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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04143061

Acronym

MET55

Enrollment

1328

Registered

2019-10-29

Start date

2019-12-30

Completion date

2023-01-28

Last updated

2025-02-03

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

Conditions

Meningococcal Immunization, Healthy Volunteers

Brief summary

This will be a Phase III, modified double-blind (open-label for toddlers in India), randomized, parallel-group, active-controlled, step-wise, multi-center study to compare and describe the immunogenicity and safety of MenACYW conjugate vaccine when administered as a single dose in healthy adults, adolescents, children, and toddlers in India and a modified double-blind, randomized, parallel-group, active-controlled, multi-center study to compare and describe the immunogenicity and safety of MenACYW conjugate vaccine when administered as a single dose in healthy adolescents and children in RSA.

Detailed description

Study duration per participant is approximately 31 to 45 days

Interventions

BIOLOGICALMeningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine

Pharmaceutical form: solution for injection; Route of administration: intramuscular, 0.5 mL

BIOLOGICALMeningococcal polysaccharide (serogroups A,C,Y and W-135) diphtheria toxoid conjugate vaccine

Pharmaceutical form: sterile aqueous solution; Route of administration: intramuscular, 0.5 mL

BIOLOGICALMeningococcal polysaccharide (serogroups A, C, Y and W-135) vaccine

Pharmaceutical form: reconstituted solution for injection; Route of administration: intramuscular, 0.5 mL

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

This trial is a modified double-blind trial (except for toddlers in India), which means that the participant's parent / legally acceptable representative, the Investigator, and other study personnel remain unaware of the treatment assignments throughout the trial. An unblinded vaccine administrator administer the appropriate vaccine but is not involved in safety data collection. The Sponsor and laboratory personnel performing the serology testing are also blinded to treatment assignments throughout the trial until database lock. It will be open-label for toddlers population in India.

Intervention model description

Toddlers (open-label), children, adolescents and adults aged 12 months and above are enrolled in India, and children and adolescents aged 2 to 17 years are included in RSA. The older populations (adults) are recruited before initiating the study in children and adolescents younger than 17 years of age in India.

Eligibility

Sex/Gender

ALL

Age

12 Months to No maximum

Healthy volunteers

Yes

Inclusion criteria

\- Age in the defined range on the day of inclusion: For Adults: Aged ≥ 18 years on the day of inclusion For Children and Adolescents: Aged 2 to 17 years on the day of inclusion For Toddlers: Aged 12 to 23 months† on the day of inclusion \- Z-score of ≥ -2 standard deviations (SD) on the Weight-for-height table of the World Health Organization (WHO) Child Growth Standards: For toddlers and children: Toddlers aged 12 to 23 months and Children aged 2 to 5 years had a Z-score of ≥ -2 SD on the Weight-for-height table of the WHO Child Growth Standards * Informed consent obtained For adults: Informed consent form has been signed and dated by the subject and by an independent witness, if required by local regulations For toddlers, children, and adolescents: Assent form has been signed and dated by the subject (for subjects 7 to 17 years of age), and informed consent form has been signed and dated by the parent(s) or legally acceptable representative and by an independent witness, if required by local regulations * Were able to attend all scheduled visits and to comply with all trial procedures For adults: Were able to attend all scheduled visits and to comply with all trial procedures For toddlers, children, and adolescents: Participants and parent / legally acceptable representative were able to attend all scheduled visits and to comply with all trial procedures * For Toddlers: All toddlers were due to receive an age-recommended RPV on D0

Exclusion criteria

* Participant was pregnant, or lactating, or of childbearing potential and was not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination. To be considered of non-childbearing potential, a female must be pre-menarche, or post-menopausal for at least 1 year, or surgically sterile * Participation at the time of study enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure * Receipt of any vaccine in the 4 weeks (28 days) preceding the IMP or planned receipt of any vaccine in the 4 weeks following vaccination except for oral poliovirus vaccine (OPV) in India, received during national immunization days. In India, OPV might have been received with a gap of at least 2 weeks before the IMP. This exception included monovalent and bivalent OPV. * Previous vaccination against meningococcal disease with either the IMP or another vaccine (i.e., mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, Y, or W; or meningococcal B serogroup containing vaccine) * Receipt of immune globulins, blood or blood-derived products in the past 3 months * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) * History of meningococcal infection, confirmed either clinically, serologically, or microbiologically * At high risk for meningococcal infection during the trial (specifically, but not limited to, subjects with persistent complement deficiency, with anatomic or functional asplenia, or subjects traveling to countries with high endemic or epidemic disease) * Known systemic hypersensitivity to latex or to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances * Verbal report of thrombocytopenia, as reported by the subject or the subject's parent / legally acceptable representative, contraindicating intramuscular vaccination in the Investigator's opinion * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination in the Investigator's opinion * Personal history of Guillain-Barré syndrome * Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine within 10 years of the proposed study vaccination * Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily * Current alcohol abuse or drug addiction * Chronic illness that, in the opinion of the investigator, was at a stage where it might interfere with trial conduct or completion * Any condition which, in the opinion of the Investigator, might have interfered with the evaluation of the study objectives. * Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination, febrile illness (temperature ≥ 38.0°C), persistent diarrhea, vomiting. A prospective subject was not included in the study until the condition has been resolved or the febrile event has been subsided * Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw * Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study

Design outcomes

Primary

Measure	Time frame	Description
Group 5 + 7 and Group 6 + 8: Percentage of Participants Who Achieved Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W	Day 30 (30 days post-vaccination on Day 0)	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.

Secondary

Measure	Time frame	Description
Group 1 and Group 2: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W	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.
Group 3 and Group 4: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W	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.
Group 3 and Group 4: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W	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.
Group 5 + 7 and Group 6 + 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W	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.
Group 1 and Group 2: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W	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 serum bactericidal assay using baby rabbit complement (rSBA).
Group 5 and Group 6: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W	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.
Group 7 and Group 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W	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.
Group 7 and Group 8: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W	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.
Group 5 and Group 6: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W	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.

Countries

India, South Africa

Participant flow

Recruitment details

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.

Pre-assignment details

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

Participants by arm

Arm	Count
Group 1: MenACYW Conjugate Vaccine 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.	98
Group 2: Menactra® 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.	100
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.	100
Group 4: Quadri Meningo™/Locally Available Licensed Meningococcal Vaccine 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.	100
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.	232
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.	233
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.	233
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.	232
Total	1,328

Withdrawals & dropouts

Period	Reason	FG000	FG004	FG005	FG006	FG007
Overall Study	Protocol Deviation	0	0	0	5	5
Overall Study	Withdrawal by Parent/Guardian	0	8	3	2	7
Overall Study	Withdrawal by Subject	2	0	1	0	0

Baseline characteristics

Characteristic	Group 1: MenACYW Conjugate Vaccine	Group 2: Menactra®	Group 3: MenACYW Conjugate Vaccine	Group 4: Quadri Meningo™/Locally Available Licensed Meningococcal Vaccine	Group 5: MenACYW Conjugate Vaccine	Group 6: Menactra®	Group 7: MenACYW Conjugate Vaccine	Group 8: Menactra®	Total
Age, Continuous	36.7 years STANDARD_DEVIATION 9.21	34.8 years STANDARD_DEVIATION 9.05	61.7 years STANDARD_DEVIATION 6.09	61.1 years STANDARD_DEVIATION 5.61	9.39 years STANDARD_DEVIATION 4.19	9.34 years STANDARD_DEVIATION 4.1	9.45 years STANDARD_DEVIATION 4.01	9.19 years STANDARD_DEVIATION 4.19	21.1 years STANDARD_DEVIATION 20.1
Race/Ethnicity, Customized Asian	98 Participants	100 Participants	100 Participants	100 Participants	232 Participants	233 Participants	0 Participants	0 Participants	863 Participants
Race/Ethnicity, Customized Black or African American	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	142 Participants	139 Participants	281 Participants
Race/Ethnicity, Customized Mixed Origin	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	70 Participants	71 Participants	141 Participants
Race/Ethnicity, Customized Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	6 Participants	3 Participants	9 Participants
Race/Ethnicity, Customized Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	6 Participants	9 Participants	15 Participants
Race/Ethnicity, Customized White	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	9 Participants	10 Participants	19 Participants
Sex: Female, Male Female	30 Participants	31 Participants	24 Participants	31 Participants	101 Participants	118 Participants	123 Participants	110 Participants	568 Participants
Sex: Female, Male Male	68 Participants	69 Participants	76 Participants	69 Participants	131 Participants	115 Participants	110 Participants	122 Participants	760 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk	EG007 affected / at risk
deaths Total, all-cause mortality	0 / 98	0 / 100	0 / 100	0 / 100	0 / 232	0 / 232	0 / 229	0 / 227
other Total, other adverse events	32 / 98	26 / 100	18 / 100	21 / 100	81 / 232	43 / 232	115 / 229	128 / 227
serious Total, serious adverse events	1 / 98	0 / 100	0 / 100	0 / 100	1 / 232	0 / 232	0 / 229	0 / 227

Outcome results

Primary

Group 5 + 7 and Group 6 + 8: Percentage of Participants Who Achieved Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W

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.

Time frame: 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.

Arm	Measure	Group	Value (NUMBER)
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 6 + Group 8: Menactra®	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	87.6 percentage of participants
Group 6 + Group 8: Menactra®	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	83.1 percentage of participants
Group 6 + Group 8: Menactra®	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	85.6 percentage of participants
Group 6 + Group 8: Menactra®	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	77.7 percentage of participants

Comparison: Statistical analysis for Serogroup A95% CI: [2.03, 11.08]

Comparison: Statistical analysis for Serogroup C95% CI: [17.82, 25.8]

Comparison: Statistical analysis for Serogroup Y95% CI: [7.43, 14.89]

Comparison: Statistical analysis for Serogroup W95% CI: [7.86, 14.47]

Secondary

Group 1 and Group 2: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W

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

Time frame: 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.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 6 + Group 8: Menactra®	Group 1 and Group 2: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W	rSBA: Serogroup W: Day 30	7732 titer
Group 6 + Group 8: Menactra®	Group 1 and Group 2: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W	hSBA: Serogroup A: Day 0	9.60 titer
Group 6 + Group 8: Menactra®	Group 1 and Group 2: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W	hSBA: Serogroup A: Day 30	39.2 titer
Group 6 + Group 8: Menactra®	Group 1 and Group 2: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W	hSBA: Serogroup C: Day 0	7.05 titer
Group 6 + Group 8: Menactra®	Group 1 and Group 2: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W	hSBA: Serogroup C: Day 30	107 titer
Group 6 + Group 8: Menactra®	Group 1 and Group 2: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W	hSBA: Serogroup Y: Day 0	4.03 titer
Group 6 + Group 8: Menactra®	Group 1 and Group 2: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W	hSBA: Serogroup Y: Day 30	47.4 titer
Group 6 + Group 8: Menactra®	Group 1 and Group 2: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W	hSBA: Serogroup W: Day 0	4.17 titer
Group 6 + Group 8: Menactra®	Group 1 and Group 2: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W	hSBA: Serogroup W: Day 30	63.1 titer
Group 6 + Group 8: Menactra®	Group 1 and Group 2: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W	rSBA: Serogroup A: Day 0	64.0 titer
Group 6 + Group 8: Menactra®	Group 1 and Group 2: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W	rSBA: Serogroup A: Day 30	4467 titer
Group 6 + Group 8: Menactra®	Group 1 and Group 2: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W	rSBA: Serogroup C: Day 0	4.88 titer
Group 6 + Group 8: Menactra®	Group 1 and Group 2: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W	rSBA: Serogroup C: Day 30	1149 titer
Group 6 + Group 8: Menactra®	Group 1 and Group 2: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W	rSBA: Serogroup Y: Day 0	9.40 titer
Group 6 + Group 8: Menactra®	Group 1 and Group 2: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W	rSBA: Serogroup W: Day 0	7.56 titer
Group 6 + Group 8: Menactra®	Group 1 and Group 2: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W	rSBA: Serogroup Y: Day 30	3534 titer

Secondary

Group 1 and Group 2: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W

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.

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

Arm	Measure	Group	Value (NUMBER)
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 6 + Group 8: Menactra®	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	97.9 percentage of participants
Group 6 + Group 8: Menactra®	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	87.9 percentage of participants
Group 6 + Group 8: Menactra®	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	61.7 percentage of participants
Group 6 + Group 8: Menactra®	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	72.7 percentage of participants
Group 6 + Group 8: Menactra®	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	25.6 percentage of participants
Group 6 + Group 8: Menactra®	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	93.9 percentage of participants
Group 6 + Group 8: Menactra®	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	48.9 percentage of participants
Group 6 + Group 8: Menactra®	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	87.9 percentage of participants
Group 6 + Group 8: Menactra®	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	20.4 percentage of participants
Group 6 + Group 8: Menactra®	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	69.7 percentage of participants
Group 6 + Group 8: Menactra®	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
Group 6 + Group 8: Menactra®	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	50.5 percentage of participants
Group 6 + Group 8: Menactra®	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	23.3 percentage of participants
Group 6 + Group 8: Menactra®	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	93.9 percentage of participants
Group 6 + Group 8: Menactra®	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
Group 6 + Group 8: Menactra®	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	88.9 percentage of participants
Group 6 + Group 8: Menactra®	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	97.9 percentage of participants
Group 6 + Group 8: Menactra®	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	30.3 percentage of participants
Group 6 + Group 8: Menactra®	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	24.5 percentage of participants
Group 6 + Group 8: Menactra®	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	24.2 percentage of participants
Group 6 + Group 8: Menactra®	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	100 percentage of participants
Group 6 + Group 8: Menactra®	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	82.8 percentage of participants
Group 6 + Group 8: Menactra®	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	10.2 percentage of participants
Group 6 + Group 8: Menactra®	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	76.8 percentage of participants
Group 6 + Group 8: Menactra®	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	20.4 percentage of participants
Group 6 + Group 8: Menactra®	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	44.4 percentage of participants
Group 6 + Group 8: Menactra®	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	95.8 percentage of participants
Group 6 + Group 8: Menactra®	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	29.3 percentage of participants
Group 6 + Group 8: Menactra®	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	100 percentage of participants
Group 6 + Group 8: Menactra®	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	96.0 percentage of participants
Group 6 + Group 8: Menactra®	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	89.6 percentage of participants
Group 6 + Group 8: Menactra®	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	90.9 percentage of participants

Secondary

Group 3 and Group 4: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W

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

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

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 6 + Group 8: Menactra®	Group 3 and Group 4: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W	rSBA: Serogroup W: Day 30	2304 titer
Group 6 + Group 8: Menactra®	Group 3 and Group 4: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W	hSBA: Serogroup A: Day 0	12.5 titer
Group 6 + Group 8: Menactra®	Group 3 and Group 4: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W	rSBA: Serogroup A: Day 0	46.3 titer
Group 6 + Group 8: Menactra®	Group 3 and Group 4: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W	hSBA: Serogroup A: Day 30	36.2 titer
Group 6 + Group 8: Menactra®	Group 3 and Group 4: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W	rSBA: Serogroup Y: Day 0	8.24 titer
Group 6 + Group 8: Menactra®	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
Group 6 + Group 8: Menactra®	Group 3 and Group 4: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W	rSBA: Serogroup A: Day 30	4677 titer
Group 6 + Group 8: Menactra®	Group 3 and Group 4: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W	hSBA: Serogroup C: Day 30	159 titer
Group 6 + Group 8: Menactra®	Group 3 and Group 4: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W	rSBA: Serogroup W: Day 0	12.4 titer
Group 6 + Group 8: Menactra®	Group 3 and Group 4: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W	hSBA: Serogroup Y: Day 0	6.97 titer
Group 6 + Group 8: Menactra®	Group 3 and Group 4: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W	rSBA: Serogroup C: Day 0	5.53 titer
Group 6 + Group 8: Menactra®	Group 3 and Group 4: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W	hSBA: Serogroup Y: Day 30	55.4 titer
Group 6 + Group 8: Menactra®	Group 3 and Group 4: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W	rSBA: Serogroup Y: Day 30	1119 titer
Group 6 + Group 8: Menactra®	Group 3 and Group 4: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W	hSBA: Serogroup W: Day 0	5.66 titer
Group 6 + Group 8: Menactra®	Group 3 and Group 4: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W	rSBA: Serogroup C: Day 30	3283 titer
Group 6 + Group 8: Menactra®	Group 3 and Group 4: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W	hSBA: Serogroup W: Day 30	34.6 titer

Secondary

Group 3 and Group 4: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W

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

Arm	Measure	Group	Value (NUMBER)
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 6 + Group 8: Menactra®	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	87.2 percentage of participants
Group 6 + Group 8: Menactra®	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	93.8 percentage of participants
Group 6 + Group 8: Menactra®	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	55.3 percentage of participants
Group 6 + Group 8: Menactra®	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	77.1 percentage of participants
Group 6 + Group 8: Menactra®	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	26.1 percentage of participants
Group 6 + Group 8: Menactra®	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	96.9 percentage of participants
Group 6 + Group 8: Menactra®	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	46.8 percentage of participants
Group 6 + Group 8: Menactra®	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	86.5 percentage of participants
Group 6 + Group 8: Menactra®	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	30.4 percentage of participants
Group 6 + Group 8: Menactra®	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	75.0 percentage of participants
Group 6 + Group 8: Menactra®	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	100 percentage of participants
Group 6 + Group 8: Menactra®	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	50.0 percentage of participants
Group 6 + Group 8: Menactra®	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	21.7 percentage of participants
Group 6 + Group 8: Menactra®	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	92.7 percentage of participants
Group 6 + Group 8: Menactra®	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	97.9 percentage of participants
Group 6 + Group 8: Menactra®	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	89.6 percentage of participants
Group 6 + Group 8: Menactra®	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	89.4 percentage of participants
Group 6 + Group 8: Menactra®	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	51.0 percentage of participants
Group 6 + Group 8: Menactra®	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	21.3 percentage of participants
Group 6 + Group 8: Menactra®	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	40.6 percentage of participants
Group 6 + Group 8: Menactra®	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	89.4 percentage of participants
Group 6 + Group 8: Menactra®	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	83.3 percentage of participants
Group 6 + Group 8: Menactra®	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	10.6 percentage of participants
Group 6 + Group 8: Menactra®	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	79.2 percentage of participants
Group 6 + Group 8: Menactra®	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	28.3 percentage of participants
Group 6 + Group 8: Menactra®	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	54.2 percentage of participants
Group 6 + Group 8: Menactra®	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	93.6 percentage of participants
Group 6 + Group 8: Menactra®	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	38.5 percentage of participants
Group 6 + Group 8: Menactra®	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	89.4 percentage of participants
Group 6 + Group 8: Menactra®	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	90.6 percentage of participants
Group 6 + Group 8: Menactra®	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	93.6 percentage of participants
Group 6 + Group 8: Menactra®	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	79.2 percentage of participants

Secondary

Group 5 + 7 and Group 6 + 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W

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.

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

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 6 + Group 8: Menactra®	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	6598 titer
Group 6 + Group 8: Menactra®	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	7.21 titer
Group 6 + Group 8: Menactra®	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	387 titer
Group 6 + Group 8: Menactra®	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	36.3 titer
Group 6 + Group 8: Menactra®	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	21.9 titer
Group 6 + Group 8: Menactra®	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	3.78 titer
Group 6 + Group 8: Menactra®	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	8313 titer
Group 6 + Group 8: Menactra®	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	47.3 titer
Group 6 + Group 8: Menactra®	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	7.46 titer
Group 6 + Group 8: Menactra®	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
Group 6 + Group 8: Menactra®	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	3.73 titer
Group 6 + Group 8: Menactra®	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	46.2 titer
Group 6 + Group 8: Menactra®	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	5966 titer
Group 6 + Group 8: Menactra®	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	4.04 titer
Group 6 + Group 8: Menactra®	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	1199 titer
Group 6 + Group 8: Menactra®	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	35.4 titer

Secondary

Group 5 and Group 6: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W

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

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

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 6 + Group 8: Menactra®	Group 5 and Group 6: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W	hSBA: Serogroup A: Day 0	7.71 titer
Group 6 + Group 8: Menactra®	Group 5 and Group 6: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W	rSBA: Serogroup A: Day 30	6877 titer
Group 6 + Group 8: Menactra®	Group 5 and Group 6: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W	rSBA: Serogroup C: Day 0	2.98 titer
Group 6 + Group 8: Menactra®	Group 5 and Group 6: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W	rSBA: Serogroup C: Day 30	659 titer
Group 6 + Group 8: Menactra®	Group 5 and Group 6: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W	rSBA: Serogroup Y: Day 0	18.8 titer
Group 6 + Group 8: Menactra®	Group 5 and Group 6: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W	rSBA: Serogroup Y: Day 30	4522 titer
Group 6 + Group 8: Menactra®	Group 5 and Group 6: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W	rSBA: Serogroup W: Day 30	4332 titer
Group 6 + Group 8: Menactra®	Group 5 and Group 6: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W	rSBA: Serogroup W: Day 0	7.78 titer
Group 6 + Group 8: Menactra®	Group 5 and Group 6: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W	rSBA: Serogroup A: Day 0	337 titer
Group 6 + Group 8: Menactra®	Group 5 and Group 6: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W	hSBA: Serogroup A: Day 30	40.9 titer
Group 6 + Group 8: Menactra®	Group 5 and Group 6: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W	hSBA: Serogroup C: Day 0	3.17 titer
Group 6 + Group 8: Menactra®	Group 5 and Group 6: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W	hSBA: Serogroup C: Day 30	38.3 titer
Group 6 + Group 8: Menactra®	Group 5 and Group 6: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W	hSBA: Serogroup Y: Day 0	3.12 titer
Group 6 + Group 8: Menactra®	Group 5 and Group 6: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W	hSBA: Serogroup Y: Day 30	27.1 titer
Group 6 + Group 8: Menactra®	Group 5 and Group 6: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W	hSBA: Serogroup W: Day 0	2.85 titer
Group 6 + Group 8: Menactra®	Group 5 and Group 6: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W	hSBA: Serogroup W: Day 30	24.3 titer

Secondary

Group 5 and Group 6: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W

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

Arm	Measure	Group	Value (NUMBER)
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 6 + Group 8: Menactra®	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	97.0 percentage of participants
Group 6 + Group 8: Menactra®	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	91.2 percentage of participants
Group 6 + Group 8: Menactra®	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	76.5 percentage of participants
Group 6 + Group 8: Menactra®	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	63.6 percentage of participants
Group 6 + Group 8: Menactra®	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	40.7 percentage of participants
Group 6 + Group 8: Menactra®	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	94.7 percentage of participants
Group 6 + Group 8: Menactra®	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	73.5 percentage of participants
Group 6 + Group 8: Menactra®	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	83.8 percentage of participants
Group 6 + Group 8: Menactra®	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	24.5 percentage of participants
Group 6 + Group 8: Menactra®	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	30.7 percentage of participants
Group 6 + Group 8: Menactra®	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
Group 6 + Group 8: Menactra®	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	18.4 percentage of participants
Group 6 + Group 8: Menactra®	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	38.5 percentage of participants
Group 6 + Group 8: Menactra®	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	82.9 percentage of participants
Group 6 + Group 8: Menactra®	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
Group 6 + Group 8: Menactra®	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	72.8 percentage of participants
Group 6 + Group 8: Menactra®	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	98.0 percentage of participants
Group 6 + Group 8: Menactra®	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	18.9 percentage of participants
Group 6 + Group 8: Menactra®	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	13.1 percentage of participants
Group 6 + Group 8: Menactra®	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	13.6 percentage of participants
Group 6 + Group 8: Menactra®	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	98.0 percentage of participants
Group 6 + Group 8: Menactra®	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	83.8 percentage of participants
Group 6 + Group 8: Menactra®	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	4.0 percentage of participants
Group 6 + Group 8: Menactra®	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	76.8 percentage of participants
Group 6 + Group 8: Menactra®	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	24.5 percentage of participants
Group 6 + Group 8: Menactra®	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	20.2 percentage of participants
Group 6 + Group 8: Menactra®	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	90.9 percentage of participants
Group 6 + Group 8: Menactra®	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	13.6 percentage of participants
Group 6 + Group 8: Menactra®	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	98.0 percentage of participants
Group 6 + Group 8: Menactra®	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	86.8 percentage of participants
Group 6 + Group 8: Menactra®	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	85.9 percentage of participants
Group 6 + Group 8: Menactra®	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	82.0 percentage of participants

Secondary

Group 7 and Group 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W

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

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

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 6 + Group 8: Menactra®	Group 7 and Group 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W	rSBA: Serogroup W: Day 30	10481 titer
Group 6 + Group 8: Menactra®	Group 7 and Group 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W	hSBA: Serogroup A: Day 0	6.71 titer
Group 6 + Group 8: Menactra®	Group 7 and Group 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W	rSBA: Serogroup A: Day 0	450 titer
Group 6 + Group 8: Menactra®	Group 7 and Group 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W	hSBA: Serogroup A: Day 30	31.9 titer
Group 6 + Group 8: Menactra®	Group 7 and Group 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W	rSBA: Serogroup Y: Day 0	25.7 titer
Group 6 + Group 8: Menactra®	Group 7 and Group 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W	hSBA: Serogroup C: Day 0	4.55 titer
Group 6 + Group 8: Menactra®	Group 7 and Group 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W	rSBA: Serogroup A: Day 30	10242 titer
Group 6 + Group 8: Menactra®	Group 7 and Group 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W	hSBA: Serogroup C: Day 30	59.2 titer
Group 6 + Group 8: Menactra®	Group 7 and Group 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W	rSBA: Serogroup W: Day 0	7.14 titer
Group 6 + Group 8: Menactra®	Group 7 and Group 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W	hSBA: Serogroup Y: Day 0	3.96 titer
Group 6 + Group 8: Menactra®	Group 7 and Group 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W	rSBA: Serogroup C: Day 0	4.77 titer
Group 6 + Group 8: Menactra®	Group 7 and Group 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W	hSBA: Serogroup Y: Day 30	81.5 titer
Group 6 + Group 8: Menactra®	Group 7 and Group 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W	rSBA: Serogroup Y: Day 30	8067 titer
Group 6 + Group 8: Menactra®	Group 7 and Group 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W	hSBA: Serogroup W: Day 0	5.85 titer
Group 6 + Group 8: Menactra®	Group 7 and Group 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W	rSBA: Serogroup C: Day 30	2317 titer
Group 6 + Group 8: Menactra®	Group 7 and Group 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W	hSBA: Serogroup W: Day 30	52.5 titer

Secondary

Group 7 and Group 8: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W

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

Arm	Measure	Group	Value (NUMBER)
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 5 + Group 7: MenACYW Conjugate Vaccine	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
Group 6 + Group 8: Menactra®	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
Group 6 + Group 8: Menactra®	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	86.6 percentage of participants
Group 6 + Group 8: Menactra®	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	83.5 percentage of participants
Group 6 + Group 8: Menactra®	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	57.6 percentage of participants
Group 6 + Group 8: Menactra®	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	46.2 percentage of participants
Group 6 + Group 8: Menactra®	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	93.5 percentage of participants
Group 6 + Group 8: Menactra®	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	80.2 percentage of participants
Group 6 + Group 8: Menactra®	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	82.3 percentage of participants
Group 6 + Group 8: Menactra®	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	26.4 percentage of participants
Group 6 + Group 8: Menactra®	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	57.1 percentage of participants
Group 6 + Group 8: Menactra®	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
Group 6 + Group 8: Menactra®	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	30.4 percentage of participants
Group 6 + Group 8: Menactra®	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	40.7 percentage of participants
Group 6 + Group 8: Menactra®	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	93.0 percentage of participants
Group 6 + Group 8: Menactra®	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
Group 6 + Group 8: Menactra®	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	82.8 percentage of participants
Group 6 + Group 8: Menactra®	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
Group 6 + Group 8: Menactra®	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	32.3 percentage of participants
Group 6 + Group 8: Menactra®	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	19.8 percentage of participants
Group 6 + Group 8: Menactra®	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	25.3 percentage of participants
Group 6 + Group 8: Menactra®	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	98.9 percentage of participants
Group 6 + Group 8: Menactra®	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	95.8 percentage of participants
Group 6 + Group 8: Menactra®	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	9.9 percentage of participants
Group 6 + Group 8: Menactra®	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	94.9 percentage of participants
Group 6 + Group 8: Menactra®	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	23.1 percentage of participants
Group 6 + Group 8: Menactra®	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	55.3 percentage of participants
Group 6 + Group 8: Menactra®	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	98.9 percentage of participants
Group 6 + Group 8: Menactra®	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	41.0 percentage of participants
Group 6 + Group 8: Menactra®	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	98.9 percentage of participants
Group 6 + Group 8: Menactra®	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	94.9 percentage of participants
Group 6 + Group 8: Menactra®	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	96.7 percentage of participants
Group 6 + Group 8: Menactra®	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	93.5 percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

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

Conditions

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Masking description

Intervention model description

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Group 5 + 7 and Group 6 + 8: Percentage of Participants Who Achieved Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W

Group 1 and Group 2: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W

Group 1 and Group 2: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W

Group 3 and Group 4: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W

Group 3 and Group 4: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W

Group 5 + 7 and Group 6 + 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W

Group 5 and Group 6: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W

Group 5 and Group 6: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W

Group 7 and Group 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W

Group 7 and Group 8: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W