) PPAS1: Anti-tetanus: >=0.01 IU/mL: Day 30 post dose 2	100 Percentage of participants Interval 99.3 to 100.0	100 Percentage of participants Interval 99.3 to 100.0	100 Percentage of participants Interval 96.1 to 100.0	—
Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) PPAS1: Anti-tetanus: >=0.1 IU/mL: Day 30 post dose 2	100 Percentage of participants Interval 99.3 to 100.0	99.8 Percentage of participants Interval 98.9 to 100.0	100 Percentage of participants Interval 96.1 to 100.0	—
Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) PPAS1: Anti-tetanus: >=1.0 IU/mL: Day 30 post dose 2	53.3 Percentage of participants Interval 48.9 to 57.7	56.3 Percentage of participants Interval 52.0 to 60.7	44.1 Percentage of participants Interval 33.8 to 54.8	—
Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) PPAS1: Anti-polio 1: >=1:8: Day 30 post dose 2	87.0 Percentage of participants Interval 83.7 to 89.9	83.2 Percentage of participants Interval 79.6 to 86.4	98.8 Percentage of participants Interval 93.5 to 100.0	—
Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) PPAS1: Anti-polio 2:>=1:8: Day 30 post dose 2	97.5 Percentage of participants Interval 95.7 to 98.7	98.6 Percentage of participants Interval 97.0 to 99.4	100 Percentage of participants Interval 95.4 to 100.0	—
Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) PPAS1: Anti-polio 3:>=1:8: Day 30 post dose 2	95.9 Percentage of participants Interval 93.7 to 97.5	96.1 Percentage of participants Interval 94.0 to 97.7	98.8 Percentage of participants Interval 93.4 to 100.0	—
Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) PPAS1: Anti-PRP: >=0.15 mcg/mL: Day 30 post dose 2	71.8 Percentage of participants Interval 67.7 to 75.6	74.9 Percentage of participants Interval 70.9 to 78.5	78.1 Percentage of participants Interval 68.5 to 85.9	—
Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) PPAS1: Anti-PRP: >=1 mcg/mL: Day 30 post dose 2	24.2 Percentage of participants Interval 20.5 to 28.1	27.3 Percentage of participants Interval 23.5 to 31.3	39.6 Percentage of participants Interval 29.7 to 50.1	—
Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) PPAS2: Anti-diphtheria: >=0.01 IU/mL: Day 0 before dose 3	98.2 Percentage of participants Interval 96.6 to 99.1	98.6 Percentage of participants Interval 97.2 to 99.4	97.8 Percentage of participants Interval 92.3 to 99.7	—
Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) PPAS2: Anti-diphtheria: >=0.01 IU/mL: Day 30 after dose 3	100 Percentage of participants Interval 99.3 to 100.0	100 Percentage of participants Interval 99.4 to 100.0	100 Percentage of participants Interval 96.1 to 100.0	—
Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) PPAS2: Anti-diphtheria: >=0.01 IU/mL: Day 30 after dose 4	—	—	—	100 Percentage of participants Interval 95.9 to 100.0
Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) PPAS2: Anti-diphtheria: >=0.1 IU/mL: Day 0 before dose 3	48.2 Percentage of participants Interval 43.9 to 52.5	41.3 Percentage of participants Interval 37.2 to 45.5	47.3 Percentage of participants Interval 36.7 to 58.0	—
Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) PPAS2: Anti-diphtheria: >=0.1 IU/mL: Day 30 after dose 3	99.6 Percentage of participants Interval 98.7 to 100.0	99.8 Percentage of participants Interval 99.0 to 100.0	100 Percentage of participants Interval 96.1 to 100.0	—
Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) PPAS2: Anti-diphtheria: >=0.1 IU/mL: Day 30 after dose 4	—	—	—	100 Percentage of participants Interval 95.9 to 100.0
Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) PPAS2: Anti-diphtheria: >=1.0 IU/mL: Day 0 before dose 3	1.1 Percentage of participants Interval 0.4 to 2.4	0.7 Percentage of participants Interval 0.2 to 1.8	0 Percentage of participants Interval 0.0 to 4.0	—
Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) PPAS2: Anti-diphtheria: >=1.0 IU/mL: Day 30 after dose 3	75.5 Percentage of participants Interval 71.7 to 79.0	72.4 Percentage of participants Interval 68.6 to 76.1	92.4 Percentage of participants Interval 84.9 to 96.9	—
Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) PPAS2: Anti-diphtheria: >=1.0 IU/mL: Day 30 after dose 4	—	—	—	100 Percentage of participants Interval 95.9 to 100.0
Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) PPAS2: Anti-tetanus: >=0.01 IU/mL: Day 0 before dose 3	100 Percentage of participants Interval 99.3 to 100.0	100 Percentage of participants Interval 99.4 to 100.0	100 Percentage of participants Interval 96.1 to 100.0	—
Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) PPAS2: Anti-tetanus: >=0.01 IU/mL: Day 30 after dose 3	100 Percentage of participants Interval 99.3 to 100.0	100 Percentage of participants Interval 99.4 to 100.0	100 Percentage of participants Interval 96.1 to 100.0	—
Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) PPAS2: Anti-tetanus: >=0.01 IU/mL: Day 30 after dose 4	—	—	—	100 Percentage of participants Interval 95.9 to 100.0
Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) PPAS2: Anti- tetanus: >=0.1 IU/mL: Day 0 before dose 3	94.1 Percentage of participants Interval 91.8 to 95.9	97.4 Percentage of participants Interval 95.7 to 98.5	83.7 Percentage of participants Interval 74.5 to 90.6	—
Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) PPAS2: Anti-tetanus: >=0.1 IU/mL: Day 30 after dose 3	100 Percentage of participants Interval 99.3 to 100.0	100 Percentage of participants Interval 99.4 to 100.0	100 Percentage of participants Interval 96.1 to 100.0	—
Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) PPAS2: Anti-tetanus: >=0.1 IU/mL: Day 30 after dose 4	—	—	—	100 Percentage of participants Interval 95.9 to 100.0
Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) PPAS2: Anti-tetanus: >=1.0 IU/mL: Day 0 before dose 3	10.7 Percentage of participants Interval 8.2 to 13.6	14.7 Percentage of participants Interval 11.9 to 17.9	6.5 Percentage of participants Interval 2.4 to 13.7	—
Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) PPAS2: Anti-tetanus: >=1.0 IU/mL: Day 30 after dose 3	99.6 Percentage of participants Interval 98.7 to 100.0	99.7 Percentage of participants Interval 98.8 to 100.0	96.7 Percentage of participants Interval 90.8 to 99.3	—
Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) PPAS2: Anti-tetanus: >=1.0 IU/mL: Day 30 after dose 4	—	—	—	98.9 Percentage of participants Interval 93.9 to 100.0
Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) PPAS2: Anti-polio 1: >=1:8: Day 0 before dose 3	64.4 Percentage of participants Interval 60.2 to 68.5	63.7 Percentage of participants Interval 59.5 to 67.7	93.3 Percentage of participants Interval 85.9 to 97.5	—
Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) PPAS2: Anti-polio 1: >=1:8: Day 30 after dose 3	99.8 Percentage of participants Interval 99.0 to 100.0	98.9 Percentage of participants Interval 97.7 to 99.6	100 Percentage of participants Interval 95.8 to 100.0	—
Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) PPAS2: Anti-polio 1: >=1:8: Day 30 after dose 4	—	—	—	100 Percentage of participants Interval 95.8 to 100.0
Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) PPAS2: Anti-polio 2: >=1:8: Day 0 before dose 3	79.5 Percentage of participants Interval 75.8 to 82.9	80.9 Percentage of participants Interval 77.4 to 84.1	95.5 Percentage of participants Interval 88.8 to 98.7	—
Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) PPAS2: Anti-polio 2: >=1:8: Day 30 after dose 3	100 Percentage of participants Interval 99.3 to 100.0	100 Percentage of participants Interval 99.3 to 100.0	100 Percentage of participants Interval 95.8 to 100.0	—
Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) PPAS2: Anti-polio 2: >=1:8: Day 30 after dose 4	—	—	—	100 Percentage of participants Interval 95.8 to 100.0
Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) PPAS2: Anti-polio 3: >=1:8: Day 0 before dose 3	68.6 Percentage of participants Interval 64.5 to 72.6	65.7 Percentage of participants Interval 61.6 to 69.6	84.3 Percentage of participants Interval 75.0 to 91.1	—
Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) PPAS2: Anti-polio 3: >=1:8: Day 30 after dose 3	99.2 Percentage of participants Interval 98.1 to 99.8	99.8 Percentage of participants Interval 99.0 to 100.0	100 Percentage of participants Interval 95.8 to 100.0	—

SECONDARY outcome

Timeframe: Groups 1, 2 and 3: Day 30 Post Doses 2 and 3 (4 MoA and 12 to 18 MoA); Group 4: Day 30 Post Dose 4 (12 to 18 MoA)

GMCs of anti-pertussis antibodies (PT, FHA) were measured by ECL assay. The pertussis vaccine seroresponse for anti-PT and anti-FHA was defined as: For groups 1, 2, and 3, 30 days after dose 2 in infancy as if the pre-primary vaccination concentration is \<4 × lower limit of quantification (LLOQ), post-primary vaccination concentration \>=4 × LLOQ, if the pre-primary vaccination concentration is \>=4 ×LLOQ, post-primary vaccination concentration \>=pre-primary vaccination concentration; and for Groups 1, 2, and 3, before and 30 days after the dose 3 and for group 4, before and 30 days after the dose 4 as if the pre-booster vaccination concentration is \<4 × LLOQ, post-booster vaccination concentration \>=4 × pre-booster concentration, if the pre-booster vaccination concentration is \>=4 × LLOQ, post-booster vaccination concentration \>=2 × pre-booster concentration. Percentages are rounded off to the tenth decimal place.

Outcome measures

Outcome measures
Measure	Group 1: MenACYW n=533 Participants Participants received 3 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV10 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 2: Nimenrix n=565 Participants Participants received 3 doses of Nimenrix® 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV10 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 3: MenACYW n=92 Participants Participants received 3 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV13 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 4: MenACYW n=89 Participants Participants received 4 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 6 MoA and dose 4: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV13 were administered in a 2+1 regimen (concomitantly with the first and second doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and the toddler dose of MenACYW conjugate vaccine \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA. The third dose of MenACYW conjugate vaccine was administered alone, without any other routine pediatric vaccines.
Percentage of Participants Who Achieved Vaccine Seroresponse for Anti-Pertussis Antibodies PPAS1: Anti-PT: Day 30 post dose 2	94.5 Percentage of participants Interval 92.2 to 96.3	97.9 Percentage of participants Interval 96.2 to 98.9	82.6 Percentage of participants Interval 73.3 to 89.7	—
Percentage of Participants Who Achieved Vaccine Seroresponse for Anti-Pertussis Antibodies PPAS1: Anti-FHA: Day 30 post dose 2	89.6 Percentage of participants Interval 86.7 to 92.1	91.5 Percentage of participants Interval 88.8 to 93.8	62.0 Percentage of participants Interval 51.2 to 71.9	—
Percentage of Participants Who Achieved Vaccine Seroresponse for Anti-Pertussis Antibodies PPAS2: Anti-PT: Day 30 post dose 3	97.0 Percentage of participants Interval 95.2 to 98.3	97.0 Percentage of participants Interval 95.2 to 98.2	93.3 Percentage of participants Interval 86.1 to 97.5	—
Percentage of Participants Who Achieved Vaccine Seroresponse for Anti-Pertussis Antibodies PPAS2: Anti-PT: Day 30 post dose 4	—	—	—	88.8 Percentage of participants Interval 80.3 to 94.5
Percentage of Participants Who Achieved Vaccine Seroresponse for Anti-Pertussis Antibodies PPAS2: Anti-FHA: Day 30 post dose 3	89.1 Percentage of participants Interval 86.2 to 91.6	90.1 Percentage of participants Interval 87.3 to 92.4	92.2 Percentage of participants Interval 84.6 to 96.8	—
Percentage of Participants Who Achieved Vaccine Seroresponse for Anti-Pertussis Antibodies PPAS2: Anti-FHA: Day 30 post dose 4	—	—	—	91.0 Percentage of participants Interval 83.1 to 96.0

SECONDARY outcome

Timeframe: Groups 1, 2 and 3: Day 30 Post Doses 2 and 3 (4 MoA and 12 to 18 MoA); Day 0 Before Dose 3 (12 to 18 MoA); Group 4: Day 30 Post Dose 4 (12 to 18 MoA)

GMCs of anti-hepatitis antibodies (anti-HBsAg) was measured by the commercially available VITROS ECi/ECiQ. Response rate for anti-HBsAg was defined as percentage of participants who achieved anti-HBsAg antibody concentrations \>=10 mIU/mL and \>=100 mIU/mL. Percentages are rounded off to the tenth decimal place.

Outcome measures

Outcome measures
Measure	Group 1: MenACYW n=546 Participants Participants received 3 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV10 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 2: Nimenrix n=571 Participants Participants received 3 doses of Nimenrix® 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV10 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 3: MenACYW n=92 Participants Participants received 3 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV13 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 4: MenACYW n=90 Participants Participants received 4 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 6 MoA and dose 4: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV13 were administered in a 2+1 regimen (concomitantly with the first and second doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and the toddler dose of MenACYW conjugate vaccine \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA. The third dose of MenACYW conjugate vaccine was administered alone, without any other routine pediatric vaccines.
Percentage of Participants Who Achieved Anti-Hepatitis B Antibody Concentrations >=10 and >=100 Milli-International Units (mIU)/mL PPAS2: Anti-HBsAg: >=100 mIU/mL: Day 0 before dose 3	38.7 Percentage of participants Interval 34.5 to 43.0	35.4 Percentage of participants Interval 31.5 to 39.5	26.4 Percentage of participants Interval 17.7 to 36.7	—
Percentage of Participants Who Achieved Anti-Hepatitis B Antibody Concentrations >=10 and >=100 Milli-International Units (mIU)/mL PPAS2: Anti-HBsAg: >=100 mIU/mL: Day 30 after dose 3	93.4 Percentage of participants Interval 91.0 to 95.3	93.5 Percentage of participants Interval 91.2 to 95.4	80.0 Percentage of participants Interval 70.2 to 87.7	—
Percentage of Participants Who Achieved Anti-Hepatitis B Antibody Concentrations >=10 and >=100 Milli-International Units (mIU)/mL PPAS2: Anti-HBsAg: >=100 mIU/mL: Day 0 before dose 4	—	—	—	27.8 Percentage of participants Interval 18.9 to 38.2
Percentage of Participants Who Achieved Anti-Hepatitis B Antibody Concentrations >=10 and >=100 Milli-International Units (mIU)/mL PPAS2: Anti-HBsAg: >=100 mIU/mL: Day 30 after dose 4	—	—	—	83.7 Percentage of participants Interval 74.2 to 90.8
Percentage of Participants Who Achieved Anti-Hepatitis B Antibody Concentrations >=10 and >=100 Milli-International Units (mIU)/mL PPAS1: Anti-HBsAg: >=10 mIU/mL: Day 30 post dose 2	96.4 Percentage of participants Interval 94.4 to 97.9	97.8 Percentage of participants Interval 96.2 to 98.9	92.4 Percentage of participants Interval 84.9 to 96.9	—
Percentage of Participants Who Achieved Anti-Hepatitis B Antibody Concentrations >=10 and >=100 Milli-International Units (mIU)/mL PPAS1: Anti-HBsAg: >=100 mIU/mL: Day 30 post dose 2	85.7 Percentage of participants Interval 82.4 to 88.7	81.8 Percentage of participants Interval 78.1 to 85.0	72.8 Percentage of participants Interval 62.6 to 81.6	—
Percentage of Participants Who Achieved Anti-Hepatitis B Antibody Concentrations >=10 and >=100 Milli-International Units (mIU)/mL PPAS2: Anti-HBsAg: >=10 mIU/mL: Day 0 before dose 3	81.5 Percentage of participants Interval 77.9 to 84.7	79.5 Percentage of participants Interval 75.9 to 82.7	65.9 Percentage of participants Interval 55.3 to 75.5	—
Percentage of Participants Who Achieved Anti-Hepatitis B Antibody Concentrations >=10 and >=100 Milli-International Units (mIU)/mL PPAS2: Anti-HBsAg: >=10 mIU/mL: Day 30 after dose 3	98.0 Percentage of participants Interval 96.4 to 99.0	98.6 Percentage of participants Interval 97.3 to 99.4	94.4 Percentage of participants Interval 87.5 to 98.2	—
Percentage of Participants Who Achieved Anti-Hepatitis B Antibody Concentrations >=10 and >=100 Milli-International Units (mIU)/mL PPAS2: Anti-HBsAg: >=10 mIU/mL: Day 0 before dose 4	—	—	—	64.4 Percentage of participants Interval 53.7 to 74.3
Percentage of Participants Who Achieved Anti-Hepatitis B Antibody Concentrations >=10 and >=100 Milli-International Units (mIU)/mL PPAS2: Anti-HBsAg: >=10 mIU/mL: Day 30 after dose 4	—	—	—	91.9 Percentage of participants Interval 83.9 to 96.7

SECONDARY outcome

Timeframe: At 30 days post Dose 2 (4 MoA) and Dose 3 (12 to 18 MoA)

GMCs of anti-pneumococcal antibodies was assessed by pneumococcal capsular polysaccharide (PnPS) Immunoglobulin G (IgG) ECL assay which was used to quantitate the amount of anti-streptococcus pneumoniae PS (serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F) antibodies in human serum.

Outcome measures

Outcome measures
Measure	Group 1: MenACYW n=545 Participants Participants received 3 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV10 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 2: Nimenrix n=569 Participants Participants received 3 doses of Nimenrix® 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV10 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 3: MenACYW Participants received 3 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV13 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 4: MenACYW Participants received 4 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 6 MoA and dose 4: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV13 were administered in a 2+1 regimen (concomitantly with the first and second doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and the toddler dose of MenACYW conjugate vaccine \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA. The third dose of MenACYW conjugate vaccine was administered alone, without any other routine pediatric vaccines.
Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine PPAS1: Serogroup 1	1.68 Titer Interval 1.52 to 1.84	1.71 Titer Interval 1.56 to 1.87	—	—
Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine PPAS1: Serogroup 4	1.97 Titer Interval 1.83 to 2.12	2.06 Titer Interval 1.91 to 2.23	—	—
Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine PPAS1: Serogroup 5	1.08 Titer Interval 0.991 to 1.17	1.10 Titer Interval 1.01 to 1.19	—	—
Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine PPAS1: Serogroup 6B	0.600 Titer Interval 0.534 to 0.675	0.660 Titer Interval 0.586 to 0.742	—	—
Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine PPAS1: Serogroup 7F	2.03 Titer Interval 1.89 to 2.17	2.20 Titer Interval 2.05 to 2.37	—	—
Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine PPAS1: Serogroup 9V	1.67 Titer Interval 1.54 to 1.81	1.81 Titer Interval 1.67 to 1.96	—	—
Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine PPAS1: Serogroup 14	5.92 Titer Interval 5.41 to 6.48	5.97 Titer Interval 5.44 to 6.55	—	—
Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine PPAS1: Serogroup 18C	0.680 Titer Interval 0.618 to 0.748	0.796 Titer Interval 0.722 to 0.879	—	—
Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine PPAS1: Serogroup 19F	1.59 Titer Interval 1.39 to 1.82	1.45 Titer Interval 1.26 to 1.66	—	—
Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine PPAS2: Serogroup 1	4.71 Titer Interval 4.32 to 5.13	4.54 Titer Interval 4.18 to 4.94	—	—
Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine PPAS2: Serogroup 18C	2.12 Titer Interval 1.99 to 2.26	2.17 Titer Interval 2.03 to 2.33	—	—
Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine PPAS1: Serogroup 23F	0.830 Titer Interval 0.746 to 0.924	0.869 Titer Interval 0.785 to 0.961	—	—
Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine PPAS2: Serogroup 4	3.61 Titer Interval 3.37 to 3.86	3.19 Titer Interval 2.99 to 3.41	—	—
Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine PPAS2: Serogroup 5	2.21 Titer Interval 2.05 to 2.39	2.05 Titer Interval 1.9 to 2.2	—	—
Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine PPAS2: Serogroup 6B	4.21 Titer Interval 3.89 to 4.55	4.36 Titer Interval 4.04 to 4.71	—	—
Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine PPAS2: Serogroup 7F	2.91 Titer Interval 2.73 to 3.1	2.89 Titer Interval 2.7 to 3.1	—	—
Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine PPAS2: Serogroup 9V	4.08 Titer Interval 3.8 to 4.38	4.17 Titer Interval 3.89 to 4.47	—	—
Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine PPAS2: Serogroup 14	9.07 Titer Interval 8.44 to 9.75	7.89 Titer Interval 7.25 to 8.59	—	—
Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine PPAS2: Serogroup 19F	9.03 Titer Interval 8.32 to 9.81	8.41 Titer Interval 7.76 to 9.12	—	—
Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine PPAS2: Serogroup 23F	2.24 Titer Interval 2.1 to 2.4	2.04 Titer Interval 1.9 to 2.18	—	—

SECONDARY outcome

Timeframe: Group 3: At 30 days post Dose 2 (4 MoA) and Dose 3 (12 to 18 MoA); Group 4: At 30 days post Dose 4 (12 to 18 MoA)

GMCs of anti-pneumococcal antibodies was assessed by PnPS IgG ECL assay which was used to quantitate the amount of anti-streptococcus pneumoniae PS (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) antibodies in human serum.

Outcome measures

Outcome measures
Measure	Group 1: MenACYW n=91 Participants Participants received 3 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV10 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 2: Nimenrix n=89 Participants Participants received 3 doses of Nimenrix® 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV10 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 3: MenACYW Participants received 3 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV13 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 4: MenACYW Participants received 4 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 6 MoA and dose 4: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV13 were administered in a 2+1 regimen (concomitantly with the first and second doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and the toddler dose of MenACYW conjugate vaccine \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA. The third dose of MenACYW conjugate vaccine was administered alone, without any other routine pediatric vaccines.
Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine PPAS1: Serogroup 1: 30 days post dose 2	1.47 Titer Interval 1.16 to 1.87	—	—	—
Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine PPAS1: Serogroup 3: 30 days post dose 2	0.658 Titer Interval 0.554 to 0.781	—	—	—
Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine PPAS1: Serogroup 4: 30 days post dose 2	1.73 Titer Interval 1.42 to 2.12	—	—	—
Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine PPAS1: Serogroup 5: 30 days post dose 2	0.803 Titer Interval 0.617 to 1.04	—	—	—
Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine PPAS1: Serogroup 6A: 30 days post dose 2	1.65 Titer Interval 1.24 to 2.19	—	—	—
Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine PPAS1: Serogroup 6B: 30 days post dose 2	0.275 Titer Interval 0.205 to 0.368	—	—	—
Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine PPAS1: Serogroup 7F: 30 days post dose 2	3.04 Titer Interval 2.59 to 3.57	—	—	—
Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine PPAS1: Serogroup 9V: 30 days post dose 2	1.25 Titer Interval 0.987 to 1.59	—	—	—
Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine PPAS1: Serogroup 14: 30 days post dose 2	5.88 Titer Interval 4.31 to 8.01	—	—	—
Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine PPAS1: Serogroup 18C: 30 days post dose 2	1.65 Titer Interval 1.3 to 2.1	—	—	—
Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine PPAS1: Serogroup 19A: 30 days post dose 2	2.17 Titer Interval 1.67 to 2.8	—	—	—
Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine PPAS1: Serogroup 19F: 30 days post dose 2	5.73 Titer Interval 4.64 to 7.08	—	—	—
Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine PPAS1: Serogroup 23F: 30 days post dose 2	0.722 Titer Interval 0.552 to 0.945	—	—	—
Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine PPAS2: Serogroup 1: 30 days post dose 3	5.32 Titer Interval 4.41 to 6.42	—	—	—
Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine PPAS2: Serogroup 1: 30 days post dose 4	—	5.47 Titer Interval 4.66 to 6.42	—	—
Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine PPAS2: Serogroup 3: 30 days post dose 3	1.13 Titer Interval 0.945 to 1.35	—	—	—
Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine PPAS2: Serogroup 3: 30 days post dose 4	—	1.21 Titer Interval 0.982 to 1.5	—	—
Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine PPAS2: Serogroup 4: 30 days post dose 3	3.99 Titer Interval 3.43 to 4.64	—	—	—
Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine PPAS2: Serogroup 4: 30 days post dose 4	—	3.97 Titer Interval 3.35 to 4.7	—	—
Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine PPAS2: Serogroup 5: 30 days post dose 3	3.33 Titer Interval 2.75 to 4.03	—	—	—
Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine PPAS2: Serogroup 5: 30 days post dose 4	—	3.95 Titer Interval 3.36 to 4.65	—	—
Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine PPAS2: Serogroup 6A: 30 days post dose 3	12.9 Titer Interval 10.9 to 15.4	—	—	—
Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine PPAS2: Serogroup 6A: 30 days post dose 4	—	14.3 Titer Interval 12.2 to 16.8	—	—
Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine PPAS2: Serogroup 6B: 30 days post dose 3	7.01 Titer Interval 5.38 to 9.13	—	—	—
Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine PPAS2: Serogroup 6B: 30 days post dose 4	—	9.41 Titer Interval 7.86 to 11.3	—	—
Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine PPAS2: Serogroup 7F: 30 days post dose 3	5.36 Titer Interval 4.56 to 6.29	—	—	—
Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine PPAS2: Serogroup 7F: 30 days post dose 4	—	4.92 Titer Interval 4.2 to 5.76	—	—
Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine PPAS2: Serogroup 9V: 30 days post dose 3	5.12 Titer Interval 4.26 to 6.17	—	—	—
Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine PPAS2: Serogroup 9V: 30 days post dose 4	—	5.40 Titer Interval 4.65 to 6.26	—	—
Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine PPAS2: Serogroup 14: 30 days post dose 3	14.8 Titer Interval 12.2 to 18.1	—	—	—
Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine PPAS2: Serogroup 14: 30 days post dose 4	—	14.7 Titer Interval 12.1 to 17.9	—	—
Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine PPAS2: Serogroup 18C: 30 days post dose 3	3.18 Titer Interval 2.7 to 3.76	—	—	—
Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine PPAS2: Serogroup 18C: 30 days post dose 4	—	3.48 Titer Interval 3.0 to 4.03	—	—
Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine PPAS2: Serogroup 19A: 30 days post dose 3	8.82 Titer Interval 7.25 to 10.7	—	—	—
Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine PPAS2: Serogroup 19A: 30 days post dose 4	—	10.9 Titer Interval 9.26 to 12.9	—	—
Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine PPAS2: Serogroup 19F: 30 days post dose 3	12.1 Titer Interval 9.91 to 14.7	—	—	—
Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine PPAS2: Serogroup 19F: 30 days post dose 4	—	12.2 Titer Interval 10.5 to 14.2	—	—
Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine PPAS2: Serogroup 23F: 30 days post dose 3	3.70 Titer Interval 3.01 to 4.55	—	—	—
Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine PPAS2: Serogroup 23F: 30 days post dose 4	—	4.06 Titer Interval 3.45 to 4.76	—	—

SECONDARY outcome

Timeframe: At 30 days post Dose 2 (4 MoA) and Dose 3 (12 to 18 MoA)

GMCs of anti-pneumococcal antibodies was assessed by PnPS IgG ECL assay which was used to quantitate the amount of anti-streptococcus pneumoniae PS (serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F) antibodies in human serum. Percentages are rounded off to the tenth decimal place.

Outcome measures

Outcome measures
Measure	Group 1: MenACYW n=545 Participants Participants received 3 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV10 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 2: Nimenrix n=569 Participants Participants received 3 doses of Nimenrix® 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV10 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 3: MenACYW Participants received 3 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV13 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 4: MenACYW Participants received 4 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 6 MoA and dose 4: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV13 were administered in a 2+1 regimen (concomitantly with the first and second doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and the toddler dose of MenACYW conjugate vaccine \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA. The third dose of MenACYW conjugate vaccine was administered alone, without any other routine pediatric vaccines.
Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine PPAS1: Serogroup 1	92.7 Percentage of participants Interval 90.0 to 94.8	93.6 Percentage of participants Interval 91.1 to 95.5	—	—
Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine PPAS1: Serogroup 4	96.8 Percentage of participants Interval 94.9 to 98.2	96.7 Percentage of participants Interval 94.7 to 98.1	—	—
Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine PPAS1: Serogroup 5	88.5 Percentage of participants Interval 85.4 to 91.2	90.6 Percentage of participants Interval 87.8 to 93.0	—	—
Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine PPAS1: Serogroup 6B	67.1 Percentage of participants Interval 62.8 to 71.2	69.9 Percentage of participants Interval 65.7 to 73.8	—	—
Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine PPAS1: Serogroup 7F	98.8 Percentage of participants Interval 97.4 to 99.6	98.2 Percentage of participants Interval 96.7 to 99.2	—	—
Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine PPAS1: Serogroup 9V	94.6 Percentage of participants Interval 92.3 to 96.4	95.1 Percentage of participants Interval 92.9 to 96.8	—	—
Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine PPAS1: Serogroup 14	97.8 Percentage of participants Interval 96.1 to 98.9	98.2 Percentage of participants Interval 96.7 to 99.2	—	—
Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine PPAS1: Serogroup 18C	72.5 Percentage of participants Interval 68.4 to 76.3	77.3 Percentage of participants Interval 73.5 to 80.9	—	—
Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine PPAS1: Serogroup 19F	82.2 Percentage of participants Interval 78.6 to 85.4	79.3 Percentage of participants Interval 75.5 to 82.7	—	—
Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine PPAS1: Serogroup 23F	77.8 Percentage of participants Interval 73.9 to 81.4	80.3 Percentage of participants Interval 76.6 to 83.6	—	—
Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine PPAS2: Serogroup 1	99.8 Percentage of participants Interval 99.0 to 100.0	99.8 Percentage of participants Interval 99.0 to 100.0	—	—
Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine PPAS2: Serogroup 4	99.8 Percentage of participants Interval 99.0 to 100.0	99.6 Percentage of participants Interval 98.7 to 100.0	—	—
Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine PPAS2: Serogroup 5	98.2 Percentage of participants Interval 96.6 to 99.1	97.7 Percentage of participants Interval 96.1 to 98.8	—	—
Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine PPAS2: Serogroup 6B	98.9 Percentage of participants Interval 97.6 to 99.6	99.5 Percentage of participants Interval 98.5 to 99.9	—	—
Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine PPAS2: Serogroup 7F	99.6 Percentage of participants Interval 98.7 to 100.0	99.3 Percentage of participants Interval 98.2 to 99.8	—	—
Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine PPAS2: Serogroup 9V	99.8 Percentage of participants Interval 99.0 to 100.0	99.8 Percentage of participants Interval 99.0 to 100.0	—	—
Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine PPAS2: Serogroup 14	100 Percentage of participants Interval 99.3 to 100.0	99.3 Percentage of participants Interval 98.2 to 99.8	—	—
Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine PPAS2: Serogroup 18C	99.1 Percentage of participants Interval 97.9 to 99.7	98.6 Percentage of participants Interval 97.2 to 99.4	—	—
Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine PPAS2: Serogroup 19F	99.3 Percentage of participants Interval 98.1 to 99.8	99.3 Percentage of participants Interval 98.2 to 99.8	—	—
Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine PPAS2: Serogroup 23F	98.5 Percentage of participants Interval 97.1 to 99.4	97.2 Percentage of participants Interval 95.5 to 98.4	—	—

SECONDARY outcome

Timeframe: Group 3: At 30 days post Dose 2 (4 MoA) and Dose 3 (12 to 18 MoA); Group 4: At 30 days post Dose 4 (12 to 18 MoA)

Outcome measures

Outcome measures
Measure	Group 1: MenACYW n=91 Participants Participants received 3 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV10 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 2: Nimenrix n=89 Participants Participants received 3 doses of Nimenrix® 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV10 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 3: MenACYW Participants received 3 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV13 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 4: MenACYW Participants received 4 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 6 MoA and dose 4: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV13 were administered in a 2+1 regimen (concomitantly with the first and second doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and the toddler dose of MenACYW conjugate vaccine \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA. The third dose of MenACYW conjugate vaccine was administered alone, without any other routine pediatric vaccines.
Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine PPAS1: Serogroup 1: 30 days post dose 2	89.9 Percentage of participants Interval 81.7 to 95.3	—	—	—
Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine PPAS1: Serogroup 3: 30 days post dose 2	82.0 Percentage of participants Interval 72.5 to 89.4	—	—	—
Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine PPAS1: Serogroup 4: 30 days post dose 2	96.6 Percentage of participants Interval 90.5 to 99.3	—	—	—
Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine PPAS1: Serogroup 5: 30 days post dose 2	76.4 Percentage of participants Interval 66.2 to 84.8	—	—	—
Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine PPAS1: Serogroup 6A: 30 days post dose 2	88.8 Percentage of participants Interval 80.3 to 94.5	—	—	—
Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine PPAS1: Serogroup 6B: 30 days post dose 2	40.4 Percentage of participants Interval 30.2 to 51.4	—	—	—
Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine PPAS1: Serogroup 7F: 30 days post dose 2	97.8 Percentage of participants Interval 92.1 to 99.7	—	—	—
Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine PPAS1: Serogroup 9V: 30 days post dose 2	88.8 Percentage of participants Interval 80.3 to 94.5	—	—	—
Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine PPAS1: Serogroup 14: 30 days post dose 2	96.6 Percentage of participants Interval 90.5 to 99.3	—	—	—
Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine PPAS1: Serogroup 18C: 30 days post dose 2	91.0 Percentage of participants Interval 83.1 to 96.0	—	—	—
Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine PPAS1: Serogroup 19A:30 days post dose 2	93.3 Percentage of participants Interval 85.9 to 97.5	—	—	—
Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine PPAS1: Serogroup 19F: 30 days post dose 2	98.9 Percentage of participants Interval 93.9 to 100.0	—	—	—
Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine PPAS1: Serogroup 23F: 30 days post dose 2	71.9 Percentage of participants Interval 61.4 to 80.9	—	—	—
Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine PPAS2: Serogroup 1: 30 days post dose 3	100 Percentage of participants Interval 96.0 to 100.0	—	—	—
Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine PPAS2: Serogroup 1: 30 days post dose 4	—	100 Percentage of participants Interval 95.9 to 100.0	—	—
Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine PPAS2: Serogroup 3: 30 days post dose 3	97.8 Percentage of participants Interval 92.3 to 99.7	—	—	—
Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine PPAS2: Serogroup 3: 30 days post dose 4	—	92.1 Percentage of participants Interval 84.5 to 96.8	—	—
Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine PPAS2: Serogroup 4: 30 days post dose 3	100 Percentage of participants Interval 96.0 to 100.0	—	—	—
Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine PPAS2: Serogroup 4: 30 days post dose 4	—	100 Percentage of participants Interval 95.9 to 100.0	—	—
Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine PPAS2: Serogroup 5: 30 days post dose 3	98.9 Percentage of participants Interval 94.0 to 100.0	—	—	—
Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine PPAS2: Serogroup 5: 30 days post dose 4	—	100 Percentage of participants Interval 95.9 to 100.0	—	—
Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine PPAS2: Serogroup 6A: 30 days post dose 3	100 Percentage of participants Interval 96.0 to 100.0	—	—	—
Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine PPAS2: Serogroup 6A: 30 days post dose 4	—	100 Percentage of participants Interval 95.9 to 100.0	—	—
Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine PPAS2: Serogroup 6B: 30 days post dose 3	98.9 Percentage of participants Interval 94.0 to 100.0	—	—	—
Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine PPAS2: Serogroup 6B: 30 days post dose 4	—	100 Percentage of participants Interval 95.9 to 100.0	—	—
Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine PPAS2: Serogroup 7F: 30 days post dose 3	100 Percentage of participants Interval 96.0 to 100.0	—	—	—
Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine PPAS2: Serogroup 7F: 30 days post dose 4	—	100 Percentage of participants Interval 95.9 to 100.0	—	—
Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine PPAS2: Serogroup 9V: 30 days post dose 3	100 Percentage of participants Interval 96.0 to 100.0	—	—	—
Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine PPAS2: Serogroup 9V: 30 days post dose 4	—	100 Percentage of participants Interval 95.9 to 100.0	—	—
Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine PPAS2: Serogroup 14: 30 days post dose 3	100 Percentage of participants Interval 96.0 to 100.0	—	—	—
Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine PPAS2: Serogroup 14: 30 days post dose 4	—	100 Percentage of participants Interval 95.9 to 100.0	—	—
Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine PPAS2: Serogroup 18C: 30 days post dose 3	100 Percentage of participants Interval 96.0 to 100.0	—	—	—
Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine PPAS2: Serogroup 18C: 30 days post dose 4	—	100 Percentage of participants Interval 95.9 to 100.0	—	—
Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine PPAS2: Serogroup 19A: 30 days post dose 3	100 Percentage of participants Interval 96.0 to 100.0	—	—	—
Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine PPAS2: Serogroup 19A: 30 days post dose 4	—	100 Percentage of participants Interval 95.9 to 100.0	—	—
Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine PPAS2: Serogroup 19F: 30 days post dose 3	100 Percentage of participants Interval 96.0 to 100.0	—	—	—
Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine PPAS2: Serogroup 19F: 30 days post dose 4	—	100 Percentage of participants Interval 95.9 to 100.0	—	—
Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine PPAS2: Serogroup 23F: 30 days post dose 3	100 Percentage of participants Interval 96.0 to 100.0	—	—	—
Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine PPAS2: Serogroup 23F: 30 days post dose 4	—	100 Percentage of participants Interval 95.9 to 100.0	—	—

SECONDARY outcome

Timeframe: Groups 1, 2 and 3: At 30 days post Dose 3 (12 to 18 MoA); Group 4: At 30 days post Dose 4 (12 to 18 MoA)

Population: PPAS2 was a subset of FAS2. FAS2 included subset of randomized participants who received at least 1 dose of the study vaccine at booster vaccination and had a valid post-booster vaccination blood sample result. Only participants with data collected for each specific serogroup are reported.

GMCs of anti-measles and anti-rubella antibodies were measured by bulk IgG enzyme immunoassay (EIA) and anti-mumps antibodies were assessed by enzyme-linked immunosorbent assay (ELISA).

Outcome measures

Outcome measures
Measure	Group 1: MenACYW n=525 Participants Participants received 3 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV10 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 2: Nimenrix n=553 Participants Participants received 3 doses of Nimenrix® 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV10 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 3: MenACYW n=94 Participants Participants received 3 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV13 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 4: MenACYW n=90 Participants Participants received 4 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 6 MoA and dose 4: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV13 were administered in a 2+1 regimen (concomitantly with the first and second doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and the toddler dose of MenACYW conjugate vaccine \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA. The third dose of MenACYW conjugate vaccine was administered alone, without any other routine pediatric vaccines.
Geometric Mean Concentrations (GMCs) of Anti-Measles, Mumps and Rubella (MMR) Antibodies Anti-measles: 30 days post dose 3	2780 Titer Interval 2581.0 to 2995.0	2919 Titer Interval 2739.0 to 3110.0	3457 Titer Interval 2972.0 to 4021.0	—
Geometric Mean Concentrations (GMCs) of Anti-Measles, Mumps and Rubella (MMR) Antibodies Anti-measles: 30 days post dose 4	—	—	—	3933 Titer Interval 3241.0 to 4773.0
Geometric Mean Concentrations (GMCs) of Anti-Measles, Mumps and Rubella (MMR) Antibodies Anti-mumps: 30 days post dose 3	83.3 Titer Interval 77.5 to 89.6	86.1 Titer Interval 80.5 to 92.1	105 Titer Interval 90.4 to 121.0	—
Geometric Mean Concentrations (GMCs) of Anti-Measles, Mumps and Rubella (MMR) Antibodies Anti-mumps: 30 days post dose 4	—	—	—	121 Titer Interval 105.0 to 141.0
Geometric Mean Concentrations (GMCs) of Anti-Measles, Mumps and Rubella (MMR) Antibodies Anti-rubella: 30 days post dose 3	56.8 Titer Interval 53.2 to 60.6	56.0 Titer Interval 52.5 to 59.8	72.8 Titer Interval 62.7 to 84.6	—
Geometric Mean Concentrations (GMCs) of Anti-Measles, Mumps and Rubella (MMR) Antibodies Anti-rubella: 30 days post dose 4	—	—	—	74.4 Titer Interval 63.7 to 86.7

SECONDARY outcome

Timeframe: Groups 1, 2 and 3: At 30 days post Dose 3 (12 to 18 MoA); Group 4: At 30 days post Dose 4 (12 to 18 MoA)

GMCs of anti-measles and anti-rubella antibodies were measured by bulk IgG EIA and anti-mumps antibodies were assessed by ELISA. Vaccine response against anti-measles, anti-mumps, anti-rubella antibodies were defined as percentage of participants with anti-measles, anti-mumps, anti-rubella antibody concentration that met the respective mentioned criterion: measles: \>=255 mIU/mL; mumps: \>=10 mumps antibody units/mL and rubella: \>=10 IU/mL. Percentages are rounded off to the tenth decimal place.

Outcome measures

Outcome measures
Measure	Group 1: MenACYW n=525 Participants Participants received 3 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV10 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 2: Nimenrix n=553 Participants Participants received 3 doses of Nimenrix® 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV10 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 3: MenACYW n=94 Participants Participants received 3 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV13 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA.	Group 4: MenACYW n=90 Participants Participants received 4 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 6 MoA and dose 4: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV13 were administered in a 2+1 regimen (concomitantly with the first and second doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and the toddler dose of MenACYW conjugate vaccine \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA. The third dose of MenACYW conjugate vaccine was administered alone, without any other routine pediatric vaccines.
Percentage of Participants Who Achieved Vaccine Response for Measles, Mumps and Rubella (MMR) Antibodies Anti-measles: 30 days post dose 3	98.3 Percentage of participants Interval 96.8 to 99.2	99.1 Percentage of participants Interval 97.9 to 99.7	100 Percentage of participants Interval 96.2 to 100.0	—
Percentage of Participants Who Achieved Vaccine Response for Measles, Mumps and Rubella (MMR) Antibodies Anti-measles: 30 days post dose 4	—	—	—	97.8 Percentage of participants Interval 92.2 to 99.7
Percentage of Participants Who Achieved Vaccine Response for Measles, Mumps and Rubella (MMR) Antibodies Anti-mumps: 30 days post dose 3	98.7 Percentage of participants Interval 97.3 to 99.5	98.7 Percentage of participants Interval 97.4 to 99.5	100 Percentage of participants Interval 96.2 to 100.0	—
Percentage of Participants Who Achieved Vaccine Response for Measles, Mumps and Rubella (MMR) Antibodies Anti-mumps: 30 days post dose 4	—	—	—	100 Percentage of participants Interval 96.0 to 100.0
Percentage of Participants Who Achieved Vaccine Response for Measles, Mumps and Rubella (MMR) Antibodies Anti-rubella: 30 days post dose 3	98.7 Percentage of participants Interval 97.3 to 99.5	97.3 Percentage of participants Interval 95.6 to 98.5	98.9 Percentage of participants Interval 94.2 to 100.0	—
Percentage of Participants Who Achieved Vaccine Response for Measles, Mumps and Rubella (MMR) Antibodies Anti-rubella: 30 days post dose 4	—	—	—	100 Percentage of participants Interval 96.0 to 100.0

Adverse Events

Group 1: MenACYW

Serious events: 51 serious events

Other events: 678 other events

Deaths: 0 deaths

Group 2: Nimenrix

Serious events: 57 serious events

Other events: 680 other events

Deaths: 0 deaths

Group 3: MenACYW

Serious events: 8 serious events

Other events: 107 other events

Deaths: 0 deaths

Group 4: MenACYW

Serious events: 3 serious events

Other events: 103 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Trial Transparency Team

Sanofi Pasteur

Phone: 800-633-1610 ext: 6#

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
Publication restrictions are in place

Restriction type: OTHER