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    Clinical Trial Results:
    Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Children 2 to 9 Years of Age

    Summary
    EudraCT number
    		 2018-001471-20
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    10 Oct 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
    MET35
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03077438
    WHO universal trial number (UTN)
    		 U1111-1161-2625
    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
    12 Apr 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Oct 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the non-inferiority of the vaccine seroresponse 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) compared to that observed following the administration of a single dose of MENVEO® in children aged 2 to 9 years.
    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
    17 Feb 2017
    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: 1000
    Worldwide total number of subjects
    1000
    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)
    1000
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    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 36 centers in the Unites States (US) and Puerto Rico from 17 February 2017 to 30 March 2017.

    Pre-assignment
    Screening details
    		 A total of 1000 subjects who met all of the inclusion criteria and none of the exclusion criteria were enrolled and randomized in the 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
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1: MenACYW Conjugate Vaccine
    Arm description
    		 Healthy, meningococcal-vaccine naïve subjects aged 2 to 9 years received a single dose of MenACYW conjugate vaccine.
    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, intramuscular, single dose on Day 0.

    Arm title
    		 Group 2: MENVEO® Vaccine
    Arm description
    		 Healthy, meningococcal-vaccine naïve subjects aged 2 to 9 years received a single dose of MENVEO® vaccine.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    MENVEO®: Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular, single dose on Day 0.

    Number of subjects in period 1
    		Group 1: MenACYW Conjugate Vaccine Group 2: MENVEO® Vaccine
    Started
    499
    501
    Safety analysis set
    498
    494
    Completed
    487
    487
    Not completed
    12
    14
         Consent withdrawn by subject
    3
    6
         Lost to follow-up
    6
    3
         Protocol deviation
    3
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1: MenACYW Conjugate Vaccine
    Reporting group description
    		 Healthy, meningococcal-vaccine naïve subjects aged 2 to 9 years received a single dose of MenACYW conjugate vaccine.

    Reporting group title
    Group 2: MENVEO® Vaccine
    Reporting group description
    		 Healthy, meningococcal-vaccine naïve subjects aged 2 to 9 years received a single dose of MENVEO® vaccine.

    Reporting group values
    		 Group 1: MenACYW Conjugate Vaccine Group 2: MENVEO® Vaccine Total
    Number of subjects
    		 499 501 1000
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 499 501 1000
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 6.0 ( 2.33 ) 6.0 ( 2.36 ) -
    Gender categorical
    Units: Subjects
        Female
    		 245 236 481
        Male
    		 254 265 519
    Region of Enrollment
    Units: Subjects
        United States
    		 499 501 1000

    End points

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    End points reporting groups
    Reporting group title
    Group 1: MenACYW Conjugate Vaccine
    Reporting group description
    		 Healthy, meningococcal-vaccine naïve subjects aged 2 to 9 years received a single dose of MenACYW conjugate vaccine.

    Reporting group title
    Group 2: MENVEO® Vaccine
    Reporting group description
    		 Healthy, meningococcal-vaccine naïve subjects aged 2 to 9 years received a single dose of MENVEO® vaccine.

    Primary: Percentages of Subjects Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Vaccine Seroresponse for Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine

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    End point title
    		 Percentages of Subjects Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Vaccine Seroresponse for Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine
    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 Per-Protocol Analysis Set (PPAS) defined for accessing the ACYW immune response data for all subjects who received at least one dose of study vaccine and had a valid post-vaccination serology result. The subjects who presented pre-defined protocol deviations were excluded from per-protocol analysis set. Here 'n' signifies number of subjects with available data for specified category.
    End point type
    Primary
    End point timeframe
    Day 30 (post-vaccination)
    End point values
    		 Group 1: MenACYW Conjugate Vaccine Group 2: MENVEO® Vaccine
    Number of subjects analysed
    458
    460
    Units: percentage of subjects
    number (confidence interval 95%)
        Serogroup A (n=455,458)
    55.4 (50.7 to 60.0)
    47.8 (43.2 to 52.5)
        Serogroup C (n=458,458)
    95.2 (92.8 to 97.0)
    47.8 (43.2 to 52.5)
        Serogroup Y (n=458,459)
    91.5 (88.5 to 93.9)
    79.3 (75.3 to 82.9)
        Serogroup W (n=458,459)
    78.8 (74.8 to 82.5)
    64.1 (59.5 to 68.4)
    Statistical analysis title
    		 Serogroup A
    Statistical analysis description
    Actual number of subjects analyzed = 913
    Comparison groups
    Group 1: MenACYW Conjugate Vaccine v Group 2: MENVEO® Vaccine
    Number of subjects included in analysis
    918
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    7.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.1
         upper limit
    		 14
    Notes
    [1] - 95% confidence interval (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 between the 2 percentages was >-10%.
    Statistical analysis title
    		 Serogroup C
    Statistical analysis description
    Actual number of subjects analyzed = 916
    Comparison groups
    Group 1: MenACYW Conjugate Vaccine v Group 2: MENVEO® Vaccine
    Number of subjects included in analysis
    918
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    47.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 42.2
         upper limit
    		 52.2
    Notes
    [2] - 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 between the 2 percentages was >-10%.
    Statistical analysis title
    		 Serogroup Y
    Statistical analysis description
    Actual number of subjects analyzed = 917
    Comparison groups
    Group 1: MenACYW Conjugate Vaccine v Group 2: MENVEO® Vaccine
    Number of subjects included in analysis
    918
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    12.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7.7
         upper limit
    		 16.7
    Notes
    [3] - 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 between the 2 percentages was >-10%.
    Statistical analysis title
    		 Serogroup W
    Statistical analysis description
    Actual number of subjects analyzed = 917
    Comparison groups
    Group 1: MenACYW Conjugate Vaccine v Group 2: MENVEO® Vaccine
    Number of subjects included in analysis
    918
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [4]
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    14.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 8.9
         upper limit
    		 20.5
    Notes
    [4] - 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 between the 2 percentages was >-10%.

    Secondary: Geometric Mean Titers (GMTs) of Meningococcal Serogroups A, C, Y, and W Antibodies Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 9 Years of Age

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    End point title
    		 Geometric Mean Titers (GMTs) of Meningococcal Serogroups A, C, Y, and W Antibodies Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 9 Years of Age
    End point description
    Antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA. Analysis was performed on PPAS. Here 'n' signifies number of subjects with available data for specified category.
    End point type
    Secondary
    End point timeframe
    Day 30 (post-vaccination)
    End point values
    		 Group 1: MenACYW Conjugate Vaccine Group 2: MENVEO® Vaccine
    Number of subjects analysed
    458
    460
    Units: titers
    geometric mean (confidence interval 95%)
        Serogroup A (n=456,458)
    24.8 (21.9 to 27.9)
    22.6 (19.7 to 26.0)
        Serogroup C (n=458,459)
    238 (209 to 270)
    17.0 (14.3 to 20.2)
        Serogroup Y (n=458,459)
    68.8 (61.3 to 77.3)
    43.5 (37.7 to 50.4)
        Serogroup W (n=458,459)
    37.5 (33.7 to 41.8)
    26.2 (23.0 to 29.9)
    Statistical analysis title
    		 Serogroup A
    Statistical analysis description
    Actual number of subjects analyzed = 914
    Comparison groups
    Group 2: MENVEO® Vaccine v Group 1: MenACYW Conjugate Vaccine
    Number of subjects included in analysis
    918
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.91
         upper limit
    		 1.32
    Statistical analysis title
    		 Serogroup C
    Statistical analysis description
    Actual number of subjects analyzed = 917
    Comparison groups
    Group 1: MenACYW Conjugate Vaccine v Group 2: MENVEO® Vaccine
    Number of subjects included in analysis
    918
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 11.3
         upper limit
    		 17.3
    Statistical analysis title
    		 Serogroup Y
    Statistical analysis description
    Actual number of subjects analyzed = 917
    Comparison groups
    Group 1: MenACYW Conjugate Vaccine v Group 2: MENVEO® Vaccine
    Number of subjects included in analysis
    918
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.31
         upper limit
    		 1.9
    Statistical analysis title
    		 Serogroup W
    Statistical analysis description
    Actual number of subjects analyzed = 917
    Comparison groups
    Group 1: MenACYW Conjugate Vaccine v Group 2: MENVEO® Vaccine
    Number of subjects included in analysis
    918
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.21
         upper limit
    		 1.69

    Secondary: GMTs of Meningococcal Serogroups A, C, Y, and W Antibodies Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 5 Years of Age

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    End point title
    		 GMTs of Meningococcal Serogroups A, C, Y, and W Antibodies Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 5 Years of Age
    End point description
    Antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA. Analysis was performed on PPAS. Here 'Number of subjects analysed' signifies number of subjects in the PPAS aged 2-5 years, and 'n' signifies number of subjects with available data for specified category.
    End point type
    Secondary
    End point timeframe
    Day 30 (post-vaccination)
    End point values
    		 Group 1: MenACYW Conjugate Vaccine Group 2: MENVEO® Vaccine
    Number of subjects analysed
    229
    223
    Units: titers
    geometric mean (confidence interval 95%)
        Serogroup A (n=228,221)
    21.6 (18.2 to 25.5)
    18.9 (15.5 to 23.0)
        Serogroup C (n=229,223)
    208 (175 to 246)
    11.9 (9.79 to 14.6)
        Serogroup Y (n=229,222)
    49.8 (43.0 to 57.6)
    36.1 (29.2 to 44.7)
        Serogroup W (n=229,222)
    28.8 (24.6 to 33.7)
    20.1 (16.7 to 24.2)
    Statistical analysis title
    		 Serogroup A
    Statistical analysis description
    Actual number of subjects analyzed = 449
    Comparison groups
    Group 1: MenACYW Conjugate Vaccine v Group 2: MENVEO® Vaccine
    Number of subjects included in analysis
    452
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.883
         upper limit
    		 1.47
    Statistical analysis title
    		 Serogroup C
    Comparison groups
    Group 1: MenACYW Conjugate Vaccine v Group 2: MENVEO® Vaccine
    Number of subjects included in analysis
    452
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    17.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 13.4
         upper limit
    		 22.6
    Statistical analysis title
    		 Serogroup Y
    Statistical analysis description
    Actual number of subjects analyzed = 451
    Comparison groups
    Group 1: MenACYW Conjugate Vaccine v Group 2: MENVEO® Vaccine
    Number of subjects included in analysis
    452
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.38
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.07
         upper limit
    		 1.78
    Statistical analysis title
    		 Serogroup W
    Statistical analysis description
    Actual number of subjects analyzed = 451
    Comparison groups
    Group 1: MenACYW Conjugate Vaccine v Group 2: MENVEO® Vaccine
    Number of subjects included in analysis
    452
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.12
         upper limit
    		 1.83

    Secondary: GMTs of Meningococcal Serogroups A, C, Y, and W Antibodies Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 6 to 9 Years of Age

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    End point title
    		 GMTs of Meningococcal Serogroups A, C, Y, and W Antibodies Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 6 to 9 Years of Age
    End point description
    Antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA. Analysis was performed on PPAS. Here 'Number of subjects analysed' signifies number of subjects in the PPAS aged 6-9 years, and 'n' signifies number of subjects with available data for specified category.
    End point type
    Secondary
    End point timeframe
    Day 30 (post-vaccination)
    End point values
    		 Group 1: MenACYW Conjugate Vaccine Group 2: MENVEO® Vaccine
    Number of subjects analysed
    229
    237
    Units: titers
    geometric mean (confidence interval 95%)
        Serogroup A (n=228,237)
    28.4 (23.9 to 33.8)
    26.8 (22.0 to 32.6)
        Serogroup C (n=229,236)
    272 (224 to 330)
    23.7 (18.2 to 31.0)
        Serogroup Y (n=229,237)
    95.1 (80.2 to 113)
    51.8 (42.5 to 63.2)
        Serogroup W (n=229,237)
    48.9 (42.5 to 56.3)
    33.6 (28.2 to 40.1)
    Statistical analysis title
    		 Serogroup A
    Statistical analysis description
    Actual number of subjects analyzed = 465
    Comparison groups
    Group 1: MenACYW Conjugate Vaccine v Group 2: MENVEO® Vaccine
    Number of subjects included in analysis
    466
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.06
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.816
         upper limit
    		 1.38
    Statistical analysis title
    		 Serogroup C
    Statistical analysis description
    Actual number of subjects analyzed = 465
    Comparison groups
    Group 1: MenACYW Conjugate Vaccine v Group 2: MENVEO® Vaccine
    Number of subjects included in analysis
    466
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    11.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 8.24
         upper limit
    		 16
    Statistical analysis title
    		 Serogroup Y
    Comparison groups
    Group 1: MenACYW Conjugate Vaccine v Group 2: MENVEO® Vaccine
    Number of subjects included in analysis
    466
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.41
         upper limit
    		 2.38
    Statistical analysis title
    		 Serogroup W
    Comparison groups
    Group 1: MenACYW Conjugate Vaccine v Group 2: MENVEO® Vaccine
    Number of subjects included in analysis
    466
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.45
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.16
         upper limit
    		 1.82

    Secondary: Percentages of Subjects Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 5 Years of Age

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    End point title
    		 Percentages of Subjects Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 5 Years of Age
    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 'Number of subjects analysed' signifies number of subjects in the PPAS aged 2-5 years, and 'n' signifies number of subjects with available data for specified category.
    End point type
    Secondary
    End point timeframe
    Day 30 (post-vaccination)
    End point values
    		 Group 1: MenACYW Conjugate Vaccine Group 2: MENVEO® Vaccine
    Number of subjects analysed
    229
    223
    Units: percentage of subjects
    number (confidence interval 95%)
        Serogroup A (n=227,221)
    52.4 (45.7 to 59.1)
    44.8 (38.1 to 51.6)
        Serogroup C (n=229,222)
    94.3 (90.5 to 96.9)
    43.2 (36.6 to 50.0)
        Serogroup Y (n=229,222)
    88.2 (83.3 to 92.1)
    77.0 (70.9 to 82.4)
        Serogroup W (n=229,222)
    73.8 (67.6 to 79.4)
    61.3 (54.5 to 67.7)
    Statistical analysis title
    		 Serogroup A
    Statistical analysis description
    Actual number of subjects analyzed = 448
    Comparison groups
    Group 1: MenACYW Conjugate Vaccine v Group 2: MENVEO® Vaccine
    Number of subjects included in analysis
    452
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    7.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.6
         upper limit
    		 16.7
    Statistical analysis title
    		 Serogroup C
    Statistical analysis description
    Actual number of subjects analyzed = 451
    Comparison groups
    Group 1: MenACYW Conjugate Vaccine v Group 2: MENVEO® Vaccine
    Number of subjects included in analysis
    452
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    51.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 43.5
         upper limit
    		 57.8
    Statistical analysis title
    		 Serogroup Y
    Statistical analysis description
    Actual number of subjects analyzed = 451
    Comparison groups
    Group 1: MenACYW Conjugate Vaccine v Group 2: MENVEO® Vaccine
    Number of subjects included in analysis
    452
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    11.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.2
         upper limit
    		 18.1
    Statistical analysis title
    		 Serogroup W
    Statistical analysis description
    Actual number of subjects analyzed = 451
    Comparison groups
    Group 1: MenACYW Conjugate Vaccine v Group 2: MENVEO® Vaccine
    Number of subjects included in analysis
    452
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    12.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.9
         upper limit
    		 20.9

    Secondary: Percentages of Subjects Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 6 to 9 Years of Age

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    End point title
    		 Percentages of Subjects Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 6 to 9 Years of Age
    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 'Number of subjects analysed' signifies number of subjects in the PPAS aged 6-9 years, and 'n' signifies number of subjects with available data for specified category.
    End point type
    Secondary
    End point timeframe
    Day 30 (post-vaccination)
    End point values
    		 Group 1: MenACYW Conjugate Vaccine Group 2: MENVEO® Vaccine
    Number of subjects analysed
    229
    237
    Units: percentage of subjects
    number (confidence interval 95%)
        Serogroup A (n=228,237)
    58.3 (51.6 to 64.8)
    50.6 (44.1 to 57.2)
        Serogroup C (n=229,236)
    96.1 (92.7 to 98.2)
    52.1 (45.5 to 58.6)
        Serogroup Y (n=229,237)
    94.8 (91.0 to 97.3)
    81.4 (75.9 to 86.2)
        Serogroup W (n=229,237)
    83.8 (78.4 to 88.4)
    66.7 (60.3 to 72.6)
    Statistical analysis title
    		 Serogroup A
    Statistical analysis description
    Actual number of subjects analyzed = 465
    Comparison groups
    Group 1: MenACYW Conjugate Vaccine v Group 2: MENVEO® Vaccine
    Number of subjects included in analysis
    466
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    7.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 16.6
    Statistical analysis title
    		 Serogroup C
    Statistical analysis description
    Actual number of subjects analyzed = 465
    Comparison groups
    Group 1: MenACYW Conjugate Vaccine v Group 2: MENVEO® Vaccine
    Number of subjects included in analysis
    466
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 36.8
         upper limit
    		 50.6
    Statistical analysis title
    		 Serogroup Y
    Comparison groups
    Group 1: MenACYW Conjugate Vaccine v Group 2: MENVEO® Vaccine
    Number of subjects included in analysis
    466
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    13.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7.6
         upper limit
    		 19.2
    Statistical analysis title
    		 Serogroup W
    Comparison groups
    Group 1: MenACYW Conjugate Vaccine v Group 2: MENVEO® Vaccine
    Number of subjects included in analysis
    466
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    17.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 9.4
         upper limit
    		 24.7

    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 2: MENVEO® Vaccine
    Reporting group description
    		 Healthy, meningococcal-vaccine naïve subjects aged 2 to 9 years received a single dose of MENVEO® vaccine.

    Reporting group title
    Group 1: MenACYW Conjugate Vaccine
    Reporting group description
    		 Healthy, meningococcal-vaccine naïve subjects aged 2 to 9 years received a single dose of MenACYW conjugate vaccine.

    Serious adverse events
    		 Group 2: MENVEO® Vaccine Group 1: MenACYW Conjugate Vaccine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 494 (0.61%)
    7 / 498 (1.41%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Vascular disorders
    Circulatory Collapse
         subjects affected / exposed
    0 / 494 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Partial Seizures
         subjects affected / exposed
    1 / 494 (0.20%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tethered Cord Syndrome
         subjects affected / exposed
    0 / 494 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Adenoidal Hypertrophy
         subjects affected / exposed
    1 / 494 (0.20%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    1 / 494 (0.20%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Status Asthmaticus
         subjects affected / exposed
    0 / 494 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillar Hypertrophy
         subjects affected / exposed
    1 / 494 (0.20%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wheezing
         subjects affected / exposed
    0 / 494 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Osteomyelitis
         subjects affected / exposed
    0 / 494 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Group 2: MENVEO® Vaccine Group 1: MenACYW Conjugate Vaccine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    335 / 494 (67.81%)
    304 / 498 (61.04%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    60 / 494 (12.15%)
    64 / 498 (12.85%)
         occurrences all number
    63
    65
    General disorders and administration site conditions
    Injection Site Erythema
         subjects affected / exposed
    153 / 494 (30.97%)
    110 / 498 (22.09%)
         occurrences all number
    154
    110
    Injection Site Pain
         subjects affected / exposed
    206 / 494 (41.70%)
    188 / 498 (37.75%)
         occurrences all number
    206
    188
    Injection Site Swelling
         subjects affected / exposed
    104 / 494 (21.05%)
    67 / 498 (13.45%)
         occurrences all number
    105
    67
    Malaise
         subjects affected / exposed
    99 / 494 (20.04%)
    103 / 498 (20.68%)
         occurrences all number
    99
    103
    Pyrexia
         subjects affected / exposed
    27 / 494 (5.47%)
    20 / 498 (4.02%)
         occurrences all number
    27
    21
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    30 / 494 (6.07%)
    34 / 498 (6.83%)
         occurrences all number
    33
    36
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    112 / 494 (22.67%)
    99 / 498 (19.88%)
         occurrences all number
    112
    99
    Infections and infestations
    Pharyngitis
         subjects affected / exposed
    25 / 494 (5.06%)
    24 / 498 (4.82%)
         occurrences all number
    34
    31
    Pharyngitis Streptococcal
         subjects affected / exposed
    34 / 494 (6.88%)
    18 / 498 (3.61%)
         occurrences all number
    38
    23
    Upper Respiratory Tract Infection
         subjects affected / exposed
    25 / 494 (5.06%)
    20 / 498 (4.02%)
         occurrences all number
    30
    24

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Aug 2017
    Following amendments were made- To accurately document the countries where the study was being conducted, Puerto Rico was added to different sections of the protocol as applicable. - Coordinating investigator information was added.

    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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