A Study of a Quadrivalent Meningococcal Tetanus Protein Conjugate Vaccine in Infants and Toddlers

Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine Administered in Infants and Toddlers

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01049035

Enrollment

580

Registered

2010-01-14

Start date

2009-12-16

Completion date

2012-02-13

Last updated

2022-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Meningitis, Meningococcal Infection

Keywords

Meningitis, Meningococcal Infection, Neisseria meningitidis, Tetravalent Meningococcal Vaccine

Brief summary

The purpose of this study was to evaluate the optimal vaccination schedule for a Quadrivalent Meningococcal Polysaccharide (A, C, Y and W-135) Tetanus Protein Conjugate Vaccine (MenACYW Conjugate vaccine) in order to provide an effective protein conjugate quadrivalent meningococcal vaccine in the population with the highest incidence of disease. Objectives: * To describe the safety profile of MenACYW Conjugate vaccine administered at 5 different schedules and concomitantly with routine pediatric vaccinations. * To describe the immunogenicity profile of MenACYW Conjugate vaccine administered at 5 different schedules and concomitantly with routine pediatric vaccinations. * To describe the immunogenicity profiles of selected licensed pediatric vaccines (Pentacel, Prevnar, M-M-RII, and Varivax) when administered either concomitantly with or without MenACYW Conjugate vaccine.

Detailed description

Participants received study vaccinations beginning at age 2, 6, 12, or 15 months, depending on the assigned schedule in their randomized groups. All participants underwent safety and immunogenicity assessments according to the schedule for their assigned group.

Interventions

BIOLOGICALQuadrivalent Meningococcal Polysaccharide (A, C, Y, and W-135) Tetanus Protein Conjugate

0.5 milliliter (mL), Intramuscular (IM) injection

BIOLOGICALDiphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus B Conjugate (Tetanus Toxoid Conjugate) Vaccine Combined (DTaP-IPV/Hib combined)

0.5 mL, IM injection

BIOLOGICALM-M-RII-Measles, Mumps, and Rubella Virus Vaccine Live

0.5 mL, Subcutaneous (SC) injection

BIOLOGICALVaricella Virus Vaccine Live

0.5 mL, SC injection

BIOLOGICALPneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)

0.5 mL, IM injection

BIOLOGICALPneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)

0.5 mL, IM injection

BIOLOGICALRotavirus Vaccine

oral

BIOLOGICALHepatitis B Vaccine

0.5 mL, IM injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

42 Days to 365 Days

Healthy volunteers

Yes

Inclusion criteria

* Groups 1, 2, 3, 6, and 7: Aged 42 to 89 days on the day of inclusion; Group 4: Aged 6 months (180 days ± 14 days) on the day of inclusion; Group 5: Aged 12 months (365 days + 14 days) on the day of inclusion. * Born at full term of pregnancy (greater than or equal to \[≥\] 37 weeks) and with a birth weight ≥2.5 kilogram (kg). * Informed consent form had been signed and dated by the parent or other legally acceptable representative. * Participant and parent/guardian were able to attend all scheduled visits and to be complied with all trial procedures. * Group 4 only: Prior receipt of Pentacel and Prevnar at 2 and 4 months; 1 or 2 doses of rotavirus vaccine; and 2 or 3 previous doses of hepatitis B vaccine. Group 5 only: Prior receipt of Pentacel and Prevnar at 2, 4, and 6 months; 2 or 3 doses of rotavirus vaccine; and 3 previous doses of hepatitis B vaccine.

Exclusion criteria

* Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination. * Planned participation in another clinical trial during the present trial period. * Receipt of any vaccine in the 4 weeks preceding the first trial vaccination. * Planned receipt of any vaccine in the 4 weeks following any trial vaccination, with the exception of influenza vaccine, which may be received 14 days before or after MenACYW Conjugate vaccine. * Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine. * Receipt of blood or blood-derived products in the past 30 days, which might interfere with assessment of the immune response. * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks). * Known personal or maternal seropositivity for human immunodeficiency virus (HIV), hepatitis B vaccine, or hepatitis C, as reported by the parent/guardian. * History of meningococcal infection, confirmed either clinically, serologically, or microbiologically. * At high risk for meningococcal infection during the trial. * Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances. * Thrombocytopenia, as reported by the parent/guardian. * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination. * History of seizures. * Personal or family history of Guillain-Barré Syndrome (GBS). * Chronic illness that, in the opinion of the investigator, was at a stage where it might interfere with trial conduct or completion. Temporary contraindications were resolved before vaccination: * Febrile illness (temperature ≥38.0 degree Celsius \[≥100.4 degree Fahrenheit\]) or moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination. * Group 5 only: Receipt of oral or injected antibiotic therapy within the 72 hours prior to the study blood draw. Topical antibiotics or antibiotic drops were not included in this exclusion criterion. (Note: This did not applied to the other groups at this time, as they did not have a blood draw within 30 days of the initial visit.).

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants With an Serum Bactericidal Assay (SBA) Using Human Complement (SBA-HC) Titer Greater or Than Equal to (≥) 1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-protocol Population (PPP)	Groups 1, 2, 4, 6, and 7: at the age of 7 months; Group 3: at the age of 5 months	Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. The PPP consisted of all participants included in the trial who received at least one dose of study or control vaccine, excluding those who did not meet all protocol-specified inclusion/exclusion criteria, did not receive the correct number of doses of the investigational vaccine, received a vaccine other than the one that he/she was randomized to receive, did not provide a post-dose serology sample in the proper time window, received a protocol-restricted therapy, medication or vaccine, was on systemic antibiotics within 3 days prior to study blood draw, had no serology sample or did not produce at least one valid test result, did not receive vaccine in the proper time window. Primary series PPP was defined as the PPP which was used for reporting data of time points prior to 12 months of age.
Percentage of Participants With SBA-HC Pre-Vaccination Titer <1:8 Who Then Achieved ≥4-Fold Rise in SBA-HC Titer After Vaccination: Group 5 - Per-Protocol Population	30 days post-vaccination at the age of 12 months (i.e. at the age of 13 months)	Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. Percentage of participants with pre-vaccination titer \<1:8 and achieved ≥4-fold rise in each meningococcal serogroups antibody titer (30-days post vaccination) were reported.
Percentage of Participants With an Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Groups 1, 3, 4, and 6: at the age of 13 months; Groups 2 and 7: at the age of 16 months	Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. PPP consisted of all participants included in the trial who received at least one dose of study or control vaccine, excluding those who did not meet all protocol-specified inclusion/exclusion criteria, did not received the correct number of doses of the investigational vaccine, received a vaccine other than the one that he/she was randomized to receive, did not provided a post-dose serology sample in the proper time window, received a protocol-restricted therapy, medication or vaccine, was on systemic antibiotics within 3 days prior to study blood draw, had no serology sample or did not produce at least one valid test result, did not receive vaccine in the proper time window. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.
Percentage of Participants With Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Group 5 - Per-Protocol Population	At the age of 13 months	Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. PPP consisted of all participants included in the trial who received at least one dose of study or control vaccine, excluding those who did not meet all protocol-specified inclusion/exclusion criteria, did not received the correct number of doses of the investigational vaccine, received a vaccine other than the one that he/she was randomized to receive, did not provided a post-dose serology sample in the proper time window, received a protocol-restricted therapy, medication or vaccine, was on systemic antibiotics within 3 days prior to study blood draw, had no serology sample or did not produce at least one valid test result, did not receive vaccine in the proper time window.
Percentage of Participants With SBA-HC Pre-booster Titer ≥1:8 Who Then Achieved ≥4-Fold Rise in SBA-HC Titer After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Groups 1, 3, and 4: 30 days post-vaccination at the age of 12 months (i.e. at the age of 13 months); Group 2: 30 days post-vaccination at the age of 15 months (i.e. at the age of 16 months)	Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. Pre-booster titer was defined as titer values reported before the age of 12 months. Percentage of participants whose pre-booster titer was ≥1:8 and achieved ≥4-fold rise in each meningococcal serogroups antibody titer (30-days post booster vaccination) were reported. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.
Percentage of Participants With SBA-HC Pre-vaccination Titer ≥1:8 Who Then Achieved ≥4-fold Rise in SBA-HC Titer After Vaccination: Group 5 - Per-Protocol Population	30 days post-vaccination at the age of 12 months (i.e. at the age of 13 months)	Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. Pre-vaccination titer was defined as titer values reported before the age of 12 months. Percentage of participants whose pre-vaccination titer was ≥1:8 and achieved ≥4-fold rise in each meningococcal serogroups antibody titer (30 days post-vaccination) were reported.
Percentage of Participants With SBA-HC Pre-booster Titer Less Than (<) 1:8 Who Then Achieved ≥4-Fold Rise in SBA-HC After Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Groups 1, 3, and 4: 30 days post-vaccination at the age of 12 months (i.e. at the age of 13 months); Group 2: 30 days post-vaccination at the age of 15 months (i.e. at the age of 16 months)	Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. Pre-booster titer was defined as titer values reported before the age of 12 months. Percentage of participants whose pre-booster titer was \<1:8 and achieved ≥4-fold rise in each meningococcal serogroups antibody titer (30-days post booster vaccination) were reported. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.
Serum Bactericidal Assay Using Human Complement Geometric Mean Titers (GMTs): Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Groups 1, 2, 4, 6, and 7: at the age of 7 months, Group 3: at the age of 5 months	Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. Primary series PPP was defined as the PPP which was used for reporting data of time points prior to 12 months of age.
Serum Bactericidal Assay Using Human Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Groups 1, 3, 4, and 6: at the age of 13 months; Groups 2 and 7: at the age of 16 months	Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.
Serum Bactericidal Assay Using Human Complement Geometric Mean Titers: Group 5 - Per-Protocol Population	At the age of 13 months	Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC.
Percentage of Participants With ≥4-fold Rise in SBA-HC Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Groups 1, 3, and 4: 30 days post-vaccination at the age of 12 months (i.e. at the age of 13 months), Group 2: 30 days post-vaccination at the age of 15 months (i.e. at the age of 16 months)	Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. Percentage of participants with ≥4-fold rise in each meningococcal serogroups antibody titer (30 days post booster vaccination) were reported. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.
Geometric Mean Fold Rise (GMFR) in SBA-HC Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Groups 1, 3 and 4: 30 days post-vaccination at the age of 12 months (i.e. at the age of 13 months), Group 2: 30 days post-vaccination at the age of 15 months (i.e. at the age of 16 months)	Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.
Percentage of Participants With a Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Groups 1, 2, 4, 6, and 7: at the age of 7 months; Group 3: at the age of 5 months	Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Primary series PPP was defined as the PPP which was used for reporting data of time points prior to 12 months of age.
Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Groups 1, 3, 4, and 6: at the age of 13 months; Groups 2 and 7: at the age of 16 months	Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.
Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Group 5 - Per-Protocol Population	At the age of 13 months	Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR.
Percentage of Participants With SBA-BR Pre-Booster Titer ≥1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titer After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Groups 1, 3, and 4: 30 days post-vaccination at the age of 12 months (i.e. at the age of 13 months); Group 2: 30 days post-vaccination at the age of 15 months (i.e. at the age of 16 months)	Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Pre-booster titer was defined as titer value reported before the age of 12 months. Percentage of participants whose pre-booster titer was ≥1:8 and achieved ≥4-fold rise in each meningococcal serogroups antibody titer (30 days post booster vaccination) were reported. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.
Percentage of Participants With SBA-BR Pre-Vaccination Titer ≥1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titer After Vaccination: Group 5 - Per-Protocol Population	30 days post-vaccination at the age of 12 months (i.e. at the age of 13 months)	Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Percentage of participants whose pre-vaccination titer was ≥1:8 and achieved ≥4-fold rise in each meningococcal serogroups antibody titer at the age of Month 13 (i.e. 30-days post vaccination at Month 12) were reported.
Percentage of Participants With SBA-BR Pre-Booster Titer <1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titers After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Groups 1, 3, and 4: 30 days post-vaccination at the age of 12 months (i.e. at the age of 13 months); Group 2: 30 days post-vaccination at the age of 15 months (i.e. at the age of 16 months)	Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Pre-booster titer was defined as titer value reported before the age of 12 months. Percentage of participants whose pre-booster titer was \<1:8 and achieved ≥4-fold rise in each meningococcal serogroups antibody titer (30-days post booster vaccination) were reported. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.
Percentage of Participants With SBA-BR Pre-Vaccination Titer <1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titer After Vaccination: Group 5 - Per-Protocol Population	30 days post-vaccination at the age of 12 months (i.e. at the age of 13 months)	Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Pre-vaccination titer was defined as titer value reported before the age of 12 months. Percentage of participants with pre-vaccination titer \<1:8 and who achieved ≥4-fold rise in each meningococcal serogroups antibody titer (30 days post-vaccination) were reported.
Percentage of Participants With ≥4-fold Rise in SBA-BR Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Groups 1, 3, and 4: 30 days post booster vaccination (i.e., at the age of 13 months); Group 2: 30 days post booster vaccination (i.e., at the age of 16 months)	Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Percentage of participants with ≥4-fold rise in each meningococcal serogroups antibody titer (30-days post booster vaccination) were reported. Booster PPP was defined as the PPP which was used for reporting data of time points at and after the age of 12 months.
Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Groups 1, 2, 4, 6, and 7: at the age of 7 months; Group 3: at the age of 5 months	Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Primary series PPP was defined as the PPP which was used for reporting data of time points prior to 12 months of age.
Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Groups 1, 3, 4, and 6: at the age of 13 months; Group 2 and 7: at the age of 16 months	Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.
Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers in Group 5: Per-Protocol Population	At the age of 13 months	Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR.
Geometric Mean Fold Rise in Serum Bactericidal Assay Using Baby Rabbit Complement Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Groups 1, 3, and 4: 30 days post booster vaccination at the age of 12 months (i.e., at the age of 13 months); Group 2: 30 days post booster vaccination at the age of 15 months (i.e. at the age of 16 months)	Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Percentage of participants with GMFR in each meningococcal serogroups antibody titer (30-days post booster vaccination) were reported. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.
Antibody Titer/Concentration to All the Antigens Contained in Pentacel Vaccines: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	At the age of 7 months	Pentacel vaccine is Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine Combined (DTaP-IPV/Hib combined). Antibody titer to all antigens contained in pentacel vaccines (i.e., Anti-PRP, Anti-Diptheria, Anti-pertussis \[pertussis toxoid \[PT\], pertactin \[PRN\], filamentous hemagglutinin \[FHA\], and fimbriae \[FIM\]\], Anti-poliovirus \[anti-poliovirus Type 1, Type 2 and Type 3\] and anti-tetanus) were reported. Primary series PPP was defined as the PPP which was used for reporting data of time points prior to 12 months of age.
Antibody Titer/Concentration to All Antigens Contained in Pentacel Vaccines: Groups 2 and 7 - Booster Per-Protocol Population	At the age of 16 months	Pentacel vaccine is Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine Combined (DTaP-IPV/Hib combined). Antibody titer to all antigens contained in pentacel vaccines (i.e., Anti-PRP, Anti-Diptheria, Anti-pertussis \[PT, PRN, FHA, and FIM\], Anti-poliovirus \[anti-poliovirus Type 1, Type 2, and Type 3\], and Anti-tetanus) were reported. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.
Percentage of Participants With Antibody Concentration ≥0.35 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	At the age of 7 months	Percentage of participants with anti-pneumococcal antibody concentrations ≥0.35 μg/mL for serotypes in Prevnar 7 or 13 vaccine i.e. 4, 6B, 9V, 14, 18C, 19F, and 23F is reported. Primary series PPP was defined as the PPP which was used for reporting data of time points prior to 12 months of age.
Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population	At the age of 13 months	Percentage of participants with anti-pneumococcal antibody concentrations ≥0.35 μg/mL and ≥1.0 μg/mL for serotypes in Prevnar 7 or 13 vaccine i.e. 4, 6B, 9V, 14, 18C, 19F and 23F is reported. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.
Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Group 5- Per-Protocol Population	At the age of 13 months	Percentage of participants with anti-pneumococcal antibody concentrations ≥0.35 μg/mL and ≥1.0 μg/mL for serotypes in Prevnar 7 or 13 vaccine i.e. 4, 6B, 9V, 14, 18C, 19F and 23F is reported.
Percentage of Participants With Antibodies to All Antigens Contained in M-M-RII and VARIVAX Vaccines: Groups 1 and 6 - Booster Per-Protocol Population	At the age of 13 months	Antibodies responses were measured by ELISA. Antigens contained in M-M-RII: Measles, Mumps, and Rubella and in Varivax®: Varicella. Percentage of participants with anti-measles, anti-mumps, anti-rubella, and anti-varicella antibody concentration that met the respective mentioned criterion were reported: Measles: ≥255 milli-International Units per milliliter (mIU/mL); Mumps: ≥10 Antibody units per milliliter (AbU/mL); Rubella: ≥10 International Units per milliliter (IU/mL); Varicella: ≥5 glycoprotein based enzyme-linked immunosorbent assay (gpELISA) unit/mL. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.
Geometric Mean Concentrations (GMCs) of Antibody Titers to Tetanus Toxoid: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Groups 1, 2, 4, 6, and 7: at the age of 7 months; Group 3: at the age of 5 months	Antibody concentrations against tetanus toxoid were measured by ELISA and expressed as GMC. Primary series PPP was defined as the PPP which was used for reporting data of time points prior to 12 months of age. Here, '0' in number analyzed field signifies none of the participants were evaluable at that specified time point because different groups had different planned data collection time points as defined in time frame and pre-specified in protocol.
Geometric Mean Concentrations of Antibodies to Tetanus Toxoid: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Groups 1, 3, 4, and 6: at the age of 13 months, Group 2 and 7: at the age of 16 months	Antibody concentrations against tetanus toxoid were measured by ELISA and expressed as GMC. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months. Here, '0' in number analyzed field signifies none of the participants were evaluable at that specified time point because different groups had different planned data collection time points as defined in time frame and pre-specified in protocol.
Geometric Mean Concentrations of Antibodies to Tetanus Toxoid: Group 5 - Per-Protocol Population	At the age of 13 months	Antibody concentrations against tetanus toxoid were measured by ELISA and expressed as GMC.
Number of Participants With Solicited Injection Site Reactions	Within 7 days post any vaccination	Solicited injection site reactions: tenderness/pain, erythema, and swelling and were planned to be collected and reported for each vaccine separately and not planned to be collected for Rotavirus vaccine. Here, '0' in number analyzed field for MenACYW categories signifies no participant were evaluable because in Groups 6 and 7 MenACYW vaccine was not administered; for Group 5, '0' in number analyzed field signifies safety data collection was not planned for Pentacel and Hepatitis-B vaccines; for Groups 2 and 7, '0' in number analyzed field signifies safety data collection was not planned for M-M-RII and VARIVAX vaccines, as pre-specified.
Number of Participants With Solicited Systemic Reactions	Within 7 days post any vaccination	An solicited reaction (SR) was an adverse reaction (AR) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). Systemic AEs were all AEs that were not injection site reactions. They, therefore, include systemic manifestations as well as localized or topical manifestations that were not associated with the vaccination site. Solicited systemic reactions included Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability.
Number of Participants With Unsolicited Adverse Events	Within 30 days post any vaccination	An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An unsolicited AE was an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or onset post-vaccination. These included both serious and non-serious events.
Number of Participants With Immediate Unsolicited AE	Within 30 minutes post any vaccination	An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An unsolicited AE was an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or onset post-vaccination. These included both serious and non-serious events. Immediate Unsolicited AE were AEs reported within 30 minutes of vaccine administration.

Countries

United States

Participant flow

Recruitment details

Study was conducted from 16 December 2009 to 13 February 2012 at 21 active sites in the United States.

Pre-assignment details

A total of 580 participants who met all inclusion and none of the exclusion criteria were enrolled and randomized in the study.

Participants by arm

Arm	Count
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 12 along with Prevnar 7 or Prevnar 13 vaccine at the age of Months 2, 4, 6, and 12, Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, and M-M-RII and VARIVAX vaccines at the age of 12 months.	107
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 15 along with Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.	108
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4 and a booster vaccination at the age of Month 12 along with Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12.	107
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months Participants aged 6 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Month 6 along with Pentacel, Prevnar 7 or 13, Hepatitis-B and Rotavirus vaccines, and a booster vaccination of MenACYW at the age of Month 12 along with M-M-RII and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2 and 4, and Hepatitis-B vaccine at the age of Month 2.	75
Group 5: MenACYW Conjugate Vaccine: 12 Months Participants aged 12 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of 12 months along with Prevnar 7 or 13, M-M-RII, and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2, 4, and 6, and Hepatitis-B vaccine at the age of Months 2 and 6.	75
Group 6: Control: 2, 4, 6, and 12 Months Participants aged 2 months (at the time of enrollment) received Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12 and M-M-RII and VARIVAX vaccines at the age of 12 months.	54
Group 7: Control: 2, 4, 6, 12, and 15 Months Participants aged 2 months (at the time of enrollment) received Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, and M-M-RII and VARIVAX vaccines at the age of 12 months, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.	54
Total	580

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005	FG006
Overall Study	Lost to Follow-up	5	4	4	1	0	3	3
Overall Study	Non-compliance with the protocol	12	6	14	5	3	4	10
Overall Study	Other adverse event (AE)	0	0	0	1	0	0	0
Overall Study	Serious adverse event	0	1	1	2	0	0	0
Overall Study	Voluntary withdrawal not due to an AE	16	10	8	2	1	5	2

Baseline characteristics

Characteristic	Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Group 5: MenACYW Conjugate Vaccine: 12 Months	Group 6: Control: 2, 4, 6, and 12 Months	Group 7: Control: 2, 4, 6, 12, and 15 Months	Total
Age, Continuous	2.19 months STANDARD_DEVIATION 0.261	2.20 months STANDARD_DEVIATION 0.259	2.23 months STANDARD_DEVIATION 0.296	6.23 months STANDARD_DEVIATION 0.148	12.4 months STANDARD_DEVIATION 0.136	2.18 months STANDARD_DEVIATION 0.217	2.20 months STANDARD_DEVIATION 0.268	4.04 months STANDARD_DEVIATION 3.49
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants	1 Participants	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants	4 Participants
Race/Ethnicity, Customized Asian	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants
Race/Ethnicity, Customized Black	10 Participants	11 Participants	15 Participants	9 Participants	4 Participants	4 Participants	10 Participants	63 Participants
Race/Ethnicity, Customized Caucasian	86 Participants	73 Participants	78 Participants	60 Participants	60 Participants	42 Participants	33 Participants	432 Participants
Race/Ethnicity, Customized Hispanic	4 Participants	4 Participants	7 Participants	0 Participants	3 Participants	2 Participants	2 Participants	22 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	2 Participants
Race/Ethnicity, Customized Other	7 Participants	17 Participants	5 Participants	5 Participants	7 Participants	6 Participants	8 Participants	55 Participants
Sex: Female, Male Female	57 Participants	60 Participants	47 Participants	38 Participants	31 Participants	24 Participants	20 Participants	277 Participants
Sex: Female, Male Male	50 Participants	48 Participants	60 Participants	37 Participants	44 Participants	30 Participants	34 Participants	303 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk
deaths Total, all-cause mortality	0 / 104	0 / 102	0 / 100	2 / 74	0 / 70	0 / 52	0 / 49
other Total, other adverse events	99 / 104	98 / 102	98 / 100	71 / 74	59 / 70	51 / 52	47 / 49
serious Total, serious adverse events	2 / 104	5 / 102	7 / 100	5 / 74	1 / 70	4 / 52	4 / 49

Outcome results

Primary

Antibody Titer/Concentration to All Antigens Contained in Pentacel Vaccines: Groups 2 and 7 - Booster Per-Protocol Population

Pentacel vaccine is Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine Combined (DTaP-IPV/Hib combined). Antibody titer to all antigens contained in pentacel vaccines (i.e., Anti-PRP, Anti-Diptheria, Anti-pertussis \[PT, PRN, FHA, and FIM\], Anti-poliovirus \[anti-poliovirus Type 1, Type 2, and Type 3\], and Anti-tetanus) were reported. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.

Time frame: At the age of 16 months

Population: Booster PPP. Here, 'Number analyzed'=participants with available data for specified categories. Data for this outcome measure was not planned to be collected and analyzed for Groups 1, 3, 4, 5, and 6, as pre-specified in protocol.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Antibody Titer/Concentration to All Antigens Contained in Pentacel Vaccines: Groups 2 and 7 - Booster Per-Protocol Population	Anti-PRP	17.2 titers (1/dilution)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Antibody Titer/Concentration to All Antigens Contained in Pentacel Vaccines: Groups 2 and 7 - Booster Per-Protocol Population	PRN	155.4 titers (1/dilution)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Antibody Titer/Concentration to All Antigens Contained in Pentacel Vaccines: Groups 2 and 7 - Booster Per-Protocol Population	Anti-Poliovirus Type 1	2498.6 titers (1/dilution)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Antibody Titer/Concentration to All Antigens Contained in Pentacel Vaccines: Groups 2 and 7 - Booster Per-Protocol Population	FIM	484.7 titers (1/dilution)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Antibody Titer/Concentration to All Antigens Contained in Pentacel Vaccines: Groups 2 and 7 - Booster Per-Protocol Population	Anti-Poliovirus Type 2	3718.9 titers (1/dilution)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Antibody Titer/Concentration to All Antigens Contained in Pentacel Vaccines: Groups 2 and 7 - Booster Per-Protocol Population	FHA	134.0 titers (1/dilution)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Antibody Titer/Concentration to All Antigens Contained in Pentacel Vaccines: Groups 2 and 7 - Booster Per-Protocol Population	Anti-Poliovirus Type 3	3473.8 titers (1/dilution)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Antibody Titer/Concentration to All Antigens Contained in Pentacel Vaccines: Groups 2 and 7 - Booster Per-Protocol Population	PT	108.6 titers (1/dilution)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Antibody Titer/Concentration to All Antigens Contained in Pentacel Vaccines: Groups 2 and 7 - Booster Per-Protocol Population	Anti-tetanus	5.1 titers (1/dilution)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Antibody Titer/Concentration to All Antigens Contained in Pentacel Vaccines: Groups 2 and 7 - Booster Per-Protocol Population	Anti-Diphtheria	5.3 titers (1/dilution)
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Antibody Titer/Concentration to All Antigens Contained in Pentacel Vaccines: Groups 2 and 7 - Booster Per-Protocol Population	Anti-tetanus	2.7 titers (1/dilution)
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Antibody Titer/Concentration to All Antigens Contained in Pentacel Vaccines: Groups 2 and 7 - Booster Per-Protocol Population	PT	102.6 titers (1/dilution)
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Antibody Titer/Concentration to All Antigens Contained in Pentacel Vaccines: Groups 2 and 7 - Booster Per-Protocol Population	PRN	122.0 titers (1/dilution)
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Antibody Titer/Concentration to All Antigens Contained in Pentacel Vaccines: Groups 2 and 7 - Booster Per-Protocol Population	FIM	619.3 titers (1/dilution)
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Antibody Titer/Concentration to All Antigens Contained in Pentacel Vaccines: Groups 2 and 7 - Booster Per-Protocol Population	Anti-PRP	18.0 titers (1/dilution)
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Antibody Titer/Concentration to All Antigens Contained in Pentacel Vaccines: Groups 2 and 7 - Booster Per-Protocol Population	Anti-Diphtheria	5.6 titers (1/dilution)
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Antibody Titer/Concentration to All Antigens Contained in Pentacel Vaccines: Groups 2 and 7 - Booster Per-Protocol Population	FHA	122.5 titers (1/dilution)
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Antibody Titer/Concentration to All Antigens Contained in Pentacel Vaccines: Groups 2 and 7 - Booster Per-Protocol Population	Anti-Poliovirus Type 1	1625.6 titers (1/dilution)
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Antibody Titer/Concentration to All Antigens Contained in Pentacel Vaccines: Groups 2 and 7 - Booster Per-Protocol Population	Anti-Poliovirus Type 2	3756.1 titers (1/dilution)
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Antibody Titer/Concentration to All Antigens Contained in Pentacel Vaccines: Groups 2 and 7 - Booster Per-Protocol Population	Anti-Poliovirus Type 3	2733.8 titers (1/dilution)

Primary

Antibody Titer/Concentration to All the Antigens Contained in Pentacel Vaccines: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population

Pentacel vaccine is Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine Combined (DTaP-IPV/Hib combined). Antibody titer to all antigens contained in pentacel vaccines (i.e., Anti-PRP, Anti-Diptheria, Anti-pertussis \[pertussis toxoid \[PT\], pertactin \[PRN\], filamentous hemagglutinin \[FHA\], and fimbriae \[FIM\]\], Anti-poliovirus \[anti-poliovirus Type 1, Type 2 and Type 3\] and anti-tetanus) were reported. Primary series PPP was defined as the PPP which was used for reporting data of time points prior to 12 months of age.

Time frame: At the age of 7 months

Population: Analysis was performed on primary series PPP. Here, 'Number analyzed'=participants with available data for specified category. Data for this outcome measure was not planned to be collected and analyzed for Groups 3 and 5, as pre-specified in protocol.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Antibody Titer/Concentration to All the Antigens Contained in Pentacel Vaccines: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	FIM	154.8 titers (1/dilution)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Antibody Titer/Concentration to All the Antigens Contained in Pentacel Vaccines: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	FHA	67.2 titers (1/dilution)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Antibody Titer/Concentration to All the Antigens Contained in Pentacel Vaccines: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Anti-PRP	4.1 titers (1/dilution)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Antibody Titer/Concentration to All the Antigens Contained in Pentacel Vaccines: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Anti-tetanus	1.7 titers (1/dilution)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Antibody Titer/Concentration to All the Antigens Contained in Pentacel Vaccines: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	PT	65.0 titers (1/dilution)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Antibody Titer/Concentration to All the Antigens Contained in Pentacel Vaccines: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	PRN	31.9 titers (1/dilution)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Antibody Titer/Concentration to All the Antigens Contained in Pentacel Vaccines: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Anti-Poliovirus Type 3	968.0 titers (1/dilution)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Antibody Titer/Concentration to All the Antigens Contained in Pentacel Vaccines: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Anti-Poliovirus Type 2	886.3 titers (1/dilution)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Antibody Titer/Concentration to All the Antigens Contained in Pentacel Vaccines: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Anti-Poliovirus Type 1	273.9 titers (1/dilution)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Antibody Titer/Concentration to All the Antigens Contained in Pentacel Vaccines: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Anti-Diphtheria	0.3 titers (1/dilution)
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Antibody Titer/Concentration to All the Antigens Contained in Pentacel Vaccines: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	PT	66.8 titers (1/dilution)
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Antibody Titer/Concentration to All the Antigens Contained in Pentacel Vaccines: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Anti-Poliovirus Type 2	1494.5 titers (1/dilution)
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Antibody Titer/Concentration to All the Antigens Contained in Pentacel Vaccines: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Anti-Poliovirus Type 1	696.1 titers (1/dilution)
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Antibody Titer/Concentration to All the Antigens Contained in Pentacel Vaccines: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Anti-tetanus	1.9 titers (1/dilution)
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Antibody Titer/Concentration to All the Antigens Contained in Pentacel Vaccines: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Anti-Diphtheria	0.6 titers (1/dilution)
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Antibody Titer/Concentration to All the Antigens Contained in Pentacel Vaccines: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	FIM	177.5 titers (1/dilution)
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Antibody Titer/Concentration to All the Antigens Contained in Pentacel Vaccines: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	FHA	81.6 titers (1/dilution)
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Antibody Titer/Concentration to All the Antigens Contained in Pentacel Vaccines: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Anti-PRP	3.8 titers (1/dilution)
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Antibody Titer/Concentration to All the Antigens Contained in Pentacel Vaccines: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Anti-Poliovirus Type 3	1381.4 titers (1/dilution)
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Antibody Titer/Concentration to All the Antigens Contained in Pentacel Vaccines: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	PRN	33.7 titers (1/dilution)
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Antibody Titer/Concentration to All the Antigens Contained in Pentacel Vaccines: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	PRN	36.7 titers (1/dilution)
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Antibody Titer/Concentration to All the Antigens Contained in Pentacel Vaccines: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	FHA	69.6 titers (1/dilution)
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Antibody Titer/Concentration to All the Antigens Contained in Pentacel Vaccines: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Anti-PRP	3.2 titers (1/dilution)
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Antibody Titer/Concentration to All the Antigens Contained in Pentacel Vaccines: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Anti-Poliovirus Type 2	1401.8 titers (1/dilution)
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Antibody Titer/Concentration to All the Antigens Contained in Pentacel Vaccines: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Anti-Poliovirus Type 1	716.2 titers (1/dilution)
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Antibody Titer/Concentration to All the Antigens Contained in Pentacel Vaccines: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	FIM	186.8 titers (1/dilution)
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Antibody Titer/Concentration to All the Antigens Contained in Pentacel Vaccines: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	PT	60.5 titers (1/dilution)
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Antibody Titer/Concentration to All the Antigens Contained in Pentacel Vaccines: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Anti-tetanus	1.6 titers (1/dilution)
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Antibody Titer/Concentration to All the Antigens Contained in Pentacel Vaccines: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Anti-Poliovirus Type 3	1674.7 titers (1/dilution)
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Antibody Titer/Concentration to All the Antigens Contained in Pentacel Vaccines: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Anti-Diphtheria	0.6 titers (1/dilution)
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Antibody Titer/Concentration to All the Antigens Contained in Pentacel Vaccines: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Anti-Diphtheria	0.6 titers (1/dilution)
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Antibody Titer/Concentration to All the Antigens Contained in Pentacel Vaccines: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Anti-Poliovirus Type 2	1054.0 titers (1/dilution)
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Antibody Titer/Concentration to All the Antigens Contained in Pentacel Vaccines: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Anti-PRP	5.4 titers (1/dilution)
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Antibody Titer/Concentration to All the Antigens Contained in Pentacel Vaccines: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	FIM	194.0 titers (1/dilution)
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Antibody Titer/Concentration to All the Antigens Contained in Pentacel Vaccines: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	PT	61.4 titers (1/dilution)
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Antibody Titer/Concentration to All the Antigens Contained in Pentacel Vaccines: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	FHA	60.9 titers (1/dilution)
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Antibody Titer/Concentration to All the Antigens Contained in Pentacel Vaccines: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	PRN	34.5 titers (1/dilution)
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Antibody Titer/Concentration to All the Antigens Contained in Pentacel Vaccines: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Anti-Poliovirus Type 1	543.9 titers (1/dilution)
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Antibody Titer/Concentration to All the Antigens Contained in Pentacel Vaccines: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Anti-Poliovirus Type 3	1069.3 titers (1/dilution)
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Antibody Titer/Concentration to All the Antigens Contained in Pentacel Vaccines: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Anti-tetanus	1.3 titers (1/dilution)
Group 6: Control: 2, 4, 6, and 12 Months	Antibody Titer/Concentration to All the Antigens Contained in Pentacel Vaccines: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	PRN	52.0 titers (1/dilution)
Group 6: Control: 2, 4, 6, and 12 Months	Antibody Titer/Concentration to All the Antigens Contained in Pentacel Vaccines: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Anti-Poliovirus Type 2	1075.9 titers (1/dilution)
Group 6: Control: 2, 4, 6, and 12 Months	Antibody Titer/Concentration to All the Antigens Contained in Pentacel Vaccines: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	FHA	93.2 titers (1/dilution)
Group 6: Control: 2, 4, 6, and 12 Months	Antibody Titer/Concentration to All the Antigens Contained in Pentacel Vaccines: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	PT	79.2 titers (1/dilution)
Group 6: Control: 2, 4, 6, and 12 Months	Antibody Titer/Concentration to All the Antigens Contained in Pentacel Vaccines: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Anti-tetanus	1.5 titers (1/dilution)
Group 6: Control: 2, 4, 6, and 12 Months	Antibody Titer/Concentration to All the Antigens Contained in Pentacel Vaccines: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Anti-Diphtheria	0.6 titers (1/dilution)
Group 6: Control: 2, 4, 6, and 12 Months	Antibody Titer/Concentration to All the Antigens Contained in Pentacel Vaccines: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Anti-PRP	3.8 titers (1/dilution)
Group 6: Control: 2, 4, 6, and 12 Months	Antibody Titer/Concentration to All the Antigens Contained in Pentacel Vaccines: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Anti-Poliovirus Type 3	927.5 titers (1/dilution)
Group 6: Control: 2, 4, 6, and 12 Months	Antibody Titer/Concentration to All the Antigens Contained in Pentacel Vaccines: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Anti-Poliovirus Type 1	327.9 titers (1/dilution)
Group 6: Control: 2, 4, 6, and 12 Months	Antibody Titer/Concentration to All the Antigens Contained in Pentacel Vaccines: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	FIM	194.4 titers (1/dilution)

Primary

Geometric Mean Concentrations (GMCs) of Antibody Titers to Tetanus Toxoid: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population

Antibody concentrations against tetanus toxoid were measured by ELISA and expressed as GMC. Primary series PPP was defined as the PPP which was used for reporting data of time points prior to 12 months of age. Here, '0' in number analyzed field signifies none of the participants were evaluable at that specified time point because different groups had different planned data collection time points as defined in time frame and pre-specified in protocol.

Time frame: Groups 1, 2, 4, 6, and 7: at the age of 7 months; Group 3: at the age of 5 months

Population: Analysis was performed on Primary series PPP. Here, 'Overall number of participants analyzed'=participants evaluable for this outcome measure and 'Number analyzed'=participants with available data for each specified categories.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Geometric Mean Concentrations (GMCs) of Antibody Titers to Tetanus Toxoid: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	At age of 7 months	1.7 International Units/milliliter (IU/mL)
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Geometric Mean Concentrations (GMCs) of Antibody Titers to Tetanus Toxoid: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	At age of 7 months	1.9 International Units/milliliter (IU/mL)
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Geometric Mean Concentrations (GMCs) of Antibody Titers to Tetanus Toxoid: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	At age of 5 months	0.9 International Units/milliliter (IU/mL)
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Geometric Mean Concentrations (GMCs) of Antibody Titers to Tetanus Toxoid: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	At age of 7 months	1.6 International Units/milliliter (IU/mL)
Group 6: Control: 2, 4, 6, and 12 Months	Geometric Mean Concentrations (GMCs) of Antibody Titers to Tetanus Toxoid: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	At age of 7 months	1.3 International Units/milliliter (IU/mL)
Group 7: Control: 2, 4, 6, 12, and 15 Months	Geometric Mean Concentrations (GMCs) of Antibody Titers to Tetanus Toxoid: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	At age of 7 months	1.5 International Units/milliliter (IU/mL)

Primary

Geometric Mean Concentrations of Antibodies to Tetanus Toxoid: Group 5 - Per-Protocol Population

Antibody concentrations against tetanus toxoid were measured by ELISA and expressed as GMC.

Time frame: At the age of 13 months

Population: Analysis was performed on PPP. Here, 'Overall number of participants analyzed'=participants evaluable for this outcome measure

Arm	Measure	Value (GEOMETRIC_MEAN)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Geometric Mean Concentrations of Antibodies to Tetanus Toxoid: Group 5 - Per-Protocol Population	2.3 IU/mL

Primary

Geometric Mean Concentrations of Antibodies to Tetanus Toxoid: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population

Antibody concentrations against tetanus toxoid were measured by ELISA and expressed as GMC. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months. Here, '0' in number analyzed field signifies none of the participants were evaluable at that specified time point because different groups had different planned data collection time points as defined in time frame and pre-specified in protocol.

Time frame: Groups 1, 3, 4, and 6: at the age of 13 months, Group 2 and 7: at the age of 16 months

Population: Analysis was performed on Booster PPP. Here, 'Overall number of participants analyzed'=participants evaluable for this outcome measure and 'Number analyzed'=participants with available data for specified categories.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Geometric Mean Concentrations of Antibodies to Tetanus Toxoid: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	At age of 13 months	1.8 IU/mL
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Geometric Mean Concentrations of Antibodies to Tetanus Toxoid: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	At age of 16 months	5.1 IU/mL
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Geometric Mean Concentrations of Antibodies to Tetanus Toxoid: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	At age of 13 months	2.2 IU/mL
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Geometric Mean Concentrations of Antibodies to Tetanus Toxoid: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	At age of 13 months	1.7 IU/mL
Group 6: Control: 2, 4, 6, and 12 Months	Geometric Mean Concentrations of Antibodies to Tetanus Toxoid: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	At age of 13 months	0.2 IU/mL
Group 7: Control: 2, 4, 6, 12, and 15 Months	Geometric Mean Concentrations of Antibodies to Tetanus Toxoid: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	At age of 16 months	2.7 IU/mL

Primary

Geometric Mean Fold Rise (GMFR) in SBA-HC Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population

Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.

Time frame: Groups 1, 3 and 4: 30 days post-vaccination at the age of 12 months (i.e. at the age of 13 months), Group 2: 30 days post-vaccination at the age of 15 months (i.e. at the age of 16 months)

Population: Analysis was performed on booster PPP. Here, 'Number analyzed'=participants with available data for specified category. Data for this outcome measure was not planned to be collected and analyzed for Groups 5, 6 and 7, as pre-specified in protocol.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Geometric Mean Fold Rise (GMFR) in SBA-HC Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup A	8.3 fold rise
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Geometric Mean Fold Rise (GMFR) in SBA-HC Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup C	19.2 fold rise
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Geometric Mean Fold Rise (GMFR) in SBA-HC Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup Y	8.7 fold rise
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Geometric Mean Fold Rise (GMFR) in SBA-HC Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup W-135	12.2 fold rise
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Geometric Mean Fold Rise (GMFR) in SBA-HC Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup C	21.7 fold rise
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Geometric Mean Fold Rise (GMFR) in SBA-HC Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup Y	14.3 fold rise
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Geometric Mean Fold Rise (GMFR) in SBA-HC Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup W-135	15.1 fold rise
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Geometric Mean Fold Rise (GMFR) in SBA-HC Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup A	12.0 fold rise
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Geometric Mean Fold Rise (GMFR) in SBA-HC Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup Y	10.6 fold rise
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Geometric Mean Fold Rise (GMFR) in SBA-HC Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup C	17.1 fold rise
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Geometric Mean Fold Rise (GMFR) in SBA-HC Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup W-135	13.1 fold rise
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Geometric Mean Fold Rise (GMFR) in SBA-HC Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup A	16.9 fold rise
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Geometric Mean Fold Rise (GMFR) in SBA-HC Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup W-135	16.0 fold rise
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Geometric Mean Fold Rise (GMFR) in SBA-HC Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup C	25.0 fold rise
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Geometric Mean Fold Rise (GMFR) in SBA-HC Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup A	24.5 fold rise
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Geometric Mean Fold Rise (GMFR) in SBA-HC Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup Y	17.3 fold rise

Primary

Geometric Mean Fold Rise in Serum Bactericidal Assay Using Baby Rabbit Complement Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population

Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Percentage of participants with GMFR in each meningococcal serogroups antibody titer (30-days post booster vaccination) were reported. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.

Time frame: Groups 1, 3, and 4: 30 days post booster vaccination at the age of 12 months (i.e., at the age of 13 months); Group 2: 30 days post booster vaccination at the age of 15 months (i.e. at the age of 16 months)

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Geometric Mean Fold Rise in Serum Bactericidal Assay Using Baby Rabbit Complement Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup A	15.8 fold rise
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Geometric Mean Fold Rise in Serum Bactericidal Assay Using Baby Rabbit Complement Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup C	26.7 fold rise
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Geometric Mean Fold Rise in Serum Bactericidal Assay Using Baby Rabbit Complement Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup Y	6.1 fold rise
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Geometric Mean Fold Rise in Serum Bactericidal Assay Using Baby Rabbit Complement Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup W-135	10.2 fold rise
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Geometric Mean Fold Rise in Serum Bactericidal Assay Using Baby Rabbit Complement Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup C	37.9 fold rise
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Geometric Mean Fold Rise in Serum Bactericidal Assay Using Baby Rabbit Complement Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup Y	10.0 fold rise
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Geometric Mean Fold Rise in Serum Bactericidal Assay Using Baby Rabbit Complement Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup W-135	12.8 fold rise
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Geometric Mean Fold Rise in Serum Bactericidal Assay Using Baby Rabbit Complement Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup A	21.1 fold rise
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Geometric Mean Fold Rise in Serum Bactericidal Assay Using Baby Rabbit Complement Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup Y	7.1 fold rise
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Geometric Mean Fold Rise in Serum Bactericidal Assay Using Baby Rabbit Complement Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup C	27.3 fold rise
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Geometric Mean Fold Rise in Serum Bactericidal Assay Using Baby Rabbit Complement Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup W-135	19.7 fold rise
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Geometric Mean Fold Rise in Serum Bactericidal Assay Using Baby Rabbit Complement Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup A	22.3 fold rise
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Geometric Mean Fold Rise in Serum Bactericidal Assay Using Baby Rabbit Complement Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup W-135	11.1 fold rise
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Geometric Mean Fold Rise in Serum Bactericidal Assay Using Baby Rabbit Complement Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup C	32.0 fold rise
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Geometric Mean Fold Rise in Serum Bactericidal Assay Using Baby Rabbit Complement Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup A	32.6 fold rise
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Geometric Mean Fold Rise in Serum Bactericidal Assay Using Baby Rabbit Complement Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup Y	8.6 fold rise

Primary

Number of Participants With Immediate Unsolicited AE

An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An unsolicited AE was an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or onset post-vaccination. These included both serious and non-serious events. Immediate Unsolicited AE were AEs reported within 30 minutes of vaccine administration.

Time frame: Within 30 minutes post any vaccination

Population: Analysis was done on safety population.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Number of Participants With Immediate Unsolicited AE	0 Participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Number of Participants With Immediate Unsolicited AE	0 Participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Number of Participants With Immediate Unsolicited AE	0 Participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Number of Participants With Immediate Unsolicited AE	0 Participants
Group 6: Control: 2, 4, 6, and 12 Months	Number of Participants With Immediate Unsolicited AE	0 Participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Number of Participants With Immediate Unsolicited AE	0 Participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Number of Participants With Immediate Unsolicited AE	0 Participants

Primary

Number of Participants With Solicited Injection Site Reactions

Solicited injection site reactions: tenderness/pain, erythema, and swelling and were planned to be collected and reported for each vaccine separately and not planned to be collected for Rotavirus vaccine. Here, '0' in number analyzed field for MenACYW categories signifies no participant were evaluable because in Groups 6 and 7 MenACYW vaccine was not administered; for Group 5, '0' in number analyzed field signifies safety data collection was not planned for Pentacel and Hepatitis-B vaccines; for Groups 2 and 7, '0' in number analyzed field signifies safety data collection was not planned for M-M-RII and VARIVAX vaccines, as pre-specified.

Time frame: Within 7 days post any vaccination

Population: Analysis was performed on safety population that included participants who received at least 1 dose of investigation vaccine and for whom safety data were available. Here, 'Number analyzed'=participants with available data for specified category.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Number of Participants With Solicited Injection Site Reactions	Pentacel: Swelling	28 Participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Number of Participants With Solicited Injection Site Reactions	MenACYW conjugate vaccine: Erythema	46 Participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Number of Participants With Solicited Injection Site Reactions	M-M-RII: Erythema	16 Participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Number of Participants With Solicited Injection Site Reactions	MenACYW conjugate vaccine: Swelling	29 Participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Number of Participants With Solicited Injection Site Reactions	M-M-RII: Tenderness	29 Participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Number of Participants With Solicited Injection Site Reactions	Pentacel: Tenderness	69 Participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Number of Participants With Solicited Injection Site Reactions	VARIVAX: Swelling	6 Participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Number of Participants With Solicited Injection Site Reactions	Hepatitis-B: Swelling	23 Participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Number of Participants With Solicited Injection Site Reactions	Hepatitis-B: Erythema	34 Participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Number of Participants With Solicited Injection Site Reactions	Pentacel: Erythema	41 Participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Number of Participants With Solicited Injection Site Reactions	VARIVAX: Erythema	17 Participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Number of Participants With Solicited Injection Site Reactions	Hepatitis-B: Tenderness	60 Participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Number of Participants With Solicited Injection Site Reactions	Prevnar or Prevnar 13: Swelling	35 Participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Number of Participants With Solicited Injection Site Reactions	MenACYW conjugate vaccine: Tenderness	76 Participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Number of Participants With Solicited Injection Site Reactions	Prevnar or Prevnar 13: Erythema	47 Participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Number of Participants With Solicited Injection Site Reactions	Prevnar or Prevnar 13: Tenderness	74 Participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Number of Participants With Solicited Injection Site Reactions	VARIVAX: Tenderness	27 Participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Number of Participants With Solicited Injection Site Reactions	M-M-RII: Swelling	10 Participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Number of Participants With Solicited Injection Site Reactions	Pentacel: Swelling	37 Participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Number of Participants With Solicited Injection Site Reactions	Hepatitis-B: Tenderness	64 Participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Number of Participants With Solicited Injection Site Reactions	Prevnar or Prevnar 13: Erythema	43 Participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Number of Participants With Solicited Injection Site Reactions	Pentacel: Tenderness	77 Participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Number of Participants With Solicited Injection Site Reactions	Prevnar or Prevnar 13: Tenderness	69 Participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Number of Participants With Solicited Injection Site Reactions	MenACYW conjugate vaccine: Swelling	28 Participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Number of Participants With Solicited Injection Site Reactions	MenACYW conjugate vaccine: Tenderness	78 Participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Number of Participants With Solicited Injection Site Reactions	Pentacel: Erythema	45 Participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Number of Participants With Solicited Injection Site Reactions	Hepatitis-B: Erythema	22 Participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Number of Participants With Solicited Injection Site Reactions	Prevnar or Prevnar 13: Swelling	33 Participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Number of Participants With Solicited Injection Site Reactions	MenACYW conjugate vaccine: Erythema	45 Participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Number of Participants With Solicited Injection Site Reactions	Hepatitis-B: Swelling	17 Participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Number of Participants With Solicited Injection Site Reactions	MenACYW conjugate vaccine: Erythema	32 Participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Number of Participants With Solicited Injection Site Reactions	Hepatitis-B: Erythema	14 Participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Number of Participants With Solicited Injection Site Reactions	MenACYW conjugate vaccine: Tenderness	70 Participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Number of Participants With Solicited Injection Site Reactions	MenACYW conjugate vaccine: Swelling	21 Participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Number of Participants With Solicited Injection Site Reactions	Pentacel: Tenderness	62 Participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Number of Participants With Solicited Injection Site Reactions	Pentacel: Erythema	21 Participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Number of Participants With Solicited Injection Site Reactions	Pentacel: Swelling	18 Participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Number of Participants With Solicited Injection Site Reactions	Prevnar or Prevnar 13: Tenderness	72 Participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Number of Participants With Solicited Injection Site Reactions	Prevnar or Prevnar 13: Erythema	38 Participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Number of Participants With Solicited Injection Site Reactions	Prevnar or Prevnar 13: Swelling	25 Participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Number of Participants With Solicited Injection Site Reactions	Hepatitis-B: Tenderness	49 Participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Number of Participants With Solicited Injection Site Reactions	Hepatitis-B: Swelling	12 Participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Number of Participants With Solicited Injection Site Reactions	M-M-RII: Tenderness	39 Participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Number of Participants With Solicited Injection Site Reactions	M-M-RII: Erythema	16 Participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Number of Participants With Solicited Injection Site Reactions	M-M-RII: Swelling	11 Participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Number of Participants With Solicited Injection Site Reactions	VARIVAX: Tenderness	36 Participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Number of Participants With Solicited Injection Site Reactions	VARIVAX: Erythema	13 Participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Number of Participants With Solicited Injection Site Reactions	VARIVAX: Swelling	9 Participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Number of Participants With Solicited Injection Site Reactions	MenACYW conjugate vaccine: Swelling	21 Participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Number of Participants With Solicited Injection Site Reactions	Pentacel: Tenderness	40 Participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Number of Participants With Solicited Injection Site Reactions	Pentacel: Swelling	14 Participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Number of Participants With Solicited Injection Site Reactions	Prevnar or Prevnar 13: Erythema	33 Participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Number of Participants With Solicited Injection Site Reactions	Hepatitis-B: Swelling	8 Participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Number of Participants With Solicited Injection Site Reactions	Prevnar or Prevnar 13: Swelling	28 Participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Number of Participants With Solicited Injection Site Reactions	M-M-RII: Swelling	9 Participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Number of Participants With Solicited Injection Site Reactions	Prevnar or Prevnar 13: Tenderness	51 Participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Number of Participants With Solicited Injection Site Reactions	VARIVAX: Tenderness	26 Participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Number of Participants With Solicited Injection Site Reactions	Pentacel: Erythema	20 Participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Number of Participants With Solicited Injection Site Reactions	VARIVAX: Swelling	7 Participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Number of Participants With Solicited Injection Site Reactions	VARIVAX: Erythema	17 Participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Number of Participants With Solicited Injection Site Reactions	Hepatitis-B: Tenderness	38 Participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Number of Participants With Solicited Injection Site Reactions	MenACYW conjugate vaccine: Tenderness	49 Participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Number of Participants With Solicited Injection Site Reactions	M-M-RII: Erythema	14 Participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Number of Participants With Solicited Injection Site Reactions	MenACYW conjugate vaccine: Erythema	31 Participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Number of Participants With Solicited Injection Site Reactions	Hepatitis-B: Erythema	17 Participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Number of Participants With Solicited Injection Site Reactions	M-M-RII: Tenderness	26 Participants
Group 6: Control: 2, 4, 6, and 12 Months	Number of Participants With Solicited Injection Site Reactions	Prevnar or Prevnar 13: Erythema	14 Participants
Group 6: Control: 2, 4, 6, and 12 Months	Number of Participants With Solicited Injection Site Reactions	VARIVAX: Swelling	6 Participants
Group 6: Control: 2, 4, 6, and 12 Months	Number of Participants With Solicited Injection Site Reactions	Prevnar or Prevnar 13: Swelling	12 Participants
Group 6: Control: 2, 4, 6, and 12 Months	Number of Participants With Solicited Injection Site Reactions	MenACYW conjugate vaccine: Swelling	11 Participants
Group 6: Control: 2, 4, 6, and 12 Months	Number of Participants With Solicited Injection Site Reactions	VARIVAX: Erythema	12 Participants
Group 6: Control: 2, 4, 6, and 12 Months	Number of Participants With Solicited Injection Site Reactions	M-M-RII: Tenderness	31 Participants
Group 6: Control: 2, 4, 6, and 12 Months	Number of Participants With Solicited Injection Site Reactions	MenACYW conjugate vaccine: Erythema	18 Participants
Group 6: Control: 2, 4, 6, and 12 Months	Number of Participants With Solicited Injection Site Reactions	M-M-RII: Erythema	8 Participants
Group 6: Control: 2, 4, 6, and 12 Months	Number of Participants With Solicited Injection Site Reactions	MenACYW conjugate vaccine: Tenderness	29 Participants
Group 6: Control: 2, 4, 6, and 12 Months	Number of Participants With Solicited Injection Site Reactions	M-M-RII: Swelling	7 Participants
Group 6: Control: 2, 4, 6, and 12 Months	Number of Participants With Solicited Injection Site Reactions	VARIVAX: Tenderness	29 Participants
Group 6: Control: 2, 4, 6, and 12 Months	Number of Participants With Solicited Injection Site Reactions	Prevnar or Prevnar 13: Tenderness	32 Participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Number of Participants With Solicited Injection Site Reactions	Prevnar or Prevnar 13: Swelling	21 Participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Number of Participants With Solicited Injection Site Reactions	Prevnar or Prevnar 13: Erythema	26 Participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Number of Participants With Solicited Injection Site Reactions	Hepatitis-B: Swelling	15 Participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Number of Participants With Solicited Injection Site Reactions	Pentacel: Tenderness	32 Participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Number of Participants With Solicited Injection Site Reactions	M-M-RII: Swelling	6 Participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Number of Participants With Solicited Injection Site Reactions	VARIVAX: Erythema	14 Participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Number of Participants With Solicited Injection Site Reactions	Hepatitis-B: Erythema	21 Participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Number of Participants With Solicited Injection Site Reactions	Prevnar or Prevnar 13: Tenderness	36 Participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Number of Participants With Solicited Injection Site Reactions	M-M-RII: Tenderness	25 Participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Number of Participants With Solicited Injection Site Reactions	Hepatitis-B: Tenderness	32 Participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Number of Participants With Solicited Injection Site Reactions	Pentacel: Swelling	15 Participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Number of Participants With Solicited Injection Site Reactions	M-M-RII: Erythema	12 Participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Number of Participants With Solicited Injection Site Reactions	Pentacel: Erythema	21 Participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Number of Participants With Solicited Injection Site Reactions	VARIVAX: Swelling	7 Participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Number of Participants With Solicited Injection Site Reactions	VARIVAX: Tenderness	27 Participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Number of Participants With Solicited Injection Site Reactions	Prevnar or Prevnar 13: Erythema	19 Participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Number of Participants With Solicited Injection Site Reactions	Hepatitis-B: Tenderness	30 Participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Number of Participants With Solicited Injection Site Reactions	Pentacel: Erythema	25 Participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Number of Participants With Solicited Injection Site Reactions	Pentacel: Tenderness	36 Participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Number of Participants With Solicited Injection Site Reactions	Prevnar or Prevnar 13: Swelling	15 Participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Number of Participants With Solicited Injection Site Reactions	Prevnar or Prevnar 13: Tenderness	38 Participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Number of Participants With Solicited Injection Site Reactions	Pentacel: Swelling	17 Participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Number of Participants With Solicited Injection Site Reactions	Hepatitis-B: Swelling	10 Participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Number of Participants With Solicited Injection Site Reactions	Hepatitis-B: Erythema	13 Participants

Primary

Number of Participants With Solicited Systemic Reactions

An solicited reaction (SR) was an adverse reaction (AR) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). Systemic AEs were all AEs that were not injection site reactions. They, therefore, include systemic manifestations as well as localized or topical manifestations that were not associated with the vaccination site. Solicited systemic reactions included Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability.

Time frame: Within 7 days post any vaccination

Population: Analysis was done on safety population. Here, 'Number analyzed'=participants with available data for specified category.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Number of Participants With Solicited Systemic Reactions	Irritability	86 Participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Number of Participants With Solicited Systemic Reactions	Vomiting	28 Participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Number of Participants With Solicited Systemic Reactions	Drowsiness	71 Participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Number of Participants With Solicited Systemic Reactions	Fever	32 Participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Number of Participants With Solicited Systemic Reactions	Crying abnormal	78 Participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Number of Participants With Solicited Systemic Reactions	Appetite lost	55 Participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Number of Participants With Solicited Systemic Reactions	Fever	42 Participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Number of Participants With Solicited Systemic Reactions	Drowsiness	81 Participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Number of Participants With Solicited Systemic Reactions	Irritability	92 Participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Number of Participants With Solicited Systemic Reactions	Vomiting	33 Participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Number of Participants With Solicited Systemic Reactions	Appetite lost	65 Participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Number of Participants With Solicited Systemic Reactions	Crying abnormal	74 Participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Number of Participants With Solicited Systemic Reactions	Appetite lost	49 Participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Number of Participants With Solicited Systemic Reactions	Crying abnormal	77 Participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Number of Participants With Solicited Systemic Reactions	Irritability	88 Participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Number of Participants With Solicited Systemic Reactions	Drowsiness	75 Participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Number of Participants With Solicited Systemic Reactions	Fever	42 Participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Number of Participants With Solicited Systemic Reactions	Vomiting	27 Participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Number of Participants With Solicited Systemic Reactions	Appetite lost	36 Participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Number of Participants With Solicited Systemic Reactions	Fever	28 Participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Number of Participants With Solicited Systemic Reactions	Vomiting	10 Participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Number of Participants With Solicited Systemic Reactions	Crying abnormal	45 Participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Number of Participants With Solicited Systemic Reactions	Drowsiness	46 Participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Number of Participants With Solicited Systemic Reactions	Irritability	63 Participants
Group 6: Control: 2, 4, 6, and 12 Months	Number of Participants With Solicited Systemic Reactions	Drowsiness	30 Participants
Group 6: Control: 2, 4, 6, and 12 Months	Number of Participants With Solicited Systemic Reactions	Vomiting	8 Participants
Group 6: Control: 2, 4, 6, and 12 Months	Number of Participants With Solicited Systemic Reactions	Appetite lost	22 Participants
Group 6: Control: 2, 4, 6, and 12 Months	Number of Participants With Solicited Systemic Reactions	Irritability	48 Participants
Group 6: Control: 2, 4, 6, and 12 Months	Number of Participants With Solicited Systemic Reactions	Crying abnormal	30 Participants
Group 6: Control: 2, 4, 6, and 12 Months	Number of Participants With Solicited Systemic Reactions	Fever	11 Participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Number of Participants With Solicited Systemic Reactions	Crying abnormal	37 Participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Number of Participants With Solicited Systemic Reactions	Drowsiness	37 Participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Number of Participants With Solicited Systemic Reactions	Vomiting	14 Participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Number of Participants With Solicited Systemic Reactions	Appetite lost	27 Participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Number of Participants With Solicited Systemic Reactions	Fever	19 Participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Number of Participants With Solicited Systemic Reactions	Irritability	44 Participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Number of Participants With Solicited Systemic Reactions	Crying abnormal	35 Participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Number of Participants With Solicited Systemic Reactions	Vomiting	12 Participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Number of Participants With Solicited Systemic Reactions	Irritability	42 Participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Number of Participants With Solicited Systemic Reactions	Drowsiness	38 Participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Number of Participants With Solicited Systemic Reactions	Appetite lost	27 Participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Number of Participants With Solicited Systemic Reactions	Fever	22 Participants

Primary

Number of Participants With Unsolicited Adverse Events

Time frame: Within 30 days post any vaccination

Population: Analysis was performed on safety population.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Number of Participants With Unsolicited Adverse Events	83 Participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Number of Participants With Unsolicited Adverse Events	81 Participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Number of Participants With Unsolicited Adverse Events	72 Participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Number of Participants With Unsolicited Adverse Events	50 Participants
Group 6: Control: 2, 4, 6, and 12 Months	Number of Participants With Unsolicited Adverse Events	35 Participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Number of Participants With Unsolicited Adverse Events	44 Participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Number of Participants With Unsolicited Adverse Events	38 Participants

Primary

Percentage of Participants With ≥4-fold Rise in SBA-BR Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population

Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Percentage of participants with ≥4-fold rise in each meningococcal serogroups antibody titer (30-days post booster vaccination) were reported. Booster PPP was defined as the PPP which was used for reporting data of time points at and after the age of 12 months.

Time frame: Groups 1, 3, and 4: 30 days post booster vaccination (i.e., at the age of 13 months); Group 2: 30 days post booster vaccination (i.e., at the age of 16 months)

Arm	Measure	Group	Value (NUMBER)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With ≥4-fold Rise in SBA-BR Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup A	79.2 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With ≥4-fold Rise in SBA-BR Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup C	87.0 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With ≥4-fold Rise in SBA-BR Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup Y	71.7 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With ≥4-fold Rise in SBA-BR Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup W-135	86.5 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With ≥4-fold Rise in SBA-BR Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup C	92.5 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With ≥4-fold Rise in SBA-BR Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup Y	84.9 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With ≥4-fold Rise in SBA-BR Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup W-135	88.7 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With ≥4-fold Rise in SBA-BR Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup A	81.1 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With ≥4-fold Rise in SBA-BR Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup Y	82.4 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With ≥4-fold Rise in SBA-BR Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup C	80.8 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With ≥4-fold Rise in SBA-BR Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup W-135	88.0 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With ≥4-fold Rise in SBA-BR Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup A	88.0 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With ≥4-fold Rise in SBA-BR Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup W-135	81.6 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With ≥4-fold Rise in SBA-BR Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup C	97.5 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With ≥4-fold Rise in SBA-BR Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup A	89.5 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With ≥4-fold Rise in SBA-BR Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup Y	78.9 percentage of participants

Primary

Percentage of Participants With ≥4-fold Rise in SBA-HC Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population

Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. Percentage of participants with ≥4-fold rise in each meningococcal serogroups antibody titer (30 days post booster vaccination) were reported. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.

Time frame: Groups 1, 3, and 4: 30 days post-vaccination at the age of 12 months (i.e. at the age of 13 months), Group 2: 30 days post-vaccination at the age of 15 months (i.e. at the age of 16 months)

Arm	Measure	Group	Value (NUMBER)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With ≥4-fold Rise in SBA-HC Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup C	93.0 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With ≥4-fold Rise in SBA-HC Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup A	83.9 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With ≥4-fold Rise in SBA-HC Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup Y	84.2 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With ≥4-fold Rise in SBA-HC Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup W-135	94.7 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With ≥4-fold Rise in SBA-HC Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup A	85.5 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With ≥4-fold Rise in SBA-HC Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup Y	92.1 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With ≥4-fold Rise in SBA-HC Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup W-135	85.7 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With ≥4-fold Rise in SBA-HC Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup C	95.3 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With ≥4-fold Rise in SBA-HC Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup Y	82.7 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With ≥4-fold Rise in SBA-HC Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup C	83.0 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With ≥4-fold Rise in SBA-HC Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup W-135	90.4 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With ≥4-fold Rise in SBA-HC Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup A	84.9 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With ≥4-fold Rise in SBA-HC Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup W-135	86.7 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With ≥4-fold Rise in SBA-HC Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup Y	93.3 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With ≥4-fold Rise in SBA-HC Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup C	97.8 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With ≥4-fold Rise in SBA-HC Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup A	97.7 percentage of participants

Primary

Percentage of Participants With an Serum Bactericidal Assay (SBA) Using Human Complement (SBA-HC) Titer Greater or Than Equal to (≥) 1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-protocol Population (PPP)

Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. The PPP consisted of all participants included in the trial who received at least one dose of study or control vaccine, excluding those who did not meet all protocol-specified inclusion/exclusion criteria, did not receive the correct number of doses of the investigational vaccine, received a vaccine other than the one that he/she was randomized to receive, did not provide a post-dose serology sample in the proper time window, received a protocol-restricted therapy, medication or vaccine, was on systemic antibiotics within 3 days prior to study blood draw, had no serology sample or did not produce at least one valid test result, did not receive vaccine in the proper time window. Primary series PPP was defined as the PPP which was used for reporting data of time points prior to 12 months of age.

Time frame: Groups 1, 2, 4, 6, and 7: at the age of 7 months; Group 3: at the age of 5 months

Population: Primary series PPP. 'Number analyzed'=number of participants with available data for specified categories and '0' in number analyzed field signifies none of the participants were evaluable at that specified time point because different groups had different planned data collection time points as defined in time frame and pre-specified in protocol.

Arm	Measure	Group	Value (NUMBER)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With an Serum Bactericidal Assay (SBA) Using Human Complement (SBA-HC) Titer Greater or Than Equal to (≥) 1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-protocol Population (PPP)	Serogroup C- at 7 months of age: ≥1:8	92.3 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With an Serum Bactericidal Assay (SBA) Using Human Complement (SBA-HC) Titer Greater or Than Equal to (≥) 1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-protocol Population (PPP)	Serogroup Y- at 7 months of age: ≥1:4	97.4 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With an Serum Bactericidal Assay (SBA) Using Human Complement (SBA-HC) Titer Greater or Than Equal to (≥) 1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-protocol Population (PPP)	Serogroup A- at 7 months of age: ≥1:8	71.4 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With an Serum Bactericidal Assay (SBA) Using Human Complement (SBA-HC) Titer Greater or Than Equal to (≥) 1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-protocol Population (PPP)	Serogroup A- at 7 months of age: ≥1:4	80.5 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With an Serum Bactericidal Assay (SBA) Using Human Complement (SBA-HC) Titer Greater or Than Equal to (≥) 1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-protocol Population (PPP)	Serogroup W-135- at 7 months of age: ≥1:8	94.9 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With an Serum Bactericidal Assay (SBA) Using Human Complement (SBA-HC) Titer Greater or Than Equal to (≥) 1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-protocol Population (PPP)	Serogroup W-135- at 7 months of age: ≥1:4	98.7 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With an Serum Bactericidal Assay (SBA) Using Human Complement (SBA-HC) Titer Greater or Than Equal to (≥) 1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-protocol Population (PPP)	Serogroup Y- at 7 months of age: ≥1:8	89.7 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With an Serum Bactericidal Assay (SBA) Using Human Complement (SBA-HC) Titer Greater or Than Equal to (≥) 1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-protocol Population (PPP)	Serogroup C- at 7 months of age: ≥1:4	96.2 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With an Serum Bactericidal Assay (SBA) Using Human Complement (SBA-HC) Titer Greater or Than Equal to (≥) 1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-protocol Population (PPP)	Serogroup C- at 7 months of age: ≥1:8	92.6 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With an Serum Bactericidal Assay (SBA) Using Human Complement (SBA-HC) Titer Greater or Than Equal to (≥) 1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-protocol Population (PPP)	Serogroup Y- at 7 months of age: ≥1:4	93.8 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With an Serum Bactericidal Assay (SBA) Using Human Complement (SBA-HC) Titer Greater or Than Equal to (≥) 1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-protocol Population (PPP)	Serogroup A- at 7 months of age: ≥1:4	80.2 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With an Serum Bactericidal Assay (SBA) Using Human Complement (SBA-HC) Titer Greater or Than Equal to (≥) 1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-protocol Population (PPP)	Serogroup W-135- at 7 months of age: ≥1:8	96.3 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With an Serum Bactericidal Assay (SBA) Using Human Complement (SBA-HC) Titer Greater or Than Equal to (≥) 1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-protocol Population (PPP)	Serogroup W-135- at 7 months of age: ≥1:4	98.8 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With an Serum Bactericidal Assay (SBA) Using Human Complement (SBA-HC) Titer Greater or Than Equal to (≥) 1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-protocol Population (PPP)	Serogroup A- at 7 months of age: ≥1:8	66.7 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With an Serum Bactericidal Assay (SBA) Using Human Complement (SBA-HC) Titer Greater or Than Equal to (≥) 1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-protocol Population (PPP)	Serogroup C- at 7 months of age: ≥1:4	93.8 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With an Serum Bactericidal Assay (SBA) Using Human Complement (SBA-HC) Titer Greater or Than Equal to (≥) 1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-protocol Population (PPP)	Serogroup Y- at 7 months of age: ≥1:8	91.4 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With an Serum Bactericidal Assay (SBA) Using Human Complement (SBA-HC) Titer Greater or Than Equal to (≥) 1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-protocol Population (PPP)	Serogroup C- at 5 months of age: ≥1:8	94.8 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With an Serum Bactericidal Assay (SBA) Using Human Complement (SBA-HC) Titer Greater or Than Equal to (≥) 1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-protocol Population (PPP)	Serogroup W-135- at 5 months of age: ≥1:4	92.2 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With an Serum Bactericidal Assay (SBA) Using Human Complement (SBA-HC) Titer Greater or Than Equal to (≥) 1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-protocol Population (PPP)	Serogroup Y- at 5 months of age: ≥1:4	83.1 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With an Serum Bactericidal Assay (SBA) Using Human Complement (SBA-HC) Titer Greater or Than Equal to (≥) 1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-protocol Population (PPP)	Serogroup A- at 5 months of age: ≥1:4	83.1 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With an Serum Bactericidal Assay (SBA) Using Human Complement (SBA-HC) Titer Greater or Than Equal to (≥) 1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-protocol Population (PPP)	Serogroup Y- at 5 months of age: ≥1:8	75.3 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With an Serum Bactericidal Assay (SBA) Using Human Complement (SBA-HC) Titer Greater or Than Equal to (≥) 1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-protocol Population (PPP)	Serogroup A- at 5 months of age: ≥1:8	74.0 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With an Serum Bactericidal Assay (SBA) Using Human Complement (SBA-HC) Titer Greater or Than Equal to (≥) 1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-protocol Population (PPP)	Serogroup W-135- at 5 months of age: ≥1:8	84.4 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With an Serum Bactericidal Assay (SBA) Using Human Complement (SBA-HC) Titer Greater or Than Equal to (≥) 1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-protocol Population (PPP)	Serogroup C- at 5 months of age: ≥1:4	97.4 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With an Serum Bactericidal Assay (SBA) Using Human Complement (SBA-HC) Titer Greater or Than Equal to (≥) 1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-protocol Population (PPP)	Serogroup Y- at 7 months of age: ≥1:8	24.6 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With an Serum Bactericidal Assay (SBA) Using Human Complement (SBA-HC) Titer Greater or Than Equal to (≥) 1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-protocol Population (PPP)	Serogroup A- at 7 months of age: ≥1:4	75.9 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With an Serum Bactericidal Assay (SBA) Using Human Complement (SBA-HC) Titer Greater or Than Equal to (≥) 1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-protocol Population (PPP)	Serogroup A- at 7 months of age: ≥1:8	62.1 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With an Serum Bactericidal Assay (SBA) Using Human Complement (SBA-HC) Titer Greater or Than Equal to (≥) 1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-protocol Population (PPP)	Serogroup C- at 7 months of age: ≥1:4	90.2 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With an Serum Bactericidal Assay (SBA) Using Human Complement (SBA-HC) Titer Greater or Than Equal to (≥) 1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-protocol Population (PPP)	Serogroup C- at 7 months of age: ≥1:8	88.5 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With an Serum Bactericidal Assay (SBA) Using Human Complement (SBA-HC) Titer Greater or Than Equal to (≥) 1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-protocol Population (PPP)	Serogroup Y- at 7 months of age: ≥1:4	29.5 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With an Serum Bactericidal Assay (SBA) Using Human Complement (SBA-HC) Titer Greater or Than Equal to (≥) 1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-protocol Population (PPP)	Serogroup W-135- at 7 months of age: ≥1:4	42.6 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With an Serum Bactericidal Assay (SBA) Using Human Complement (SBA-HC) Titer Greater or Than Equal to (≥) 1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-protocol Population (PPP)	Serogroup W-135- at 7 months of age: ≥1:8	24.6 percentage of participants
Group 6: Control: 2, 4, 6, and 12 Months	Percentage of Participants With an Serum Bactericidal Assay (SBA) Using Human Complement (SBA-HC) Titer Greater or Than Equal to (≥) 1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-protocol Population (PPP)	Serogroup Y- at 7 months of age: ≥1:8	6.7 percentage of participants
Group 6: Control: 2, 4, 6, and 12 Months	Percentage of Participants With an Serum Bactericidal Assay (SBA) Using Human Complement (SBA-HC) Titer Greater or Than Equal to (≥) 1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-protocol Population (PPP)	Serogroup W-135- at 7 months of age: ≥1:8	2.2 percentage of participants
Group 6: Control: 2, 4, 6, and 12 Months	Percentage of Participants With an Serum Bactericidal Assay (SBA) Using Human Complement (SBA-HC) Titer Greater or Than Equal to (≥) 1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-protocol Population (PPP)	Serogroup W-135- at 7 months of age: ≥1:4	11.1 percentage of participants
Group 6: Control: 2, 4, 6, and 12 Months	Percentage of Participants With an Serum Bactericidal Assay (SBA) Using Human Complement (SBA-HC) Titer Greater or Than Equal to (≥) 1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-protocol Population (PPP)	Serogroup C- at 7 months of age: ≥1:8	2.2 percentage of participants
Group 6: Control: 2, 4, 6, and 12 Months	Percentage of Participants With an Serum Bactericidal Assay (SBA) Using Human Complement (SBA-HC) Titer Greater or Than Equal to (≥) 1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-protocol Population (PPP)	Serogroup A- at 7 months of age: ≥1:4	15.9 percentage of participants
Group 6: Control: 2, 4, 6, and 12 Months	Percentage of Participants With an Serum Bactericidal Assay (SBA) Using Human Complement (SBA-HC) Titer Greater or Than Equal to (≥) 1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-protocol Population (PPP)	Serogroup C- at 7 months of age: ≥1:4	11.1 percentage of participants
Group 6: Control: 2, 4, 6, and 12 Months	Percentage of Participants With an Serum Bactericidal Assay (SBA) Using Human Complement (SBA-HC) Titer Greater or Than Equal to (≥) 1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-protocol Population (PPP)	Serogroup A- at 7 months of age: ≥1:8	4.5 percentage of participants
Group 6: Control: 2, 4, 6, and 12 Months	Percentage of Participants With an Serum Bactericidal Assay (SBA) Using Human Complement (SBA-HC) Titer Greater or Than Equal to (≥) 1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-protocol Population (PPP)	Serogroup Y- at 7 months of age: ≥1:4	8.9 percentage of participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Percentage of Participants With an Serum Bactericidal Assay (SBA) Using Human Complement (SBA-HC) Titer Greater or Than Equal to (≥) 1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-protocol Population (PPP)	Serogroup A- at 7 months of age: ≥1:4	25.7 percentage of participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Percentage of Participants With an Serum Bactericidal Assay (SBA) Using Human Complement (SBA-HC) Titer Greater or Than Equal to (≥) 1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-protocol Population (PPP)	Serogroup C- at 7 months of age: ≥1:4	17.1 percentage of participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Percentage of Participants With an Serum Bactericidal Assay (SBA) Using Human Complement (SBA-HC) Titer Greater or Than Equal to (≥) 1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-protocol Population (PPP)	Serogroup Y- at 7 months of age: ≥1:8	5.7 percentage of participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Percentage of Participants With an Serum Bactericidal Assay (SBA) Using Human Complement (SBA-HC) Titer Greater or Than Equal to (≥) 1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-protocol Population (PPP)	Serogroup A- at 7 months of age: ≥1:8	2.9 percentage of participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Percentage of Participants With an Serum Bactericidal Assay (SBA) Using Human Complement (SBA-HC) Titer Greater or Than Equal to (≥) 1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-protocol Population (PPP)	Serogroup Y- at 7 months of age: ≥1:4	11.4 percentage of participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Percentage of Participants With an Serum Bactericidal Assay (SBA) Using Human Complement (SBA-HC) Titer Greater or Than Equal to (≥) 1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-protocol Population (PPP)	Serogroup W-135- at 7 months of age: ≥1:4	11.4 percentage of participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Percentage of Participants With an Serum Bactericidal Assay (SBA) Using Human Complement (SBA-HC) Titer Greater or Than Equal to (≥) 1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-protocol Population (PPP)	Serogroup C- at 7 months of age: ≥1:8	2.9 percentage of participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Percentage of Participants With an Serum Bactericidal Assay (SBA) Using Human Complement (SBA-HC) Titer Greater or Than Equal to (≥) 1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-protocol Population (PPP)	Serogroup W-135- at 7 months of age: ≥1:8	2.9 percentage of participants

Primary

Percentage of Participants With an Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population

Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. PPP consisted of all participants included in the trial who received at least one dose of study or control vaccine, excluding those who did not meet all protocol-specified inclusion/exclusion criteria, did not received the correct number of doses of the investigational vaccine, received a vaccine other than the one that he/she was randomized to receive, did not provided a post-dose serology sample in the proper time window, received a protocol-restricted therapy, medication or vaccine, was on systemic antibiotics within 3 days prior to study blood draw, had no serology sample or did not produce at least one valid test result, did not receive vaccine in the proper time window. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.

Time frame: Groups 1, 3, 4, and 6: at the age of 13 months; Groups 2 and 7: at the age of 16 months

Population: Booster PPP. Here, 'Number analyzed'=number of participants with available data for specified categories and '0' in number analyzed field signifies none of the participants were evaluable at that specified time point because different groups had different planned data collection time points as defined in time frame and pre-specified in protocol.

Arm	Measure	Group	Value (NUMBER)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With an Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup Y- at 13 months of age: ≥1:4	100.0 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With an Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup Y- at 13 months of age: ≥1:8	100.0 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With an Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup A- at 13 months of age: ≥1:8	94.9 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With an Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup W-135- at 13 months of age: ≥1:8	100.0 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With an Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup C- at 13 months of age: ≥1:4	94.9 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With an Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup A- at 13 months of age: ≥1:4	94.9 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With an Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup C- at 13 months of age: ≥1:8	94.9 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With an Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup W-135- at 13 months of age: ≥1:4	100.0 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With an Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup A- at 16 months of age: ≥1:8	93.8 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With an Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup Y- at 16 months of age: ≥1:4	100.0 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With an Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup W-135- at 16 months of age: ≥1:8	100.0 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With an Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup C- at 16 months of age: ≥1:4	98.5 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With an Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup C- at 16 months of age: ≥1:8	96.9 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With an Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup A- at 16 months of age: ≥1:4	96.9 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With an Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup Y- at 16 months of age: ≥1:8	100.0 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With an Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup W-135- at 16 months of age: ≥1:4	100.0 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With an Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup A- at 13 months of age: ≥1:4	96.4 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With an Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup W-135- at 13 months of age: ≥1:8	98.1 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With an Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup C- at 13 months of age: ≥1:4	94.5 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With an Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup W-135- at 13 months of age: ≥1:4	100.0 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With an Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup Y- at 13 months of age: ≥1:4	100.0 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With an Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup Y- at 13 months of age: ≥1:8	98.1 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With an Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup C- at 13 months of age: ≥1:8	90.9 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With an Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup A- at 13 months of age: ≥1:8	94.5 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With an Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup C- at 13 months of age: ≥1:8	100.0 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With an Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup A- at 13 months of age: ≥1:4	100.0 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With an Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup A- at 13 months of age: ≥1:8	100.0 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With an Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup C- at 13 months of age: ≥1:4	100.0 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With an Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup Y- at 13 months of age: ≥1:4	100.0 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With an Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup Y- at 13 months of age: ≥1:8	97.8 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With an Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup W-135- at 13 months of age: ≥1:4	100.0 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With an Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup W-135- at 13 months of age: ≥1:8	97.8 percentage of participants
Group 6: Control: 2, 4, 6, and 12 Months	Percentage of Participants With an Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup C- at 13 months of age: ≥1:8	7.7 percentage of participants
Group 6: Control: 2, 4, 6, and 12 Months	Percentage of Participants With an Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup C- at 13 months of age: ≥1:4	30.8 percentage of participants
Group 6: Control: 2, 4, 6, and 12 Months	Percentage of Participants With an Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup A- at 13 months of age: ≥1:4	28.0 percentage of participants
Group 6: Control: 2, 4, 6, and 12 Months	Percentage of Participants With an Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup W-135- at 13 months of age: ≥1:8	4.0 percentage of participants
Group 6: Control: 2, 4, 6, and 12 Months	Percentage of Participants With an Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup A- at 13 months of age: ≥1:8	12.0 percentage of participants
Group 6: Control: 2, 4, 6, and 12 Months	Percentage of Participants With an Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup Y- at 13 months of age: ≥1:4	11.5 percentage of participants
Group 6: Control: 2, 4, 6, and 12 Months	Percentage of Participants With an Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup W-135- at 13 months of age: ≥1:4	8.0 percentage of participants
Group 6: Control: 2, 4, 6, and 12 Months	Percentage of Participants With an Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup Y- at 13 months of age: ≥1:8	3.8 percentage of participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Percentage of Participants With an Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup A- at 16 months of age: ≥1:8	15.4 percentage of participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Percentage of Participants With an Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup Y- at 16 months of age: ≥1:4	11.5 percentage of participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Percentage of Participants With an Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup C- at 16 months of age: ≥1:4	34.6 percentage of participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Percentage of Participants With an Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup Y- at 16 months of age: ≥1:8	3.8 percentage of participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Percentage of Participants With an Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup C- at 16 months of age: ≥1:8	3.8 percentage of participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Percentage of Participants With an Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup A- at 16 months of age: ≥1:4	30.8 percentage of participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Percentage of Participants With an Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup W-135- at 16 months of age: ≥1:8	3.8 percentage of participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Percentage of Participants With an Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup W-135- at 16 months of age: ≥1:4	3.8 percentage of participants

Primary

Percentage of Participants With Antibodies to All Antigens Contained in M-M-RII and VARIVAX Vaccines: Groups 1 and 6 - Booster Per-Protocol Population

Antibodies responses were measured by ELISA. Antigens contained in M-M-RII: Measles, Mumps, and Rubella and in Varivax®: Varicella. Percentage of participants with anti-measles, anti-mumps, anti-rubella, and anti-varicella antibody concentration that met the respective mentioned criterion were reported: Measles: ≥255 milli-International Units per milliliter (mIU/mL); Mumps: ≥10 Antibody units per milliliter (AbU/mL); Rubella: ≥10 International Units per milliliter (IU/mL); Varicella: ≥5 glycoprotein based enzyme-linked immunosorbent assay (gpELISA) unit/mL. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.

Time frame: At the age of 13 months

Population: Analysis was performed on booster PPP. Here, 'Overall number of participants analyzed'=participants evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for Groups 2, 3, 4, 5, and 7, as pre-specified in protocol.

Arm	Measure	Group	Value (NUMBER)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With Antibodies to All Antigens Contained in M-M-RII and VARIVAX Vaccines: Groups 1 and 6 - Booster Per-Protocol Population	Measles: ≥255 mIU/mL	100.0 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With Antibodies to All Antigens Contained in M-M-RII and VARIVAX Vaccines: Groups 1 and 6 - Booster Per-Protocol Population	Mumps: ≥10 AbU/mL	100.0 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With Antibodies to All Antigens Contained in M-M-RII and VARIVAX Vaccines: Groups 1 and 6 - Booster Per-Protocol Population	Rubella: ≥10 IU/mL	100.0 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With Antibodies to All Antigens Contained in M-M-RII and VARIVAX Vaccines: Groups 1 and 6 - Booster Per-Protocol Population	Varicella: ≥5 gpELISA unit/mL	100.0 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With Antibodies to All Antigens Contained in M-M-RII and VARIVAX Vaccines: Groups 1 and 6 - Booster Per-Protocol Population	Varicella: ≥5 gpELISA unit/mL	100.0 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With Antibodies to All Antigens Contained in M-M-RII and VARIVAX Vaccines: Groups 1 and 6 - Booster Per-Protocol Population	Measles: ≥255 mIU/mL	100.0 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With Antibodies to All Antigens Contained in M-M-RII and VARIVAX Vaccines: Groups 1 and 6 - Booster Per-Protocol Population	Rubella: ≥10 IU/mL	100.0 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With Antibodies to All Antigens Contained in M-M-RII and VARIVAX Vaccines: Groups 1 and 6 - Booster Per-Protocol Population	Mumps: ≥10 AbU/mL	100.0 percentage of participants

Primary

Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Group 5- Per-Protocol Population

Percentage of participants with anti-pneumococcal antibody concentrations ≥0.35 μg/mL and ≥1.0 μg/mL for serotypes in Prevnar 7 or 13 vaccine i.e. 4, 6B, 9V, 14, 18C, 19F and 23F is reported.

Time frame: At the age of 13 months

Population: Analysis was performed on PPP. Here, 'Overall number of participants analyzed'=participants evaluable for this outcome measure.

Arm	Measure	Group	Value (NUMBER)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Group 5- Per-Protocol Population	Serotype 4: ≥0.35 μg/mL	100.0 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Group 5- Per-Protocol Population	Serotype 9V: ≥0.35 μg/mL	100.0 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Group 5- Per-Protocol Population	Serotype 14: ≥0.35 μg/mL	100.0 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Group 5- Per-Protocol Population	Serotype 18C: ≥0.35 μg/mL	100.0 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Group 5- Per-Protocol Population	Serotype 19F: ≥0.35 μg/mL	100.0 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Group 5- Per-Protocol Population	Serotype 6B: ≥1.0 μg/mL	100.0 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Group 5- Per-Protocol Population	Serotype 19F: ≥1.0 μg/mL	83.3 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Group 5- Per-Protocol Population	Serotype 23F: ≥1.0 μg/mL	91.7 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Group 5- Per-Protocol Population	Serotype 6B: ≥0.35 μg/mL	100.0 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Group 5- Per-Protocol Population	Serotype 23F: ≥0.35 μg/mL	100.0 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Group 5- Per-Protocol Population	Serotype 4: ≥1.0 μg/mL	66.7 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Group 5- Per-Protocol Population	Serotype 9V: ≥1.0 μg/mL	91.7 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Group 5- Per-Protocol Population	Serotype 14: ≥1.0 μg/mL	100.0 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Group 5- Per-Protocol Population	Serotype 18C: ≥1.0 μg/mL	75.0 percentage of participants

Primary

Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population

Percentage of participants with anti-pneumococcal antibody concentrations ≥0.35 μg/mL and ≥1.0 μg/mL for serotypes in Prevnar 7 or 13 vaccine i.e. 4, 6B, 9V, 14, 18C, 19F and 23F is reported. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.

Time frame: At the age of 13 months

Population: Analysis was performed on booster PPP. Here, 'Number analyzed'=participants with available data for specified categories. Data for this outcome measure was not planned to be collected and analyzed for Groups 2 and 7.

Arm	Measure	Group	Value (NUMBER)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population	Serotype 23F: ≥1.0 μg/mL	100.0 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population	Serotype 14: ≥1.0 μg/mL	100.0 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population	Serotype 6B: ≥0.35 μg/mL	100.0 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population	Serotype 4: ≥1.0 μg/mL	80.0 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population	Serotype 9V: ≥0.35 μg/mL	96.0 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population	Serotype 6B: ≥1.0 μg/mL	96.0 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population	Serotype 18C: ≥1.0 μg/mL	88.0 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population	Serotype 9V: ≥1.0 μg/mL	84.0 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population	Serotype 14: ≥0.35 μg/mL	100.0 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population	Serotype 19F: ≥1.0 μg/mL	96.0 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population	Serotype 19F: ≥0.35 μg/mL	100.0 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population	Serotype 4: ≥0.35 μg/mL	96.0 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population	Serotype 18C: ≥0.35 μg/mL	100.0 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population	Serotype 23F: ≥0.35 μg/mL	100.0 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population	Serotype 18C: ≥0.35 μg/mL	100.0 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population	Serotype 19F: ≥0.35 μg/mL	100.0 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population	Serotype 4: ≥1.0 μg/mL	66.7 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population	Serotype 23F: ≥1.0 μg/mL	90.5 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population	Serotype 19F: ≥1.0 μg/mL	95.2 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population	Serotype 14: ≥1.0 μg/mL	100.0 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population	Serotype 4: ≥0.35 μg/mL	100.0 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population	Serotype 6B: ≥0.35 μg/mL	100.0 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population	Serotype 9V: ≥1.0 μg/mL	76.2 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population	Serotype 9V: ≥0.35 μg/mL	100.0 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population	Serotype 14: ≥0.35 μg/mL	100.0 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population	Serotype 18C: ≥1.0 μg/mL	85.7 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population	Serotype 6B: ≥1.0 μg/mL	100.0 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population	Serotype 23F: ≥0.35 μg/mL	100.0 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population	Serotype 4: ≥0.35 μg/mL	100.0 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population	Serotype 6B: ≥0.35 μg/mL	100.0 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population	Serotype 18C: ≥1.0 μg/mL	89.5 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population	Serotype 23F: ≥1.0 μg/mL	89.5 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population	Serotype 9V: ≥0.35 μg/mL	100.0 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population	Serotype 14: ≥0.35 μg/mL	100.0 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population	Serotype 18C: ≥0.35 μg/mL	100.0 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population	Serotype 19F: ≥0.35 μg/mL	94.7 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population	Serotype 23F: ≥0.35 μg/mL	100.0 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population	Serotype 4: ≥1.0 μg/mL	84.2 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population	Serotype 6B: ≥1.0 μg/mL	100.0 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population	Serotype 9V: ≥1.0 μg/mL	77.8 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population	Serotype 14: ≥1.0 μg/mL	100.0 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population	Serotype 19F: ≥1.0 μg/mL	94.7 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population	Serotype 14: ≥0.35 μg/mL	90.0 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population	Serotype 18C: ≥1.0 μg/mL	70.0 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population	Serotype 6B: ≥1.0 μg/mL	90.0 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population	Serotype 9V: ≥0.35 μg/mL	100.0 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population	Serotype 6B: ≥0.35 μg/mL	100.0 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population	Serotype 14: ≥1.0 μg/mL	90.0 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population	Serotype 9V: ≥1.0 μg/mL	60.0 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population	Serotype 4: ≥0.35 μg/mL	100.0 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population	Serotype 23F: ≥1.0 μg/mL	90.0 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population	Serotype 23F: ≥0.35 μg/mL	100.0 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population	Serotype 19F: ≥0.35 μg/mL	100.0 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population	Serotype 19F: ≥1.0 μg/mL	100.0 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population	Serotype 4: ≥1.0 μg/mL	60.0 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population	Serotype 18C: ≥0.35 μg/mL	100.0 percentage of participants

Primary

Percentage of Participants With Antibody Concentration ≥0.35 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population

Percentage of participants with anti-pneumococcal antibody concentrations ≥0.35 μg/mL for serotypes in Prevnar 7 or 13 vaccine i.e. 4, 6B, 9V, 14, 18C, 19F, and 23F is reported. Primary series PPP was defined as the PPP which was used for reporting data of time points prior to 12 months of age.

Time frame: At the age of 7 months

Population: Analysis was performed on primary series PPP. Here, 'Number analyzed'=participants with available data for specified categories. Data for this outcome measure was not planned to be collected and analyzed for Group 3, as pre-specified in protocol.

Arm	Measure	Group	Value (NUMBER)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Serotype 14: ≥0.35 μg/mL	100.0 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Serotype 4: ≥0.35 μg/mL	100.0 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Serotype 6B: ≥0.35 μg/mL	94.3 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Serotype 9V: ≥0.35 μg/mL	97.2 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Serotype 19F: ≥0.35 μg/mL	97.2 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Serotype 23F: ≥0.35 μg/mL	94.4 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Serotype 18C: ≥0.35 μg/mL	97.1 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Serotype 19F: ≥0.35 μg/mL	100.0 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Serotype 14: ≥0.35 μg/mL	100.0 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Serotype 18C: ≥0.35 μg/mL	100.0 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Serotype 4: ≥0.35 μg/mL	100.0 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Serotype 6B: ≥0.35 μg/mL	91.2 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Serotype 9V: ≥0.35 μg/mL	100.0 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Serotype 23F: ≥0.35 μg/mL	97.1 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Serotype 6B: ≥0.35 μg/mL	82.6 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Serotype 9V: ≥0.35 μg/mL	95.7 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Serotype 19F: ≥0.35 μg/mL	100.0 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Serotype 23F: ≥0.35 μg/mL	91.3 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Serotype 18C: ≥0.35 μg/mL	95.7 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Serotype 14: ≥0.35 μg/mL	100.0 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Serotype 4: ≥0.35 μg/mL	100.0 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Serotype 4: ≥0.35 μg/mL	100.0 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Serotype 14: ≥0.35 μg/mL	100.0 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Serotype 18C: ≥0.35 μg/mL	100.0 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Serotype 6B: ≥0.35 μg/mL	77.8 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Serotype 9V: ≥0.35 μg/mL	94.4 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Serotype 19F: ≥0.35 μg/mL	100.0 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Serotype 23F: ≥0.35 μg/mL	83.3 percentage of participants
Group 6: Control: 2, 4, 6, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Serotype 6B: ≥0.35 μg/mL	92.9 percentage of participants
Group 6: Control: 2, 4, 6, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Serotype 23F: ≥0.35 μg/mL	92.9 percentage of participants
Group 6: Control: 2, 4, 6, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Serotype 19F: ≥0.35 μg/mL	100.0 percentage of participants
Group 6: Control: 2, 4, 6, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Serotype 14: ≥0.35 μg/mL	100.0 percentage of participants
Group 6: Control: 2, 4, 6, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Serotype 4: ≥0.35 μg/mL	92.9 percentage of participants
Group 6: Control: 2, 4, 6, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Serotype 18C: ≥0.35 μg/mL	100.0 percentage of participants
Group 6: Control: 2, 4, 6, and 12 Months	Percentage of Participants With Antibody Concentration ≥0.35 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population	Serotype 9V: ≥0.35 μg/mL	85.7 percentage of participants

Primary

Percentage of Participants With a Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population

Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Primary series PPP was defined as the PPP which was used for reporting data of time points prior to 12 months of age.

Time frame: Groups 1, 2, 4, 6, and 7: at the age of 7 months; Group 3: at the age of 5 months

Population: Primary series PPP. Here, 'Number analyzed'=participants with available data for specified categories and '0' in number analyzed field signifies none of participants were evaluable at that specified time point because different groups had different planned data collection time points as defined in time frame and pre-specified in protocol.

Arm	Measure	Group	Value (NUMBER)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With a Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup C- at 7 months of age: ≥1:128	94.3 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With a Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup W-135- at 7 months of age: ≥1:8	100.0 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With a Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup A- at 7 months of age: ≥1:128	31.4 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With a Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup Y- at 7 months of age: ≥1:128	87.3 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With a Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup C- at 7 months of age: ≥1:8	95.7 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With a Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup A- at 7 months of age: ≥1:8	50.0 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With a Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup Y- at 7 months of age: ≥1:8	97.2 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With a Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup W-135- at 7 months of age: ≥1:128	97.1 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With a Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup C- at 7 months of age: ≥1:128	93.5 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With a Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup A- at 7 months of age: ≥1:8	54.5 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With a Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup W-135- at 7 months of age: ≥1:8	98.7 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With a Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup A- at 7 months of age: ≥1:128	37.7 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With a Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup W-135- at 7 months of age: ≥1:128	94.8 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With a Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup C- at 7 months of age: ≥1:8	94.8 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With a Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup Y- at 7 months of age: ≥1:128	92.2 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With a Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup Y- at 7 months of age: ≥1:8	100.0 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With a Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup C- at 5 months of age: ≥1:128	92.1 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With a Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup A- at 5 months of age: ≥1:128	34.2 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With a Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup Y- at 5 months of age: ≥1:128	81.6 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With a Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup A- at 5 months of age: ≥1:8	52.6 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With a Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup Y- at 5 months of age: ≥1:8	98.7 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With a Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup W-135- at 5 months of age: ≥1:128	96.1 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With a Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup W-135- at 5 months of age: ≥1:8	100.0 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With a Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup C- at 5 months of age: ≥1:8	93.4 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With a Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup Y- at 7 months of age: ≥1:128	46.4 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With a Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup A- at 7 months of age: ≥1:8	43.6 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With a Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup A- at 7 months of age: ≥1:128	21.8 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With a Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup C- at 7 months of age: ≥1:8	91.2 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With a Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup Y- at 7 months of age: ≥1:8	82.1 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With a Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup C- at 7 months of age: ≥1:128	80.7 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With a Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup W-135- at 7 months of age: ≥1:8	80.4 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With a Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup W-135- at 7 months of age: ≥1:128	66.1 percentage of participants
Group 6: Control: 2, 4, 6, and 12 Months	Percentage of Participants With a Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup C- at 7 months of age: ≥1:8	2.6 percentage of participants
Group 6: Control: 2, 4, 6, and 12 Months	Percentage of Participants With a Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup A- at 7 months of age: ≥1:8	2.6 percentage of participants
Group 6: Control: 2, 4, 6, and 12 Months	Percentage of Participants With a Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup W-135- at 7 months of age: ≥1:128	2.6 percentage of participants
Group 6: Control: 2, 4, 6, and 12 Months	Percentage of Participants With a Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup W-135- at 7 months of age: ≥1:8	13.2 percentage of participants
Group 6: Control: 2, 4, 6, and 12 Months	Percentage of Participants With a Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup Y- at 7 months of age: ≥1:128	15.4 percentage of participants
Group 6: Control: 2, 4, 6, and 12 Months	Percentage of Participants With a Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup C- at 7 months of age: ≥1:128	0.0 percentage of participants
Group 6: Control: 2, 4, 6, and 12 Months	Percentage of Participants With a Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup A- at 7 months of age: ≥1:128	2.6 percentage of participants
Group 6: Control: 2, 4, 6, and 12 Months	Percentage of Participants With a Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup Y- at 7 months of age: ≥1:8	38.5 percentage of participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Percentage of Participants With a Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup A- at 7 months of age: ≥1:8	2.9 percentage of participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Percentage of Participants With a Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup C- at 7 months of age: ≥1:8	8.6 percentage of participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Percentage of Participants With a Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup W-135- at 7 months of age: ≥1:128	5.7 percentage of participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Percentage of Participants With a Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup Y- at 7 months of age: ≥1:128	17.1 percentage of participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Percentage of Participants With a Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup A- at 7 months of age: ≥1:128	2.9 percentage of participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Percentage of Participants With a Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup Y- at 7 months of age: ≥1:8	37.1 percentage of participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Percentage of Participants With a Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup C- at 7 months of age: ≥1:128	5.7 percentage of participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Percentage of Participants With a Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup W-135- at 7 months of age: ≥1:8	14.3 percentage of participants

Primary

Percentage of Participants With SBA-BR Pre-Booster Titer ≥1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titer After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population

Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Pre-booster titer was defined as titer value reported before the age of 12 months. Percentage of participants whose pre-booster titer was ≥1:8 and achieved ≥4-fold rise in each meningococcal serogroups antibody titer (30 days post booster vaccination) were reported. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.

Time frame: Groups 1, 3, and 4: 30 days post-vaccination at the age of 12 months (i.e. at the age of 13 months); Group 2: 30 days post-vaccination at the age of 15 months (i.e. at the age of 16 months)

Arm	Measure	Group	Value (NUMBER)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With SBA-BR Pre-Booster Titer ≥1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titer After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup A	100.0 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With SBA-BR Pre-Booster Titer ≥1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titer After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup C	86.2 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With SBA-BR Pre-Booster Titer ≥1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titer After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup Y	70.0 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With SBA-BR Pre-Booster Titer ≥1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titer After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup W-135	85.1 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With SBA-BR Pre-Booster Titer ≥1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titer After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup C	86.4 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With SBA-BR Pre-Booster Titer ≥1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titer After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup Y	83.0 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With SBA-BR Pre-Booster Titer ≥1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titer After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup W-135	87.2 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With SBA-BR Pre-Booster Titer ≥1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titer After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup A	100.0 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With SBA-BR Pre-Booster Titer ≥1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titer After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup Y	81.3 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With SBA-BR Pre-Booster Titer ≥1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titer After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup C	77.3 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With SBA-BR Pre-Booster Titer ≥1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titer After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup W-135	82.9 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With SBA-BR Pre-Booster Titer ≥1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titer After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup A	33.3 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With SBA-BR Pre-Booster Titer ≥1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titer After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup W-135	80.6 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With SBA-BR Pre-Booster Titer ≥1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titer After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup C	96.4 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With SBA-BR Pre-Booster Titer ≥1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titer After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup A	66.7 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With SBA-BR Pre-Booster Titer ≥1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titer After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup Y	77.8 percentage of participants

Primary

Percentage of Participants With SBA-BR Pre-Booster Titer <1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titers After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population

Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Pre-booster titer was defined as titer value reported before the age of 12 months. Percentage of participants whose pre-booster titer was \<1:8 and achieved ≥4-fold rise in each meningococcal serogroups antibody titer (30-days post booster vaccination) were reported. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.

Arm	Measure	Group	Value (NUMBER)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With SBA-BR Pre-Booster Titer <1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titers After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup A	78.0 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With SBA-BR Pre-Booster Titer <1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titers After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup C	88.0 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With SBA-BR Pre-Booster Titer <1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titers After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup Y	100.0 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With SBA-BR Pre-Booster Titer <1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titers After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup W-135	100.0 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With SBA-BR Pre-Booster Titer <1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titers After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup C	96.8 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With SBA-BR Pre-Booster Titer <1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titers After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup Y	100.0 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With SBA-BR Pre-Booster Titer <1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titers After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup W-135	100.0 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With SBA-BR Pre-Booster Titer <1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titers After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup A	79.2 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With SBA-BR Pre-Booster Titer <1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titers After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup Y	100.0 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With SBA-BR Pre-Booster Titer <1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titers After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup C	83.3 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With SBA-BR Pre-Booster Titer <1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titers After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup W-135	100.0 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With SBA-BR Pre-Booster Titer <1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titers After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup A	95.5 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With SBA-BR Pre-Booster Titer <1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titers After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup W-135	85.7 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With SBA-BR Pre-Booster Titer <1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titers After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup C	100.0 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With SBA-BR Pre-Booster Titer <1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titers After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup A	93.8 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With SBA-BR Pre-Booster Titer <1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titers After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup Y	100.0 percentage of participants

Primary

Percentage of Participants With SBA-BR Pre-Vaccination Titer <1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titer After Vaccination: Group 5 - Per-Protocol Population

Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Pre-vaccination titer was defined as titer value reported before the age of 12 months. Percentage of participants with pre-vaccination titer \<1:8 and who achieved ≥4-fold rise in each meningococcal serogroups antibody titer (30 days post-vaccination) were reported.

Time frame: 30 days post-vaccination at the age of 12 months (i.e. at the age of 13 months)

Population: Analysis was performed on PPP. Here, 'Number analyzed'=participants with available data for specified category.

Arm	Measure	Group	Value (NUMBER)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With SBA-BR Pre-Vaccination Titer <1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titer After Vaccination: Group 5 - Per-Protocol Population	Serogroup A	61.8 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With SBA-BR Pre-Vaccination Titer <1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titer After Vaccination: Group 5 - Per-Protocol Population	Serogroup C	90.7 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With SBA-BR Pre-Vaccination Titer <1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titer After Vaccination: Group 5 - Per-Protocol Population	Serogroup Y	74.1 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With SBA-BR Pre-Vaccination Titer <1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titer After Vaccination: Group 5 - Per-Protocol Population	Serogroup W-135	97.6 percentage of participants

Primary

Percentage of Participants With SBA-BR Pre-Vaccination Titer ≥1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titer After Vaccination: Group 5 - Per-Protocol Population

Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Percentage of participants whose pre-vaccination titer was ≥1:8 and achieved ≥4-fold rise in each meningococcal serogroups antibody titer at the age of Month 13 (i.e. 30-days post vaccination at Month 12) were reported.

Time frame: 30 days post-vaccination at the age of 12 months (i.e. at the age of 13 months)

Population: Analysis was performed on PPP. Here, 'Overall number of participants analyzed= participants evaluable for this outcome measure' and 'Number analyzed'=participants with available data for specified category. In addition, '0' in number analyzed field signifies none of the participants had titer ≥1:8.

Arm	Measure	Group	Value (NUMBER)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With SBA-BR Pre-Vaccination Titer ≥1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titer After Vaccination: Group 5 - Per-Protocol Population	Serogroup C	66.7 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With SBA-BR Pre-Vaccination Titer ≥1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titer After Vaccination: Group 5 - Per-Protocol Population	Serogroup Y	53.3 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With SBA-BR Pre-Vaccination Titer ≥1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titer After Vaccination: Group 5 - Per-Protocol Population	Serogroup W-135	93.3 percentage of participants
Unknown	Percentage of Participants With SBA-BR Pre-Vaccination Titer ≥1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titer After Vaccination: Group 5 - Per-Protocol Population	Serogroup A	— percentage of participants

Primary

Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Group 5 - Per-Protocol Population

Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR.

Time frame: At the age of 13 months

Population: Analysis was performed on PPP. Here, 'Overall number of participant analyzed'=participants evaluable for this outcome measure.

Arm	Measure	Group	Value (NUMBER)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Group 5 - Per-Protocol Population	Serogroup C: ≥1:8	91.4 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Group 5 - Per-Protocol Population	Serogroup A: ≥1:8	62.1 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Group 5 - Per-Protocol Population	Serogroup A: ≥1:128	46.6 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Group 5 - Per-Protocol Population	Serogroup C: ≥1:128	82.8 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Group 5 - Per-Protocol Population	Serogroup Y: ≥1:8	94.8 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Group 5 - Per-Protocol Population	Serogroup Y: ≥1:128	70.7 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Group 5 - Per-Protocol Population	Serogroup W-135: ≥1:8	100.0 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Group 5 - Per-Protocol Population	Serogroup W-135: ≥1:128	86.2 percentage of participants

Primary

Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population

Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.

Time frame: Groups 1, 3, 4, and 6: at the age of 13 months; Groups 2 and 7: at the age of 16 months

Population: Booster PPP. Here, 'Number analyzed'=participants with available data for specified categories and '0' in number analyzed field signifies none of the participants were evaluable at that specified time point because different groups had different planned data collection time points as defined in time frame and pre-specified in protocol.

Arm	Measure	Group	Value (NUMBER)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup Y- at 13 months of age ≥1:8	100.0 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup A- at 13 months of age ≥1:128	69.6 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup Y- at 13 months of age ≥1:128	94.6 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup W-135- at 13 months of age ≥1:128	98.2 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup C- at 13 months of age ≥1:8	93.0 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup A- at 13 months of age ≥1:8	80.4 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup C- at 13 months of age ≥1:128	93.0 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup W-135- at 13 months of age ≥1:8	100.0 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup W-135- at 16 months of age ≥1:8	100.0 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup A- at 16 months of age ≥1:128	74.6 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup Y- at 16 months of age ≥1:8	100.0 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup C- at 16 months of age ≥1:8	98.3 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup Y- at 16 months of age ≥1:128	96.6 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup C- at 16 months of age ≥1:128	96.6 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup W-135- at 16 months of age ≥1:128	98.3 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup A- at 16 months of age ≥1:8	81.4 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup A- at 13 months of age ≥1:128	88.2 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup W-135- at 13 months of age ≥1:128	94.1 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup Y- at 13 months of age ≥1:8	100.0 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup C- at 13 months of age ≥1:128	86.8 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup Y- at 13 months of age ≥1:128	94.2 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup C- at 13 months of age ≥1:8	88.7 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup A- at 13 months of age ≥1:8	96.1 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup W-135- at 13 months of age ≥1:8	98.0 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup A- at 13 months of age ≥1:128	90.5 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup A- at 13 months of age ≥1:8	95.2 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup C- at 13 months of age ≥1:8	100.0 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup C- at 13 months of age ≥1:128	97.7 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup Y- at 13 months of age ≥1:8	100.0 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup Y- at 13 months of age ≥1:128	100.0 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup W-135- at 13 months of age ≥1:8	97.6 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup W-135- at 13 months of age ≥1:128	95.2 percentage of participants
Group 6: Control: 2, 4, 6, and 12 Months	Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup C- at 13 months of age ≥1:128	16.7 percentage of participants
Group 6: Control: 2, 4, 6, and 12 Months	Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup C- at 13 months of age ≥1:8	16.7 percentage of participants
Group 6: Control: 2, 4, 6, and 12 Months	Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup A- at 13 months of age ≥1:8	8.3 percentage of participants
Group 6: Control: 2, 4, 6, and 12 Months	Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup W-135- at 13 months of age ≥1:128	0.0 percentage of participants
Group 6: Control: 2, 4, 6, and 12 Months	Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup A- at 13 months of age ≥1:128	4.2 percentage of participants
Group 6: Control: 2, 4, 6, and 12 Months	Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup Y- at 13 months of age ≥1:8	66.7 percentage of participants
Group 6: Control: 2, 4, 6, and 12 Months	Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup W-135- at 13 months of age ≥1:8	16.7 percentage of participants
Group 6: Control: 2, 4, 6, and 12 Months	Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup Y- at 13 months of age ≥1:128	37.5 percentage of participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup A- at 16 months of age ≥1:128	0.0 percentage of participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup Y- at 16 months of age ≥1:8	73.9 percentage of participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup C- at 16 months of age ≥1:8	8.3 percentage of participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup Y- at 16 months of age ≥1:128	30.4 percentage of participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup C- at 16 months of age ≥1:128	0.0 percentage of participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup A- at 16 months of age ≥1:8	0.0 percentage of participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup W-135- at 16 months of age ≥1:128	4.3 percentage of participants
Group 7: Control: 2, 4, 6, 12, and 15 Months	Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup W-135- at 16 months of age ≥1:8	17.4 percentage of participants

Primary

Percentage of Participants With SBA-HC Pre-booster Titer ≥1:8 Who Then Achieved ≥4-Fold Rise in SBA-HC Titer After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population

Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. Pre-booster titer was defined as titer values reported before the age of 12 months. Percentage of participants whose pre-booster titer was ≥1:8 and achieved ≥4-fold rise in each meningococcal serogroups antibody titer (30-days post booster vaccination) were reported. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.

Population: Analysis was performed on booster PPP. Here, 'Number analyzed'=participants with available data for specified category. Data for this outcome measure were not planned to be collected and analyzed for Groups 6 and 7, as pre-specified in protocol.

Arm	Measure	Group	Value (NUMBER)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With SBA-HC Pre-booster Titer ≥1:8 Who Then Achieved ≥4-Fold Rise in SBA-HC Titer After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup A	82.6 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With SBA-HC Pre-booster Titer ≥1:8 Who Then Achieved ≥4-Fold Rise in SBA-HC Titer After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup C	97.0 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With SBA-HC Pre-booster Titer ≥1:8 Who Then Achieved ≥4-Fold Rise in SBA-HC Titer After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup Y	83.7 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With SBA-HC Pre-booster Titer ≥1:8 Who Then Achieved ≥4-Fold Rise in SBA-HC Titer After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup W-135	94.2 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With SBA-HC Pre-booster Titer ≥1:8 Who Then Achieved ≥4-Fold Rise in SBA-HC Titer After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup C	97.1 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With SBA-HC Pre-booster Titer ≥1:8 Who Then Achieved ≥4-Fold Rise in SBA-HC Titer After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup Y	91.5 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With SBA-HC Pre-booster Titer ≥1:8 Who Then Achieved ≥4-Fold Rise in SBA-HC Titer After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup W-135	84.5 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With SBA-HC Pre-booster Titer ≥1:8 Who Then Achieved ≥4-Fold Rise in SBA-HC Titer After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup A	85.0 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With SBA-HC Pre-booster Titer ≥1:8 Who Then Achieved ≥4-Fold Rise in SBA-HC Titer After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup Y	81.0 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With SBA-HC Pre-booster Titer ≥1:8 Who Then Achieved ≥4-Fold Rise in SBA-HC Titer After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup C	92.3 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With SBA-HC Pre-booster Titer ≥1:8 Who Then Achieved ≥4-Fold Rise in SBA-HC Titer After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup W-135	90.7 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With SBA-HC Pre-booster Titer ≥1:8 Who Then Achieved ≥4-Fold Rise in SBA-HC Titer After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup A	66.7 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With SBA-HC Pre-booster Titer ≥1:8 Who Then Achieved ≥4-Fold Rise in SBA-HC Titer After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup W-135	88.1 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With SBA-HC Pre-booster Titer ≥1:8 Who Then Achieved ≥4-Fold Rise in SBA-HC Titer After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup C	100.0 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With SBA-HC Pre-booster Titer ≥1:8 Who Then Achieved ≥4-Fold Rise in SBA-HC Titer After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup A	100.0 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With SBA-HC Pre-booster Titer ≥1:8 Who Then Achieved ≥4-Fold Rise in SBA-HC Titer After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup Y	94.9 percentage of participants

Primary

Percentage of Participants With SBA-HC Pre-booster Titer Less Than (<) 1:8 Who Then Achieved ≥4-Fold Rise in SBA-HC After Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population

Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. Pre-booster titer was defined as titer values reported before the age of 12 months. Percentage of participants whose pre-booster titer was \<1:8 and achieved ≥4-fold rise in each meningococcal serogroups antibody titer (30-days post booster vaccination) were reported. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.

Arm	Measure	Group	Value (NUMBER)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With SBA-HC Pre-booster Titer Less Than (<) 1:8 Who Then Achieved ≥4-Fold Rise in SBA-HC After Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup A	84.8 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With SBA-HC Pre-booster Titer Less Than (<) 1:8 Who Then Achieved ≥4-Fold Rise in SBA-HC After Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup C	87.5 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With SBA-HC Pre-booster Titer Less Than (<) 1:8 Who Then Achieved ≥4-Fold Rise in SBA-HC After Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup Y	87.5 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With SBA-HC Pre-booster Titer Less Than (<) 1:8 Who Then Achieved ≥4-Fold Rise in SBA-HC After Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup W-135	100.0 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With SBA-HC Pre-booster Titer Less Than (<) 1:8 Who Then Achieved ≥4-Fold Rise in SBA-HC After Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup C	93.1 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With SBA-HC Pre-booster Titer Less Than (<) 1:8 Who Then Achieved ≥4-Fold Rise in SBA-HC After Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup Y	100.0 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With SBA-HC Pre-booster Titer Less Than (<) 1:8 Who Then Achieved ≥4-Fold Rise in SBA-HC After Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup W-135	100.0 percentage of participants
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Percentage of Participants With SBA-HC Pre-booster Titer Less Than (<) 1:8 Who Then Achieved ≥4-Fold Rise in SBA-HC After Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup A	85.7 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With SBA-HC Pre-booster Titer Less Than (<) 1:8 Who Then Achieved ≥4-Fold Rise in SBA-HC After Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup Y	90.0 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With SBA-HC Pre-booster Titer Less Than (<) 1:8 Who Then Achieved ≥4-Fold Rise in SBA-HC After Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup C	74.1 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With SBA-HC Pre-booster Titer Less Than (<) 1:8 Who Then Achieved ≥4-Fold Rise in SBA-HC After Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup W-135	88.9 percentage of participants
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Percentage of Participants With SBA-HC Pre-booster Titer Less Than (<) 1:8 Who Then Achieved ≥4-Fold Rise in SBA-HC After Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup A	92.1 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With SBA-HC Pre-booster Titer Less Than (<) 1:8 Who Then Achieved ≥4-Fold Rise in SBA-HC After Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup W-135	66.7 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With SBA-HC Pre-booster Titer Less Than (<) 1:8 Who Then Achieved ≥4-Fold Rise in SBA-HC After Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup C	83.3 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With SBA-HC Pre-booster Titer Less Than (<) 1:8 Who Then Achieved ≥4-Fold Rise in SBA-HC After Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup A	97.0 percentage of participants
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Percentage of Participants With SBA-HC Pre-booster Titer Less Than (<) 1:8 Who Then Achieved ≥4-Fold Rise in SBA-HC After Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population	Serogroup Y	83.3 percentage of participants

Primary

Percentage of Participants With SBA-HC Pre-vaccination Titer ≥1:8 Who Then Achieved ≥4-fold Rise in SBA-HC Titer After Vaccination: Group 5 - Per-Protocol Population

Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. Pre-vaccination titer was defined as titer values reported before the age of 12 months. Percentage of participants whose pre-vaccination titer was ≥1:8 and achieved ≥4-fold rise in each meningococcal serogroups antibody titer (30 days post-vaccination) were reported.

Time frame: 30 days post-vaccination at the age of 12 months (i.e. at the age of 13 months)

Population: Analysis was performed on PPP. Here, 'Overall number of participants analyzed'=participants evaluable for this outcome measure and '0' in the number analyzed field signifies none of the participants had pre-vaccination titer ≥1:8.

Arm	Measure	Group	Value (NUMBER)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With SBA-HC Pre-vaccination Titer ≥1:8 Who Then Achieved ≥4-fold Rise in SBA-HC Titer After Vaccination: Group 5 - Per-Protocol Population	Serogroup A	33.3 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With SBA-HC Pre-vaccination Titer ≥1:8 Who Then Achieved ≥4-fold Rise in SBA-HC Titer After Vaccination: Group 5 - Per-Protocol Population	Serogroup C	66.7 percentage of participants

Primary

Percentage of Participants With SBA-HC Pre-Vaccination Titer <1:8 Who Then Achieved ≥4-Fold Rise in SBA-HC Titer After Vaccination: Group 5 - Per-Protocol Population

Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. Percentage of participants with pre-vaccination titer \<1:8 and achieved ≥4-fold rise in each meningococcal serogroups antibody titer (30-days post vaccination) were reported.

Time frame: 30 days post-vaccination at the age of 12 months (i.e. at the age of 13 months)

Population: Analysis was performed on PPP. Here, 'Number analyzed'=participants with available data for specified category.

Arm	Measure	Group	Value (NUMBER)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With SBA-HC Pre-Vaccination Titer <1:8 Who Then Achieved ≥4-Fold Rise in SBA-HC Titer After Vaccination: Group 5 - Per-Protocol Population	Serogroup A	60.0 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With SBA-HC Pre-Vaccination Titer <1:8 Who Then Achieved ≥4-Fold Rise in SBA-HC Titer After Vaccination: Group 5 - Per-Protocol Population	Serogroup C	87.7 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With SBA-HC Pre-Vaccination Titer <1:8 Who Then Achieved ≥4-Fold Rise in SBA-HC Titer After Vaccination: Group 5 - Per-Protocol Population	Serogroup Y	35.0 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With SBA-HC Pre-Vaccination Titer <1:8 Who Then Achieved ≥4-Fold Rise in SBA-HC Titer After Vaccination: Group 5 - Per-Protocol Population	Serogroup W-135	29.3 percentage of participants

Primary

Percentage of Participants With Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Group 5 - Per-Protocol Population

Time frame: At the age of 13 months

Population: Analysis was performed on PPP. Here, 'Number analyzed'=participants with available data for specified category.

Arm	Measure	Group	Value (NUMBER)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Group 5 - Per-Protocol Population	Serogroup A: ≥1:8	74.6 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Group 5 - Per-Protocol Population	Serogroup A: ≥1:4	81.4 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Group 5 - Per-Protocol Population	Serogroup C: ≥1:4	96.7 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Group 5 - Per-Protocol Population	Serogroup C: ≥1:8	90.2 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Group 5 - Per-Protocol Population	Serogroup Y: ≥1:4	60.7 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Group 5 - Per-Protocol Population	Serogroup Y: ≥1:8	47.5 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Group 5 - Per-Protocol Population	Serogroup W-135: ≥1:4	69.5 percentage of participants
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Percentage of Participants With Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Group 5 - Per-Protocol Population	Serogroup W-135: ≥1:8	54.2 percentage of participants

Primary

Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population

Time frame: Groups 1, 3, 4, and 6: at the age of 13 months; Group 2 and 7: at the age of 16 months

Population: Booster PPP. Here, 'Number analyzed'=participants with available data for specified categories and '0' in number analyzed field signifies none of participants were evaluable at that specified time point because different groups had different planned data collection time points as defined in timeframe and pre-specified in protocol.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup A- at 13 months of age	137.9 titers (1/dilution)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup C- at 13 months of age	975.4 titers (1/dilution)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup Y- at 13 months of age	579.5 titers (1/dilution)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup W-135- at 13 months of age	1011.2 titers (1/dilution)
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup W-135- at 16 months of age	1389.8 titers (1/dilution)
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup Y- at 16 months of age	1024.0 titers (1/dilution)
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup C- at 16 months of age	1086.0 titers (1/dilution)
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup A- at 16 months of age	169.7 titers (1/dilution)
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup A- at 13 months of age	256.0 titers (1/dilution)
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup Y- at 13 months of age	642.2 titers (1/dilution)
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup W-135- at 13 months of age	769.7 titers (1/dilution)
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup C- at 13 months of age	691.7 titers (1/dilution)
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup Y- at 13 months of age	942.9 titers (1/dilution)
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup C- at 13 months of age	3164.8 titers (1/dilution)
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup W-135- at 13 months of age	826.3 titers (1/dilution)
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup A- at 13 months of age	406.4 titers (1/dilution)
Group 6: Control: 2, 4, 6, and 12 Months	Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup Y- at 13 months of age	32.9 titers (1/dilution)
Group 6: Control: 2, 4, 6, and 12 Months	Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup W-135- at 13 months of age	5.8 titers (1/dilution)
Group 6: Control: 2, 4, 6, and 12 Months	Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup A- at 13 months of age	5.3 titers (1/dilution)
Group 6: Control: 2, 4, 6, and 12 Months	Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup C- at 13 months of age	7.3 titers (1/dilution)
Group 7: Control: 2, 4, 6, 12, and 15 Months	Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup C- at 16 months of age	4.8 titers (1/dilution)
Group 7: Control: 2, 4, 6, 12, and 15 Months	Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup Y- at 16 months of age	43.3 titers (1/dilution)
Group 7: Control: 2, 4, 6, 12, and 15 Months	Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup W-135- at 16 months of age	6.3 titers (1/dilution)
Group 7: Control: 2, 4, 6, 12, and 15 Months	Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup A- at 16 months of age	4.0 titers (1/dilution)

Primary

Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population

Time frame: Groups 1, 2, 4, 6, and 7: at the age of 7 months; Group 3: at the age of 5 months

Population: Primary series PPP. 'Number analyzed'=participants with available data for specified categories and '0' in number analyzed field signifies none of the participants were evaluable at that specified time point because different groups had different planned data collection time points as defined in time frame and pre-specified in protocol.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup C- at 7 months of age	696.0 titers (1/dilution)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup Y- at 7 months of age	333.2 titers (1/dilution)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup W-135- at 7 months of age	655.8 titers (1/dilution)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup A- at 7 months of age	24.0 titers (1/dilution)
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup C- at 7 months of age	689.1 titers (1/dilution)
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup Y- at 7 months of age	530.8 titers (1/dilution)
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup A- at 7 months of age	27.5 titers (1/dilution)
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup W-135- at 7 months of age	781.7 titers (1/dilution)
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup A- at 5 months of age	26.2 titers (1/dilution)
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup C- at 5 months of age	807.8 titers (1/dilution)
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup Y- at 5 months of age	265.5 titers (1/dilution)
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup W-135- at 5 months of age	526.2 titers (1/dilution)
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup W-135- at 7 months of age	120.3 titers (1/dilution)
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup C- at 7 months of age	377.8 titers (1/dilution)
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup Y- at 7 months of age	53.2 titers (1/dilution)
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup A- at 7 months of age	17.7 titers (1/dilution)
Group 6: Control: 2, 4, 6, and 12 Months	Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup A- at 7 months of age	4.4 titers (1/dilution)
Group 6: Control: 2, 4, 6, and 12 Months	Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup C- at 7 months of age	4.3 titers (1/dilution)
Group 6: Control: 2, 4, 6, and 12 Months	Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup W-135- at 7 months of age	5.9 titers (1/dilution)
Group 6: Control: 2, 4, 6, and 12 Months	Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup Y- at 7 months of age	12.3 titers (1/dilution)
Group 7: Control: 2, 4, 6, 12, and 15 Months	Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup C- at 7 months of age	5.4 titers (1/dilution)
Group 7: Control: 2, 4, 6, 12, and 15 Months	Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup A- at 7 months of age	4.6 titers (1/dilution)
Group 7: Control: 2, 4, 6, 12, and 15 Months	Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup Y- at 7 months of age	13.1 titers (1/dilution)
Group 7: Control: 2, 4, 6, 12, and 15 Months	Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup W-135- at 7 months of age	5.9 titers (1/dilution)

Primary

Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers in Group 5: Per-Protocol Population

Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR.

Time frame: At the age of 13 months

Population: Analysis was performed on PPP. Here, 'Overall number of participants analyzed'=participants evaluable for this outcome measure.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers in Group 5: Per-Protocol Population	Serogroup A	42.6 titers (1/dilution)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers in Group 5: Per-Protocol Population	Serogroup C	403.1 titers (1/dilution)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers in Group 5: Per-Protocol Population	Serogroup Y	166.5 titers (1/dilution)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers in Group 5: Per-Protocol Population	Serogroup W-135	403.1 titers (1/dilution)

Primary

Serum Bactericidal Assay Using Human Complement Geometric Mean Titers (GMTs): Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population

Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. Primary series PPP was defined as the PPP which was used for reporting data of time points prior to 12 months of age.

Time frame: Groups 1, 2, 4, 6, and 7: at the age of 7 months, Group 3: at the age of 5 months

Population: Primary series PPP. Here, 'Number analyzed'=participants with available data for specified categories and '0' in number analyzed field signifies none of the participants were evaluable at that specified time point because different groups had different planned data collection time points as defined in time frame and pre-specified in protocol.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Serum Bactericidal Assay Using Human Complement Geometric Mean Titers (GMTs): Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup C- at 7 months of age	101.6 titers (1/dilution)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Serum Bactericidal Assay Using Human Complement Geometric Mean Titers (GMTs): Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup Y- at 7 months of age	33.8 titers (1/dilution)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Serum Bactericidal Assay Using Human Complement Geometric Mean Titers (GMTs): Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup W-135- at 7 months of age	50.8 titers (1/dilution)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Serum Bactericidal Assay Using Human Complement Geometric Mean Titers (GMTs): Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup A- at 7 months of age	14.8 titers (1/dilution)
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Serum Bactericidal Assay Using Human Complement Geometric Mean Titers (GMTs): Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup C- at 7 months of age	93.3 titers (1/dilution)
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Serum Bactericidal Assay Using Human Complement Geometric Mean Titers (GMTs): Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup Y- at 7 months of age	39.3 titers (1/dilution)
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Serum Bactericidal Assay Using Human Complement Geometric Mean Titers (GMTs): Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup A- at 7 months of age	16.1 titers (1/dilution)
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Serum Bactericidal Assay Using Human Complement Geometric Mean Titers (GMTs): Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup W-135- at 7 months of age	47.4 titers (1/dilution)
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Serum Bactericidal Assay Using Human Complement Geometric Mean Titers (GMTs): Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup A- at 5 months of age	16.3 titers (1/dilution)
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Serum Bactericidal Assay Using Human Complement Geometric Mean Titers (GMTs): Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup C- at 5 months of age	103.1 titers (1/dilution)
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Serum Bactericidal Assay Using Human Complement Geometric Mean Titers (GMTs): Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup Y- at 5 months of age	17.8 titers (1/dilution)
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Serum Bactericidal Assay Using Human Complement Geometric Mean Titers (GMTs): Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup W-135- at 5 months of age	23.4 titers (1/dilution)
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Serum Bactericidal Assay Using Human Complement Geometric Mean Titers (GMTs): Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup W-135- at 7 months of age	3.7 titers (1/dilution)
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Serum Bactericidal Assay Using Human Complement Geometric Mean Titers (GMTs): Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup C- at 7 months of age	40.2 titers (1/dilution)
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Serum Bactericidal Assay Using Human Complement Geometric Mean Titers (GMTs): Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup Y- at 7 months of age	3.3 titers (1/dilution)
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Serum Bactericidal Assay Using Human Complement Geometric Mean Titers (GMTs): Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup A- at 7 months of age	9.8 titers (1/dilution)
Group 6: Control: 2, 4, 6, and 12 Months	Serum Bactericidal Assay Using Human Complement Geometric Mean Titers (GMTs): Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup A- at 7 months of age	2.4 titers (1/dilution)
Group 6: Control: 2, 4, 6, and 12 Months	Serum Bactericidal Assay Using Human Complement Geometric Mean Titers (GMTs): Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup C- at 7 months of age	2.3 titers (1/dilution)
Group 6: Control: 2, 4, 6, and 12 Months	Serum Bactericidal Assay Using Human Complement Geometric Mean Titers (GMTs): Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup W-135- at 7 months of age	2.4 titers (1/dilution)
Group 6: Control: 2, 4, 6, and 12 Months	Serum Bactericidal Assay Using Human Complement Geometric Mean Titers (GMTs): Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup Y- at 7 months of age	2.4 titers (1/dilution)
Group 7: Control: 2, 4, 6, 12, and 15 Months	Serum Bactericidal Assay Using Human Complement Geometric Mean Titers (GMTs): Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup C- at 7 months of age	2.3 titers (1/dilution)
Group 7: Control: 2, 4, 6, 12, and 15 Months	Serum Bactericidal Assay Using Human Complement Geometric Mean Titers (GMTs): Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup A- at 7 months of age	2.5 titers (1/dilution)
Group 7: Control: 2, 4, 6, 12, and 15 Months	Serum Bactericidal Assay Using Human Complement Geometric Mean Titers (GMTs): Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup Y- at 7 months of age	2.3 titers (1/dilution)
Group 7: Control: 2, 4, 6, 12, and 15 Months	Serum Bactericidal Assay Using Human Complement Geometric Mean Titers (GMTs): Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population	Serogroup W-135- at 7 months of age	2.2 titers (1/dilution)

Primary

Serum Bactericidal Assay Using Human Complement Geometric Mean Titers: Group 5 - Per-Protocol Population

Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC.

Time frame: At the age of 13 months

Population: Analysis was performed on PPP. Here, 'Number analyzed'=participants with available data for specified category.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Serum Bactericidal Assay Using Human Complement Geometric Mean Titers: Group 5 - Per-Protocol Population	Serogroup A	13.1 titers (1/dilution)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Serum Bactericidal Assay Using Human Complement Geometric Mean Titers: Group 5 - Per-Protocol Population	Serogroup C	57.8 titers (1/dilution)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Serum Bactericidal Assay Using Human Complement Geometric Mean Titers: Group 5 - Per-Protocol Population	Serogroup Y	6.6 titers (1/dilution)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Serum Bactericidal Assay Using Human Complement Geometric Mean Titers: Group 5 - Per-Protocol Population	Serogroup W-135	6.5 titers (1/dilution)

Primary

Serum Bactericidal Assay Using Human Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population

Time frame: Groups 1, 3, 4, and 6: at the age of 13 months; Groups 2 and 7: at the age of 16 months

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Serum Bactericidal Assay Using Human Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup A- at 13 months of age	58.9 titers (1/dilution)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Serum Bactericidal Assay Using Human Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup C- at 13 months of age	271.5 titers (1/dilution)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Serum Bactericidal Assay Using Human Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup Y- at 13 months of age	253.0 titers (1/dilution)
Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months	Serum Bactericidal Assay Using Human Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup W-135- at 13 months of age	355.7 titers (1/dilution)
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Serum Bactericidal Assay Using Human Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup W-135- at 16 months of age	685.9 titers (1/dilution)
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Serum Bactericidal Assay Using Human Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup Y- at 16 months of age	469.5 titers (1/dilution)
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Serum Bactericidal Assay Using Human Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup C- at 16 months of age	272.9 titers (1/dilution)
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months	Serum Bactericidal Assay Using Human Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup A- at 16 months of age	76.1 titers (1/dilution)
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Serum Bactericidal Assay Using Human Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup A- at 13 months of age	98.2 titers (1/dilution)
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Serum Bactericidal Assay Using Human Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup Y- at 13 months of age	216.7 titers (1/dilution)
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Serum Bactericidal Assay Using Human Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup W-135- at 13 months of age	306.4 titers (1/dilution)
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months	Serum Bactericidal Assay Using Human Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup C- at 13 months of age	179.9 titers (1/dilution)
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Serum Bactericidal Assay Using Human Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup Y- at 13 months of age	396.3 titers (1/dilution)
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Serum Bactericidal Assay Using Human Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup C- at 13 months of age	641.8 titers (1/dilution)
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Serum Bactericidal Assay Using Human Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup W-135- at 13 months of age	384.5 titers (1/dilution)
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months	Serum Bactericidal Assay Using Human Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup A- at 13 months of age	151.1 titers (1/dilution)
Group 6: Control: 2, 4, 6, and 12 Months	Serum Bactericidal Assay Using Human Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup Y- at 13 months of age	2.3 titers (1/dilution)
Group 6: Control: 2, 4, 6, and 12 Months	Serum Bactericidal Assay Using Human Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup W-135- at 13 months of age	2.4 titers (1/dilution)
Group 6: Control: 2, 4, 6, and 12 Months	Serum Bactericidal Assay Using Human Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup A- at 13 months of age	2.7 titers (1/dilution)
Group 6: Control: 2, 4, 6, and 12 Months	Serum Bactericidal Assay Using Human Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup C- at 13 months of age	2.8 titers (1/dilution)
Group 7: Control: 2, 4, 6, 12, and 15 Months	Serum Bactericidal Assay Using Human Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup C- at 16 months of age	2.8 titers (1/dilution)
Group 7: Control: 2, 4, 6, 12, and 15 Months	Serum Bactericidal Assay Using Human Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup Y- at 16 months of age	2.3 titers (1/dilution)
Group 7: Control: 2, 4, 6, 12, and 15 Months	Serum Bactericidal Assay Using Human Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup W-135- at 16 months of age	2.2 titers (1/dilution)
Group 7: Control: 2, 4, 6, 12, and 15 Months	Serum Bactericidal Assay Using Human Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population	Serogroup A- at 16 months of age	2.8 titers (1/dilution)

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026

A Study of a Quadrivalent Meningococcal Tetanus Protein Conjugate Vaccine in Infants and Toddlers

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Outcome results

Antibody Titer/Concentration to All Antigens Contained in Pentacel Vaccines: Groups 2 and 7 - Booster Per-Protocol Population

Antibody Titer/Concentration to All the Antigens Contained in Pentacel Vaccines: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population

Geometric Mean Concentrations (GMCs) of Antibody Titers to Tetanus Toxoid: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population

Geometric Mean Concentrations of Antibodies to Tetanus Toxoid: Group 5 - Per-Protocol Population

Geometric Mean Concentrations of Antibodies to Tetanus Toxoid: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population

Geometric Mean Fold Rise (GMFR) in SBA-HC Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population

Geometric Mean Fold Rise in Serum Bactericidal Assay Using Baby Rabbit Complement Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population

Number of Participants With Immediate Unsolicited AE

Number of Participants With Solicited Injection Site Reactions

Number of Participants With Solicited Systemic Reactions

Number of Participants With Unsolicited Adverse Events

Percentage of Participants With ≥4-fold Rise in SBA-BR Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population

Percentage of Participants With ≥4-fold Rise in SBA-HC Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population

Percentage of Participants With an Serum Bactericidal Assay (SBA) Using Human Complement (SBA-HC) Titer Greater or Than Equal to (≥) 1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-protocol Population (PPP)

Percentage of Participants With an Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population

Percentage of Participants With Antibodies to All Antigens Contained in M-M-RII and VARIVAX Vaccines: Groups 1 and 6 - Booster Per-Protocol Population

Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Group 5- Per-Protocol Population

Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population

Percentage of Participants With Antibody Concentration ≥0.35 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population

Percentage of Participants With a Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population

Percentage of Participants With SBA-BR Pre-Booster Titer ≥1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titer After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population

Percentage of Participants With SBA-BR Pre-Booster Titer <1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titers After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population

Percentage of Participants With SBA-BR Pre-Vaccination Titer <1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titer After Vaccination: Group 5 - Per-Protocol Population

Percentage of Participants With SBA-BR Pre-Vaccination Titer ≥1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titer After Vaccination: Group 5 - Per-Protocol Population

Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Group 5 - Per-Protocol Population

Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population

Percentage of Participants With SBA-HC Pre-booster Titer ≥1:8 Who Then Achieved ≥4-Fold Rise in SBA-HC Titer After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population

Percentage of Participants With SBA-HC Pre-booster Titer Less Than (<) 1:8 Who Then Achieved ≥4-Fold Rise in SBA-HC After Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population

Percentage of Participants With SBA-HC Pre-vaccination Titer ≥1:8 Who Then Achieved ≥4-fold Rise in SBA-HC Titer After Vaccination: Group 5 - Per-Protocol Population

Percentage of Participants With SBA-HC Pre-Vaccination Titer <1:8 Who Then Achieved ≥4-Fold Rise in SBA-HC Titer After Vaccination: Group 5 - Per-Protocol Population

Percentage of Participants With Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Group 5 - Per-Protocol Population

Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population

Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population

Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers in Group 5: Per-Protocol Population

Serum Bactericidal Assay Using Human Complement Geometric Mean Titers (GMTs): Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population

Serum Bactericidal Assay Using Human Complement Geometric Mean Titers: Group 5 - Per-Protocol Population

Serum Bactericidal Assay Using Human Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population