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    Clinical Trial Results:
    Immune Lot Consistency, Immunogenicity, and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Adolescents and Adults Aged 10 to 55 Years

    Summary
    EudraCT number
    		 2018-001468-48
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    28 Feb 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Dec 2018
    First version publication date
    29 Dec 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    MET43
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02842853
    WHO universal trial number (UTN)
    		 U1111-1161-3060
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur Inc.
    Sponsor organisation address
    1 Discovery Drive, Swiftwater, United States, 18370
    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)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001930-PIP01-16
    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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    29 Mar 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Feb 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1) To demonstrate the immune lot consistency of the antibody responses to meningococcal serogroups A, C, Y, and W following the administration of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) conjugate vaccine with respect to serum bactericidal assay using human complement (hSBA) geometric mean titers (GMTs). 2) To demonstrate the non-inferiority of the antibody responses to meningococcal serogroups A, C, Y, and W following the administration of a single dose of MenACYW conjugate vaccine (pooled Lots 1 to 3) compared to those observed following the administration of a single dose of Menactra®.
    Protection of trial subjects
    Vaccinations were performed by qualified and trained study personnel. Subjects with allergy to any of the vaccine components were not vaccinated. After vaccination, subjects were also kept under clinical observation for 30 minutes to ensure their safety. Appropriate medical equipment was also available on site in case of any immediate allergic reactions.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Jul 2016
    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
    United States: 3344
    Worldwide total number of subjects
    3344
    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)
    992
    Adolescents (12-17 years)
    536
    Adults (18-64 years)
    1816
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study subjects were enrolled in 90 centers in the United States (US) from 15 July 2016 to 16 August 2016.

    Pre-assignment
    Screening details
    		 A total of 3344 subjects who met all inclusion and none of the exclusion criteria were enrolled and randomized in the study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1: MenACYW Conjugate Vaccine Lot 1
    Arm description
    		 Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 1a) and adults aged 18 to 55 years (Group 1b) received a single dose of MenACYW conjugate vaccine from lot 1.
    Arm type
    		 Experimental

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

    Arm title
    		 Group 2: MenACYW Conjugate Vaccine Lot 2
    Arm description
    		 Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 2a) and adults aged 18 to 55 years (Group 2b) received a single dose of MenACYW conjugate vaccine from lot 2.
    Arm type
    		 Experimental

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

    Arm title
    		 Group 3: MenACYW Conjugate Vaccine Lot 3
    Arm description
    		 Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 3a) and adults aged 18 to 55 years (Group 3b) received a single dose of MenACYW conjugate vaccine from lot 3.
    Arm type
    		 Experimental

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

    Arm title
    		 Group 4: Menactra®
    Arm description
    		 Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 4a) and adults aged 18 to 55 years (Group 4b) received a single dose of Menactra®.
    Arm type
    		 Active comparator

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

    Number of subjects in period 1
    		Group 1: MenACYW Conjugate Vaccine Lot 1 Group 2: MenACYW Conjugate Vaccine Lot 2 Group 3: MenACYW Conjugate Vaccine Lot 3 Group 4: Menactra®
    Started
    902
    895
    906
    641
    Vaccinated
    895
    886
    900
    636
    Safety Analysis Set
    895
    883
    898
    635
    Completed
    879
    861
    885
    617
    Not completed
    23
    34
    21
    24
         Consent withdrawn by subject
    11
    13
    9
    8
         Lost to follow-up
    9
    13
    10
    11
         Subject met exclusion criteria
    -
    1
    -
    -
         Non-compliance with the protocol
    3
    7
    2
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1: MenACYW Conjugate Vaccine Lot 1
    Reporting group description
    		 Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 1a) and adults aged 18 to 55 years (Group 1b) received a single dose of MenACYW conjugate vaccine from lot 1.

    Reporting group title
    Group 2: MenACYW Conjugate Vaccine Lot 2
    Reporting group description
    		 Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 2a) and adults aged 18 to 55 years (Group 2b) received a single dose of MenACYW conjugate vaccine from lot 2.

    Reporting group title
    Group 3: MenACYW Conjugate Vaccine Lot 3
    Reporting group description
    		 Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 3a) and adults aged 18 to 55 years (Group 3b) received a single dose of MenACYW conjugate vaccine from lot 3.

    Reporting group title
    Group 4: Menactra®
    Reporting group description
    		 Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 4a) and adults aged 18 to 55 years (Group 4b) received a single dose of Menactra®.

    Reporting group values
    		 Group 1: MenACYW Conjugate Vaccine Lot 1 Group 2: MenACYW Conjugate Vaccine Lot 2 Group 3: MenACYW Conjugate Vaccine Lot 3 Group 4: Menactra® Total
    Number of subjects
    		 902 895 906 641 3344
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 257 270 255 210 992
        Adolescents (12-17 years)
    		 145 130 142 119 536
        Adults (18-64 years)
    		 500 495 509 312 1816
        From 65-84 years
    		 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 27.4 ± 15.6 27.1 ± 15.7 27.3 ± 15.5 25.6 ± 15.4 -
    Gender categorical
    Units: Subjects
        Female
    		 535 531 496 357 1919
        Male
    		 367 364 410 284 1425

    End points

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    End points reporting groups
    Reporting group title
    Group 1: MenACYW Conjugate Vaccine Lot 1
    Reporting group description
    		 Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 1a) and adults aged 18 to 55 years (Group 1b) received a single dose of MenACYW conjugate vaccine from lot 1.

    Reporting group title
    Group 2: MenACYW Conjugate Vaccine Lot 2
    Reporting group description
    		 Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 2a) and adults aged 18 to 55 years (Group 2b) received a single dose of MenACYW conjugate vaccine from lot 2.

    Reporting group title
    Group 3: MenACYW Conjugate Vaccine Lot 3
    Reporting group description
    		 Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 3a) and adults aged 18 to 55 years (Group 3b) received a single dose of MenACYW conjugate vaccine from lot 3.

    Reporting group title
    Group 4: Menactra®
    Reporting group description
    		 Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 4a) and adults aged 18 to 55 years (Group 4b) received a single dose of Menactra®.

    Subject analysis set title
    MenACYW conjugate vaccine (Group 1, 2, 3 pooled)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years and adults aged 18 to 55 years received a single dose of MenACYW conjugate vaccine from any of the lots 1, 2 or 3.

    Primary: Geometric Mean Titers (GMTs) of Meningococcal Serogroups A, C, Y, And W Antibodies Following Vaccination With 3 Lots of MenACYW Conjugate

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    End point title
    		 Geometric Mean Titers (GMTs) of Meningococcal Serogroups A, C, Y, And W Antibodies Following Vaccination With 3 Lots of MenACYW Conjugate [1]
    End point description
    Antibody titers against Meningococcal Serogroups A, C, Y, and W were measured by hSBA. Analysis was performed on Per-Protocol Analysis Set (PPAS) defined for accessing the ACYW immune response data for all subjects who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result. The subjects who presented protocol deviations were excluded from per-protocol analysis set. Here, "n" signifies number of subjects with available data for each category, for each arm respectively.
    End point type
    Primary
    End point timeframe
    Day 30 (post-vaccination)
    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: This endpoint was evaluated for reported arms only.
    End point values
    		 Group 1: MenACYW Conjugate Vaccine Lot 1 Group 2: MenACYW Conjugate Vaccine Lot 2 Group 3: MenACYW Conjugate Vaccine Lot 3
    Number of subjects analysed
    843
    820
    845
    Units: Titer
    geometric mean (confidence interval 95%)
        Serogroup A (n= 843, 819, 843)
    84.9 (75.8 to 95.1)
    96.5 (86.4 to 108)
    97.9 (87.7 to 109)
        Serogroup C (n= 841, 820, 845)
    326 (286 to 372)
    305 (267 to 349)
    352 (307 to 405)
        Serogroup Y (n= 843, 820, 844)
    213 (191 to 238)
    210 (188 to 234)
    218 (194 to 246)
        Serogroup W (n= 843, 820, 844)
    84.5 (75.1 to 95.1)
    81.6 (72.7 to 91.5)
    87.2 (77.2 to 98.5)
    Statistical analysis title
    		 Serogroup A: Lot 1 vs Lot 2
    Statistical analysis description
    Actual number of subjects analyzed = 1662.
    Comparison groups
    Group 1: MenACYW Conjugate Vaccine Lot 1 v Group 2: MenACYW Conjugate Vaccine Lot 2
    Number of subjects included in analysis
    1663
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [2]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.751
         upper limit
    		 1.03
    Notes
    [2] - Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% confidence interval (CI) for the ratio of the GMTs lies between 1/2 and 2.
    Statistical analysis title
    		 Serogroup A: Lot 2 vs Lot 3
    Statistical analysis description
    Actual number of subjects analyzed = 1662.
    Comparison groups
    Group 2: MenACYW Conjugate Vaccine Lot 2 v Group 3: MenACYW Conjugate Vaccine Lot 3
    Number of subjects included in analysis
    1665
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [3]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.985
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.843
         upper limit
    		 1.15
    Notes
    [3] - Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.
    Statistical analysis title
    		 Serogroup A: Lot 1 vs Lot 3
    Statistical analysis description
    Actual number of subjects analyzed = 1686.
    Comparison groups
    Group 1: MenACYW Conjugate Vaccine Lot 1 v Group 3: MenACYW Conjugate Vaccine Lot 3
    Number of subjects included in analysis
    1688
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [4]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.867
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.74
         upper limit
    		 1.02
    Notes
    [4] - Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.
    Statistical analysis title
    		 Serogroup C: Lot 1 vs Lot 2
    Statistical analysis description
    Actual number of subjects analyzed = 1661.
    Comparison groups
    Group 1: MenACYW Conjugate Vaccine Lot 1 v Group 2: MenACYW Conjugate Vaccine Lot 2
    Number of subjects included in analysis
    1663
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [5]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.888
         upper limit
    		 1.29
    Notes
    [5] - Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.
    Statistical analysis title
    		 Serogroup C: Lot 2 vs Lot 3
    Comparison groups
    Group 2: MenACYW Conjugate Vaccine Lot 2 v Group 3: MenACYW Conjugate Vaccine Lot 3
    Number of subjects included in analysis
    1665
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [6]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.866
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.714
         upper limit
    		 1.05
    Notes
    [6] - Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.
    Statistical analysis title
    		 Serogroup C: Lot 1 vs Lot 3
    Statistical analysis description
    Actual number of subjects analyzed = 1686.
    Comparison groups
    Group 1: MenACYW Conjugate Vaccine Lot 1 v Group 3: MenACYW Conjugate Vaccine Lot 3
    Number of subjects included in analysis
    1688
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [7]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.927
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.766
         upper limit
    		 1.12
    Notes
    [7] - Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.
    Statistical analysis title
    		 Serogroup Y: Lot 1 vs Lot 2
    Comparison groups
    Group 1: MenACYW Conjugate Vaccine Lot 1 v Group 2: MenACYW Conjugate Vaccine Lot 2
    Number of subjects included in analysis
    1663
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [8]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.869
         upper limit
    		 1.19
    Notes
    [8] - Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.
    Statistical analysis title
    		 Serogroup Y: Lot 2 vs Lot 3
    Statistical analysis description
    Actual number of subjects analyzed = 1664.
    Comparison groups
    Group 2: MenACYW Conjugate Vaccine Lot 2 v Group 3: MenACYW Conjugate Vaccine Lot 3
    Number of subjects included in analysis
    1665
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [9]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.961
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.816
         upper limit
    		 1.13
    Notes
    [9] - Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.
    Statistical analysis title
    		 Serogroup Y: Lot 1 vs Lot 3
    Statistical analysis description
    Actual number of subjects analyzed = 1687.
    Comparison groups
    Group 1: MenACYW Conjugate Vaccine Lot 1 v Group 3: MenACYW Conjugate Vaccine Lot 3
    Number of subjects included in analysis
    1688
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [10]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.975
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.829
         upper limit
    		 1.15
    Notes
    [10] - Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.
    Statistical analysis title
    		 Serogroup W: Lot 1 vs Lot 2
    Comparison groups
    Group 1: MenACYW Conjugate Vaccine Lot 1 v Group 2: MenACYW Conjugate Vaccine Lot 2
    Number of subjects included in analysis
    1663
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [11]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.878
         upper limit
    		 1.22
    Notes
    [11] - Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.
    Statistical analysis title
    		 Serogroup W: Lot 2 vs Lot 3
    Statistical analysis description
    Actual number of subjects analyzed = 1664.
    Comparison groups
    Group 2: MenACYW Conjugate Vaccine Lot 2 v Group 3: MenACYW Conjugate Vaccine Lot 3
    Number of subjects included in analysis
    1665
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [12]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.936
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.791
         upper limit
    		 1.11
    Notes
    [12] - Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.
    Statistical analysis title
    		 Serogroup W: Lot 1 vs Lot 3
    Statistical analysis description
    Actual number of subjects analyzed = 1687.
    Comparison groups
    Group 1: MenACYW Conjugate Vaccine Lot 1 v Group 3: MenACYW Conjugate Vaccine Lot 3
    Number of subjects included in analysis
    1688
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [13]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.818
         upper limit
    		 1.15
    Notes
    [13] - Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.

    Primary: Percentage of Subjects Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y And W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine

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    End point title
    		 Percentage of Subjects Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y And W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine [14]
    End point description
    Antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA. The hSBA vaccine seroresponse for serogroups A, C, Y, and W was defined as post-vaccination hSBA titers >= 1:16 for subjects with pre-vaccination hSBA titers < 1:8 or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for subjects with pre-vaccination hSBA titers >= 1:8. Analysis was performed on PPAS. Here, "n" signifies number of subjects with available data for each category, for each arm respectively.
    End point type
    Primary
    End point timeframe
    Day 30 (post-vaccination)
    Notes
    [14] - 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: This endpoint was evaluated for reported arms only.
    End point values
    		 Group 4: Menactra® MenACYW conjugate vaccine (Group 1, 2, 3 pooled)
    Number of subjects analysed
    593
    2508
    Units: Percentage of Subjects
    number (confidence interval 95%)
        Serogroup A (n= 593, 2503)
    54.6 (50.5 to 58.7)
    73.8 (72.0 to 75.5)
        Serogroup C (n= 593, 2503)
    47.9 (43.8 to 52.0)
    88.8 (87.5 to 90.0)
        Serogroup Y (n= 593, 2505)
    73.4 (69.6 to 76.9)
    91.4 (90.3 to 92.5)
        Serogroup W (n= 593, 2505)
    61.2 (57.2 to 65.2)
    80.3 (78.7 to 81.8)
    Statistical analysis title
    		 Serogroup A
    Statistical analysis description
    Actual number of subjects analyzed = 3096.
    Comparison groups
    Group 4: Menactra® v MenACYW conjugate vaccine (Group 1, 2, 3 pooled)
    Number of subjects included in analysis
    3101
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [15]
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    19.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 14.8
         upper limit
    		 23.5
    Notes
    [15] - 95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is > -10% for all serogroups.
    Statistical analysis title
    		 Serogroup C
    Statistical analysis description
    Actual number of subjects analyzed = 3096.
    Comparison groups
    Group 4: Menactra® v MenACYW conjugate vaccine (Group 1, 2, 3 pooled)
    Number of subjects included in analysis
    3101
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [16]
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    40.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 36.7
         upper limit
    		 45
    Notes
    [16] - 95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is > -10% for all serogroups.
    Statistical analysis title
    		 Serogroup Y
    Statistical analysis description
    Actual number of subjects analyzed = 3098.
    Comparison groups
    Group 4: Menactra® v MenACYW conjugate vaccine (Group 1, 2, 3 pooled)
    Number of subjects included in analysis
    3101
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [17]
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    18.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 14.5
         upper limit
    		 21.9
    Notes
    [17] - 95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is > -10% for all serogroups.
    Statistical analysis title
    		 Serogroup W
    Statistical analysis description
    Actual number of subjects analyzed = 3098.
    Comparison groups
    Group 4: Menactra® v MenACYW conjugate vaccine (Group 1, 2, 3 pooled)
    Number of subjects included in analysis
    3101
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [18]
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    19.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 14.9
         upper limit
    		 23.3
    Notes
    [18] - 95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is > -10% for all serogroups.

    Secondary: Percentage of Subjects Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y And W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine in Adults

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    End point title
    		 Percentage of Subjects Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y And W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine in Adults [19]
    End point description
    Antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA. The hSBA vaccine seroresponse for serogroups A, C, Y, and W was defined as post-vaccination hSBA titers >= 1:16 for subjects with pre-vaccination hSBA titers < 1:8 or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for subjects with pre-vaccination hSBA titers >= 1:8. Analysis was performed on PPAS. Only adults aged 18-55 years who received a single dose of Menactra® (Group 4b) or MenACYW conjugate vaccine (Group 1b-3b) from any of the lots 1, 2 or 3, were included in this endpoint analysis. Here, "n" signifies number of subjects with available data for each category, for each arm respectively.
    End point type
    Secondary
    End point timeframe
    Day 30 (post-vaccination)
    Notes
    [19] - 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: This endpoint was evaluated for reported arms only.
    End point values
    		 Group 4: Menactra® MenACYW conjugate vaccine (Group 1, 2, 3 pooled)
    Number of subjects analysed
    293
    1410
    Units: Percentage of Subjects
    number (confidence interval 95%)
        Serogroup A (n= 293, 1406)
    53.9 (48.0 to 59.7)
    73.5 (71.2 to 75.8)
        Serogroup C (n= 293, 1406)
    42.3 (36.6 to 48.2)
    83.4 (81.4 to 85.3)
        Serogroup Y (n= 293, 1408)
    60.8 (54.9 to 66.4)
    88.1 (86.3 to 89.8)
        Serogroup W (n= 293, 1408)
    50.2 (44.3 to 56.0)
    77.0 (74.7 to 79.2)
    Statistical analysis title
    		 Serogroup A
    Statistical analysis description
    Actual number of subjects analyzed = 1699.
    Comparison groups
    Group 4: Menactra® v MenACYW conjugate vaccine (Group 1, 2, 3 pooled)
    Number of subjects included in analysis
    1703
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [20]
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    19.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 13.5
         upper limit
    		 25.8
    Notes
    [20] - 95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is > -10% for all serogroups.
    Statistical analysis title
    		 Serogroup C
    Statistical analysis description
    Actual number of subjects analyzed = 1699.
    Comparison groups
    Group 4: Menactra® v MenACYW conjugate vaccine (Group 1, 2, 3 pooled)
    Number of subjects included in analysis
    1703
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [21]
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    41.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 35
         upper limit
    		 46.9
    Notes
    [21] - 95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is > -10% for all serogroups.
    Statistical analysis title
    		 Serogroup Y
    Statistical analysis description
    Actual number of subjects analyzed = 1701.
    Comparison groups
    Group 4: Menactra® v MenACYW conjugate vaccine (Group 1, 2, 3 pooled)
    Number of subjects included in analysis
    1703
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [22]
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    27.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 21.7
         upper limit
    		 33.3
    Notes
    [22] - 95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is > -10% for all serogroups.
    Statistical analysis title
    		 Serogroup W
    Statistical analysis description
    Actual number of subjects analyzed = 1701.
    Comparison groups
    Group 4: Menactra® v MenACYW conjugate vaccine (Group 1, 2, 3 pooled)
    Number of subjects included in analysis
    1703
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [23]
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    26.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 20.7
         upper limit
    		 32.9
    Notes
    [23] - 95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is > -10% for all serogroups.

    Secondary: Percentage of Subjects Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y And W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine in Adolescents

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    End point title
    		 Percentage of Subjects Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y And W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine in Adolescents [24]
    End point description
    Antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA. The hSBA vaccine seroresponse for serogroups A, C, Y, and W was defined as post-vaccination hSBA titers >= 1:16 for subjects with pre-vaccination hSBA titers < 1:8 or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for subjects with pre-vaccination hSBA titers >= 1:8. Analysis was performed on PPAS. Only adolescents aged 10-17 years who received a single dose of Menactra® (Group 4a) or MenACYW conjugate vaccine (Group 1a-3a) from any of the lots 1, 2 or 3, were included in this endpoint analysis. Here, "n" signifies number of subjects with available data for each category, for each arm respectively.
    End point type
    Secondary
    End point timeframe
    Day 30 (post-vaccination)
    Notes
    [24] - 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: This endpoint was evaluated for reported arms only.
    End point values
    		 Group 4: Menactra® MenACYW conjugate vaccine (Group 1, 2, 3 pooled)
    Number of subjects analysed
    300
    1098
    Units: Percentage of Subjects
    number (confidence interval 95%)
        Serogroup A (n= 300, 1097)
    55.3 (49.5 to 61.0)
    74.0 (71.3 to 76.6)
        Serogroup C (n= 300, 1097)
    53.3 (47.5 to 59.1)
    95.6 (94.2 to 96.8)
        Serogroup Y (n= 300, 1097)
    85.7 (81.2 to 89.4)
    95.6 (94.2 to 96.8)
        Serogroup W (n= 300, 1097)
    72.0 (66.6 to 77.0)
    84.5 (82.2 to 86.6)
    Statistical analysis title
    		 Serogroup A
    Statistical analysis description
    Actual number of subjects analyzed = 1397.
    Comparison groups
    Group 4: Menactra® v MenACYW conjugate vaccine (Group 1, 2, 3 pooled)
    Number of subjects included in analysis
    1398
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [25]
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    18.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 12.5
         upper limit
    		 24.9
    Notes
    [25] - 95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is > -10% for all serogroups.
    Statistical analysis title
    		 Serogroup C
    Statistical analysis description
    Actual number of subjects analyzed = 1397.
    Comparison groups
    Group 4: Menactra® v MenACYW conjugate vaccine (Group 1, 2, 3 pooled)
    Number of subjects included in analysis
    1398
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [26]
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    42.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 36.6
         upper limit
    		 48
    Notes
    [26] - 95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is > -10% for all serogroups.
    Statistical analysis title
    		 Serogroup Y
    Statistical analysis description
    Actual number of subjects analyzed = 1397.
    Comparison groups
    Group 4: Menactra® v MenACYW conjugate vaccine (Group 1, 2, 3 pooled)
    Number of subjects included in analysis
    1398
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [27]
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    10
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.18
         upper limit
    		 14.5
    Notes
    [27] - 95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is > -10% for all serogroups.
    Statistical analysis title
    		 Serogroup W
    Statistical analysis description
    Actual number of subjects analyzed = 1397.
    Comparison groups
    Group 4: Menactra® v MenACYW conjugate vaccine (Group 1, 2, 3 pooled)
    Number of subjects included in analysis
    1398
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [28]
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    12.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7.22
         upper limit
    		 18.2
    Notes
    [28] - 95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is > -10% for all serogroups.

    Secondary: Percentage of Subjects Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y And W Following Vaccination With 3 Lots of MenACYW Conjugate

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    End point title
    		 Percentage of Subjects Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y And W Following Vaccination With 3 Lots of MenACYW Conjugate [29]
    End point description
    Antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA. The hSBA vaccine seroresponse for serogroups A, C, Y, and W was defined as post-vaccination hSBA titers >= 1:16 for subjects with pre-vaccination hSBA titers < 1:8 or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for subjects with pre-vaccination hSBA titers >= 1:8. Analysis was performed on PPAS. Here, "n" signifies number of subjects with available data for each category, for each arm respectively.
    End point type
    Secondary
    End point timeframe
    Day 30 (post-vaccination)
    Notes
    [29] - 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: This endpoint was evaluated for reported arms only.
    End point values
    		 Group 1: MenACYW Conjugate Vaccine Lot 1 Group 2: MenACYW Conjugate Vaccine Lot 2 Group 3: MenACYW Conjugate Vaccine Lot 3
    Number of subjects analysed
    843
    820
    845
    Units: Percentage of Subjects
    number (confidence interval 95%)
        Serogroup A (n= 842, 818, 843)
    71.1 (67.9 to 74.2)
    76.5 (73.5 to 79.4)
    73.7 (70.6 to 76.6)
        Serogroup C (n= 840, 819, 844)
    90.5 (88.3 to 92.4)
    89.1 (86.8 to 91.2)
    86.7 (84.3 to 88.9)
        Serogroup Y (n= 842, 819, 844)
    92.4 (90.4 to 94.1)
    91.9 (89.9 to 93.7)
    89.9 (87.7 to 91.9)
        Serogroup W (n= 842, 819, 844)
    81.5 (78.7 to 84.0)
    80.7 (77.8 to 83.4)
    78.7 (75.8 to 81.4)
    Statistical analysis title
    		 Serogroup A: Lot 1 vs Lot 2
    Statistical analysis description
    Actual number of subjects analyzed = 1660.
    Comparison groups
    Group 1: MenACYW Conjugate Vaccine Lot 1 v Group 2: MenACYW Conjugate Vaccine Lot 2
    Number of subjects included in analysis
    1663
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    -5.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.59
         upper limit
    		 -1.16
    Statistical analysis title
    		 Serogroup A: Lot 2 vs Lot 3
    Statistical analysis description
    Actual number of subjects analyzed = 1661.
    Comparison groups
    Group 2: MenACYW Conjugate Vaccine Lot 2 v Group 3: MenACYW Conjugate Vaccine Lot 3
    Number of subjects included in analysis
    1665
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    2.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 7.01
    Statistical analysis title
    		 Serogroup A: Lot 1 vs Lot 3
    Statistical analysis description
    Actual number of subjects analyzed = 1685.
    Comparison groups
    Group 1: MenACYW Conjugate Vaccine Lot 1 v Group 3: MenACYW Conjugate Vaccine Lot 3
    Number of subjects included in analysis
    1688
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    -2.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.78
         upper limit
    		 1.74
    Statistical analysis title
    		 Serogroup C: Lot 1 vs Lot 2
    Statistical analysis description
    Actual number of subjects analyzed = 1659.
    Comparison groups
    Group 1: MenACYW Conjugate Vaccine Lot 1 v Group 2: MenACYW Conjugate Vaccine Lot 2
    Number of subjects included in analysis
    1663
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.58
         upper limit
    		 4.28
    Statistical analysis title
    		 Serogroup C: Lot 2 vs Lot 3
    Statistical analysis description
    Actual number of subjects analyzed = 1663.
    Comparison groups
    Group 2: MenACYW Conjugate Vaccine Lot 2 v Group 3: MenACYW Conjugate Vaccine Lot 3
    Number of subjects included in analysis
    1665
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    2.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.74
         upper limit
    		 5.54
    Statistical analysis title
    		 Serogroup C: Lot 1 vs Lot 3
    Statistical analysis description
    Actual number of subjects analyzed = 1684.
    Comparison groups
    Group 1: MenACYW Conjugate Vaccine Lot 1 v Group 3: MenACYW Conjugate Vaccine Lot 3
    Number of subjects included in analysis
    1688
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    3.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.708
         upper limit
    		 6.79
    Statistical analysis title
    		 Serogroup Y: Lot 1 vs Lot 2
    Statistical analysis description
    Actual number of subjects analyzed = 1661.
    Comparison groups
    Group 1: MenACYW Conjugate Vaccine Lot 1 v Group 2: MenACYW Conjugate Vaccine Lot 2
    Number of subjects included in analysis
    1663
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.14
         upper limit
    		 3.07
    Statistical analysis title
    		 Serogroup Y: Lot 2 vs Lot 3
    Statistical analysis description
    Actual number of subjects analyzed = 1663.
    Comparison groups
    Group 2: MenACYW Conjugate Vaccine Lot 2 v Group 3: MenACYW Conjugate Vaccine Lot 3
    Number of subjects included in analysis
    1665
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.763
         upper limit
    		 4.79
    Statistical analysis title
    		 Serogroup Y: Lot 1 vs Lot 3
    Statistical analysis description
    Actual number of subjects analyzed = 1686.
    Comparison groups
    Group 1: MenACYW Conjugate Vaccine Lot 1 v Group 3: MenACYW Conjugate Vaccine Lot 3
    Number of subjects included in analysis
    1688
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    2.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.248
         upper limit
    		 5.2
    Statistical analysis title
    		 Serogroup W: Lot 1 vs Lot 2
    Statistical analysis description
    Actual number of subjects analyzed = 1661.
    Comparison groups
    Group 1: MenACYW Conjugate Vaccine Lot 1 v Group 2: MenACYW Conjugate Vaccine Lot 2
    Number of subjects included in analysis
    1663
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3
         upper limit
    		 4.54
    Statistical analysis title
    		 Serogroup W: Lot 2 vs Lot 3
    Statistical analysis description
    Actual number of subjects analyzed = 1663.
    Comparison groups
    Group 2: MenACYW Conjugate Vaccine Lot 2 v Group 3: MenACYW Conjugate Vaccine Lot 3
    Number of subjects included in analysis
    1665
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.84
         upper limit
    		 5.89
    Statistical analysis title
    		 Serogroup W: Lot 1 vs Lot 3
    Statistical analysis description
    Actual number of subjects analyzed = 1686.
    Comparison groups
    Group 1: MenACYW Conjugate Vaccine Lot 1 v Group 3: MenACYW Conjugate Vaccine Lot 3
    Number of subjects included in analysis
    1688
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    2.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.02
         upper limit
    		 6.61

    Secondary: Geometric Mean Titers (GMTs) of Meningococcal Serogroups A, C, Y, and W Antibodies Following Vaccination With MenACYW Conjugate and Menactra®

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    End point title
    		 Geometric Mean Titers (GMTs) of Meningococcal Serogroups A, C, Y, and W Antibodies Following Vaccination With MenACYW Conjugate and Menactra® [30]
    End point description
    Antibody titers against Meningococcal Serogroups A, C, Y, and W were measured by hSBA. Analysis was performed on PPAS. Here, "n" signifies number of subjects with available data for each category, for each arm respectively.
    End point type
    Secondary
    End point timeframe
    Day 30 (post-vaccination)
    Notes
    [30] - 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: This endpoint was evaluated for reported arms only.
    End point values
    		 Group 4: Menactra® MenACYW conjugate vaccine (Group 1, 2, 3 pooled)
    Number of subjects analysed
    593
    2508
    Units: Titer
    geometric mean (confidence interval 95%)
        Serogroup A (n= 593, 2505)
    48.1 (41.8 to 55.2)
    92.9 (87.1 to 99.1)
        Serogroup C (n= 593, 2506)
    40.7 (33.8 to 49.0)
    328 (303 to 354)
        Serogroup Y (n= 593, 2507)
    66.4 (56.4 to 78.0)
    214 (200 to 228)
        Serogroup W (n= 593, 2507)
    44.5 (38.3 to 51.7)
    84.4 (78.8 to 90.4)
    Statistical analysis title
    		 Serogroup A
    Statistical analysis description
    Actual number of subjects analyzed = 3098.
    Comparison groups
    Group 4: Menactra® v MenACYW conjugate vaccine (Group 1, 2, 3 pooled)
    Number of subjects included in analysis
    3101
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.67
         upper limit
    		 2.24
    Statistical analysis title
    		 Serogroup C
    Statistical analysis description
    Actual number of subjects analyzed = 3099.
    Comparison groups
    Group 4: Menactra® v MenACYW conjugate vaccine (Group 1, 2, 3 pooled)
    Number of subjects included in analysis
    3101
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    8.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.58
         upper limit
    		 9.84
    Statistical analysis title
    		 Serogroup Y
    Statistical analysis description
    Actual number of subjects analyzed = 3100.
    Comparison groups
    Group 4: Menactra® v MenACYW conjugate vaccine (Group 1, 2, 3 pooled)
    Number of subjects included in analysis
    3101
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    3.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.71
         upper limit
    		 3.84
    Statistical analysis title
    		 Serogroup W
    Statistical analysis description
    Actual number of subjects analyzed = 3100.
    Comparison groups
    Group 4: Menactra® v MenACYW conjugate vaccine (Group 1, 2, 3 pooled)
    Number of subjects included in analysis
    3101
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.61
         upper limit
    		 2.24

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse event (AE) data were collected from Day 0 up to Day 30 post-vaccination. Solicited Reaction (SR) data were collected from Day 0 up to Day 7 post-vaccination.
    Adverse event reporting additional description
    A SR was an AE that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e.,solicited) in terms of symptom and/or onset post-vaccination. Safety Analysis Set.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Group 1 MenACYW Lot 1
    Reporting group description
    		 Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 1a) and adults aged 18 to 55 years (Group 1b) received a single dose of MenACYW conjugate vaccine from lot 1.

    Reporting group title
    Group 2 MenACYW Lot 2
    Reporting group description
    		 Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 2a) and adults aged 18 to 55 years (Group 2b) received a single dose of MenACYW conjugate vaccine from lot 2.

    Reporting group title
    Group 3 MenACYW Lot 3
    Reporting group description
    		 Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 3a) and adults aged 18 to 55 years (Group 3b) received a single dose of MenACYW conjugate vaccine from lot 3.

    Reporting group title
    Group 4 Menactra
    Reporting group description
    		 Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 4a) and adults aged 18 to 55 years (Group 4b) received a single dose of Menactra®.

    Serious adverse events
    		 Group 1 MenACYW Lot 1 Group 2 MenACYW Lot 2 Group 3 MenACYW Lot 3 Group 4 Menactra
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 895 (1.01%)
    13 / 883 (1.47%)
    6 / 898 (0.67%)
    5 / 635 (0.79%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Uterine Leiomyoma
         subjects affected / exposed
    1 / 895 (0.11%)
    0 / 883 (0.00%)
    0 / 898 (0.00%)
    0 / 635 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion Spontaneous
         subjects affected / exposed
    0 / 895 (0.00%)
    1 / 883 (0.11%)
    0 / 898 (0.00%)
    0 / 635 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abortion Spontaneous Incomplete
         subjects affected / exposed
    0 / 895 (0.00%)
    1 / 883 (0.11%)
    0 / 898 (0.00%)
    0 / 635 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest Pain
         subjects affected / exposed
    1 / 895 (0.11%)
    1 / 883 (0.11%)
    0 / 898 (0.00%)
    0 / 635 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 895 (0.11%)
    0 / 883 (0.00%)
    0 / 898 (0.00%)
    0 / 635 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic Obstructive Pulmonary Disease
         subjects affected / exposed
    1 / 895 (0.11%)
    0 / 883 (0.00%)
    0 / 898 (0.00%)
    0 / 635 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Throat Tightness
         subjects affected / exposed
    0 / 895 (0.00%)
    0 / 883 (0.00%)
    0 / 898 (0.00%)
    1 / 635 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Conversion Disorder
         subjects affected / exposed
    0 / 895 (0.00%)
    0 / 883 (0.00%)
    1 / 898 (0.11%)
    0 / 635 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    0 / 895 (0.00%)
    1 / 883 (0.11%)
    0 / 898 (0.00%)
    0 / 635 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Disruptive Mood Dysregulation Disorder
         subjects affected / exposed
    0 / 895 (0.00%)
    0 / 883 (0.00%)
    0 / 898 (0.00%)
    1 / 635 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Somatic Symptom Disorder
         subjects affected / exposed
    0 / 895 (0.00%)
    1 / 883 (0.11%)
    0 / 898 (0.00%)
    0 / 635 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicidal Ideation
         subjects affected / exposed
    0 / 895 (0.00%)
    0 / 883 (0.00%)
    1 / 898 (0.11%)
    0 / 635 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Craniocerebral Injury
         subjects affected / exposed
    0 / 895 (0.00%)
    1 / 883 (0.11%)
    0 / 898 (0.00%)
    0 / 635 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foot Fracture
         subjects affected / exposed
    1 / 895 (0.11%)
    0 / 883 (0.00%)
    0 / 898 (0.00%)
    0 / 635 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Coronary Artery Disease
         subjects affected / exposed
    0 / 895 (0.00%)
    1 / 883 (0.11%)
    0 / 898 (0.00%)
    0 / 635 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Alcoholic Seizure
         subjects affected / exposed
    0 / 895 (0.00%)
    1 / 883 (0.11%)
    0 / 898 (0.00%)
    0 / 635 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    0 / 895 (0.00%)
    0 / 883 (0.00%)
    1 / 898 (0.11%)
    0 / 635 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple Sclerosis
         subjects affected / exposed
    0 / 895 (0.00%)
    1 / 883 (0.11%)
    0 / 898 (0.00%)
    0 / 635 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Paraesthesia
         subjects affected / exposed
    1 / 895 (0.11%)
    0 / 883 (0.00%)
    0 / 898 (0.00%)
    0 / 635 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    0 / 895 (0.00%)
    0 / 883 (0.00%)
    1 / 898 (0.11%)
    0 / 635 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Status Epilepticus
         subjects affected / exposed
    0 / 895 (0.00%)
    1 / 883 (0.11%)
    0 / 898 (0.00%)
    0 / 635 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal Ulcer Perforation
         subjects affected / exposed
    0 / 895 (0.00%)
    0 / 883 (0.00%)
    1 / 898 (0.11%)
    0 / 635 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis Acute
         subjects affected / exposed
    1 / 895 (0.11%)
    0 / 883 (0.00%)
    0 / 898 (0.00%)
    0 / 635 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 895 (0.00%)
    0 / 883 (0.00%)
    1 / 898 (0.11%)
    0 / 635 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Henoch-Schonlein Purpura
         subjects affected / exposed
    0 / 895 (0.00%)
    0 / 883 (0.00%)
    0 / 898 (0.00%)
    1 / 635 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 895 (0.00%)
    0 / 883 (0.00%)
    0 / 898 (0.00%)
    1 / 635 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back Pain
         subjects affected / exposed
    0 / 895 (0.00%)
    1 / 883 (0.11%)
    0 / 898 (0.00%)
    0 / 635 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal Abscess
         subjects affected / exposed
    0 / 895 (0.00%)
    0 / 883 (0.00%)
    1 / 898 (0.11%)
    0 / 635 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    1 / 895 (0.11%)
    2 / 883 (0.23%)
    0 / 898 (0.00%)
    0 / 635 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis Perforated
         subjects affected / exposed
    0 / 895 (0.00%)
    1 / 883 (0.11%)
    0 / 898 (0.00%)
    0 / 635 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis Norovirus
         subjects affected / exposed
    0 / 895 (0.00%)
    0 / 883 (0.00%)
    0 / 898 (0.00%)
    1 / 635 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia Pseudomonal
         subjects affected / exposed
    1 / 895 (0.11%)
    0 / 883 (0.00%)
    0 / 898 (0.00%)
    0 / 635 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 895 (0.11%)
    0 / 883 (0.00%)
    0 / 898 (0.00%)
    0 / 635 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetes Mellitus Inadequate Control
         subjects affected / exposed
    0 / 895 (0.00%)
    0 / 883 (0.00%)
    0 / 898 (0.00%)
    1 / 635 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Type 2 Diabetes Mellitus
         subjects affected / exposed
    1 / 895 (0.11%)
    0 / 883 (0.00%)
    0 / 898 (0.00%)
    0 / 635 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Group 1 MenACYW Lot 1 Group 2 MenACYW Lot 2 Group 3 MenACYW Lot 3 Group 4 Menactra
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    477 / 895 (53.30%)
    485 / 883 (54.93%)
    489 / 898 (54.45%)
    353 / 635 (55.59%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    247 / 895 (27.60%)
    248 / 883 (28.09%)
    253 / 898 (28.17%)
    175 / 635 (27.56%)
         occurrences all number
    253
    254
    265
    178
    General disorders and administration site conditions
    Injection Site Erythema
         subjects affected / exposed
    45 / 895 (5.03%)
    39 / 883 (4.42%)
    43 / 898 (4.79%)
    25 / 635 (3.94%)
         occurrences all number
    45
    39
    43
    25
    Injection Site Pain
         subjects affected / exposed
    344 / 895 (38.44%)
    339 / 883 (38.39%)
    333 / 898 (37.08%)
    235 / 635 (37.01%)
         occurrences all number
    344
    339
    334
    235
    Malaise
         subjects affected / exposed
    184 / 895 (20.56%)
    186 / 883 (21.06%)
    189 / 898 (21.05%)
    132 / 635 (20.79%)
         occurrences all number
    184
    187
    189
    132
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    278 / 895 (31.06%)
    271 / 883 (30.69%)
    294 / 898 (32.74%)
    192 / 635 (30.24%)
         occurrences all number
    280
    272
    295
    193

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Jun 2016
    - Updated Clinical Trial Manager information. - Identified the Coordinating Investigator. - Clarified the blood sample collection procedure when antibiotics have been used near the time of collection. - Included information about MET50 since it is a relevant study to age groups in this study. - Indicated that subject termination would only be recorded in the Case Report Form (CRF). - Clarified the definition of Category 3 medications and included the period of collection. - The definition of hSBA vaccine seroresponse was updated at the request of the Center for Biologics Evaluation and Research (CBER). - Indicated the location of the hSBA and rSBA testing. - Indicated the priority of hSBA testing in the event of insufficient sample volume.

    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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