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    Clinical Trial Results:
    Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Other Pediatric Vaccines in Healthy Toddlers

    Summary
    EudraCT number
    2018-001472-38
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    19 Jul 2018

    Results information
    Results version number
    v2(current)
    This version publication date
    11 Jun 2020
    First version publication date
    08 Aug 2019
    Other versions
    v1
    Version creation reason
    • Correction of full data set
    Minor revision of results data

    Trial information

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    Trial identification
    Sponsor protocol code
    MET57
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03205371
    WHO universal trial number (UTN)
    U1111-1161-2787
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur
    Sponsor organisation address
    Discovery Drive, Swiftwater, PA, United States, 18370-0187
    Public contact
    Trial Transparency Team, Sanofi Pasteur, Contact-US@sanofi.com
    Scientific contact
    Trial Transparency Team, Sanofi Pasteur, Contact-US@sanofi.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    27 Feb 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Jul 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To describe the immunogenicity profile of MenACYW conjugate vaccine administered alone or concomitantly with licensed pediatric vaccine(s) ((measles-mumps-rubella vaccine [MMR] +Varicella, diphtheria, tetanus, acellular pertussis, hepatitis B, poliomyelitis, and Haemophilus influenzae type-b Conjugate vaccine [DTaP-IPV-HB-Hib], or pneumococcal Conjugate vaccine [PCV13]).
    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 were also available on site in case of any immediate allergic reactions.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    07 Nov 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Thailand: 170
    Country: Number of subjects enrolled
    Korea, Republic of: 213
    Country: Number of subjects enrolled
    Mexico: 400
    Country: Number of subjects enrolled
    Russian Federation: 400
    Worldwide total number of subjects
    1183
    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)
    1183
    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
    Study subjects were enrolled in South Korea, Mexico, the Russian Federation, and Thailand from 07 November 2016 to 13 June 2018.

    Pre-assignment
    Screening details
    A total of 1183 subjects 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
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    South Korea(Group1): MenACYW Conjugate +MMR+ Varicella Vaccine
    Arm description
    Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine, measles-mumps-rubella vaccine (MMR) vaccine, and varicella vaccine on Day 0.
    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 milliliter (mL), intramuscular, single dose on Day 0.

    Investigational medicinal product name
    Measles, Mumps, and Rubella Vaccine
    Investigational medicinal product code
    Other name
    M-M-R® II
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.5 mL, subcutaneous, single dose on Day 0.

    Investigational medicinal product name
    Varicella Vaccine
    Investigational medicinal product code
    Other name
    VARIVAX
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.5 mL, subcutaneous, single dose on Day 0.

    Arm title
    South Korea (Group 2): MenACYW Conjugate Vaccine
    Arm description
    Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
    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
    South Korea (Group 3): MMR + Varicella Vaccine
    Arm description
    Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MMR vaccine and varicella vaccine on Day 0.
    Arm type
    Active comparator

    Investigational medicinal product name
    Measles, Mumps, and Rubella Vaccine
    Investigational medicinal product code
    Other name
    M-M-R® II
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.5 mL, subcutaneous, single dose on Day 0.

    Investigational medicinal product name
    Varicella Vaccine
    Investigational medicinal product code
    Other name
    VARIVAX
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.5 mL, subcutaneous, single dose on Day 0.

    Arm title
    Thailand (Group 10): MenACYW Conjugate +MMR+Varicella Vaccine
    Arm description
    Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine , MMR vaccine, and Varicella vaccine on Day 0.
    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.

    Investigational medicinal product name
    Measles, Mumps, and Rubella Vaccine
    Investigational medicinal product code
    Other name
    M-M-R® II
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.5 mL, subcutaneous, single dose on Day 0.

    Investigational medicinal product name
    Varicella Vaccine
    Investigational medicinal product code
    Other name
    VARIVAX
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.5 mL, subcutaneous, single dose on Day 0.

    Arm title
    Thailand (Group 11): MenACYW Conjugate Vaccine
    Arm description
    Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
    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
    Thailand (Group 12): MMR + Varicella Vaccine
    Arm description
    Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MMR vaccine and varicella vaccine on Day 0.
    Arm type
    Experimental

    Investigational medicinal product name
    Measles, Mumps, and Rubella Vaccine
    Investigational medicinal product code
    Other name
    M-M-R® II
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.5 mL, subcutaneous, single dose on Day 0.

    Investigational medicinal product name
    Varicella Vaccine
    Investigational medicinal product code
    Other name
    VARIVAX
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.5 mL, subcutaneous, single dose on Day 0.

    Arm title
    Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine
    Arm description
    Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine and diphtheria, tetanus, acellular pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type-b (DTaP-IPV-HB-Hib) vaccine on Day 0.
    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.

    Investigational medicinal product name
    DTaP-IPV-HB-Hib: Diphtheria, tetanus, pertussis (acellular), hepatitis B, poliomyelitis (inactivated), and Haemophilus influenzae type b conjugate vaccine
    Investigational medicinal product code
    Other name
    Hexaxim ®
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular, single dose on Day 0.

    Arm title
    Mexico (Group 5): MenACYW Conjugate Vaccine
    Arm description
    Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
    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
    Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine
    Arm description
    Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of DTaP-IPV-HB-Hib Vaccine on Day 0.
    Arm type
    Active comparator

    Investigational medicinal product name
    DTaP-IPV-HB-Hib: Diphtheria, tetanus, acellular pertussis, hepatitis B, poliomyelitis, and Haemophilus influenzae type-b conjugate vaccine
    Investigational medicinal product code
    Other name
    Hexaxim ®
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular, single dose on Day 0.

    Arm title
    Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine
    Arm description
    Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of MenACYW Conjugate and pneumococcal Conjugate vaccine (PCV13) on Day 0.
    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.

    Investigational medicinal product name
    PCV13: Pneumococcal 13-valent Conjugate Vaccine
    Investigational medicinal product code
    Other name
    Prevenar 13
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular, single dose on Day 0.

    Arm title
    Russian Federation (Group 8): MenACYW Conjugate Vaccine
    Arm description
    Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 14 months or 16 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
    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
    Russian Federation (Group 9): PCV13 Vaccine
    Arm description
    Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of PCV13 vaccine on Day 0.
    Arm type
    Active comparator

    Investigational medicinal product name
    PCV13: Pneumococcal 13-valent Conjugate Vaccine
    Investigational medicinal product code
    Other name
    Prevenar 13
    Pharmaceutical forms
    Suspension 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
    South Korea(Group1): MenACYW Conjugate +MMR+ Varicella Vaccine South Korea (Group 2): MenACYW Conjugate Vaccine South Korea (Group 3): MMR + Varicella Vaccine Thailand (Group 10): MenACYW Conjugate +MMR+Varicella Vaccine Thailand (Group 11): MenACYW Conjugate Vaccine Thailand (Group 12): MMR + Varicella Vaccine Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine Mexico (Group 5): MenACYW Conjugate Vaccine Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine Russian Federation (Group 8): MenACYW Conjugate Vaccine Russian Federation (Group 9): PCV13 Vaccine
    Started
    107
    53
    53
    86
    42
    42
    200
    100
    100
    200
    100
    100
    Safety Analysis Set
    103
    52
    53
    86
    42
    42
    200
    100
    100
    200
    100
    99
    Per-protocol Analysis Set
    92 [1]
    45 [2]
    50 [3]
    85 [4]
    42
    42
    155 [5]
    79 [6]
    68 [7]
    196 [8]
    96 [9]
    92 [10]
    Completed
    103
    52
    53
    86
    42
    42
    190
    97
    95
    200
    100
    99
    Not completed
    4
    1
    0
    0
    0
    0
    10
    3
    5
    0
    0
    1
         Protocol deviation
    -
    -
    -
    -
    -
    -
    1
    -
    -
    -
    -
    -
         Adverse event, non-fatal
    -
    -
    -
    -
    -
    -
    -
    1
    -
    -
    -
    -
         Consent withdrawn by subject
    4
    1
    -
    -
    -
    -
    4
    -
    2
    -
    -
    1
         Lost to follow-up
    -
    -
    -
    -
    -
    -
    5
    2
    3
    -
    -
    -
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Per-Protocol analysis set included all subjects who received at least 1 dose of study vaccine, and had no protocol deviations.
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Per-Protocol analysis set included all subjects who received at least 1 dose of study vaccine, and had no protocol deviations.
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Per-Protocol analysis set included all subjects who received at least 1 dose of study vaccine, and had no protocol deviations.
    [4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Per-Protocol analysis set included all subjects who received at least 1 dose of study vaccine, and had no protocol deviations.
    [5] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Per-Protocol analysis set included all subjects who received at least 1 dose of study vaccine, and had no protocol deviations.
    [6] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Per-Protocol analysis set included all subjects who received at least 1 dose of study vaccine, and had no protocol deviations.
    [7] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Per-Protocol analysis set included all subjects who received at least 1 dose of study vaccine, and had no protocol deviations.
    [8] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Per-Protocol analysis set included all subjects who received at least 1 dose of study vaccine, and had no protocol deviations.
    [9] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Per-Protocol analysis set included all subjects who received at least 1 dose of study vaccine, and had no protocol deviations.
    [10] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Per-Protocol analysis set included all subjects who received at least 1 dose of study vaccine, and had no protocol deviations.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    South Korea(Group1): MenACYW Conjugate +MMR+ Varicella Vaccine
    Reporting group description
    Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine, measles-mumps-rubella vaccine (MMR) vaccine, and varicella vaccine on Day 0.

    Reporting group title
    South Korea (Group 2): MenACYW Conjugate Vaccine
    Reporting group description
    Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.

    Reporting group title
    South Korea (Group 3): MMR + Varicella Vaccine
    Reporting group description
    Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MMR vaccine and varicella vaccine on Day 0.

    Reporting group title
    Thailand (Group 10): MenACYW Conjugate +MMR+Varicella Vaccine
    Reporting group description
    Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine , MMR vaccine, and Varicella vaccine on Day 0.

    Reporting group title
    Thailand (Group 11): MenACYW Conjugate Vaccine
    Reporting group description
    Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.

    Reporting group title
    Thailand (Group 12): MMR + Varicella Vaccine
    Reporting group description
    Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MMR vaccine and varicella vaccine on Day 0.

    Reporting group title
    Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine
    Reporting group description
    Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine and diphtheria, tetanus, acellular pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type-b (DTaP-IPV-HB-Hib) vaccine on Day 0.

    Reporting group title
    Mexico (Group 5): MenACYW Conjugate Vaccine
    Reporting group description
    Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.

    Reporting group title
    Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine
    Reporting group description
    Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of DTaP-IPV-HB-Hib Vaccine on Day 0.

    Reporting group title
    Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine
    Reporting group description
    Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of MenACYW Conjugate and pneumococcal Conjugate vaccine (PCV13) on Day 0.

    Reporting group title
    Russian Federation (Group 8): MenACYW Conjugate Vaccine
    Reporting group description
    Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 14 months or 16 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.

    Reporting group title
    Russian Federation (Group 9): PCV13 Vaccine
    Reporting group description
    Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of PCV13 vaccine on Day 0.

    Reporting group values
    South Korea(Group1): MenACYW Conjugate +MMR+ Varicella Vaccine South Korea (Group 2): MenACYW Conjugate Vaccine South Korea (Group 3): MMR + Varicella Vaccine Thailand (Group 10): MenACYW Conjugate +MMR+Varicella Vaccine Thailand (Group 11): MenACYW Conjugate Vaccine Thailand (Group 12): MMR + Varicella Vaccine Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine Mexico (Group 5): MenACYW Conjugate Vaccine Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine Russian Federation (Group 8): MenACYW Conjugate Vaccine Russian Federation (Group 9): PCV13 Vaccine Total
    Number of subjects
    107 53 53 86 42 42 200 100 100 200 100 100 1183
    Age categorical
    Units: Subjects
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    12.7 ± 1.58 12.7 ± 1.50 12.3 ± 0.96 12.4 ± 0.90 12.4 ± 0.88 12.8 ± 1.76 16.4 ± 2.73 16.8 ± 2.83 16.8 ± 2.99 16.5 ± 2.36 16.0 ± 3.10 16.3 ± 2.26 -
    Gender categorical
    Units: Subjects
        Female
    49 18 29 47 23 23 93 46 48 78 51 45 550
        Male
    58 35 24 39 19 19 107 54 52 122 49 55 633
    Race
    Units: Subjects
        American Indian or Alaska Native
    0 0 0 0 0 0 0 0 0 0 0 0 0
        Asian
    1 0 0 86 42 42 0 0 1 2 1 4 179
        Native Hawaiian or Other Pacific Islander
    0 0 0 0 0 0 0 0 0 0 0 0 0
        Black or African American
    0 0 0 0 0 0 0 0 0 0 0 0 0
        White
    0 0 0 0 0 0 200 100 99 198 99 96 792
        More than one race
    0 0 0 0 0 0 0 0 0 0 0 0 0
        Unknown or Not Reported
    106 53 53 0 0 0 0 0 0 0 0 0 212

    End points

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    End points reporting groups
    Reporting group title
    South Korea(Group1): MenACYW Conjugate +MMR+ Varicella Vaccine
    Reporting group description
    Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine, measles-mumps-rubella vaccine (MMR) vaccine, and varicella vaccine on Day 0.

    Reporting group title
    South Korea (Group 2): MenACYW Conjugate Vaccine
    Reporting group description
    Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.

    Reporting group title
    South Korea (Group 3): MMR + Varicella Vaccine
    Reporting group description
    Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MMR vaccine and varicella vaccine on Day 0.

    Reporting group title
    Thailand (Group 10): MenACYW Conjugate +MMR+Varicella Vaccine
    Reporting group description
    Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine , MMR vaccine, and Varicella vaccine on Day 0.

    Reporting group title
    Thailand (Group 11): MenACYW Conjugate Vaccine
    Reporting group description
    Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.

    Reporting group title
    Thailand (Group 12): MMR + Varicella Vaccine
    Reporting group description
    Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MMR vaccine and varicella vaccine on Day 0.

    Reporting group title
    Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine
    Reporting group description
    Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine and diphtheria, tetanus, acellular pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type-b (DTaP-IPV-HB-Hib) vaccine on Day 0.

    Reporting group title
    Mexico (Group 5): MenACYW Conjugate Vaccine
    Reporting group description
    Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.

    Reporting group title
    Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine
    Reporting group description
    Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of DTaP-IPV-HB-Hib Vaccine on Day 0.

    Reporting group title
    Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine
    Reporting group description
    Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of MenACYW Conjugate and pneumococcal Conjugate vaccine (PCV13) on Day 0.

    Reporting group title
    Russian Federation (Group 8): MenACYW Conjugate Vaccine
    Reporting group description
    Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 14 months or 16 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.

    Reporting group title
    Russian Federation (Group 9): PCV13 Vaccine
    Reporting group description
    Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of PCV13 vaccine on Day 0.

    Subject analysis set title
    Groups 1 and10:MenACYW Conjugate Vaccine+MMR+Varicella Vaccine
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) from South Korea and Thailand received single dose of MenACYW Conjugate vaccine, MMR vaccine, and varicella vaccine on Day 0.

    Subject analysis set title
    Groups 2 and 11: MenACYW Conjugate Vaccine
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) from South Korea and Thailand received single dose of MenACYW conjugate vaccine on Day 0.

    Subject analysis set title
    Groups 3 and 12: MMR + Varicella Vaccine
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) from South Korea and Thailand received single dose of MMR vaccine and varicella vaccine on Day 0.

    Primary: Geometric Mean Titers of MenACYW Antibodies Following Injection With MenACYW Conjugate Vaccine Administered Alone or Concomitantly With Other Paediatric Vaccines: Groups 1, 2, 4, 5, 7, 8, 10, and 11

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    End point title
    Geometric Mean Titers of MenACYW Antibodies Following Injection With MenACYW Conjugate Vaccine Administered Alone or Concomitantly With Other Paediatric Vaccines: Groups 1, 2, 4, 5, 7, 8, 10, and 11 [1] [2]
    End point description
    Antibody titers of MenACYW were measured by serum bactericidal assay using human complement (hSBA) assay. Data for this endpoint was reported for the combined population of Groups 1 and 10, Groups 2 and 11. Analysis was performed on PPAS which included subjects who received at least one dose of the study vaccine(s), had a valid post-vaccination blood sample result and no protocol deviations. Data for this endpoint were not planned to be collected and analysed for Groups 3, 6, 9, and 12.
    End point type
    Primary
    End point timeframe
    Day 0 and Day 30 post-vaccination
    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 was descriptive in nature, no statistical analysis was 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: This endpoint was evaluated for reported arms only.
    End point values
    Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine Mexico (Group 5): MenACYW Conjugate Vaccine Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine Russian Federation (Group 8): MenACYW Conjugate Vaccine Groups 1 and10:MenACYW Conjugate Vaccine+MMR+Varicella Vaccine Groups 2 and 11: MenACYW Conjugate Vaccine
    Number of subjects analysed
    155
    79
    196
    96
    177
    87
    Units: titers (1/dilution)
    geometric mean (confidence interval 95%)
        Serogroup A: Day 0
    5.35 (4.82 to 5.94)
    5.49 (4.66 to 6.45)
    5.99 (5.30 to 6.76)
    8.54 (6.47 to 11.3)
    5.20 (4.56 to 5.93)
    6.10 (5.00 to 7.44)
        Serogroup A: Day 30
    31.4 (25.9 to 38.1)
    37.8 (28.5 to 50.2)
    24.6 (20.2 to 30.1)
    49.0 (36.8 to 65.3)
    43.9 (37.4 to 51.6)
    30.0 (23.1 to 39.0)
        Serogroup C: Day 0
    2.21 (2.11 to 2.31)
    2.16 (2.00 to 2.34)
    2.77 (2.43 to 3.16)
    3.69 (2.84 to 4.81)
    2.37 (2.11 to 2.65)
    2.58 (2.15 to 3.10)
        Serogroup C: Day 30
    749 (633 to 886)
    666 (538 to 825)
    205 (156 to 269)
    309 (218 to 437)
    876 (725 to 1057)
    600 (456 to 790)
        Serogroup Y: Day 0
    2.63 (2.37 to 2.92)
    2.94 (2.45 to 3.53)
    2.90 (2.56 to 3.28)
    3.49 (2.68 to 4.53)
    3.14 (2.78 to 3.54)
    3.12 (2.58 to 3.78)
        Serogroup Y: Day 30
    79.7 (65.7 to 96.6)
    90.9 (66.8 to 124)
    139 (111 to 173)
    172 (130 to 229)
    88.9 (75.1 to 105)
    60.0 (47.3 to 76.3)
        Serogroup W: Day 0
    2.41 (2.22 to 2.62)
    2.16 (2.04 to 2.30)
    2.93 (2.54 to 3.38)
    3.62 (2.73 to 4.79)
    2.15 (2.00 to 2.30)
    2.31 (2.02 to 2.64)
        Serogroup W: Day 30
    40.0 (32.5 to 49.3)
    50.9 (37.2 to 69.8)
    57.4 (47.9 to 68.6)
    57.0 (44.3 to 73.5)
    46.8 (39.1 to 56.0)
    35.5 (27.6 to 45.7)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Injection With MenACYW Conjugate Vaccine Administered Alone or With Other Paediatric Vaccines: Groups 1, 2, 4, 5, 7, 8, 10, and 11

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    End point title
    Percentage of Subjects With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Injection With MenACYW Conjugate Vaccine Administered Alone or With Other Paediatric Vaccines: Groups 1, 2, 4, 5, 7, 8, 10, and 11 [3] [4]
    End point description
    Antibody titers of Men A, C, Y, and W were measured by hSBA assay. Data for this endpoint was reported for the combined population of Groups 1 and 10, Groups 2 and 11. Analysis was performed on PPAS. Data for this endpoint were not planned to be collected and analysed for Groups 3, 6, 9, and 12.
    End point type
    Primary
    End point timeframe
    Day 0 and Day 30 post-vaccination
    Notes
    [3] - 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 was descriptive in nature, no statistical analysis was provided.
    [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: This endpoint was evaluated for reported arms only.
    End point values
    Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine Mexico (Group 5): MenACYW Conjugate Vaccine Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine Russian Federation (Group 8): MenACYW Conjugate Vaccine Groups 1 and10:MenACYW Conjugate Vaccine+MMR+Varicella Vaccine Groups 2 and 11: MenACYW Conjugate Vaccine
    Number of subjects analysed
    155
    79
    196
    96
    177
    87
    Units: percentage of subjects
    number (confidence interval 95%)
        Serogroup A: Day 0 (>=1:4)
    82.6 (75.7 to 88.2)
    82.3 (72.1 to 90.0)
    82.1 (76.1 to 87.2)
    85.4 (76.7 to 91.8)
    75.1 (68.1 to 81.3)
    82.8 (73.2 to 90.0)
        Serogroup A: Day 0 (>=1:8)
    45.8 (37.8 to 54.0)
    46.8 (35.5 to 58.4)
    49.0 (41.8 to 56.2)
    54.2 (43.7 to 64.4)
    37.9 (30.7 to 45.4)
    44.8 (34.1 to 55.9)
        Serogroup A: Day 30 (>=1:4)
    98.1 (94.4 to 99.6)
    97.5 (91.2 to 99.7)
    94.9 (90.8 to 97.5)
    97.9 (92.7 to 99.7)
    98.9 (96.0 to 99.9)
    95.4 (88.6 to 98.7)
        Serogroup A: Day 30 (>=1:8)
    92.9 (87.7 to 96.4)
    89.9 (81.0 to 95.5)
    83.7 (77.7 to 88.6)
    90.6 (82.9 to 95.6)
    97.7 (94.3 to 99.4)
    92.0 (84.1 to 96.7)
        Serogroup C: Day 0 (>=1:4)
    12.3 (7.5 to 18.5)
    7.6 (2.8 to 15.8)
    19.9 (14.5 to 26.2)
    36.5 (26.9 to 46.9)
    9.6 (5.7 to 14.9)
    16.1 (9.1 to 25.5)
        Serogroup C: Day 0 (>=1:8)
    1.9 (0.4 to 5.6)
    1.3 (0.0 to 6.9)
    8.7 (5.1 to 13.5)
    17.7 (10.7 to 26.8)
    4.0 (1.6 to 8.0)
    6.9 (2.6 to 14.4)
        Serogroup C: Day 30 (>=1:4)
    100.0 (97.6 to 100.0)
    100.0 (95.4 to 100.0)
    98.5 (95.6 to 99.7)
    99.0 (94.3 to 100.0)
    100.0 (97.9 to 100.0)
    100.0 (95.8 to 100.0)
        Serogroup C: Day 30 (>=1:8)
    100.0 (97.6 to 100.0)
    100.0 (95.4 to 100.0)
    93.9 (89.5 to 96.8)
    99.0 (94.3 to 100.0)
    100.0 (97.9 to 100.0)
    100.0 (95.8 to 100.0)
        Serogroup Y: Day 0 (>=1:4)
    19.4 (13.5 to 26.5)
    25.3 (16.2 to 36.4)
    21.9 (16.4 to 28.4)
    32.3 (23.1 to 42.6)
    32.2 (25.4 to 39.6)
    28.7 (19.5 to 39.4)
        Serogroup Y: Day 0 (>=1:8)
    11.0 (6.5 to 17.0)
    12.7 (6.2 to 22.0)
    14.3 (9.7 to 20.0)
    15.6 (9.0 to 24.5)
    18.6 (13.2 to 25.2)
    17.2 (10.0 to 26.8)
        Serogroup Y: Day 30 (>=1:4)
    98.7 (95.4 to 99.8)
    100.0 (95.4 to 100.0)
    98.5 (95.6 to 99.7)
    99.0 (94.3 to 100.0)
    99.4 (96.9 to 100.0)
    96.6 (90.3 to 99.3)
        Serogroup Y: Day 30 (>=1:8)
    98.7 (95.4 to 99.8)
    98.7 (93.1 to 100.0)
    97.4 (94.1 to 99.2)
    97.9 (92.7 to 99.7)
    99.4 (96.9 to 100.0)
    95.4 (88.6 to 98.7)
        Serogroup W: Day 0 (>=1:4)
    14.8 (9.6 to 21.4)
    8.9 (3.6 to 17.4)
    16.8 (11.9 to 22.8)
    26.0 (17.6 to 36.0)
    5.1 (2.4 to 9.4)
    11.5 (5.7 to 20.1)
        Serogroup W: Day 0 (>=1:8)
    7.7 (4.1 to 13.1)
    2.5 (0.3 to 8.8)
    12.8 (8.4 to 18.3)
    20.8 (13.2 to 30.3)
    1.1 (0.1 to 4.0)
    2.3 (0.3 to 8.1)
        Serogroup W: Day 30 (>=1:4)
    97.4 (93.5 to 99.3)
    96.2 (89.3 to 99.2)
    95.9 (92.1 to 98.2)
    96.9 (91.1 to 99.4)
    98.9 (96.0 to 99.9)
    96.6 (90.3 to 99.3)
        Serogroup W: Day 30 (>=1:8)
    90.3 (84.5 to 94.5)
    92.4 (84.2 to 97.2)
    94.4 (90.2 to 97.2)
    95.8 (89.7 to 98.9)
    96.0 (92.0 to 98.4)
    92.0 (84.1 to 96.7)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With >=4-Fold Rise in Antibody Titers Against Meningococcal Serogroups A, C, Y, and W Following Injection With MenACYW Conjugate Vaccine Administered Alone or With Other Paediatric Vaccines: Groups 1, 2, 4, 5, 7, 8, 10, and 11

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    End point title
    Percentage of Subjects With >=4-Fold Rise in Antibody Titers Against Meningococcal Serogroups A, C, Y, and W Following Injection With MenACYW Conjugate Vaccine Administered Alone or With Other Paediatric Vaccines: Groups 1, 2, 4, 5, 7, 8, 10, and 11 [5] [6]
    End point description
    Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Data for this endpoint was reported for the combined population of Groups 1 and 10, Groups 2 and 11. Analysis was performed on PPAS. Data for this endpoint were not planned to be collected and analysed for Groups 3, 6, 9, and 12.
    End point type
    Primary
    End point timeframe
    Day 0 up to Day 30 post-vaccination
    Notes
    [5] - 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 was descriptive in nature, no statistical analysis was provided.
    [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: This endpoint was evaluated for reported arms only.
    End point values
    Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine Mexico (Group 5): MenACYW Conjugate Vaccine Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine Russian Federation (Group 8): MenACYW Conjugate Vaccine Groups 1 and10:MenACYW Conjugate Vaccine+MMR+Varicella Vaccine Groups 2 and 11: MenACYW Conjugate Vaccine
    Number of subjects analysed
    155
    79
    196
    96
    177
    87
    Units: percentage of subjects
    number (confidence interval 95%)
        Serogroup A
    69.0 (61.1 to 76.2)
    70.9 (59.6 to 80.6)
    58.2 (50.9 to 65.2)
    72.9 (62.9 to 81.5)
    82.5 (76.1 to 87.8)
    64.4 (53.4 to 74.4)
        Serogroup C
    100.0 (97.6 to 100.0)
    98.7 (93.1 to 100.0)
    92.3 (87.7 to 95.7)
    91.7 (84.2 to 96.3)
    98.3 (95.1 to 99.6)
    98.9 (93.8 to 100.0)
        Serogroup Y
    96.8 (92.6 to 98.9)
    94.9 (87.5 to 98.6)
    94.4 (90.2 to 97.2)
    93.8 (86.9 to 97.7)
    95.5 (91.3 to 98.0)
    89.7 (81.3 to 95.2)
        Serogroup W
    86.5 (80.0 to 91.4)
    92.4 (84.2 to 97.2)
    88.8 (83.5 to 92.8)
    90.6 (82.9 to 95.6)
    94.9 (90.6 to 97.6)
    89.7 (81.3 to 95.2)
    No statistical analyses for this end point

    Primary: Percentage of Subjects Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y, and W Following Injection With MenACYW Conjugate Vaccine Administered Alone or Concomitantly With Paediatric Vaccines: Groups 1, 2, 4, 5, 7, 8, 10, and 11

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    End point title
    Percentage of Subjects Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y, and W Following Injection With MenACYW Conjugate Vaccine Administered Alone or Concomitantly With Paediatric Vaccines: Groups 1, 2, 4, 5, 7, 8, 10, and 11 [7] [8]
    End point description
    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 titers <1:8 or at least a 4-fold increase in post-vaccination hSBA titers from pre- to post-vaccination, for subjects with pre-vaccination titers >=1:8. Data for this endpoint was reported for the combined population of Groups 1 and 10, Groups 2 and 11. Analysis was performed on PPAS. Data for this endpoint were not planned to be collected and analysed for Groups 3, 6, 9, and 12.
    End point type
    Primary
    End point timeframe
    Day 30 post-vaccination
    Notes
    [7] - 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 was descriptive in nature, no statistical analysis was provided.
    [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: This endpoint was evaluated for reported arms only.
    End point values
    Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine Mexico (Group 5): MenACYW Conjugate Vaccine Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine Russian Federation (Group 8): MenACYW Conjugate Vaccine Groups 1 and10:MenACYW Conjugate Vaccine+MMR+Varicella Vaccine Groups 2 and 11: MenACYW Conjugate Vaccine
    Number of subjects analysed
    155
    79
    196
    96
    177
    87
    Units: percentage of subjects
    number (confidence interval 95%)
        Serogroup A
    67.1 (59.1 to 74.4)
    69.6 (58.2 to 79.5)
    56.1 (48.9 to 63.2)
    71.9 (61.8 to 80.6)
    78.5 (71.7 to 84.3)
    63.2 (52.2 to 73.3)
        Serogroup C
    100.0 (97.6 to 100)
    98.7 (93.1 to 100.0)
    90.8 (85.9 to 94.5)
    91.7 (84.2 to 96.3)
    97.7 (94.3 to 99.4)
    98.9 (93.8 to 100.0)
        Serogroup Y
    92.3 (86.9 to 95.9)
    87.3 (78.0 to 93.8)
    92.9 (88.3 to 96.0)
    92.7 (85.6 to 97.0)
    93.2 (88.5 to 96.4)
    88.5 (79.9 to 94.3)
        Serogroup W
    82.6 (75.7 to 88.2)
    82.3 (72.1 to 90.0)
    82.1 (76.1 to 87.2)
    90.6 (82.9 to 95.6)
    86.4 (80.5 to 91.1)
    83.9 (74.5 to 90.9)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers of MMR-Varicella Antibodies Following Injection With MMR-Varicella Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 1, 3, 10, and 12

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    End point title
    Geometric Mean Titers of MMR-Varicella Antibodies Following Injection With MMR-Varicella Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 1, 3, 10, and 12
    End point description
    Antibodies titers of Measles and Rubella were measured by enzyme immunoassay (EIA). Antibodies titers for mumps and varicella were measured by enzyme-linked immunosorbent assay (ELISA). Data for this endpoint was reported for the combined population of Groups 1 and 10, Groups 3 and 12. Analysis was performed on PPAS. Here, ‘n’ = subjects with available data for each specified category. Data for this endpoint were not planned to be collected and analysed for Groups 2, 4, 5, 6, 7, 8, 9, and 11.
    End point type
    Secondary
    End point timeframe
    Day 0 and Day 30 post-vaccination
    End point values
    Groups 1 and10:MenACYW Conjugate Vaccine+MMR+Varicella Vaccine Groups 3 and 12: MMR + Varicella Vaccine
    Number of subjects analysed
    177
    92
    Units: titers (1/dilution)
    geometric mean (confidence interval 95%)
        Measles: Day 0 (n=176,92)
    40.0 (37.2 to 43.1)
    45.0 (40.1 to 50.4)
        Measles: Day 30 (n=177,92)
    2156 (1893 to 2455)
    2840 (2389 to 3378)
        Mumps: Day 0 (n=176,92)
    5.51 (5.20 to 5.84)
    5.43 (5.05 to 5.83)
        Mumps: Day 30 (n=177,92)
    85.9 (74.7 to 98.7)
    97.6 (83.1 to 115)
        Rubella: Day 0 (n=176,92)
    5.94 (5.32 to 6.63)
    7.12 (6.07 to 8.34)
        Rubella: Day 30 (n=177,92)
    87.6 (79.4 to 96.7)
    104 (91.2 to 118)
        Varicella: Day 0 (n=176,92)
    0.556 (0.484 to 0.638)
    0.665 (0.508 to 0.869)
        Varicella: Day 30 (n=177,92)
    13.4 (11.6 to 15.4)
    17.4 (15.2 to 19.9)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Immune Response Following Injection With MMR-Varicella Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 1, 3, 10, and 12

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    End point title
    Percentage of Subjects With Immune Response Following Injection With MMR-Varicella Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 1, 3, 10, and 12
    End point description
    Immune response for MMR-Varicella vaccine was defined as: anti-measles Antibody (Ab) concentrations >=255 milli-international unit per milliliter (mIU/mL), anti-mumps Ab concentrations: >=10 Ab units/mL, anti-rubella Ab concentrations >=10 international unit per milliliter (IU/mL),anti-varicella Ab concentrations >=5 glycoprotein enzyme-linked immunosorbent assay (gpELISA) Ab units/mL. Data for this endpoint was planned to be analysed and reported for the combined population of Groups 1 and 10, Groups 3 and 12. Analysis was performed on PPAS. Here, ‘n’ = subjects with available data for each specified category. Data for this endpoint were not planned to be collected and analysed for Groups 2, 4, 5, 6, 7, 8, 9, and 11.
    End point type
    Secondary
    End point timeframe
    Day 0 and Day 30 post-vaccination
    End point values
    Groups 1 and10:MenACYW Conjugate Vaccine+MMR+Varicella Vaccine Groups 3 and 12: MMR + Varicella Vaccine
    Number of subjects analysed
    177
    92
    Units: percentage of subjects
    number (confidence interval 95%)
        Measles: Day 0 (n=176,92)
    0.6 (0.0 to 3.1)
    0.0 (0.0 to 3.9)
        Measles: Day 30 (n=177,92)
    96.6 (92.8 to 98.7)
    97.8 (92.4 to 99.7)
        Mumps: Day 0 (n=176,92)
    7.4 (4.0 to 12.3)
    6.5 (2.4 to 13.7)
        Mumps: Day 30 (n=177,92)
    97.7 (94.3 to 99.4)
    100.0 (96.1 to 100.0)
        Rubella: Day 0 (n=176,92)
    27.3 (20.8 to 34.5)
    31.5 (22.2 to 42.0)
        Rubella: Day 30 (n=177,92)
    100.0 (97.9 to 100)
    100.0 (96.1 to 100)
        Varicella: Day 0 (n=176,92)
    4.0 (1.6 to 8.0)
    7.6 (3.1 to 15.1)
        Varicella: Day 30 (n=177,92)
    93.2 (88.5 to 96.4)
    98.9 (94.1 to 100.0)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers of Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA) Antibodies Following Injection With DTaP-IPV-HB-Hib Vaccine Administrated Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 4 and 6

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    End point title
    Geometric Mean Titers of Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA) Antibodies Following Injection With DTaP-IPV-HB-Hib Vaccine Administrated Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 4 and 6 [9]
    End point description
    Antibodies titers of PT and FHA were measured by electrochemiluminescent (ECL) assay. Analysis was performed on PPAS. Data for this endpoint were not planned to be collected and analysed for Groups 1, 2, 3, 5, 7, 8, 9, 10, 11, and 12.
    End point type
    Secondary
    End point timeframe
    Day 0 and Day 30 post-vaccination
    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: This endpoint was evaluated for reported arms only.
    End point values
    Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine
    Number of subjects analysed
    155
    68
    Units: titers (1/dilution)
    geometric mean (confidence interval 95%)
        PT: Day 0
    17.9 (15.1 to 21.3)
    20.4 (15.3 to 27.0)
        PT: Day 30
    144 (130 to 159)
    169 (144 to 198)
        FHA: Day 0
    45.5 (37.0 to 55.9)
    57.4 (41.4 to 79.5)
        FHA: Day 30
    299 (265 to 337)
    391 (319 to 480)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers of DTaP-IPV-HB-Hib Antibodies Following Injection With DTaP-IPV-HB-Hib Administered Alone or Concomitantly With The MenACYW Conjugate Vaccine: Groups 4 and 6

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    End point title
    Geometric Mean Titers of DTaP-IPV-HB-Hib Antibodies Following Injection With DTaP-IPV-HB-Hib Administered Alone or Concomitantly With The MenACYW Conjugate Vaccine: Groups 4 and 6 [10]
    End point description
    Antibodies titers of Diphtheria, Tetanus and Pertussis were meausured by ECL assay. Antibodies titers of poliovirus types 1, 2, and 3 were measured by neutralization assay. Antibodies titers of Hepatitis B were measured by an immunodiagnostic system using chemiluminescence detection. Antibodies titers of Polyribosyl-ribitol phosphate (PRP) were measured by Farr-type radioimmunoassay (RIA). Analysis was performed on PPAS. Here, ‘n’ = subjects with available data for each specified category. Data for this endpoint were not planned to be collected and analysed for Groups 1, 2, 3, 5, 7, 8, 9, 10, 11, and 12.
    End point type
    Secondary
    End point timeframe
    Day 0 (for tetanus only) and Day 30 post-vaccination
    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: This endpoint was evaluated for reported arms only.
    End point values
    Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine
    Number of subjects analysed
    155
    68
    Units: titers (1/dilution)
    geometric mean (confidence interval 95%)
        Diphtheria: Day 30 (n =155,68)
    5.52 (4.94 to 6.17)
    6.34 (5.51 to 7.30)
        Tetanus: Day 0 (n =155, 67)
    0.238 (0.196 to 0.289)
    0.234 (0.177 to 0.309)
        Tetanus: Day 30 (n =155,68)
    7.06 (6.01 to 8.29)
    7.11 (5.79 to 8.74)
        Polio 1: Day 30 (n=155,68)
    4560 (3870 to 5373)
    4034 (3052 to 5332)
        Polio 2: Day 30 (n=155,68)
    7244 (6208 to 8453)
    5618 (4578 to 6895)
        Polio 3: Day 30 (n=155,68)
    5977 (4958 to 7205)
    5100 (3840 to 6772)
        Hepatitis B: Day 30 (n=155,68)
    5171 (4104 to 6515)
    7308 (5135 to 10401)
        PRP: Day30 (n=155,68)
    46.6 (39.6 to 54.9)
    56.2 (41.5 to 76.1)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Immune Response Following Injection With DTaP-IPV-HB-Hib Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 4 and 6

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    End point title
    Percentage of Subjects With Immune Response Following Injection With DTaP-IPV-HB-Hib Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 4 and 6 [11]
    End point description
    Immune response for DTaP-IPV-HB-Hib vaccine was defined as: anti-tetanus Ab concentrations: >=0.01 and 0.1 IU/mL at Day 0 and >=0.1 and 1.0 IU/mL at Day 30, anti-diphtheria Ab concentrations: >=0.1 and 1.0 IU/mL, anti-PRP Ab concentrations and >= 0.15 and 1.0 microgram per milliliter (mcg/mL), anti-poliovirus types 1, 2, and 3 Ab titers >=1:8, anti-hepatitis B surface antigen Ab concentrations >=10 mIU/mL, >=100 mIU/mL. Analysis was performed on PPAS. Here, ‘n’ = subjects with available data for each specified category. Data for this endpoint were not planned to be collected and analysed for Groups 1, 2, 3, 5, 7, 8, 9, 10, 11 and 12.
    End point type
    Secondary
    End point timeframe
    Day 0 (tetanus only) and Day 30 post-vaccination
    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: This endpoint was evaluated for reported arms only.
    End point values
    Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine
    Number of subjects analysed
    155
    68
    Units: Percentage of subjects
    number (confidence interval 95%)
        Diphtheria: Day 30 (>=0.1 IU/mL)(n=155,68)
    100.0 (97.6 to 100)
    100.0 (94.7 to 100)
        Diphtheria: Day 30 (>=1 IU/mL) (n=155,68)
    98.7 (95.4 to 99.8)
    100.0 (94.7 to 100)
        Tetanus: Day 0 (>=0.01 IU/mL) (n=155,67)
    100.0 (97.6 to 100)
    100.0 (94.6 to 100)
        Tetanus: Day 0 (>=0.1 IU/mL) (n=155,67)
    81.3 (74.2 to 87.1)
    77.6 (65.8 to 86.9)
        Tetanus: Day 30 (>=0.1 IU/mL) (n=155,68)
    100.0 (97.6 to 100)
    100.0 (94.7 to 100)
        Tetanus: Day 30 (>=1 IU/mL) (n=155,68)
    98.1 (94.4 to 99.6)
    98.5 (92.1 to 100.0)
        Polio 1: Day 30 (>=8 [1/dilution]) (n=155,68)
    100.0 (97.6 to 100)
    100.0 (94.7 to 100)
        Polio 2: Day 30 (>=8 [1/dilution]) (n=155,68)
    100.0 (97.6 to 100)
    100.0 (94.7 to 100)
        Polio 3: Day 30 (>=8 [1/dilution]) (n=155,68)
    100.0 (97.6 to 100)
    100.0 (94.7 to 100)
        Hepatitis B: Day 30 (>=10 mIU/mL) (n=155,68)
    100.0 (97.6 to 100)
    100.0 (94.7 to 100)
        Hepatitis B: Day 30 (>=100 mIU/mL) (n=155,68)
    98.7 (95.4 to 99.8)
    100.0 (94.7 to 100)
        PRP: Day 30 (>=0.15 mcg/mL) (n=155,68)
    100.0 (97.6 to 100)
    100.0 (94.7 to 100)
        PRP: Day 30 (>=1.0 mcg/mL) (n=155,68)
    100.0 (97.6 to 100)
    100.0 (94.7 to 100)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Vaccine Response of PT and FHA Antibodies Following Injection With DTaP-IPV-HB-Hib Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 4 and 6

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    End point title
    Percentage of Subjects With Vaccine Response of PT and FHA Antibodies Following Injection With DTaP-IPV-HB-Hib Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 4 and 6 [12]
    End point description
    Pertussis and FHA vaccine response was defined as: if the pre-vaccination concentration is < 4 * lower limit of quantification (LLOQ is equal to 2), then the post-vaccination concentration is >=4 * pre-vaccination concentration and if the pre-vaccination concentration is >= 4 * LLOQ, then the post-vaccination concentration is >= 2 * pre-vaccination concentration. Analysis was performed on PPAS. Data for this endpoint were not planned to be collected and analysed for Groups 1, 2, 3, 5, 7, 8, 9, 10, 11, and 12.
    End point type
    Secondary
    End point timeframe
    Day 0 and Day 30 post-vaccination
    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: This endpoint was evaluated for reported arms only.
    End point values
    Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine
    Number of subjects analysed
    155
    68
    Units: percentage of subjects
    number (confidence interval 95%)
        PT: Day 30/Day 0
    91.0 (85.3 to 95.0)
    92.6 (83.7 to 97.6)
        FHA: Day 30/Day 0
    89.0 (83.0 to 93.5)
    88.2 (78.1 to 94.8)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers of PCV13 Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F Antibodies Following Injection With PCV13 Vaccine Administrated Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9

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    End point title
    Geometric Mean Titers of PCV13 Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F Antibodies Following Injection With PCV13 Vaccine Administrated Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 [13]
    End point description
    Antibodies of pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F were measured by ECL assay. Analysis was performed on PPAS. Here, ‘n’ = subjects with available data for each specified category. Data for this endpoint were not planned to be collected and analysed for Groups 1, 2, 3, 4, 5, 6, 8, 10, 11, and 12.
    End point type
    Secondary
    End point timeframe
    Day 0 and Day 30 post-vaccination
    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: This endpoint was evaluated for reported arms only.
    End point values
    Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine Russian Federation (Group 9): PCV13 Vaccine
    Number of subjects analysed
    196
    92
    Units: titers (1/dilution)
    geometric mean (confidence interval 95%)
        Serotype 1: Day 0 (n=193,92)
    0.867 (0.741 to 1.01)
    0.918 (0.713 to 1.18)
        Serotype 1: Day 30 (n=191,92)
    2.33 (1.98 to 2.75)
    2.14 (1.63 to 2.81)
        Serotype 3: Day 0 (n=193,92)
    0.409 (0.341 to 0.491)
    0.414 (0.322 to 0.533)
        Serotype 3: Day 30 (n=191,92)
    0.802 (0.664 to 0.967)
    0.773 (0.608 to 0.983)
        Serotype 4: Day 0 (n=193,92)
    0.604 (0.511 to 0.715)
    0.653 (0.507 to 0.840)
        Serotype 4: Day 30 (n=191,92)
    1.97 (1.68 to 2.31)
    1.49 (1.15 to 1.93)
        Serotype 5: Day 0 (n=193,92)
    0.828 (0.719 to 0.953)
    0.782 (0.610 to 1.00)
        Serotype 5: Day 30 (n=191,92)
    1.99 (1.70 to 2.31)
    1.73 (1.33 to 2.24)
        Serotype 6A: Day 0 (n=193,92)
    1.61 (1.33 to 1.95)
    1.48 (1.09 to 2.00)
        Serotype 6A: Day 30 (n=191,92)
    5.96 (4.99 to 7.13)
    6.13 (4.47 to 8.41)
        Serotype 6B: Day 0 (n=193,92)
    0.895 (0.715 to 1.12)
    0.691 (0.514 to 0.929)
        Serotype 6B: Day 30 (n=191,92)
    3.66 (2.99 to 4.50)
    2.57 (1.83 to 3.61)
        Serotype 7F: Day 0 (n=193,92)
    1.32 (1.12 to 1.55)
    1.39 (1.08 to 1.77)
        Serotype 7F: Day 30 (n=191,92)
    3.05 (2.59 to 3.58)
    2.67 (2.05 to 3.47)
        Serotype 9V: Day 0 (n=193,92)
    0.841 (0.710 to 0.997)
    0.863 (0.660 to 1.13)
        Serotype 9V: Day 30 (n=191,92)
    2.34 (1.95 to 2.81)
    2.52 (1.92 to 3.30)
        Serotype 14: Day 0 (n=192,92)
    3.25 (2.74 to 3.86)
    3.00 (2.30 to 3.91)
        Serotype 14: Day 30 (n=191,92)
    7.62 (6.56 to 8.83)
    6.30 (5.00 to 7.93)
        Serotype 18C: Day 0 (n=193,92)
    0.737 (0.620 to 0.876)
    0.995 (0.766 to 1.29)
        Serotype 18C: Day 30 (n=191,92)
    2.19 (1.87 to 2.58)
    2.21 (1.73 to 2.83)
        Serotype 19A: Day 0 (n=193,92)
    1.65 (1.36 to 2.01)
    1.96 (1.46 to 2.64)
        Serotype 19A: Day 30 (n=191,92)
    5.75 (4.85 to 6.80)
    5.91 (4.54 to 7.69)
        Serotype 19F: Day 0 (n=193,92)
    1.78 (1.43 to 2.21)
    1.74 (1.28 to 2.35)
        Serotype 19F: Day 30 (n=191,92)
    5.58 (4.57 to 6.81)
    5.53 (3.98 to 7.69)
        Serotype 23F: Day 0 (n=192,92)
    0.631 (0.519 to 0.768)
    0.733 (0.537 to 1.00)
        Serotype 23F: Day 30 (n=191,92)
    2.42 (2.04 to 2.86)
    2.58 (1.98 to 3.37)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With The MenACYW Conjugate Vaccine: Groups 7 and 9

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    End point title
    Percentage of Subjects With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With The MenACYW Conjugate Vaccine: Groups 7 and 9 [14]
    End point description
    Immune response for PCV13 for serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F was defined as antibodies concentrations >=0.35 mcg/mL or >=1.0 mcg/mL. Analysis was performed on PPAS. Here, ‘n’ = subjects with available data for each specified category. Data for this endpoint were not planned to be collected and analysed for Groups 1, 2, 3, 4, 5, 6, 8, 10, 11, and 12.
    End point type
    Secondary
    End point timeframe
    Day 0 and Day 30 post-vaccination
    Notes
    [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was evaluated for reported arms only.
    End point values
    Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine Russian Federation (Group 9): PCV13 Vaccine
    Number of subjects analysed
    196
    92
    Units: percentage of subjects
    number (confidence interval 95%)
        Serotype 1: Day 0 (>=0.35 mcg/mL)(n=193,92)
    80.8 (74.6 to 86.1)
    79.3 (69.6 to 87.1)
        Serotype 1: Day 0 (>=1.0 mcg/mL) (n=193,92)
    43.0 (35.9 to 50.3)
    45.7 (35.2 to 56.4)
        Serotype 1: Day 30 (>=0.35 mcg/mL) (n=191,92)
    97.4 (94.0 to 99.1)
    94.6 (87.8 to 98.2)
        Serotype 1: Day 30 (>=1.0 mcg/mL) (n=191,92)
    76.4 (69.8 to 82.3)
    70.7 (60.2 to 79.7)
        Serotype 3: Day 0 (>=0.35 mcg/mL) (n=193,92)
    49.2 (42.0 to 56.5)
    53.3 (42.6 to 63.7)
        Serotype 3: Day 0 (>=1.0 mcg/mL) (n=193,92)
    22.3 (16.6 to 28.8)
    18.5 (11.1 to 27.9)
        Serotype 3: Day 30 (>=0.35 mcg/mL) (n=191,92)
    72.3 (65.3 to 78.5)
    76.1 (66.1 to 84.4)
        Serotype 3: Day 30 (>=1.0 mcg/mL) (n=191,92)
    48.2 (40.9 to 55.5)
    38.0 (28.1 to 48.8)
        Serotype 4: Day 0 (>=0.35 mcg/mL) (n=193,92)
    66.8 (59.7 to 73.4)
    68.5 (58.0 to 77.8)
        Serotype 4: Day 0 (>=1.0 mcg/mL) (n=193,92)
    33.7 (27.1 to 40.8)
    38.0 (28.1 to 48.8)
        Serotype 4: Day 30 (>=0.35 mcg/mL) (n=191,92)
    92.7 (88.0 to 95.9)
    90.2 (82.2 to 95.4)
        Serotype 4: Day 30 (>=1.0 mcg/mL) (n=191,92)
    80.1 (73.7 to 85.5)
    62.0 (51.2 to 71.9)
        Serotype 5: Day 0 (>=0.35 mcg/mL) (n=193,92)
    81.3 (75.1 to 86.6)
    76.1 (66.1 to 84.4)
        Serotype 5: Day 0 (>=1.0 mcg/mL) (n=193,92)
    41.5 (34.4 to 48.7)
    50.0 (39.4 to 60.6)
        Serotype 5: Day 30 (>=0.35 mcg/mL) (n=191,92)
    94.8 (90.6 to 97.5)
    90.2 (82.2 to 95.4)
        Serotype 5: Day 30 (>=1.0 mcg/mL) (n=191,92)
    71.2 (64.2 to 77.5)
    69.6 (59.1 to 78.7)
        Serotype 6A: Day 0 (>=0.35 mcg/mL) (n=193,92)
    90.2 (85.1 to 94.0)
    82.6 (73.3 to 89.7)
        Serotype 6A: Day 0 (>=1.0 mcg/mL) (n=193,92)
    63.7 (56.5 to 70.5)
    65.2 (54.6 to 74.9)
        Serotype 6A: Day 30 (>=0.35 mcg/mL) (n=191,92)
    97.4 (94.0 to 99.1)
    96.7 (90.8 to 99.3)
        Serotype 6A: Day 30 (>=1.0 mcg/mL) (n=191,92)
    96.3 (92.6 to 98.5)
    90.2 (82.2 to 95.4)
        Serotype 6B: Day 0 (>=0.35 mcg/mL) (n=193,92)
    72.0 (65.1 to 78.2)
    68.5 (58.0 to 77.8)
        Serotype 6B: Day 0 (>=1.0 mcg/mL) (n=193,92)
    44.6 (37.4 to 51.9)
    41.3 (31.1 to 52.1)
        Serotype 6B: Day 30 (>=0.35 mcg/mL) (n=191,92)
    94.8 (90.6 to 97.5)
    92.4 (84.9 to 96.9)
        Serotype 6B: Day 30 (>=1.0 mcg/mL) (n=191,92)
    86.4 (80.7 to 90.9)
    75.0 (64.9 to 83.4)
        Serotype 7F: Day 0 (>=0.35 mcg/mL) (n=193,92)
    87.0 (81.5 to 91.4)
    88.0 (79.6 to 93.9)
        Serotype 7F: Day 0 (>=1.0 mcg/mL) (n=193,92)
    62.7 (55.5 to 69.5)
    65.2 (54.6 to 74.9)
        Serotype 7F: Day 30 (>=0.35 mcg/mL) (n=191,92)
    98.4 (95.5 to 99.7)
    94.6 (87.8 to 98.2)
        Serotype 7F: Day 30 (>=1.0 mcg/mL) (n=191,92)
    80.1 (73.7 to 85.5)
    83.7 (74.5 to 90.6)
        Serotype 9V: Day 0 (>=0.35 mcg/mL) (n=193,92)
    77.2 (70.6 to 82.9)
    79.3 (69.6 to 87.1)
        Serotype 9V: Day 0 (>=1.0 mcg/mL) (n=193,92)
    42.0 (34.9 to 49.3)
    43.5 (33.2 to 54.2)
        Serotype 9V: Day 30 (>=0.35 mcg/mL) (n=191,92)
    95.3 (91.2 to 97.8)
    92.4 (84.9 to 96.9)
        Serotype 9V: Day 30 (>=1.0 mcg/mL) (n=191,92)
    74.3 (67.5 to 80.4)
    75.0 (64.9 to 83.4)
        Serotype 14: Day 0 (>=0.35 mcg/mL) (n=192,92)
    95.8 (92.0 to 98.2)
    92.4 (84.9 to 96.9)
        Serotype 14: Day 0 (>=1.0 mcg/mL) (n=192,92)
    83.3 (77.3 to 88.3)
    87.0 (78.0 to 93.1)
        Serotype 14: Day 30 (>=0.35 mcg/mL) (n=191,92)
    99.0 (96.3 to 99.9)
    98.9 (94.1 to 100.0)
        Serotype 14: Day 30 (>=1.0 mcg/mL) (n=191,92)
    97.4 (94.0 to 99.1)
    94.6 (87.8 to 98.2)
        Serotype 18C: Day 0 (>=0.35 mcg/mL) (n=193,92)
    71.5 (64.6 to 77.8)
    84.8 (75.8 to 91.4)
        Serotype 18C: Day 0 (>=1.0 mcg/mL) (n=193,92)
    40.9 (33.9 to 48.2)
    48.9 (38.3 to 59.6)
        Serotype 18C: Day 30 (>=0.35 mcg/mL) (n=191,92)
    95.3 (91.2 to 97.8)
    92.4 (84.9 to 96.9)
        Serotype 18C: Day 30 (>=1.0 mcg/mL) (n=191,92)
    79.1 (72.6 to 84.6)
    79.3 (69.6 to 87.1)
        Serotype 19A: Day 0 (>=0.35 mcg/mL) (n=193,92)
    87.0 (81.5 to 91.4)
    87.0 (78.3 to 93.1)
        Serotype 19A: Day 0 (>=1.0 mcg/mL) (n=193,92)
    62.7 (55.5 to 69.5)
    69.6 (59.1 to 78.7)
        Serotype 19A: Day 30 (>=0.35 mcg/mL) (n=191,92)
    96.3 (92.6 to 98.5)
    98.9 (94.1 to 100.0)
        Serotype 19A: Day 30 (>=1.0 mcg/mL) (n=191,92)
    92.7 (88.0 to 95.9)
    90.2 (82.2 to 95.4)
        Serotype 19F: Day 0 (>=0.35 mcg/mL) (n=193,92)
    87.0 (81.5 to 91.4)
    89.1 (80.9 to 94.7)
        Serotype 19F: Day 0 (>=1.0 mcg/mL) (n=193,92)
    64.2 (57.0 to 71.0)
    65.2 (54.6 to 74.9)
        Serotype 19F: Day 30 (>=0.35 mcg/mL) (n=191,92)
    96.9 (93.3 to 98.8)
    97.8 (92.4 to 99.7)
        Serotype 19F: Day 30 (>=1.0 mcg/mL) (n=191,92)
    88.0 (82.5 to 92.2)
    85.9 (77.0 to 92.3)
        Serotype 23F: Day 0 (>=0.35 mcg/mL) (n=192,92)
    68.2 (61.1 to 74.7)
    64.1 (53.5 to 73.9)
        Serotype 23F: Day 0 (>=1.0 mcg/mL) (n=192,92)
    34.9 (28.2 to 42.1)
    44.6 (34.2 to 55.3)
        Serotype 23F: Day 30 (>=0.35 mcg/mL) (n=191,92)
    96.3 (92.6 to 98.5)
    93.5 (86.3 to 97.6)
        Serotype 23F: Day 30 (>=1.0 mcg/mL) (n=191,92)
    72.3 (65.3 to 78.5)
    78.3 (68.4 to 86.2)
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema and Swelling): Groups 1, 2, 3, 10, 11 and 12

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    End point title
    Number of Subjects Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema and Swelling): Groups 1, 2, 3, 10, 11 and 12 [15]
    End point description
    Solicited Reaction(SR) was defined as an Adverse Event (AE) that was prelisted (i.e., solicited) in the electronic Case Report Form(eCRF) and considered to be related to vaccination (adverse drug reaction [ADR]). Solicited injection site reactions: tenderness, erythema and swelling. Tenderness: Grade 3: cries when injected limb moved or the movement of the injected limb reduced, Erythema and swelling: Grade 3: >= 50 millimeter (mm). Subjects with any of the Grade and Grade 3 solicited injection-site reactions were reported. Analysis was performed on safety analysis set (SafAS) which included all subjects who received at least 1 dose of study vaccine and had any safety data available. Here, ‘n’ = subjects with available data for each specified category and '99999' was used as space fillers and indicate that the vaccines mentioned in the respective categories were not administered to the specified group.
    End point type
    Secondary
    End point timeframe
    Within 7 days post vaccination
    Notes
    [15] - 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: Data for Groups 4, 5, 6, 7, 8, and 9 are reported in separate endpoints.
    End point values
    South Korea(Group1): MenACYW Conjugate +MMR+ Varicella Vaccine South Korea (Group 2): MenACYW Conjugate Vaccine South Korea (Group 3): MMR + Varicella Vaccine Thailand (Group 10): MenACYW Conjugate +MMR+Varicella Vaccine Thailand (Group 11): MenACYW Conjugate Vaccine Thailand (Group 12): MMR + Varicella Vaccine
    Number of subjects analysed
    103
    52
    53
    86
    42
    42
    Units: subjects
    number (not applicable)
        MenACYW: Tenderness: Any Grade(n=103,52,0,86,42,0)
    28
    15
    99999
    29
    17
    99999
        MenACYW: Tenderness: Grade 3(n=103,52,0,86,42,0)
    1
    0
    99999
    0
    1
    99999
        MenACYW: Erythema: Any Grade(n=103,52,0,86,42,0)
    27
    20
    99999
    29
    13
    99999
        MenACYW: Erythema: Grade 3(n=103,52,0,86,42,0)
    0
    2
    99999
    0
    0
    99999
        MenACYW: Swelling: Any Grade(n=103,52,0,86,42,0)
    18
    14
    99999
    15
    7
    99999
        MenACYW: Swelling: Grade 3(n=103,52,0,86,42,0)
    0
    0
    99999
    0
    0
    99999
        MMR: Tenderness: Any Grade(n=103,0,53,86,0,42)
    21
    99999
    10
    17
    99999
    18
        MMR: Tenderness: Grade 3(n=103,0,53,86,0,42)
    1
    99999
    0
    0
    99999
    0
        MMR: Erythema: Any Grade(n=103,0,53,86,0,42)
    13
    99999
    6
    24
    99999
    10
        MMR: Erythema: Grade 3(n=103,0,53,86,0,42)
    0
    99999
    0
    0
    99999
    0
        MMR: Swelling: Any Grade(n=103,0,53,86,0,42)
    7
    99999
    1
    11
    99999
    4
        MMR: Swelling: Grade 3(n=103,0,53,86,0,42)
    0
    99999
    0
    0
    99999
    0
        Varicella:Tenderness:Any Grade(n=103,0,53,86,0,42)
    23
    99999
    11
    17
    99999
    14
        Varicella:Tenderness:Grade 3(n=103,0,53,86,0,42)
    0
    99999
    0
    0
    99999
    1
        Varicella:Erythema:Any Grade(n=103,0,53,86,0,42)
    19
    99999
    4
    18
    99999
    13
        Varicella:Erythema:Grade 3(n=103,0,53,86,0,42)
    1
    99999
    0
    0
    99999
    0
        Varicella:Swelling:Any Grade(n=103,0,53,86,0,42)
    10
    99999
    2
    12
    99999
    5
        Varicella:Swelling:Grade 3(n=103,0,53,86,0,42)
    0
    99999
    0
    0
    99999
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema and Swelling): Groups 4, 5 and 6

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    End point title
    Number of Subjects Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema and Swelling): Groups 4, 5 and 6 [16]
    End point description
    SR was defined as an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (ADR). Solicited injection site reactions: tenderness, erythema and swelling. Tenderness: Grade 3: cries when injected limb moved or the movement of the injected limb reduced, Erythema and swelling: Grade 3: >= 50 mm. Subjects with any of the Grade and Grade 3 solicited injection-site reactions were reported. Analysis was performed on SafAS. Here, ‘n’ = subjects with available data for each specified category. Here, '99999' was used as space fillers and indicate that the vaccines mentioned in the respective categories were not administered to the specified group.
    End point type
    Secondary
    End point timeframe
    Within 7 days post vaccination
    Notes
    [16] - 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: Data for Groups 1, 2, 3, 10, 11, 12, 7, 8, and 9 are reported in separate endpoints.
    End point values
    Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine Mexico (Group 5): MenACYW Conjugate Vaccine Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine
    Number of subjects analysed
    200
    100
    100
    Units: subjects
    number (not applicable)
        MenACYW: Tenderness: Any Grade (n=191,98,0)
    68
    27
    99999
        MenACYW: Tenderness:Grade 3 (n=191,98,0)
    6
    1
    99999
        MenACYW: Erythema: Any Grade (n=191,98,0)
    40
    15
    99999
        MenACYW: Erythema: Grade 3 (n=191,98,0)
    3
    3
    99999
        MenACYW: Swelling: Any Grade (n=191,98,0)
    23
    8
    99999
        MenACYW: Swelling: Grade 3 (n=191,98,0)
    2
    2
    99999
        DTaP-IPV-HB-Hib:Tenderness:Any Grade (n=191,0,95)
    80
    99999
    54
        DTaP-IPV-HB-Hib: Tenderness:Grade 3 (n=191,0,95)
    6
    99999
    10
        DTaP-IPV-HB-Hib: Erythema:Any Grade (n=191,0,95)
    56
    99999
    37
        DTaP-IPV-HB-Hib: Erythema:Grade 3 (n=191,0,95)
    8
    99999
    5
        DTaP-IPV-HB-Hib: Swelling: Any Grade (n=191,0,95)
    45
    99999
    30
        DTaP-IPV-HB-Hib: Swelling:Grade 3 (n=191,0,95)
    8
    99999
    4
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema and Swelling): Groups 7, 8 and 9

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    End point title
    Number of Subjects Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema and Swelling): Groups 7, 8 and 9 [17]
    End point description
    SR was defined as an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (ADR). Solicited injection site reactions: tenderness, erythema and swelling. Tenderness: Grade 3: cries when injected limb moved or the movement of the injected limb reduced, Erythema and swelling: Grade 3: >= 50 mm. Subjects with any of the Grade and Grade 3 solicited injection-site reactions were reported. Analysis was performed on SafAS. Here, ‘n’ = subjects with available data for each specified category and '99999' was used as space fillers and indicate that the vaccines mentioned in the respective categories were not administered to the specified group.
    End point type
    Secondary
    End point timeframe
    Within 7 days post vaccination
    Notes
    [17] - 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: Data for Groups 1, 2, 3, 10, 11, 12, 4, 5, and 6 are reported in separate endpoints.
    End point values
    Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine Russian Federation (Group 8): MenACYW Conjugate Vaccine Russian Federation (Group 9): PCV13 Vaccine
    Number of subjects analysed
    200
    100
    99
    Units: subjects
    number (not applicable)
        MenACYW: Tenderness: Any Grade(n=200,100,0)
    28
    8
    99999
        MenACYW: Tenderness: Grade 3(n=200,100,0)
    4
    0
    99999
        MenACYW: Erythema: Any Grade(n=200,100,0)
    43
    17
    99999
        MenACYW: Erythema: Grade 3(n=200,100,0)
    0
    0
    99999
        MenACYW: Swelling: Any Grade(n=200,100,0)
    8
    7
    99999
        MenACYW: Swelling: Grade 3(n=200,100,0)
    0
    0
    99999
        PCV13: Tenderness: Any Grade(n=200,0,99)
    34
    99999
    9
        PCV13: Tenderness: Grade 3(n=200,0,99)
    5
    99999
    1
        PCV13: Erythema: Any Grade(n=200,0,99)
    48
    99999
    8
        PCV13: Erythema: Grade 3(n=200,0,99)
    0
    99999
    0
        PCV13: Swelling: Any Grade(n=200,0,99)
    19
    99999
    2
        PCV13: Swelling: Grade 3(n=200,0,99)
    0
    99999
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, Irritability)

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    End point title
    Number of Subjects Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, Irritability)
    End point description
    SR was defined as an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (ADR). Solicited systemic reaction: Fever: Grade 3: > 39.5°C, Vomiting: Grade 3: >= 6 episodes per 24 hours or requiring parenteral hydration, Crying abnormal: Grade 3: >3 hours, Drowsiness: Grade 3: sleeping most of the time or difficult to wake up, Appetite lost: Grade 3: refuses >= 3 feeds/meals or refuses most feeds/meals, Irritability: Grade 3: inconsolable. Subjects with any of the Grade and Grade 3 solicited systemic reactions were reported. Analysis was performed on SafAS. Here, ‘number of subjects analysed' = subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Within 7 days post vaccination
    End point values
    South Korea(Group1): MenACYW Conjugate +MMR+ Varicella Vaccine South Korea (Group 2): MenACYW Conjugate Vaccine South Korea (Group 3): MMR + Varicella Vaccine Thailand (Group 10): MenACYW Conjugate +MMR+Varicella Vaccine Thailand (Group 11): MenACYW Conjugate Vaccine Thailand (Group 12): MMR + Varicella Vaccine Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine Mexico (Group 5): MenACYW Conjugate Vaccine Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine Russian Federation (Group 8): MenACYW Conjugate Vaccine Russian Federation (Group 9): PCV13 Vaccine
    Number of subjects analysed
    103
    52
    53
    86
    42
    42
    191
    98
    95
    200
    100
    99
    Units: subjects
    number (not applicable)
        Fever: Any Grade
    17
    9
    5
    6
    1
    3
    32
    7
    16
    12
    3
    2
        Fever: Grade 3
    1
    2
    1
    0
    1
    0
    4
    1
    0
    0
    0
    0
        Vomiting: Any Grade
    6
    3
    2
    5
    4
    5
    15
    6
    9
    0
    0
    0
        Vomiting: Grade 3
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
        Abnormal crying: Any Grade
    21
    9
    6
    14
    17
    12
    46
    25
    26
    8
    4
    2
        Abnormal crying: Grade 3
    0
    0
    0
    0
    0
    0
    1
    1
    1
    2
    0
    0
        Drowsiness: Any Grade
    17
    8
    9
    8
    7
    7
    31
    15
    17
    25
    6
    4
        Drowsiness: Grade 3
    0
    0
    0
    0
    0
    1
    1
    0
    2
    1
    0
    0
        Appetite Lost: Any Grade
    29
    10
    8
    11
    12
    5
    51
    25
    20
    19
    12
    7
        Appetite Lost: Grade 3
    1
    0
    0
    0
    0
    2
    8
    2
    3
    1
    0
    0
        Irritability: Any Grade
    31
    12
    11
    14
    11
    14
    64
    34
    33
    26
    16
    9
        Irritability: Grade 3
    0
    0
    0
    0
    1
    0
    4
    1
    3
    4
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AE data were collected from Day 0 up to Day 30 post-vaccination and SR data within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination)
    Adverse event reporting additional description
    SR:AE that was prelisted(i.e.,solicited) in eCRF and considered related to vaccination. Unsolicited AE: observed AE that did not fulfill the conditions prelisted in eCRF. SafAS. In AE section, solicited reactions Fever, Abnormal crying,Drowsiness,and Appetite lost are reported under Pyrexia, Crying, Somnolence, and Decreased Appetite, respectively.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    South Korea(Group1):MenACYW Conjugate +MMR +Varicella Vaccine
    Reporting group description
    Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine, MMR vaccine, and varicella vaccine on Day 0.

    Reporting group title
    South Korea (Group 2): MenACYW Conjugate Vaccine
    Reporting group description
    Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.

    Reporting group title
    South Korea (Group 3): MMR + Varicella Vaccine
    Reporting group description
    Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MMR vaccine and Varicella vaccine on Day 0.

    Reporting group title
    Thailand (Group 10):MenACYW Conjugate + MMR+ Varicella Vaccine
    Reporting group description
    Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine, MMR, vaccine and varicella vaccine on Day 0.

    Reporting group title
    Thailand (Group 11): MenACYW Conjugate Vaccine
    Reporting group description
    Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.

    Reporting group title
    Thailand (Group 12): MMR + Varicella Vaccine
    Reporting group description
    Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MMR vaccine and varicella vaccine on Day 0.

    Reporting group title
    Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine
    Reporting group description
    Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine and DTaP-IPV-HB-Hib vaccine on Day 0.

    Reporting group title
    Mexico (Group 5): MenACYW Conjugate Vaccine
    Reporting group description
    Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.

    Reporting group title
    Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine
    Reporting group description
    Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of DTaP-IPV-HB-Hib Vaccine on Day 0.

    Reporting group title
    Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine
    Reporting group description
    Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of MenACYW Conjugate vaccine and PCV13 vaccine on Day 0.

    Reporting group title
    Russian Federation (Group 8): MenACYW Conjugate Vaccine
    Reporting group description
    Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 14 months or 16 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.

    Reporting group title
    Russian Federation (Group 9): PCV13 Vaccine
    Reporting group description
    Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of PCV13 vaccine on Day 0.

    Serious adverse events
    South Korea(Group1):MenACYW Conjugate +MMR +Varicella Vaccine South Korea (Group 2): MenACYW Conjugate Vaccine South Korea (Group 3): MMR + Varicella Vaccine Thailand (Group 10):MenACYW Conjugate + MMR+ Varicella Vaccine Thailand (Group 11): MenACYW Conjugate Vaccine Thailand (Group 12): MMR + Varicella Vaccine Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine Mexico (Group 5): MenACYW Conjugate Vaccine Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine Russian Federation (Group 8): MenACYW Conjugate Vaccine Russian Federation (Group 9): PCV13 Vaccine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 103 (5.83%)
    4 / 52 (7.69%)
    2 / 53 (3.77%)
    0 / 86 (0.00%)
    1 / 42 (2.38%)
    0 / 42 (0.00%)
    0 / 200 (0.00%)
    0 / 100 (0.00%)
    1 / 100 (1.00%)
    0 / 200 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 103 (0.00%)
    0 / 52 (0.00%)
    0 / 53 (0.00%)
    0 / 86 (0.00%)
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 200 (0.00%)
    0 / 100 (0.00%)
    1 / 100 (1.00%)
    0 / 200 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Febrile Convulsion
         subjects affected / exposed
    0 / 103 (0.00%)
    0 / 52 (0.00%)
    0 / 53 (0.00%)
    0 / 86 (0.00%)
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 200 (0.00%)
    0 / 100 (0.00%)
    1 / 100 (1.00%)
    0 / 200 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    0 / 103 (0.00%)
    2 / 52 (3.85%)
    0 / 53 (0.00%)
    0 / 86 (0.00%)
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 200 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 103 (0.00%)
    1 / 52 (1.92%)
    0 / 53 (0.00%)
    0 / 86 (0.00%)
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 200 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis Viral
         subjects affected / exposed
    2 / 103 (1.94%)
    0 / 52 (0.00%)
    0 / 53 (0.00%)
    0 / 86 (0.00%)
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 200 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Croup Infectious
         subjects affected / exposed
    0 / 103 (0.00%)
    0 / 52 (0.00%)
    0 / 53 (0.00%)
    0 / 86 (0.00%)
    1 / 42 (2.38%)
    0 / 42 (0.00%)
    0 / 200 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 103 (0.97%)
    1 / 52 (1.92%)
    0 / 53 (0.00%)
    0 / 86 (0.00%)
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 200 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hand-Foot-And-Mouth Disease
         subjects affected / exposed
    1 / 103 (0.97%)
    1 / 52 (1.92%)
    0 / 53 (0.00%)
    0 / 86 (0.00%)
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 200 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Otitis Media Viral
         subjects affected / exposed
    0 / 103 (0.00%)
    0 / 52 (0.00%)
    1 / 53 (1.89%)
    0 / 86 (0.00%)
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 200 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia Viral
         subjects affected / exposed
    0 / 103 (0.00%)
    0 / 52 (0.00%)
    1 / 53 (1.89%)
    0 / 86 (0.00%)
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 200 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory Syncytial Virus Bronchiolitis
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 52 (0.00%)
    0 / 53 (0.00%)
    0 / 86 (0.00%)
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 200 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 52 (0.00%)
    0 / 53 (0.00%)
    0 / 86 (0.00%)
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 200 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    South Korea(Group1):MenACYW Conjugate +MMR +Varicella Vaccine South Korea (Group 2): MenACYW Conjugate Vaccine South Korea (Group 3): MMR + Varicella Vaccine Thailand (Group 10):MenACYW Conjugate + MMR+ Varicella Vaccine Thailand (Group 11): MenACYW Conjugate Vaccine Thailand (Group 12): MMR + Varicella Vaccine Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine Mexico (Group 5): MenACYW Conjugate Vaccine Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine Russian Federation (Group 8): MenACYW Conjugate Vaccine Russian Federation (Group 9): PCV13 Vaccine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    85 / 103 (82.52%)
    43 / 52 (82.69%)
    37 / 53 (69.81%)
    58 / 86 (67.44%)
    37 / 42 (88.10%)
    37 / 42 (88.10%)
    142 / 200 (71.00%)
    65 / 100 (65.00%)
    85 / 100 (85.00%)
    75 / 200 (37.50%)
    30 / 100 (30.00%)
    17 / 99 (17.17%)
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    3 / 103 (2.91%)
    0 / 52 (0.00%)
    5 / 53 (9.43%)
    0 / 86 (0.00%)
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    5 / 200 (2.50%)
    3 / 100 (3.00%)
    2 / 100 (2.00%)
    1 / 200 (0.50%)
    1 / 100 (1.00%)
    0 / 99 (0.00%)
         occurrences all number
    3
    0
    5
    0
    0
    0
    5
    3
    2
    1
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    1 / 103 (0.97%)
    3 / 52 (5.77%)
    4 / 53 (7.55%)
    0 / 86 (0.00%)
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    1 / 200 (0.50%)
    0 / 100 (0.00%)
    1 / 100 (1.00%)
    0 / 200 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    1
    3
    4
    0
    0
    0
    1
    0
    1
    0
    0
    0
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    17 / 103 (16.50%)
    8 / 52 (15.38%)
    9 / 53 (16.98%)
    8 / 86 (9.30%)
    7 / 42 (16.67%)
    7 / 42 (16.67%)
    31 / 200 (15.50%)
    15 / 100 (15.00%)
    17 / 100 (17.00%)
    25 / 200 (12.50%)
    6 / 100 (6.00%)
    4 / 99 (4.04%)
         occurrences all number
    17
    8
    9
    8
    7
    7
    31
    15
    17
    25
    6
    4
    General disorders and administration site conditions
    Crying
    Additional description: Crying/Abnormal crying events that occurred after 7 days post-vaccination were considered as unsolicited AE.
         subjects affected / exposed
    21 / 103 (20.39%)
    9 / 52 (17.31%)
    6 / 53 (11.32%)
    15 / 86 (17.44%)
    17 / 42 (40.48%)
    12 / 42 (28.57%)
    46 / 200 (23.00%)
    25 / 100 (25.00%)
    26 / 100 (26.00%)
    8 / 200 (4.00%)
    4 / 100 (4.00%)
    2 / 99 (2.02%)
         occurrences all number
    21
    9
    6
    15
    17
    12
    46
    25
    26
    8
    4
    2
    Injection Site Erythema
         subjects affected / exposed
    35 / 103 (33.98%)
    20 / 52 (38.46%)
    8 / 53 (15.09%)
    36 / 86 (41.86%)
    13 / 42 (30.95%)
    16 / 42 (38.10%)
    67 / 200 (33.50%)
    15 / 100 (15.00%)
    37 / 100 (37.00%)
    55 / 200 (27.50%)
    17 / 100 (17.00%)
    8 / 99 (8.08%)
         occurrences all number
    60
    20
    10
    71
    13
    23
    96
    15
    37
    91
    17
    8
    Injection Site Pain
         subjects affected / exposed
    31 / 103 (30.10%)
    15 / 52 (28.85%)
    12 / 53 (22.64%)
    31 / 86 (36.05%)
    17 / 42 (40.48%)
    19 / 42 (45.24%)
    87 / 200 (43.50%)
    27 / 100 (27.00%)
    54 / 100 (54.00%)
    37 / 200 (18.50%)
    8 / 100 (8.00%)
    9 / 99 (9.09%)
         occurrences all number
    72
    15
    21
    63
    17
    32
    148
    27
    54
    62
    8
    9
    Injection Site Swelling
         subjects affected / exposed
    25 / 103 (24.27%)
    14 / 52 (26.92%)
    3 / 53 (5.66%)
    18 / 86 (20.93%)
    7 / 42 (16.67%)
    5 / 42 (11.90%)
    52 / 200 (26.00%)
    8 / 100 (8.00%)
    30 / 100 (30.00%)
    21 / 200 (10.50%)
    7 / 100 (7.00%)
    2 / 99 (2.02%)
         occurrences all number
    35
    14
    3
    38
    7
    9
    68
    8
    30
    27
    7
    2
    Pyrexia
    Additional description: Pyrexia/Fever events that occurred after 7 days post-vaccination were considered as unsolicited AE.
         subjects affected / exposed
    21 / 103 (20.39%)
    11 / 52 (21.15%)
    10 / 53 (18.87%)
    6 / 86 (6.98%)
    3 / 42 (7.14%)
    4 / 42 (9.52%)
    35 / 200 (17.50%)
    8 / 100 (8.00%)
    17 / 100 (17.00%)
    13 / 200 (6.50%)
    3 / 100 (3.00%)
    2 / 99 (2.02%)
         occurrences all number
    21
    12
    12
    6
    3
    4
    35
    8
    17
    13
    3
    3
    Psychiatric disorders
    Irritability
         subjects affected / exposed
    31 / 103 (30.10%)
    12 / 52 (23.08%)
    11 / 53 (20.75%)
    14 / 86 (16.28%)
    11 / 42 (26.19%)
    14 / 42 (33.33%)
    64 / 200 (32.00%)
    34 / 100 (34.00%)
    33 / 100 (33.00%)
    26 / 200 (13.00%)
    16 / 100 (16.00%)
    9 / 99 (9.09%)
         occurrences all number
    31
    12
    11
    15
    11
    14
    64
    34
    33
    26
    16
    9
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    3 / 103 (2.91%)
    2 / 52 (3.85%)
    0 / 53 (0.00%)
    1 / 86 (1.16%)
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    12 / 200 (6.00%)
    5 / 100 (5.00%)
    6 / 100 (6.00%)
    0 / 200 (0.00%)
    1 / 100 (1.00%)
    0 / 99 (0.00%)
         occurrences all number
    3
    2
    0
    1
    0
    0
    13
    6
    6
    0
    1
    0
    Vomiting
    Additional description: Vomiting events that occurred after 7 days post-vaccination were considered as unsolicited AE.
         subjects affected / exposed
    7 / 103 (6.80%)
    3 / 52 (5.77%)
    2 / 53 (3.77%)
    6 / 86 (6.98%)
    4 / 42 (9.52%)
    6 / 42 (14.29%)
    16 / 200 (8.00%)
    7 / 100 (7.00%)
    9 / 100 (9.00%)
    0 / 200 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    7
    3
    2
    6
    4
    6
    17
    7
    9
    0
    0
    0
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    29 / 103 (28.16%)
    10 / 52 (19.23%)
    8 / 53 (15.09%)
    11 / 86 (12.79%)
    12 / 42 (28.57%)
    5 / 42 (11.90%)
    51 / 200 (25.50%)
    25 / 100 (25.00%)
    20 / 100 (20.00%)
    19 / 200 (9.50%)
    12 / 100 (12.00%)
    7 / 99 (7.07%)
         occurrences all number
    29
    10
    8
    11
    12
    5
    51
    25
    20
    19
    12
    7
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    4 / 103 (3.88%)
    1 / 52 (1.92%)
    4 / 53 (7.55%)
    1 / 86 (1.16%)
    0 / 42 (0.00%)
    1 / 42 (2.38%)
    0 / 200 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    1 / 200 (0.50%)
    0 / 100 (0.00%)
    1 / 99 (1.01%)
         occurrences all number
    4
    1
    5
    1
    0
    1
    0
    0
    0
    1
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    29 / 103 (28.16%)
    17 / 52 (32.69%)
    13 / 53 (24.53%)
    5 / 86 (5.81%)
    3 / 42 (7.14%)
    6 / 42 (14.29%)
    29 / 200 (14.50%)
    18 / 100 (18.00%)
    15 / 100 (15.00%)
    2 / 200 (1.00%)
    1 / 100 (1.00%)
    0 / 99 (0.00%)
         occurrences all number
    37
    23
    18
    5
    4
    7
    31
    18
    16
    2
    1
    0
    Pharyngitis
         subjects affected / exposed
    1 / 103 (0.97%)
    2 / 52 (3.85%)
    3 / 53 (5.66%)
    2 / 86 (2.33%)
    1 / 42 (2.38%)
    2 / 42 (4.76%)
    9 / 200 (4.50%)
    6 / 100 (6.00%)
    4 / 100 (4.00%)
    0 / 200 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    1
    2
    4
    2
    1
    2
    9
    6
    4
    0
    0
    0
    Rhinitis
         subjects affected / exposed
    0 / 103 (0.00%)
    1 / 52 (1.92%)
    0 / 53 (0.00%)
    0 / 86 (0.00%)
    0 / 42 (0.00%)
    1 / 42 (2.38%)
    0 / 200 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    3 / 200 (1.50%)
    6 / 100 (6.00%)
    1 / 99 (1.01%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    0
    3
    6
    1
    Upper Respiratory Tract Infection
         subjects affected / exposed
    6 / 103 (5.83%)
    3 / 52 (5.77%)
    0 / 53 (0.00%)
    3 / 86 (3.49%)
    2 / 42 (4.76%)
    4 / 42 (9.52%)
    6 / 200 (3.00%)
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    7
    3
    0
    3
    2
    4
    6
    1
    0
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Jul 2016
    Following amendment changes were made: Identified the Coordinating Investigator for each country, provided available Health Authority file numbers and update of Regional Clinical Trial Manager information; revised to anticipate the need to potentially include additional sites in South Korea; Visit 0 including activities performed were added for subjects in the Russian Federation; primary endpoint measurement was changed so that it was measured by hSBA instead of rSBA and the definition of hSBA in the primary objective was updated; included screening criteria for the subjects in the Russian Federation; neurological examinations were added according to the recommendations of Russian Health Authorities; updated the planned trial calendar; provided specific labeling information; and updated wording so that Abs to diphtheria, inactivated polio, hepatitis B and Haemophilus influenzae antigens would not be measured before vaccination.
    05 May 2017
    Following amendment changes were made: Updated to expand the age range of toddlers in Russia who were eligible to receive the 3rd dose of PCV13 vaccine as part of the Russian National Immunization program; specified for pertussis antigens; clarified timing of the 2nd dose of PCV13; included hepatitis B Ab level threshold of 100 mIU/mL for reliable prediction of long-term protection against hepatitis B virus; clarified that only tetanus and pertussis antigens would be tested before and 30 days after vaccination; and defined the end of the trail period as when the last assay results were available and updated trial calendar.
    11 Sep 2017
    Following amendment changes were made: Updated protocol to include Thailand as well as information pertaining to Thailand (including but not limited to Principal Investigators, number of sites, number of subjects planned to be enrolled, age of subjects, reporting requirements for SAEs in Thailand) as the study would also be conducted there; updated the number of subjects planned to be enrolled in South Korea; clarified the number of subjects in each group that would have the Ab responses to the meningococcal serogroups A, C, Y, and W measured by rSBA for the observational objective; specified the serostatus cutoffs for Abs to the antigens contained in MMR vaccine and Varicella vaccine based on the assays that were to be used for the analysis;and updated the definition of pertussis vaccine response specific for the booster vaccination response in order to make the definition specific to the manner the vaccine was being used in the study.

    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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