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

    Summary
    EudraCT number
    		 2020-004341-36
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    28 Jan 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Feb 2025
    First version publication date
    09 Feb 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MET55
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04143061
    WHO universal trial number (UTN)
    		 U1111-1183-6581
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur Inc.
    Sponsor organisation address
    Discovery Drive, Swiftwater, PA, United States, 18370-0187
    Public contact
    Trial Transparency Team, Sanofi Pasteur, Contact-US@sanofi.com
    Scientific contact
    Trial Transparency Team, Sanofi Pasteur, Contact-US@sanofi.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    08 Nov 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Jan 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the non-inferiority of immunogenicity of a single dose of meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine [MenACYW conjugate vaccine] compared to meningococcal (groups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine [Menactra®] in adolescents and children aged 2 to 17 years in terms of serum bactericidal assay using human complement (hSBA) titers.
    Protection of trial subjects
    Vaccinations were performed by qualified and trained study personnel. Participants with allergy to any of the vaccine components were not vaccinated. After vaccination, participants were also kept under clinical observation for 30 minutes to ensure their safety. Appropriate medical equipment were also available on site in case of any immediate allergic reactions.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Dec 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    India: 863
    Country: Number of subjects enrolled
    South Africa: 465
    Worldwide total number of subjects
    1328
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    626
    Adolescents (12-17 years)
    304
    Adults (18-64 years)
    356
    From 65 to 84 years
    41
    85 years and over
    1

    Subject disposition

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

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Assessor, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1: MenACYW Conjugate Vaccine
    Arm description
    		 Adult participants aged 18 to 55 years in India received a single dose of 0.5 milliliter (mL) MenACYW conjugate vaccine as an intramuscular (IM) injection on Day 0.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MenACYW conjugate vaccine
    Investigational medicinal product code
    Other name
    Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants received MenACYW conjugate vaccine 0.5 mL IM injection into the deltoid muscle of the arm.

    Arm title
    		 Group 2: Menactra®
    Arm description
    		 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.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Menactra®
    Investigational medicinal product code
    Other name
    Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants received Menactra® 0.5 mL IM injection into the deltoid muscle of the arm.

    Arm title
    		 Group 3: MenACYW Conjugate Vaccine
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MenACYW conjugate vaccine
    Investigational medicinal product code
    Other name
    Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants received MenACYW conjugate vaccine 0.5 mL IM injection into the deltoid muscle of the arm.

    Arm title
    		 Group 4: Quadri Meningo™/Local Licensed Meningococcal Vaccine
    Arm description
    		 Adult participants aged ≥56 years in India received a single dose of 0.5 mL meningococcal polysaccharide vaccine (group A, C, Y and W135) [Quadri Meningo™] or any locally available licensed meningococcal vaccine as an IM injection on Day 0.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Quadri Meningo™
    Investigational medicinal product code
    Other name
    Meningococcal Polysaccharide Vaccine (Group A, C, Y & W135)
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants received Quadri Meningo™ or any locally available licensed meningococcal vaccine 0.5 mL IM injection into the deltoid muscle of the arm.

    Arm title
    		 Group 5: MenACYW Conjugate Vaccine
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MenACYW conjugate vaccine
    Investigational medicinal product code
    Other name
    Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants received MenACYW conjugate vaccine 0.5 mL IM injection into the deltoid muscle of the arm.

    Arm title
    		 Group 6: Menactra®
    Arm description
    		 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.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Menactra®
    Investigational medicinal product code
    Other name
    Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants received Menactra® 0.5 mL IM injection into the deltoid muscle of the arm.

    Arm title
    		 Group 7: MenACYW Conjugate Vaccine
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MenACYW conjugate vaccine
    Investigational medicinal product code
    Other name
    Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants received MenACYW conjugate vaccine 0.5 mL IM injection into the deltoid muscle of the arm.

    Arm title
    		 Group 8: Menactra®
    Arm description
    		 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.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Menactra®
    Investigational medicinal product code
    Other name
    Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants received Menactra® 0.5 mL IM injection into the deltoid muscle of the arm.

    Number of subjects in period 1
    		Group 1: MenACYW Conjugate Vaccine Group 2: Menactra® Group 3: MenACYW Conjugate Vaccine Group 4: Quadri Meningo™/Local Licensed Meningococcal Vaccine Group 5: MenACYW Conjugate Vaccine Group 6: Menactra® Group 7: MenACYW Conjugate Vaccine Group 8: Menactra®
    Started
    98
    100
    100
    100
    232
    233
    233
    232
    Completed
    96
    100
    100
    100
    224
    229
    226
    220
    Not completed
    2
    0
    0
    0
    8
    4
    7
    12
         Consent withdrawn by subject
    2
    -
    -
    -
    -
    1
    -
    -
         Protocol Deviation
    -
    -
    -
    -
    -
    -
    5
    5
         Withdrawal by Parent/Guardian
    -
    -
    -
    -
    8
    3
    2
    7

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1: MenACYW Conjugate Vaccine
    Reporting group description
    		 Adult participants aged 18 to 55 years in India received a single dose of 0.5 milliliter (mL) MenACYW conjugate vaccine as an intramuscular (IM) injection on Day 0.

    Reporting group title
    Group 2: Menactra®
    Reporting group description
    		 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.

    Reporting group title
    Group 3: MenACYW Conjugate Vaccine
    Reporting group description
    		 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.

    Reporting group title
    Group 4: Quadri Meningo™/Local Licensed Meningococcal Vaccine
    Reporting group description
    		 Adult participants aged ≥56 years in India received a single dose of 0.5 mL meningococcal polysaccharide vaccine (group A, C, Y and W135) [Quadri Meningo™] or any locally available licensed meningococcal vaccine as an IM injection on Day 0.

    Reporting group title
    Group 5: MenACYW Conjugate Vaccine
    Reporting group description
    		 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.

    Reporting group title
    Group 6: Menactra®
    Reporting group description
    		 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.

    Reporting group title
    Group 7: MenACYW Conjugate Vaccine
    Reporting group description
    		 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.

    Reporting group title
    Group 8: Menactra®
    Reporting group description
    		 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.

    Reporting group values
    		 Group 1: MenACYW Conjugate Vaccine Group 2: Menactra® Group 3: MenACYW Conjugate Vaccine Group 4: Quadri Meningo™/Local Licensed Meningococcal Vaccine Group 5: MenACYW Conjugate Vaccine Group 6: Menactra® Group 7: MenACYW Conjugate Vaccine Group 8: Menactra® Total
    Number of subjects
    		 98 100 100 100 232 233 233 232 1328
    Age categorical
    Units: participants
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 36.7 ( 9.21 ) 34.8 ( 9.05 ) 61.7 ( 6.09 ) 61.1 ( 5.61 ) 9.39 ( 4.19 ) 9.34 ( 4.10 ) 9.45 ( 4.01 ) 9.19 ( 4.19 ) -
    Sex: Female, Male
    Units: participants
        Female
    		 30 31 24 31 101 118 123 110 568
        Male
    		 68 69 76 69 131 115 110 122 760
    Race/Ethnicity, Customized
    Units: Subjects
        Asian
    		 98 100 100 100 232 233 0 0 863
        Black or African American
    		 0 0 0 0 0 0 142 139 281
        White
    		 0 0 0 0 0 0 9 10 19
        Not Reported
    		 0 0 0 0 0 0 6 3 9
        Unknown
    		 0 0 0 0 0 0 6 9 15
        Mixed Origin
    		 0 0 0 0 0 0 70 71 141

    End points

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    End points reporting groups
    Reporting group title
    Group 1: MenACYW Conjugate Vaccine
    Reporting group description
    		 Adult participants aged 18 to 55 years in India received a single dose of 0.5 milliliter (mL) MenACYW conjugate vaccine as an intramuscular (IM) injection on Day 0.

    Reporting group title
    Group 2: Menactra®
    Reporting group description
    		 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.

    Reporting group title
    Group 3: MenACYW Conjugate Vaccine
    Reporting group description
    		 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.

    Reporting group title
    Group 4: Quadri Meningo™/Local Licensed Meningococcal Vaccine
    Reporting group description
    		 Adult participants aged ≥56 years in India received a single dose of 0.5 mL meningococcal polysaccharide vaccine (group A, C, Y and W135) [Quadri Meningo™] or any locally available licensed meningococcal vaccine as an IM injection on Day 0.

    Reporting group title
    Group 5: MenACYW Conjugate Vaccine
    Reporting group description
    		 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.

    Reporting group title
    Group 6: Menactra®
    Reporting group description
    		 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.

    Reporting group title
    Group 7: MenACYW Conjugate Vaccine
    Reporting group description
    		 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.

    Reporting group title
    Group 8: Menactra®
    Reporting group description
    		 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.

    Subject analysis set title
    Group 5 + Group 7: MenACYW Conjugate Vaccine
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Children and adolescent participants aged 2 to 17 years in India and RSA received a single dose of 0.5 mL MenACYW conjugate vaccine as an IM injection on Day 0.

    Subject analysis set title
    Group 6 + Group 8: Menactra®
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Children and adolescent participants aged 2 to 17 years in India and RSA received a single dose of 0.5 mL Menactra® as an IM injection on Day 0.

    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

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    End point title
    		 Group 5 + 7 and Group 6 + 8: Percentage of Participants who Achieved Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W
    End point description
    Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured by 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. 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. Here, n=number of participants with data collected for each specific serogroup.
    End point type
    Primary
    End point timeframe
    Day 30 (30 days post-vaccination on Day 0)
    End point values
    		 Group 5 + Group 7: MenACYW Conjugate Vaccine Group 6 + Group 8: Menactra®
    Number of subjects analysed
    445
    445
    Units: percentage of participants
    number (confidence interval 95%)
        Serogroup A (n=443, 443)
    89.6 (86.4 to 92.3)
    83.1 (79.2 to 86.4)
        Serogroup C (n=445, 443)
    99.3 (98.0 to 99.9)
    77.7 (73.5 to 81.4)
        Serogroup Y (n=445, 443)
    96.6 (94.5 to 98.1)
    85.6 (81.9 to 88.7)
        Serogroup W (n=445, 445)
    98.7 (97.1 to 99.5)
    87.6 (84.2 to 90.6)
    Statistical analysis title
    		 Statistical analysis for Serogroup A
    Statistical analysis description
    The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) was >-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.
    Comparison groups
    Group 5 + Group 7: MenACYW Conjugate Vaccine v Group 6 + Group 8: Menactra®
    Number of subjects included in analysis
    890
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in percentage of participants
    Point estimate
    6.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.03
         upper limit
    		 11.08
    Statistical analysis title
    		 Statistical analysis for Serogroup W
    Statistical analysis description
    The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was >-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.
    Comparison groups
    Group 5 + Group 7: MenACYW Conjugate Vaccine v Group 6 + Group 8: Menactra®
    Number of subjects included in analysis
    890
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in percentage of participants
    Point estimate
    11.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7.86
         upper limit
    		 14.47
    Statistical analysis title
    		 Statistical analysis for Serogroup Y
    Statistical analysis description
    The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was >-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.
    Comparison groups
    Group 5 + Group 7: MenACYW Conjugate Vaccine v Group 6 + Group 8: Menactra®
    Number of subjects included in analysis
    890
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in percentage of participants
    Point estimate
    11.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7.43
         upper limit
    		 14.89
    Statistical analysis title
    		 Statistical analysis for Serogroup C
    Statistical analysis description
    The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was >-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.
    Comparison groups
    Group 5 + Group 7: MenACYW Conjugate Vaccine v Group 6 + Group 8: Menactra®
    Number of subjects included in analysis
    890
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in percentage of participants
    Point estimate
    21.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 17.82
         upper limit
    		 25.8

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

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    End point title
    		 Group 1 and Group 2: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W [1]
    End point description
    Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured by hSBA and serum bactericidal assay using baby rabbit complement (rSBA). 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. Here, n=number of participants with data collected for each specific serogroup at the specified timepoint.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only participants in Group 1 and Group 2 of the study were analyzed in this endpoint.
    End point values
    		 Group 1: MenACYW Conjugate Vaccine Group 2: Menactra®
    Number of subjects analysed
    95
    99
    Units: titer
    geometric mean (confidence interval 95%)
        hSBA: Serogroup A: Day 0 (n=95,99)
    7.28 (6.03 to 8.78)
    9.60 (7.68 to 12.0)
        hSBA: Serogroup A: Day 30 (n=94,99)
    52.8 (34.7 to 80.3)
    39.2 (27.8 to 55.3)
        hSBA: Serogroup C: Day 0 (n=95,99)
    6.20 (4.99 to 7.70)
    7.05 (5.53 to 8.99)
        hSBA: Serogroup C: Day 30 (n=95,99)
    551 (365 to 831)
    107 (68.8 to 165)
        hSBA: Serogroup Y: Day 0 (n=95,99)
    5.24 (3.86 to 7.11)
    4.03 (3.09 to 5.25)
        hSBA: Serogroup Y: Day 30 (n=95,99)
    119 (80.2 to 177)
    47.4 (30.7 to 73.1)
        hSBA: Serogroup W: Day 0 (n=95,99)
    4.18 (3.39 to 5.15)
    4.17 (3.39 to 5.14)
        hSBA: Serogroup W: Day 30 (n=94,99)
    106 (72.8 to 153)
    63.1 (44.7 to 89.1)
        rSBA: Serogroup A: Day 0 (n=45,47)
    194 (81.3 to 463)
    64.0 (25.9 to 158)
        rSBA: Serogroup A: Day 30 (n=45,48)
    10644 (7745 to 14629)
    4467 (3428 to 5820)
        rSBA: Serogroup C: Day 0 (n=45,49)
    5.88 (3.51 to 9.86)
    4.88 (3.00 to 7.93)
        rSBA: Serogroup C: Day 30 (n=45,48)
    12227 (7923 to 18868)
    1149 (612 to 2158)
        rSBA: Serogroup Y: Day 0 (n=44,43)
    9.36 (4.33 to 20.2)
    9.40 (4.12 to 21.5)
        rSBA: Serogroup Y: Day 30 (n=43,47)
    5934 (3758 to 9372)
    3534 (2545 to 4909)
        rSBA: Serogroup W: Day 0 (n=45,49)
    15.5 (6.49 to 37.1)
    7.56 (3.49 to 16.4)
        rSBA: Serogroup W: Day 30 (n=45,48)
    16638 (10325 to 26812)
    7732 (4098 to 14589)
    No statistical analyses for this end point

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

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    End point title
    		 Group 1 and Group 2: Percentage of Participants who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W [2]
    End point description
    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. 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. Here, n=number of participants with data collected for each specific serogroup at the specified timepoint.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only participants in Group 1 and Group 2 of the study were analyzed in this endpoint.
    End point values
    		 Group 1: MenACYW Conjugate Vaccine Group 2: Menactra®
    Number of subjects analysed
    95
    99
    Units: percentage of participants
    number (confidence interval 95%)
        hSBA: Serogroup A: Day 0: ≥1:4 (n=95,99)
    81.1 (71.7 to 88.4)
    87.9 (79.8 to 93.6)
        hSBA: Serogroup A: Day 0: ≥1:8 (n=95,99)
    61.1 (50.5 to 70.9)
    72.7 (62.9 to 81.2)
        hSBA: Serogroup A: Day 30: ≥1:4 (n=94,99)
    87.2 (78.8 to 93.2)
    93.9 (87.3 to 97.7)
        hSBA: Serogroup A: Day 30: ≥1:8 (n=94,99)
    76.6 (66.7 to 84.7)
    87.9 (79.8 to 93.6)
        hSBA: Serogroup C: Day 0: ≥1:4 (n=95,99)
    69.5 (59.2 to 78.5)
    69.7 (59.6 to 78.5)
        hSBA: Serogroup C: Day 0: ≥1:8 (n=95,99)
    47.4 (37.0 to 57.9)
    50.5 (40.3 to 60.7)
        hSBA: Serogroup C: Day 30: ≥1:4 (n=95,99)
    98.9 (94.3 to 100)
    93.9 (87.3 to 97.7)
        hSBA: Serogroup C: Day 30: ≥1:8 (n=95,99)
    96.8 (91.0 to 99.3)
    88.9 (81.0 to 94.3)
        hSBA: Serogroup Y: Day 0: ≥1:4 (n=95,99)
    38.9 (29.1 to 49.5)
    30.3 (21.5 to 40.4)
        hSBA: Serogroup Y: Day 0: ≥1:8 (n=95,99)
    29.5 (20.6 to 39.7)
    24.2 (16.2 to 33.9)
        hSBA: Serogroup Y: Day 30: ≥1:4 (n=95,99)
    93.7 (86.8 to 97.6)
    82.8 (73.9 to 89.7)
        hSBA: Serogroup Y: Day 30: ≥1:8 (n=95,99)
    92.6 (85.4 to 97.0)
    76.8 (67.2 to 84.7)
        hSBA: Serogroup W: Day 0: ≥1:4 (n=95,99)
    44.2 (34.0 to 54.8)
    44.4 (34.5 to 54.8)
        hSBA: Serogroup W: Day 0: ≥1:8 (n=95,99)
    29.5 (20.6 to 39.7)
    29.3 (20.6 to 39.3)
        hSBA: Serogroup W: Day 30: ≥1:4 (n=94,99)
    96.8 (91.0 to 99.3)
    96.0 (90.0 to 98.9)
        hSBA: Serogroup W: Day 30: ≥1:8 (n=94,99)
    93.6 (86.6 to 97.6)
    90.9 (83.4 to 95.8)
        rSBA: Serogroup A: Day 0: ≥1:8 (n=45,47)
    75.6 (60.5 to 87.1)
    61.7 (46.4 to 75.5)
        rSBA: Serogroup A: Day 0: ≥1:128 (n=45,47)
    62.2 (46.5 to 76.2)
    48.9 (34.1 to 63.9)
        rSBA: Serogroup A: Day 30: ≥1:8 (n=45,48)
    100 (92.1 to 100)
    100 (92.6 to 100)
        rSBA: Serogroup A: Day 30: ≥1:128 (n=45,48)
    100 (92.1 to 100)
    100 (92.6 to 100)
        rSBA: Serogroup C: Day 0: ≥1:8 (n=45,49)
    28.9 (16.4 to 44.3)
    24.5 (13.3 to 38.9)
        rSBA: Serogroup C: Day 0: ≥1:128 (n=45,49)
    11.1 (3.7 to 24.1)
    10.2 (3.4 to 22.2)
        rSBA: Serogroup C: Day 30: ≥1:8 (n=45,48)
    100 (92.1 to 100)
    95.8 (85.7 to 99.5)
        rSBA: Serogroup C: Day 30: ≥1:128 (n=45,48)
    100 (92.1 to 100)
    89.6 (77.3 to 96.5)
        rSBA: Serogroup Y: Day 0: ≥1:8 (n=44,43)
    29.5 (16.8 to 45.2)
    25.6 (13.5 to 41.2)
        rSBA: Serogroup Y: Day 0: ≥1:128 (n=44,43)
    25.0 (13.2 to 40.3)
    23.3 (11.8 to 38.6)
        rSBA: Serogroup Y: Day 30: ≥1:8 (n=43,47)
    97.7 (87.7 to 99.9)
    100 (92.5 to 100)
        rSBA: Serogroup Y: Day 30: ≥1:128 (n=43,47)
    97.7 (87.7 to 99.9)
    100 (92.5 to 100)
        rSBA: Serogroup W: Day 0: ≥1:8 (n=45,49)
    35.6 (21.9 to 51.2)
    20.4 (10.2 to 34.3)
        rSBA: Serogroup W: Day 0: ≥1:128 (n=45,49)
    31.1 (18.2 to 46.6)
    20.4 (10.2 to 34.3)
        rSBA: Serogroup W: Day 30: ≥1:8 (n=45,48)
    100 (92.1 to 100)
    97.9 (88.9 to 99.9)
        rSBA: Serogroup W: Day 30: ≥1:128 (n=45,48)
    100 (92.1 to 100)
    97.9 (88.9 to 99.9)
    No statistical analyses for this end point

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

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    End point title
    		 Group 3 and Group 4: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W [3]
    End point description
    Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured by hSBA and rSBA. 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. Here, n=number of participants with data collected for each specific serogroup at the specified timepoint.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only participants in Group 3 and Group 4 of the study were analyzed in this endpoint.
    End point values
    		 Group 3: MenACYW Conjugate Vaccine Group 4: Quadri Meningo™/Local Licensed Meningococcal Vaccine
    Number of subjects analysed
    97
    96
    Units: titer
    geometric mean (confidence interval 95%)
        hSBA: Serogroup A: Day 0 (n=97,96)
    15.3 (12.2 to 19.3)
    12.5 (10.2 to 15.4)
        hSBA: Serogroup A: Day 30 (n=96,96)
    56.6 (38.2 to 83.9)
    36.2 (26.8 to 48.8)
        hSBA: Serogroup C: Day 0 (n=97,96)
    8.00 (6.18 to 10.4)
    8.00 (6.13 to 10.4)
        hSBA: Serogroup C: Day 30 (n=97,96)
    393 (255 to 606)
    159 (102 to 248)
        hSBA: Serogroup Y: Day 0 (n=97,96)
    6.36 (4.57 to 8.86)
    6.97 (5.03 to 9.68)
        hSBA: Serogroup Y: Day 30 (n=97,96)
    197 (127 to 303)
    55.4 (35.5 to 86.4)
        hSBA: Serogroup W: Day 0 (n=97,96)
    4.42 (3.53 to 5.54)
    5.66 (4.40 to 7.27)
        hSBA: Serogroup W: Day 30 (n=97,96)
    90.8 (60.4 to 137)
    34.6 (23.5 to 51.2)
        rSBA: Serogroup A: Day 0 (n=48,47)
    83.0 (37.0 to 186)
    46.3 (20.1 to 106)
        rSBA: Serogroup A: Day 30 (n=49,47)
    5834 (3730 to 9124)
    4677 (2935 to 7455)
        rSBA: Serogroup C: Day 0 (n=49,47)
    6.47 (3.69 to 11.3)
    5.53 (3.06 to 9.99)
        rSBA: Serogroup C: Day 30 (n=49,47)
    9304 (5532 to 15649)
    3283 (1680 to 6415)
        rSBA: Serogroup Y: Day 0 (n=45,46)
    6.86 (3.33 to 14.1)
    8.24 (3.94 to 17.3)
        rSBA: Serogroup Y: Day 30 (n=49,47)
    4274 (2640 to 6917)
    1119 (529 to 2366)
        rSBA: Serogroup W: Day 0 (n=48,46)
    11.6 (5.55 to 24.4)
    12.4 (5.04 to 30.4)
        rSBA: Serogroup W: Day 30 (n=49,47)
    6626 (3243 to 13539)
    2304 (925 to 5739)
    No statistical analyses for this end point

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

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    End point title
    		 Group 3 and Group 4: Percentage of Participants who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W [4]
    End point description
    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. 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. Here, n=number of participants with data collected for each specific serogroup at the specified timepoint.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only participants in Group 3 and Group 4 of the study were analyzed in this endpoint.
    End point values
    		 Group 3: MenACYW Conjugate Vaccine Group 4: Quadri Meningo™/Local Licensed Meningococcal Vaccine
    Number of subjects analysed
    97
    96
    Units: percentage of participants
    number (confidence interval 95%)
        hSBA: Serogroup A: Day 0: ≥1:4 (n=97,96)
    94.8 (88.4 to 98.3)
    93.8 (86.9 to 97.7)
        hSBA: Serogroup A: Day 0: ≥1:8 (n=97,96)
    82.5 (73.4 to 89.4)
    77.1 (67.4 to 85.0)
        hSBA: Serogroup A: Day 30: ≥1:4 (n=96,96)
    89.6 (81.7 to 94.9)
    96.9 (91.1 to 99.4)
        hSBA: Serogroup A: Day 30: ≥1:8 (n=96,96)
    82.3 (73.2 to 89.3)
    86.5 (78.0 to 92.6)
        hSBA: Serogroup C: Day 0: ≥1:4 (n=97,96)
    71.1 (61.0 to 79.9)
    75.0 (65.1 to 83.3)
        hSBA: Serogroup C: Day 0: ≥1:8 (n=97,96)
    53.6 (43.2 to 63.8)
    50.0 (39.6 to 60.4)
        hSBA: Serogroup C: Day 30: ≥1:4 (n=97,96)
    97.9 (92.7 to 99.7)
    92.7 (85.6 to 97.0)
        hSBA: Serogroup C: Day 30: ≥1:8 (n=97,96)
    95.9 (89.8 to 98.9)
    89.6 (81.7 to 94.9)
        hSBA: Serogroup Y: Day 0: ≥1:4 (n=97,96)
    45.4 (35.2 to 55.8)
    51.0 (40.6 to 61.4)
        hSBA: Serogroup Y: Day 0: ≥1:8 (n=97,96)
    36.1 (26.6 to 46.5)
    40.6 (30.7 to 51.1)
        hSBA: Serogroup Y: Day 30: ≥1:4 (n=97,96)
    93.8 (87.0 to 97.7)
    83.3 (74.4 to 90.2)
        hSBA: Serogroup Y: Day 30: ≥1:8 (n=97,96)
    93.8 (87.0 to 97.7)
    79.2 (69.7 to 86.8)
        hSBA: Serogroup W: Day 0: ≥1:4 (n=97,96)
    45.4 (35.2 to 55.8)
    54.2 (43.7 to 64.4)
        hSBA: Serogroup W: Day 0: ≥1:8 (n=97,96)
    30.9 (21.9 to 41.1)
    38.5 (28.8 to 49.0)
        hSBA: Serogroup W: Day 30: ≥1:4 (n=97,96)
    91.8 (84.4 to 96.4)
    90.6 (82.9 to 95.6)
        hSBA: Serogroup W: Day 30: ≥1:8 (n=97,96)
    89.7 (81.9 to 94.9)
    79.2 (69.7 to 86.8)
        rSBA: Serogroup A: Day 0: ≥1:8 (n=48,47)
    68.8 (53.7 to 81.3)
    55.3 (40.1 to 69.8)
        rSBA: Serogroup A: Day 0: ≥1:128 (n=48,47)
    56.3 (41.2 to 70.5)
    46.8 (32.1 to 61.9)
        rSBA: Serogroup A: Day 30: ≥1:8 (n=49,47)
    98.0 (89.1 to 99.9)
    100 (92.5 to 100)
        rSBA: Serogroup A: Day 30: ≥1:128 (n=49,47)
    98.0 (89.1 to 99.9)
    97.9 (88.7 to 99.9)
        rSBA: Serogroup C: Day 0: ≥1:8 (n=49,47)
    30.6 (18.3 to 45.4)
    21.3 (10.7 to 35.7)
        rSBA: Serogroup C: Day 0: ≥1:128 (n=49,47)
    16.3 (7.3 to 29.7)
    10.6 (3.5 to 23.1)
        rSBA: Serogroup C: Day 30: ≥1:8 (n=49,47)
    98.0 (89.1 to 99.9)
    93.6 (82.5 to 98.7)
        rSBA: Serogroup C: Day 30: ≥1:128 (n=49,47)
    98.0 (89.1 to 99.9)
    93.6 (82.5 to 98.7)
        rSBA: Serogroup Y: Day 0: ≥1:8 (n=45,46)
    20.0 (9.6 to 34.6)
    26.1 (14.3 to 41.1)
        rSBA: Serogroup Y: Day 0: ≥1:128 (n=45,46)
    20.0 (9.6 to 34.6)
    21.7 (10.9 to 36.4)
        rSBA: Serogroup Y: Day 30: ≥1:8 (n=49,47)
    98.0 (89.1 to 99.9)
    89.4 (76.9 to 96.5)
        rSBA: Serogroup Y: Day 30: ≥1:128 (n=49,47)
    98.0 (89.1 to 99.9)
    89.4 (76.9 to 96.5)
        rSBA: Serogroup W: Day 0: ≥1:8 (n=48,46)
    33.3 (20.4 to 48.4)
    30.4 (17.7 to 45.8)
        rSBA: Serogroup W: Day 0: ≥1:128 (n=48,46)
    31.3 (18.7 to 46.3)
    28.3 (16.0 to 43.5)
        rSBA: Serogroup W: Day 30: ≥1:8 (n=49,47)
    95.9 (86.0 to 99.5)
    89.4 (76.9 to 96.5)
        rSBA: Serogroup W: Day 30: ≥1:128 (n=49,47)
    93.9 (83.1 to 98.7)
    87.2 (74.3 to 95.2)
    No statistical analyses for this end point

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

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    End point title
    		 Group 5 + 7 and Group 6 + 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W
    End point description
    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. 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. Here, n=number of participants with data collected for each specific serogroup at the specified timepoint.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)
    End point values
    		 Group 5 + Group 7: MenACYW Conjugate Vaccine Group 6 + Group 8: Menactra®
    Number of subjects analysed
    445
    445
    Units: titer
    geometric mean (confidence interval 95%)
        hSBA: Serogroup A: Day 0 (n=445,445)
    7.40 (6.79 to 8.07)
    7.21 (6.66 to 7.80)
        hSBA: Serogroup A: Day 30 (n=443,443)
    56.1 (48.5 to 65.0)
    36.3 (31.0 to 42.5)
        hSBA: Serogroup C: Day 0 (n=445,445)
    3.97 (3.63 to 4.34)
    3.78 (3.46 to 4.13)
        hSBA: Serogroup C: Day 30 (n=445,443)
    600 (521 to 692)
    47.3 (38.3 to 58.4)
        hSBA: Serogroup Y: Day 0 (n=443,445)
    3.50 (3.13 to 3.91)
    3.50 (3.14 to 3.91)
        hSBA: Serogroup Y: Day 30 (n=445,443)
    167 (145 to 191)
    46.2 (39.3 to 54.3)
        hSBA: Serogroup W: Day 0 (n=445,445)
    4.31 (3.88 to 4.78)
    4.04 (3.65 to 4.48)
        hSBA: Serogroup W: Day 30 (n=445,445)
    121 (106 to 137)
    35.4 (30.4 to 41.1)
        rSBA: Serogroup A: Day 0 (n=186,189)
    308 (199 to 478)
    387 (260 to 577)
        rSBA: Serogroup A: Day 30 (n=191,189)
    10561 (9223 to 12094)
    8313 (7275 to 9499)
        rSBA: Serogroup C: Day 0 (n=191,190)
    3.56 (2.91 to 4.36)
    3.73 (3.02 to 4.62)
        rSBA: Serogroup C: Day 30 (n=191,189)
    14430 (11923 to 17463)
    1199 (869 to 1655)
        rSBA: Serogroup Y: Day 0 (n=181,182)
    17.3 (11.5 to 26.2)
    21.9 (14.4 to 33.4)
        rSBA: Serogroup Y: Day 30 (n=191,188)
    15404 (13409 to 17696)
    5966 (4850 to 7339)
        rSBA: Serogroup W: Day 0 (n=189,189)
    7.01 (5.00 to 9.83)
    7.46 (5.36 to 10.4)
        rSBA: Serogroup W: Day 30 (n=191,189)
    19644 (16338 to 23618)
    6598 (5160 to 8437)
    No statistical analyses for this end point

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

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    End point title
    		 Group 5 and Group 6: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W [5]
    End point description
    Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured by hSBA and rSBA. 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. Here, n=number of participants with data collected for each specific serogroup at the specified timepoint.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only participants in Group 5 and Group 6 of the study were analyzed in this endpoint.
    End point values
    		 Group 5: MenACYW Conjugate Vaccine Group 6: Menactra®
    Number of subjects analysed
    222
    228
    Units: titer
    geometric mean (confidence interval 95%)
        hSBA: Serogroup A: Day 0 (n=222,228)
    7.33 (6.50 to 8.26)
    7.71 (6.94 to 8.58)
        hSBA: Serogroup A: Day 30 (n=220,228)
    70.3 (56.5 to 87.6)
    40.9 (32.8 to 51.1)
        hSBA: Serogroup C: Day 0 (n=222,228)
    3.36 (3.00 to 3.76)
    3.17 (2.84 to 3.55)
        hSBA: Serogroup C: Day 30 (n=222,228)
    595 (494 to 716)
    38.3 (28.4 to 51.6)
        hSBA: Serogroup Y: Day 0 (n=222,228)
    3.32 (2.84 to 3.88)
    3.12 (2.70 to 3.60)
        hSBA: Serogroup Y: Day 30 (n=222,228)
    119 (97.4 to 145)
    27.1 (21.7 to 33.8)
        hSBA: Serogroup W: Day 0 (n=222,228)
    3.23 (2.86 to 3.65)
    2.85 (2.56 to 3.17)
        hSBA: Serogroup W: Day 30 (n=222,228)
    92.8 (78.7 to 109)
    24.3 (19.8 to 29.7)
        rSBA: Serogroup A: Day 0 (n=92,98)
    159 (81.9 to 310)
    337 (188 to 605)
        rSBA: Serogroup A: Day 30 (n=97,99)
    11462 (9425 to 13938)
    6877 (5755 to 8217)
        rSBA: Serogroup C: Day 0 (n=97,99)
    3.09 (2.39 to 4.01)
    2.98 (2.40 to 3.70)
        rSBA: Serogroup C: Day 30 (n=97,99)
    11139 (8843 to 14030)
    659 (413 to 1052)
        rSBA: Serogroup Y: Day 0 (n=87,91)
    11.4 (6.25 to 20.6)
    18.8 (10.4 to 33.7)
        rSBA: Serogroup Y: Day 30 (n=97,98)
    15696 (12565 to 19609)
    4522 (3316 to 6168)
        rSBA: Serogroup W: Day 0 (n=95,98)
    6.62 (4.10 to 10.7)
    7.78 (4.78 to 12.7)
        rSBA: Serogroup W: Day 30 (n=97,99)
    19037 (14748 to 24572)
    4332 (2969 to 6320)
    No statistical analyses for this end point

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

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    End point title
    		 Group 5 and Group 6: Percentage of Participants who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W [6]
    End point description
    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. 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. Here, n=number of participants with data collected for each specific serogroup at the specified timepoint.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only participants in Group 5 and Group 6 of the study were analyzed in this endpoint.
    End point values
    		 Group 5: MenACYW Conjugate Vaccine Group 6: Menactra®
    Number of subjects analysed
    222
    228
    Units: percentage of participants
    number (confidence interval 95%)
        hSBA: Serogroup A: Day 0: ≥1:4 (n=222,228)
    85.1 (79.8 to 89.5)
    91.2 (86.8 to 94.6)
        hSBA: Serogroup A: Day 0: ≥1:8 (n=222,228)
    60.8 (54.1 to 67.3)
    63.6 (57.0 to 69.8)
        hSBA: Serogroup A: Day 30: ≥1:4 (n=220,228)
    92.3 (87.9 to 95.4)
    94.7 (91.0 to 97.3)
        hSBA: Serogroup A: Day 30: ≥1:8 (n=220,228)
    89.5 (84.7 to 93.3)
    83.8 (78.3 to 88.3)
        hSBA: Serogroup C: Day 0: ≥1:4 (n=222,228)
    37.8 (31.4 to 44.6)
    30.7 (24.8 to 37.1)
        hSBA: Serogroup C: Day 0: ≥1:8 (n=222,228)
    19.8 (14.8 to 25.7)
    18.4 (13.6 to 24.1)
        hSBA: Serogroup C: Day 30: ≥1:4 (n=222,228)
    99.5 (97.5 to 100)
    82.9 (77.4 to 87.5)
        hSBA: Serogroup C: Day 30: ≥1:8 (n=222,228)
    99.5 (97.5 to 100)
    72.8 (66.5 to 78.5)
        hSBA: Serogroup Y: Day 0: ≥1:4 (n=222,228)
    21.2 (16.0 to 27.1)
    18.9 (14.0 to 24.6)
        hSBA: Serogroup Y: Day 0: ≥1:8 (n=222,228)
    16.2 (11.6 to 21.7)
    13.6 (9.4 to 18.7)
        hSBA: Serogroup Y: Day 30: ≥1:4 (n=222,228)
    94.1 (90.2 to 96.8)
    83.8 (78.3 to 88.3)
        hSBA: Serogroup Y: Day 30: ≥1:8 (n=222,228)
    93.7 (89.6 to 96.5)
    76.8 (70.7 to 82.1)
        hSBA: Serogroup W: Day 0: ≥1:4 (n=222,228)
    27.9 (22.1 to 34.3)
    20.2 (15.2 to 26.0)
        hSBA: Serogroup W: Day 0: ≥1:8 (n=222,228)
    18.9 (14.0 to 24.7)
    13.6 (9.4 to 18.7)
        hSBA: Serogroup W: Day 30: ≥1:4 (n=222,228)
    99.1 (96.8 to 99.9)
    86.8 (81.8 to 90.9)
        hSBA: Serogroup W: Day 30: ≥1:8 (n=222,228)
    98.2 (95.5 to 99.5)
    82.0 (76.4 to 86.8)
        rSBA: Serogroup A: Day 0: ≥1:8 (n=92,98)
    66.3 (55.7 to 75.8)
    76.5 (66.9 to 84.5)
        rSBA: Serogroup A: Day 0: ≥1:128 (n=92,98)
    62.0 (51.2 to 71.9)
    73.5 (63.6 to 81.9)
        rSBA: Serogroup A: Day 30: ≥1:8 (n=97,99)
    100 (96.3 to 100)
    100 (96.3 to 100)
        rSBA: Serogroup A: Day 30: ≥1:128 (n=97,99)
    100 (96.3 to 100)
    100 (96.3 to 100)
        rSBA: Serogroup C: Day 0: ≥1:8 (n=97,99)
    11.3 (5.8 to 19.4)
    13.1 (7.2 to 21.4)
        rSBA: Serogroup C: Day 0: ≥1:128 (n=97,99)
    5.2 (1.7 to 11.6)
    4.0 (1.1 to 10.0)
        rSBA: Serogroup C: Day 30: ≥1:8 (n=97,99)
    100 (96.3 to 100)
    90.9 (83.4 to 95.8)
        rSBA: Serogroup C: Day 30: ≥1:128 (n=97,99)
    100 (96.3 to 100)
    85.9 (77.4 to 92.0)
        rSBA: Serogroup Y: Day 0: ≥1:8 (n=87,91)
    28.7 (19.5 to 39.4)
    40.7 (30.5 to 51.5)
        rSBA: Serogroup Y: Day 0: ≥1:128 (n=87,91)
    28.7 (19.5 to 39.4)
    38.5 (28.4 to 49.2)
        rSBA: Serogroup Y: Day 30: ≥1:8 (n=97,98)
    100 (96.3 to 100)
    98.0 (92.8 to 99.8)
        rSBA: Serogroup Y: Day 30: ≥1:128 (n=97,98)
    100 (96.3 to 100)
    98.0 (92.8 to 99.8)
        rSBA: Serogroup W: Day 0: ≥1:8 (n=95,98)
    21.1 (13.4 to 30.6)
    24.5 (16.4 to 34.2)
        rSBA: Serogroup W: Day 0: ≥1:128 (n=95,98)
    21.1 (13.4 to 30.6)
    24.5 (16.4 to 34.2)
        rSBA: Serogroup W: Day 30: ≥1:8 (n=97,99)
    100 (96.3 to 100)
    98.0 (92.9 to 99.8)
        rSBA: Serogroup W: Day 30: ≥1:128 (n=97,99)
    100 (96.3 to 100)
    97.0 (91.4 to 99.4)
    No statistical analyses for this end point

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

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    End point title
    		 Group 7 and Group 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W [7]
    End point description
    Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured by hSBA and rSBA. 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. Here, n=number of participants with data collected for each specific serogroup at the specified timepoint.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only participants in Group 7 and Group 8 of the study were analyzed in this endpoint.
    End point values
    		 Group 7: MenACYW Conjugate Vaccine Group 8: Menactra®
    Number of subjects analysed
    223
    217
    Units: titer
    geometric mean (confidence interval 95%)
        hSBA: Serogroup A: Day 0 (n=223, 217)
    7.47 (6.59 to 8.47)
    6.71 (5.97 to 7.55)
        hSBA: Serogroup A: Day 30 (n=223, 215)
    44.9 (37.1 to 54.4)
    31.9 (25.5 to 40.0)
        hSBA: Serogroup C: Day 0 (n=223, 217)
    4.69 (4.10 to 5.36)
    4.55 (3.97 to 5.20)
        hSBA: Serogroup C: Day 30 (n=223, 215)
    606 (488 to 751)
    59.2 (44.0 to 79.7)
        hSBA: Serogroup Y: Day 0 (n=221, 217)
    3.69 (3.13 to 4.34)
    3.96 (3.35 to 4.69)
        hSBA: Serogroup Y: Day 30 (n=223, 215)
    233 (195 to 279)
    81.5 (66.0 to 101)
        hSBA: Serogroup W: Day 0 (n=223, 217)
    5.74 (4.89 to 6.74)
    5.85 (4.97 to 6.88)
        hSBA: Serogroup W: Day 30 (n=223, 217)
    157 (129 to 191)
    52.5 (42.3 to 65.2)
        rSBA: Serogroup A: Day 0 (n=94, 91)
    589 (338 to 1026)
    450 (260 to 778)
        rSBA: Serogroup A: Day 30 (n=94, 90)
    9706 (8032 to 11729)
    10242 (8432 to 12440)
        rSBA: Serogroup C: Day 0 (n=94, 91)
    4.12 (3.00 to 5.66)
    4.77 (3.28 to 6.93)
        rSBA: Serogroup C: Day 30 (n=94, 90)
    18848 (13953 to 25460)
    2317 (1544 to 3476)
        rSBA: Serogroup Y: Day 0 (n=94, 91)
    25.6 (14.6 to 45.2)
    25.7 (13.9 to 47.3)
        rSBA: Serogroup Y: Day 30 (n=94, 90)
    15108 (12775 to 17865)
    8067 (6207 to 10483)
        rSBA: Serogroup W: Day 0 (n=94, 91)
    7.43 (4.57 to 12.1)
    7.14 (4.55 to 11.2)
        rSBA: Serogroup W: Day 30 (n=94, 90)
    20290 (15479 to 26598)
    10481 (7890 to 13924)
    No statistical analyses for this end point

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

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    End point title
    		 Group 7 and Group 8: Percentage of Participants who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W [8]
    End point description
    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. 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. Here, n=number of participants with data collected for each specific serogroup at the specified timepoint.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only participants in Group 7 and Group 8 of the study were analyzed in this endpoint.
    End point values
    		 Group 7: MenACYW Conjugate Vaccine Group 8: Menactra®
    Number of subjects analysed
    223
    217
    Units: percentage of participants
    number (confidence interval 95%)
        hSBA: Serogroup A: Day 0: ≥1:4 (n=223,217)
    88.8 (83.9 to 92.6)
    86.6 (81.4 to 90.9)
        hSBA: Serogroup A: Day 0: ≥1:8 (n=223,217)
    61.0 (54.2 to 67.4)
    57.6 (50.7 to 64.3)
        hSBA: Serogroup A: Day 30: ≥1:4 (n=223,215)
    96.9 (93.6 to 98.7)
    93.5 (89.3 to 96.4)
        hSBA: Serogroup A: Day 30: ≥1:8 (n=223,215)
    89.7 (84.9 to 93.3)
    82.3 (76.6 to 87.2)
        hSBA: Serogroup C: Day 0: ≥1:4 (n=223,217)
    58.3 (51.5 to 64.8)
    57.1 (50.3 to 63.8)
        hSBA: Serogroup C: Day 0: ≥1:8 (n=223,217)
    32.3 (26.2 to 38.9)
    30.4 (24.4 to 37.0)
        hSBA: Serogroup C: Day 30: ≥1:4 (n=223,215)
    99.6 (97.5 to 100)
    93.0 (88.8 to 96.0)
        hSBA: Serogroup C: Day 30: ≥1:8 (n=223,215)
    99.1 (96.8 to 99.9)
    82.8 (77.1 to 87.6)
        hSBA: Serogroup Y: Day 0: ≥1:4 (n=221,217)
    28.1 (22.2 to 34.5)
    32.3 (26.1 to 38.9)
        hSBA: Serogroup Y: Day 0: ≥1:8 (n=221,217)
    21.3 (16.1 to 27.3)
    25.3 (19.7 to 31.7)
        hSBA: Serogroup Y: Day 30: ≥1:4 (n=223,215)
    99.6 (97.5 to 100)
    95.8 (92.2 to 98.1)
        hSBA: Serogroup Y: Day 30: ≥1:8 (n=223,215)
    99.6 (97.5 to 100)
    94.9 (91.0 to 97.4)
        hSBA: Serogroup W: Day 0: ≥1:4 (n=223,217)
    53.4 (46.6 to 60.1)
    55.3 (48.4 to 62.0)
        hSBA: Serogroup W: Day 0: ≥1:8 (n=223,217)
    42.2 (35.6 to 48.9)
    41.0 (34.4 to 47.9)
        hSBA: Serogroup W: Day 30: ≥1:4 (n=223,217)
    99.1 (96.8 to 99.9)
    94.9 (91.1 to 97.4)
        hSBA: Serogroup W: Day 30: ≥1:8 (n=223,217)
    99.1 (96.8 to 99.9)
    93.5 (89.4 to 96.4)
        rSBA: Serogroup A: Day 0: ≥1:8 (n=94,91)
    84.0 (75.0 to 90.8)
    83.5 (74.3 to 90.5)
        rSBA: Serogroup A: Day 0: ≥1:128 (n=94,91)
    81.9 (72.6 to 89.1)
    80.2 (70.6 to 87.8)
        rSBA: Serogroup A: Day 30: ≥1:8 (n=94,90)
    100 (96.2 to 100)
    100 (96.0 to 100)
        rSBA: Serogroup A: Day 30: ≥1:128 (n=94,90)
    100 (96.2 to 100)
    100 (96.0 to 100)
        rSBA: Serogroup C: Day 0: ≥1:8 (n=94,91)
    19.1 (11.8 to 28.6)
    19.8 (12.2 to 29.4)
        rSBA: Serogroup C: Day 0: ≥1:128 (n=94,91)
    6.4 (2.4 to 13.4)
    9.9 (4.6 to 17.9)
        rSBA: Serogroup C: Day 30: ≥1:8 (n=94,90)
    100 (96.2 to 100)
    98.9 (94.0 to 100)
        rSBA: Serogroup C: Day 30: ≥1:128 (n=94,90)
    100 (96.2 to 100)
    96.7 (90.6 to 99.3)
        rSBA: Serogroup Y: Day 0: ≥1:8 (n=94,91)
    47.9 (37.5 to 58.4)
    46.2 (35.6 to 56.9)
        rSBA: Serogroup Y: Day 0: ≥1:128 (n=94,91)
    46.8 (36.4 to 57.4)
    40.7 (30.5 to 51.5)
        rSBA: Serogroup Y: Day 30: ≥1:8 (n=94,90)
    100 (96.2 to 100)
    98.9 (94.0 to 100)
        rSBA: Serogroup Y: Day 30: ≥1:128 (n=94,90)
    100 (96.2 to 100)
    98.9 (94.0 to 100)
        rSBA: Serogroup W: Day 0: ≥1:8 (n=94,91)
    24.5 (16.2 to 34.4)
    26.4 (17.7 to 36.7)
        rSBA: Serogroup W: Day 0: ≥1:128 (n=94,91)
    22.3 (14.4 to 32.1)
    23.1 (14.9 to 33.1)
        rSBA: Serogroup W: Day 30: ≥1:8 (n=94,90)
    100 (96.2 to 100)
    100 (96.0 to 100)
        rSBA: Serogroup W: Day 30: ≥1:128 (n=94,90)
    100 (96.2 to 100)
    100 (96.0 to 100)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8.
    Adverse event reporting additional description
    Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccine and had any safety data available. All participants had their safety analyzed according to the vaccine they actually received.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    Group 1: MenACYW Conjugate Vaccine
    Reporting group description
    		 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.

    Reporting group title
    Group 3: MenACYW Conjugate Vaccine
    Reporting group description
    		 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.

    Reporting group title
    Group 8: Menactra®
    Reporting group description
    		 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.

    Reporting group title
    Group 5: MenACYW Conjugate Vaccine
    Reporting group description
    		 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.

    Reporting group title
    Group 6: Menactra®
    Reporting group description
    		 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.

    Reporting group title
    Group 7: MenACYW Conjugate Vaccine
    Reporting group description
    		 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.

    Reporting group title
    Group 2: Menactra®
    Reporting group description
    		 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.

    Reporting group title
    Group 4: Quadri Meningo™/Local Licensed Meningococcal Vaccine
    Reporting group description
    		 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.

    Serious adverse events
    		 Group 1: MenACYW Conjugate Vaccine Group 3: MenACYW Conjugate Vaccine Group 8: Menactra® Group 5: MenACYW Conjugate Vaccine Group 6: Menactra® Group 7: MenACYW Conjugate Vaccine Group 2: Menactra® Group 4: Quadri Meningo™/Local Licensed Meningococcal Vaccine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 100 (0.00%)
    0 / 227 (0.00%)
    1 / 232 (0.43%)
    0 / 232 (0.00%)
    0 / 229 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    Infections and infestations
    Dengue Fever
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 100 (0.00%)
    0 / 227 (0.00%)
    1 / 232 (0.43%)
    0 / 232 (0.00%)
    0 / 229 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Covid-19
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 100 (0.00%)
    0 / 227 (0.00%)
    0 / 232 (0.00%)
    0 / 232 (0.00%)
    0 / 229 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Group 1: MenACYW Conjugate Vaccine Group 3: MenACYW Conjugate Vaccine Group 8: Menactra® Group 5: MenACYW Conjugate Vaccine Group 6: Menactra® Group 7: MenACYW Conjugate Vaccine Group 2: Menactra® Group 4: Quadri Meningo™/Local Licensed Meningococcal Vaccine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    32 / 98 (32.65%)
    18 / 100 (18.00%)
    128 / 227 (56.39%)
    81 / 232 (34.91%)
    43 / 232 (18.53%)
    115 / 229 (50.22%)
    26 / 100 (26.00%)
    21 / 100 (21.00%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 98 (6.12%)
    3 / 100 (3.00%)
    57 / 227 (25.11%)
    13 / 232 (5.60%)
    3 / 232 (1.29%)
    56 / 229 (24.45%)
    6 / 100 (6.00%)
    3 / 100 (3.00%)
         occurrences all number
    6
    3
    61
    13
    3
    57
    6
    3
    General disorders and administration site conditions
    Injection Site Erythema
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 100 (0.00%)
    27 / 227 (11.89%)
    1 / 232 (0.43%)
    0 / 232 (0.00%)
    28 / 229 (12.23%)
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    1
    0
    27
    1
    0
    28
    0
    1
    Malaise
         subjects affected / exposed
    6 / 98 (6.12%)
    1 / 100 (1.00%)
    44 / 227 (19.38%)
    11 / 232 (4.74%)
    4 / 232 (1.72%)
    45 / 229 (19.65%)
    5 / 100 (5.00%)
    1 / 100 (1.00%)
         occurrences all number
    6
    1
    44
    11
    4
    45
    5
    1
    Injection Site Swelling
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 100 (0.00%)
    37 / 227 (16.30%)
    1 / 232 (0.43%)
    1 / 232 (0.43%)
    25 / 229 (10.92%)
    0 / 100 (0.00%)
    2 / 100 (2.00%)
         occurrences all number
    1
    0
    37
    1
    1
    25
    0
    2
    Pyrexia
         subjects affected / exposed
    5 / 98 (5.10%)
    4 / 100 (4.00%)
    8 / 227 (3.52%)
    37 / 232 (15.95%)
    16 / 232 (6.90%)
    8 / 229 (3.49%)
    2 / 100 (2.00%)
    4 / 100 (4.00%)
         occurrences all number
    5
    4
    8
    37
    16
    8
    2
    4
    Injection Site Pain
         subjects affected / exposed
    27 / 98 (27.55%)
    9 / 100 (9.00%)
    82 / 227 (36.12%)
    52 / 232 (22.41%)
    29 / 232 (12.50%)
    85 / 229 (37.12%)
    24 / 100 (24.00%)
    14 / 100 (14.00%)
         occurrences all number
    27
    9
    82
    52
    29
    85
    24
    14
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    5 / 98 (5.10%)
    2 / 100 (2.00%)
    49 / 227 (21.59%)
    7 / 232 (3.02%)
    3 / 232 (1.29%)
    46 / 229 (20.09%)
    6 / 100 (6.00%)
    0 / 100 (0.00%)
         occurrences all number
    5
    2
    49
    7
    3
    46
    6
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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