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    Clinical Trial Results:
    Phase III, modified double-blind, randomized, parallel group, active-controlled, multi-center study to compare the immunogenicity of MenACYW conjugate vaccine with that of MENVEO®, describe the immunogenicity of MenACYW conjugate vaccine and Menactra®, and describe the safety of MenACYW conjugate vaccine, MENVEO®, and Menactra® when administered in a 1 + 1 schedule concomitantly with routine pediatric vaccines to healthy infants and toddlers in the United States

    Summary
    EudraCT number
    		 2019-004460-22
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    20 Oct 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Apr 2024
    First version publication date
    28 Apr 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MET61
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03691610
    WHO universal trial number (UTN)
    		 U1111-1205-2836
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur Inc.
    Sponsor organisation address
    Discovery Drive, Swiftwater, Pennsylvania, United States, 18370-0187
    Public contact
    Trial Transparency Team, Sanofi Pasteur, Contact-US@sanofi.com
    Scientific contact
    Trial Transparency Team, Sanofi Pasteur, Contact-US@sanofi.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    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
    08 Jan 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Oct 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the non-inferiority (NI) of the vaccine seroresponse to meningococcal serogroups A, C, Y, and W following administration of 2 doses of MenACYW conjugate vaccine compared to 2 doses of MENVEO® when given concomitantly with routine pediatric vaccines to infants and toddlers 6 to 7 months of age (MoA) and 12 to 13 MoA.
    Protection of trial subjects
    Vaccinations were performed by qualified and trained study personnel. Participants with allergy to any of the vaccine components were not vaccinated. After vaccination, participants were also kept under clinical observation for 30 minutes to ensure their safety. Appropriate medical equipment were also available on site in case of any immediate allergic reactions.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Oct 2018
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Puerto Rico: 21
    Country: Number of subjects enrolled
    United States: 929
    Worldwide total number of subjects
    950
    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)
    950
    Children (2-11 years)
    0
    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
    		 The study was conducted at 47 centers in the United States and Puerto Rico between 04 October 2018 and 23 October 2023.

    Pre-assignment
    Screening details
    		 A total of 950 participants 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
    		 Infants: Group 1
    Arm description
    		 Participants received 2 doses of meningococcal polysaccharide (serogroups A, C, Y and W [MenACYW conjugate vaccine]) 0.5 milliliter (mL) intramuscular (IM) injection at 6 to 7 month of age (MoA) and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MenACYW conjugate vaccine
    Investigational medicinal product code
    Other name
    MenQuadfi®
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants were administered MenACYW conjugate vaccine 0.5 mL IM injection in the deltoid muscle of arm.

    Arm title
    		 Infants: Group 2
    Arm description
    		 Participants received 2 doses of MENVEO® 0.5 mL IM injection at 6 to 7 MoA and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    MENVEO®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants were administered MENVEO® 0.5 mL IM injection in the deltoid muscle of arm.

    Arm title
    		 Toddlers: Group 3
    Arm description
    		 Participants received 2 doses of meningococcal polysaccharide (serogroups A, C, Y and W [MenACYW conjugate vaccine]) 0.5 mL IM injection at 17 to 19 MoA and 20 to 23 MoA.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MenACYW conjugate vaccine
    Investigational medicinal product code
    Other name
    MenQuadfi®
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants were administered MenACYW conjugate vaccine 0.5 mL IM injection in the deltoid muscle of arm.

    Arm title
    		 Toddlers: Group 4
    Arm description
    		 Participants received 2 doses of Menactra® 0.5 mL IM injection at 17 to 19 MoA and 20 to 23 MoA.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Menactra®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants were administered Menactra® 0.5 mL IM injection in the deltoid muscle of arm.

    Number of subjects in period 1
    		Infants: Group 1 Infants: Group 2 Toddlers: Group 3 Toddlers: Group 4
    Started
    380
    370
    96
    104
    Completed
    298
    290
    83
    94
    Not completed
    82
    80
    13
    10
         Adverse Event
    -
    1
    -
    -
         Protocol Deviation
    15
    8
    1
    2
         Withdrawal by Parent/Guardian
    47
    60
    7
    6
         Lost to follow-up
    20
    11
    5
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Infants: Group 1
    Reporting group description
    		 Participants received 2 doses of meningococcal polysaccharide (serogroups A, C, Y and W [MenACYW conjugate vaccine]) 0.5 milliliter (mL) intramuscular (IM) injection at 6 to 7 month of age (MoA) and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.

    Reporting group title
    Infants: Group 2
    Reporting group description
    		 Participants received 2 doses of MENVEO® 0.5 mL IM injection at 6 to 7 MoA and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.

    Reporting group title
    Toddlers: Group 3
    Reporting group description
    		 Participants received 2 doses of meningococcal polysaccharide (serogroups A, C, Y and W [MenACYW conjugate vaccine]) 0.5 mL IM injection at 17 to 19 MoA and 20 to 23 MoA.

    Reporting group title
    Toddlers: Group 4
    Reporting group description
    		 Participants received 2 doses of Menactra® 0.5 mL IM injection at 17 to 19 MoA and 20 to 23 MoA.

    Reporting group values
    		 Infants: Group 1 Infants: Group 2 Toddlers: Group 3 Toddlers: Group 4 Total
    Number of subjects
    		 380 370 96 104 950
    Age Categorical
    Units: Subjects
    Age Continuous
    Units: months
        arithmetic mean (standard deviation)
    		 6.01 ± 0.700 6.02 ± 0.396 17.9 ± 0.632 17.9 ± 0.673 -
    Gender Categorical
    Units: Subjects
        Female
    		 180 172 48 52 452
        Male
    		 200 198 48 52 498
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 1 0 0 1
        Asian
    		 6 6 2 1 15
        Black or African American
    		 70 68 11 11 160
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0
        White
    		 277 264 79 87 707
        Mixed origin
    		 14 20 4 5 43
        Not Reported
    		 10 4 0 0 14
        Unknown
    		 3 7 0 0 10

    End points

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    End points reporting groups
    Reporting group title
    Infants: Group 1
    Reporting group description
    		 Participants received 2 doses of meningococcal polysaccharide (serogroups A, C, Y and W [MenACYW conjugate vaccine]) 0.5 milliliter (mL) intramuscular (IM) injection at 6 to 7 month of age (MoA) and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.

    Reporting group title
    Infants: Group 2
    Reporting group description
    		 Participants received 2 doses of MENVEO® 0.5 mL IM injection at 6 to 7 MoA and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.

    Reporting group title
    Toddlers: Group 3
    Reporting group description
    		 Participants received 2 doses of meningococcal polysaccharide (serogroups A, C, Y and W [MenACYW conjugate vaccine]) 0.5 mL IM injection at 17 to 19 MoA and 20 to 23 MoA.

    Reporting group title
    Toddlers: Group 4
    Reporting group description
    		 Participants received 2 doses of Menactra® 0.5 mL IM injection at 17 to 19 MoA and 20 to 23 MoA.

    Primary: Infants Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or MENVEO

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    End point title
    		 Infants Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or MENVEO [1] [2]
    End point description
    Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination titer >= 1:16 for participants with pre-vaccination hSBA titer < 1:8, or a post-vaccination titer >= 4-fold increase from baseline for participant with pre-vaccination hSBA titer >= 1:8. Per-protocol analysis set 2 (PPAS2) was a subset of the full analysis set 2 (FAS2). The FAS2 included all randomized participants who received at least 1 dose of the study vaccine in the second year of life (>= 12 MOA) and had a valid post vaccination serology result in the second year of life. Here, n= number of participants with available data for each specific serogroup.
    End point type
    Primary
    End point timeframe
    Baseline (Day 0) and 30 days post second dose of MenACYW conjugate vaccine or MENVEO
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As the endpoint is descriptive in nature, no statistical analysis is provided.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only infants randomized in Groups 1 and 2 were analyzed in the primary endpoint.
    End point values
    		 Infants: Group 1 Infants: Group 2
    Number of subjects analysed
    180
    163
    Units: percentage of participants
    number (confidence interval 95%)
        Serogroup A (n=141, 123)
    89.4 (83.1 to 93.9)
    82.9 (75.1 to 89.1)
        Serogroup C (n=134, 126)
    99.3 (95.9 to 100)
    97.6 (93.2 to 99.5)
        Serogroup Y (n=140, 128)
    98.6 (94.9 to 99.8)
    97.7 (93.3 to 99.5)
        Serogroup W (n=143, 127)
    99.3 (96.2 to 100)
    92.9 (87.0 to 96.7)
    No statistical analyses for this end point

    Secondary: Infants Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titer (Seroprotection) >=1:8 by hSBA at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or MENVEO

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    End point title
    		 Infants Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titer (Seroprotection) >=1:8 by hSBA at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or MENVEO [3]
    End point description
    Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Seroprotection rate was defined as percentage of participants with hSBA titers >= 1:8. The PPAS2 was a subset of the FAS2. The FAS2 included all randomized participants who received at least 1 dose of the study vaccine in the second year of life (>= 12 MOA) and had a valid post vaccination serology result in the second year of life. Here, n= number of participants with available data for each specific serogroup.
    End point type
    Secondary
    End point timeframe
    At 30 days post second dose of MenACYW conjugate vaccine or MENVEO
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only infants randomized in Groups 1 and 2 were analyzed in this secondary endpoint.
    End point values
    		 Infants: Group 1 Infants: Group 2
    Number of subjects analysed
    180
    163
    Units: percentage of participants
    number (confidence interval 95%)
        Serogroup A (n=170, 158)
    95.3 (90.9 to 97.9)
    93.0 (87.9 to 96.5)
        Serogroup C (n=162, 160)
    100 (97.7 to 100)
    98.1 (94.6 to 99.6)
        Serogroup Y (n=170, 160)
    100 (97.9 to 100)
    97.5 (93.7 to 99.3)
        Serogroup W (n=171, 159)
    100 (97.9 to 100)
    95.6 (91.1 to 98.2)
    No statistical analyses for this end point

    Secondary: Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8

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    End point title
    		 Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 [4]
    End point description
    Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA titers >= 1:4 and >= 1:8 were analyzed. Per-Protocol Analysis Set 1 (PPAS1) was a subset of full analysis set 1 (FAS1). FAS1 included all randomized participants who received at least 1 dose of study vaccine in infancy (< 12 MOA) and had a valid post vaccination serology result in infancy. PPAS2 analysis set. Per-Protocol Analysis Set 3 (PPAS3) was a subset of full analysis set 3 (FAS3). FAS3 included all randomized participants who received at least 1 dose of study vaccine in infancy (< 12 MOA) and had a valid pre-vaccination serology result at visit 3. Here, n= number of participants with available data for each specific serogroup.
    End point type
    Secondary
    End point timeframe
    PPAS1: At 30 days post first dose; PPAS2: At Baseline (pre-dose on Day 0) and 30 days post second dose; and PPAS3: At 6 months post first dose of MenACYW conjugate vaccine or MENVEO
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only infants randomized in Groups 1 and 2 were analyzed in this secondary endpoint.
    End point values
    		 Infants: Group 1 Infants: Group 2
    Number of subjects analysed
    380
    370
    Units: percentage of participants
    number (confidence interval 95%)
        PPAS1, Serogroup A: >=1:4 (n=130, 132)
    64.6 (55.8 to 72.8)
    55.3 (46.4 to 64.0)
        PPAS1, Serogroup A: >=1:8 (n=130, 132)
    54.6 (45.7 to 63.4)
    37.9 (29.6 to 46.7)
        PPAS1, Serogroup C: >=1:4 (n=127, 133)
    96.9 (92.1 to 99.1)
    93.2 (87.5 to 96.9)
        PPAS1, Serogroup C: >=1:8 (n=127, 133)
    96.9 (92.1 to 99.1)
    90.2 (83.9 to 94.7)
        PPAS1, Serogroup Y: >=1:4 (n=125, 128)
    70.4 (61.6 to 78.2)
    43.0 (34.3 to 52.0)
        PPAS1, Serogroup Y: >=1:8 (n=125, 128)
    60.8 (51.7 to 69.4)
    26.6 (19.1 to 35.1)
        PPAS1, Serogroup W: >=1:4 (n=134, 134)
    49.3 (40.5 to 58.0)
    37.3 (29.1 to 46.1)
        PPAS1, Serogroup W: >=1:8 (n=134, 134)
    38.1 (29.8 to 46.8)
    28.4 (20.9 to 36.8)
        PPAS2, Serogroup A, Day 0: >=1:4 (n=144, 127)
    56.3 (47.7 to 64.5)
    51.2 (42.2 to 60.1)
        PPAS2, Serogroup A, Day 0: >=1:8 (n=144, 127)
    29.2 (21.9 to 37.3)
    24.4 (17.2 to 32.8)
        PPAS2, Serogroup A, Day 30: >=1:4 (n=170, 158)
    97.1 (93.3 to 99.0)
    94.9 (90.3 to 97.8)
        PPAS2, Serogroup A, Day 30: >=1:8 (n=170, 158)
    95.3 (90.9 to 97.9)
    93.0 (87.9 to 96.5)
        PPAS2, Serogroup C, Day 0: >=1:4 (n=147, 129)
    10.2 (5.8 to 16.3)
    12.4 (7.3 to 19.4)
        PPAS2, Serogroup C, Day 0: >=1:8 (n=147, 129)
    6.1 (2.8 to 11.3)
    7.0 (3.2 to 12.8)
        PPAS2, Serogroup C, Day 30: >=1:4 (n=162, 160)
    100 (97.7 to 100)
    99.4 (96.6 to 100)
        PPAS2, Serogroup C, Day 30: >=1:8 (n=162, 160)
    100 (97.7 to 100)
    98.1 (94.6 to 99.6)
        PPAS2, Serogroup Y, Day 0: >=1:4 (n=149, 130)
    15.4 (10.0 to 22.3)
    12.3 (7.2 to 19.2)
        PPAS2, Serogroup Y, Day 0: >=1:8 (n=149, 130)
    8.7 (4.7 to 14.5)
    6.2 (2.7 to 11.8)
        PPAS2, Serogroup Y, Day 30: >=1:4 (n=170, 160)
    100 (97.9 to 100)
    98.1 (94.6 to 99.6)
        PPAS2, Serogroup Y, Day 30: >=1:8 (n=170, 160)
    100 (97.9 to 100)
    97.5 (93.7 to 99.3)
        PPAS2, Serogroup W, Day 0: >=1:4 (n=148, 130)
    6.8 (3.3 to 12.1)
    10.8 (6.0 to 17.4)
        PPAS2, Serogroup W, Day 0: >=1:8 (n=148, 130)
    4.7 (1.9 to 9.5)
    6.2 (2.7 to 11.8)
        PPAS2, Serogroup W, Day 30: >=1:4 (n=171, 159)
    100 (97.9 to 100)
    96.9 (92.8 to 99.0)
        PPAS2, Serogroup W, Day 30: >=1:8 (n=171, 159)
    100 (97.9 to 100)
    95.6 (91.1 to 98.2)
        PPAS3, Serogroup A: >=1:4 (n=103, 91)
    87.4 (79.4 to 93.1)
    85.7 (76.8 to 92.2)
        PPAS3, Serogroup A: >=1:8 (n=103, 91)
    77.7 (68.4 to 85.3)
    73.6 (63.3 to 82.3)
        PPAS3, Serogroup C: >=1:4 (n=104, 94)
    99.0 (94.8 to 100)
    77.7 (67.9 to 85.6)
        PPAS3, Serogroup C: >=1:8 (n=104, 94)
    98.1 (93.2 to 99.8)
    69.1 (58.8 to 78.3)
        PPAS3, Serogroup Y: >=1:4 (n=106, 93)
    98.1 (93.4 to 99.8)
    69.9 (59.5 to 79.0)
        PPAS3, Serogroup Y: >=1:8 (n=106, 93)
    96.2 (90.6 to 99.0)
    54.8 (44.2 to 65.2)
        PPAS3, Serogroup W: >=1:4 (n=106, 93)
    98.1 (93.4 to 99.8)
    61.3 (50.6 to 71.2)
        PPAS3, Serogroup W: >=1:8 (n=106, 93)
    96.2 (90.6 to 99.0)
    50.5 (40.0 to 61.1)
    No statistical analyses for this end point

    Secondary: Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y

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    End point title
    		 Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y [5]
    End point description
    Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA and the results were expressed as geometric mean titers. The PPAS1 was a subset of the FAS1. The FAS1 included all randomized participants who received at least 1 dose of the study vaccine in infancy (< 12 MOA) and had a valid post vaccination serology result in infancy. The PPAS2 was a subset of the FAS2. The FAS2 included all randomized participants who received at least 1 dose of the study vaccine in the second year of life (>= 12 MOA) and had a valid post vaccination serology result in the second year of life. The PPAS3 was a subset of the FAS3. The FAS3 included all randomized participants who received at least 1 dose of the study vaccine in infancy (< 12 MOA) and had a valid pre-vaccination serology result at visit 3. Here, n= number of participants with available data for each specific serogroup.
    End point type
    Secondary
    End point timeframe
    PPAS1: At 30 days post first dose; PPAS2: At Baseline (pre-dose on Day 0) and 30 days post second dose; and PPAS3: At 6 months post first dose of MenACYW conjugate vaccine or MENVEO
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only infants randomized in Groups 1 and 2 were analyzed in this secondary endpoint.
    End point values
    		 Infants: Group 1 Infants: Group 2
    Number of subjects analysed
    380
    370
    Units: titer
    geometric mean (confidence interval 95%)
        PPAS1: Serogroup A (n=130, 132)
    8.26 (6.55 to 10.4)
    5.45 (4.42 to 6.72)
        PPAS1: Serogroup C (n=127, 133)
    167 (129 to 217)
    41.3 (32.8 to 52.1)
        PPAS1: Serogroup Y (n=125, 128)
    8.36 (6.61 to 10.6)
    3.79 (3.20 to 4.49)
        PPAS1: Serogroup W (n=134, 134)
    5.51 (4.39 to 6.92)
    3.82 (3.22 to 4.52)
        PPAS2, Serogroup A: Day 0 (n=144, 127)
    4.73 (3.92 to 5.72)
    4.64 (3.74 to 5.74)
        PPAS2, Serogroup A: Day 30 (n=170, 158)
    184 (143 to 237)
    119 (90.6 to 157)
        PPAS2, Serogroup C: Day 0 (n=147, 129)
    2.57 (2.21 to 2.99)
    2.48 (2.20 to 2.79)
        PPAS2, Serogroup C: Day 30 (n=162, 160)
    1473 (1236 to 1756)
    319 (263 to 388)
        PPAS2, Serogroup Y: Day 0 (n=149, 130)
    2.54 (2.27 to 2.83)
    2.37 (2.16 to 2.60)
        PPAS2, Serogroup Y: Day 30 (n=170, 160)
    423 (358 to 499)
    133 (107 to 166)
        PPAS2, Serogroup W: Day 0 (n=148, 130)
    2.23 (2.05 to 2.42)
    2.31 (2.13 to 2.51)
        PPAS2, Serogroup W: Day 30 (n=171, 159)
    442 (367 to 533)
    106 (83.4 to 135)
        PPAS3: Serogroup A (n=103, 91)
    20.1 (14.7 to 27.4)
    14.9 (11.0 to 20.3)
        PPAS3: Serogroup C (n=104, 94)
    150 (117 to 193)
    12.7 (9.63 to 16.8)
        PPAS3: Serogroup Y (n=106, 93)
    46.2 (36.3 to 58.6)
    6.74 (5.43 to 8.36)
        PPAS3: Serogroup W (n=106, 93)
    46.8 (36.1 to 60.5)
    6.16 (4.87 to 7.80)
    No statistical analyses for this end point

    Secondary: Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128

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    End point title
    		 Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 [6]
    End point description
    Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA titers >= 1:4 to >= 1:128 were analyzed. The PPAS1 was a subset of FAS1. The FAS1 included all randomized participants who received at least 1 dose of the study vaccine in infancy (< 12 MOA) and had a valid post vaccination serology result in infancy. The PPAS2 was a subset of FAS2. The FAS2 included all randomized participants who received at least 1 dose of the study vaccine in the second year of life (>= 12 MOA) and had a valid post vaccination serology result in the second year of life. The PPAS3 was a subset of FAS3. The FAS3 included all randomized participants who received at least 1 dose of the study vaccine in infancy (< 12 MOA) and had a valid pre-vaccination serology result at visit 3. Here, n= number of participants with available data for each specific serogroup.
    End point type
    Secondary
    End point timeframe
    PPAS1: At 30 days post first dose; PPAS2: At Baseline (pre-dose on Day 0) and 30 days post second dose; and PPAS3: At 6 months post first dose of MenACYW conjugate vaccine or MENVEO
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only infants randomized in Groups 1 and 2 were analyzed in this secondary endpoint.
    End point values
    		 Infants: Group 1 Infants: Group 2
    Number of subjects analysed
    380
    370
    Units: percentage of participants
    number (not applicable)
        PPAS1, Serogroup A: >=1:4 (n= 130, 132)
    64.6
    55.3
        PPAS1, Serogroup A: >=1:128 (n= 130, 132)
    3.1
    3.0
        PPAS1, Serogroup C: >=1:4 (n= 127, 133)
    96.9
    93.2
        PPAS1, Serogroup C: >=1:128 (n= 127, 133)
    67.7
    32.3
        PPAS1, Serogroup Y: >=1:4 (n= 125, 128)
    70.4
    43.0
        PPAS1, Serogroup Y: >=1:128 (n= 125, 128)
    5.6
    0.8
        PPAS1, Serogroup W: >=1:4 (n= 134, 134)
    49.3
    37.3
        PPAS1, Serogroup W: >=1:128 (n= 134, 134)
    4.5
    0
        PPAS2, Serogroup A, Day 0: >=1:4 (n=144, 127)
    56.3
    51.2
        PPAS2, Serogroup A, Day 0: >=1:128 (n=144, 127)
    4.9
    3.1
        PPAS2, Serogroup A, Day 30: >=1:4 (n=170, 158)
    97.1
    94.9
        PPAS2, Serogroup A, Day 30: >=1:128 (n=170, 158)
    68.8
    62.7
        PPAS2, Serogroup C, Day 0: >=1:4 (n=147, 129)
    10.2
    12.4
        PPAS2, Serogroup C, Day 0: >=1:128 (n=147, 129)
    2.0
    0
        PPAS2, Serogroup C, Day 30: >=1:4 (n=162, 160)
    100
    99.4
        PPAS2, Serogroup C, Day 30: >=1:128 (n=162, 160)
    98.1
    88.1
        PPAS2, Serogroup Y, Day 0: >=1:4 (n=149, 130)
    15.4
    12.3
        PPAS2, Serogroup Y, Day 0: >=1:128 (n=149, 130)
    0.7
    0
        PPAS2, Serogroup Y, Day 30: >=1:4 (n=170, 160)
    100
    98.1
        PPAS2, Serogroup Y, Day 30: >=1:128 (n=170, 160)
    90.0
    58.8
        PPAS2, Serogroup W, Day 0: >=1:4 (n=148, 130)
    6.8
    10.8
        PPAS2, Serogroup W, Day 0: >=1:128 (n=148, 130)
    0.7
    0
        PPAS2, Serogroup W, Day 30: >=1:4 (n=171, 159)
    100
    96.9
        PPAS2, Serogroup W, Day 30: >=1:128 (n=171, 159)
    90.6
    56.0
        PPAS3, Serogroup A: >=1:4 (n=103, 91)
    87.4
    85.7
        PPAS3, Serogroup A: >=1:128 (n=103, 91)
    18.4
    12.1
        PPAS3, Serogroup C: >=1:4 (n=104, 94)
    99.0
    77.7
        PPAS3, Serogroup C: >=1:128 (n=104, 94)
    69.2
    6.4
        PPAS3, Serogroup Y: >=1:4 (n=106, 93)
    98.1
    69.9
        PPAS3, Serogroup Y: >=1:128 (n=106, 93)
    27.4
    1.1
        PPAS3, Serogroup W: >=1:4 (n=106, 93)
    98.1
    61.3
        PPAS3, Serogroup W: >=1:128 (n=106, 93)
    33.0
    3.2
    No statistical analyses for this end point

    Secondary: Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 4-Fold Rise From Pre-Vaccination to Post-Vaccination

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    End point title
    		 Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 4-Fold Rise From Pre-Vaccination to Post-Vaccination [7]
    End point description
    Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA titers >= 4-fold increase from baseline (pre-vaccination) were analyzed. The PPAS1 was a subset of the FAS1. The FAS1 included all randomized participants who received at least 1 dose of the study vaccine in infancy (< 12 MOA) and had a valid post vaccination serology result in infancy. The PPAS2 was a subset of the FAS2. The FAS2 included all randomized participants who received at least 1 dose of the study vaccine in the second year of life (>= 12 MOA) and had a valid post vaccination serology result in the second year of life. Here, n= number of participants with available data for each specific serogroup.
    End point type
    Secondary
    End point timeframe
    PPAS1: At 30 days post first dose; and PPAS2: At 30 days post second dose of MenACYW conjugate vaccine or MENVEO
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only infants randomized in Groups 1 and 2 were analyzed in this secondary endpoint.
    End point values
    		 Infants: Group 1 Infants: Group 2
    Number of subjects analysed
    380
    370
    Units: percentage of participants
    number (confidence interval 95%)
        PPAS1: Serogroup A (n= 108, 111)
    30.6 (22.1 to 40.2)
    15.3 (9.2 to 23.4)
        PPAS1: Serogroup C (n= 104, 107)
    92.3 (85.4 to 96.6)
    81.3 (72.6 to 88.2)
        PPAS1: Serogroup Y (n= 102, 106)
    30.4 (21.7 to 40.3)
    7.5 (3.3 to 14.3)
        PPAS1: Serogroup W (n= 108, 112)
    18.5 (11.7 to 27.1)
    8.0 (3.7 to 14.7)
        PPAS2: Serogroup A (n= 141, 123)
    89.4 (83.1 to 93.9)
    82.9 (75.1 to 89.1)
        PPAS2: Serogroup C (n= 134, 126)
    99.3 (95.9 to 100)
    97.6 (93.2 to 99.5)
        PPAS2: Serogroup Y (n= 140, 128)
    98.6 (94.9 to 99.8)
    97.7 (93.3 to 99.5)
        PPAS2: Serogroup W (n= 143, 127)
    99.3 (96.2 to 100)
    92.9 (87.0 to 96.7)
    No statistical analyses for this end point

    Secondary: Infants Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse Measured by hSBA at 30 Days Post First Dose of MenACYW Conjugate Vaccine or MENVEO

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    End point title
    		 Infants Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse Measured by hSBA at 30 Days Post First Dose of MenACYW Conjugate Vaccine or MENVEO [8]
    End point description
    Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA vaccine seroresponse which was defined as >= 4-fold increase from baseline (pre-vaccination) were analyzed. The PPAS1 was a subset of the FAS1. The FAS1 included all randomized participants who received at least 1 dose of the study vaccine in infancy (< 12 MOA) and had a valid post vaccination serology result in infancy. Here, n= number of participants with available data for each specific serogroup.
    End point type
    Secondary
    End point timeframe
    At 30 days post first dose of MenACYW conjugate vaccine or MENVEO
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only infants randomized in Groups 1 and 2 were analyzed in this secondary endpoint.
    End point values
    		 Infants: Group 1 Infants: Group 2
    Number of subjects analysed
    135
    138
    Units: percentage of participants
    number (confidence interval 95%)
        Serogroup A (n= 108, 111)
    30.6 (22.1 to 40.2)
    15.3 (9.2 to 23.4)
        Serogroup C (n= 104, 107)
    92.3 (85.4 to 96.6)
    81.3 (72.6 to 88.2)
        Serogroup Y (n= 102, 106)
    30.4 (21.7 to 40.3)
    7.5 (3.3 to 14.3)
        Serogroup W (n= 108, 112)
    18.5 (11.7 to 27.1)
    8.0 (3.7 to 14.7)
    No statistical analyses for this end point

    Secondary: Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8

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    End point title
    		 Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 [9]
    End point description
    Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA titers >= 1:4 and >= 1:8 were analyzed. The PPAS2 was a subset of the FAS2. The FAS2 included all randomized participants who received at least 1 dose of the study vaccine in the second year of life (>= 12 MOA) and had a valid post vaccination serology result in the second year of life. Here, n= number of participants with available data for each specific serogroup.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 0) and 30 days post second dose of MenACYW conjugate vaccine or Menactra
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only toddlers randomized in Groups 3 and 4 were analyzed in this secondary endpoint.
    End point values
    		 Toddlers: Group 3 Toddlers: Group 4
    Number of subjects analysed
    61
    65
    Units: percentage of participants
    number (confidence interval 95%)
        Serogroup A, Day 0: >=1:4 (n=59, 59)
    54.2 (40.8 to 67.3)
    33.9 (22.1 to 47.4)
        Serogroup A, Day 0: >=1:8 (n=59, 59)
    28.8 (17.8 to 42.1)
    18.6 (9.7 to 30.9)
        Serogroup A, Day 30: >=1:4 (n=61, 64)
    93.4 (84.1 to 98.2)
    76.6 (64.3 to 86.2)
        Serogroup A, Day 30: >=1:8 (n=61, 64)
    88.5 (77.8 to 95.3)
    62.5 (49.5 to 74.3)
        Serogroup C, Day 0: >=1:4 (n=59, 59)
    3.4 (0.4 to 11.7)
    10.2 (3.8 to 20.8)
        Serogroup C, Day 0: >=1:8 (n=59, 59)
    1.7 (0 to 9.1)
    5.1 (1.1 to 14.1)
        Serogroup C, Day 30: >=1:4 (n=61, 65)
    100 (94.1 to 100)
    98.5 (91.7 to 100)
        Serogroup C, Day 30: >=1:8 (n=61, 65)
    100 (94.1 to 100)
    98.5 (91.7 to 100)
        Serogroup Y, Day 0: >=1:4 (n=59, 59)
    11.9 (4.9 to 22.9)
    10.2 (3.8 to 20.8)
        Serogroup Y, Day 0: >=1:8 (n=59, 59)
    8.5 (2.8 to 18.7)
    8.5 (2.8 to 18.7)
        Serogroup Y, Day 30: >=1:4 (n=61, 65)
    100 (94.1 to 100)
    93.8 (85.0 to 98.3)
        Serogroup Y, Day 30: >=1:8 (n=61, 65)
    100 (94.1 to 100)
    92.3 (83.0 to 97.5)
        Serogroup W, Day 0: >=1:4 (n=59, 59)
    1.7 (0 to 9.1)
    3.4 (0.4 to 11.7)
        Serogroup W, Day 0: >=1:8 (n=59, 59)
    0 (0 to 6.1)
    1.7 (0 to 9.1)
        Serogroup W, Day 30: >=1:4 (n=61, 65)
    100 (94.1 to 100)
    86.2 (75.3 to 93.5)
        Serogroup W, Day 30: >=1:8 (n=61, 65)
    100 (94.1 to 100)
    84.6 (73.5 to 92.4)
    No statistical analyses for this end point

    Secondary: Toddlers Groups 3 and 4: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y

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    End point title
    		 Toddlers Groups 3 and 4: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y [10]
    End point description
    Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA and the results were expressed as geometric mean titers. The PPAS2 was a subset of the FAS2. The FAS2 included all randomized participants who received at least 1 dose of the study vaccine in the second year of life (>= 12 MOA) and had a valid post vaccination serology result in the second year of life. Here, n= number of participants with available data for each specific serogroup.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 0) and 30 days post second dose of MenACYW conjugate vaccine or Menactra
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only toddlers randomized in Groups 3 and 4 were analyzed in this secondary endpoint.
    End point values
    		 Toddlers: Group 3 Toddlers: Group 4
    Number of subjects analysed
    61
    65
    Units: titer
    geometric mean (confidence interval 95%)
        Serogroup A: Day 0 (n=59, 59)
    4.29 (3.36 to 5.49)
    3.43 (2.61 to 4.51)
        Serogroup A: Day 30 (n=61, 64)
    45.0 (29.8 to 68.0)
    13.2 (8.72 to 19.9)
        Serogroup C: Day 0 (n=59, 59)
    2.10 (1.95 to 2.26)
    2.41 (2.01 to 2.90)
        Serogroup C: Day 30 (n=61, 65)
    1727 (1300 to 2294)
    59.4 (44.3 to 79.6)
        Serogroup Y: Day 0 (n=59, 59)
    2.44 (2.07 to 2.88)
    2.44 (2.05 to 2.91)
        Serogroup Y: Day 30 (n=61, 65)
    284 (218 to 369)
    45.5 (32.9 to 62.8)
        Serogroup W: Day 0 (n=59, 59)
    2.02 (1.98 to 2.07)
    2.12 (1.93 to 2.34)
        Serogroup W: Day 30 (n=61, 65)
    202 (152 to 267)
    25.0 (17.6 to 35.7)
    No statistical analyses for this end point

    Secondary: Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128

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    End point title
    		 Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128 [11]
    End point description
    Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA titers >= 1:4 to >= 1:128 were analyzed. The PPAS2 was a subset of the FAS2. The FAS2 included all randomized participants who received at least 1 dose of the study vaccine in the second year of life (>= 12 MOA) and had a valid post vaccination serology result in the second year of life. Here, n= number of participants with available data for each specific serogroup.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 0) and at 30 days post second dose of MenACYW conjugate vaccine or Menactra
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only toddlers randomized in Groups 3 and 4 were analyzed in this secondary endpoint.
    End point values
    		 Toddlers: Group 3 Toddlers: Group 4
    Number of subjects analysed
    61
    65
    Units: percentage of participants
    number (not applicable)
        Serogroup A, Day 0: >=1:4 (n=59, 59)
    54.2
    33.9
        Serogroup A, Day 0: >=1:128 (n=59, 59)
    0
    3.4
        Serogroup A, Day 30: >=1:4 (n=61, 64)
    93.4
    76.6
        Serogroup A, Day 30: >=1:128 (n=61, 64)
    32.8
    14.1
        Serogroup C, Day 0: >=1:4 (n=59, 59)
    3.4
    10.2
        Serogroup C, Day 0: >=1:128 (n=59, 59)
    0
    1.7
        Serogroup C, Day 30: >=1:4 (n=61, 65)
    100
    98.5
        Serogroup C, Day 30: >=1:128 (n=61, 65)
    100
    32.3
        Serogroup Y, Day 0: >=1:4 (n=59, 59)
    11.9
    10.2
        Serogroup Y, Day 0: >=1:128 (n=59, 59)
    0
    0
        Serogroup Y, Day 30: >=1:4 (n=61, 65)
    100
    93.8
        Serogroup Y, Day 30: >=1:128 (n=61, 65)
    85.2
    24.6
        Serogroup W, Day 0: >=1:4 (n=59, 59)
    1.7
    3.4
        Serogroup W, Day 0: >=1:128 (n=59, 59)
    0
    0
        Serogroup W, Day 30: >=1:4 (n=61, 65)
    100
    86.2
        Serogroup W, Day 30: >=1:128 (n=61, 65)
    78.7
    13.8
    No statistical analyses for this end point

    Secondary: Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 4-Fold Rise From Pre-Vaccination to Post-Vaccination

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    End point title
    		 Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 4-Fold Rise From Pre-Vaccination to Post-Vaccination [12]
    End point description
    Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA titers >= 4-fold increase from baseline (pre-vaccination) were analyzed. The PPAS2 was a subset of the FAS2. The FAS2 included all randomized participants who received at least 1 dose of the study vaccine in the second year of life (>= 12 MOA) and had a valid post vaccination serology result in the second year of life. Here, n= number of participants with available data for each specific serogroup.
    End point type
    Secondary
    End point timeframe
    At 30 days post second dose of MenACYW conjugate vaccine or Menactra
    Notes
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only toddlers randomized in Groups 3 and 4 were analyzed in this secondary endpoint.
    End point values
    		 Toddlers: Group 3 Toddlers: Group 4
    Number of subjects analysed
    61
    65
    Units: percentage of participants
    number (confidence interval 95%)
        Serogroup A (n= 59, 58)
    72.9 (59.7 to 83.6)
    46.6 (33.3 to 60.1)
        Serogroup C (n= 59, 59)
    100 (93.9 to 100)
    93.2 (83.5 to 98.1)
        Serogroup Y (n= 59, 59)
    100 (93.9 to 100)
    88.1 (77.1 to 95.1)
        Serogroup W (n= 59, 59)
    100 (93.9 to 100)
    76.3 (63.4 to 86.4)
    No statistical analyses for this end point

    Secondary: Toddlers Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse Measured by hSBA at 30 Days Post Second Dose of MenACYW conjugate vaccine or Menactra

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    End point title
    		 Toddlers Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse Measured by hSBA at 30 Days Post Second Dose of MenACYW conjugate vaccine or Menactra [13]
    End point description
    Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA vaccine seroresponse which was defined as >= 4-fold increase from baseline (pre-vaccination) were analyzed. The PPAS2 was a subset of the FAS2. The FAS2 included all randomized participants who received at least 1 dose of the study vaccine in the second year of life (>= 12 MOA) and had a valid post vaccination serology result in the second year of life. Here, n= number of participants with available data for each specific serogroup.
    End point type
    Secondary
    End point timeframe
    At 30 days post second dose of MenACYW conjugate vaccine or Menactra
    Notes
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only toddlers randomized in Groups 3 and 4 were analyzed in this secondary endpoint.
    End point values
    		 Toddlers: Group 3 Toddlers: Group 4
    Number of subjects analysed
    61
    65
    Units: percentage of participants
    number (confidence interval 95%)
        Serogroup A (n=59, 58)
    72.9 (59.7 to 83.6)
    46.6 (33.3 to 60.1)
        Serogroup C (n=59, 59)
    100 (93.9 to 100)
    93.2 (83.5 to 98.1)
        Serogroup Y (n=59, 59)
    100 (93.9 to 100)
    88.1 (77.1 to 95.1)
        Serogroup W (n=59, 59)
    100 (93.9 to 100)
    76.3 (63.4 to 86.4)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the first study vaccine administration (Day 0) up to 6 months after the last vaccination (Groups 1 and 2: up to 1846 days and Groups 3 and 4: up to 1109 days)
    Adverse event reporting additional description
    Analysis was performed on the overall safety analysis set for any dose.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    Infants: Group 1
    Reporting group description
    		 Participants received 2 doses of meningococcal polysaccharide (serogroups A, C, Y and W [MenACYW conjugate vaccine]) 0.5 mL IM injection at 6 to 7 MoA and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.

    Reporting group title
    Toddlers: Group 3
    Reporting group description
    		 Participants received 2 doses of meningococcal polysaccharide (serogroups A, C, Y and W [MenACYW conjugate vaccine]) 0.5 mL IM injection at 17 to 19 MoA and 20 to 23 MoA.

    Reporting group title
    Toddlers: Group 4
    Reporting group description
    		 Participants received 2 doses of Menactra® 0.5 mL IM injection at 17 to 19 MoA and 20 to 23 MoA.

    Reporting group title
    Infants: Group 2
    Reporting group description
    		 Participants received 2 doses of MENVEO® 0.5 mL IM injection at 6 to 7 MoA and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.

    Serious adverse events
    		 Infants: Group 1 Toddlers: Group 3 Toddlers: Group 4 Infants: Group 2
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 370 (1.62%)
    1 / 96 (1.04%)
    4 / 103 (3.88%)
    12 / 361 (3.32%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute Myeloid Leukaemia
         subjects affected / exposed
    0 / 370 (0.00%)
    0 / 96 (0.00%)
    0 / 103 (0.00%)
    1 / 361 (0.28%)
         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
    Injury, poisoning and procedural complications
    Burns First Degree
         subjects affected / exposed
    0 / 370 (0.00%)
    0 / 96 (0.00%)
    0 / 103 (0.00%)
    1 / 361 (0.28%)
         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
    Accidental Exposure To Product
         subjects affected / exposed
    0 / 370 (0.00%)
    1 / 96 (1.04%)
    0 / 103 (0.00%)
    0 / 361 (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
    Febrile Convulsion
         subjects affected / exposed
    1 / 370 (0.27%)
    0 / 96 (0.00%)
    2 / 103 (1.94%)
    2 / 361 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory Depression
         subjects affected / exposed
    0 / 370 (0.00%)
    0 / 96 (0.00%)
    0 / 103 (0.00%)
    1 / 361 (0.28%)
         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
    Infections and infestations
    Abscess Limb
         subjects affected / exposed
    1 / 370 (0.27%)
    0 / 96 (0.00%)
    0 / 103 (0.00%)
    0 / 361 (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
    Arthritis Bacterial
         subjects affected / exposed
    1 / 370 (0.27%)
    0 / 96 (0.00%)
    0 / 103 (0.00%)
    0 / 361 (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
    Bronchiolitis
         subjects affected / exposed
    1 / 370 (0.27%)
    0 / 96 (0.00%)
    0 / 103 (0.00%)
    2 / 361 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis Escherichia Coli
         subjects affected / exposed
    0 / 370 (0.00%)
    0 / 96 (0.00%)
    0 / 103 (0.00%)
    1 / 361 (0.28%)
         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
    Croup Infectious
         subjects affected / exposed
    0 / 370 (0.00%)
    0 / 96 (0.00%)
    1 / 103 (0.97%)
    0 / 361 (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
    Gastroenteritis Salmonella
         subjects affected / exposed
    0 / 370 (0.00%)
    0 / 96 (0.00%)
    0 / 103 (0.00%)
    1 / 361 (0.28%)
         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
    Gastroenteritis Viral
         subjects affected / exposed
    0 / 370 (0.00%)
    0 / 96 (0.00%)
    1 / 103 (0.97%)
    0 / 361 (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
    Pneumonia
         subjects affected / exposed
    1 / 370 (0.27%)
    0 / 96 (0.00%)
    0 / 103 (0.00%)
    0 / 361 (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
    Pneumonia Parainfluenzae Viral
         subjects affected / exposed
    0 / 370 (0.00%)
    0 / 96 (0.00%)
    0 / 103 (0.00%)
    1 / 361 (0.28%)
         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
    Respiratory Syncytial Virus Bronchiolitis
         subjects affected / exposed
    0 / 370 (0.00%)
    0 / 96 (0.00%)
    0 / 103 (0.00%)
    2 / 361 (0.55%)
         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
    Staphylococcal Scalded Skin Syndrome
         subjects affected / exposed
    1 / 370 (0.27%)
    0 / 96 (0.00%)
    0 / 103 (0.00%)
    0 / 361 (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
    Viral Infection
         subjects affected / exposed
    0 / 370 (0.00%)
    0 / 96 (0.00%)
    0 / 103 (0.00%)
    1 / 361 (0.28%)
         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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Infants: Group 1 Toddlers: Group 3 Toddlers: Group 4 Infants: Group 2
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    288 / 370 (77.84%)
    68 / 96 (70.83%)
    74 / 103 (71.84%)
    257 / 361 (71.19%)
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    160 / 370 (43.24%)
    28 / 96 (29.17%)
    30 / 103 (29.13%)
    157 / 361 (43.49%)
         occurrences all number
    208
    41
    36
    218
    General disorders and administration site conditions
    Crying
         subjects affected / exposed
    160 / 370 (43.24%)
    35 / 96 (36.46%)
    34 / 103 (33.01%)
    138 / 361 (38.23%)
         occurrences all number
    200
    45
    45
    179
    Injection Site Bruising
         subjects affected / exposed
    19 / 370 (5.14%)
    3 / 96 (3.13%)
    3 / 103 (2.91%)
    13 / 361 (3.60%)
         occurrences all number
    35
    3
    4
    17
    Injection Site Erythema
         subjects affected / exposed
    151 / 370 (40.81%)
    29 / 96 (30.21%)
    26 / 103 (25.24%)
    138 / 361 (38.23%)
         occurrences all number
    479
    41
    37
    460
    Injection Site Pain
         subjects affected / exposed
    202 / 370 (54.59%)
    43 / 96 (44.79%)
    41 / 103 (39.81%)
    180 / 361 (49.86%)
         occurrences all number
    782
    65
    60
    691
    Injection Site Swelling
         subjects affected / exposed
    125 / 370 (33.78%)
    23 / 96 (23.96%)
    14 / 103 (13.59%)
    105 / 361 (29.09%)
         occurrences all number
    361
    34
    19
    331
    Pyrexia
         subjects affected / exposed
    68 / 370 (18.38%)
    18 / 96 (18.75%)
    20 / 103 (19.42%)
    71 / 361 (19.67%)
         occurrences all number
    83
    28
    23
    81
    Gastrointestinal disorders
    Teething
         subjects affected / exposed
    29 / 370 (7.84%)
    1 / 96 (1.04%)
    3 / 103 (2.91%)
    25 / 361 (6.93%)
         occurrences all number
    44
    1
    3
    42
    Vomiting
         subjects affected / exposed
    44 / 370 (11.89%)
    8 / 96 (8.33%)
    10 / 103 (9.71%)
    39 / 361 (10.80%)
         occurrences all number
    50
    9
    10
    41
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    11 / 370 (2.97%)
    6 / 96 (6.25%)
    1 / 103 (0.97%)
    6 / 361 (1.66%)
         occurrences all number
    11
    7
    1
    8
    Psychiatric disorders
    Irritability
         subjects affected / exposed
    202 / 370 (54.59%)
    44 / 96 (45.83%)
    52 / 103 (50.49%)
    186 / 361 (51.52%)
         occurrences all number
    289
    65
    74
    264
    Infections and infestations
    Influenza
         subjects affected / exposed
    1 / 370 (0.27%)
    5 / 96 (5.21%)
    1 / 103 (0.97%)
    0 / 361 (0.00%)
         occurrences all number
    1
    5
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    20 / 370 (5.41%)
    1 / 96 (1.04%)
    0 / 103 (0.00%)
    11 / 361 (3.05%)
         occurrences all number
    22
    1
    0
    16
    Otitis Media
         subjects affected / exposed
    15 / 370 (4.05%)
    5 / 96 (5.21%)
    5 / 103 (4.85%)
    14 / 361 (3.88%)
         occurrences all number
    17
    5
    5
    17
    Upper Respiratory Tract Infection
         subjects affected / exposed
    41 / 370 (11.08%)
    3 / 96 (3.13%)
    4 / 103 (3.88%)
    40 / 361 (11.08%)
         occurrences all number
    45
    4
    4
    44
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    83 / 370 (22.43%)
    28 / 96 (29.17%)
    34 / 103 (33.01%)
    83 / 361 (22.99%)
         occurrences all number
    104
    36
    47
    102

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Mar 2021
    WIP
    12 May 2022
    WIP

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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