Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine when Administered Concomitantly with Routine Pediatric Vaccines in Healthy Infants and Toddlers in Europe

    Summary
    EudraCT number
    		 2017-004731-36
    Trial protocol
    		 CZ   SE   FI   IT   ES   PL   RO  
    Global end of trial date
    24 May 2023

    Results information
    Results version number
    		 v1
    This version publication date
    12 Jan 2025
    First version publication date
    12 Jan 2025
    Other versions
    		 v2

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    MET58
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03547271
    WHO universal trial number (UTN)
    		 U1111-1183-6653
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur Inc.
    Sponsor organisation address
    Discovery Drive, Swiftwater, PA, United States, 18370-0187
    Public contact
    Trial Transparency Team, Sanofi Pasteur, Contact-US@sanofi.com
    Scientific contact
    Trial Transparency Team, Sanofi Pasteur, Contact-US@sanofi.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    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
    08 Jul 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 May 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the non-inferiority of the antibody response against meningococcal serogroups A, C, W, and Y following the administration of a 3-dose series of MenACYW conjugate vaccine compared to a 3-dose series of Nimenrix® when each vaccine is administered concomitantly with routine pediatric vaccines [pneumococcal conjugate vaccine, 10-valent absorbed (PCV10), and hexavalent vaccine] to infants and toddlers from 6 weeks to 18 months old (Group 1 versus Group 2).
    Protection of trial subjects
    Vaccinations were performed by qualified and trained study personnel. Participants with allergy to any of the vaccine components were not vaccinated. After vaccination, participants were also kept under clinical observation for 30 minutes to ensure their safety. Appropriate medical equipment were also available on site in case of any immediate allergic reactions.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Dec 2018
    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
    Czechia: 140
    Country: Number of subjects enrolled
    Finland: 907
    Country: Number of subjects enrolled
    Italy: 60
    Country: Number of subjects enrolled
    Poland: 241
    Country: Number of subjects enrolled
    Romania: 132
    Country: Number of subjects enrolled
    Spain: 160
    Country: Number of subjects enrolled
    Sweden: 20
    Worldwide total number of subjects
    1660
    EEA total number of subjects
    1660
    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)
    1660
    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

    		 Close Top of page
    Recruitment
    Recruitment details
    		 This study was conducted at 33 investigational sites in 7 countries between 14 December 2018 to 24 May 2023.

    Pre-assignment
    Screening details
    		 A total of 1660 participants were enrolled in this study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1: MenACYW
    Arm description
    		 Participants received 3 doses of meningococcal polysaccharide (serogroups A, C, Y and W) tetanus toxoid [MenACYW conjugate vaccine] 0.5 milliliter (mL) as an intramuscular (IM) injection at dose 1: 2 months of age (MoA), dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and haemophilus influenzae type b conjugate vaccine [DTaP-IPV-HB-Hib], the pneumococcal vaccine (PCV10) were administered in a 2+1 regimen (ie, 2 doses in infancy [first between 6 and 12 weeks of age and second between 4 to 5 MoA] and 1 final dose in the second year of life [12 to 18 MoA]); and the measles, mumps, rubella (MMR) vaccine was administered at 12 to 18 MoA.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MenACYW conjugate vaccine
    Investigational medicinal product code
    Other name
    Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants received MenACYW conjugate vaccine 0.5 mL IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA.

    Investigational medicinal product name
    Hexavalent vaccine
    Investigational medicinal product code
    Other name
    DTaP-IPV-HB-Hib; Hexyon®; Hexacima®
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants received hexavalent vaccine 0.5 mL IM injection in a 2+1 regimen (2 doses in infancy [first between 6 and 12 weeks of age and second between 4 to 5 MoA] and 1 final dose in the second year of life [12 to 18 MoA])

    Investigational medicinal product name
    PCV10
    Investigational medicinal product code
    Other name
    Synflorix®
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants received PCV10 0.5 mL IM injection in a 2+1 regimen (2 doses in infancy [first between 6 and 12 weeks of age and second between 4 to 5 MoA] and 1 final dose in the second year of life [12 to 18 MoA])

    Investigational medicinal product name
    MMR vaccine
    Investigational medicinal product code
    Other name
    M-M-RVAXPRO®
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants received MMR vaccine 0.5 mL IM injection at 12 to 18 MoA.

    Arm title
    		 Group 2: Nimenrix
    Arm description
    		 Participants received 3 doses of Nimenrix® 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV10 were administered in a 2+1 regimen (ie, 2 doses in infancy [first between 6 and 12 weeks of age and second between 4 to 5 MoA] and 1 final dose in the second year of life [12 to 18 MoA]); and the MMR vaccine was administered at 12 to 18 MoA.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nimenrix®
    Investigational medicinal product code
    Other name
    Meningococcal group A, C, W-135, and Y conjugate vaccine
    Pharmaceutical forms
    Powder and solvent for solution for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants received Nimenrix® 0.5 mL IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA.

    Investigational medicinal product name
    MMR vaccine
    Investigational medicinal product code
    Other name
    M-M-RVAXPRO®
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants received MMR vaccine 0.5 mL IM injection at 12 to 18 MoA.

    Investigational medicinal product name
    PCV10
    Investigational medicinal product code
    Other name
    Synflorix®
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants received PCV10 0.5 mL IM injection in a 2+1 regimen (2 doses in infancy [first between 6 and 12 weeks of age and second between 4 to 5 MoA] and 1 final dose in the second year of life [12 to 18 MoA])

    Investigational medicinal product name
    Hexavalent vaccine
    Investigational medicinal product code
    Other name
    DTaP-IPV-HB-Hib; Hexyon®; Hexacima®
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants received hexavalent vaccine 0.5 mL IM injection in a 2+1 regimen (2 doses in infancy [first between 6 and 12 weeks of age and second between 4 to 5 MoA] and 1 final dose in the second year of life [12 to 18 MoA])

    Arm title
    		 Group 3: MenACYW
    Arm description
    		 Participants received 3 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the pneumococcal conjugate vaccine (13-valent, adsorbed) [PCV13] were administered in a 2+1 regimen (ie, 2 doses in infancy [first between 6 and 12 weeks of age and second between 4 to 5 MoA] and 1 final dose in the second year of life [12 to 18 MoA]); and the MMR vaccine was administered at 12 to 18 MoA.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MenACYW conjugate vaccine
    Investigational medicinal product code
    Other name
    Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants received MenACYW conjugate vaccine 0.5 mL IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA.

    Investigational medicinal product name
    PCV13
    Investigational medicinal product code
    Other name
    Prevenar 13®
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants received PCV13 0.5 mL IM injection in a 2+1 regimen (2 doses in infancy [first between 6 and 12 weeks of age and second between 4 to 5 MoA] and 1 final dose in the second year of life [12 to 18 MoA])

    Investigational medicinal product name
    Hexavalent vaccine
    Investigational medicinal product code
    Other name
    DTaP-IPV-HB-Hib; Hexyon®; Hexacima®
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants received hexavalent vaccine 0.5 mL IM injection in a 2+1 regimen (2 doses in infancy [first between 6 and 12 weeks of age and second between 4 to 5 MoA] and 1 final dose in the second year of life [12 to 18 MoA])

    Investigational medicinal product name
    MMR vaccine
    Investigational medicinal product code
    Other name
    M-M-RVAXPRO®
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants received MMR vaccine 0.5 mL IM injection at 12 to 18 MoA.

    Arm title
    		 Group 4: MenACYW
    Arm description
    		 Participants received 4 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 6 MoA and dose 4: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV13 were administered in a 2+1 regimen (concomitantly with the first and second doses in infancy [first between 6 and 12 weeks of age and second between 4 to 5 MoA] and the toddler dose of MenACYW conjugate vaccine [12 to 18 MoA]); and the MMR vaccine was administered at 12 to 18 MoA. The third dose of MenACYW conjugate vaccine was administered alone, without any other routine pediatric vaccines.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MenACYW conjugate vaccine
    Investigational medicinal product code
    Other name
    Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants received MenACYW conjugate vaccine 0.5 mL IM injection at dose 1: 2 MoA, dose 2: 4MoA, and dose 3: 6 MoA and dose 4: 12 to 18 MoA.

    Investigational medicinal product name
    Hexavalent vaccine
    Investigational medicinal product code
    Other name
    DTaP-IPV-HB-Hib; Hexyon®; Hexacima®
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants received hexavalent vaccine 0.5 mL IM injection in a 2+1 regimen (first between 6 and 12 weeks of age and second between 4 to 5 MoA in infancy and the toddler dose at 12 to 18 MoA).

    Investigational medicinal product name
    PCV13
    Investigational medicinal product code
    Other name
    Prevenar 13®
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants received PCV13 0.5 mL IM injection in a 2+1 regimen (first between 6 and 12 weeks of age and second between 4 to 5 MoA in infancy and the toddler dose at 12 to 18 MoA).

    Investigational medicinal product name
    MMR vaccine
    Investigational medicinal product code
    Other name
    M-M-RVAXPRO®
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants received MMR vaccine 0.5 mL IM injection at 12 to 18 MoA.

    Number of subjects in period 1
    		Group 1: MenACYW Group 2: Nimenrix Group 3: MenACYW Group 4: MenACYW
    Started
    714
    726
    112
    108
    Safety analysis set (SafAS)
    696
    706
    112
    108
    Completed
    681
    691
    106
    104
    Not completed
    33
    35
    6
    4
         Adverse event, non-fatal
    1
    1
    -
    -
         Protocol deviation
    5
    7
    3
    -
         Withdrawal by Parent/Guardian
    24
    24
    2
    4
         Lost to follow-up
    3
    3
    1
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Group 1: MenACYW
    Reporting group description
    		 Participants received 3 doses of meningococcal polysaccharide (serogroups A, C, Y and W) tetanus toxoid [MenACYW conjugate vaccine] 0.5 milliliter (mL) as an intramuscular (IM) injection at dose 1: 2 months of age (MoA), dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and haemophilus influenzae type b conjugate vaccine [DTaP-IPV-HB-Hib], the pneumococcal vaccine (PCV10) were administered in a 2+1 regimen (ie, 2 doses in infancy [first between 6 and 12 weeks of age and second between 4 to 5 MoA] and 1 final dose in the second year of life [12 to 18 MoA]); and the measles, mumps, rubella (MMR) vaccine was administered at 12 to 18 MoA.

    Reporting group title
    Group 2: Nimenrix
    Reporting group description
    		 Participants received 3 doses of Nimenrix® 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV10 were administered in a 2+1 regimen (ie, 2 doses in infancy [first between 6 and 12 weeks of age and second between 4 to 5 MoA] and 1 final dose in the second year of life [12 to 18 MoA]); and the MMR vaccine was administered at 12 to 18 MoA.

    Reporting group title
    Group 3: MenACYW
    Reporting group description
    		 Participants received 3 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the pneumococcal conjugate vaccine (13-valent, adsorbed) [PCV13] were administered in a 2+1 regimen (ie, 2 doses in infancy [first between 6 and 12 weeks of age and second between 4 to 5 MoA] and 1 final dose in the second year of life [12 to 18 MoA]); and the MMR vaccine was administered at 12 to 18 MoA.

    Reporting group title
    Group 4: MenACYW
    Reporting group description
    		 Participants received 4 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 6 MoA and dose 4: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV13 were administered in a 2+1 regimen (concomitantly with the first and second doses in infancy [first between 6 and 12 weeks of age and second between 4 to 5 MoA] and the toddler dose of MenACYW conjugate vaccine [12 to 18 MoA]); and the MMR vaccine was administered at 12 to 18 MoA. The third dose of MenACYW conjugate vaccine was administered alone, without any other routine pediatric vaccines.

    Reporting group values
    		 Group 1: MenACYW Group 2: Nimenrix Group 3: MenACYW Group 4: MenACYW Total
    Number of subjects
    		 714 726 112 108 1660
    Age categorical
    Units: Subjects
        Infants and toddlers (28 days-23 months)
    		 714 726 112 108 1660
    Age Continuous
    Units: Days
        arithmetic mean (standard deviation)
    		 72.6 ( 12.2 ) 72.4 ( 12.1 ) 62.5 ( 7.12 ) 63.3 ( 7.93 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 355 378 45 58 836
        Male
    		 359 348 67 50 824
    Race/Ethnicity, Customized
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 1 0 1
        Asian
    		 2 1 4 2 9
        Black or African American
    		 0 0 1 3 4
        Native Hawaiian or Other Pacific Islander
    		 0 1 0 0 1
        White
    		 693 699 106 101 1599
        Not Reported
    		 13 16 0 1 30
        Unknown
    		 2 3 0 0 5
        Multiple origin
    		 4 6 0 1 11

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Group 1: MenACYW
    Reporting group description
    		 Participants received 3 doses of meningococcal polysaccharide (serogroups A, C, Y and W) tetanus toxoid [MenACYW conjugate vaccine] 0.5 milliliter (mL) as an intramuscular (IM) injection at dose 1: 2 months of age (MoA), dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and haemophilus influenzae type b conjugate vaccine [DTaP-IPV-HB-Hib], the pneumococcal vaccine (PCV10) were administered in a 2+1 regimen (ie, 2 doses in infancy [first between 6 and 12 weeks of age and second between 4 to 5 MoA] and 1 final dose in the second year of life [12 to 18 MoA]); and the measles, mumps, rubella (MMR) vaccine was administered at 12 to 18 MoA.

    Reporting group title
    Group 2: Nimenrix
    Reporting group description
    		 Participants received 3 doses of Nimenrix® 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV10 were administered in a 2+1 regimen (ie, 2 doses in infancy [first between 6 and 12 weeks of age and second between 4 to 5 MoA] and 1 final dose in the second year of life [12 to 18 MoA]); and the MMR vaccine was administered at 12 to 18 MoA.

    Reporting group title
    Group 3: MenACYW
    Reporting group description
    		 Participants received 3 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the pneumococcal conjugate vaccine (13-valent, adsorbed) [PCV13] were administered in a 2+1 regimen (ie, 2 doses in infancy [first between 6 and 12 weeks of age and second between 4 to 5 MoA] and 1 final dose in the second year of life [12 to 18 MoA]); and the MMR vaccine was administered at 12 to 18 MoA.

    Reporting group title
    Group 4: MenACYW
    Reporting group description
    		 Participants received 4 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 6 MoA and dose 4: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV13 were administered in a 2+1 regimen (concomitantly with the first and second doses in infancy [first between 6 and 12 weeks of age and second between 4 to 5 MoA] and the toddler dose of MenACYW conjugate vaccine [12 to 18 MoA]); and the MMR vaccine was administered at 12 to 18 MoA. The third dose of MenACYW conjugate vaccine was administered alone, without any other routine pediatric vaccines.

    Primary: Groups 1 and 2: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y

    		 Close Top of page
    End point title
    		 Groups 1 and 2: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y [1]
    End point description
    Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the serum bactericidal assay using human complement (hSBA). Per-Protocol Analysis Set 2 (PPAS2) was a subset of Full Analysis Set 2 (FAS2). The FAS2 included the subset of randomized participants who received at least 1 dose of the study vaccine at booster vaccination and had a valid post-booster vaccination blood sample result. Here, n=number of participants with data collected for each specific serogroup.
    End point type
    Primary
    End point timeframe
    At 30 days post Dose 3 [12 to 18 months of age (MoA)]
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only participants randomized in Groups 1 and 2 were analyzed in this endpoint.
    End point values
    		 Group 1: MenACYW Group 2: Nimenrix
    Number of subjects analysed
    554
    579
    Units: Titer
    geometric mean (confidence interval 95%)
        Serogroup A (n=543, 567)
    131 (113 to 151)
    189 (165 to 218)
        Serogroup C (n=550, 578)
    565 (505 to 632)
    120 (106 to 135)
        Serogroup W (n=547, 575)
    423 (382 to 468)
    275 (247 to 305)
        Serogroup Y (n=554, 579)
    285 (260 to 313)
    160 (145 to 177)
    Statistical analysis title
    		 Statistical analysis for Serogroup C
    Statistical analysis description
    The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was >1/1.5 for all 4 serogroups. 95% CI of the GMT ratio was calculated using a normal approximation of log-transformed titers.
    Comparison groups
    Group 1: MenACYW v Group 2: Nimenrix
    Number of subjects included in analysis
    1133
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT ratio
    Point estimate
    4.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4
         upper limit
    		 5.58
    Statistical analysis title
    		 Statistical analysis for Serogroup Y
    Statistical analysis description
    The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was >1/1.5 for all 4 serogroups. 95% CI of the GMT ratio was calculated using a normal approximation of log-transformed titers.
    Comparison groups
    Group 1: MenACYW v Group 2: Nimenrix
    Number of subjects included in analysis
    1133
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT ratio
    Point estimate
    1.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.55
         upper limit
    		 2.04
    Statistical analysis title
    		 Statistical analysis for Serogroup W
    Statistical analysis description
    The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was >1/1.5 for all 4 serogroups. 95% CI of the GMT ratio was calculated using a normal approximation of log-transformed titers.
    Comparison groups
    Group 1: MenACYW v Group 2: Nimenrix
    Number of subjects included in analysis
    1133
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Slope
    Point estimate
    1.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.33
         upper limit
    		 1.78
    Statistical analysis title
    		 Statistical analysis for Serogroup A
    Statistical analysis description
    The non-inferiority was demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) was >1/1.5 for all 4 serogroups. 95% CI of the GMT ratio was calculated using a normal approximation of log-transformed titers.
    Comparison groups
    Group 2: Nimenrix v Group 1: MenACYW
    Number of subjects included in analysis
    1133
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT ratio
    Point estimate
    0.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.565
         upper limit
    		 0.842

    Secondary: Groups 1 and 2: Percentage of Participants who Achieved Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, W, and Y

    		 Close Top of page
    End point title
    		 Groups 1 and 2: Percentage of Participants who Achieved Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, W, and Y [2]
    End point description
    Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the hSBA. Percentages are rounded off to the tenth decimal place. PPAS1 was a subset of FAS1. The FAS1 included the subset of randomized participants who received at least 1 dose of the study vaccine in the primary series and had a valid post-primary series vaccination blood sample result. Here, n=number of participants with data collected for each specific serogroup.
    End point type
    Secondary
    End point timeframe
    At 30 days post Dose 2 (4 MoA)
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only participants randomized in Groups 1 and 2 were analyzed in this endpoint.
    End point values
    		 Group 1: MenACYW Group 2: Nimenrix
    Number of subjects analysed
    518
    523
    Units: Percentage of participants
    number (confidence interval 95%)
        Serogroup A (n=508, 508)
    63.6 (59.2 to 67.8)
    75.8 (71.8 to 79.5)
        Serogroup C (n=513, 521)
    98.8 (97.5 to 99.6)
    91.9 (89.3 to 94.1)
        Serogroup W (n=518, 523)
    96.5 (94.6 to 97.9)
    94.5 (92.1 to 96.3)
        Serogroup Y (n=516, 523)
    96.5 (94.5 to 97.9)
    93.5 (91.0 to 95.5)
    Statistical analysis title
    		 Statistical analysis for Serogroup A
    Statistical analysis description
    The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was >-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson score method without continuity correction.
    Comparison groups
    Group 1: MenACYW v Group 2: Nimenrix
    Number of subjects included in analysis
    1041
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in percentage of participants
    Point estimate
    -12.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17.74
         upper limit
    		 -6.56
    Statistical analysis title
    		 Statistical analysis for Serogroup Y
    Statistical analysis description
    The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was >-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson score method without continuity correction.
    Comparison groups
    Group 1: MenACYW v Group 2: Nimenrix
    Number of subjects included in analysis
    1041
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in percentage of participants
    Point estimate
    3.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.34
         upper limit
    		 5.77
    Statistical analysis title
    		 Statistical analysis for Serogroup W
    Statistical analysis description
    The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was >-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson score method without continuity correction.
    Comparison groups
    Group 1: MenACYW v Group 2: Nimenrix
    Number of subjects included in analysis
    1041
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in percentage of participants
    Point estimate
    2.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.49
         upper limit
    		 4.7
    Statistical analysis title
    		 Statistical analysis for Serogroup C
    Statistical analysis description
    The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was >-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson score method without continuity correction.
    Comparison groups
    Group 1: MenACYW v Group 2: Nimenrix
    Number of subjects included in analysis
    1041
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in percentage of participants
    Point estimate
    6.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.44
         upper limit
    		 9.62

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

    		 Close Top of page
    End point title
    		 Groups 3 and 4: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y [3]
    End point description
    Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the hSBA. PPAS1 was a subset of FAS1. FAS1: subset of randomized participants who received at least 1 dose of study vaccine in primary series and had valid post-primary series vaccination blood sample result. PPAS2 was a subset of FAS2. FAS2: subset of randomized participants who received at least 1 dose of study vaccine at booster vaccination and had valid post-booster vaccination blood sample result. Here, n=number of participants with data collected for each specific serogroup. ‘9999' denotes that there were no participants analyzed.
    End point type
    Secondary
    End point timeframe
    Group 3: Day 0 before Dose 1 (2 MoA) and Dose 3 (12 to 18 MoA) and Day 30 Post Dose 2 (4 MoA) and Dose 3 (12 to 18 MoA); Group 4: Day 0 before Dose 1 (2 MoA) and Dose 4 (12 to 18 MoA) and Day 30 Post Dose 3 (6 MoA) and Dose 4 (12 to 18 MoA)
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only participants randomized in Groups 3 and 4 were analyzed in this endpoint.
    End point values
    		 Group 3: MenACYW Group 4: MenACYW
    Number of subjects analysed
    96
    90
    Units: Titer
    geometric mean (confidence interval 95%)
        PPAS1: Serogroup A: Day 0 before dose 1 (n=94, 89)
    3.00 (2.58 to 3.49)
    2.86 (2.49 to 3.28)
        PPAS1: Serogroup A: Day 30 post dose 2 (n=91, 0)
    14.8 (10.6 to 20.8)
    9999 (9999 to 9999)
        PPAS1: Serogroup A: Day 30 post dose 3 (n=0, 88)
    9999 (9999 to 9999)
    23.0 (17.1 to 30.9)
        PPAS1: Serogroup C: Day 0 before dose 1 (n=94, 90)
    3.91 (3.16 to 4.84)
    3.88 (3.25 to 4.62)
        PPAS1: Serogroup C: Day 30 post dose 2 (n=95, 0)
    309 (235 to 407)
    9999 (9999 to 9999)
        PPAS1: Serogroup C: Day 30 post dose 3 (n=0, 90)
    9999 (9999 to 9999)
    481 (376 to 616)
        PPAS1: Serogroup W: Day 0 before dose 1 (n=94, 90)
    2.67 (2.40 to 2.96)
    3.08 (2.63 to 3.60)
        PPAS1: Serogroup W: Day 30 post dose 2 (n=96, 0)
    102 (79.7 to 131)
    9999 (9999 to 9999)
        PPAS1: Serogroup W: Day 30 post dose 3 (n=0, 90)
    9999 (9999 to 9999)
    196 (156 to 245)
        PPAS1: Serogroup Y: Day 0 before dose 1 (n=94, 90)
    2.85 (2.45 to 3.32)
    2.76 (2.36 to 3.23)
        PPAS1: Serogroup Y: Day 30 post dose 2 (n=96, 0)
    73.4 (57.7 to 93.5)
    9999 (9999 to 9999)
        PPAS1: Serogroup Y: Day 30 post dose 3 (n=0, 90)
    9999 (9999 to 9999)
    150 (116 to 195)
        PPAS2: Serogroup A: Day 0 before dose 3 (n=91, 0)
    5.18 (4.22 to 6.37)
    9999 (9999 to 9999)
        PPAS2: Serogroup A: Day 30 post dose 3 (n=92, 0)
    104 (67.9 to 161)
    9999 (9999 to 9999)
        PPAS2: Serogroup A: Day 0 before dose 4 (n=0, 89)
    9999 (9999 to 9999)
    8.13 (6.33 to 10.4)
        PPAS2: Serogroup A: Day 30 post dose 4 (n=0, 89)
    9999 (9999 to 9999)
    62.0 (39.9 to 96.4)
        PPAS2: Serogroup C: Day 0 before dose 3 (n=94, 0)
    26.2 (18.7 to 36.8)
    9999 (9999 to 9999)
        PPAS2: Serogroup C: Day 30 post dose 3 (n=93, 0)
    819 (622 to 1078)
    9999 (9999 to 9999)
        PPAS2: Serogroup C: Day 0 before dose 4 (n=0, 89)
    9999 (9999 to 9999)
    56.9 (42.4 to 76.4)
        PPAS2: Serogroup C: Day 30 post dose 4 (n=0, 86)
    9999 (9999 to 9999)
    791 (608 to 1029)
        PPAS2: Serogroup W: Day 0 before dose 3 (n=93, 0)
    39.1 (29.6 to 51.8)
    9999 (9999 to 9999)
        PPAS2: Serogroup W: Day 30 post dose 3 (n=87, 0)
    1049 (782 to 1406)
    9999 (9999 to 9999)
        PPAS2: Serogroup W: Day 0 before dose 4 (n=0, 90)
    9999 (9999 to 9999)
    92.6 (74.3 to 115)
        PPAS2: Serogroup W: Day 30 post dose 4 (n=0, 86)
    9999 (9999 to 9999)
    1024 (806 to 1301)
        PPAS2: Serogroup Y: Day 0 before dose 3 (n=94, 0)
    33.0 (25.0 to 43.5)
    9999 (9999 to 9999)
        PPAS2: Serogroup Y: Day 30 post dose 3 (n=94, 0)
    589 (470 to 737)
    9999 (9999 to 9999)
        PPAS2: Serogroup Y: Day 0 before dose 4 (n=0, 90)
    9999 (9999 to 9999)
    85.8 (68.2 to 108)
        PPAS2: Serogroup Y: Day 30 post dose 4 (n=0, 89)
    9999 (9999 to 9999)
    632 (512 to 780)
    No statistical analyses for this end point

    Secondary: Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement Antibody Titers >=1:4 and >=1:8

    		 Close Top of page
    End point title
    		 Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement Antibody Titers >=1:4 and >=1:8 [4]
    End point description
    Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the hSBA. Percentages are rounded off to the tenth decimal place. PPAS1 was a subset of FAS1. FAS1: subset of randomized participants who received at least 1 dose of study vaccine in primary series and had valid post-primary series vaccination blood sample result. PPAS2 was a subset of FAS2. FAS2: subset of randomized participants who received at least 1 dose of study vaccine at booster vaccination and had valid post-booster vaccination blood sample result. Here, n=number of participants with data collected for each specific serogroup. Dose=D.
    End point type
    Secondary
    End point timeframe
    Day 0 Before Dose 1 (2 MoA) and Day 30 Post Dose 2 (4 MoA); Day 0 Before Dose 3 (12 to 18 MoA) and Day 30 Post Dose 3 (12 to 18 MoA)
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only participants randomized in Groups 1 and 2 were analyzed in this endpoint.
    End point values
    		 Group 1: MenACYW Group 2: Nimenrix
    Number of subjects analysed
    554
    579
    Units: Percentage of participants
    number (confidence interval 95%)
        PPAS1:Serogroup A: >=1:4:Day0 before D1(n=521,519)
    31.1 (27.1 to 35.3)
    28.3 (24.5 to 32.4)
        PPAS1:Serogroup A:>=1:8: Day0 before D1(n=521,519)
    5.6 (3.8 to 7.9)
    6.4 (4.4 to 8.8)
        PPAS1:Serogroup A:>=1:4:Day30 post D2(n=508,508)
    77.2 (73.3 to 80.7)
    88.0 (84.8 to 90.7)
        PPAS1:Serogroup A:>=1:8:Day30 post D2(n=508,508)
    63.6 (59.2 to 67.8)
    75.8 (71.8 to 79.5)
        PPAS1:Serogroup C:>=1:4:Day0 before D1(n=517,517)
    14.3 (11.4 to 17.6)
    14.9 (11.9 to 18.3)
        PPAS1:Serogroup C:>=1:8:Day0 before D1(n=517,517)
    5.2 (3.5 to 7.5)
    5.2 (3.5 to 7.5)
        PPAS1:Serogroup C:>=1:4:Day30 post D2(n=513,521)
    99.0 (97.7 to 99.7)
    96.4 (94.4 to 97.8)
        PPAS1:Serogroup C:>=1:8:Day30 post D2(n=513,521)
    98.8 (97.5 to 99.6)
    91.9 (89.3 to 94.1)
        PPAS1:Serogroup W:>=1:4:Day0 before D1(n=520,520)
    11.7 (9.1 to 14.8)
    11.0 (8.4 to 14.0)
        PPAS1:Serogroup W:>=1:8:Day0 before D1(n=520,520)
    3.7 (2.2 to 5.6)
    3.5 (2.1 to 5.4)
        PPAS1:Serogroup W:>=1:4:Day30 post D2(n=518,523)
    98.6 (97.2 to 99.5)
    98.3 (96.8 to 99.2)
        PPAS1:Serogroup W:>=1:8:Day30 post D2(n=518,523)
    96.5 (94.6 to 97.9)
    94.5 (92.1 to 96.3)
        PPAS1:Serogroup Y:>=1:4:Day0 before D1(n=519,518)
    10.0 (7.6 to 12.9)
    9.8 (7.4 to 12.7)
        PPAS1:Serogroup Y:>=1:8:Day0 before D1(n=519,518)
    6.4 (4.4 to 8.8)
    5.6 (3.8 to 7.9)
        PPAS1:Serogroup Y:>=1:4:Day30 post D2(n=516,523)
    98.3 (96.7 to 99.2)
    97.3 (95.5 to 98.5)
        PPAS1:Serogroup Y:>=1:8:Day30 post D2(n=516,523)
    96.5 (94.5 to 97.9)
    93.5 (91.0 to 95.5)
        PPAS2:Serogroup A:>=1:4:Day0 before D3(n=540,567)
    69.1 (65.0 to 73.0)
    73.7 (69.9 to 77.3)
        PPAS2:Serogroup A:>=1:8:Day0 before D3(n=540,567)
    33.7 (29.7 to 37.9)
    46.2 (42.0 to 50.4)
        PPAS2:Serogroup A:>=1:4:Day30 post D3(n=543,567)
    98.2 (96.6 to 99.1)
    98.1 (96.6 to 99.0)
        PPAS2:Serogroup A:>=1:8:Day30 post D3(n=543,567)
    94.7 (92.4 to 96.4)
    96.5 (94.6 to 97.8)
        PPAS2:Serogroup C:>=1:4:Day0 before D3(n=545,572)
    92.5 (89.9 to 94.5)
    62.1 (57.9 to 66.1)
        PPAS2:Serogroup C:>=1:8:Day0 before D3(n=545,572)
    88.1 (85.1 to 90.7)
    41.6 (37.5 to 45.8)
        PPAS2:Serogroup C:>=1:4:Day30 post D3(n=550,578)
    99.8 (99.0 to 100)
    98.1 (96.6 to 99.0)
        PPAS2:Serogroup C:>=1:8:Day30 post D3(n=550,578)
    99.6 (98.7 to 100)
    95.5 (93.5 to 97.0)
        PPAS2:Serogroup W:>=1:4:Day0 before D3(n=541,567)
    96.7 (94.8 to 98.0)
    91.2 (88.5 to 93.4)
        PPAS2:Serogroup W:>=1:8:Day0 before D3(n=541,567)
    89.1 (86.2 to 91.6)
    77.6 (73.9 to 81.0)
        PPAS2:Serogroup W:>=1:4:Day30 post D3(n=547,575)
    100 (99.3 to 100)
    100 (99.4 to 100)
        PPAS2:Serogroup W:>=1:8:Day30 post D3(n=547,575)
    99.8 (99.0 to 100)
    99.5 (98.5 to 99.9)
        PPAS2:Serogroup Y:>=1:4:Day0 before D3(n=545,572)
    95.8 (93.7 to 97.3)
    85.7 (82.5 to 88.4)
        PPAS2:Serogroup Y:>=1:8:Day0 before D3(n=545,572)
    87.9 (84.9 to 90.5)
    69.6 (65.6 to 73.3)
        PPAS2:Serogroup Y:>=1:4:Day30 post D3(n=554,579)
    100 (99.3 to 100)
    100 (99.4 to 100)
        PPAS2:Serogroup Y:>=1:8:Day30 post D3(n=554,579)
    100 (99.3 to 100)
    99.8 (99.0 to 100)
    No statistical analyses for this end point

    Secondary: Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement Antibody Titers >=1:4 and >=1:8

    		 Close Top of page
    End point title
    		 Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement Antibody Titers >=1:4 and >=1:8 [5]
    End point description
    Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the hSBA. Percentages are rounded off to the tenth decimal place. PPAS1 was a subset of FAS1. FAS1: subset of randomized participants who received at least 1 dose of study vaccine in primary series and had valid post-primary series vaccination blood sample result. PPAS2 was a subset of FAS2. FAS2: subset of randomized participants who received at least 1 dose of study vaccine at booster vaccination and had valid post-booster vaccination blood sample result. Here, n=number of participants with data collected for each specific serogroup. ‘9999' denotes that there were no participants analyzed. Dose=D.
    End point type
    Secondary
    End point timeframe
    Group 3: Day 0 before Dose 1 (2 MoA) and Dose 3 (12 to 18 MoA) and Day 30 Post Dose 2 (4 MoA) and Dose 3 (12 to 18 MoA); Group 4: Day 0 before Dose 1 (2 MoA) and Dose 4 (12 to 18 MoA) and Day 30 Post Dose 3 (6 MoA) and Dose 4 (12 to 18 MoA)
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only participants randomized in Groups 3 and 4 were analyzed in this endpoint.
    End point values
    		 Group 3: MenACYW Group 4: MenACYW
    Number of subjects analysed
    96
    90
    Units: Percentage of participants
    number (confidence interval 95%)
        PPAS1:Serogroup A:>=1:4:Day0 before D1(n=94,89)
    33.0 (23.6 to 43.4)
    32.6 (23.0 to 43.3)
        PPAS1:Serogroup A:>=1:8:Day0 before D1(n=94,89)
    14.9 (8.4 to 23.7)
    11.2 (5.5 to 19.7)
        PPAS1:Serogroup A:>=1:4:Day30 post D2(n=91,0)
    79.1 (69.3 to 86.9)
    9999 (9999 to 9999)
        PPAS1:Serogroup A:>=1:8:Day30 post D2(n=91,0)
    63.7 (53.0 to 73.6)
    9999 (9999 to 9999)
        PPAS1:Serogroup A:>=1:4:Day30 post D3(n=0,88)
    9999 (9999 to 9999)
    92.0 (84.3 to 96.7)
        PPAS1:Serogroup A:>=1:8:Day30 post D3(n=0,88)
    9999 (9999 to 9999)
    81.8 (72.2 to 89.2)
        PPAS1:Serogroup C:>=1:4:Day0 before D1(n=94,90)
    43.6 (33.4 to 54.2)
    48.9 (38.2 to 59.7)
        PPAS1:Serogroup C:>=1:8:Day0 before D1(n=94,90)
    26.6 (18.0 to 36.7)
    32.2 (22.8 to 42.9)
        PPAS1:Serogroup C:>=1:4:Day30 post D2(n=95,0)
    98.9 (94.3 to 100)
    9999 (9999 to 9999)
        PPAS1:Serogroup C:>=1:8:Day30 post D2(n=95,0)
    98.9 (94.3 to 100)
    9999 (9999 to 9999)
        PPAS1:Serogroup C:>=1:4:Day30 post D3(n=0,90)
    9999 (9999 to 9999)
    98.9 (94.0 to 100)
        PPAS1:Serogroup C:>=1:8:Day30 post D3(n=0,90)
    9999 (9999 to 9999)
    98.9 (94.0 to 100)
        PPAS1:Serogroup W:>=1:4:Day0 before D1(n=94,90)
    28.7 (19.9 to 39.0)
    35.6 (25.7 to 46.3)
        PPAS1:Serogroup W:>=1:8:Day0 before D1(n=94,90)
    10.6 (5.2 to 18.7)
    16.7 (9.6 to 26.0)
        PPAS1:Serogroup W:>=1:4:Day30 post D2(n=96,0)
    99.0 (94.3 to 100)
    9999 (9999 to 9999)
        PPAS1:Serogroup W:>=1:8:Day30 post D2(n=96,0)
    96.9 (91.1 to 99.4)
    9999 (9999 to 9999)
        PPAS1:Serogroup W:>=1:4:Day30 post D3(n=0,90)
    9999 (9999 to 9999)
    98.9 (94.0 to 100)
        PPAS1:Serogroup W:>=1:8:Day30 post D3(n=0,90)
    9999 (9999 to 9999)
    98.9 (94.0 to 100)
        PPAS1:Serogroup Y:>=1:4:Day0 before D1(n=94,90)
    26.6 (18.0 to 36.7)
    22.2 (14.1 to 32.2)
        PPAS1:Serogroup Y:>=1:8:Day0 before D1(n=94,90)
    12.8 (6.8 to 21.2)
    12.2 (6.3 to 20.8)
        PPAS1:Serogroup Y:>=1:4:Day30 post D2(n=96,0)
    99.0 (94.3 to 100)
    9999 (9999 to 9999)
        PPAS1:Serogroup Y:>=1:8:Day30 post D2(n=96,0)
    95.8 (89.7 to 98.9)
    9999 (9999 to 9999)
        PPAS1:Serogroup Y:>=1:4:Day30 post D3(n=0,90)
    9999 (9999 to 9999)
    98.9 (94.0 to 100)
        PPAS1:Serogroup Y:>=1:8:Day30 post D3(n=0,90)
    9999 (9999 to 9999)
    98.9 (94.0 to 100)
        PPAS2:Serogroup A:>=1:4:Day0 before D3(n=91,0)
    65.9 (55.3 to 75.5)
    9999 (9999 to 9999)
        PPAS2:Serogroup A:>=1:8:Day0 before D3(n=91,0)
    37.4 (27.4 to 48.1)
    9999 (9999 to 9999)
        PPAS2:Serogroup A:>=1:4:Day30 post D3(n=92,0)
    92.4 (84.9 to 96.9)
    9999 (9999 to 9999)
        PPAS2:Serogroup A:>=1:8:Day30 post D3(n=92,0)
    89.1 (80.9 to 94.7)
    9999 (9999 to 9999)
        PPAS2:Serogroup A:>=1:4:Day0 before D4(n=0,89)
    9999 (9999 to 9999)
    80.9 (71.2 to 88.5)
        PPAS2:Serogroup A:>=1:8:Day0 before D4(n=0,89)
    9999 (9999 to 9999)
    52.8 (41.9 to 63.5)
        PPAS2:Serogroup A:>=1:4:Day30 post D4(n=0,89)
    9999 (9999 to 9999)
    82.0 (72.5 to 89.4)
        PPAS2: Serogroup A: >=1:8: Day 30 post D4(n=0,89)
    9999 (9999 to 9999)
    82.0 (72.5 to 89.4)
        PPAS2:Serogroup C:>=1:4:Day0 before D3(n=94,0)
    87.2 (78.8 to 93.2)
    9999 (9999 to 9999)
        PPAS2:Serogroup C:>=1:8:Day0 before D3(n=94,0)
    79.8 (70.2 to 87.4)
    9999 (9999 to 9999)
        PPAS2:Serogroup C:>=1:4:Day30 post D3(n=93,0)
    100 (96.1 to 100)
    9999 (9999 to 9999)
        PPAS2:Serogroup C:>=1:8:Day30 post D3(n=93,0)
    100 (96.1 to 100)
    9999 (9999 to 9999)
        PPAS2:Serogroup C:>=1:4:Day0 before D4(n=0,89)
    9999 (9999 to 9999)
    97.8 (92.1 to 99.7)
        PPAS2:Serogroup C:>=1:8:Day0 before D4(n=0,89)
    9999 (9999 to 9999)
    92.1 (84.5 to 96.8)
        PPAS2:Serogroup C:>=1:4:Day30 post D4(n=0,86)
    9999 (9999 to 9999)
    100 (95.8 to 100)
        PPAS2:Serogroup C:>=1:8:Day30 post D4(n=0,86)
    9999 (9999 to 9999)
    100 (95.8 to 100)
        PPAS2:Serogroup W:>=1:4:Day0 before D3(n=93,0)
    96.8 (90.9 to 99.3)
    9999 (9999 to 9999)
        PPAS2:Serogroup W:>=1:8:Day0 before D3(n=93,0)
    92.5 (85.1 to 96.9)
    9999 (9999 to 9999)
        PPAS2:Serogroup W:>=1:4:Day30 post D3(n=87,0)
    100 (95.8 to 100)
    9999 (9999 to 9999)
        PPAS2:Serogroup W:>=1:8:Day30 post D3(n=87,0)
    100 (95.8 to 100)
    9999 (9999 to 9999)
        PPAS2:Serogroup W:>=1:4:Day0 before D4(n=0,90)
    9999 (9999 to 9999)
    100 (96.0 to 100)
        PPAS2:Serogroup W:>=1:8:Day0 before D4(n=0,90)
    9999 (9999 to 9999)
    100 (96.0 to 100)
        PPAS2:Serogroup W:>=1:4:Day30 post D4(n=0,86)
    9999 (9999 to 9999)
    100 (95.8 to 100)
        PPAS2:Serogroup W:>=1:8:Day30 post D4(n=0,86)
    9999 (9999 to 9999)
    100 (95.8 to 100)
        PPAS2:Serogroup Y:>=1:4:Day0 before D3(n=94,0)
    94.7 (88.0 to 98.3)
    9999 (9999 to 9999)
        PPAS2:Serogroup Y:>=1:8:Day0 before D3(n=94,0)
    89.4 (81.3 to 94.8)
    9999 (9999 to 9999)
        PPAS2:Serogroup Y:>=1:4:Day30 post D3(n=94,0)
    100 (96.2 to 100)
    9999 (9999 to 9999)
        PPAS2:Serogroup Y:>=1:8:Day30 post D3(n=94,0)
    100 (96.2 to 100)
    9999 (9999 to 9999)
        PPAS2:Serogroup Y:>=1:4:Day0 before D4(n=0,90)
    9999 (9999 to 9999)
    100 (96.0 to 100)
        PPAS2:Serogroup Y:>=1:8:Day0 before D4(n=0,90)
    9999 (9999 to 9999)
    100 (96.0 to 100)
        PPAS2:Serogroup Y:>=1:4:Day30 post D4(n=0,89)
    9999 (9999 to 9999)
    100 (95.9 to 100)
        PPAS2:Serogroup Y:>=1:8:Day30 post D4(n=0,89)
    9999 (9999 to 9999)
    100 (95.9 to 100)
    No statistical analyses for this end point

    Secondary: Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse

    		 Close Top of page
    End point title
    		 Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse [6]
    End point description
    Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the hSBA. hSBA vaccine seroresponse was defined for a participant with a pre vaccination titer <1:8, post-vaccination titer must be >=1:16 and for a participant with a pre vaccination titer >=1:8, post-vaccination titer must be at least 4-fold greater than the pre vaccination titer. Percentages are rounded off to tenth decimal place. PPAS1 was subset of FAS1. FAS1: subset of randomized participants who received at least 1 dose of study vaccine in primary series and had valid post-primary series vaccination blood sample result. PPAS2 was subset of FAS2. FAS2: subset of randomized participants who received at least 1 dose of study vaccine at booster vaccination and had valid post-booster vaccination blood sample result. Here, n=number of participants with data collected for each specific serogroup.
    End point type
    Secondary
    End point timeframe
    Day 30 Post Doses 2 and 3 (4 MoA and 12 to 18 MoA)
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only participants randomized in Groups 1 and 2 were analyzed in this endpoint.
    End point values
    		 Group 1: MenACYW Group 2: Nimenrix
    Number of subjects analysed
    539
    568
    Units: Percentage of participants
    number (confidence interval 95%)
        PPAS1: Serogroup A: Day 30 post dose 2 (n=507,504)
    46.7 (42.3 to 51.2)
    60.9 (56.5 to 65.2)
        PPAS1: Serogroup C: Day 30 post dose 2 (n=508,514)
    97.4 (95.7 to 98.6)
    86.8 (83.5 to 89.6)
        PPAS1: Serogroup W: Day 30 post dose 2 (n=516,519)
    92.6 (90.0 to 94.7)
    88.4 (85.4 to 91.1)
        PPAS1: Serogroup Y: Day 30 post dose 2 (n=513,517)
    87.1 (83.9 to 89.9)
    81.4 (77.8 to 84.7)
        PPAS2: Serogroup A: Day 30 post dose 3 (n=525,553)
    88.6 (85.5 to 91.2)
    87.7 (84.7 to 90.3)
        PPAS2: Serogroup C: Day 30 post dose 3 (n=536,567)
    93.7 (91.2 to 95.6)
    88.9 (86.0 to 91.4)
        PPAS2: Serogroup W: Day 30 post dose 3 (n=531,560)
    92.3 (89.7 to 94.4)
    94.6 (92.4 to 96.4)
        PPAS2: Serogroup Y: Day 30 post dose 3 (n=539,568)
    89.4 (86.5 to 91.9)
    90.1 (87.4 to 92.5)
    No statistical analyses for this end point

    Secondary: Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse

    		 Close Top of page
    End point title
    		 Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse [7]
    End point description
    Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing hSBA. hSBA vaccine seroresponse was defined for a participant with a pre vaccination titer <1:8, post-vaccination titer must be >=1:16 and for a participant with a pre vaccination titer >=1:8, post-vaccination titer must be at least 4-fold greater than pre vaccination titer. Percentages are rounded off to tenth decimal place. PPAS1 was a subset of FAS1. PPAS2 was a subset of FAS2. Here, n=number of participants with data collected for each specific serogroup. ‘9999' denotes that there were no participants analyzed.
    End point type
    Secondary
    End point timeframe
    Group 3: Day 30 Post Dose 2 (4 MoA), Day 30 Post Dose 3 (12 to 18 MoA); Group 4: D30 Post Dose 3 (6 MoA), Day 30 Post Dose 4 (12 to 18 MoA)
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only participants randomized in Groups 3 and 4 were analyzed in this endpoint.
    End point values
    		 Group 3: MenACYW Group 4: MenACYW
    Number of subjects analysed
    94
    90
    Units: Percentage of participants
    number (confidence interval 95%)
        PPAS1: Serogroup A: Day 30 post dose 2 (n=89,0)
    51.7 (40.8 to 62.4)
    9999 (9999 to 9999)
        PPAS1: Serogroup A: Day 30 post dose 3 (n=0,87)
    9999 (9999 to 9999)
    65.5 (54.6 to 75.4)
        PPAS1: Serogroup C: Day 30 post dose 2 (n=93,0)
    92.5 (85.1 to 96.9)
    9999 (9999 to 9999)
        PPAS1: Serogroup C: Day 30 post dose 3 (n=0,90)
    9999 (9999 to 9999)
    96.7 (90.6 to 99.3)
        PPAS1: Serogroup W: Day 30 post dose 2 (n=94,0)
    94.7 (88.0 to 98.3)
    9999 (9999 to 9999)
        PPAS1: Serogroup W: Day 30 post dose 3 (n=0,90)
    9999 (9999 to 9999)
    95.6 (89.0 to 98.8)
        PPAS1: Serogroup Y: Day 30 post dose 2 (n=94,0)
    89.4 (81.3 to 94.8)
    9999 (9999 to 9999)
        PPAS1: Serogroup Y: Day 30 post dose 3 (n=0,90)
    9999 (9999 to 9999)
    94.4 (87.5 to 98.2)
        PPAS2: Serogroup A: Day 30 post dose 3 (n=90,0)
    77.8 (67.8 to 85.9)
    9999 (9999 to 9999)
        PPAS2: Serogroup A: Day 30 post dose 4 (n=0,88)
    9999 (9999 to 9999)
    63.6 (52.7 to 73.6)
        PPAS2: Serogroup C: Day 30 post dose 3 (n=93,0)
    97.8 (92.4 to 99.7)
    9999 (9999 to 9999)
        PPAS2: Serogroup C: Day 30 post dose 4 (n=0,86)
    9999 (9999 to 9999)
    95.3 (88.5 to 98.7)
        PPAS2: Serogroup W: Day 30 post dose 3 (n=86,0)
    97.7 (91.9 to 99.7)
    9999 (9999 to 9999)
        PPAS2: Serogroup W: Day 30 post dose 4 (n=0,86)
    9999 (9999 to 9999)
    89.5 (81.1 to 95.1)
        PPAS2: Serogroup Y: Day 30 post dose 3 (n=94,0)
    91.5 (83.9 to 96.3)
    9999 (9999 to 9999)
        PPAS2: Serogroup Y: Day 30 post dose 4 (n=0,89)
    9999 (9999 to 9999)
    80.9 (71.2 to 88.5)
    No statistical analyses for this end point

    Secondary: Geometric Mean Concentrations (GMCs) of Anti-Pertussis Antibodies

    		 Close Top of page
    End point title
    		 Geometric Mean Concentrations (GMCs) of Anti-Pertussis Antibodies
    End point description
    GMCs of anti-pertussis antibodies (pertussis toxin [PT], filamentous hemagglutinin [FHA]) were measured by electrochemiluminescent (ECL) assay. PPAS1 was a subset of FAS1. FAS1: subset of randomized participants who received at least 1 dose of study vaccine in primary series and had valid post-primary series vaccination blood sample result. PPAS2 was a subset of FAS2. FAS2: subset of randomized participants who received at least 1 dose of study vaccine at booster vaccination and had valid post-booster vaccination blood sample result. Here, n=number of participants with data collected for each specific serogroup. ‘9999' denotes that there were no participants analyzed. Dose=D.
    End point type
    Secondary
    End point timeframe
    Groups 1, 2 and 3: Day 0 before Dose 1 (2 MoA); Group 4: Day 0 before Dose 4 (12 to 18 MoA)
    End point values
    		 Group 1: MenACYW Group 2: Nimenrix Group 3: MenACYW Group 4: MenACYW
    Number of subjects analysed
    520
    521
    95
    90
    Units: Titer
    geometric mean (confidence interval 95%)
        PPAS1: Anti-PT: Day 0 before D1 (n=520,521,95,0)
    2.97 (2.68 to 3.29)
    2.61 (2.38 to 2.87)
    11.0 (8.74 to 14.0)
    9999 (9999 to 9999)
        PPAS1: Anti-FHA: Day 0 before D1 (n=520,521,95,0)
    10.8 (9.73 to 12.1)
    10.1 (9.10 to 11.2)
    55.6 (42.4 to 73.0)
    9999 (9999 to 9999)
        PPAS2: Anti-PT: Day 0 before D4 (n=0,0,0,90)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    10.7 (8.82 to 13.1)
        PPAS2: Anti-FHA: Day 0 before D4 (n=0,0,0,90)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    30.3 (25.0 to 36.7)
    No statistical analyses for this end point

    Secondary: Geometric Mean Concentrations of Hexavalent Vaccines

    		 Close Top of page
    End point title
    		 Geometric Mean Concentrations of Hexavalent Vaccines
    End point description
    GMCs of hexavalent vaccines were measured as:anti-diphtheria (AD),anti-tetanus (AT), anti-pertussis antibodies (PT, FHA) by ECL assay,anti-hepatitis antibodies (anti-Hepatitis B surface antigen [HBsAg]) by the commercially available VITROS ECi/ECiQ, anti-poliovirus(AP) types 1, 2, and 3 by neutralization assay and anti-Haemophilus influenzae type b (anti-polyribosylribitol phosphate [PRP]) by Farr-type radioimmunoassay (RIA). PPAS1: subset of FAS1. FAS1: subset of randomized participants who received at least 1 dose of study vaccine in primary series and had valid post-primary series vaccination blood sample result. PPAS2: subset of FAS2. FAS2: subset of randomized participants who received at least 1 dose of study vaccine at booster vaccination and had valid post-booster vaccination blood sample result. Here, n=number of participants with data collected for each specific serogroup. ‘9999':no participants analyzed. Dose=D.
    End point type
    Secondary
    End point timeframe
    Groups 1, 2 and 3: Day 30 Post Doses 2 and 3 (4 MoA and 12 to 18 MoA); Day 0 Before Dose 3 (12 to 18 MoA); Group 4: Day 30 Post Dose 4 (12 to 18 MoA)
    End point values
    		 Group 1: MenACYW Group 2: Nimenrix Group 3: MenACYW Group 4: MenACYW
    Number of subjects analysed
    555
    583
    96
    90
    Units: Titer
    geometric mean (confidence interval 95%)
        PPAS1: AD: Day 30 after D2 (n=514,520,93,0)
    0.523 (0.474 to 0.578)
    0.489 (0.443 to 0.541)
    0.563 (0.458 to 0.691)
    9999 (9999 to 9999)
        PPAS1: AT: Day 30 after D2 (n=514,520,93,0)
    1.10 (1.02 to 1.18)
    1.13 (1.05 to 1.22)
    0.931 (0.788 to 1.10)
    9999 (9999 to 9999)
        PPAS1: Anti-PT: Day 30 after D2 (n=514,520,93,0)
    64.9 (61.4 to 68.7)
    68.1 (64.5 to 72.0)
    50.0 (43.2 to 58.0)
    9999 (9999 to 9999)
        PPAS1: Anti-FHA: Day 30 after D2 (n=514,520,93,0)
    92.4 (87.3 to 97.8)
    96.6 (90.8 to 103)
    125 (109 to 144)
    9999 (9999 to 9999)
        PPAS1: Anti-HBsAg:Day30 after D2 (n=505,510,92,0)
    369 (323 to 421)
    345 (303 to 393)
    218 (147 to 322)
    9999 (9999 to 9999)
        PPAS1: AP 1: Day 30 after D2 (n=486,489,83,0)
    47.1 (40.1 to 55.3)
    43.5 (37.0 to 51.2)
    362 (260 to 504)
    9999 (9999 to 9999)
        PPAS1: AP 2: Day 30 after D2 (n=482,485,79,0)
    139 (117 to 167)
    143 (120 to 171)
    618 (429 to 890)
    9999 (9999 to 9999)
        PPAS1: AP 3: Day 30 after D2 (n=488,492,82,0)
    133 (112 to 157)
    145 (123 to 172)
    584 (419 to 814)
    9999 (9999 to 9999)
        PPAS1: Anti-PRP: Day 30 after D2 (n=517,521,96,0)
    0.376 (0.326 to 0.435)
    0.435 (0.379 to 0.499)
    0.725 (0.492 to 1.07)
    9999 (9999 to 9999)
        PPAS2: AD: Day 0 before D3 (n=542,569,91,0)
    0.086 (0.079 to 0.095)
    0.080 (0.073 to 0.087)
    0.094 (0.076 to 0.116)
    9999 (9999 to 9999)
        PPAS2: AD: Day 30 after D3 (n=551,577,92,0)
    1.82 (1.69 to 1.96)
    1.69 (1.57 to 1.81)
    2.71 (2.36 to 3.11)
    9999 (9999 to 9999)
        PPAS2: AD: Day 30 after D4 (n=0,0,0,89)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    3.26 (2.88 to 3.69)
        PPAS2: AT: Day 0 before D3 (n=542,571,92,0)
    0.362 (0.336 to 0.391)
    0.424 (0.397 to 0.453)
    0.218 (0.180 to 0.264)
    9999 (9999 to 9999)
        PPAS2: AT: Day 30 after D3 (n=551,577,92,0)
    6.71 (6.33 to 7.12)
    8.59 (8.13 to 9.08)
    6.02 (5.06 to 7.16)
    9999 (9999 to 9999)
        PPAS2: AT: Day 30 after D4 (n=0,0,0,89)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    7.00 (5.99 to 8.18)
        PPAS2: Anti-PT: Day 0 before D3 (n=542,571,92,0)
    14.8 (13.8 to 15.8)
    14.6 (13.7 to 15.6)
    10.4 (8.99 to 12.0)
    9999 (9999 to 9999)
        PPAS2: Anti-PT: Day 30 after D3 (n=551,577,92,0)
    111 (105 to 118)
    109 (104 to 115)
    79.2 (66.2 to 94.6)
    9999 (9999 to 9999)
        PPAS2: Anti-PT: Day 30 after D4 (n=0,0,0,89)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    80.9 (68.2 to 95.9)
        PPAS2: Anti-FHA: Day 0 before D3 (n=542,571,92,0)
    38.4 (35.8 to 41.2)
    38.1 (35.5 to 40.8)
    30.6 (26.0 to 36.0)
    9999 (9999 to 9999)
        PPAS2: Anti-FHA: Day 30 after D3 (n=551,577,92,0)
    177 (167 to 187)
    184 (173 to 195)
    168 (142 to 200)
    9999 (9999 to 9999)
        PPAS2: Anti-FHA: Day 30 after D4 (n=0,0,0,89)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    181 (151 to 217)
        PPAS2: Anti-HBsAg:Day0 before D3 (n=535,565,91,0)
    53.0 (45.5 to 61.8)
    48.8 (42.1 to 56.5)
    26.0 (17.6 to 38.2)
    9999 (9999 to 9999)
        PPAS2:Anti-HBsAg:Day30 after D3 (n=546,571,90,0)
    2273 (1927 to 2681)
    2158 (1852 to 2515)
    1117 (666 to 1872)
    9999 (9999 to 9999)
        PPAS2:Anti-HBsAg:Day30 after D4 (n=0,0,0,86)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    1144 (648 to 2020)
        PPAS2: AP 1: Day 0 before D3 (n=526,559,89,0)
    14.5 (12.7 to 16.5)
    13.6 (12.0 to 15.4)
    55.2 (40.8 to 74.6)
    9999 (9999 to 9999)
        PPAS2: AP 1: Day 30 after D3 (n=533,553,86,0)
    1099 (980 to 1233)
    994 (883 to 1119)
    1538 (1212 to 1952)
    9999 (9999 to 9999)
        PPAS2: AP 1: Day 30 after D4 (n=0,0,0,87)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    1625 (1291 to 2047)
        PPAS2: AP 2: Day 0 before D3 (n=528,560,88,0)
    33.2 (28.7 to 38.4)
    33.1 (28.8 to 37.9)
    85.3 (63.9 to 114)
    9999 (9999 to 9999)
        PPAS2: AP 2: Day 30 after D3 (n=530,554,87,0)
    2214 (1982 to 2472)
    2146 (1937 to 2379)
    3549 (2846 to 4425)
    9999 (9999 to 9999)
        PPAS2: AP 2: Day 30 after D4 (n=0,0,0,87)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    3858 (3001 to 4960)
        PPAS2: AP 3: Day 0 before D3 (n=529,560,89,0)
    19.7 (17.1 to 22.6)
    18.4 (16.0 to 21.1)
    37.7 (27.6 to 51.5)
    9999 (9999 to 9999)
        PPAS2: AP 3: Day 30 after D3 (n=531,557,87,0)
    1595 (1393 to 1827)
    1533 (1361 to 1728)
    2431 (1897 to 3115)
    9999 (9999 to 9999)
        PPAS2: AP 3: Day 30 after D4 (n=0,0,0,87)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    3397 (2567 to 4495)
        PPAS2: Anti-PRP: Day 0 before D3 (n=545,571,93,0)
    0.201 (0.176 to 0.230)
    0.224 (0.197 to 0.255)
    0.244 (0.174 to 0.343)
    9999 (9999 to 9999)
        PPAS2: Anti-PRP: Day 30 after D3 (n=555,583,91,0)
    9.42 (8.31 to 10.7)
    11.5 (10.3 to 12.9)
    16.1 (11.9 to 21.6)
    9999 (9999 to 9999)
        PPAS2: Anti-PRP: Day 30 after D4 (n=0,0,0,90)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    16.1 (12.1 to 21.6)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP)

    		 Close Top of page
    End point title
    		 Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP)
    End point description
    GMCs of AD, AT, AP types 1, 2, and 3, anti-haemophilus influenzae type b (anti-PRP) vaccines were measured as AD, AT by ECL assay, AP types 1, 2, and 3 by neutralization assay and anti-Haemophilus influenzae type b (anti-PRP) by Farr-type RIA. Response rate was defined as percentage of participants who achieved: AD and AT antibody concentrations >=0.01 international units (IU)/milliliter (mL), >=0.1 IU/mL and>=1.0 IU/mL; AP types 1, 2, and 3 antibody titers >=1:8; anti-PRP antibody concentrations >=0.15 microgram(mcg)/mL and >=1 mcg/mL. Percentages are rounded off to the tenth decimal place. PPAS1 was a subset of FAS1. PPAS2 was a subset of FAS2. Here, n=number of participants with data collected for each specific serogroup. ‘9999' denotes that there were no participants analyzed. Dose=D.
    End point type
    Secondary
    End point timeframe
    Groups 1, 2 and 3: Day 30 Post Doses 2 and 3 (4 MoA and 12 to 18 MoA); Day 0 Before Dose 3 (12 to 18 MoA); Group 4: Day 30 Post Dose 4 (12 to 18 MoA)
    End point values
    		 Group 1: MenACYW Group 2: Nimenrix Group 3: MenACYW Group 4: MenACYW
    Number of subjects analysed
    555
    583
    96
    90
    Units: Percentage of participants
    number (confidence interval 95%)
        PPAS1:AD:>=0.01IU/mL:Day30 post D2(n=514,520,93,0)
    100 (99.3 to 100)
    99.8 (98.9 to 100)
    100 (96.1 to 100)
    9999 (9999 to 9999)
        PPAS1:AD:>=0.1IU/mL:Day30 post D2(n=514,520,93,0)
    90.5 (87.6 to 92.9)
    89.6 (86.7 to 92.1)
    94.6 (87.9 to 98.2)
    9999 (9999 to 9999)
        PPAS1:AD:>=1.0IU/mL:Day30 post D2(n=514,520,93,0)
    32.7 (28.6 to 36.9)
    32.5 (28.5 to 36.7)
    33.3 (23.9 to 43.9)
    9999 (9999 to 9999)
        PPAS1:AT:>=0.01IU/mL:Day30 post D2(n=514,520,93,0)
    100 (99.3 to 100)
    100 (99.3 to 100)
    100 (96.1 to 100)
    9999 (9999 to 9999)
        PPAS1:AT:>=0.1IU/mL:Day30 post D2(n=514,520,93,0)
    100 (99.3 to 100)
    99.8 (98.9 to 100)
    100 (96.1 to 100)
    9999 (9999 to 9999)
        PPAS1:AT:>=1.0IU/mL:Day30 post D2(n=514,520,93,0)
    53.3 (48.9 to 57.7)
    56.3 (52.0 to 60.7)
    44.1 (33.8 to 54.8)
    9999 (9999 to 9999)
        PPAS1:AP 1:>=1:8:Day30 post D2(n=486,489,83,0)
    87.0 (83.7 to 89.9)
    83.2 (79.6 to 86.4)
    98.8 (93.5 to 100)
    9999 (9999 to 9999)
        PPAS1:AP 2:>=1:8:Day30 post D2(n=482,485,79,0)
    97.5 (95.7 to 98.7)
    98.6 (97.0 to 99.4)
    100 (95.4 to 100)
    9999 (9999 to 9999)
        PPAS1:AP 3:>=1:8:Day30 post D2(n=488,492,82,0)
    95.9 (93.7 to 97.5)
    96.1 (94.0 to 97.7)
    98.8 (93.4 to 100)
    9999 (9999 to 9999)
        PPAS1:Anti-PRP:>=0.15:Day30 postD2(n=517,521,96,0)
    71.8 (67.7 to 75.6)
    74.9 (70.9 to 78.5)
    78.1 (68.5 to 85.9)
    9999 (9999 to 9999)
        PPAS1:Anti-PRP:>=1:Day30 postD2(n=517,521,96,0)
    24.2 (20.5 to 28.1)
    27.3 (23.5 to 31.3)
    39.6 (29.7 to 50.1)
    9999 (9999 to 9999)
        PPAS2:AD:>=0.01IU/mL:Day0 beforeD3(n=542,569,91,0)
    98.2 (96.6 to 99.1)
    98.6 (97.2 to 99.4)
    97.8 (92.3 to 99.7)
    9999 (9999 to 9999)
        PPAS2:AD:>=0.01IU/mL:Day30 afterD3(n=551,577,92,0)
    100 (99.3 to 100)
    100 (99.4 to 100)
    100 (96.1 to 100)
    9999 (9999 to 9999)
        PPAS2:AD:>=0.01IU/mL:Day30 afterD4(n=0,0,0,89)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    100 (95.9 to 100)
        PPAS2:AD:>=0.1IU/mL:Day0 beforeD3(n=542,569,91,0)
    48.2 (43.9 to 52.5)
    41.3 (37.2 to 45.5)
    47.3 (36.7 to 58.0)
    9999 (9999 to 9999)
        PPAS2:AD:>=0.1IU/mL:Day30 afterD3(n=551,577,92,0)
    99.6 (98.7 to 100)
    99.8 (99.0 to 100)
    100 (96.1 to 100)
    9999 (9999 to 9999)
        PPAS2:AD:>=0.1IU/mL:Day30 afterD4(n=0,0,0,89)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    100 (95.9 to 100)
        PPAS2:AD:>=1.0IU/mL:Day0 beforeD3(n=542,569,91,0)
    1.1 (0.4 to 2.4)
    0.7 (0.2 to 1.8)
    0 (0 to 4.0)
    9999 (9999 to 9999)
        PPAS2:AD:>=1.0IU/mL:Day30 afterD3(n=551,577,92,0)
    75.5 (71.7 to 79.0)
    72.4 (68.6 to 76.1)
    92.4 (84.9 to 96.9)
    9999 (9999 to 9999)
        PPAS2:AD:>=1.0IU/mL:Day30 afterD4(n=0,0,0,89)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    100 (95.9 to 100)
        PPAS2:AT:>=0.01IU/mL:Day0 beforeD3(n=542,571,92,0)
    100 (99.3 to 100)
    100 (99.4 to 100)
    100 (96.1 to 100)
    9999 (9999 to 9999)
        PPAS2:AT:>=0.01IU/mL:Day30 afterD3(n=551,577,92,0)
    100 (99.3 to 100)
    100 (99.4 to 100)
    100 (96.1 to 100)
    9999 (9999 to 9999)
        PPAS2:AT:>=0.01IU/mL:Day30 afterD4(n=0,0,0,89)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    100 (95.9 to 100)
        PPAS2:AT:>=0.1IU/mL:Day0 beforeD3(n=542,571,92,0)
    94.1 (91.8 to 95.9)
    97.4 (95.7 to 98.5)
    83.7 (74.5 to 90.6)
    9999 (9999 to 9999)
        PPAS2:AT:>=0.1IU/mL:Day30 afterD3(n=551,577,92,0)
    100 (99.3 to 100)
    100 (99.4 to 100)
    100 (96.1 to 100)
    9999 (9999 to 9999)
        PPAS2:AT:>=0.1IU/mL:Day30 afterD4(n=0,0,0,89)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    100 (95.9 to 100)
        PPAS2:AT:>=1.0IU/mL:Day0 beforeD3(n=542,571,92,0)
    10.7 (8.2 to 13.6)
    14.7 (11.9 to 17.9)
    6.5 (2.4 to 13.7)
    9999 (9999 to 9999)
        PPAS2:AT:>=1.0IU/mL:Day30 afterD3(n=551,577,92,0)
    99.6 (98.7 to 100)
    99.7 (98.8 to 100)
    96.7 (90.8 to 99.3)
    9999 (9999 to 9999)
        PPAS2:AT:>=1.0IU/mL:Day30 afterD4(n=0,0,0,89)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    98.9 (93.9 to 100)
        PPAS2:AP 1:>=1:8:Day0 before D3(n=526,559,89,0)
    64.4 (60.2 to 68.5)
    63.7 (59.5 to 67.7)
    93.3 (85.9 to 97.5)
    9999 (9999 to 9999)
        PPAS2:AP 1:>=1:8:Day30 after D3(n=533,553,86,0)
    99.8 (99.0 to 100)
    98.9 (97.7 to 99.6)
    100 (95.8 to 100)
    9999 (9999 to 9999)
        PPAS2:AP 1:>=1:8:Day30 after D4(n=0,0,0,87)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    100 (95.8 to 100)
        PPAS2:AP 2:>=1:8:Day0 before D3(n=528,560,88,0)
    79.5 (75.8 to 82.9)
    80.9 (77.4 to 84.1)
    95.5 (88.8 to 98.7)
    9999 (9999 to 9999)
        PPAS2:AP 2:>=1:8:Day30 after D3(n=530,554,87,0)
    100 (99.3 to 100)
    100 (99.3 to 100)
    100 (95.8 to 100)
    9999 (9999 to 9999)
        PPAS2:AP 2:>=1:8:Day30 after D4(n=0,0,0,87)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    100 (95.8 to 100)
        PPAS2:AP 3:>=1:8:Day0 before D3(n=529,560,89,0)
    68.6 (64.5 to 72.6)
    65.7 (61.6 to 69.6)
    84.3 (75.0 to 91.1)
    9999 (9999 to 9999)
        PPAS2:AP 3:>=1:8:Day30 after D3(n=531,557,87,0)
    99.2 (98.1 to 99.8)
    99.8 (99.0 to 100)
    100 (95.8 to 100)
    9999 (9999 to 9999)
        PPAS2:AP 3:>=1:8:Day30 after D4(n=0,0,0,87)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    100 (95.8 to 100)
        PPAS2:Anti-PRP:>=0.15:Day0beforeD3(n=545,571,93,0)
    56.5 (52.2 to 60.7)
    60.4 (56.3 to 64.5)
    60.2 (49.5 to 70.2)
    9999 (9999 to 9999)
        PPAS2:Anti-PRP:>=0.15:Day30afterD3(n=555,583,91,0)
    98.2 (96.7 to 99.1)
    98.8 (97.5 to 99.5)
    100 (96.0 to 100)
    9999 (9999 to 9999)
        PPAS2:Anti-PRP:>=0.15:Day30afterD4(n=0,0,0,90)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    100 (96.0 to 100)
        PPAS2:Anti-PRP:>=1:Day0beforeD3(n=545,571,93,0)
    13.9 (11.1 to 17.1)
    14.9 (12.1 to 18.1)
    15.1 (8.5 to 24.0)
    9999 (9999 to 9999)
        PPAS2:Anti-PRP:>=1:Day30afterD3(n=555,583,91,0)
    91.5 (88.9 to 93.7)
    94.9 (92.7 to 96.5)
    97.8 (92.3 to 99.7)
    9999 (9999 to 9999)
        PPAS2:Anti-PRP:>=1:Day30afterD4(n=0,0,0,90)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    96.7 (90.6 to 99.3)
    No statistical analyses for this end point

    Secondary: Percentage of Participants who Achieved Vaccine Seroresponse for Anti-Pertussis Antibodies

    		 Close Top of page
    End point title
    		 Percentage of Participants who Achieved Vaccine Seroresponse for Anti-Pertussis Antibodies
    End point description
    GMCs of anti-pertussis antibodies (PT, FHA) were measured by ECL assay. Pertussis vaccine seroresponse was defined as: For groups 1, 2, and 3, 30 days after dose 2 in infancy as if pre-primary vaccination concentration is <4 × lower limit of quantification (LLOQ), post-primary vaccination concentration >=4 × LLOQ, if pre-primary vaccination concentration is >=4 ×LLOQ, post-primary vaccination concentration >=pre-primary vaccination concentration; for Groups 1, 2, and 3, before and 30 days after dose 3 and for group 4, before and 30 days after dose 4 as if pre-booster vaccination concentration is <4 × LLOQ, post-booster vaccination concentration >=4 × pre-booster concentration, if pre-booster vaccination concentration is >=4 × LLOQ, post-booster vaccination concentration >=2 × pre-booster concentration. Percentages are rounded off to tenth decimal place. PPAS1 and PPAS2. n=number of participants with data collected for each specific serogroup. ‘9999': no participants analyzed. Dose=D.
    End point type
    Secondary
    End point timeframe
    Groups 1, 2 and 3: Day 30 Post Doses 2 and 3 (4 MoA and 12 to 18 MoA); Group 4: Day 30 Post Dose 4 (12 to 18 MoA)
    End point values
    		 Group 1: MenACYW Group 2: Nimenrix Group 3: MenACYW Group 4: MenACYW
    Number of subjects analysed
    533
    565
    92
    89
    Units: Percentage of participants
    number (confidence interval 95%)
        PPAS1: Anti-PT: Day 30 post D2 (n=512,518,92,0)
    94.5 (92.2 to 96.3)
    97.9 (96.2 to 98.9)
    82.6 (73.3 to 89.7)
    9999 (9999 to 9999)
        PPAS1: Anti-FHA: Day 30 post D2 (n=512,518,92,0)
    89.6 (86.7 to 92.1)
    91.5 (88.8 to 93.8)
    62.0 (51.2 to 71.9)
    9999 (9999 to 9999)
        PPAS2: Anti-PT: Day 30 post D3 (n=533,565,90,0)
    97.0 (95.2 to 98.3)
    97.0 (95.2 to 98.2)
    93.3 (86.1 to 97.5)
    9999 (9999 to 9999)
        PPAS2: Anti-PT: Day 30 post D4 (n=0,0,0,89)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    88.8 (80.3 to 94.5)
        PPAS2: Anti-FHA: Day 30 post D3 (n=533,565,90,0)
    89.1 (86.2 to 91.6)
    90.1 (87.3 to 92.4)
    92.2 (84.6 to 96.8)
    9999 (9999 to 9999)
        PPAS2: Anti-FHA: Day 30 post D4 (n=0,0,0,89)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    91.0 (83.1 to 96.0)
    No statistical analyses for this end point

    Secondary: Percentage of Participants who Achieved Anti-Hepatitis B Antibody Concentrations >=10 and >=100 Milli-International Units (mIU)/mL

    		 Close Top of page
    End point title
    		 Percentage of Participants who Achieved Anti-Hepatitis B Antibody Concentrations >=10 and >=100 Milli-International Units (mIU)/mL
    End point description
    GMCs of anti-hepatitis antibodies (anti-HBsAg) was measured by the commercially available VITROS ECi/ECiQ. Response rate for anti-HBsAg was defined as percentage of participants who achieved anti-HBsAg antibody concentrations >=10 mIU/mL and >=100 mIU/mL. Percentages are rounded off to the tenth decimal place. PPAS1 was a subset of FAS1. FAS1: subset of randomized participants who received at least 1 dose of study vaccine in primary series and hadvalid post-primary series vaccination blood sample result. PPAS2 was a subset of FAS2. FAS2: subset of randomized participants who received at least 1 dose of study vaccine at booster vaccination and had valid post-booster vaccination blood sample result. Here, n=number of participants with data collected for each specific serogroup. ‘9999' denotes that there were no participants analyzed. Dose=D.
    End point type
    Secondary
    End point timeframe
    Groups 1, 2 and 3: Day 30 Post Doses 2 and 3 (4 MoA and 12 to 18 MoA); Day 0 Before Dose 3 (12 to 18 MoA); Group 4: Day 30 Post Dose 4 (12 to 18 MoA)
    End point values
    		 Group 1: MenACYW Group 2: Nimenrix Group 3: MenACYW Group 4: MenACYW
    Number of subjects analysed
    546
    571
    92
    90
    Units: Percentage of participants
    number (confidence interval 95%)
        PPAS1:Anti-HBsAg:>=10:Day30postD2(n=505,510,92,0)
    96.4 (94.4 to 97.9)
    97.8 (96.2 to 98.9)
    92.4 (84.9 to 96.9)
    9999 (9999 to 9999)
        PPAS1:Anti-HBsAg:>=100:Day30postD2(n=505,510,92,0)
    85.7 (82.4 to 88.7)
    81.8 (78.1 to 85.0)
    72.8 (62.6 to 81.6)
    9999 (9999 to 9999)
        PPAS2:Anti-HBsAg:>=10:Day0beforeD3(n=535,565,91,0)
    81.5 (77.9 to 84.7)
    79.5 (75.9 to 82.7)
    65.9 (55.3 to 75.5)
    9999 (9999 to 9999)
        PPAS2:Anti-HBsAg:>=10:Day30afterD3(n=546,571,90,0)
    98.0 (96.4 to 99.0)
    98.6 (97.3 to 99.4)
    94.4 (87.5 to 98.2)
    9999 (9999 to 9999)
        PPAS2:Anti-HBsAg:>=10:Day0beforeD4(n=0,0,0,90)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    64.4 (53.7 to 74.3)
        PPAS2:Anti-HBsAg:>=10:Day30afterD4(n=0,0,0,86)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    91.9 (83.9 to 96.7)
        PPAS2:AntiHBsAg:>=100:Day0beforeD3(n=535,565,91,0)
    38.7 (34.5 to 43.0)
    35.4 (31.5 to 39.5)
    26.4 (17.7 to 36.7)
    9999 (9999 to 9999)
        PPAS2:AntiHBsAg:>=100:Day30afterD3(n=546,571.90,1)
    93.4 (91.0 to 95.3)
    93.5 (91.2 to 95.4)
    80.0 (70.2 to 87.7)
    9999 (9999 to 9999)
        PPAS2:AntiHBsAg:>=100: Day0beforeD 4(n=0,0,0,90)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    27.8 (18.9 to 38.2)
        PPAS2:AntiHBsAg:>=100:Day30afterD4(n=0,0,0,86)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    83.7 (74.2 to 90.8)
    No statistical analyses for this end point

    Secondary: Groups 1 and 2: Geometric Mean Concentrations of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) Vaccine

    		 Close Top of page
    End point title
    		 Groups 1 and 2: Geometric Mean Concentrations of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) Vaccine [8]
    End point description
    GMCs of anti-pneumococcal antibodies was assessed by pneumococcal capsular polysaccharide (PnPS) Immunoglobulin G (IgG) ECL assay which was used to quantitate the amount of anti-streptococcus pneumoniae PS (serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F) antibodies in human serum. PPAS1 was a subset of FAS1. FAS1: subset of randomized participants who received at least 1 dose of study vaccine in primary series and hadvalid post-primary series vaccination blood sample result. PPAS2 was a subset of FAS2. FAS2: subset of randomized participants who received at least 1 dose of study vaccine at booster vaccination and had valid post-booster vaccination blood sample result. Here, n=number of participants with data collected for each specific serogroup.
    End point type
    Secondary
    End point timeframe
    At 30 days post Dose 2 (4 MoA) and Dose 3 (12 to 18 MoA)
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only participants randomized in Groups 1 and 2 were analyzed in this endpoint.
    End point values
    		 Group 1: MenACYW Group 2: Nimenrix
    Number of subjects analysed
    545
    569
    Units: Titer
    geometric mean (confidence interval 95%)
        PPAS1: Serogroup 1 (n=505, 512)
    1.68 (1.52 to 1.84)
    1.71 (1.56 to 1.87)
        PPAS1: Serogroup 4 (n=505, 512)
    1.97 (1.83 to 2.12)
    2.06 (1.91 to 2.23)
        PPAS1: Serogroup 5 (n=505, 512)
    1.08 (0.991 to 1.17)
    1.10 (1.01 to 1.19)
        PPAS1: Serogroup 6B (n=505, 511)
    0.600 (0.534 to 0.675)
    0.660 (0.586 to 0.742)
        PPAS1: Serogroup 7F (n=505, 512)
    2.03 (1.89 to 2.17)
    2.20 (2.05 to 2.37)
        PPAS1: Serogroup 9V (n=504, 512)
    1.67 (1.54 to 1.81)
    1.81 (1.67 to 1.96)
        PPAS1: Serogroup 14 (n=505, 512)
    5.92 (5.41 to 6.48)
    5.97 (5.44 to 6.55)
        PPAS1: Serogroup 18C (n=505, 512)
    0.680 (0.618 to 0.748)
    0.796 (0.722 to 0.879)
        PPAS1: Serogroup 19F (n=505, 512)
    1.59 (1.39 to 1.82)
    1.45 (1.26 to 1.66)
        PPAS1: Serogroup 23F (n=505, 512)
    0.830 (0.746 to 0.924)
    0.869 (0.785 to 0.961)
        PPAS2: Serogroup 1 (n=545, 569)
    4.71 (4.32 to 5.13)
    4.54 (4.18 to 4.94)
        PPAS2: Serogroup 4 (n=545, 569)
    3.61 (3.37 to 3.86)
    3.19 (2.99 to 3.41)
        PPAS2: Serogroup 5 (n=544, 569)
    2.21 (2.05 to 2.39)
    2.05 (1.90 to 2.20)
        PPAS2: Serogroup 6B (n=545, 569)
    4.21 (3.89 to 4.55)
    4.36 (4.04 to 4.71)
        PPAS2: Serogroup 7F (n=545, 568)
    2.91 (2.73 to 3.10)
    2.89 (2.70 to 3.10)
        PPAS2: Serogroup 9V (n=545, 569)
    4.08 (3.80 to 4.38)
    4.17 (3.89 to 4.47)
        PPAS2: Serogroup 14 (n=544, 568)
    9.07 (8.44 to 9.75)
    7.89 (7.25 to 8.59)
        PPAS2: Serogroup 18C (n=545, 569)
    2.12 (1.99 to 2.26)
    2.17 (2.03 to 2.33)
        PPAS2: Serogroup 19F (n=545, 569)
    9.03 (8.32 to 9.81)
    8.41 (7.76 to 9.12)
        PPAS2: Serogroup 23F (n=545, 569)
    2.24 (2.10 to 2.40)
    2.04 (1.90 to 2.18)
    No statistical analyses for this end point

    Secondary: Groups 3 and 4: Geometric Mean Concentrations of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) Vaccine

    		 Close Top of page
    End point title
    		 Groups 3 and 4: Geometric Mean Concentrations of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) Vaccine [9]
    End point description
    GMCs of anti-pneumococcal antibodies was assessed by PnPS IgG ECL assay which was used to quantitate the amount of anti-streptococcus pneumoniae PS (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) antibodies in human serum. PPAS1 was a subset of FAS1. FAS1: subset of randomized participants who received at least 1 dose of study vaccine in primary series and hadvalid post-primary series vaccination blood sample result. PPAS2 was a subset of FAS2. FAS2: subset of randomized participants who received at least 1 dose of study vaccine at booster vaccination and had valid post-booster vaccination blood sample result. Here, n=number of participants with data collected for each specific serogroup. ‘9999' denotes that there were no participants analyzed.
    End point type
    Secondary
    End point timeframe
    Group 3: At 30 days post Dose 2 (4 MoA) and Dose 3 (12 to 18 MoA); Group 4: At 30 days post Dose 4 (12 to 18 MoA)
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only participants randomized in Groups 3 and 4 were analyzed in this endpoint.
    End point values
    		 Group 3: MenACYW Group 4: MenACYW
    Number of subjects analysed
    91
    89
    Units: Titer
    geometric mean (confidence interval 95%)
        PPAS1: Serogroup 1: 30 days post dose 2(n=89, 0)
    1.47 (1.16 to 1.87)
    9999 (9999 to 9999)
        PPAS1: Serogroup 3: 30 days post dose 2(n=89,0)
    0.658 (0.554 to 0.781)
    9999 (9999 to 9999)
        PPAS1: Serogroup 4: 30 days post dose 2(n=89,0)
    1.73 (1.42 to 2.12)
    9999 (9999 to 9999)
        PPAS1: Serogroup 5: 30 days post dose 2(n=89,0)
    0.803 (0.617 to 1.04)
    9999 (9999 to 9999)
        PPAS1: Serogroup 6A: 30 days post dose 2(n=89,0)
    1.65 (1.24 to 2.19)
    9999 (9999 to 9999)
        PPAS1: Serogroup 6B: 30 days post dose 2(n=89,0)
    0.275 (0.205 to 0.368)
    9999 (9999 to 9999)
        PPAS1: Serogroup 7F: 30 days post dose 2(n=89,0)
    3.04 (2.59 to 3.57)
    9999 (9999 to 9999)
        PPAS1: Serogroup 9V: 30 days post dose 2(n=89,0)
    1.25 (0.987 to 1.59)
    9999 (9999 to 9999)
        PPAS1: Serogroup 14: 30 days post dose 2(n=89,0)
    5.88 (4.31 to 8.01)
    9999 (9999 to 9999)
        PPAS1: Serogroup 18C: 30 days post dose 2(n=89,0)
    1.65 (1.30 to 2.10)
    9999 (9999 to 9999)
        PPAS1: Serogroup 19A: 30 days post dose 2(n=89,0)
    2.17 (1.67 to 2.80)
    9999 (9999 to 9999)
        PPAS1: Serogroup 19F: 30 days post dose 2(n=89,0)
    5.73 (4.64 to 7.08)
    9999 (9999 to 9999)
        PPAS1: Serogroup 23F: 30 days post dose 2(n=89,0)
    0.722 (0.552 to 0.945)
    9999 (9999 to 9999)
        PPAS2: Serogroup 1: 30 days post dose 3(n=91,0)
    5.32 (4.41 to 6.42)
    9999 (9999 to 9999)
        PPAS2: Serogroup 1: 30 days post dose 4(n=0,89)
    9999 (9999 to 9999)
    5.47 (4.66 to 6.42)
        PPAS2: Serogroup 3: 30 days post dose 3(n=91,0)
    1.13 (0.945 to 1.35)
    9999 (9999 to 9999)
        PPAS2: Serogroup 3: 30 days post dose 4(n=0,89)
    9999 (9999 to 9999)
    1.21 (0.982 to 1.50)
        PPAS2: Serogroup 4: 30 days post dose 3(n=91,0)
    3.99 (3.43 to 4.64)
    9999 (9999 to 9999)
        PPAS2: Serogroup 4: 30 days post dose 4(n=0,89)
    9999 (9999 to 9999)
    3.97 (3.35 to 4.70)
        PPAS2: Serogroup 5: 30 days post dose 3(n=91,0)
    3.33 (2.75 to 4.03)
    9999 (9999 to 9999)
        PPAS2: Serogroup 5: 30 days post dose 4(n=0,89)
    9999 (9999 to 9999)
    3.95 (3.36 to 4.65)
        PPAS2: Serogroup 6A: 30 days post dose 3(n=91,0)
    12.9 (10.9 to 15.4)
    9999 (9999 to 9999)
        PPAS2: Serogroup 6A: 30 days post dose 4(n=0,89)
    9999 (9999 to 9999)
    14.3 (12.2 to 16.8)
        PPAS2: Serogroup 6B: 30 days post dose 3(n=91,0)
    7.01 (5.38 to 9.13)
    9999 (9999 to 9999)
        PPAS2: Serogroup 6B: 30 days post dose 4(n=0,89)
    9999 (9999 to 9999)
    9.41 (7.86 to 11.3)
        PPAS2: Serogroup 7F: 30 days post dose 3(n=91,0)
    5.36 (4.56 to 6.29)
    9999 (9999 to 9999)
        PPAS2: Serogroup 7F: 30 days post dose 4(n=0,89)
    9999 (9999 to 9999)
    4.92 (4.20 to 5.76)
        PPAS2: Serogroup 9V: 30 days post dose 3(n=91,0)
    5.12 (4.26 to 6.17)
    9999 (9999 to 9999)
        PPAS2: Serogroup 9V: 30 days post dose 4(n=0,89)
    9999 (9999 to 9999)
    5.40 (4.65 to 6.26)
        PPAS2: Serogroup 14: 30 days post dose 3(n=91,0)
    14.8 (12.2 to 18.1)
    9999 (9999 to 9999)
        PPAS2: Serogroup 14: 30 days post dose 4(n=0,89)
    9999 (9999 to 9999)
    14.7 (12.1 to 17.9)
        PPAS2: Serogroup 18C: 30 days post dose 3(n=91,0)
    3.18 (2.70 to 3.76)
    9999 (9999 to 9999)
        PPAS2: Serogroup 18C: 30 days post dose 4(n=0,89)
    9999 (9999 to 9999)
    3.48 (3.00 to 4.03)
        PPAS2: Serogroup 19A: 30 days post dose 3(n=91,0)
    8.82 (7.25 to 10.7)
    9999 (9999 to 9999)
        PPAS2: Serogroup 19A: 30 days post dose 4(n=0,89)
    9999 (9999 to 9999)
    10.9 (9.26 to 12.9)
        PPAS2: Serogroup 19F: 30 days post dose 3(n=91,0)
    12.1 (9.91 to 14.7)
    9999 (9999 to 9999)
        PPAS2: Serogroup 19F: 30 days post dose 4(n=0,89)
    9999 (9999 to 9999)
    12.2 (10.5 to 14.2)
        PPAS2: Serogroup 23F: 30 days post dose 3(n=91,0)
    3.70 (3.01 to 4.55)
    9999 (9999 to 9999)
        PPAS2: Serogroup 23F: 30 days post dose 4(n=0,89)
    9999 (9999 to 9999)
    4.06 (3.45 to 4.76)
    No statistical analyses for this end point

    Secondary: Groups 1 and 2: Percentage of Participants with Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) Vaccine

    		 Close Top of page
    End point title
    		 Groups 1 and 2: Percentage of Participants with Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) Vaccine [10]
    End point description
    GMCs of anti-pneumococcal antibodies was assessed by PnPS IgG ECL assay which was used to quantitate the amount of anti-streptococcus pneumoniae PS (serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F) antibodies in human serum. Percentages are rounded off to the tenth decimal place. PPAS1 was a subset of FAS1. FAS1: subset of randomized participants who received at least 1 dose of study vaccine in primary series and hadvalid post-primary series vaccination blood sample result. PPAS2 was a subset of FAS2. FAS2: subset of randomized participants who received at least 1 dose of study vaccine at booster vaccination and had valid post-booster vaccination blood sample result. Here, n=number of participants with data collected for each specific serogroup.
    End point type
    Secondary
    End point timeframe
    At 30 days post Dose 2 (4 MoA) and Dose 3 (12 to 18 MoA)
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only participants randomized in Groups 1 and 2 were analyzed in this endpoint.
    End point values
    		 Group 1: MenACYW Group 2: Nimenrix
    Number of subjects analysed
    545
    569
    Units: Percentage of participants
    number (confidence interval 95%)
        PPAS1: Serogroup 1 (n=505, 512)
    92.7 (90.0 to 94.8)
    93.6 (91.1 to 95.5)
        PPAS1: Serogroup 4 (n=505, 512)
    96.8 (94.9 to 98.2)
    96.7 (94.7 to 98.1)
        PPAS1: Serogroup 5 (n=505, 512)
    88.5 (85.4 to 91.2)
    90.6 (87.8 to 93.0)
        PPAS1: Serogroup 6B (n=505, 511)
    67.1 (62.8 to 71.2)
    69.9 (65.7 to 73.8)
        PPAS1: Serogroup 7F (n=505, 512)
    98.8 (97.4 to 99.6)
    98.2 (96.7 to 99.2)
        PPAS1: Serogroup 9V (n=504, 512)
    94.6 (92.3 to 96.4)
    95.1 (92.9 to 96.8)
        PPAS1: Serogroup 14 (n=505, 512)
    97.8 (96.1 to 98.9)
    98.2 (96.7 to 99.2)
        PPAS1: Serogroup 18C (n=505, 512)
    72.5 (68.4 to 76.3)
    77.3 (73.5 to 80.9)
        PPAS1: Serogroup 19F (n=505, 512)
    82.2 (78.6 to 85.4)
    79.3 (75.5 to 82.7)
        PPAS1: Serogroup 23F (n=505, 512)
    77.8 (73.9 to 81.4)
    80.3 (76.6 to 83.6)
        PPAS2: Serogroup 1 (n=545, 569)
    99.8 (99.0 to 100)
    99.8 (99.0 to 100)
        PPAS2: Serogroup 4 (n=545, 569)
    99.8 (99.0 to 100)
    99.6 (98.7 to 100)
        PPAS2: Serogroup 5 (n=544, 569)
    98.2 (96.6 to 99.1)
    97.7 (96.1 to 98.8)
        PPAS2: Serogroup 6B (n=545, 569)
    98.9 (97.6 to 99.6)
    99.5 (98.5 to 99.9)
        PPAS2: Serogroup 7F (n=545, 568)
    99.6 (98.7 to 100)
    99.3 (98.2 to 99.8)
        PPAS2: Serogroup 9V (n=545, 569)
    99.8 (99.0 to 100)
    99.8 (99.0 to 100)
        PPAS2: Serogroup 14 (n=544, 568)
    100 (99.3 to 100)
    99.3 (98.2 to 99.8)
        PPAS2: Serogroup 18C (n=545, 569)
    99.1 (97.9 to 99.7)
    98.6 (97.2 to 99.4)
        PPAS2: Serogroup 19F (n=545, 569)
    99.3 (98.1 to 99.8)
    99.3 (98.2 to 99.8)
        PPAS2: Serogroup 23F (n=545, 569)
    98.5 (97.1 to 99.4)
    97.2 (95.5 to 98.4)
    No statistical analyses for this end point

    Secondary: Groups 3 and 4: Percentage of Participants with Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) Vaccine

    		 Close Top of page
    End point title
    		 Groups 3 and 4: Percentage of Participants with Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) Vaccine [11]
    End point description
    GMCs of anti-pneumococcal antibodies was assessed by PnPS IgG ECL assay which was used to quantitate the amount of anti-streptococcus pneumoniae PS (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) antibodies in human serum. Percentages are rounded off to the tenth decimal place. PPAS1 was a subset of FAS1. FAS1: subset of randomized participants who received at least 1 dose of study vaccine in primary series and hadvalid post-primary series vaccination blood sample result. PPAS2 was a subset of FAS2. FAS2: subset of randomized participants who received at least 1 dose of study vaccine at booster vaccination and had valid post-booster vaccination blood sample result. Here, n=number of participants with data collected for each specific serogroup. ‘9999' denotes that there were no participants analyzed. Dose=D.
    End point type
    Secondary
    End point timeframe
    Group 3: At 30 days post Dose 2 (4 MoA) and Dose 3 (12 to 18 MoA); Group 4: At 30 days post Dose 4 (12 to 18 MoA)
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only participants randomized in Groups 3 and 4 were analyzed in this endpoint.
    End point values
    		 Group 3: MenACYW Group 4: MenACYW
    Number of subjects analysed
    91
    89
    Units: Percentage of participants
    number (confidence interval 95%)
        PPAS1: Serogroup 1: 30 days post D2 (n=89,0)
    89.9 (81.7 to 95.3)
    9999 (9999 to 9999)
        PPAS1: Serogroup 3: 30 days post D2 (n=89,0)
    82.0 (72.5 to 89.4)
    9999 (9999 to 9999)
        PPAS1: Serogroup 4: 30 days post D2 (n=89,0)
    96.6 (90.5 to 99.3)
    9999 (9999 to 9999)
        PPAS1: Serogroup 5: 30 days post D2 (n=89,0)
    76.4 (66.2 to 84.8)
    9999 (9999 to 9999)
        PPAS1: Serogroup 6A: 30 days post D2 (n=89,0)
    88.8 (80.3 to 94.5)
    9999 (9999 to 9999)
        PPAS1: Serogroup 6B: 30 days post D2 (n=89,0)
    40.4 (30.2 to 51.4)
    9999 (9999 to 9999)
        PPAS1: Serogroup 7F: 30 days post D2 (n=89,0)
    97.8 (92.1 to 99.7)
    9999 (9999 to 9999)
        PPAS1: Serogroup 9V: 30 days post D2 (n=89,0)
    88.8 (80.3 to 94.5)
    9999 (9999 to 9999)
        PPAS1: Serogroup 14: 30 days post D2 (n=89,0)
    96.6 (90.5 to 99.3)
    9999 (9999 to 9999)
        PPAS1: Serogroup 18C: 30 days post D2 (n=89,0)
    91.0 (83.1 to 96.0)
    9999 (9999 to 9999)
        PPAS1: Serogroup 19A: 30 days post D2 (n=89,0)
    93.3 (85.9 to 97.5)
    9999 (9999 to 9999)
        PPAS1: Serogroup 19F: 30 days post D2 (n=89,0)
    98.9 (93.9 to 100)
    9999 (9999 to 9999)
        PPAS1: Serogroup 23F: 30 days post D2 (n=89,0)
    71.9 (61.4 to 80.9)
    9999 (9999 to 9999)
        PPAS2: Serogroup 1: 30 days post D3 (n=91,0)
    100 (96.0 to 100)
    9999 (9999 to 9999)
        PPAS2: Serogroup 1: 30 days post D4 (n=0,89)
    9999 (9999 to 9999)
    100 (95.9 to 100)
        PPAS2: Serogroup 3: 30 days post D3 (n=91,0)
    97.8 (92.3 to 99.7)
    9999 (9999 to 9999)
        PPAS2: Serogroup 3: 30 days post D4 (n=0,89)
    9999 (9999 to 9999)
    92.1 (84.5 to 96.8)
        PPAS2: Serogroup 4: 30 days post D3 (n=91,0)
    100 (96.0 to 100)
    9999 (9999 to 9999)
        PPAS2: Serogroup 4: 30 days post D4 (n=0,89)
    9999 (9999 to 9999)
    100 (95.9 to 100)
        PPAS2: Serogroup 5: 30 days post D3 (n=91,0)
    98.9 (94.0 to 100)
    9999 (9999 to 9999)
        PPAS2: Serogroup 5: 30 days post D4 (n=0,89)
    9999 (9999 to 9999)
    100 (95.9 to 100)
        PPAS2: Serogroup 6A: 30 days post D3 (n=91,0)
    100 (96.0 to 100)
    9999 (9999 to 9999)
        PPAS2: Serogroup 6A: 30 days post D4 (n=0,89)
    9999 (9999 to 9999)
    100 (95.9 to 100)
        PPAS2: Serogroup 6B: 30 days post D3 (n=91,0)
    98.9 (94.0 to 100)
    9999 (9999 to 9999)
        PPAS2: Serogroup 6B: 30 days post D4 (n=0,89)
    9999 (9999 to 9999)
    100 (95.9 to 100)
        PPAS2: Serogroup 7F: 30 days post D3 (n=91,0)
    100 (96.0 to 100)
    9999 (9999 to 9999)
        PPAS2: Serogroup 7F: 30 days post D4 (n=0,89)
    9999 (9999 to 9999)
    100 (95.9 to 100)
        PPAS2: Serogroup 9V: 30 days post D3 (n=91,0)
    100 (96.0 to 100)
    9999 (9999 to 9999)
        PPAS2: Serogroup 9V: 30 days post D4 (n=0,89)
    9999 (9999 to 9999)
    100 (95.9 to 100)
        PPAS2: Serogroup 14: 30 days post D3 (n=91,0)
    100 (96.0 to 100)
    9999 (9999 to 9999)
        PPAS2: Serogroup 14: 30 days post D4 (n=0,89)
    9999 (9999 to 9999)
    100 (95.9 to 100)
        PPAS2: Serogroup 18C: 30 days post D3 (n=91,0)
    100 (96.0 to 100)
    9999 (9999 to 9999)
        PPAS2: Serogroup 18C: 30 days post D4 (n=0,89)
    9999 (9999 to 9999)
    100 (95.9 to 100)
        PPAS2: Serogroup 19A: 30 days post D3 (n=91,0)
    100 (96.0 to 100)
    9999 (9999 to 9999)
        PPAS2: Serogroup 19A: 30 days post D4 (n=0,89)
    9999 (9999 to 9999)
    100 (95.9 to 100)
        PPAS2: Serogroup 19F: 30 days post D3 (n=91,0)
    100 (96.0 to 100)
    9999 (9999 to 9999)
        PPAS2: Serogroup 19F: 30 days post D4 (n=0,89)
    9999 (9999 to 9999)
    100 (95.9 to 100)
        PPAS2: Serogroup 23F: 30 days post D3 (n=91,0)
    100 (96.0 to 100)
    9999 (9999 to 9999)
        PPAS2: Serogroup 23F: 30 days post D4 (n=0,89)
    9999 (9999 to 9999)
    100 (95.9 to 100)
    No statistical analyses for this end point

    Secondary: Geometric Mean Concentrations of Anti-Measles, Mumps and Rubella Antibodies

    		 Close Top of page
    End point title
    		 Geometric Mean Concentrations of Anti-Measles, Mumps and Rubella Antibodies
    End point description
    GMCs of anti-measles and anti-rubella antibodies were measured by bulk IgG enzyme immunoassay (EIA) and anti-mumps antibodies were assessed by enzyme-linked immunosorbent assay (ELISA). PPAS2 was a subset of FAS2. FAS2 included subset of randomized participants who received at least 1 dose of the study vaccine at booster vaccination and had a valid post-booster vaccination blood sample result. Here, n=number of participants with data collected for each specific serogroup. ‘9999' denotes that there were no participants analyzed. Dose=D.
    End point type
    Secondary
    End point timeframe
    Groups 1, 2 and 3: At 30 days post Dose 3 (12 to 18 MoA); Group 4: At 30 days post Dose 4 (12 to 18 MoA)
    End point values
    		 Group 1: MenACYW Group 2: Nimenrix Group 3: MenACYW Group 4: MenACYW
    Number of subjects analysed
    525
    553
    94
    90
    Units: Titer
    geometric mean (confidence interval 95%)
        Anti-measles: 30 days post D3 (n=525,553,94,0)
    2780 (2581 to 2995)
    2919 (2739 to 3110)
    3457 (2972 to 4021)
    9999 (9999 to 9999)
        Anti-measles: 30 days post D4(n=0,0,0,90)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    3933 (3241 to 4773)
        Anti-mumps: 30 days post D3(n=525,553,94,0)
    83.3 (77.5 to 89.6)
    86.1 (80.5 to 92.1)
    105 (90.4 to 121)
    9999 (9999 to 9999)
        Anti-mumps: 30 days post D4(n=0,0,0,90)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    121 (105 to 141)
        Anti-rubella: 30 days post D3 (n=525,553,94,0)
    56.8 (53.2 to 60.6)
    56.0 (52.5 to 59.8)
    72.8 (62.7 to 84.6)
    9999 (9999 to 9999)
        Anti-rubella: 30 days post D4 (n=0,0,0,90)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    74.4 (63.7 to 86.7)
    No statistical analyses for this end point

    Secondary: Percentage of Participants who Achieved Vaccine Response for Measles, Mumps and Rubella Antibodies

    		 Close Top of page
    End point title
    		 Percentage of Participants who Achieved Vaccine Response for Measles, Mumps and Rubella Antibodies
    End point description
    GMCs of anti-measles and anti-rubella antibodies were measured by bulk IgG EIA and anti-mumps antibodies were assessed by ELISA. Vaccine response against anti-measles, anti-mumps, anti-rubella antibodies were defined as percentage of participants with anti-measles, anti-mumps, anti-rubella antibody concentration that met the respective mentioned criterion: measles: >=255 mIU/mL; mumps: >=10 mumps antibody units/mL and rubella: >=10 IU/mL. Percentages are rounded off to the tenth decimal place. PPAS2 was a subset of FAS2. FAS2 included subset of randomized participants who received at least 1 dose of the study vaccine at booster vaccination and had a valid post-booster vaccination blood sample result. Here, n=number of participants with data collected for each specific serogroup. ‘9999' denotes that there were no participants analyzed. Dose=D.
    End point type
    Secondary
    End point timeframe
    Groups 1, 2 and 3: At 30 days post Dose 3 (12 to 18 MoA); Group 4: At 30 days post Dose 4 (12 to 18 MoA)
    End point values
    		 Group 1: MenACYW Group 2: Nimenrix Group 3: MenACYW Group 4: MenACYW
    Number of subjects analysed
    525
    553
    94
    90
    Units: Percentage of participants
    number (confidence interval 95%)
        Anti-measles: 30 days post D3 (n=525,553,94,0)
    98.3 (96.8 to 99.2)
    99.1 (97.9 to 99.7)
    100 (96.2 to 100)
    9999 (9999 to 9999)
        Anti-measles: 30 days post D4 (n=0,0,0,90)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    97.8 (92.2 to 99.7)
        Anti-mumps: 30 days post D3 (n=525,553,94,0)
    98.7 (97.3 to 99.5)
    98.7 (97.4 to 99.5)
    100 (96.2 to 100)
    9999 (9999 to 9999)
        Anti-mumps: 30 days post D4 (n=0,0,0,90)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    100 (96.0 to 100)
        Anti-rubella: 30 days post D3 (n=525,553,94,0)
    98.7 (97.3 to 99.5)
    97.3 (95.6 to 98.5)
    98.9 (94.2 to 100)
    9999 (9999 to 9999)
        Anti-rubella: 30 days post D4 (n=0,0,0,90)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    100 (96.0 to 100)
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Adverse events (AEs), serious adverse events (SAEs) and deaths: From study vaccine administration (Day 0) until 30 days after last vaccination (Visit 5 [13 to 19 MoA] for Groups 1, 2, and 3 and Visit 6 [13 to 19 MoA] for Group 4), up to 14 to 20 MoA.
    Adverse event reporting additional description
    Analysis was performed on the safety analysis set (SafAS)which included those participants who had received at least 1 dose of the study vaccine(s) and had any safety data available.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    Group 1: MenACYW
    Reporting group description
    		 Participants received 3 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV10 were administered in a 2+1 regimen (ie, 2 doses in infancy [first between 6 and 12 weeks of age and second between 4 to 5 MoA] and 1 final dose in the second year of life [12 to 18 MoA]); and the MMR vaccine was administered at 12 to 18 MoA.

    Reporting group title
    Group 4: MenACYW
    Reporting group description
    		 Participants received 4 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4MoA, and dose 3: 6 MoA and dose 4: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV13 were administered in a 2+1 regimen (concomitantly with the first and second doses in infancy [first between 6 and 12 weeks of age and second between 4 to 5 MoA] and the toddler dose of MenACYW conjugate vaccine [12 to 18 MoA]); and the MMR vaccine was administered at 12 to 18 MoA. The third dose of MenACYW conjugate vaccine was administered alone, without any other routine pediatric vaccines.

    Reporting group title
    Group 3: MenACYW
    Reporting group description
    		 Participants received 3 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV13 were administered in a 2+1 regimen (ie, 2 doses in infancy [first between 6 and 12 weeks of age and second between 4 to 5 MoA] and 1 final dose in the second year of life [12 to 18 MoA]); and the MMR vaccine was administered at 12 to 18 MoA.

    Reporting group title
    Group 2: Nimenrix
    Reporting group description
    		 Participants received 3 doses of Nimenrix® 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), thePCV10 were administered in a 2+1 regimen (ie, 2 doses in infancy [first between 6 and 12 weeks of age and second between 4 to 5 MoA] and 1 final dose in the second year of life [12 to 18 MoA]); and the MMR vaccine was administered at 12 to 18 MoA.

    Serious adverse events
    		 Group 1: MenACYW Group 4: MenACYW Group 3: MenACYW Group 2: Nimenrix
    Total subjects affected by serious adverse events
         subjects affected / exposed
    51 / 696 (7.33%)
    3 / 108 (2.78%)
    8 / 112 (7.14%)
    57 / 706 (8.07%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Haemangioma
         subjects affected / exposed
    1 / 696 (0.14%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    1 / 706 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Testicular Yolk Sac Tumour Stage Iii
         subjects affected / exposed
    0 / 696 (0.00%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    1 / 706 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Haematoma
         subjects affected / exposed
    1 / 696 (0.14%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    0 / 706 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Systemic Inflammatory Response Syndrome
         subjects affected / exposed
    1 / 696 (0.14%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    0 / 706 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Balanoposthitis
         subjects affected / exposed
    1 / 696 (0.14%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    0 / 706 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Interstitial Lung Disease
         subjects affected / exposed
    1 / 696 (0.14%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    3 / 706 (0.42%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Apnoea
         subjects affected / exposed
    0 / 696 (0.00%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    1 / 706 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 696 (0.00%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    1 / 706 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiration Abnormal
         subjects affected / exposed
    1 / 696 (0.14%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    0 / 706 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 696 (0.00%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    1 / 706 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Burns Second Degree
         subjects affected / exposed
    1 / 696 (0.14%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    0 / 706 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Craniocerebral Injury
         subjects affected / exposed
    0 / 696 (0.00%)
    1 / 108 (0.93%)
    0 / 112 (0.00%)
    0 / 706 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Burns Third Degree
         subjects affected / exposed
    1 / 696 (0.14%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    0 / 706 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    1 / 696 (0.14%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    1 / 706 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Exposure To Toxic Agent
         subjects affected / exposed
    1 / 696 (0.14%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    0 / 706 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skull Fracture
         subjects affected / exposed
    0 / 696 (0.00%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    1 / 706 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Femur Fracture
         subjects affected / exposed
    1 / 696 (0.14%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    0 / 706 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Road Traffic Accident
         subjects affected / exposed
    0 / 696 (0.00%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    1 / 706 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Congenital Hydronephrosis
         subjects affected / exposed
    0 / 696 (0.00%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    1 / 706 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hydrocele
         subjects affected / exposed
    0 / 696 (0.00%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    1 / 706 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Laryngomalacia
         subjects affected / exposed
    0 / 696 (0.00%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    1 / 706 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphatic Malformation
         subjects affected / exposed
    0 / 696 (0.00%)
    1 / 108 (0.93%)
    0 / 112 (0.00%)
    0 / 706 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Phimosis
         subjects affected / exposed
    1 / 696 (0.14%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    0 / 706 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Clinically Isolated Syndrome
         subjects affected / exposed
    0 / 696 (0.00%)
    0 / 108 (0.00%)
    1 / 112 (0.89%)
    0 / 706 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Febrile Convulsion
         subjects affected / exposed
    1 / 696 (0.14%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    2 / 706 (0.28%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Somnolence
         subjects affected / exposed
    0 / 696 (0.00%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    1 / 706 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    1 / 696 (0.14%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    0 / 706 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Petit Mal Epilepsy
         subjects affected / exposed
    0 / 696 (0.00%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    1 / 706 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Immune Thrombocytopenia
         subjects affected / exposed
    1 / 696 (0.14%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    0 / 706 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 696 (0.00%)
    0 / 108 (0.00%)
    1 / 112 (0.89%)
    0 / 706 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    1 / 696 (0.14%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    0 / 706 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Blepharitis
         subjects affected / exposed
    0 / 696 (0.00%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    1 / 706 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Anal Stenosis
         subjects affected / exposed
    0 / 696 (0.00%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    1 / 706 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspepsia
         subjects affected / exposed
    1 / 696 (0.14%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    0 / 706 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    2 / 696 (0.29%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    0 / 706 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aphthous Ulcer
         subjects affected / exposed
    1 / 696 (0.14%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    0 / 706 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterocolitis
         subjects affected / exposed
    1 / 696 (0.14%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    1 / 706 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal Inflammation
         subjects affected / exposed
    1 / 696 (0.14%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    0 / 706 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Food Protein-Induced Enterocolitis Syndrome
         subjects affected / exposed
    1 / 696 (0.14%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    0 / 706 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal Pain
         subjects affected / exposed
    0 / 696 (0.00%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    1 / 706 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal Hernia
         subjects affected / exposed
    1 / 696 (0.14%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    0 / 706 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intussusception
         subjects affected / exposed
    1 / 696 (0.14%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    0 / 706 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Regurgitation
         subjects affected / exposed
    0 / 696 (0.00%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    1 / 706 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Melaena
         subjects affected / exposed
    0 / 696 (0.00%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    1 / 706 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 696 (0.00%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    2 / 706 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis Atopic
         subjects affected / exposed
    0 / 696 (0.00%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    1 / 706 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urticaria
         subjects affected / exposed
    0 / 696 (0.00%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    1 / 706 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Tubulointerstitial Nephritis
         subjects affected / exposed
    1 / 696 (0.14%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    0 / 706 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal Stiffness
         subjects affected / exposed
    1 / 696 (0.14%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    0 / 706 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    2 / 696 (0.29%)
    0 / 108 (0.00%)
    2 / 112 (1.79%)
    2 / 706 (0.28%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    6 / 696 (0.86%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    5 / 706 (0.71%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 0
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear Infection
         subjects affected / exposed
    1 / 696 (0.14%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    0 / 706 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cytomegalovirus Infection
         subjects affected / exposed
    1 / 696 (0.14%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    0 / 706 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Covid-19
         subjects affected / exposed
    1 / 696 (0.14%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    1 / 706 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis Viral
         subjects affected / exposed
    1 / 696 (0.14%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    0 / 706 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Exanthema Subitum
         subjects affected / exposed
    1 / 696 (0.14%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    1 / 706 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Escherichia Urinary Tract Infection
         subjects affected / exposed
    0 / 696 (0.00%)
    0 / 108 (0.00%)
    1 / 112 (0.89%)
    0 / 706 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal Infection
         subjects affected / exposed
    0 / 696 (0.00%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    1 / 706 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    3 / 696 (0.43%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    4 / 706 (0.57%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal Candidiasis
         subjects affected / exposed
    0 / 696 (0.00%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    1 / 706 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis Rotavirus
         subjects affected / exposed
    0 / 696 (0.00%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    1 / 706 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis Norovirus
         subjects affected / exposed
    0 / 696 (0.00%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    1 / 706 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis Adenovirus
         subjects affected / exposed
    0 / 696 (0.00%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    1 / 706 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    3 / 696 (0.43%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    5 / 706 (0.71%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    0 / 696 (0.00%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    1 / 706 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pharyngotonsillitis
         subjects affected / exposed
    0 / 696 (0.00%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    1 / 706 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 696 (0.14%)
    2 / 108 (1.85%)
    2 / 112 (1.79%)
    5 / 706 (0.71%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Otitis Media
         subjects affected / exposed
    1 / 696 (0.14%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    2 / 706 (0.28%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Orchitis
         subjects affected / exposed
    1 / 696 (0.14%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    0 / 706 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mastoiditis
         subjects affected / exposed
    1 / 696 (0.14%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    0 / 706 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Laryngitis
         subjects affected / exposed
    2 / 696 (0.29%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    2 / 706 (0.28%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rhinovirus Infection
         subjects affected / exposed
    1 / 696 (0.14%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    0 / 706 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subcutaneous Abscess
         subjects affected / exposed
    1 / 696 (0.14%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    0 / 706 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia Pneumococcal
         subjects affected / exposed
    1 / 696 (0.14%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    0 / 706 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia Respiratory Syncytial Viral
         subjects affected / exposed
    1 / 696 (0.14%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    1 / 706 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 696 (0.14%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    2 / 706 (0.28%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory Syncytial Virus Bronchiolitis
         subjects affected / exposed
    0 / 696 (0.00%)
    2 / 108 (1.85%)
    1 / 112 (0.89%)
    1 / 706 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory Syncytial Virus Infection
         subjects affected / exposed
    1 / 696 (0.14%)
    0 / 108 (0.00%)
    1 / 112 (0.89%)
    0 / 706 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary Tract Infection
         subjects affected / exposed
    2 / 696 (0.29%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    0 / 706 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    2 / 696 (0.29%)
    0 / 108 (0.00%)
    1 / 112 (0.89%)
    0 / 706 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tracheitis
         subjects affected / exposed
    0 / 696 (0.00%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    1 / 706 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    1 / 696 (0.14%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    1 / 706 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral Upper Respiratory Tract Infection
         subjects affected / exposed
    0 / 696 (0.00%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    1 / 706 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Weight Gain Poor
         subjects affected / exposed
    1 / 696 (0.14%)
    0 / 108 (0.00%)
    0 / 112 (0.00%)
    0 / 706 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Group 1: MenACYW Group 4: MenACYW Group 3: MenACYW Group 2: Nimenrix
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    678 / 696 (97.41%)
    103 / 108 (95.37%)
    107 / 112 (95.54%)
    680 / 706 (96.32%)
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    529 / 696 (76.01%)
    75 / 108 (69.44%)
    67 / 112 (59.82%)
    545 / 706 (77.20%)
         occurrences all number
    1094
    155
    112
    1060
    General disorders and administration site conditions
    Crying
         subjects affected / exposed
    579 / 696 (83.19%)
    75 / 108 (69.44%)
    74 / 112 (66.07%)
    579 / 706 (82.01%)
         occurrences all number
    1274
    158
    138
    1279
    Injection Site Bruising
         subjects affected / exposed
    110 / 696 (15.80%)
    4 / 108 (3.70%)
    3 / 112 (2.68%)
    124 / 706 (17.56%)
         occurrences all number
    194
    7
    5
    188
    Injection Site Erythema
         subjects affected / exposed
    537 / 696 (77.16%)
    58 / 108 (53.70%)
    61 / 112 (54.46%)
    520 / 706 (73.65%)
         occurrences all number
    2207
    188
    173
    2169
    Injection Site Haematoma
         subjects affected / exposed
    55 / 696 (7.90%)
    16 / 108 (14.81%)
    7 / 112 (6.25%)
    56 / 706 (7.93%)
         occurrences all number
    97
    21
    10
    92
    Injection Site Swelling
         subjects affected / exposed
    422 / 696 (60.63%)
    47 / 108 (43.52%)
    41 / 112 (36.61%)
    417 / 706 (59.07%)
         occurrences all number
    1445
    164
    118
    1458
    Injection Site Induration
         subjects affected / exposed
    68 / 696 (9.77%)
    4 / 108 (3.70%)
    6 / 112 (5.36%)
    52 / 706 (7.37%)
         occurrences all number
    137
    6
    8
    91
    Injection Site Mass
         subjects affected / exposed
    64 / 696 (9.20%)
    1 / 108 (0.93%)
    3 / 112 (2.68%)
    60 / 706 (8.50%)
         occurrences all number
    139
    1
    3
    134
    Injection Site Pain
         subjects affected / exposed
    562 / 696 (80.75%)
    76 / 108 (70.37%)
    88 / 112 (78.57%)
    566 / 706 (80.17%)
         occurrences all number
    2842
    450
    430
    2851
    Pyrexia
         subjects affected / exposed
    375 / 696 (53.88%)
    42 / 108 (38.89%)
    46 / 112 (41.07%)
    345 / 706 (48.87%)
         occurrences all number
    570
    70
    57
    537
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    55 / 696 (7.90%)
    2 / 108 (1.85%)
    4 / 112 (3.57%)
    37 / 706 (5.24%)
         occurrences all number
    63
    2
    4
    44
    Teething
         subjects affected / exposed
    99 / 696 (14.22%)
    15 / 108 (13.89%)
    7 / 112 (6.25%)
    93 / 706 (13.17%)
         occurrences all number
    142
    28
    10
    135
    Toothache
         subjects affected / exposed
    13 / 696 (1.87%)
    5 / 108 (4.63%)
    6 / 112 (5.36%)
    8 / 706 (1.13%)
         occurrences all number
    16
    5
    7
    13
    Vomiting
         subjects affected / exposed
    196 / 696 (28.16%)
    27 / 108 (25.00%)
    25 / 112 (22.32%)
    197 / 706 (27.90%)
         occurrences all number
    268
    33
    32
    271
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    1 / 696 (0.14%)
    6 / 108 (5.56%)
    2 / 112 (1.79%)
    3 / 706 (0.42%)
         occurrences all number
    1
    7
    4
    3
    Dermatitis Diaper
         subjects affected / exposed
    6 / 696 (0.86%)
    3 / 108 (2.78%)
    6 / 112 (5.36%)
    3 / 706 (0.42%)
         occurrences all number
    6
    3
    6
    4
    Rash
         subjects affected / exposed
    16 / 696 (2.30%)
    6 / 108 (5.56%)
    1 / 112 (0.89%)
    23 / 706 (3.26%)
         occurrences all number
    18
    6
    1
    25
    Psychiatric disorders
    Irritability
         subjects affected / exposed
    600 / 696 (86.21%)
    86 / 108 (79.63%)
    91 / 112 (81.25%)
    608 / 706 (86.12%)
         occurrences all number
    1413
    217
    190
    1426
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    65 / 696 (9.34%)
    8 / 108 (7.41%)
    2 / 112 (1.79%)
    64 / 706 (9.07%)
         occurrences all number
    80
    8
    2
    76
    Gastroenteritis
         subjects affected / exposed
    10 / 696 (1.44%)
    9 / 108 (8.33%)
    6 / 112 (5.36%)
    18 / 706 (2.55%)
         occurrences all number
    10
    11
    6
    18
    Conjunctivitis
         subjects affected / exposed
    16 / 696 (2.30%)
    7 / 108 (6.48%)
    4 / 112 (3.57%)
    21 / 706 (2.97%)
         occurrences all number
    16
    9
    4
    21
    Bronchiolitis
         subjects affected / exposed
    1 / 696 (0.14%)
    12 / 108 (11.11%)
    11 / 112 (9.82%)
    1 / 706 (0.14%)
         occurrences all number
    1
    13
    12
    1
    Respiratory Tract Infection
         subjects affected / exposed
    7 / 696 (1.01%)
    2 / 108 (1.85%)
    7 / 112 (6.25%)
    12 / 706 (1.70%)
         occurrences all number
    8
    2
    7
    13
    Respiratory Tract Infection Viral
         subjects affected / exposed
    0 / 696 (0.00%)
    22 / 108 (20.37%)
    18 / 112 (16.07%)
    1 / 706 (0.14%)
         occurrences all number
    0
    31
    21
    1
    Rhinitis
         subjects affected / exposed
    47 / 696 (6.75%)
    1 / 108 (0.93%)
    1 / 112 (0.89%)
    47 / 706 (6.66%)
         occurrences all number
    56
    1
    1
    50
    Upper Respiratory Tract Infection
         subjects affected / exposed
    54 / 696 (7.76%)
    5 / 108 (4.63%)
    3 / 112 (2.68%)
    61 / 706 (8.64%)
         occurrences all number
    64
    6
    3
    71
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    389 / 696 (55.89%)
    58 / 108 (53.70%)
    60 / 112 (53.57%)
    372 / 706 (52.69%)
         occurrences all number
    594
    103
    90
    566

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Jun 2019
    Study calendar was readjusted considering the study starts (FVFS) and the same inclusion period. Study design, schedule of study procedures, and methodology were modified. Inclusion and exclusion criteria were updated. Table of study procedures for Groups 1, 2, 3, 4 and list of abbreviations was updated. Clarification was given on the need to ensure that parents/legally acceptable representative agrees for further contact to follow those specific AEs as per protocol. Definitive contraindications, labeling and packaging concomitant medications and other therapies were modified. Rewording was done in management of samples section. Future use of stored serum samples for research was updated. Immunogenicity assessment methods was modified to clarify that the testing laboratories which would perform the assays described below would be reported in the final clinical study report. Safety definitions, confidentiality of data, data protection and access to subject records and reference list were updated.
    22 Jan 2020
    Cover page was modified for team member update. History of protocol versions, planned study period, study design, schedule of study procedures, and methodology and study plan were modified. Update was made in secondary objectives, secondary endpoints, immunogenicity and observational endpoints. Inclusion and exclusion criteria were modifed. Table of study procedures for Groups 1, 2, 3, 4 and investigators and study organization details were updated. Clarified justification of the study design, vaccination and blood sampling schedule in Groups 1, 2, 3 and 4, study plan and study procedures. Planned study calendar, temporary contraindications, dose selection and timing were updated. Labeling and packaging, concomitant medications and other therapies, immunogenicity assessment methods and blood sampling schedule and testing plan in Groups 1, 2, 3 and 4 were modified. Team member updates were made in initial reporting by the investigator and reporting SAEs to health authorities and institutional ethics committee/ institutional review boards. Updated were made in the reference list.
    03 Feb 2022
    Cover page was modified for team member update. Updates were made in the table on “history of protocol versions”, planned study period, study design, schedule of study procedures, and methodology. Secondary endpoints were corrected for few inconsistencies. Observational objective and observational endpoints were modified. Updated were made in planned sample size, study plan, investigators and trial organization and planned study calendar. Clarifications were made in temporary contraindications, contraindications for subsequent blood draw, concomitant medications and other therapies, statistical methods for observational objectives and monitoring. Blood sampling schedule and testing plan in Groups 1, 2, 3 and 4 were corrected. Immunogenicity assessment method was updated.

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

    European Medicines Agency © 1995-Sat May 10 01:19:22 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA