Trial Outcomes & Findings for Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the US (NCT NCT03537508)

NCT ID: NCT03537508

Last Updated: 2024-10-15

Results Overview

Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Vaccine seroresponse was defined as a post 4th dose (Day 30 after 12-month) hSBA titer \>=1:16 for participants with pre 1st dose (Day 0 before 2-month) hSBA titer less than (\<) 1:8, or at least a 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \>=1:8. Percentages are rounded off to the tenth decimal place.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 2627 participants
• Primary outcome timeframe: Day 30 post 12-month vaccination (Month 13)
• Results posted on: 2024-10-15

Participant Flow

The study was conducted at 69 investigational sites in Puerto Rico and the United States. Healthy infants aged >=42 to <=89 days were randomized in 2:1 ratio to either Group 1: Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine (MenACYW conjugate vaccine) and routine pediatric vaccines or Group 2: Meningococcal (groups A, C, Y, and W-135) oligosaccharide diphtheria cross reacting material (CRM) 197 conjugate vaccine (MENVEO®) and routine pediatric vaccines.

Each group was further divided into 2 subgroups based on the time of analyses conducted in the 2nd year of life (30 days after the 12-month vaccinations [Groups 1a and 2a] or 30 days after the 15-month vaccinations [Groups 1b and 2b], respectively. The division of the subgroups did not determine when participants received their vaccinations in the 2nd year of life. A total of 2627 participants were enrolled in this study.

Participant milestones

Measure	Group 1: MenACYW Conjugate Vaccine Participants received MenACYW conjugate vaccine 0.5 milliliter (mL) as an intramuscular (IM) injection at 2, 4, 6, and 12 to 15/15 to 18 months of age along with Pentacel® (diphtheria-tetanus-acellular pertussis \[DTaP-IPV/Hib\] vaccine) at 2, 4, 6 and 15 to 18 months of age; PREVNAR 13® (pneumococcal 13-valent conjugate vaccine \[PCV13\] at 2, 4, 6, and 12 to 15 months of age; RotaTeq® (pentavalent rotavirus vaccine \[RV5\]) at 2, 4, and 6 months of age; ENGERIX-B® (hepatitis B vaccine) at 2 and 6 months of age; M-M-R® II (measles, mumps, and rubella vaccine) and VARIVAX® (varicella vaccine) at 12 to 15 months of age. Additionally, participants received first dose of HAVRIX® (hepatitis A vaccine) at 15 to 18 months of age as a part of the study. Group 1 was divided as Groups 1a and 1b based on the time of analyses, i.e. 30 days after 12 months and 30 days after 15 months respectively. The division of the subgroups did not determine when participants received their vaccinations in the 2nd year of life.	Group 2: MENVEO Participants received MENVEO conjugate vaccine 0.5 mL as an IM injection at 2, 4, 6, and 12 months of age along with Pentacel (DTaP-IPV/Hib vaccine) at 2, 4, 6 and 15 to 18 months of age; PREVNAR 13 (PCV13) at 2, 4, 6, and 12 months of age; RotaTeq (rotavirus vaccine) at 2, 4, and 6 months of age; ENGERIX-B (hepatitis B vaccine) at 2 and 6 months of age; M-M-R II (measles, mumps, and rubella vaccine) and VARIVAX (varicella vaccine) at 12 months of age. In addition, they also received first dose of HAVRIX (hepatitis A vaccine) at 15 to 18 months of age. Group 2 was further divided as Groups 2a and 2b based on the time of analyses, i.e. 30 days after 12 months and 30 days after 15 months respectively. The division of the subgroups did not determine when participants received their vaccinations in the 2nd year of life.
Overall Study STARTED	1746	881
Overall Study Safety Analysis Set (SafAS)	1727	867
Overall Study Vaccinated at 2 Months	1727	869
Overall Study Vaccinated at 4 Months	1619	828
Overall Study Vaccinated at 6 Months	1543	793
Overall Study Vaccinated at 12 Months	1411	708
Overall Study Vaccinated at 15 Months	445	644
Overall Study COMPLETED	1330	623
Overall Study NOT COMPLETED	416	258

Reasons for withdrawal

Measure	Group 1: MenACYW Conjugate Vaccine Participants received MenACYW conjugate vaccine 0.5 milliliter (mL) as an intramuscular (IM) injection at 2, 4, 6, and 12 to 15/15 to 18 months of age along with Pentacel® (diphtheria-tetanus-acellular pertussis \[DTaP-IPV/Hib\] vaccine) at 2, 4, 6 and 15 to 18 months of age; PREVNAR 13® (pneumococcal 13-valent conjugate vaccine \[PCV13\] at 2, 4, 6, and 12 to 15 months of age; RotaTeq® (pentavalent rotavirus vaccine \[RV5\]) at 2, 4, and 6 months of age; ENGERIX-B® (hepatitis B vaccine) at 2 and 6 months of age; M-M-R® II (measles, mumps, and rubella vaccine) and VARIVAX® (varicella vaccine) at 12 to 15 months of age. Additionally, participants received first dose of HAVRIX® (hepatitis A vaccine) at 15 to 18 months of age as a part of the study. Group 1 was divided as Groups 1a and 1b based on the time of analyses, i.e. 30 days after 12 months and 30 days after 15 months respectively. The division of the subgroups did not determine when participants received their vaccinations in the 2nd year of life.	Group 2: MENVEO Participants received MENVEO conjugate vaccine 0.5 mL as an IM injection at 2, 4, 6, and 12 months of age along with Pentacel (DTaP-IPV/Hib vaccine) at 2, 4, 6 and 15 to 18 months of age; PREVNAR 13 (PCV13) at 2, 4, 6, and 12 months of age; RotaTeq (rotavirus vaccine) at 2, 4, and 6 months of age; ENGERIX-B (hepatitis B vaccine) at 2 and 6 months of age; M-M-R II (measles, mumps, and rubella vaccine) and VARIVAX (varicella vaccine) at 12 months of age. In addition, they also received first dose of HAVRIX (hepatitis A vaccine) at 15 to 18 months of age. Group 2 was further divided as Groups 2a and 2b based on the time of analyses, i.e. 30 days after 12 months and 30 days after 15 months respectively. The division of the subgroups did not determine when participants received their vaccinations in the 2nd year of life.
Overall Study Adverse Event	2	1
Overall Study Protocol Violation	65	48
Overall Study Lost to Follow-up	86	60
Overall Study Withdrawal by parent/guardian	263	149

Baseline Characteristics

Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the US

Baseline characteristics by cohort

Measure	Group 1: MenACYW Conjugate Vaccine n=1746 Participants Participants received MenACYW conjugate vaccine 0.5 mL as an IM injection at 2, 4, 6, and 12 to 15/15 to 18 months of age along with Pentacel (diphtheria-tetanus-acellular pertussis \[DTaP-IPV/Hib\] vaccine) at 2, 4, 6 and 15 to 18 months of age; PREVNAR 13 (pneumococcal 13-valent conjugate vaccine \[PCV13\] at 2, 4, 6, and 12 to 15 months of age; RotaTeq (pentavalent rotavirus vaccine \[RV5\]) at 2, 4, and 6 months of age; ENGERIX-B (hepatitis B vaccine) at 2 and 6 months of age; M-M-R II (measles, mumps, and rubella vaccine) and VARIVAX (varicella vaccine) at 12 to 15 months of age. Additionally, participants received first dose of HAVRIX (hepatitis A vaccine) at 15 to 18 months of age as a part of the study. Group 1 was divided as Groups 1a and 1b based on the time of analyses, i.e. 30 days after 12 months and 30 days after 15 months respectively. The division of the subgroups did not determine when participants received their vaccinations in the 2nd year of life.	Group 2: MENVEO n=881 Participants Participants received MENVEO conjugate vaccine 0.5 mL as an IM injection at 2, 4, 6, and 12 months of age along with Pentacel (DTaP-IPV/Hib vaccine) at 2, 4, 6 and 15 to 18 months of age; PREVNAR 13 (PCV13) at 2, 4, 6, and 12 months of age; RotaTeq (rotavirus vaccine) at 2, 4, and 6 months of age; ENGERIX-B (hepatitis B vaccine) at 2 and 6 months of age; M-M-R II (measles, mumps, and rubella vaccine) and VARIVAX (varicella vaccine) at 12 months of age. In addition, they also received first dose of HAVRIX (hepatitis A vaccine) at 15 to 18 months of age. Group 2 was further divided as Groups 2a and 2b based on the time of analyses, i.e. 30 days after 12 months and 30 days after 15 months respectively. The division of the subgroups did not determine when participants received their vaccinations in the 2nd year of life.	Total n=2627 Participants Total of all reporting groups
Age, Continuous	65.3 days STANDARD_DEVIATION 8.02 • n=5 Participants	65.3 days STANDARD_DEVIATION 7.81 • n=7 Participants	65.3 days STANDARD_DEVIATION 7.95 • n=5 Participants
Sex: Female, Male Female	828 Participants n=5 Participants	415 Participants n=7 Participants	1243 Participants n=5 Participants
Sex: Female, Male Male	918 Participants n=5 Participants	466 Participants n=7 Participants	1384 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	11 Participants n=5 Participants	3 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) Asian	15 Participants n=5 Participants	10 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) Black or African American	204 Participants n=5 Participants	99 Participants n=7 Participants	303 Participants n=5 Participants
Race (NIH/OMB) White	1428 Participants n=5 Participants	722 Participants n=7 Participants	2150 Participants n=5 Participants
Race (NIH/OMB) More than one race	44 Participants n=5 Participants	30 Participants n=7 Participants	74 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	37 Participants n=5 Participants	11 Participants n=7 Participants	48 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 30 post 12-month vaccination (Month 13)

Population: Per-Protocol Analysis Set 3 (PPAS3) (for 2nd year of life vaccination). PPAS3 included participants of Full Analysis set 3 (FAS3: a subset of all randomized participants who received \>=1 dose of the study vaccine in the 2nd year of life \[\>=12 months of age\] and had a valid post-vaccination serology result in the 2nd year of life) with no relevant protocol deviations. Only those participants with data collected for each specific serogroup are reported.

Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Vaccine seroresponse was defined as a post 4th dose (Day 30 after 12-month) hSBA titer >=1:16 for participants with pre 1st dose (Day 0 before 2-month) hSBA titer less than (<) 1:8, or at least a 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer >=1:8. Percentages are rounded off to the tenth decimal place.

Outcome measures

Measure	Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) n=540 Participants Participants received MenACYW conjugate vaccine and routine vaccines at 2, 4, 6, and 12 to 15 months of age. The time of analyses as well as the collection of blood samples conducted in the 2nd year of life for this subgroup was 30 days after the 12-month vaccination.	Group 2a: MENVEO (Post 12-month Vaccination) n=250 Participants Participants received MENVEO at 2, 4, 6, and 12 months of age and routine vaccines at 2, 4, 6, 12, and 15 to 18 months of age. The time of analyses as well as the collection of blood samples conducted in the 2nd year of life for this subgroup was 30 days after the 12-month vaccination.
Groups 1a and 2a: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at Day 30 Post 12-Month Vaccination Serogroup A	79.4 percentage of participants Interval 75.6 to 82.9	77.6 percentage of participants Interval 71.5 to 82.9
Groups 1a and 2a: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at Day 30 Post 12-Month Vaccination Serogroup C	97.0 percentage of participants Interval 95.1 to 98.3	88.2 percentage of participants Interval 83.4 to 92.0
Groups 1a and 2a: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at Day 30 Post 12-Month Vaccination Serogroup Y	96.4 percentage of participants Interval 94.4 to 97.8	92.3 percentage of participants Interval 88.1 to 95.4
Groups 1a and 2a: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at Day 30 Post 12-Month Vaccination Serogroup W	97.6 percentage of participants Interval 95.9 to 98.7	96.4 percentage of participants Interval 93.3 to 98.3

PRIMARY outcome

Timeframe: Day 30 post 6-month vaccination (Month 7)

Population: PPAS1 (for infant vaccination). PPAS1 included participants of FAS1 (subset of all randomized participants who received \>=1 dose of the study vaccine in infancy \[\<12 months of age\] and had a valid post-vaccination serology result in infancy) with no relevant protocol deviations during infancy. Only those participants with data collected for each specific serogroup are reported.

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

Outcome measures

Measure	Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) n=883 Participants Participants received MenACYW conjugate vaccine and routine vaccines at 2, 4, 6, and 12 to 15 months of age. The time of analyses as well as the collection of blood samples conducted in the 2nd year of life for this subgroup was 30 days after the 12-month vaccination.	Group 2a: MENVEO (Post 12-month Vaccination) n=438 Participants Participants received MENVEO at 2, 4, 6, and 12 months of age and routine vaccines at 2, 4, 6, 12, and 15 to 18 months of age. The time of analyses as well as the collection of blood samples conducted in the 2nd year of life for this subgroup was 30 days after the 12-month vaccination.
Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titers >=1:8 by hSBA at Day 30 Post 6-Month Vaccination Serogroup A	77.9 percentage of participants Interval 75.0 to 80.7	67.7 percentage of participants Interval 63.0 to 72.2
Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titers >=1:8 by hSBA at Day 30 Post 6-Month Vaccination Serogroup C	99.0 percentage of participants Interval 98.1 to 99.6	91.2 percentage of participants Interval 88.1 to 93.7
Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titers >=1:8 by hSBA at Day 30 Post 6-Month Vaccination Serogroup Y	98.3 percentage of participants Interval 97.1 to 99.0	91.7 percentage of participants Interval 88.7 to 94.2
Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titers >=1:8 by hSBA at Day 30 Post 6-Month Vaccination Serogroup W	98.6 percentage of participants Interval 97.6 to 99.3	92.9 percentage of participants Interval 90.1 to 95.1

SECONDARY outcome

Timeframe: Day 30 post 6-month vaccination (Month 7)

Population: Analysis was performed on PPAS1 (for infant vaccination) which included participants of FAS1 with no relevant protocol deviations during infancy. Only those participants with data collected are reported.

Anti-Hepatitis B surface antibodies (HBsAg) were measured by the commercially available VITROS ECi/ECiQ immunodiagnostic system using chemiluminescence detection technology. The percentage of participants with an anti-HBsAg antibody titer >=10 mIU/mL was assessed. Percentages are rounded off to the tenth decimal place.

Outcome measures

Measure	Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) n=765 Participants Participants received MenACYW conjugate vaccine and routine vaccines at 2, 4, 6, and 12 to 15 months of age. The time of analyses as well as the collection of blood samples conducted in the 2nd year of life for this subgroup was 30 days after the 12-month vaccination.	Group 2a: MENVEO (Post 12-month Vaccination) n=348 Participants Participants received MENVEO at 2, 4, 6, and 12 months of age and routine vaccines at 2, 4, 6, 12, and 15 to 18 months of age. The time of analyses as well as the collection of blood samples conducted in the 2nd year of life for this subgroup was 30 days after the 12-month vaccination.
Groups 1 and 2: Percentage of Participants Who Achieved Anti-Hepatitis B Antibody Concentrations >=10 Milli-International Units Per Milliliter (mIU/mL) at Day 30 Post 6-Month Vaccination	98.6 percentage of participants 95% Confidence Interval 97.4 • Interval 97.4 to 99.3	98.0 percentage of participants 95% Confidence Interval 95.9 • Interval 95.9 to 99.2

SECONDARY outcome

Timeframe: Day 30 post 6-month vaccination (Month 7)

Population: Analysis was performed on PPAS1 (for infant vaccination) which included participants of FAS1 with no relevant protocol deviations during infancy. Only those participants with data collected for each specified category are reported.

Anti-PRP concentrations were measured using a farr-type radioimmunoassay (RIA). The percentage of participants with an PRP antibody titer >=0.15 mcg/mL and >=1.0 mcg/mL were assessed. Percentages are rounded off to the tenth decimal place.

Outcome measures

Measure	Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) n=882 Participants Participants received MenACYW conjugate vaccine and routine vaccines at 2, 4, 6, and 12 to 15 months of age. The time of analyses as well as the collection of blood samples conducted in the 2nd year of life for this subgroup was 30 days after the 12-month vaccination.	Group 2a: MENVEO (Post 12-month Vaccination) n=420 Participants Participants received MENVEO at 2, 4, 6, and 12 months of age and routine vaccines at 2, 4, 6, 12, and 15 to 18 months of age. The time of analyses as well as the collection of blood samples conducted in the 2nd year of life for this subgroup was 30 days after the 12-month vaccination.
Groups 1 and 2: Percentage of Participants Who Achieved Anti-Polyribosyl-Ribitol (PRP) Antibody Concentrations >=0.15 and >=1.0 Microgram (mcg)/mL at Day 30 Post 6-Month Vaccination >=0.15 mcg/mL	99.0 percentage of participants 95% Confidence Interval 98.1 • Interval 98.1 to 99.5	96.4 percentage of participants 95% Confidence Interval 94.2 • Interval 94.2 to 98.0
Groups 1 and 2: Percentage of Participants Who Achieved Anti-Polyribosyl-Ribitol (PRP) Antibody Concentrations >=0.15 and >=1.0 Microgram (mcg)/mL at Day 30 Post 6-Month Vaccination >=1.0 mcg/mL	91.3 percentage of participants 95% Confidence Interval 89.2 • Interval 89.2 to 93.0	85.7 percentage of participants 95% Confidence Interval 82.0 • Interval 82.0 to 88.9

SECONDARY outcome

Timeframe: Day 30 post 6-month vaccination (Month 7)

Population: Analysis was performed on PPAS1 (for infant vaccination) which included participants of FAS1 with no relevant protocol deviations during infancy. Only those participants with data collected for each specified category are reported.

Anti-poliovirus types 1, 2, and 3 were measured by neutralization assay. The percentage of participants with anti-polio antibody titers >=1:8 were assessed.

Outcome measures

Measure	Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) n=854 Participants Participants received MenACYW conjugate vaccine and routine vaccines at 2, 4, 6, and 12 to 15 months of age. The time of analyses as well as the collection of blood samples conducted in the 2nd year of life for this subgroup was 30 days after the 12-month vaccination.	Group 2a: MENVEO (Post 12-month Vaccination) n=415 Participants Participants received MENVEO at 2, 4, 6, and 12 months of age and routine vaccines at 2, 4, 6, 12, and 15 to 18 months of age. The time of analyses as well as the collection of blood samples conducted in the 2nd year of life for this subgroup was 30 days after the 12-month vaccination.
Groups 1 and 2: Percentage of Participants Who Achieved Anti-Poliovirus Antibody Titers >=1:8 at Day 30 Post 6-Month Vaccination Anti-polio 1	100 percentage of participants Interval 99.6 to 100.0	100 percentage of participants Interval 99.1 to 100.0
Groups 1 and 2: Percentage of Participants Who Achieved Anti-Poliovirus Antibody Titers >=1:8 at Day 30 Post 6-Month Vaccination Anti-polio 2	100 percentage of participants Interval 99.6 to 100.0	100 percentage of participants Interval 99.1 to 100.0
Groups 1 and 2: Percentage of Participants Who Achieved Anti-Poliovirus Antibody Titers >=1:8 at Day 30 Post 6-Month Vaccination Anti-polio 3	100 percentage of participants Interval 99.6 to 100.0	100 percentage of participants Interval 99.1 to 100.0

SECONDARY outcome

Timeframe: Day 30 post 6-month vaccination (Month 7)

Population: Analysis was performed on PPAS1 (for infant vaccination) which included participants of FAS1 with no relevant protocol deviations during infancy. Only those participants with data collected are reported.

Anti-rotavirus IgA antibodies in human serum were measured by enzyme-linked immunosorbent assay (ELISA). The percentage of participants who achieved anti-rotavirus IgA Ab concentrations >=3-fold rise were assessed. Percentages are rounded off to the tenth decimal place.

Outcome measures

Measure	Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) n=663 Participants Participants received MenACYW conjugate vaccine and routine vaccines at 2, 4, 6, and 12 to 15 months of age. The time of analyses as well as the collection of blood samples conducted in the 2nd year of life for this subgroup was 30 days after the 12-month vaccination.	Group 2a: MENVEO (Post 12-month Vaccination) n=321 Participants Participants received MENVEO at 2, 4, 6, and 12 months of age and routine vaccines at 2, 4, 6, 12, and 15 to 18 months of age. The time of analyses as well as the collection of blood samples conducted in the 2nd year of life for this subgroup was 30 days after the 12-month vaccination.
Groups 1 and 2: Percentage of Participants Who Achieved Anti-Rotavirus Immunoglobulin A (IgA) Antibody Concentrations >=3-Fold Rise at Day 30 Post 6-Month Vaccination	91.0 percentage of participants 95% Confidence Interval 88.5 • Interval 88.5 to 93.0	92.8 percentage of participants 95% Confidence Interval 89.4 • Interval 89.4 to 95.4

SECONDARY outcome

Timeframe: Day 30 post 6-month vaccination (Month 7)

Population: Analysis was performed on PPAS1 (for infant vaccination) which included participants of FAS1 with no relevant protocol deviations during infancy. Only those participants with data collected are reported.

GMCs of anti-rotavirus serum IgA antibodies were assessed using ELISA.

Outcome measures

Measure	Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) n=857 Participants Participants received MenACYW conjugate vaccine and routine vaccines at 2, 4, 6, and 12 to 15 months of age. The time of analyses as well as the collection of blood samples conducted in the 2nd year of life for this subgroup was 30 days after the 12-month vaccination.	Group 2a: MENVEO (Post 12-month Vaccination) n=403 Participants Participants received MENVEO at 2, 4, 6, and 12 months of age and routine vaccines at 2, 4, 6, 12, and 15 to 18 months of age. The time of analyses as well as the collection of blood samples conducted in the 2nd year of life for this subgroup was 30 days after the 12-month vaccination.
Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Anti-Rotavirus IgA Antibodies at Day 30 Post 6-Month Vaccination	272 Units/mL 95% Confidence Interval 244 • Interval 244.0 to 303.0	308 Units/mL 95% Confidence Interval 264 • Interval 264.0 to 360.0

SECONDARY outcome

Timeframe: Day 30 post 6-month vaccination (Month 7)

Population: Analysis was performed on PPAS1 (for infant vaccination) which included participants of FAS1 with no relevant protocol deviations during infancy. Only those participants with data collected for each specified category are reported.

GMCs of anti-pertussis antibodies (pertussis toxoid [PT], filamentous hemagglutinin adhesin [FHA], pertactin [PRN] and fimbriae types 2 and 3 [FIM]) were measured by electrochemiluminescent (ECL) assay.

Outcome measures

Measure	Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) n=906 Participants Participants received MenACYW conjugate vaccine and routine vaccines at 2, 4, 6, and 12 to 15 months of age. The time of analyses as well as the collection of blood samples conducted in the 2nd year of life for this subgroup was 30 days after the 12-month vaccination.	Group 2a: MENVEO (Post 12-month Vaccination) n=444 Participants Participants received MENVEO at 2, 4, 6, and 12 months of age and routine vaccines at 2, 4, 6, 12, and 15 to 18 months of age. The time of analyses as well as the collection of blood samples conducted in the 2nd year of life for this subgroup was 30 days after the 12-month vaccination.
Groups 1 and 2: GMCs of Anti-Pertussis Antibodies at Day 30 Post 6-Month Vaccination Anti-PT	75.8 ELISA units/mL 95% Confidence Interval 72.2 • Interval 72.2 to 79.6	78.6 ELISA units/mL 95% Confidence Interval 72.8 • Interval 72.8 to 84.9
Groups 1 and 2: GMCs of Anti-Pertussis Antibodies at Day 30 Post 6-Month Vaccination Anti-FHA	95.7 ELISA units/mL 95% Confidence Interval 90.9 • Interval 90.9 to 101.0	98.6 ELISA units/mL 95% Confidence Interval 91.7 • Interval 91.7 to 106.0
Groups 1 and 2: GMCs of Anti-Pertussis Antibodies at Day 30 Post 6-Month Vaccination Anti-PRN	39.4 ELISA units/mL 95% Confidence Interval 36.8 • Interval 36.8 to 42.3	42.1 ELISA units/mL 95% Confidence Interval 37.9 • Interval 37.9 to 46.6
Groups 1 and 2: GMCs of Anti-Pertussis Antibodies at Day 30 Post 6-Month Vaccination Anti-FIM	309 ELISA units/mL 95% Confidence Interval 291 • Interval 291.0 to 330.0	311 ELISA units/mL 95% Confidence Interval 284 • Interval 284.0 to 341.0

SECONDARY outcome

Timeframe: Day 30 post 6-month vaccination (Month 7)

Population: Analysis was performed on PPAS1 (for infant vaccination) which included participants of FAS1 with no relevant protocol deviations during infancy. Only those participants with data collected for each specified serotype are reported.

GMCs of anti-pneumococcal antibodies was assessed by pneumococcal capsular polysaccharide (PnPS) IgG ECL assay which is 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

Measure	Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) n=874 Participants Participants received MenACYW conjugate vaccine and routine vaccines at 2, 4, 6, and 12 to 15 months of age. The time of analyses as well as the collection of blood samples conducted in the 2nd year of life for this subgroup was 30 days after the 12-month vaccination.	Group 2a: MENVEO (Post 12-month Vaccination) n=420 Participants Participants received MENVEO at 2, 4, 6, and 12 months of age and routine vaccines at 2, 4, 6, 12, and 15 to 18 months of age. The time of analyses as well as the collection of blood samples conducted in the 2nd year of life for this subgroup was 30 days after the 12-month vaccination.
Groups 1 and 2: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 6-Month Vaccination Serotype 1	2.26 mcg/mL Interval 2.13 to 2.4	1.93 mcg/mL Interval 1.77 to 2.12
Groups 1 and 2: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 6-Month Vaccination Serotype 3	0.607 mcg/mL Interval 0.577 to 0.638	0.544 mcg/mL Interval 0.505 to 0.585
Groups 1 and 2: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 6-Month Vaccination Serotype 4	1.46 mcg/mL Interval 1.4 to 1.53	1.33 mcg/mL Interval 1.24 to 1.42
Groups 1 and 2: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 6-Month Vaccination Serotype 5	1.54 mcg/mL Interval 1.46 to 1.63	1.26 mcg/mL Interval 1.15 to 1.37
Groups 1 and 2: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 6-Month Vaccination Serotype 6A	4.01 mcg/mL Interval 3.82 to 4.22	3.34 mcg/mL Interval 3.09 to 3.62
Groups 1 and 2: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 6-Month Vaccination Serotype 6B	2.47 mcg/mL Interval 2.29 to 2.67	1.97 mcg/mL Interval 1.75 to 2.21
Groups 1 and 2: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 6-Month Vaccination Serotype 7F	3.48 mcg/mL Interval 3.32 to 3.64	3.40 mcg/mL Interval 3.18 to 3.63
Groups 1 and 2: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 6-Month Vaccination Serotype 9V	1.88 mcg/mL Interval 1.78 to 1.99	1.61 mcg/mL Interval 1.48 to 1.74
Groups 1 and 2: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 6-Month Vaccination Serotype 14	6.95 mcg/mL Interval 6.53 to 7.41	7.17 mcg/mL Interval 6.58 to 7.81
Groups 1 and 2: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 6-Month Vaccination Serotype 18C	1.95 mcg/mL Interval 1.86 to 2.04	1.82 mcg/mL Interval 1.69 to 1.96
Groups 1 and 2: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 6-Month Vaccination Serotype 19A	2.21 mcg/mL Interval 2.1 to 2.32	2.00 mcg/mL Interval 1.86 to 2.14
Groups 1 and 2: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 6-Month Vaccination Serotype 19F	3.36 mcg/mL Interval 3.21 to 3.52	2.98 mcg/mL Interval 2.77 to 3.21
Groups 1 and 2: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 6-Month Vaccination Serotype 23F	1.59 mcg/mL Interval 1.49 to 1.69	1.30 mcg/mL Interval 1.18 to 1.44

SECONDARY outcome

Timeframe: Day 30 post 12-month vaccination (Month 13)

Population: Analysis was performed on PPAS3 (for 2nd year of life vaccination) which included participants of FAS3 with no relevant protocol deviations. Only those participants with data collected for each specified category are reported.

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

Outcome measures

Measure	Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) n=662 Participants Participants received MenACYW conjugate vaccine and routine vaccines at 2, 4, 6, and 12 to 15 months of age. The time of analyses as well as the collection of blood samples conducted in the 2nd year of life for this subgroup was 30 days after the 12-month vaccination.	Group 2a: MENVEO (Post 12-month Vaccination) n=301 Participants Participants received MENVEO at 2, 4, 6, and 12 months of age and routine vaccines at 2, 4, 6, 12, and 15 to 18 months of age. The time of analyses as well as the collection of blood samples conducted in the 2nd year of life for this subgroup was 30 days after the 12-month vaccination.
Groups 1a and 2a: Percentage of Participants Who Achieved Vaccine Response for Measles, Mumps and Rubella (MMR) Antibodies at Day 30 Post 12-Month Vaccination Anti-measles	97.6 percentage of participants Interval 96.1 to 98.6	97.3 percentage of participants Interval 94.8 to 98.8
Groups 1a and 2a: Percentage of Participants Who Achieved Vaccine Response for Measles, Mumps and Rubella (MMR) Antibodies at Day 30 Post 12-Month Vaccination Anti-mumps	95.5 percentage of participants Interval 93.6 to 96.9	97.7 percentage of participants Interval 95.3 to 99.1
Groups 1a and 2a: Percentage of Participants Who Achieved Vaccine Response for Measles, Mumps and Rubella (MMR) Antibodies at Day 30 Post 12-Month Vaccination Anti-rubella	97.9 percentage of participants Interval 96.5 to 98.8	98.0 percentage of participants Interval 95.7 to 99.3

SECONDARY outcome

Timeframe: Day 30 post 12-month vaccination (Month 13)

Population: Analysis was performed on PPAS3 (for 2nd year of life vaccination) which included participants of FAS3 with no relevant protocol deviations. Only those participants with data collected are reported.

Vaccine response against anti-varicella antibodies were measured by glycoprotein (gp) ELISA. Percentage of participants with anti-varicella antibody concentration >=5 antibody (Ab) gpELISA units/mL are reported. Percentages are rounded off to the tenth decimal place.

Outcome measures

Measure	Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) n=662 Participants Participants received MenACYW conjugate vaccine and routine vaccines at 2, 4, 6, and 12 to 15 months of age. The time of analyses as well as the collection of blood samples conducted in the 2nd year of life for this subgroup was 30 days after the 12-month vaccination.	Group 2a: MENVEO (Post 12-month Vaccination) n=301 Participants Participants received MENVEO at 2, 4, 6, and 12 months of age and routine vaccines at 2, 4, 6, 12, and 15 to 18 months of age. The time of analyses as well as the collection of blood samples conducted in the 2nd year of life for this subgroup was 30 days after the 12-month vaccination.
Groups 1a and 2a: Percentage of Participants Who Achieved Vaccine Response for Varicella Antibodies at Day 30 Post 12-Month Vaccination	96.4 percentage of participants Interval 94.7 to 97.7	94.7 percentage of participants Interval 91.5 to 96.9

SECONDARY outcome

Timeframe: Day 30 post 12-month vaccination (Month 13)

Population: Analysis was performed on PPAS3 (for 2nd year of life vaccination) which included participants of FAS3 with no relevant protocol deviations. Only those participants with data collected for each specified serotype are reported.

GMCs of anti-pneumococcal antibodies was assessed by PnPS IgG ECL assay which is 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

Measure	Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) n=653 Participants Participants received MenACYW conjugate vaccine and routine vaccines at 2, 4, 6, and 12 to 15 months of age. The time of analyses as well as the collection of blood samples conducted in the 2nd year of life for this subgroup was 30 days after the 12-month vaccination.	Group 2a: MENVEO (Post 12-month Vaccination) n=300 Participants Participants received MENVEO at 2, 4, 6, and 12 months of age and routine vaccines at 2, 4, 6, 12, and 15 to 18 months of age. The time of analyses as well as the collection of blood samples conducted in the 2nd year of life for this subgroup was 30 days after the 12-month vaccination.
Groups 1a and 2a: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 12-Month Vaccination Serotype 1	3.81 mcg/mL Interval 3.56 to 4.08	3.44 mcg/mL Interval 3.12 to 3.81
Groups 1a and 2a: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 12-Month Vaccination Serotype 3	0.771 mcg/mL Interval 0.728 to 0.817	0.751 mcg/mL Interval 0.69 to 0.818
Groups 1a and 2a: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 12-Month Vaccination Serotype 5	2.70 mcg/mL Interval 2.53 to 2.88	2.46 mcg/mL Interval 2.25 to 2.69
Groups 1a and 2a: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 12-Month Vaccination Serotype 6A	9.65 mcg/mL Interval 9.09 to 10.2	9.51 mcg/mL Interval 8.72 to 10.4
Groups 1a and 2a: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 12-Month Vaccination Serotype 6B	7.41 mcg/mL Interval 6.92 to 7.93	6.37 mcg/mL Interval 5.77 to 7.03
Groups 1a and 2a: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 12-Month Vaccination Serotype 7F	5.40 mcg/mL Interval 5.08 to 5.73	6.04 mcg/mL Interval 5.56 to 6.55
Groups 1a and 2a: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 12-Month Vaccination Serotype 9V	3.53 mcg/mL Interval 3.31 to 3.77	3.62 mcg/mL Interval 3.3 to 3.96
Groups 1a and 2a: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 12-Month Vaccination Serotype 14	7.80 mcg/mL Interval 7.26 to 8.38	9.20 mcg/mL Interval 8.37 to 10.1
Groups 1a and 2a: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 12-Month Vaccination Serotype 18C	2.60 mcg/mL Interval 2.44 to 2.78	2.92 mcg/mL Interval 2.68 to 3.19
Groups 1a and 2a: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 12-Month Vaccination Serotype 19A	6.19 mcg/mL Interval 5.82 to 6.59	5.86 mcg/mL Interval 5.32 to 6.45
Groups 1a and 2a: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 12-Month Vaccination Serotype 19F	6.49 mcg/mL Interval 6.11 to 6.9	6.01 mcg/mL Interval 5.45 to 6.62
Groups 1a and 2a: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 12-Month Vaccination Serotype 23F	3.88 mcg/mL Interval 3.6 to 4.17	3.41 mcg/mL Interval 3.09 to 3.78
Groups 1a and 2a: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 12-Month Vaccination Serotype 4	2.08 mcg/mL Interval 1.95 to 2.22	2.00 mcg/mL Interval 1.83 to 2.18

SECONDARY outcome

Timeframe: Day 30 post 15-month vaccination (Month 16)

Population: Analysis was performed on PPAS3 (for 2nd year of life vaccination) which included participants of FAS3 with no relevant protocol deviations. Only those participants with data collected are reported.

Anti-PRP concentrations were measured using a farr-type RIA. The percentage of participants with an PRP antibody titers >=1.0 mcg/mL were assessed. Percentages are rounded off to the tenth decimal place.

Outcome measures

Measure	Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) n=297 Participants Participants received MenACYW conjugate vaccine and routine vaccines at 2, 4, 6, and 12 to 15 months of age. The time of analyses as well as the collection of blood samples conducted in the 2nd year of life for this subgroup was 30 days after the 12-month vaccination.	Group 2a: MENVEO (Post 12-month Vaccination) n=125 Participants Participants received MENVEO at 2, 4, 6, and 12 months of age and routine vaccines at 2, 4, 6, 12, and 15 to 18 months of age. The time of analyses as well as the collection of blood samples conducted in the 2nd year of life for this subgroup was 30 days after the 12-month vaccination.
Groups 1b and 2b: Percentage of Participants Who Achieved Anti-PRP Antibody Concentrations >=1.0 mcg/mL at Day 30 Post 15-Month Vaccination	98.3 percentage of participants Interval 96.1 to 99.5	98.4 percentage of participants Interval 94.3 to 99.8

SECONDARY outcome

Timeframe: Day 30 post 15-month vaccination (Month 16)

Population: Analysis was performed on PPAS3 (for 2nd year of life vaccination) which included participants of FAS3 with no relevant protocol deviations. Only those participants with data collected for each specified category are reported.

Anti-poliovirus types 1, 2, and 3 were measured by neutralization assay. The percentage of participants with anti-polio antibody titers >=1:8 are assessed.

Outcome measures

Measure	Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) n=291 Participants Participants received MenACYW conjugate vaccine and routine vaccines at 2, 4, 6, and 12 to 15 months of age. The time of analyses as well as the collection of blood samples conducted in the 2nd year of life for this subgroup was 30 days after the 12-month vaccination.	Group 2a: MENVEO (Post 12-month Vaccination) n=122 Participants Participants received MENVEO at 2, 4, 6, and 12 months of age and routine vaccines at 2, 4, 6, 12, and 15 to 18 months of age. The time of analyses as well as the collection of blood samples conducted in the 2nd year of life for this subgroup was 30 days after the 12-month vaccination.
Groups 1b and 2b: Percentage of Participants Who Achieved Anti-Poliovirus Antibody Titers >=1:8 at Day 30 Post 15-Month Vaccination Anti-polio 1	100 percentage of participants Interval 98.7 to 100.0	100 percentage of participants Interval 97.0 to 100.0
Groups 1b and 2b: Percentage of Participants Who Achieved Anti-Poliovirus Antibody Titers >=1:8 at Day 30 Post 15-Month Vaccination Anti-polio 2	100 percentage of participants Interval 98.7 to 100.0	100 percentage of participants Interval 97.0 to 100.0
Groups 1b and 2b: Percentage of Participants Who Achieved Anti-Poliovirus Antibody Titers >=1:8 at Day 30 Post 15-Month Vaccination Anti-polio 3	100 percentage of participants Interval 98.7 to 100.0	100 percentage of participants Interval 97.0 to 100.0

SECONDARY outcome

Timeframe: Day 30 post 15-month vaccination (Month 16)

Population: Analysis was performed on PPAS3 (for 2nd year of life vaccination) which included participants of FAS3 with no relevant protocol deviations. Only those participants with data collected for each specified category are reported.

Vaccine response was defined as: if the pre-booster (4th) vaccination concentration was <lower limit of quantification (LLOQ), then the post-booster (4th) vaccination concentration should be >=4 times LLOQ. The LLOQ was equal to 2.00 EU/mL. Percentages are rounded off to the tenth decimal place.

Outcome measures

Measure	Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) n=273 Participants Participants received MenACYW conjugate vaccine and routine vaccines at 2, 4, 6, and 12 to 15 months of age. The time of analyses as well as the collection of blood samples conducted in the 2nd year of life for this subgroup was 30 days after the 12-month vaccination.	Group 2a: MENVEO (Post 12-month Vaccination) n=121 Participants Participants received MENVEO at 2, 4, 6, and 12 months of age and routine vaccines at 2, 4, 6, 12, and 15 to 18 months of age. The time of analyses as well as the collection of blood samples conducted in the 2nd year of life for this subgroup was 30 days after the 12-month vaccination.
Groups 1b and 2b: Percentage of Participants Who Achieved Vaccine Response for Anti-Pertussis Antibodies at Day 30 Post 15-Month Vaccination Anti-PT	98.5 percentage of participants Interval 96.3 to 99.6	98.3 percentage of participants Interval 94.2 to 99.8
Groups 1b and 2b: Percentage of Participants Who Achieved Vaccine Response for Anti-Pertussis Antibodies at Day 30 Post 15-Month Vaccination Anti-FHA	96.7 percentage of participants Interval 93.8 to 98.5	96.7 percentage of participants Interval 91.8 to 99.1
Groups 1b and 2b: Percentage of Participants Who Achieved Vaccine Response for Anti-Pertussis Antibodies at Day 30 Post 15-Month Vaccination Anti-PRN	96.3 percentage of participants Interval 93.4 to 98.2	97.5 percentage of participants Interval 92.9 to 99.5
Groups 1b and 2b: Percentage of Participants Who Achieved Vaccine Response for Anti-Pertussis Antibodies at Day 30 Post 15-Month Vaccination Anti-FIM	98.2 percentage of participants Interval 95.8 to 99.4	97.5 percentage of participants Interval 92.9 to 99.5

SECONDARY outcome

Timeframe: Day 30 post 6-month vaccination (Month 7) and Day 0 before 12-month vaccination (Month 12)

Population: Analysis was performed on PPAS2 (for immunogenicity persistence evaluation). Only those participants with data collected for each specified category are reported. 3rd dose is 6-month vaccination and 4th dose is 12-month vaccination.

GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by hSBA. PPAS2 included participants of FAS2 (subset of all randomized participants who received >=1 dose of the study vaccine in infancy [at Visit 1 to 3, < 12 months of age] and had a valid pre-vaccination serology result at Visit 5 before the 12-month vaccinations for Subgroups 1a and 2a or at Visit 6 before the 15-month vaccinations for Subgroups 1b and 2b) with no relevant protocol deviations during infancy and for whom a pre-dose serology sample at Visit 5 for Subgroups 1a and 2a before the 12-month vaccinations or Visit 6 for Subgroups 1b and 2b before the 15-month vaccinations was not withdrawn.

Outcome measures

Measure	Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) n=644 Participants Participants received MenACYW conjugate vaccine and routine vaccines at 2, 4, 6, and 12 to 15 months of age. The time of analyses as well as the collection of blood samples conducted in the 2nd year of life for this subgroup was 30 days after the 12-month vaccination.	Group 2a: MENVEO (Post 12-month Vaccination) n=329 Participants Participants received MENVEO at 2, 4, 6, and 12 months of age and routine vaccines at 2, 4, 6, 12, and 15 to 18 months of age. The time of analyses as well as the collection of blood samples conducted in the 2nd year of life for this subgroup was 30 days after the 12-month vaccination.
Groups 1a and 2a: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination Serogroup A: Day 30 post 3rd dose	24.9 titer Interval 21.6 to 28.6	16.3 titer Interval 13.5 to 19.6
Groups 1a and 2a: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination Serogroup A: Day 0 before 4th dose	9.33 titer Interval 8.45 to 10.3	6.43 titer Interval 5.64 to 7.33
Groups 1a and 2a: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination Serogroup C: Day 30 post 3rd dose	365 titer Interval 325.0 to 411.0	51.4 titer Interval 42.9 to 61.5
Groups 1a and 2a: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination Serogroup C: Day 0 before 4th dose	57.8 titer Interval 51.5 to 64.8	4.82 titer Interval 4.22 to 5.5
Groups 1a and 2a: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination Serogroup Y: Day 30 post 3rd dose	83.0 titer Interval 75.0 to 91.8	42.9 titer Interval 36.7 to 50.0
Groups 1a and 2a: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination Serogroup Y: Day 0 before 4th dose	42.9 titer Interval 39.3 to 46.7	10.4 titer Interval 9.15 to 11.9
Groups 1a and 2a: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination Serogroup W: Day 30 post 3rd dose	92.8 titer Interval 84.8 to 102.0	51.4 titer Interval 43.9 to 60.0
Groups 1a and 2a: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination Serogroup W: Day 0 before 4th dose	57.8 titer Interval 52.7 to 63.3	9.27 titer Interval 8.15 to 10.5

SECONDARY outcome

Timeframe: Day 30 post 6-month vaccination (Month 7) and Day 0 before 12-month vaccination (Month 12)

Population: Analysis was performed on PPAS2 (for immunogenicity persistence evaluation). Only those participants with data collected for each specified category are reported. 3rd dose is 6-month vaccination, 4th dose is 12-month vaccination. D0 is Day 0 and D30 is Day 30.

Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. PPAS2 included participants of FAS2 with no relevant protocol deviations during infancy and for whom a pre-dose serology sample at Visit 5 for Subgroups 1a and 2a before the 12-month vaccinations or Visit 6 for Subgroups 1b and 2b before the 15-month vaccinations was not withdrawn. Percentages are rounded off to the tenth decimal place.

Outcome measures

Measure	Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) n=644 Participants Participants received MenACYW conjugate vaccine and routine vaccines at 2, 4, 6, and 12 to 15 months of age. The time of analyses as well as the collection of blood samples conducted in the 2nd year of life for this subgroup was 30 days after the 12-month vaccination.	Group 2a: MENVEO (Post 12-month Vaccination) n=329 Participants Participants received MENVEO at 2, 4, 6, and 12 months of age and routine vaccines at 2, 4, 6, 12, and 15 to 18 months of age. The time of analyses as well as the collection of blood samples conducted in the 2nd year of life for this subgroup was 30 days after the 12-month vaccination.
Groups 1a and 2a: Percentage of Participants Who Achieved Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination Serogroup A: D30 post 3rd dose:>=1:4	87.0 percentage of participants Interval 83.9 to 89.7	84.9 percentage of participants Interval 79.9 to 89.0
Groups 1a and 2a: Percentage of Participants Who Achieved Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination Serogroup A:D0 before 4th dose:>=1:8	59.0 percentage of participants Interval 55.0 to 62.9	47.0 percentage of participants Interval 41.5 to 52.7
Groups 1a and 2a: Percentage of Participants Who Achieved Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination Serogroup C: D30 post 3rd dose:>=1:4 (n=)	99.3 percentage of participants Interval 98.1 to 99.8	93.7 percentage of participants Interval 90.0 to 96.3
Groups 1a and 2a: Percentage of Participants Who Achieved Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination Serogroup C: D30 post 3rd dose:>=1:8	99.1 percentage of participants Interval 97.9 to 99.7	91.0 percentage of participants Interval 87.0 to 94.2
Groups 1a and 2a: Percentage of Participants Who Achieved Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination Serogroup C:D0 before 4th dose:>=1:4	95.4 percentage of participants Interval 93.5 to 96.9	49.1 percentage of participants Interval 43.5 to 54.7
Groups 1a and 2a: Percentage of Participants Who Achieved Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination Serogroup C:D0 before 4th dose:>=1:8	92.9 percentage of participants Interval 90.7 to 94.8	34.0 percentage of participants Interval 28.8 to 39.4
Groups 1a and 2a: Percentage of Participants Who Achieved Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination Serogroup Y: D30 post 3rd dose:>=1:4	99.1 percentage of participants Interval 97.9 to 99.7	96.3 percentage of participants Interval 93.3 to 98.2
Groups 1a and 2a: Percentage of Participants Who Achieved Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination Serogroup Y: D30 post 3rd dose:>=1:8	98.6 percentage of participants Interval 97.2 to 99.4	92.2 percentage of participants Interval 88.4 to 95.1
Groups 1a and 2a: Percentage of Participants Who Achieved Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination Serogroup Y:D0 before 4th dose:>=1:4	99.2 percentage of participants Interval 98.2 to 99.7	83.5 percentage of participants Interval 79.0 to 87.3
Groups 1a and 2a: Percentage of Participants Who Achieved Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination Serogroup Y:D0 before 4th dose:>=1:8	96.8 percentage of participants Interval 95.2 to 98.1	69.1 percentage of participants Interval 63.8 to 74.1
Groups 1a and 2a: Percentage of Participants Who Achieved Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination Serogroup W: D30 post 3rd dose:>=1:4	99.8 percentage of participants Interval 99.0 to 100.0	97.5 percentage of participants Interval 94.9 to 99.0
Groups 1a and 2a: Percentage of Participants Who Achieved Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination Serogroup W: D30 post 3rd dose:>=1:8	98.8 percentage of participants Interval 97.5 to 99.5	94.2 percentage of participants Interval 90.8 to 96.7
Groups 1a and 2a: Percentage of Participants Who Achieved Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination Serogroup W:D0 before 4th dose:>=1:4	98.9 percentage of participants Interval 97.8 to 99.6	82.7 percentage of participants Interval 78.1 to 86.6
Groups 1a and 2a: Percentage of Participants Who Achieved Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination Serogroup W:D0 before 4th dose:>=1:8	97.2 percentage of participants Interval 95.6 to 98.3	62.0 percentage of participants Interval 56.5 to 67.3
Groups 1a and 2a: Percentage of Participants Who Achieved Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination Serogroup A: D30 post 3rd dose:>=1:8	77.3 percentage of participants Interval 73.6 to 80.8	70.2 percentage of participants Interval 64.2 to 75.7
Groups 1a and 2a: Percentage of Participants Who Achieved Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination Serogroup A:D0 before 4th dose:>=1:4	82.5 percentage of participants Interval 79.2 to 85.4	66.4 percentage of participants Interval 60.9 to 71.5

Adverse Events

Group 1: MenACYW Conjugate Vaccine

Serious events: 99 serious events

Other events: 1471 other events

Deaths: 1 deaths

Group 2: MENVEO

Serious events: 38 serious events

Other events: 746 other events

Deaths: 0 deaths

Serious adverse events

Measure	Group 1: MenACYW Conjugate Vaccine n=1727 participants at risk Participants received MenACYW conjugate vaccine 0.5 mL as an IM injection at 2, 4, 6, and 12 to 15/15 to 18 months of age along with Pentacel (diphtheria-tetanus-acellular pertussis \[DTaP-IPV/Hib\] vaccine) at 2, 4, 6 and 15 to 18 months of age; PREVNAR 13 (pneumococcal 13-valent conjugate vaccine \[PCV13\] at 2, 4, 6, and 12 to 15 months of age; RotaTeq (pentavalent rotavirus vaccine \[RV5\]) at 2, 4, and 6 months of age; ENGERIX-B (hepatitis B vaccine) at 2 and 6 months of age; M-M-R II (measles, mumps, and rubella vaccine) and VARIVAX (varicella vaccine) at 12 to 15 months of age. Additionally, participants received first dose of HAVRIX (hepatitis A vaccine) at 15 to 18 months of age as a part of the study. Group 1 was divided as Groups 1a and 1b based on the time of analyses, i.e. 30 days after 12 months and 30 days after 15 months respectively. The division of the subgroups did not determine when participants received their vaccinations in the 2nd year of life.	Group 2: MENVEO n=867 participants at risk Participants received MENVEO conjugate vaccine 0.5 mL as an IM injection at 2, 4, 6, and 12 months of age along with Pentacel (DTaP-IPV/Hib vaccine) at 2, 4, 6 and 15 to 18 months of age; PREVNAR 13 (PCV13) at 2, 4, 6, and 12 months of age; RotaTeq (rotavirus vaccine) at 2, 4, and 6 months of age; ENGERIX-B (hepatitis B vaccine) at 2 and 6 months of age; M-M-R II (measles, mumps, and rubella vaccine) and VARIVAX (varicella vaccine) at 12 months of age. In addition, they also received first dose of HAVRIX (hepatitis A vaccine) at 15 to 18 months of age. Group 2 was further divided as Groups 2a and 2b based on the time of analyses, i.e. 30 days after 12 months and 30 days after 15 months respectively. The division of the subgroups did not determine when participants received their vaccinations in the 2nd year of life.
Injury, poisoning and procedural complications Craniocerebral Injury	0.06% 1/1727 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.00% 0/867 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Injury, poisoning and procedural complications Femur Fracture	0.06% 1/1727 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.00% 0/867 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Injury, poisoning and procedural complications Head Injury	0.06% 1/1727 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.00% 0/867 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Injury, poisoning and procedural complications Post Vaccination Fever	0.00% 0/1727 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.12% 1/867 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Injury, poisoning and procedural complications Skull Fracture	0.17% 3/1727 • Number of events 3 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.00% 0/867 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Injury, poisoning and procedural complications Skull Fractured Base	0.06% 1/1727 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.00% 0/867 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Injury, poisoning and procedural complications Subdural Haematoma	0.12% 2/1727 • Number of events 2 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.00% 0/867 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Injury, poisoning and procedural complications Upper Limb Fracture	0.06% 1/1727 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.00% 0/867 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Cardiac disorders Cardiac Arrest	0.06% 1/1727 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.00% 0/867 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Congenital, familial and genetic disorders Congenital Absence Of Bile Ducts	0.00% 0/1727 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.12% 1/867 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Congenital, familial and genetic disorders Pyloric Stenosis	0.06% 1/1727 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.00% 0/867 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Congenital, familial and genetic disorders Talipes	0.06% 1/1727 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.00% 0/867 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Congenital, familial and genetic disorders Urachal Abnormality	0.06% 1/1727 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.00% 0/867 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Blood and lymphatic system disorders Coagulopathy	0.00% 0/1727 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.12% 1/867 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Nervous system disorders Epilepsy	0.00% 0/1727 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.12% 1/867 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Nervous system disorders Febrile Convulsion	0.46% 8/1727 • Number of events 11 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.35% 3/867 • Number of events 4 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Nervous system disorders Infantile Spasms	0.06% 1/1727 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.00% 0/867 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Nervous system disorders Seizure	0.17% 3/1727 • Number of events 4 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.12% 1/867 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Nervous system disorders Seizure Like Phenomena	0.06% 1/1727 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.00% 0/867 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Nervous system disorders Subarachnoid Haemorrhage	0.06% 1/1727 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.00% 0/867 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Gastrointestinal disorders Abdominal Pain	0.06% 1/1727 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.00% 0/867 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Gastrointestinal disorders Constipation	0.00% 0/1727 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.12% 1/867 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Gastrointestinal disorders Dysphagia	0.06% 1/1727 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.00% 0/867 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	0.12% 2/1727 • Number of events 2 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.00% 0/867 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Gastrointestinal disorders Sandifer's Syndrome	0.06% 1/1727 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.00% 0/867 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Gastrointestinal disorders Vomiting	0.06% 1/1727 • Number of events 2 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.00% 0/867 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Renal and urinary disorders Hydronephrosis	0.06% 1/1727 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.00% 0/867 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Metabolism and nutrition disorders Dehydration	0.17% 3/1727 • Number of events 3 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.46% 4/867 • Number of events 4 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Metabolism and nutrition disorders Ketoacidosis	0.00% 0/1727 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.12% 1/867 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Metabolism and nutrition disorders Type 1 Diabetes Mellitus	0.00% 0/1727 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.12% 1/867 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Infections and infestations Abscess Neck	0.00% 0/1727 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.12% 1/867 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Infections and infestations Adenovirus Infection	0.06% 1/1727 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.00% 0/867 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Infections and infestations Bacteraemia	0.00% 0/1727 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.12% 1/867 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Infections and infestations Bacterial Pyelonephritis	0.06% 1/1727 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.00% 0/867 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Infections and infestations Bordetella Infection	0.06% 1/1727 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.00% 0/867 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Infections and infestations Bronchiolitis	0.87% 15/1727 • Number of events 16 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.46% 4/867 • Number of events 4 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Infections and infestations Covid-19	0.06% 1/1727 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.12% 1/867 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Infections and infestations Cellulitis	0.00% 0/1727 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.12% 1/867 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Infections and infestations Croup Infectious	0.12% 2/1727 • Number of events 2 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.00% 0/867 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Infections and infestations Eczema Coxsackium	0.06% 1/1727 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.00% 0/867 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Infections and infestations Escherichia Urinary Tract Infection	0.06% 1/1727 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.00% 0/867 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Infections and infestations Exanthema Subitum	0.06% 1/1727 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.00% 0/867 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Infections and infestations Gastroenteritis	0.12% 2/1727 • Number of events 2 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.35% 3/867 • Number of events 3 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Infections and infestations Gastroenteritis Norovirus	0.06% 1/1727 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.00% 0/867 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Infections and infestations Gastroenteritis Viral	0.06% 1/1727 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.00% 0/867 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Infections and infestations Gastrointestinal Viral Infection	0.06% 1/1727 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.00% 0/867 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Infections and infestations Impetigo	0.06% 1/1727 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.00% 0/867 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Infections and infestations Influenza	0.23% 4/1727 • Number of events 5 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.12% 1/867 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Infections and infestations Otitis Media	0.06% 1/1727 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.00% 0/867 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Infections and infestations Otitis Media Acute	0.06% 1/1727 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.12% 1/867 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Infections and infestations Parainfluenzae Virus Infection	0.12% 2/1727 • Number of events 3 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.00% 0/867 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Infections and infestations Perirectal Abscess	0.06% 1/1727 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.00% 0/867 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Infections and infestations Pharyngitis	0.06% 1/1727 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.00% 0/867 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Infections and infestations Pharyngitis Streptococcal	0.06% 1/1727 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.00% 0/867 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Infections and infestations Pneumonia	0.35% 6/1727 • Number of events 6 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.23% 2/867 • Number of events 2 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Infections and infestations Pneumonia Mycoplasmal	0.06% 1/1727 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.12% 1/867 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Infections and infestations Pneumonia Viral	0.12% 2/1727 • Number of events 2 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.00% 0/867 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Infections and infestations Pyelonephritis	0.17% 3/1727 • Number of events 3 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.00% 0/867 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Infections and infestations Pyelonephritis Acute	0.12% 2/1727 • Number of events 2 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.00% 0/867 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Infections and infestations Respiratory Syncytial Virus Bronchiolitis	0.52% 9/1727 • Number of events 9 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.46% 4/867 • Number of events 4 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Infections and infestations Respiratory Syncytial Virus Infection	0.41% 7/1727 • Number of events 7 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.69% 6/867 • Number of events 6 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Infections and infestations Rhinovirus Infection	0.06% 1/1727 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.00% 0/867 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Infections and infestations Roseola	0.06% 1/1727 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.00% 0/867 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Infections and infestations Sepsis	0.06% 1/1727 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.00% 0/867 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Infections and infestations Skin Bacterial Infection	0.06% 1/1727 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.00% 0/867 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Infections and infestations Staphylococcal Scalded Skin Syndrome	0.00% 0/1727 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.12% 1/867 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Infections and infestations Systemic Infection	0.06% 1/1727 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.00% 0/867 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Infections and infestations Systemic Viral Infection	0.06% 1/1727 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.00% 0/867 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Infections and infestations Upper Respiratory Tract Infection	0.12% 2/1727 • Number of events 2 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.00% 0/867 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Infections and infestations Urinary Tract Infection	0.12% 2/1727 • Number of events 2 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.35% 3/867 • Number of events 4 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Infections and infestations Viral Infection	0.06% 1/1727 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.12% 1/867 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioma	0.06% 1/1727 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.00% 0/867 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
General disorders Pyrexia	0.06% 1/1727 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.00% 0/867 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	0.12% 2/1727 • Number of events 2 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.12% 1/867 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Respiratory, thoracic and mediastinal disorders Apnoea	0.00% 0/1727 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.12% 1/867 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Respiratory, thoracic and mediastinal disorders Aspiration	0.06% 1/1727 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.00% 0/867 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.06% 1/1727 • Number of events 1 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.00% 0/867 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Respiratory, thoracic and mediastinal disorders Respiratory Distress	0.23% 4/1727 • Number of events 4 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.35% 3/867 • Number of events 3 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.12% 2/1727 • Number of events 2 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	0.00% 0/867 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.

Other adverse events

Measure	Group 1: MenACYW Conjugate Vaccine n=1727 participants at risk Participants received MenACYW conjugate vaccine 0.5 mL as an IM injection at 2, 4, 6, and 12 to 15/15 to 18 months of age along with Pentacel (diphtheria-tetanus-acellular pertussis \[DTaP-IPV/Hib\] vaccine) at 2, 4, 6 and 15 to 18 months of age; PREVNAR 13 (pneumococcal 13-valent conjugate vaccine \[PCV13\] at 2, 4, 6, and 12 to 15 months of age; RotaTeq (pentavalent rotavirus vaccine \[RV5\]) at 2, 4, and 6 months of age; ENGERIX-B (hepatitis B vaccine) at 2 and 6 months of age; M-M-R II (measles, mumps, and rubella vaccine) and VARIVAX (varicella vaccine) at 12 to 15 months of age. Additionally, participants received first dose of HAVRIX (hepatitis A vaccine) at 15 to 18 months of age as a part of the study. Group 1 was divided as Groups 1a and 1b based on the time of analyses, i.e. 30 days after 12 months and 30 days after 15 months respectively. The division of the subgroups did not determine when participants received their vaccinations in the 2nd year of life.	Group 2: MENVEO n=867 participants at risk Participants received MENVEO conjugate vaccine 0.5 mL as an IM injection at 2, 4, 6, and 12 months of age along with Pentacel (DTaP-IPV/Hib vaccine) at 2, 4, 6 and 15 to 18 months of age; PREVNAR 13 (PCV13) at 2, 4, 6, and 12 months of age; RotaTeq (rotavirus vaccine) at 2, 4, and 6 months of age; ENGERIX-B (hepatitis B vaccine) at 2 and 6 months of age; M-M-R II (measles, mumps, and rubella vaccine) and VARIVAX (varicella vaccine) at 12 months of age. In addition, they also received first dose of HAVRIX (hepatitis A vaccine) at 15 to 18 months of age. Group 2 was further divided as Groups 2a and 2b based on the time of analyses, i.e. 30 days after 12 months and 30 days after 15 months respectively. The division of the subgroups did not determine when participants received their vaccinations in the 2nd year of life.
General disorders Injection Site Swelling	36.6% 632/1727 • Number of events 2651 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	37.3% 323/867 • Number of events 1491 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
General disorders Pyrexia	33.6% 580/1727 • Number of events 912 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	36.0% 312/867 • Number of events 512 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Psychiatric disorders Irritability	66.8% 1154/1727 • Number of events 3082 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	69.0% 598/867 • Number of events 1694 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Nervous system disorders Somnolence	56.5% 975/1727 • Number of events 2319 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	58.5% 507/867 • Number of events 1273 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Gastrointestinal disorders Teething	6.1% 106/1727 • Number of events 124 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	7.2% 62/867 • Number of events 73 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Gastrointestinal disorders Vomiting	24.1% 417/1727 • Number of events 607 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	22.6% 196/867 • Number of events 276 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Metabolism and nutrition disorders Decreased Appetite	40.8% 704/1727 • Number of events 1246 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	44.8% 388/867 • Number of events 732 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Infections and infestations Nasopharyngitis	5.6% 96/1727 • Number of events 105 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	5.8% 50/867 • Number of events 62 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Infections and infestations Otitis Media	4.6% 79/1727 • Number of events 91 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	5.5% 48/867 • Number of events 64 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
Infections and infestations Upper Respiratory Tract Infection	12.4% 214/1727 • Number of events 264 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	15.0% 130/867 • Number of events 162 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
General disorders Crying	59.2% 1023/1727 • Number of events 2366 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	62.4% 541/867 • Number of events 1303 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
General disorders Injection Site Bruising	10.7% 185/1727 • Number of events 380 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	10.1% 88/867 • Number of events 158 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
General disorders Injection Site Erythema	46.7% 806/1727 • Number of events 3898 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	47.2% 409/867 • Number of events 2054 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
General disorders Injection Site Pain	69.5% 1201/1727 • Number of events 9341 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.	73.5% 637/867 • Number of events 5053 • From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.

Additional Information

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