Trial Outcomes & Findings for Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adults, Adolescents, Children, and Toddlers in India and Healthy Adolescents and Children in the Republic of South Africa (NCT NCT04143061)

Last Updated: 2025-02-03

Results Overview

Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured by serum bactericidal assay using human complement (hSBA). Percentages are rounded off to the tenth decimal place. As pre-specified in protocol, the endpoint was assessed in children and adolescents aged 2 to 17 years in India and RSA as combined groups: Group 5 + Group 7 and Group 6 + Group 8 as they received the same dose of MenACYW conjugate vaccine and Menactra® respectively.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1328 participants

Primary outcome timeframe

Day 30 (30 days post-vaccination on Day 0)

Results posted on

2025-02-03

Participant Flow

This study was conducted at 17 investigational sites: 10 centers in India and 7 centers in the Republic of South Africa (RSA) between 30 December 2019 and 28 January 2023.

A total of 1328 participants were enrolled and randomized in the study. Toddlers were not enrolled in this study.

Participant milestones

Participant milestones
Measure	Group 1: MenACYW Conjugate Vaccine Adult participants aged 18 to 55 years in India received a single dose of 0.5 milliliter (mL) meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine \[MenACYW conjugate vaccine\] as an intramuscular (IM) injection on Day 0.	Group 2: Menactra® Adult participants aged 18 to 55 years in India received a single dose of 0.5 mL meningococcal (groups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine \[Menactra®\] as an IM injection on Day 0.	Group 3: MenACYW Conjugate Vaccine Adult participants aged ≥56 years in India received a single dose of 0.5 mL MenACYW conjugate vaccine as an IM injection on Day 0.	Group 4: Quadri Meningo™/Locally Available Licensed Meningococcal Vaccine Adult participants aged ≥56 years in India received a single dose of 0.5 mL meningococcal polysaccharide vaccine (group A, C, Y and W135) \[Quadri Meningo™\] or any locally available licensed meningococcal vaccine as an IM injection on Day 0.	Group 5: MenACYW Conjugate Vaccine Children and adolescent participants aged 2 to 17 years in India received a single dose of 0.5 mL MenACYW conjugate vaccine as an IM injection on Day 0.	Group 6: Menactra® Children and adolescent participants aged 2 to 17 years in India received a single dose of 0.5 mL Menactra® as an IM injection on Day 0.	Group 7: MenACYW Conjugate Vaccine Children and adolescent participants aged 2 to 17 years in RSA received a single dose of 0.5 mL MenACYW conjugate vaccine as an IM injection on Day 0.	Group 8: Menactra® Children and adolescent participants aged 2 to 17 years in RSA received a single dose of 0.5 mL Menactra® as an IM injection on Day 0.
Overall Study STARTED	98	100	100	100	232	233	233	232
Overall Study COMPLETED	96	100	100	100	224	229	226	220
Overall Study NOT COMPLETED	2	0	0	0	8	4	7	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1: MenACYW Conjugate Vaccine Adult participants aged 18 to 55 years in India received a single dose of 0.5 milliliter (mL) meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine \[MenACYW conjugate vaccine\] as an intramuscular (IM) injection on Day 0.	Group 5: MenACYW Conjugate Vaccine Children and adolescent participants aged 2 to 17 years in India received a single dose of 0.5 mL MenACYW conjugate vaccine as an IM injection on Day 0.	Group 6: Menactra® Children and adolescent participants aged 2 to 17 years in India received a single dose of 0.5 mL Menactra® as an IM injection on Day 0.	Group 7: MenACYW Conjugate Vaccine Children and adolescent participants aged 2 to 17 years in RSA received a single dose of 0.5 mL MenACYW conjugate vaccine as an IM injection on Day 0.	Group 8: Menactra® Children and adolescent participants aged 2 to 17 years in RSA received a single dose of 0.5 mL Menactra® as an IM injection on Day 0.
Overall Study Protocol Deviation	0	0	0	5	5
Overall Study Withdrawal by Subject	2	0	1	0	0
Overall Study Withdrawal by Parent/Guardian	0	8	3	2	7

Baseline Characteristics

Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adults, Adolescents, Children, and Toddlers in India and Healthy Adolescents and Children in the Republic of South Africa

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1: MenACYW Conjugate Vaccine n=98 Participants Adult participants aged 18 to 55 years in India received a single dose of 0.5 mL MenACYW conjugate vaccine as an IM injection on Day 0.	Group 2: Menactra® n=100 Participants Adult participants aged 18 to 55 years in India received a single dose of 0.5 mL Menactra® as an IM injection on Day 0.	Group 3: MenACYW Conjugate Vaccine n=100 Participants Adult participants aged ≥56 years in India received a single dose of 0.5 mL MenACYW conjugate vaccine as an IM injection on Day 0.	Group 4: Quadri Meningo™/Locally Available Licensed Meningococcal Vaccine n=100 Participants Adult participants aged ≥56 years in India received a single dose of 0.5 mL Quadri Meningo™ or any locally available licensed meningococcal vaccine as an IM injection on Day 0.	Group 5: MenACYW Conjugate Vaccine n=232 Participants Children and adolescent participants aged 2 to 17 years in India received a single dose of 0.5 mL MenACYW conjugate vaccine as an IM injection on Day 0.	Group 6: Menactra® n=233 Participants Children and adolescent participants aged 2 to 17 years in India received a single dose of 0.5 mL Menactra® as an IM injection on Day 0.	Group 7: MenACYW Conjugate Vaccine n=233 Participants Children and adolescent participants aged 2 to 17 years in RSA received a single dose of 0.5 mL MenACYW conjugate vaccine as an IM injection on Day 0.	Group 8: Menactra® n=232 Participants Children and adolescent participants aged 2 to 17 years in RSA received a single dose of 0.5 mL Menactra® as an IM injection on Day 0.	Total n=1328 Participants Total of all reporting groups
Age, Continuous	36.7 years STANDARD_DEVIATION 9.21 • n=5 Participants	34.8 years STANDARD_DEVIATION 9.05 • n=7 Participants	61.7 years STANDARD_DEVIATION 6.09 • n=5 Participants	61.1 years STANDARD_DEVIATION 5.61 • n=4 Participants	9.39 years STANDARD_DEVIATION 4.19 • n=21 Participants	9.34 years STANDARD_DEVIATION 4.10 • n=8 Participants	9.45 years STANDARD_DEVIATION 4.01 • n=8 Participants	9.19 years STANDARD_DEVIATION 4.19 • n=24 Participants	21.1 years STANDARD_DEVIATION 20.1 • n=42 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	31 Participants n=7 Participants	24 Participants n=5 Participants	31 Participants n=4 Participants	101 Participants n=21 Participants	118 Participants n=8 Participants	123 Participants n=8 Participants	110 Participants n=24 Participants	568 Participants n=42 Participants
Sex: Female, Male Male	68 Participants n=5 Participants	69 Participants n=7 Participants	76 Participants n=5 Participants	69 Participants n=4 Participants	131 Participants n=21 Participants	115 Participants n=8 Participants	110 Participants n=8 Participants	122 Participants n=24 Participants	760 Participants n=42 Participants
Race/Ethnicity, Customized Asian	98 Participants n=5 Participants	100 Participants n=7 Participants	100 Participants n=5 Participants	100 Participants n=4 Participants	232 Participants n=21 Participants	233 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	863 Participants n=42 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	142 Participants n=8 Participants	139 Participants n=24 Participants	281 Participants n=42 Participants
Race/Ethnicity, Customized White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	9 Participants n=8 Participants	10 Participants n=24 Participants	19 Participants n=42 Participants
Race/Ethnicity, Customized Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	6 Participants n=8 Participants	3 Participants n=24 Participants	9 Participants n=42 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	6 Participants n=8 Participants	9 Participants n=24 Participants	15 Participants n=42 Participants
Race/Ethnicity, Customized Mixed Origin	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	70 Participants n=8 Participants	71 Participants n=24 Participants	141 Participants n=42 Participants

PRIMARY outcome

Timeframe: Day 30 (30 days post-vaccination on Day 0)

Population: Analysis was performed on the per-protocol analysis set (PPAS) which was a subset of the full analysis set (FAS). The FAS was the subset of randomized participants who received at least 1 dose of the study vaccine and had a valid post-vaccination blood sample result. Only participants with data collected for each specific serogroup are reported.

Outcome measures

Outcome measures
Measure	Group 5 + Group 7: MenACYW Conjugate Vaccine n=445 Participants Children and adolescent participants aged 2 to 17 years in India and RSA received a single dose of 0.5 mL MenACYW conjugate vaccine as an IM injection on Day 0.	Group 6 + Group 8: Menactra® n=445 Participants Children and adolescent participants aged 2 to 17 years in India and RSA received a single dose of 0.5 mL Menactra® as an IM injection on Day 0.
Group 5 + 7 and Group 6 + 8: Percentage of Participants Who Achieved Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W Serogroup A	89.6 percentage of participants Interval 86.4 to 92.3	83.1 percentage of participants Interval 79.2 to 86.4
Group 5 + 7 and Group 6 + 8: Percentage of Participants Who Achieved Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W Serogroup C	99.3 percentage of participants Interval 98.0 to 99.9	77.7 percentage of participants Interval 73.5 to 81.4
Group 5 + 7 and Group 6 + 8: Percentage of Participants Who Achieved Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W Serogroup Y	96.6 percentage of participants Interval 94.5 to 98.1	85.6 percentage of participants Interval 81.9 to 88.7
Group 5 + 7 and Group 6 + 8: Percentage of Participants Who Achieved Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W Serogroup W	98.7 percentage of participants Interval 97.1 to 99.5	87.6 percentage of participants Interval 84.2 to 90.6

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)

Population: Analysis was performed on the PPAS which was a subset of the FAS. The FAS was the subset of randomized participants who received at least 1 dose of the study vaccine and had a valid post-vaccination blood sample result. Only participants with data collected for each specific serogroup at specified timepoints are reported.

Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured by hSBA and serum bactericidal assay using baby rabbit complement (rSBA).

Outcome measures

Outcome measures
Measure	Group 5 + Group 7: MenACYW Conjugate Vaccine n=95 Participants Children and adolescent participants aged 2 to 17 years in India and RSA received a single dose of 0.5 mL MenACYW conjugate vaccine as an IM injection on Day 0.	Group 6 + Group 8: Menactra® n=99 Participants Children and adolescent participants aged 2 to 17 years in India and RSA received a single dose of 0.5 mL Menactra® as an IM injection on Day 0.
Group 1 and Group 2: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup A: Day 0	7.28 titer Interval 6.03 to 8.78	9.60 titer Interval 7.68 to 12.0
Group 1 and Group 2: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup A: Day 30	52.8 titer Interval 34.7 to 80.3	39.2 titer Interval 27.8 to 55.3
Group 1 and Group 2: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup C: Day 0	6.20 titer Interval 4.99 to 7.7	7.05 titer Interval 5.53 to 8.99
Group 1 and Group 2: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup C: Day 30	551 titer Interval 365.0 to 831.0	107 titer Interval 68.8 to 165.0
Group 1 and Group 2: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup Y: Day 0	5.24 titer Interval 3.86 to 7.11	4.03 titer Interval 3.09 to 5.25
Group 1 and Group 2: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup Y: Day 30	119 titer Interval 80.2 to 177.0	47.4 titer Interval 30.7 to 73.1
Group 1 and Group 2: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup W: Day 0	4.18 titer Interval 3.39 to 5.15	4.17 titer Interval 3.39 to 5.14
Group 1 and Group 2: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup W: Day 30	106 titer Interval 72.8 to 153.0	63.1 titer Interval 44.7 to 89.1
Group 1 and Group 2: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup A: Day 0	194 titer Interval 81.3 to 463.0	64.0 titer Interval 25.9 to 158.0
Group 1 and Group 2: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup A: Day 30	10644 titer Interval 7745.0 to 14629.0	4467 titer Interval 3428.0 to 5820.0
Group 1 and Group 2: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup C: Day 0	5.88 titer Interval 3.51 to 9.86	4.88 titer Interval 3.0 to 7.93
Group 1 and Group 2: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup C: Day 30	12227 titer Interval 7923.0 to 18868.0	1149 titer Interval 612.0 to 2158.0
Group 1 and Group 2: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup Y: Day 0	9.36 titer Interval 4.33 to 20.2	9.40 titer Interval 4.12 to 21.5
Group 1 and Group 2: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup Y: Day 30	5934 titer Interval 3758.0 to 9372.0	3534 titer Interval 2545.0 to 4909.0
Group 1 and Group 2: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup W: Day 0	15.5 titer Interval 6.49 to 37.1	7.56 titer Interval 3.49 to 16.4
Group 1 and Group 2: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup W: Day 30	16638 titer Interval 10325.0 to 26812.0	7732 titer Interval 4098.0 to 14589.0

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)

Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured by hSBA and rSBA. Percentages are rounded off to the tenth decimal place. Percentage of participants who achieved antibody titers ≥1:4 and ≥1:8 by hSBA and ≥1:8 and ≥1:128 by rSBA are reported.

Outcome measures

Outcome measures
Measure	Group 5 + Group 7: MenACYW Conjugate Vaccine n=95 Participants Children and adolescent participants aged 2 to 17 years in India and RSA received a single dose of 0.5 mL MenACYW conjugate vaccine as an IM injection on Day 0.	Group 6 + Group 8: Menactra® n=99 Participants Children and adolescent participants aged 2 to 17 years in India and RSA received a single dose of 0.5 mL Menactra® as an IM injection on Day 0.
Group 1 and Group 2: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup A: Day 0: ≥1:4	81.1 percentage of participants Interval 71.7 to 88.4	87.9 percentage of participants Interval 79.8 to 93.6
Group 1 and Group 2: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup A: Day 0: ≥1:8	61.1 percentage of participants Interval 50.5 to 70.9	72.7 percentage of participants Interval 62.9 to 81.2
Group 1 and Group 2: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup A: Day 30: ≥1:4	87.2 percentage of participants Interval 78.8 to 93.2	93.9 percentage of participants Interval 87.3 to 97.7
Group 1 and Group 2: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup A: Day 30: ≥1:8	76.6 percentage of participants Interval 66.7 to 84.7	87.9 percentage of participants Interval 79.8 to 93.6
Group 1 and Group 2: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup C: Day 0: ≥1:4	69.5 percentage of participants Interval 59.2 to 78.5	69.7 percentage of participants Interval 59.6 to 78.5
Group 1 and Group 2: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup C: Day 0: ≥1:8	47.4 percentage of participants Interval 37.0 to 57.9	50.5 percentage of participants Interval 40.3 to 60.7
Group 1 and Group 2: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup C: Day 30: ≥1:4	98.9 percentage of participants Interval 94.3 to 100.0	93.9 percentage of participants Interval 87.3 to 97.7
Group 1 and Group 2: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup C: Day 30: ≥1:8	96.8 percentage of participants Interval 91.0 to 99.3	88.9 percentage of participants Interval 81.0 to 94.3
Group 1 and Group 2: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup Y: Day 0: ≥1:4	38.9 percentage of participants Interval 29.1 to 49.5	30.3 percentage of participants Interval 21.5 to 40.4
Group 1 and Group 2: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup Y: Day 0: ≥1:8	29.5 percentage of participants Interval 20.6 to 39.7	24.2 percentage of participants Interval 16.2 to 33.9
Group 1 and Group 2: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup Y: Day 30: ≥1:4	93.7 percentage of participants Interval 86.8 to 97.6	82.8 percentage of participants Interval 73.9 to 89.7
Group 1 and Group 2: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup Y: Day 30: ≥1:8	92.6 percentage of participants Interval 85.4 to 97.0	76.8 percentage of participants Interval 67.2 to 84.7
Group 1 and Group 2: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup W: Day 0: ≥1:4	44.2 percentage of participants Interval 34.0 to 54.8	44.4 percentage of participants Interval 34.5 to 54.8
Group 1 and Group 2: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup W: Day 0: ≥1:8	29.5 percentage of participants Interval 20.6 to 39.7	29.3 percentage of participants Interval 20.6 to 39.3
Group 1 and Group 2: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup W: Day 30: ≥1:4	96.8 percentage of participants Interval 91.0 to 99.3	96.0 percentage of participants Interval 90.0 to 98.9
Group 1 and Group 2: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup W: Day 30: ≥1:8	93.6 percentage of participants Interval 86.6 to 97.6	90.9 percentage of participants Interval 83.4 to 95.8
Group 1 and Group 2: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup A: Day 0: ≥1:8	75.6 percentage of participants Interval 60.5 to 87.1	61.7 percentage of participants Interval 46.4 to 75.5
Group 1 and Group 2: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup A: Day 0: ≥1:128	62.2 percentage of participants Interval 46.5 to 76.2	48.9 percentage of participants Interval 34.1 to 63.9
Group 1 and Group 2: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup A: Day 30: ≥1:8	100 percentage of participants Interval 92.1 to 100.0	100 percentage of participants Interval 92.6 to 100.0
Group 1 and Group 2: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup A: Day 30: ≥1:128	100 percentage of participants Interval 92.1 to 100.0	100 percentage of participants Interval 92.6 to 100.0
Group 1 and Group 2: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup C: Day 0: ≥1:8	28.9 percentage of participants Interval 16.4 to 44.3	24.5 percentage of participants Interval 13.3 to 38.9
Group 1 and Group 2: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup C: Day 0: ≥1:128	11.1 percentage of participants Interval 3.7 to 24.1	10.2 percentage of participants Interval 3.4 to 22.2
Group 1 and Group 2: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup C: Day 30: ≥1:8	100 percentage of participants Interval 92.1 to 100.0	95.8 percentage of participants Interval 85.7 to 99.5
Group 1 and Group 2: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup C: Day 30: ≥1:128	100 percentage of participants Interval 92.1 to 100.0	89.6 percentage of participants Interval 77.3 to 96.5
Group 1 and Group 2: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup Y: Day 0: ≥1:8	29.5 percentage of participants Interval 16.8 to 45.2	25.6 percentage of participants Interval 13.5 to 41.2
Group 1 and Group 2: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup Y: Day 0: ≥1:128	25.0 percentage of participants Interval 13.2 to 40.3	23.3 percentage of participants Interval 11.8 to 38.6
Group 1 and Group 2: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup Y: Day 30: ≥1:8	97.7 percentage of participants Interval 87.7 to 99.9	100 percentage of participants Interval 92.5 to 100.0
Group 1 and Group 2: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup Y: Day 30: ≥1:128	97.7 percentage of participants Interval 87.7 to 99.9	100 percentage of participants Interval 92.5 to 100.0
Group 1 and Group 2: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup W: Day 0: ≥1:8	35.6 percentage of participants Interval 21.9 to 51.2	20.4 percentage of participants Interval 10.2 to 34.3
Group 1 and Group 2: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup W: Day 0: ≥1:128	31.1 percentage of participants Interval 18.2 to 46.6	20.4 percentage of participants Interval 10.2 to 34.3
Group 1 and Group 2: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup W: Day 30: ≥1:8	100 percentage of participants Interval 92.1 to 100.0	97.9 percentage of participants Interval 88.9 to 99.9
Group 1 and Group 2: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup W: Day 30: ≥1:128	100 percentage of participants Interval 92.1 to 100.0	97.9 percentage of participants Interval 88.9 to 99.9

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)

Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured by hSBA and rSBA.

Outcome measures

Outcome measures
Measure	Group 5 + Group 7: MenACYW Conjugate Vaccine n=97 Participants Children and adolescent participants aged 2 to 17 years in India and RSA received a single dose of 0.5 mL MenACYW conjugate vaccine as an IM injection on Day 0.	Group 6 + Group 8: Menactra® n=96 Participants Children and adolescent participants aged 2 to 17 years in India and RSA received a single dose of 0.5 mL Menactra® as an IM injection on Day 0.
Group 3 and Group 4: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup A: Day 0	83.0 titer Interval 37.0 to 186.0	46.3 titer Interval 20.1 to 106.0
Group 3 and Group 4: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup A: Day 0	15.3 titer Interval 12.2 to 19.3	12.5 titer Interval 10.2 to 15.4
Group 3 and Group 4: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup A: Day 30	56.6 titer Interval 38.2 to 83.9	36.2 titer Interval 26.8 to 48.8
Group 3 and Group 4: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup C: Day 0	8.00 titer Interval 6.18 to 10.4	8.00 titer Interval 6.13 to 10.4
Group 3 and Group 4: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup C: Day 30	393 titer Interval 255.0 to 606.0	159 titer Interval 102.0 to 248.0
Group 3 and Group 4: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup Y: Day 0	6.36 titer Interval 4.57 to 8.86	6.97 titer Interval 5.03 to 9.68
Group 3 and Group 4: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup Y: Day 30	197 titer Interval 127.0 to 303.0	55.4 titer Interval 35.5 to 86.4
Group 3 and Group 4: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup W: Day 0	4.42 titer Interval 3.53 to 5.54	5.66 titer Interval 4.4 to 7.27
Group 3 and Group 4: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup W: Day 30	90.8 titer Interval 60.4 to 137.0	34.6 titer Interval 23.5 to 51.2
Group 3 and Group 4: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup A: Day 30	5834 titer Interval 3730.0 to 9124.0	4677 titer Interval 2935.0 to 7455.0
Group 3 and Group 4: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup C: Day 0	6.47 titer Interval 3.69 to 11.3	5.53 titer Interval 3.06 to 9.99
Group 3 and Group 4: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup C: Day 30	9304 titer Interval 5532.0 to 15649.0	3283 titer Interval 1680.0 to 6415.0
Group 3 and Group 4: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup Y: Day 0	6.86 titer Interval 3.33 to 14.1	8.24 titer Interval 3.94 to 17.3
Group 3 and Group 4: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup Y: Day 30	4274 titer Interval 2640.0 to 6917.0	1119 titer Interval 529.0 to 2366.0
Group 3 and Group 4: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup W: Day 0	11.6 titer Interval 5.55 to 24.4	12.4 titer Interval 5.04 to 30.4
Group 3 and Group 4: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup W: Day 30	6626 titer Interval 3243.0 to 13539.0	2304 titer Interval 925.0 to 5739.0

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)

Outcome measures

Outcome measures
Measure	Group 5 + Group 7: MenACYW Conjugate Vaccine n=97 Participants Children and adolescent participants aged 2 to 17 years in India and RSA received a single dose of 0.5 mL MenACYW conjugate vaccine as an IM injection on Day 0.	Group 6 + Group 8: Menactra® n=96 Participants Children and adolescent participants aged 2 to 17 years in India and RSA received a single dose of 0.5 mL Menactra® as an IM injection on Day 0.
Group 3 and Group 4: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup Y: Day 30: ≥1:8	98.0 percentage of participants Interval 89.1 to 99.9	89.4 percentage of participants Interval 76.9 to 96.5
Group 3 and Group 4: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup Y: Day 30: ≥1:128	98.0 percentage of participants Interval 89.1 to 99.9	89.4 percentage of participants Interval 76.9 to 96.5
Group 3 and Group 4: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup W: Day 0: ≥1:8	33.3 percentage of participants Interval 20.4 to 48.4	30.4 percentage of participants Interval 17.7 to 45.8
Group 3 and Group 4: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup W: Day 0: ≥1:128	31.3 percentage of participants Interval 18.7 to 46.3	28.3 percentage of participants Interval 16.0 to 43.5
Group 3 and Group 4: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup W: Day 30: ≥1:8	95.9 percentage of participants Interval 86.0 to 99.5	89.4 percentage of participants Interval 76.9 to 96.5
Group 3 and Group 4: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup W: Day 30: ≥1:128	93.9 percentage of participants Interval 83.1 to 98.7	87.2 percentage of participants Interval 74.3 to 95.2
Group 3 and Group 4: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup A: Day 0: ≥1:4	94.8 percentage of participants Interval 88.4 to 98.3	93.8 percentage of participants Interval 86.9 to 97.7
Group 3 and Group 4: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup A: Day 0: ≥1:8	82.5 percentage of participants Interval 73.4 to 89.4	77.1 percentage of participants Interval 67.4 to 85.0
Group 3 and Group 4: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup A: Day 30: ≥1:4	89.6 percentage of participants Interval 81.7 to 94.9	96.9 percentage of participants Interval 91.1 to 99.4
Group 3 and Group 4: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup A: Day 30: ≥1:8	82.3 percentage of participants Interval 73.2 to 89.3	86.5 percentage of participants Interval 78.0 to 92.6
Group 3 and Group 4: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup C: Day 0: ≥1:4	71.1 percentage of participants Interval 61.0 to 79.9	75.0 percentage of participants Interval 65.1 to 83.3
Group 3 and Group 4: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup C: Day 0: ≥1:8	53.6 percentage of participants Interval 43.2 to 63.8	50.0 percentage of participants Interval 39.6 to 60.4
Group 3 and Group 4: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup C: Day 30: ≥1:4	97.9 percentage of participants Interval 92.7 to 99.7	92.7 percentage of participants Interval 85.6 to 97.0
Group 3 and Group 4: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup C: Day 30: ≥1:8	95.9 percentage of participants Interval 89.8 to 98.9	89.6 percentage of participants Interval 81.7 to 94.9
Group 3 and Group 4: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup Y: Day 0: ≥1:4	45.4 percentage of participants Interval 35.2 to 55.8	51.0 percentage of participants Interval 40.6 to 61.4
Group 3 and Group 4: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup Y: Day 0: ≥1:8	36.1 percentage of participants Interval 26.6 to 46.5	40.6 percentage of participants Interval 30.7 to 51.1
Group 3 and Group 4: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup Y: Day 30: ≥1:4	93.8 percentage of participants Interval 87.0 to 97.7	83.3 percentage of participants Interval 74.4 to 90.2
Group 3 and Group 4: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup Y: Day 30: ≥1:8	93.8 percentage of participants Interval 87.0 to 97.7	79.2 percentage of participants Interval 69.7 to 86.8
Group 3 and Group 4: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup W: Day 0: ≥1:4	45.4 percentage of participants Interval 35.2 to 55.8	54.2 percentage of participants Interval 43.7 to 64.4
Group 3 and Group 4: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup W: Day 0: ≥1:8	30.9 percentage of participants Interval 21.9 to 41.1	38.5 percentage of participants Interval 28.8 to 49.0
Group 3 and Group 4: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup W: Day 30: ≥1:4	91.8 percentage of participants Interval 84.4 to 96.4	90.6 percentage of participants Interval 82.9 to 95.6
Group 3 and Group 4: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup W: Day 30: ≥1:8	89.7 percentage of participants Interval 81.9 to 94.9	79.2 percentage of participants Interval 69.7 to 86.8
Group 3 and Group 4: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup A: Day 0: ≥1:8	68.8 percentage of participants Interval 53.7 to 81.3	55.3 percentage of participants Interval 40.1 to 69.8
Group 3 and Group 4: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup A: Day 0: ≥1:128	56.3 percentage of participants Interval 41.2 to 70.5	46.8 percentage of participants Interval 32.1 to 61.9
Group 3 and Group 4: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup A: Day 30: ≥1:8	98.0 percentage of participants Interval 89.1 to 99.9	100 percentage of participants Interval 92.5 to 100.0
Group 3 and Group 4: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup A: Day 30: ≥1:128	98.0 percentage of participants Interval 89.1 to 99.9	97.9 percentage of participants Interval 88.7 to 99.9
Group 3 and Group 4: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup C: Day 0: ≥1:8	30.6 percentage of participants Interval 18.3 to 45.4	21.3 percentage of participants Interval 10.7 to 35.7
Group 3 and Group 4: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup C: Day 0: ≥1:128	16.3 percentage of participants Interval 7.3 to 29.7	10.6 percentage of participants Interval 3.5 to 23.1
Group 3 and Group 4: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup C: Day 30: ≥1:8	98.0 percentage of participants Interval 89.1 to 99.9	93.6 percentage of participants Interval 82.5 to 98.7
Group 3 and Group 4: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup C: Day 30: ≥1:128	98.0 percentage of participants Interval 89.1 to 99.9	93.6 percentage of participants Interval 82.5 to 98.7
Group 3 and Group 4: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup Y: Day 0: ≥1:8	20.0 percentage of participants Interval 9.6 to 34.6	26.1 percentage of participants Interval 14.3 to 41.1
Group 3 and Group 4: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup Y: Day 0: ≥1:128	20.0 percentage of participants Interval 9.6 to 34.6	21.7 percentage of participants Interval 10.9 to 36.4

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)

Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured by hSBA and rSBA. As pre-specified in protocol, the endpoint was assessed in children and adolescents aged 2 to 17 years in India and RSA as combined groups: Group 5 + Group 7 and Group 6 + Group 8 as they received the same dose of MenACYW conjugate vaccine and Menactra® respectively.

Outcome measures

Outcome measures
Measure	Group 5 + Group 7: MenACYW Conjugate Vaccine n=445 Participants Children and adolescent participants aged 2 to 17 years in India and RSA received a single dose of 0.5 mL MenACYW conjugate vaccine as an IM injection on Day 0.	Group 6 + Group 8: Menactra® n=445 Participants Children and adolescent participants aged 2 to 17 years in India and RSA received a single dose of 0.5 mL Menactra® as an IM injection on Day 0.
Group 5 + 7 and Group 6 + 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup A: Day 0	7.40 titer Interval 6.79 to 8.07	7.21 titer Interval 6.66 to 7.8
Group 5 + 7 and Group 6 + 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup A: Day 30	56.1 titer Interval 48.5 to 65.0	36.3 titer Interval 31.0 to 42.5
Group 5 + 7 and Group 6 + 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup C: Day 0	3.97 titer Interval 3.63 to 4.34	3.78 titer Interval 3.46 to 4.13
Group 5 + 7 and Group 6 + 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup C: Day 30	600 titer Interval 521.0 to 692.0	47.3 titer Interval 38.3 to 58.4
Group 5 + 7 and Group 6 + 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup Y: Day 0	3.50 titer Interval 3.13 to 3.91	3.50 titer Interval 3.14 to 3.91
Group 5 + 7 and Group 6 + 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup Y: Day 30	167 titer Interval 145.0 to 191.0	46.2 titer Interval 39.3 to 54.3
Group 5 + 7 and Group 6 + 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup W: Day 0	4.31 titer Interval 3.88 to 4.78	4.04 titer Interval 3.65 to 4.48
Group 5 + 7 and Group 6 + 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup W: Day 30	121 titer Interval 106.0 to 137.0	35.4 titer Interval 30.4 to 41.1
Group 5 + 7 and Group 6 + 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup A: Day 0	308 titer Interval 199.0 to 478.0	387 titer Interval 260.0 to 577.0
Group 5 + 7 and Group 6 + 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup A: Day 30	10561 titer Interval 9223.0 to 12094.0	8313 titer Interval 7275.0 to 9499.0
Group 5 + 7 and Group 6 + 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup C: Day 0	3.56 titer Interval 2.91 to 4.36	3.73 titer Interval 3.02 to 4.62
Group 5 + 7 and Group 6 + 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup C: Day 30	14430 titer Interval 11923.0 to 17463.0	1199 titer Interval 869.0 to 1655.0
Group 5 + 7 and Group 6 + 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup Y: Day 0	17.3 titer Interval 11.5 to 26.2	21.9 titer Interval 14.4 to 33.4
Group 5 + 7 and Group 6 + 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup Y: Day 30	15404 titer Interval 13409.0 to 17696.0	5966 titer Interval 4850.0 to 7339.0
Group 5 + 7 and Group 6 + 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup W: Day 0	7.01 titer Interval 5.0 to 9.83	7.46 titer Interval 5.36 to 10.4
Group 5 + 7 and Group 6 + 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup W: Day 30	19644 titer Interval 16338.0 to 23618.0	6598 titer Interval 5160.0 to 8437.0

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)

Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured by hSBA and rSBA.

Outcome measures

Outcome measures
Measure	Group 5 + Group 7: MenACYW Conjugate Vaccine n=222 Participants Children and adolescent participants aged 2 to 17 years in India and RSA received a single dose of 0.5 mL MenACYW conjugate vaccine as an IM injection on Day 0.	Group 6 + Group 8: Menactra® n=228 Participants Children and adolescent participants aged 2 to 17 years in India and RSA received a single dose of 0.5 mL Menactra® as an IM injection on Day 0.
Group 5 and Group 6: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup A: Day 0	7.33 titer Interval 6.5 to 8.26	7.71 titer Interval 6.94 to 8.58
Group 5 and Group 6: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup A: Day 30	70.3 titer Interval 56.5 to 87.6	40.9 titer Interval 32.8 to 51.1
Group 5 and Group 6: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup C: Day 0	3.36 titer Interval 3.0 to 3.76	3.17 titer Interval 2.84 to 3.55
Group 5 and Group 6: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup C: Day 30	595 titer Interval 494.0 to 716.0	38.3 titer Interval 28.4 to 51.6
Group 5 and Group 6: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup Y: Day 0	3.32 titer Interval 2.84 to 3.88	3.12 titer Interval 2.7 to 3.6
Group 5 and Group 6: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup Y: Day 30	119 titer Interval 97.4 to 145.0	27.1 titer Interval 21.7 to 33.8
Group 5 and Group 6: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup W: Day 0	3.23 titer Interval 2.86 to 3.65	2.85 titer Interval 2.56 to 3.17
Group 5 and Group 6: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup W: Day 30	92.8 titer Interval 78.7 to 109.0	24.3 titer Interval 19.8 to 29.7
Group 5 and Group 6: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup A: Day 0	159 titer Interval 81.9 to 310.0	337 titer Interval 188.0 to 605.0
Group 5 and Group 6: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup A: Day 30	11462 titer Interval 9425.0 to 13938.0	6877 titer Interval 5755.0 to 8217.0
Group 5 and Group 6: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup C: Day 0	3.09 titer Interval 2.39 to 4.01	2.98 titer Interval 2.4 to 3.7
Group 5 and Group 6: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup C: Day 30	11139 titer Interval 8843.0 to 14030.0	659 titer Interval 413.0 to 1052.0
Group 5 and Group 6: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup Y: Day 0	11.4 titer Interval 6.25 to 20.6	18.8 titer Interval 10.4 to 33.7
Group 5 and Group 6: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup Y: Day 30	15696 titer Interval 12565.0 to 19609.0	4522 titer Interval 3316.0 to 6168.0
Group 5 and Group 6: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup W: Day 0	6.62 titer Interval 4.1 to 10.7	7.78 titer Interval 4.78 to 12.7
Group 5 and Group 6: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup W: Day 30	19037 titer Interval 14748.0 to 24572.0	4332 titer Interval 2969.0 to 6320.0

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)

Outcome measures

Outcome measures
Measure	Group 5 + Group 7: MenACYW Conjugate Vaccine n=222 Participants Children and adolescent participants aged 2 to 17 years in India and RSA received a single dose of 0.5 mL MenACYW conjugate vaccine as an IM injection on Day 0.	Group 6 + Group 8: Menactra® n=228 Participants Children and adolescent participants aged 2 to 17 years in India and RSA received a single dose of 0.5 mL Menactra® as an IM injection on Day 0.
Group 5 and Group 6: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup A: Day 0: ≥1:4	85.1 percentage of participants Interval 79.8 to 89.5	91.2 percentage of participants Interval 86.8 to 94.6
Group 5 and Group 6: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup A: Day 0: ≥1:8	60.8 percentage of participants Interval 54.1 to 67.3	63.6 percentage of participants Interval 57.0 to 69.8
Group 5 and Group 6: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup A: Day 30: ≥1:4	92.3 percentage of participants Interval 87.9 to 95.4	94.7 percentage of participants Interval 91.0 to 97.3
Group 5 and Group 6: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup A: Day 30: ≥1:8	89.5 percentage of participants Interval 84.7 to 93.3	83.8 percentage of participants Interval 78.3 to 88.3
Group 5 and Group 6: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup C: Day 0: ≥1:4	37.8 percentage of participants Interval 31.4 to 44.6	30.7 percentage of participants Interval 24.8 to 37.1
Group 5 and Group 6: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup C: Day 0: ≥1:8	19.8 percentage of participants Interval 14.8 to 25.7	18.4 percentage of participants Interval 13.6 to 24.1
Group 5 and Group 6: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup C: Day 30: ≥1:4	99.5 percentage of participants Interval 97.5 to 100.0	82.9 percentage of participants Interval 77.4 to 87.5
Group 5 and Group 6: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup C: Day 30: ≥1:8	99.5 percentage of participants Interval 97.5 to 100.0	72.8 percentage of participants Interval 66.5 to 78.5
Group 5 and Group 6: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup Y: Day 0: ≥1:4	21.2 percentage of participants Interval 16.0 to 27.1	18.9 percentage of participants Interval 14.0 to 24.6
Group 5 and Group 6: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup Y: Day 0: ≥1:8	16.2 percentage of participants Interval 11.6 to 21.7	13.6 percentage of participants Interval 9.4 to 18.7
Group 5 and Group 6: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup Y: Day 30: ≥1:4	94.1 percentage of participants Interval 90.2 to 96.8	83.8 percentage of participants Interval 78.3 to 88.3
Group 5 and Group 6: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup Y: Day 30: ≥1:8	93.7 percentage of participants Interval 89.6 to 96.5	76.8 percentage of participants Interval 70.7 to 82.1
Group 5 and Group 6: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup W: Day 0: ≥1:4	27.9 percentage of participants Interval 22.1 to 34.3	20.2 percentage of participants Interval 15.2 to 26.0
Group 5 and Group 6: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup W: Day 0: ≥1:8	18.9 percentage of participants Interval 14.0 to 24.7	13.6 percentage of participants Interval 9.4 to 18.7
Group 5 and Group 6: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup W: Day 30: ≥1:4	99.1 percentage of participants Interval 96.8 to 99.9	86.8 percentage of participants Interval 81.8 to 90.9
Group 5 and Group 6: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup W: Day 30: ≥1:8	98.2 percentage of participants Interval 95.5 to 99.5	82.0 percentage of participants Interval 76.4 to 86.8
Group 5 and Group 6: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup A: Day 0: ≥1:8	66.3 percentage of participants Interval 55.7 to 75.8	76.5 percentage of participants Interval 66.9 to 84.5
Group 5 and Group 6: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup A: Day 0: ≥1:128	62.0 percentage of participants Interval 51.2 to 71.9	73.5 percentage of participants Interval 63.6 to 81.9
Group 5 and Group 6: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup A: Day 30: ≥1:8	100 percentage of participants Interval 96.3 to 100.0	100 percentage of participants Interval 96.3 to 100.0
Group 5 and Group 6: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup A: Day 30: ≥1:128	100 percentage of participants Interval 96.3 to 100.0	100 percentage of participants Interval 96.3 to 100.0
Group 5 and Group 6: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup C: Day 0: ≥1:8	11.3 percentage of participants Interval 5.8 to 19.4	13.1 percentage of participants Interval 7.2 to 21.4
Group 5 and Group 6: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup C: Day 0: ≥1:128	5.2 percentage of participants Interval 1.7 to 11.6	4.0 percentage of participants Interval 1.1 to 10.0
Group 5 and Group 6: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup C: Day 30: ≥1:8	100 percentage of participants Interval 96.3 to 100.0	90.9 percentage of participants Interval 83.4 to 95.8
Group 5 and Group 6: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup C: Day 30: ≥1:128	100 percentage of participants Interval 96.3 to 100.0	85.9 percentage of participants Interval 77.4 to 92.0
Group 5 and Group 6: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup Y: Day 0: ≥1:8	28.7 percentage of participants Interval 19.5 to 39.4	40.7 percentage of participants Interval 30.5 to 51.5
Group 5 and Group 6: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup Y: Day 0: ≥1:128	28.7 percentage of participants Interval 19.5 to 39.4	38.5 percentage of participants Interval 28.4 to 49.2
Group 5 and Group 6: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup Y: Day 30: ≥1:8	100 percentage of participants Interval 96.3 to 100.0	98.0 percentage of participants Interval 92.8 to 99.8
Group 5 and Group 6: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup Y: Day 30: ≥1:128	100 percentage of participants Interval 96.3 to 100.0	98.0 percentage of participants Interval 92.8 to 99.8
Group 5 and Group 6: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup W: Day 0: ≥1:8	21.1 percentage of participants Interval 13.4 to 30.6	24.5 percentage of participants Interval 16.4 to 34.2
Group 5 and Group 6: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup W: Day 0: ≥1:128	21.1 percentage of participants Interval 13.4 to 30.6	24.5 percentage of participants Interval 16.4 to 34.2
Group 5 and Group 6: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup W: Day 30: ≥1:8	100 percentage of participants Interval 96.3 to 100.0	98.0 percentage of participants Interval 92.9 to 99.8
Group 5 and Group 6: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup W: Day 30: ≥1:128	100 percentage of participants Interval 96.3 to 100.0	97.0 percentage of participants Interval 91.4 to 99.4

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)

Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured by hSBA and rSBA.

Outcome measures

Outcome measures
Measure	Group 5 + Group 7: MenACYW Conjugate Vaccine n=223 Participants Children and adolescent participants aged 2 to 17 years in India and RSA received a single dose of 0.5 mL MenACYW conjugate vaccine as an IM injection on Day 0.	Group 6 + Group 8: Menactra® n=217 Participants Children and adolescent participants aged 2 to 17 years in India and RSA received a single dose of 0.5 mL Menactra® as an IM injection on Day 0.
Group 7 and Group 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup A: Day 0	7.47 titer Interval 6.59 to 8.47	6.71 titer Interval 5.97 to 7.55
Group 7 and Group 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup A: Day 30	44.9 titer Interval 37.1 to 54.4	31.9 titer Interval 25.5 to 40.0
Group 7 and Group 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup C: Day 0	4.69 titer Interval 4.1 to 5.36	4.55 titer Interval 3.97 to 5.2
Group 7 and Group 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup C: Day 30	606 titer Interval 488.0 to 751.0	59.2 titer Interval 44.0 to 79.7
Group 7 and Group 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup Y: Day 0	3.69 titer Interval 3.13 to 4.34	3.96 titer Interval 3.35 to 4.69
Group 7 and Group 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup Y: Day 30	233 titer Interval 195.0 to 279.0	81.5 titer Interval 66.0 to 101.0
Group 7 and Group 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup W: Day 0	5.74 titer Interval 4.89 to 6.74	5.85 titer Interval 4.97 to 6.88
Group 7 and Group 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup W: Day 30	157 titer Interval 129.0 to 191.0	52.5 titer Interval 42.3 to 65.2
Group 7 and Group 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup A: Day 0	589 titer Interval 338.0 to 1026.0	450 titer Interval 260.0 to 778.0
Group 7 and Group 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup A: Day 30	9706 titer Interval 8032.0 to 11729.0	10242 titer Interval 8432.0 to 12440.0
Group 7 and Group 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup C: Day 0	4.12 titer Interval 3.0 to 5.66	4.77 titer Interval 3.28 to 6.93
Group 7 and Group 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup C: Day 30	18848 titer Interval 13953.0 to 25460.0	2317 titer Interval 1544.0 to 3476.0
Group 7 and Group 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup Y: Day 0	25.6 titer Interval 14.6 to 45.2	25.7 titer Interval 13.9 to 47.3
Group 7 and Group 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup Y: Day 30	15108 titer Interval 12775.0 to 17865.0	8067 titer Interval 6207.0 to 10483.0
Group 7 and Group 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup W: Day 0	7.43 titer Interval 4.57 to 12.1	7.14 titer Interval 4.55 to 11.2
Group 7 and Group 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup W: Day 30	20290 titer Interval 15479.0 to 26598.0	10481 titer Interval 7890.0 to 13924.0

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)

Outcome measures

Outcome measures
Measure	Group 5 + Group 7: MenACYW Conjugate Vaccine n=223 Participants Children and adolescent participants aged 2 to 17 years in India and RSA received a single dose of 0.5 mL MenACYW conjugate vaccine as an IM injection on Day 0.	Group 6 + Group 8: Menactra® n=217 Participants Children and adolescent participants aged 2 to 17 years in India and RSA received a single dose of 0.5 mL Menactra® as an IM injection on Day 0.
Group 7 and Group 8: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup A: Day 0: ≥1:4	88.8 percentage of participants Interval 83.9 to 92.6	86.6 percentage of participants Interval 81.4 to 90.9
Group 7 and Group 8: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup A: Day 0: ≥1:8	61.0 percentage of participants Interval 54.2 to 67.4	57.6 percentage of participants Interval 50.7 to 64.3
Group 7 and Group 8: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup A: Day 30: ≥1:4	96.9 percentage of participants Interval 93.6 to 98.7	93.5 percentage of participants Interval 89.3 to 96.4
Group 7 and Group 8: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup A: Day 30: ≥1:8	89.7 percentage of participants Interval 84.9 to 93.3	82.3 percentage of participants Interval 76.6 to 87.2
Group 7 and Group 8: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup C: Day 0: ≥1:4	58.3 percentage of participants Interval 51.5 to 64.8	57.1 percentage of participants Interval 50.3 to 63.8
Group 7 and Group 8: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup C: Day 0: ≥1:8	32.3 percentage of participants Interval 26.2 to 38.9	30.4 percentage of participants Interval 24.4 to 37.0
Group 7 and Group 8: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup C: Day 30: ≥1:4	99.6 percentage of participants Interval 97.5 to 100.0	93.0 percentage of participants Interval 88.8 to 96.0
Group 7 and Group 8: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup C: Day 30: ≥1:8	99.1 percentage of participants Interval 96.8 to 99.9	82.8 percentage of participants Interval 77.1 to 87.6
Group 7 and Group 8: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup Y: Day 0: ≥1:4	28.1 percentage of participants Interval 22.2 to 34.5	32.3 percentage of participants Interval 26.1 to 38.9
Group 7 and Group 8: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup Y: Day 0: ≥1:8	21.3 percentage of participants Interval 16.1 to 27.3	25.3 percentage of participants Interval 19.7 to 31.7
Group 7 and Group 8: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup Y: Day 30: ≥1:4	99.6 percentage of participants Interval 97.5 to 100.0	95.8 percentage of participants Interval 92.2 to 98.1
Group 7 and Group 8: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup Y: Day 30: ≥1:8	99.6 percentage of participants Interval 97.5 to 100.0	94.9 percentage of participants Interval 91.0 to 97.4
Group 7 and Group 8: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup W: Day 0: ≥1:4	53.4 percentage of participants Interval 46.6 to 60.1	55.3 percentage of participants Interval 48.4 to 62.0
Group 7 and Group 8: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup W: Day 0: ≥1:8	42.2 percentage of participants Interval 35.6 to 48.9	41.0 percentage of participants Interval 34.4 to 47.9
Group 7 and Group 8: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup W: Day 30: ≥1:4	99.1 percentage of participants Interval 96.8 to 99.9	94.9 percentage of participants Interval 91.1 to 97.4
Group 7 and Group 8: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W hSBA: Serogroup W: Day 30: ≥1:8	99.1 percentage of participants Interval 96.8 to 99.9	93.5 percentage of participants Interval 89.4 to 96.4
Group 7 and Group 8: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup A: Day 0: ≥1:8	84.0 percentage of participants Interval 75.0 to 90.8	83.5 percentage of participants Interval 74.3 to 90.5
Group 7 and Group 8: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup A: Day 0: ≥1:128	81.9 percentage of participants Interval 72.6 to 89.1	80.2 percentage of participants Interval 70.6 to 87.8
Group 7 and Group 8: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup A: Day 30: ≥1:8	100 percentage of participants Interval 96.2 to 100.0	100 percentage of participants Interval 96.0 to 100.0
Group 7 and Group 8: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup A: Day 30: ≥1:128	100 percentage of participants Interval 96.2 to 100.0	100 percentage of participants Interval 96.0 to 100.0
Group 7 and Group 8: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup C: Day 0: ≥1:8	19.1 percentage of participants Interval 11.8 to 28.6	19.8 percentage of participants Interval 12.2 to 29.4
Group 7 and Group 8: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup C: Day 0: ≥1:128	6.4 percentage of participants Interval 2.4 to 13.4	9.9 percentage of participants Interval 4.6 to 17.9
Group 7 and Group 8: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup C: Day 30: ≥1:8	100 percentage of participants Interval 96.2 to 100.0	98.9 percentage of participants Interval 94.0 to 100.0
Group 7 and Group 8: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup C: Day 30: ≥1:128	100 percentage of participants Interval 96.2 to 100.0	96.7 percentage of participants Interval 90.6 to 99.3
Group 7 and Group 8: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup Y: Day 0: ≥1:8	47.9 percentage of participants Interval 37.5 to 58.4	46.2 percentage of participants Interval 35.6 to 56.9
Group 7 and Group 8: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup Y: Day 0: ≥1:128	46.8 percentage of participants Interval 36.4 to 57.4	40.7 percentage of participants Interval 30.5 to 51.5
Group 7 and Group 8: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup Y: Day 30: ≥1:8	100 percentage of participants Interval 96.2 to 100.0	98.9 percentage of participants Interval 94.0 to 100.0
Group 7 and Group 8: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup Y: Day 30: ≥1:128	100 percentage of participants Interval 96.2 to 100.0	98.9 percentage of participants Interval 94.0 to 100.0
Group 7 and Group 8: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup W: Day 0: ≥1:8	24.5 percentage of participants Interval 16.2 to 34.4	26.4 percentage of participants Interval 17.7 to 36.7
Group 7 and Group 8: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup W: Day 0: ≥1:128	22.3 percentage of participants Interval 14.4 to 32.1	23.1 percentage of participants Interval 14.9 to 33.1
Group 7 and Group 8: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup W: Day 30: ≥1:8	100 percentage of participants Interval 96.2 to 100.0	100 percentage of participants Interval 96.0 to 100.0
Group 7 and Group 8: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W rSBA: Serogroup W: Day 30: ≥1:128	100 percentage of participants Interval 96.2 to 100.0	100 percentage of participants Interval 96.0 to 100.0

Adverse Events

Group 1: MenACYW Conjugate Vaccine

Serious events: 1 serious events

Other events: 32 other events

Deaths: 0 deaths

Group 2: Menactra®

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

Group 3: MenACYW Conjugate Vaccine

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Group 4: Quadri Meningo™/Locally Available Licensed Meningococcal Vaccine

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Group 5: MenACYW Conjugate Vaccine

Serious events: 1 serious events

Other events: 81 other events

Deaths: 0 deaths

Group 6: Menactra®

Serious events: 0 serious events

Other events: 43 other events

Deaths: 0 deaths

Group 7: MenACYW Conjugate Vaccine

Serious events: 0 serious events

Other events: 115 other events

Deaths: 0 deaths

Group 8: Menactra®

Serious events: 0 serious events

Other events: 128 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Group 1: MenACYW Conjugate Vaccine n=98 participants at risk Adult participants aged 18 to 55 years in India received a single dose of 0.5 mL MenACYW conjugate vaccine as an IM injection on Day 0.	Group 2: Menactra® n=100 participants at risk Adult participants aged 18 to 55 years in India received a single dose of 0.5 mL Menactra® as an IM injection on Day 0.	Group 3: MenACYW Conjugate Vaccine n=100 participants at risk Adult participants aged ≥56 years in India received a single dose of 0.5 mL MenACYW conjugate vaccine as an IM injection on Day 0.	Group 4: Quadri Meningo™/Locally Available Licensed Meningococcal Vaccine n=100 participants at risk Adult participants aged ≥56 years in India received a single dose of 0.5 mL Quadri Meningo™ or any locally available licensed meningococcal vaccine as an IM injection on Day 0.	Group 5: MenACYW Conjugate Vaccine n=232 participants at risk Children and adolescent participants aged 2 to 17 years in India received a single dose of 0.5 mL MenACYW conjugate vaccine as an IM injection on Day 0.	Group 6: Menactra® n=232 participants at risk Children and adolescent participants aged 2 to 17 years in India received a single dose of 0.5 mL Menactra® as an IM injection on Day 0.	Group 7: MenACYW Conjugate Vaccine n=229 participants at risk Children and adolescent participants aged 2 to 17 years in RSA received a single dose of 0.5 mL MenACYW conjugate vaccine as an IM injection on Day 0.	Group 8: Menactra® n=227 participants at risk Children and adolescent participants aged 2 to 17 years in RSA received a single dose of 0.5 mL Menactra® as an IM injection on Day 0.
Infections and infestations Covid-19	1.0% 1/98 • Number of events 1 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	0.00% 0/100 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	0.00% 0/100 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	0.00% 0/100 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	0.00% 0/232 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	0.00% 0/232 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	0.00% 0/229 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	0.00% 0/227 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.
Infections and infestations Dengue Fever	0.00% 0/98 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	0.00% 0/100 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	0.00% 0/100 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	0.00% 0/100 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	0.43% 1/232 • Number of events 1 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	0.00% 0/232 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	0.00% 0/229 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	0.00% 0/227 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.

Other adverse events

Other adverse events
Measure	Group 1: MenACYW Conjugate Vaccine n=98 participants at risk Adult participants aged 18 to 55 years in India received a single dose of 0.5 mL MenACYW conjugate vaccine as an IM injection on Day 0.	Group 2: Menactra® n=100 participants at risk Adult participants aged 18 to 55 years in India received a single dose of 0.5 mL Menactra® as an IM injection on Day 0.	Group 3: MenACYW Conjugate Vaccine n=100 participants at risk Adult participants aged ≥56 years in India received a single dose of 0.5 mL MenACYW conjugate vaccine as an IM injection on Day 0.	Group 4: Quadri Meningo™/Locally Available Licensed Meningococcal Vaccine n=100 participants at risk Adult participants aged ≥56 years in India received a single dose of 0.5 mL Quadri Meningo™ or any locally available licensed meningococcal vaccine as an IM injection on Day 0.	Group 5: MenACYW Conjugate Vaccine n=232 participants at risk Children and adolescent participants aged 2 to 17 years in India received a single dose of 0.5 mL MenACYW conjugate vaccine as an IM injection on Day 0.	Group 6: Menactra® n=232 participants at risk Children and adolescent participants aged 2 to 17 years in India received a single dose of 0.5 mL Menactra® as an IM injection on Day 0.	Group 7: MenACYW Conjugate Vaccine n=229 participants at risk Children and adolescent participants aged 2 to 17 years in RSA received a single dose of 0.5 mL MenACYW conjugate vaccine as an IM injection on Day 0.	Group 8: Menactra® n=227 participants at risk Children and adolescent participants aged 2 to 17 years in RSA received a single dose of 0.5 mL Menactra® as an IM injection on Day 0.
Musculoskeletal and connective tissue disorders Myalgia	5.1% 5/98 • Number of events 5 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	6.0% 6/100 • Number of events 6 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	2.0% 2/100 • Number of events 2 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	0.00% 0/100 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	3.0% 7/232 • Number of events 7 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	1.3% 3/232 • Number of events 3 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	20.1% 46/229 • Number of events 46 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	21.6% 49/227 • Number of events 49 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.
General disorders Injection Site Erythema	1.0% 1/98 • Number of events 1 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	0.00% 0/100 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	0.00% 0/100 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	1.0% 1/100 • Number of events 1 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	0.43% 1/232 • Number of events 1 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	0.00% 0/232 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	12.2% 28/229 • Number of events 28 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	11.9% 27/227 • Number of events 27 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.
General disorders Injection Site Pain	27.6% 27/98 • Number of events 27 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	24.0% 24/100 • Number of events 24 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	9.0% 9/100 • Number of events 9 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	14.0% 14/100 • Number of events 14 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	22.4% 52/232 • Number of events 52 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	12.5% 29/232 • Number of events 29 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	37.1% 85/229 • Number of events 85 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	36.1% 82/227 • Number of events 82 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.
General disorders Injection Site Swelling	1.0% 1/98 • Number of events 1 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	0.00% 0/100 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	0.00% 0/100 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	2.0% 2/100 • Number of events 2 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	0.43% 1/232 • Number of events 1 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	0.43% 1/232 • Number of events 1 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	10.9% 25/229 • Number of events 25 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	16.3% 37/227 • Number of events 37 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.
General disorders Malaise	6.1% 6/98 • Number of events 6 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	5.0% 5/100 • Number of events 5 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	1.0% 1/100 • Number of events 1 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	1.0% 1/100 • Number of events 1 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	4.7% 11/232 • Number of events 11 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	1.7% 4/232 • Number of events 4 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	19.7% 45/229 • Number of events 45 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	19.4% 44/227 • Number of events 44 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.
General disorders Pyrexia	5.1% 5/98 • Number of events 5 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	2.0% 2/100 • Number of events 2 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	4.0% 4/100 • Number of events 4 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	4.0% 4/100 • Number of events 4 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	15.9% 37/232 • Number of events 37 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	6.9% 16/232 • Number of events 16 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	3.5% 8/229 • Number of events 8 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	3.5% 8/227 • Number of events 8 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.
Nervous system disorders Headache	6.1% 6/98 • Number of events 6 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	6.0% 6/100 • Number of events 6 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	3.0% 3/100 • Number of events 3 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	3.0% 3/100 • Number of events 3 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	5.6% 13/232 • Number of events 13 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	1.3% 3/232 • Number of events 3 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	24.5% 56/229 • Number of events 57 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.	25.1% 57/227 • Number of events 61 • From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8. Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.

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