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    Clinical Trial Results:
    A phase IIb, open, randomized, controlled primary vaccination study to evaluate the non-inferiority and the persistence of the immune response of GSK Biologicals’ meningococcal serogroup ACWY conjugate vaccine given intramuscularly versus Meningitec™ or Mencevax™ ACWY to healthy subjects aged 1 through 10 years of age.

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    2006-004236-70
    Trial protocol
    FI  
    Global end of trial date
    24 May 2012

    Results information
    Results version number
    v2(current)
    This version publication date
    11 Jun 2016
    First version publication date
    17 Jun 2015
    Other versions
    v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    Data correction due to a system error in EudraCT – Results

    Trial information

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    Trial identification
    Sponsor protocol code
    108658-60-61-63-65-68
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00427908
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    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
    24 May 2012
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 May 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    One month after vaccination: For Subjects of 2 years of age and above •To evaluate the non-inferiority of MenACWY-TT conjugate vaccine compared to MenACWY plain polysaccharide vaccine in terms of the vaccine response$ to MenA, MenC, MenY, and MenW-135. For Subjects below 2 years of age •To evaluate the non-inferiority of the vaccine response induced by MenACWY-TT conjugate vaccine when compared to the licensed MenC-CRM vaccine for MenC as measured by rSBA. •To evaluate the immunogenicity induced by MenACWY-TT conjugate vaccine for MenA, MenW-135, and MenY as measured by rSBA.
    Protection of trial subjects
    All subjects were supervised for 30 min after vaccination/product administration with appropriate medical treatment readily available. Vaccines/products were administered by qualified and trained personnel. Vaccines/products were administered only to eligible subjects that had no contraindications to any components of the vaccines/products. Subjects were followed-up for 30 days after the last vaccination/product administration.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    07 Feb 2007
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Efficacy
    Long term follow-up duration
    5 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Finland: 613
    Worldwide total number of subjects
    613
    EEA total number of subjects
    613
    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)
    304
    Children (2-11 years)
    309
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

    Period 1
    Period 1 title
    Primary phase
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Nimenrix™ 1-2 years of age Group
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Nimenrix™
    Investigational medicinal product code
    Other name
    MenACWY-TT
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose administered intramuscularly in the non-dominant deltoid or thigh region.

    Arm title
    Nimenrix™ 2-6 years of age Group
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Nimenrix™
    Investigational medicinal product code
    Other name
    MenACWY-TT
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose administered intramuscularly in the non-dominant deltoid or thigh region.

    Arm title
    Nimenrix™ 6-11 years of age Group
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Nimenrix™
    Investigational medicinal product code
    Other name
    MenACWY-TT
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose administered intramuscularly in the non-dominant deltoid or thigh region.

    Arm title
    Meningitec™ 1-2 years of age Group
    Arm description
    -
    Arm type
    Active comparator

    Investigational medicinal product name
    Meningitec™
    Investigational medicinal product code
    Other name
    MenC-CRM
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose administered intramuscularly in the non-dominant deltoid or thigh region.

    Arm title
    Mencevax™ 2-6 years of age Group
    Arm description
    -
    Arm type
    Active comparator

    Investigational medicinal product name
    Mencevax™
    Investigational medicinal product code
    Other name
    MenACWY
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose administered subcutaneously in the non-dominant upper arm.

    Arm title
    Mencevax™ 6-11 years of age Group
    Arm description
    -
    Arm type
    Active comparator

    Investigational medicinal product name
    Mencevax™
    Investigational medicinal product code
    Other name
    MenACWY
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose administered subcutaneously in the non-dominant upper arm.

    Number of subjects in period 1
    Nimenrix™ 1-2 years of age Group Nimenrix™ 2-6 years of age Group Nimenrix™ 6-11 years of age Group Meningitec™ 1-2 years of age Group Mencevax™ 2-6 years of age Group Mencevax™ 6-11 years of age Group
    Started
    229
    114
    117
    75
    39
    39
    Completed
    224
    110
    112
    72
    39
    39
    Not completed
    5
    4
    5
    3
    0
    0
         Lost to follow-up (complete vaccination)
    4
    1
    -
    2
    -
    -
         Lost to follow-up (completed vaccination)
    -
    -
    5
    -
    -
    -
         Consent withdrawn by subject
    1
    3
    -
    1
    -
    -
    Period 2
    Period 2 title
    Persistence Phase Year 1
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Nimenrix™ 1-2 years of age Group
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Nimenrix™
    Investigational medicinal product code
    Other name
    MenACWY-TT
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose administered intramuscularly in the non-dominant deltoid or thigh region.

    Arm title
    Nimenrix™ 2-11 years of age Group
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Nimenrix™
    Investigational medicinal product code
    Other name
    MenACWY-TT
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose administered intramuscularly in the non-dominant deltoid or thigh region

    Arm title
    Meningitec™ 1-2 years of age Group
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Meningitec™
    Investigational medicinal product code
    Other name
    MenC-CRM
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose administered intramuscularly in the non-dominant deltoid or thigh region

    Arm title
    Mencevax™ 2-11 years of age Group
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Mencevax™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose administered subcutaneously in the non-dominant upper arm.

    Number of subjects in period 2 [1]
    Nimenrix™ 1-2 years of age Group Nimenrix™ 2-11 years of age Group Meningitec™ 1-2 years of age Group Mencevax™ 2-11 years of age Group
    Started
    222
    221
    71
    78
    Completed
    222
    221
    71
    78
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Not all study participants returned in time for every study visit, but they were allowed to continue the study nonetheless. The number of participants who started each study period depends on the actual rate of return of the subjects.
    Period 3
    Period 3 title
    Persistence Phase Year 2
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Nimenrix™ 1-2 years of age Group
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Nimenrix™
    Investigational medicinal product code
    Other name
    MenACWY-TT
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose administered intramuscularly in the non-dominant deltoid or thigh region

    Arm title
    Nimenrix™ 2-11 years of age Group
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Nimenrix™
    Investigational medicinal product code
    Other name
    MenACWY-TT
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose administered intramuscularly in the non-dominant deltoid or thigh region

    Arm title
    Meningitec™ 1-2 years of age Group
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Meningitec™
    Investigational medicinal product code
    Other name
    MenC-CRM
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose administered intramuscularly in the non-dominant deltoid or thigh region

    Arm title
    Mencevax™ 2-11 years of age Group
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Mencevax™
    Investigational medicinal product code
    Other name
    MenACWY
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose administered subcutaneously in the non-dominant upper arm.

    Number of subjects in period 3 [2]
    Nimenrix™ 1-2 years of age Group Nimenrix™ 2-11 years of age Group Meningitec™ 1-2 years of age Group Mencevax™ 2-11 years of age Group
    Started
    208
    215
    53
    61
    Completed
    208
    215
    53
    61
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Not all study participants returned in time for every study visit, but they were allowed to continue the study nonetheless. The number of participants who started each study period depends on the actual rate of return of the subjects.
    Period 4
    Period 4 title
    Persistence Phase Year 3
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Nimenrix™ 1-2 years of age Group
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Nimenrix™
    Investigational medicinal product code
    Other name
    MenACWY-TT
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose administered intramuscularly in the non-dominant deltoid or thigh region

    Arm title
    Nimenrix™ 2-11 years of age Group
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Nimenrix™
    Investigational medicinal product code
    Other name
    MenACWY-TT
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose administered intramuscularly in the non-dominant deltoid or thigh region

    Arm title
    Meningitec™ 1-2 years of age Group
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Meningitec™
    Investigational medicinal product code
    Other name
    MenC-CRM
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose administered intramuscularly in the non-dominant deltoid or thigh region

    Arm title
    Mencevax™ 2-11 years of age Group
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Meningitec™
    Investigational medicinal product code
    Other name
    MenACWY
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose administered intramuscularly in the non-dominant deltoid or thigh region

    Number of subjects in period 4 [3]
    Nimenrix™ 1-2 years of age Group Nimenrix™ 2-11 years of age Group Meningitec™ 1-2 years of age Group Mencevax™ 2-11 years of age Group
    Started
    185
    201
    38
    38
    Completed
    185
    201
    38
    38
    Notes
    [3] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Not all study participants returned in time for every study visit, but they were allowed to continue the study nonetheless. The number of participants who started each study period depends on the actual rate of return of the subjects.
    Period 5
    Period 5 title
    Persistence Phase Year 4
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Nimenrix™ 1-2 years of age Group
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Nimenrix™
    Investigational medicinal product code
    Other name
    MenACWY-TT
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose administered intramuscularly in the non-dominant deltoid or thigh region

    Arm title
    Nimenrix™ 2-11 years of age Group
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Nimenrix™
    Investigational medicinal product code
    Other name
    MenACWY-TT
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose administered intramuscularly in the non-dominant deltoid or thigh region

    Arm title
    Meningitec™ 1-2 years of age Group
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Meningitec™
    Investigational medicinal product code
    Other name
    MenC-CRM
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose administered intramuscularly in the non-dominant deltoid or thigh region

    Arm title
    Mencevax™ 2-11 years of age Group
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Mencevax™
    Investigational medicinal product code
    Other name
    MenACWY
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose administered subcutaneously in the non-dominant upper arm.

    Number of subjects in period 5 [4]
    Nimenrix™ 1-2 years of age Group Nimenrix™ 2-11 years of age Group Meningitec™ 1-2 years of age Group Mencevax™ 2-11 years of age Group
    Started
    165
    192
    34
    32
    Completed
    165
    192
    34
    32
    Notes
    [4] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Not all study participants returned in time for every study visit, but they were allowed to continue the study nonetheless. The number of participants who started each study period depends on the actual rate of return of the subjects.
    Period 6
    Period 6 title
    Persistence Phase Year 5
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Nimenrix™ 1-2 years of age Group
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Nimenrix™
    Investigational medicinal product code
    Other name
    MenACWY-TT
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose administered intramuscularly in the non-dominant deltoid or thigh region

    Arm title
    Nimenrix™ 2-11 years of age Group
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Nimenrix™
    Investigational medicinal product code
    Other name
    MenACWY-TT
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose administered intramuscularly in the non-dominant deltoid or thigh region

    Arm title
    Meningitec™ 1-2 years of age Group
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Meningitec™
    Investigational medicinal product code
    Other name
    MenC-CRM
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose administered intramuscularly in the non-dominant deltoid or thigh region

    Arm title
    Mencevax™ 2-11 years of age Group
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Mencevax™
    Investigational medicinal product code
    Other name
    MenACWY
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose administered subcutaneously in the non-dominant upper arm.

    Number of subjects in period 6 [5]
    Nimenrix™ 1-2 years of age Group Nimenrix™ 2-11 years of age Group Meningitec™ 1-2 years of age Group Mencevax™ 2-11 years of age Group
    Started
    52
    99
    12
    13
    Completed
    52
    99
    12
    13
    Notes
    [5] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Not all study participants returned in time for every study visit, but they were allowed to continue the study nonetheless. The number of participants who started each study period depends on the actual rate of return of the subjects.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Nimenrix™ 1-2 years of age Group
    Reporting group description
    -

    Reporting group title
    Nimenrix™ 2-6 years of age Group
    Reporting group description
    -

    Reporting group title
    Nimenrix™ 6-11 years of age Group
    Reporting group description
    -

    Reporting group title
    Meningitec™ 1-2 years of age Group
    Reporting group description
    -

    Reporting group title
    Mencevax™ 2-6 years of age Group
    Reporting group description
    -

    Reporting group title
    Mencevax™ 6-11 years of age Group
    Reporting group description
    -

    Reporting group values
    Nimenrix™ 1-2 years of age Group Nimenrix™ 2-6 years of age Group Nimenrix™ 6-11 years of age Group Meningitec™ 1-2 years of age Group Mencevax™ 2-6 years of age Group Mencevax™ 6-11 years of age Group Total
    Number of subjects
    229 114 117 75 39 39 613
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    0
        Children (2-11 years)
    0
        Adolescents (12-17 years)
    0
        Adults (18-64 years)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    19.1 ± 2.96 44.1 ± 12.97 99 ± 16.27 19.3 ± 3.07 44.8 ± 12.51 98.3 ± 15.06 -
    Gender categorical
    Units: Subjects
        Female
    116 60 55 39 18 19 307
        Male
    113 54 62 36 21 20 306
    Subject analysis sets

    Subject analysis set title
    Nimenrix™ 2-11 years of age Primary Phase Group
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Pooled group of subjects above 2 years of age, participating in the Primary Phase.

    Subject analysis set title
    Mencevax™ 2-11 years of age Primary Phase Group
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Pooled group of subjects above 2 years of age, participating in the Primary phase.

    Subject analysis sets values
    Nimenrix™ 2-11 years of age Primary Phase Group Mencevax™ 2-11 years of age Primary Phase Group
    Number of subjects
    231
    78
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    71.91 ± 31.19
    71.55 ± 30.23
    Gender categorical
    Units: Subjects
        Female
    115
    37
        Male
    116
    41

    End points

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    End points reporting groups
    Reporting group title
    Nimenrix™ 1-2 years of age Group
    Reporting group description
    -

    Reporting group title
    Nimenrix™ 2-6 years of age Group
    Reporting group description
    -

    Reporting group title
    Nimenrix™ 6-11 years of age Group
    Reporting group description
    -

    Reporting group title
    Meningitec™ 1-2 years of age Group
    Reporting group description
    -

    Reporting group title
    Mencevax™ 2-6 years of age Group
    Reporting group description
    -

    Reporting group title
    Mencevax™ 6-11 years of age Group
    Reporting group description
    -
    Reporting group title
    Nimenrix™ 1-2 years of age Group
    Reporting group description
    -

    Reporting group title
    Nimenrix™ 2-11 years of age Group
    Reporting group description
    -

    Reporting group title
    Meningitec™ 1-2 years of age Group
    Reporting group description
    -

    Reporting group title
    Mencevax™ 2-11 years of age Group
    Reporting group description
    -
    Reporting group title
    Nimenrix™ 1-2 years of age Group
    Reporting group description
    -

    Reporting group title
    Nimenrix™ 2-11 years of age Group
    Reporting group description
    -

    Reporting group title
    Meningitec™ 1-2 years of age Group
    Reporting group description
    -

    Reporting group title
    Mencevax™ 2-11 years of age Group
    Reporting group description
    -
    Reporting group title
    Nimenrix™ 1-2 years of age Group
    Reporting group description
    -

    Reporting group title
    Nimenrix™ 2-11 years of age Group
    Reporting group description
    -

    Reporting group title
    Meningitec™ 1-2 years of age Group
    Reporting group description
    -

    Reporting group title
    Mencevax™ 2-11 years of age Group
    Reporting group description
    -
    Reporting group title
    Nimenrix™ 1-2 years of age Group
    Reporting group description
    -

    Reporting group title
    Nimenrix™ 2-11 years of age Group
    Reporting group description
    -

    Reporting group title
    Meningitec™ 1-2 years of age Group
    Reporting group description
    -

    Reporting group title
    Mencevax™ 2-11 years of age Group
    Reporting group description
    -
    Reporting group title
    Nimenrix™ 1-2 years of age Group
    Reporting group description
    -

    Reporting group title
    Nimenrix™ 2-11 years of age Group
    Reporting group description
    -

    Reporting group title
    Meningitec™ 1-2 years of age Group
    Reporting group description
    -

    Reporting group title
    Mencevax™ 2-11 years of age Group
    Reporting group description
    -

    Subject analysis set title
    Nimenrix™ 2-11 years of age Primary Phase Group
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Pooled group of subjects above 2 years of age, participating in the Primary Phase.

    Subject analysis set title
    Mencevax™ 2-11 years of age Primary Phase Group
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Pooled group of subjects above 2 years of age, participating in the Primary phase.

    Primary: Number of subjects with rSBA antibodies vaccine response

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    End point title
    Number of subjects with rSBA antibodies vaccine response
    End point description
    End point type
    Primary
    End point timeframe
    One Month after vaccination
    End point values
    Nimenrix™ 2-11 years of age Primary Phase Group Mencevax™ 2-11 years of age Primary Phase Group
    Number of subjects analysed
    219
    70
    Units: Subjects
        rSBA-MenA [N= 185;62]
    182
    57
        rSBA-MenC [N= 212;69]
    200
    56
        rSBA-MenW-135 [N= 199;68]
    199
    65
        rSBA-MenY [N=219;70]
    217
    58
    Statistical analysis title
    Difference in VRR to rSBA-MenA
    Statistical analysis description
    To evaluate the non-inferiority of MenACWY-TT conjugate vaccine compared to MenACWY plain polysaccharide vaccine in terms of the vaccine response (VRR) to MenA. Response to a vaccine antigen component was defined as: - For initially seronegative subject, post-vaccination serum bactericidal assay using rabbit complement (rSBA) titer ≥ 1:32; - For initially seropositive subject, at least 4-fold increase in rSBA titer from pre- to post-vaccination.
    Comparison groups
    Nimenrix™ 2-11 years of age Primary Phase Group v Mencevax™ 2-11 years of age Primary Phase Group
    Number of subjects included in analysis
    289
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [1]
    Method
    Parameter type
    Difference in percentage
    Point estimate
    6.44
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.15
         upper limit
    16.04
    Notes
    [1] - Criterion indicative of non-inferiority: lower limit of the standardized asymptotic 95% confidence interval (CI) for the group difference (MenACWY-TT minus MenACWY) in the percentage of subjects with bactericidal vaccine response to be greater than or equal to -15% for each of the four antigens.
    Statistical analysis title
    Difference in VRR to rSBA-MenC
    Statistical analysis description
    To evaluate the non-inferiority of MenACWY-TT conjugate vaccine compared to MenACWY plain polysaccharide vaccine in terms of the vaccine response (VRR) to MenC. Response to a vaccine antigen component was defined as: - For initially seronegative subject, post-vaccination serum bactericidal assay using rabbit complement (rSBA) titer ≥ 1:32; - For initially seropositive subject, at least 4-fold increase in rSBA titer from pre- to post-vaccination.
    Comparison groups
    Mencevax™ 2-11 years of age Primary Phase Group v Nimenrix™ 2-11 years of age Primary Phase Group
    Number of subjects included in analysis
    289
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [2]
    Method
    Parameter type
    Difference in percentage
    Point estimate
    13.18
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    4.79
         upper limit
    24.32
    Notes
    [2] - Criterion indicative of non-inferiority: lower limit of the standardized asymptotic 95% confidence interval (CI) for the group difference (MenACWY-TT minus MenACWY) in the percentage of subjects with bactericidal vaccine response is greater than or equal to -15% for each of the four antigens.
    Statistical analysis title
    Difference in VRR to rSBA-MenW-135
    Statistical analysis description
    To evaluate the non-inferiority of MenACWY-TT conjugate vaccine compared to MenACWY plain polysaccharide vaccine in terms of the vaccine response to MenW-135. Response to a vaccine antigen component was defined as: - For initially seronegative subject, post-vaccination serum bactericidal assay using rabbit complement (rSBA) titer ≥ 1:32; - For initially seropositive subject, at least 4-fold increase in rSBA titer from pre- to post-vaccination.
    Comparison groups
    Nimenrix™ 2-11 years of age Primary Phase Group v Mencevax™ 2-11 years of age Primary Phase Group
    Number of subjects included in analysis
    289
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [3]
    Method
    Parameter type
    Difference in percentage
    Point estimate
    4.41
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.51
         upper limit
    12.21
    Notes
    [3] - Criterion indicative of non-inferiority: lower limit of the standardized asymptotic 95% confidence interval (CI) for the group difference (MenACWY-TT minus MenACWY) in the percentage of subjects with bactericidal vaccine response is greater than or equal to -15% for each of the four antigens.
    Statistical analysis title
    Difference in VRR to rSBA-MenY
    Statistical analysis description
    To evaluate the non-inferiority of MenACWY-TT conjugate vaccine compared to MenACWY plain polysaccharide vaccine in terms of the vaccine response to MenY. Response to a vaccine antigen component was defined as: - For initially seronegative subject, post-vaccination serum bactericidal assay using rabbit complement (rSBA) titer ≥ 1:32; - For initially seropositive subject, at least 4-fold increase in rSBA titer from pre- to post-vaccination.
    Comparison groups
    Nimenrix™ 2-11 years of age Primary Phase Group v Mencevax™ 2-11 years of age Primary Phase Group
    Number of subjects included in analysis
    289
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [4]
    Method
    Parameter type
    Difference in percentage
    Point estimate
    16.23
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    8.99
         upper limit
    26.78
    Notes
    [4] - Criterion indicative of non-inferiority: lower limit of the standardized asymptotic 95% confidence interval (CI) for the group difference (MenACWY-TT minus MenACWY) in the percentage of subjects with bactericidal vaccine response is greater than or equal to -15% for each of the four antigens.

    Primary: Number of subjects with rSBA antibodies titers ≥ 1:8

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    End point title
    Number of subjects with rSBA antibodies titers ≥ 1:8 [5]
    End point description
    End point type
    Primary
    End point timeframe
    Prior to (PRE) and one month after vaccination [PI(M1)]
    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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    Nimenrix™ 1-2 years of age Group Meningitec™ 1-2 years of age Group
    Number of subjects analysed
    222
    68
    Units: Subjects
        rSBA-MenA (PRE) [N= 191;65]
    81
    26
        rSBA-MenA (PI[M1]) [N= 222;63]
    222
    22
        rSBA-MenC (PRE) [N= 203;61]
    80
    19
        rSBA-MenC (PI[M1]) [N= 220;68]
    220
    67
        rSBA-MenW-135 (PRE) [N=208;62]
    59
    24
        rSBA-MenW-135 (PI[M1]) [N=222;63]
    222
    27
        rSBA-MenY (PRE) [N=208;67]
    115
    41
        rSBA-MenY (PI[M1]) [N=222;66]
    222
    49
    Statistical analysis title
    Difference in VRR to rSBA-MenC
    Statistical analysis description
    To evaluate the non-inferiority of the vaccine response induced by MenACWY-TT conjugate vaccine when compared to the licensed MenC-CRM vaccine for MenC as measured by rSBA.
    Comparison groups
    Meningitec™ 1-2 years of age Group v Nimenrix™ 1-2 years of age Group
    Number of subjects included in analysis
    290
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [6]
    Method
    Parameter type
    Difference in percentage
    Point estimate
    1.47
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.27
         upper limit
    7.89
    Notes
    [6] - Criterion indicative of non-inferiority (serogroup C only): one month after vaccination, the lower limit of the 2-sided standardized asymptotic 95% CI for the group difference (MenACWY-TT minus MenC-CRM) in the percentage of subjects with rSBA titer ≥ 1:8 is greater than or equal to the pre-defined clinical limit of -15%.

    Primary: Percentage of subjects with rSBA antibodies titers ≥ 1:8

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    End point title
    Percentage of subjects with rSBA antibodies titers ≥ 1:8 [7] [8]
    End point description
    End point type
    Primary
    End point timeframe
    Prior to (PRE) and one month after vaccination [PI(M1)]
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    [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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    Nimenrix™ 1-2 years of age Group
    Number of subjects analysed
    222
    Units: Percentage
    number (confidence interval 95%)
        rSBA-MenA (PRE) [N=191]
    42.4 (35.3 to 49.8)
        rSBA-MenA [PI(M1)] [N=222]
    100 (98.4 to 100)
        rSBA-MenC (PRE) [N=203]
    39.4 (32.6 to 46.5)
        rSBA-MenC [PI(M1)] [N=220]
    100 (98.3 to 100)
        rSBA-MenW-135 (PRE) [N=208]
    28.4 (22.3 to 35)
        rSBA-MenW-135 [PI(M1)] [N=222]
    100 (98.4 to 100)
        rSBA-MenY (PRE) [N=208]
    55.3 (48.3 to 62.2)
        rSBA-MenY [PI(M1)] [N=222]
    100 (98.4 to 100)
    No statistical analyses for this end point

    Secondary: Number of subjects with rSBA antibodies titers ≥ 1:8 and ≥ 1:128

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    End point title
    Number of subjects with rSBA antibodies titers ≥ 1:8 and ≥ 1:128
    End point description
    These analyses were performed by the GSK Biologicals’ laboratory.
    End point type
    Secondary
    End point timeframe
    Prior to (PRE) and one month after vaccination [PI(M1)]
    End point values
    Nimenrix™ 2-11 years of age Primary Phase Group Mencevax™ 2-11 years of age Primary Phase Group
    Number of subjects analysed
    225
    75
    Units: Subjects
        rSBA-MenA (PRE) ≥ 1:8 [N=185;62]
    124
    40
        rSBA-MenA (PRE) ≥ 1:128 [N=185;62]
    96
    32
        rSBA-MenA (PI[M1]) ≥ 1:8 [N=225;75]
    225
    75
        rSBA-MenA (PI[M1]) ≥ 1:128 [N=225;75]
    224
    75
        rSBA-MenC (PRE) ≥ 1:8 [N=212;70]
    133
    36
        rSBA-MenC (PRE) ≥ 1:128 [N=212;70]
    59
    19
        rSBA-MenC (PI[M1]) ≥ 1:8 [N=225;74]
    225
    74
        rSBA-MenC (PI[M1]) ≥ 1:128 [N=225;74]
    224
    70
        rSBA-MenW-135 (PRE) ≥ 1:8 [N=199;68]
    120
    39
        rSBA-MenW-135 (PRE) ≥ 1:128 [N=199;68]
    90
    24
        rSBA-MenW-135 (PI[M1]) ≥ 1:8 [N=225;75]
    225
    75
        rSBA-MenW-135 (PI[M1]) ≥ 1:128 [N=225;75]
    225
    75
        rSBA-MenY (PRE) ≥ 1:8 [N=219;70]
    147
    42
        rSBA-MenY (PRE) ≥ 1:128 [N=219;70]
    98
    28
        rSBA-MenY (PI[M1]) ≥ 1:8 [N=225;75]
    225
    75
        rSBA-MenY (PI[M1]) ≥ 1:128 [N=225;75]
    224
    73
    No statistical analyses for this end point

    Secondary: rSBA antibodies titers

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    End point title
    rSBA antibodies titers
    End point description
    These analyses were performed by the GSK Biologicals’ laboratory.
    End point type
    Secondary
    End point timeframe
    Prior to (PRE) and one month after vaccination [PI(M1)]
    End point values
    Nimenrix™ 2-11 years of age Primary Phase Group Mencevax™ 2-11 years of age Primary Phase Group
    Number of subjects analysed
    225
    75
    Units: Titers
    geometric mean (confidence interval 95%)
        rSBA-MenA (PRE) [N=185;62]
    57.9 (43.3 to 77.5)
    58.2 (33.8 to 100.1)
        rSBA-MenA (PI[M1]) [N=225;75]
    7300.9 (6586 to 8093.4)
    2033.4 (1667.1 to 2480.2)
        rSBA-MenC (PRE) [N=212;70]
    33.5 (26 to 43.1)
    24.1 (15.2 to 38.2)
        rSBA-MenC (PI[M1]) [N=225;74]
    2435.3 (2105.8 to 2816.3)
    750.2 (555.2 to 1013.7)
        rSBA-MenW-135 (PRE) [N=199;68]
    43.1 (32.4 to 57.4)
    40.1 (23.9 to 67.3)
        rSBA-MenW-135 (PI[M1]) [N=225;75]
    11777 (10666.2 to 13003.5)
    2186.3 (1723.1 to 2773.9)
        rSBA-MenY (PRE) [N=219;70]
    57.3 (43.7 to 75.2)
    45.5 (26.8 to 77)
        rSBA-MenY (PI[M1]) [N=225;75]
    6641.4 (6044.3 to 7297.4)
    1409.9 (1085.9 to 1830.5)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-PS antibodies concentrations ≥ 0.3 µg/mL and ≥ 2.0 µg/mL

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    End point title
    Number of subjects with anti-PS antibodies concentrations ≥ 0.3 µg/mL and ≥ 2.0 µg/mL [9]
    End point description
    End point type
    Secondary
    End point timeframe
    Prior to (PRE) and one month after vaccination [PI(M1)]
    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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    Nimenrix™ 1-2 years of age Group Meningitec™ 1-2 years of age Group
    Number of subjects analysed
    168
    51
    Units: Subjects
        Anti-PSA (PRE) ≥ 0.3 µg/mL [N=147;43]
    10
    4
        Anti-PSA (PRE) ≥ 2.0 µg/mL [N=147;43]
    2
    1
        Anti-PSA [PI(M1)] ≥ 0.3 µg/mL [N=162;36]
    162
    2
        Anti-PSA [PI(M1)] ≥ 2.0 µg/mL [N=162;36]
    162
    1
        Anti-PSC (PRE) ≥ 0.3 µg/mL [N=141;42]
    3
    1
        Anti-PSC (PRE) ≥ 2.0 µg/mL [N=141;42]
    1
    1
        Anti-PSC [PI(M1)] ≥ 0.3 µg/mL [N=168;51]
    168
    51
        Anti-PSC [PI(M1)] ≥ 2.0 µg/mL [N=168;51]
    166
    50
        Anti-PSW-135 (PRE) ≥ 0.3 µg/mL [N=141;39]
    2
    0
        Anti-PSW-135 (PRE) ≥ 2.0 µg/mL [N=141;39]
    1
    0
        Anti-PSW-135 [PI(M1)] ≥ 0.3 µg/mL [N=143;36]
    143
    0
        Anti-PSW-135 [PI(M1)] ≥ 2.0 µg/mL [N=143;36]
    131
    0
        Anti-PSY (PRE) ≥ 0.3 µg/mL [N=107;30]
    1
    1
        Anti-PSY (PRE) ≥ 2.0 µg/mL [N=107;30]
    0
    0
        Anti-PSY [PI(M1)] ≥ 0.3 µg/mL [N=152;32]
    152
    0
        Anti-PSY [PI(M1)] ≥ 2.0 µg/mL [N=152;32]
    147
    0
    No statistical analyses for this end point

    Secondary: Anti-PS antibodies concentrations

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    End point title
    Anti-PS antibodies concentrations [10]
    End point description
    End point type
    Secondary
    End point timeframe
    Prior to (PRE) and one month after vaccination [PI(M1)]
    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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    Nimenrix™ 1-2 years of age Group Meningitec™ 1-2 years of age Group
    Number of subjects analysed
    168
    51
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PSA (PRE) [N=147;43]
    0.17 (0.15 to 0.18)
    0.18 (0.14 to 0.23)
        Anti-PSA [PI(M1)] [N=162;36]
    33.36 (29.07 to 38.27)
    0.17 (0.14 to 0.2)
        Anti-PSC (PRE) [N=141;42]
    0.16 (0.15 to 0.17)
    0.16 (0.14 to 0.18)
        Anti-PSC [PI(M1)] [N=168;51]
    13.47 (12 to 15.12)
    8.29 (6.8 to 10.1)
        Anti-PSW-135 (PRE) [N=141;39]
    0.15 (0.15 to 0.16)
    0.15 (0.15 to 0.15)
        Anti-PSW-135 [PI(M1)] [N=143;36]
    6.86 (5.87 to 8.02)
    0.15 (0.15 to 0.15)
        Anti-PSY (PRE) [N=107;30]
    0.15 (0.15 to 0.15)
    0.16 (0.14 to 0.17)
        Anti-PSY [PI(M1)] [N=152;32]
    10.35 (9.12 to 11.74)
    0.15 (0.15 to 0.15)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-TT antibody concentrations ≥ 0.1 IU/mL

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    End point title
    Number of subjects with anti-TT antibody concentrations ≥ 0.1 IU/mL [11]
    End point description
    End point type
    Secondary
    End point timeframe
    Prior to (PRE) and one month after vaccination [PI(M1)]
    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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    Nimenrix™ 1-2 years of age Group Meningitec™ 1-2 years of age Group
    Number of subjects analysed
    30
    6
    Units: Subjects
        Anti-TT (PRE) [N=19;6]
    18
    5
        Anti-TT [PI(M1)] [N=30;4]
    30
    4
    No statistical analyses for this end point

    Secondary: Anti-TT antibody concentrations

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    End point title
    Anti-TT antibody concentrations [12]
    End point description
    End point type
    Secondary
    End point timeframe
    Prior to (PRE) and one month after vaccination [PI(M1)]
    Notes
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    Nimenrix™ 1-2 years of age Group Meningitec™ 1-2 years of age Group
    Number of subjects analysed
    30
    6
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-TT (PRE) [N=19;6]
    1.226 (0.609 to 2.47)
    0.57 (0.102 to 3.188)
        Anti-TT [PI(M1)] [N=30;4]
    14.199 (9.628 to 20.94)
    1.341 (0.316 to 5.686)
    No statistical analyses for this end point

    Secondary: Number of subjects with rSBA antibodies titers ≥ 1:8

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    End point title
    Number of subjects with rSBA antibodies titers ≥ 1:8
    End point description
    End point type
    Secondary
    End point timeframe
    Persistence Year 1
    End point values
    Nimenrix™ 1-2 years of age Group Meningitec™ 1-2 years of age Group
    Number of subjects analysed
    216
    66
    Units: Subjects
        rSBA-MenA (PRE) [N=185;64]
    80
    26
        rSBA-MenA (PI[M1]) [N=216;61]
    216
    21
        rSBA-MenA (PI[M12]) [N=212;49]
    210
    16
        rSBA-MenC (PRE) [N=197;61]
    78
    20
        rSBA-MenC (PI[M1]) [N=214;66]
    214
    66
        rSBA-MenC (PI[M12]) [N=207;63]
    203
    50
        rSBA-MenW-135 (PRE) [N=202;62]
    57
    23
        rSBA-MenW-135 (PI[M1]) [N=216;61]
    216
    26
        rSBA-MenW-135 (PI[M12]) [N=216;64]
    216
    38
        rSBA-MenY (PRE) [N=202;66]
    113
    40
        rSBA-MenY (PI[M1]) [N=216;65]
    216
    48
        rSBA-MenY (PI[M12]) [N=216;66]
    214
    42
    No statistical analyses for this end point

    Secondary: rSBA antibodies titers

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    End point title
    rSBA antibodies titers
    End point description
    End point type
    Secondary
    End point timeframe
    Persistence Year 1
    End point values
    Nimenrix™ 1-2 years of age Group Meningitec™ 1-2 years of age Group
    Number of subjects analysed
    216
    66
    Units: Titers
    geometric mean (confidence interval 95%)
        rSBA-MenA (PRE) [N=185;64]
    22.6 (16.7 to 30.6)
    20.7 (12.3 to 34.9)
        rSBA-MenA (PI[M1]) [N=216;61]
    3684.2 (3302.8 to 4109.5)
    16.9 (9.9 to 29)
        rSBA-MenA (PI[M12]) [N=212;49]
    967 (843 to 1109.3)
    18.3 (9.5 to 35.1)
        rSBA-MenC (PRE) [N=197;61]
    14 (11 to 17.6)
    10.2 (7.1 to 14.7)
        rSBA-MenC (PI[M1]) [N=214;66]
    864.2 (763.6 to 978.2)
    448.2 (327.5 to 613.6)
        rSBA-MenC (PI[M12]) [N=207;63]
    195.3 (166.3 to 229.3)
    77.1 (49.1 to 121.1)
        rSBA-MenW-135 (PRE) [N=202;62]
    11.3 (8.9 to 14.4)
    15.5 (9.6 to 24.9)
        rSBA-MenW-135 (PI[M1]) [N=216;61]
    5386.9 (4859.3 to 5971.7)
    20.2 (12.3 to 33.2)
        rSBA-MenW-135 (PI[M12]) [N=216;64]
    855.1 (757.1 to 965.9)
    36.7 (22.6 to 59.7)
        rSBA-MenY (PRE) [N=202;66]
    34.6 (26.1 to 45.9)
    44.1 (26.2 to 74.3)
        rSBA-MenY (PI[M1]) [N=216;65]
    2836.5 (2536.4 to 3172)
    78.1 (46.6 to 130.9)
        rSBA-MenY (PI[M12]) [N=216;66]
    766.4 (661 to 888.5)
    65.1 (36.9 to 114.7)
    No statistical analyses for this end point

    Secondary: Number of subjects with rSBA antibodies titers ≥ 1:8

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    End point title
    Number of subjects with rSBA antibodies titers ≥ 1:8
    End point description
    This analysis was performed by the GSK Biologicals’ laboratory.
    End point type
    Secondary
    End point timeframe
    Persistence Year 1
    End point values
    Nimenrix™ 2-11 years of age Group Mencevax™ 2-11 years of age Group
    Number of subjects analysed
    216
    75
    Units: Subjects
        rSBA-MenA (PRE) [N=175;62]
    118
    40
        rSBA-MenA (PI[M1]) [N=214;75]
    214
    75
        rSBA-MenA (PI[M12]) [N=216;71]
    215
    64
        rSBA-MenC (PRE) [N=202;70]
    128
    36
        rSBA-MenC (PI[M1]) [N=214;74]
    214
    74
        rSBA-MenC (PI[M12]) [N=215;65]
    214
    52
        rSBA-MenW-135 (PRE) [N=190;68]
    113
    39
        rSBA-MenW-135 (PI[M1]) [N=214;75]
    214
    75
        rSBA-MenW-135 (PI[M12]) [N=216;75]
    216
    75
        rSBA-MenY (PRE) [N=210;70]
    141
    42
        rSBA-MenY (PI[M1]) [N=214;75]
    214
    75
        rSBA-MenY (PI[M12]) [N=216;71]
    216
    64
    No statistical analyses for this end point

    Secondary: rSBA antibodies titers

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    End point title
    rSBA antibodies titers
    End point description
    This analysis was performed at the GSK Biologicals’ laboratory.
    End point type
    Secondary
    End point timeframe
    Persistence Year 1
    End point values
    Nimenrix™ 2-11 years of age Group Mencevax™ 2-11 years of age Group
    Number of subjects analysed
    216
    75
    Units: Titers
    geometric mean (confidence interval 95%)
        rSBA-MenA (PRE) [N=175;62]
    59.6 (44.1 to 80.3)
    58.2 (33.8 to 100.1)
        rSBA-MenA (PI[M1]) [N=214;75]
    7395.3 (6652.7 to 8220.7)
    2033.4 (1667.1 to 2480.2)
        rSBA-MenA (PI[M12]) [N=216;71]
    2448.1 (2149.6 to 2788.1)
    358.5 (230.2 to 558.4)
        rSBA-MenC (PRE) [N=202;70]
    34.4 (26.6 to 44.5)
    24.1 (15.2 to 38.2)
        rSBA-MenC (PI[M1]) [N=214;74]
    2488.5 (2145 to 2887)
    750.2 (555.2 to 1013.7)
        rSBA-MenC (PI[M12]) [N=215;65]
    489.5 (419.5 to 571.1)
    113.5 (67.3 to 191.5)
        rSBA-MenW-135 (PRE) [N=190;68]
    41.6 (31.1 to 55.8)
    40.1 (23.9 to 67.3)
        rSBA-MenW-135 (PI[M1]) [N=214;75]
    11943.7 (10782.7 to 13229.7)
    2186.3 (1723.1 to 2773.9)
        rSBA-MenW-135 (PI[M12]) [N=216;75]
    2983.3 (2628.2 to 3386.3)
    463 (367.4 to 583.5)
        rSBA-MenY (PRE) [N=210;70]
    57.4 (43.5 to 75.9)
    45.5 (26.8 to 77)
        rSBA-MenY (PI[M1]) [N=214;75]
    6666.3 (6057.7 to 7336.1)
    1409.9 (1085.9 to 1830.5)
        rSBA-MenY (PI[M12]) [N=216;71]
    2172.1 (1939.6 to 2432.5)
    332.4 (213.5 to 517.7)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-PS antibodies concentrations ≥ 0.3 µg/mL

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    End point title
    Number of subjects with anti-PS antibodies concentrations ≥ 0.3 µg/mL
    End point description
    End point type
    Secondary
    End point timeframe
    Persistence Year 1
    End point values
    Nimenrix™ 1-2 years of age Group Meningitec™ 1-2 years of age Group
    Number of subjects analysed
    161
    49
    Units: Subjects
        Anti-PSA (PRE) [N=142;44]
    9
    4
        Anti-PSA (PI[M1]) [N=155;35]
    155
    2
        Anti-PSA (PI[M12]) [N=131;38]
    118
    3
        Anti-PSC (PRE) [N=137;41]
    3
    1
        Anti-PSC (PI[M1]) [N=161;49]
    161
    49
        Anti-PSC (PI[M12]) [N=128;35]
    73
    17
        Anti-PSW-135 (PRE) [N=137;38]
    2
    0
        Anti-PSW-135 (PI[M1]) [N=138;35]
    138
    0
        Anti-PSW-135 (PI[M12]) [N=132;32]
    124
    0
        Anti-PSY (PRE) [N=104;30]
    1
    1
        Anti-PSY (PI[M1]) [N=145;31]
    145
    0
        Anti-PSY (PI[M12]) [N=157;45]
    153
    2
    No statistical analyses for this end point

    Secondary: Anti-PS antibodies concentrations

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    End point title
    Anti-PS antibodies concentrations
    End point description
    End point type
    Secondary
    End point timeframe
    Persistence Year 1
    End point values
    Nimenrix™ 1-2 years of age Group Meningitec™ 1-2 years of age Group
    Number of subjects analysed
    161
    49
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PSA (PRE) [N=142;44]
    0.17 (0.15 to 0.18)
    0.18 (0.14 to 0.23)
        Anti-PSA (PI[M1]) [N=155;35]
    33.31 (28.94 to 38.35)
    0.17 (0.14 to 0.2)
        Anti-PSA (PI[M12]) [N=131;38]
    1.07 (0.89 to 1.3)
    0.17 (0.15 to 0.18)
        Anti-PSC (PRE) [N=137;41]
    0.16 (0.15 to 0.17)
    0.16 (0.14 to 0.19)
        Anti-PSC (PI[M1]) [N=161;49]
    13.44 (11.93 to 15.14)
    8.53 (6.97 to 10.43)
        Anti-PSC (PI[M12]) [N=128;35]
    0.39 (0.33 to 0.46)
    0.34 (0.24 to 0.47)
        Anti-PSW-135 (PRE) [N=137;38]
    0.15 (0.15 to 0.16)
    0.15 (0.15 to 0.15)
        Anti-PSW-135 (PI[M1]) [N=138;35]
    6.87 (5.85 to 8.07)
    0.15 (0.15 to 0.15)
        Anti-PSW-135 (PI[M12]) [N=132;32]
    1.33 (1.13 to 1.56)
    0.15 (0.15 to 0.15)
        Anti-PSY (PRE) [N=104;30]
    0.15 (0.15 to 0.15)
    0.16 (0.14 to 0.17)
        Anti-PSY (PI[M1]) [N=145;31]
    10.21 (8.96 to 11.62)
    0.15 (0.15 to 0.15)
        Anti-PSY (PI[M12]) [N=157;45]
    1.97 (1.7 to 2.28)
    0.16 (0.15 to 0.17)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-PS antibodies concentrations ≥ 0.3 µg/mL

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    End point title
    Number of subjects with anti-PS antibodies concentrations ≥ 0.3 µg/mL
    End point description
    End point type
    Secondary
    End point timeframe
    Persistence Year 1
    End point values
    Nimenrix™ 2-11 years of age Group Mencevax™ 2-11 years of age Group
    Number of subjects analysed
    216
    75
    Units: Subjects
        Anti-PSA (PRE) [N=209;75]
    26
    12
        Anti-PSA (PI[M1]) [N=213;74]
    213
    73
        Anti-PSA (PI[M12]) [N=213;73]
    209
    70
        Anti-PSC (PRE) [N=216;74]
    29
    6
        Anti-PSC (PI[M1]) [N=213;74]
    213
    74
        Anti-PSC (PI[M12]) [N=216;75]
    169
    74
        Anti-PSW-135 (PRE) [N=216;75]
    2
    1
        Anti-PSW-135 (PI[M1]) [N=213;74]
    213
    72
        Anti-PSW-135 (PI[M12]) [N=210;72]
    206
    65
        Anti-PSY (PRE) [N=215;74]
    4
    0
        Anti-PSY (PI[M1]) [N=214;74]
    214
    72
        Anti-PSY (PI[M12]) [N=215;74]
    213
    71
    No statistical analyses for this end point

    Secondary: Anti-PS antibodies concentrations

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    End point title
    Anti-PS antibodies concentrations
    End point description
    End point type
    Secondary
    End point timeframe
    Persistence Year 1
    End point values
    Nimenrix™ 2-11 years of age Group Mencevax™ 2-11 years of age Group
    Number of subjects analysed
    216
    75
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PSA (PRE) [N=209;75]
    0.19 (0.17 to 0.21)
    0.2 (0.16 to 0.23)
        Anti-PSA (PI[M1]) [N=213;74]
    35.95 (31.79 to 40.65)
    10.34 (7.79 to 13.72)
        Anti-PSA (PI[M12]) [N=213;73]
    2.33 (1.94 to 2.79)
    4.05 (2.88 to 5.68)
        Anti-PSC (PRE) [N=216;74]
    0.2 (0.18 to 0.23)
    0.19 (0.15 to 0.22)
        Anti-PSC (PI[M1]) [N=213;74]
    13.34 (11.7 to 15.2)
    14.53 (11.13 to 18.95)
        Anti-PSC (PI[M12]) [N=216;75]
    0.76 (0.64 to 0.91)
    4.4 (3.2 to 6.04)
        Anti-PSW-135 (PRE) [N=216;75]
    0.15 (0.15 to 0.15)
    0.15 (0.15 to 0.16)
        Anti-PSW-135 (PI[M1]) [N=213;74]
    6.26 (5.43 to 7.22)
    4.62 (3.37 to 6.35)
        Anti-PSW-135 (PI[M12]) [N=210;72]
    1.94 (1.7 to 2.22)
    2.21 (1.54 to 3.15)
        Anti-PSY (PRE) [N=215;74]
    0.15 (0.15 to 0.16)
    0.15 (0.15 to 0.15)
        Anti-PSY (PI[M1]) [N=214;74]
    11.2 (9.86 to 12.71)
    15.45 (11.42 to 20.91)
        Anti-PSY (PI[M12]) [N=215;74]
    2.76 (2.43 to 3.15)
    5.77 (4.2 to 7.93)
    No statistical analyses for this end point

    Secondary: Number of subjects with rSBA antibodies titers ≥ 1:8

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    End point title
    Number of subjects with rSBA antibodies titers ≥ 1:8
    End point description
    End point type
    Secondary
    End point timeframe
    Persistence Year 2
    End point values
    Nimenrix™ 1-2 years of age Group Meningitec™ 1-2 years of age Group
    Number of subjects analysed
    199
    52
    Units: Subjects
        rSBA-MenA (PRE) [N=171;48]
    73
    21
        rSBA-MenA (PI[M1]) [N=199;47]
    199
    18
        rSBA-MenA (PI[M12]) [N=195;36]
    193
    13
        rSBA-MenA (PI[M24]) [N=190;45]
    188
    30
        rSBA-MenC (PRE) [N=181;47]
    72
    16
        rSBA-MenC (PI[M1]) [N=197;50]
    197
    50
        rSBA-MenC (PI[M12]) [N=189;47]
    188
    47
        rSBA-MenC (PI[M24]) [N=197;52]
    185
    38
        rSBA-MenW-135 (PRE) [N=188;47]
    54
    16
        rSBA-MenW-135 (PI[M1]) [N=199;48]
    199
    19
        rSBA-MenW-135 (PI[M12]) [N=198;49]
    198
    29
        rSBA-MenW-135 (PI[M24]) [N=199;44]
    198
    24
        rSBA-MenY (PRE) [N=185;50]
    104
    31
        rSBA-MenY (PI[M1]) [N=199;50]
    199
    38
        rSBA-MenY (PI[M12]) [N=198;50]
    196
    35
        rSBA-MenY (PI[M24]) [N=197;50]
    193
    37
    No statistical analyses for this end point

    Secondary: rSBA antibodies titers

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    End point title
    rSBA antibodies titers
    End point description
    End point type
    Secondary
    End point timeframe
    Persistence Year 2
    End point values
    Nimenrix™ 1-2 years of age Group Meningitec™ 1-2 years of age Group
    Number of subjects analysed
    199
    52
    Units: Titers
    geometric mean (confidence interval 95%)
        rSBA-MenA (PRE) [N=171;48]
    22.7 (16.5 to 31.2)
    24 (12.9 to 44.6)
        rSBA-MenA (PI[M1]) [N=199;47]
    3743 (3341.1 to 4193.2)
    20 (10.6 to 37.8)
        rSBA-MenA (PI[M12]) [N=195;36]
    961.4 (830 to 1113.5)
    21.5 (9.8 to 47)
        rSBA-MenA (PI[M24]) [N=190;45]
    567.7 (489.8 to 658)
    51.3 (29 to 90.8)
        rSBA-MenC (PRE) [N=181;47]
    13.7 (10.8 to 17.5)
    11.2 (7.2 to 17.4)
        rSBA-MenC (PI[M1]) [N=197;50]
    870.9 (766 to 990.1)
    626.4 (442.7 to 886.3)
        rSBA-MenC (PI[M12]) [N=189;47]
    203.9 (174.2 to 238.6)
    163.7 (118.6 to 226)
        rSBA-MenC (PI[M24]) [N=197;52]
    117.4 (97.1 to 141.9)
    57.7 (33.5 to 99.3)
        rSBA-MenW-135 (PRE) [N=188;47]
    11.5 (8.9 to 14.7)
    13 (7.8 to 21.8)
        rSBA-MenW-135 (PI[M1]) [N=199;48]
    5424.4 (4867.9 to 6044.4)
    17.6 (10.2 to 30.5)
        rSBA-MenW-135 (PI[M12]) [N=198;49]
    856.6 (755.4 to 971.3)
    35.4 (20.4 to 61.5)
        rSBA-MenW-135 (PI[M24]) [N=199;44]
    415.9 (362.4 to 477.3)
    27.5 (15.7 to 48.1)
        rSBA-MenY (PRE) [N=185;50]
    34 (25.4 to 45.5)
    44.6 (24.8 to 80.2)
        rSBA-MenY (PI[M1]) [N=199;50]
    2797.6 (2494.9 to 3137.1)
    86 (49.3 to 150)
        rSBA-MenY (PI[M12]) [N=198;50]
    749.4 (642.9 to 873.6)
    82.7 (44.7 to 152.9)
        rSBA-MenY (PI[M24]) [N=197;50]
    504.1 (421 to 603.6)
    93.5 (51.8 to 168.7)
    No statistical analyses for this end point

    Secondary: Number of subjects with rSBA antibodies titers ≥ 1:8

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    End point title
    Number of subjects with rSBA antibodies titers ≥ 1:8
    End point description
    End point type
    Secondary
    End point timeframe
    Persistence Year 2
    End point values
    Nimenrix™ 2-11 years of age Group Mencevax™ 2-11 years of age Group
    Number of subjects analysed
    210
    59
    Units: Subjects
        rSBA-MenA (PRE) [N=170;48]
    113
    32
        rSBA-MenA (PI[M1]) [N=209;59]
    209
    59
        rSBA-MenA (PI[M12]) [N=208;57]
    207
    53
        rSBA-MenA (PI[M24]) [N=208;56]
    208
    51
        rSBA-MenC (PRE) [N=196;56]
    125
    34
        rSBA-MenC (PI[M1]) [N=209;59]
    209
    59
        rSBA-MenC (PI[M12]) [N=207;49]
    207
    49
        rSBA-MenC (PI[M24]) [N=210;59]
    207
    39
        rSBA-MenW-135 (PRE) [N=189;53]
    115
    32
        rSBA-MenW-135 (PI[M1]) [N=209;59]
    209
    59
        rSBA-MenW-135 (PI[M12]) [N=208;59]
    208
    59
        rSBA-MenW-135 (PI[M24]) [N=210;54]
    209
    46
        rSBA-MenY (PRE) [N=204;54]
    138
    31
        rSBA-MenY (PI[M1]) [N=209;59]
    209
    59
        rSBA-MenY (PI[M12]) [N=208;55]
    208
    52
        rSBA-MenY (PI[M24]) [N=210;55]
    210
    41
    No statistical analyses for this end point

    Secondary: rSBA antibodies titers

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    End point title
    rSBA antibodies titers
    End point description
    This analysis was performed by the GSK Biologicals’ laboratory.
    End point type
    Secondary
    End point timeframe
    Persistence Year 2
    End point values
    Nimenrix™ 2-11 years of age Group Mencevax™ 2-11 years of age Group
    Number of subjects analysed
    210
    59
    Units: Titers
    geometric mean (confidence interval 95%)
        rSBA-MenA (PRE) [N=170;48]
    57.1 (42.1 to 77.4)
    64.5 (34.9 to 119)
        rSBA-MenA (PI[M1]) [N=209;59]
    7392.2 (6645 to 8223.3)
    2230.8 (1797.6 to 2768.3)
        rSBA-MenA (PI[M12]) [N=208;57]
    2475.3 (2170.5 to 2822.9)
    450.6 (289 to 702.7)
        rSBA-MenA (PI[M24]) [N=208;56]
    1333.4 (1181.9 to 1504.2)
    202.5 (135.3 to 303)
        rSBA-MenC (PRE) [N=196;56]
    35.4 (27.2 to 46)
    33.7 (20 to 56.8)
        rSBA-MenC (PI[M1]) [N=209;59]
    2475.6 (2128.8 to 2878.9)
    966.7 (695.7 to 1343.2)
        rSBA-MenC (PI[M12]) [N=207;49]
    490.3 (421.7 to 570.2)
    277 (187.4 to 409.6)
        rSBA-MenC (PI[M24]) [N=210;59]
    256 (213.9 to 306.2)
    59.9 (33 to 108.7)
        rSBA-MenW-135 (PRE) [N=189;53]
    43.9 (32.8 to 58.8)
    46.2 (25.7 to 83)
        rSBA-MenW-135 (PI[M1]) [N=209;59]
    11892.6 (10744.2 to 13163.7)
    2215 (1679.2 to 2921.7)
        rSBA-MenW-135 (PI[M12]) [N=208;59]
    2969.7 (2612.5 to 3375.9)
    496.2 (383.5 to 641.9)
        rSBA-MenW-135 (PI[M24]) [N=210;54]
    1298 (1135.5 to 1483.7)
    144 (90.1 to 230.2)
        rSBA-MenY (PRE) [N=204;54]
    58.3 (44 to 77.3)
    40.9 (22.3 to 75)
        rSBA-MenY (PI[M1]) [N=209;59]
    6594.5 (5971.2 to 7282.9)
    1574.2 (1177.1 to 2105.3)
        rSBA-MenY (PI[M12]) [N=208;55]
    2115.5 (1886.4 to 2372.5)
    418 (269.2 to 649.2)
        rSBA-MenY (PI[M24]) [N=210;55]
    1530.2 (1339.2 to 1748.4)
    96.9 (54.1 to 173.6)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-PS antibodies concentrations ≥ 0.3 µg/mL

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    End point title
    Number of subjects with anti-PS antibodies concentrations ≥ 0.3 µg/mL
    End point description
    End point type
    Secondary
    End point timeframe
    Persistence Year 2
    End point values
    Nimenrix™ 1-2 years of age Group Meningitec™ 1-2 years of age Group
    Number of subjects analysed
    161
    39
    Units: Subjects
        Anti-PSA (PRE) [N=132;35]
    7
    4
        Anti-PSA (PI[M1]) [N=143;27]
    143
    2
        Anti-PSA (PI[M12]) [N=121;31]
    109
    2
        Anti-PSA (PI[M24]) [N=140;39]
    107
    7
        Anti-PSC (PRE) [N=126;31]
    3
    1
        Anti-PSC (PI[M1]) [N=148;35]
    148
    35
        Anti-PSC (PI[M12]) [N=117;30]
    68
    15
        Anti-PSC (PI[M24]) [N=107;22]
    38
    6
        Anti-PSW-135 (PRE) [N=127;29]
    1
    0
        Anti-PSW-135 (PI[M1]) [N=129;24]
    129
    0
        Anti-PSW-135 (PI[M12]) [N=122;26]
    114
    0
        Anti-PSW-135 (PI[M24]) [N=135;32]
    98
    0
        Anti-PSY (PRE) [N=96;22]
    1
    1
        Anti-PSY (PI[M1]) [N=135;24]
    135
    0
        Anti-PSY (PI[M12]) [N=144;35]
    140
    1
        Anti-PSY (PI[M24]) [N=161;33]
    144
    1
    No statistical analyses for this end point

    Secondary: Anti-PS antibodies concentrations

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    End point title
    Anti-PS antibodies concentrations
    End point description
    End point type
    Secondary
    End point timeframe
    Persistence Year 2
    End point values
    Nimenrix™ 1-2 years of age Group Meningitec™ 1-2 years of age Group
    Number of subjects analysed
    148
    39
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PSA (PRE) [N=132;35]
    0.16 (0.15 to 0.18)
    0.19 (0.14 to 0.25)
        Anti-PSA (PI[M1]) [N=143;27]
    32.63 (28.2 to 37.75)
    0.18 (0.14 to 0.22)
        Anti-PSA (PI[M12]) [N=121;31]
    1.08 (0.89 to 1.32)
    0.16 (0.14 to 0.18)
        Anti-PSA (PI[M24]) [N=140;39]
    0.59 (0.5 to 0.69)
    0.19 (0.16 to 0.23)
        Anti-PSC (PRE) [N=126;31]
    0.16 (0.15 to 0.17)
    0.16 (0.14 to 0.2)
        Anti-PSC (PI[M1]) [N=148;35]
    13.58 (12.01 to 15.36)
    9.16 (7.31 to 11.47)
        Anti-PSC (PI[M12]) [N=117;30]
    0.39 (0.33 to 0.47)
    0.36 (0.24 to 0.53)
        Anti-PSC (PI[M24]) [N=107;22]
    0.26 (0.22 to 0.3)
    0.24 (0.17 to 0.36)
        Anti-PSW-135 (PRE) [N=127;29]
    0.15 (0.15 to 0.15)
    0.15 (0.15 to 0.15)
        Anti-PSW-135 (PI[M1]) [N=129;24]
    6.58 (5.6 to 7.74)
    0.15 (0.15 to 0.15)
        Anti-PSW-135 (PI[M12]) [N=122;26]
    1.33 (1.12 to 1.58)
    0.15 (0.15 to 0.15)
        Anti-PSW-135 (PI[M24]) [N=135;32]
    0.65 (0.54 to 0.79)
    0.15 (0.15 to 0.15)
        Anti-PSY (PRE) [N=96;22]
    0.15 (0.15 to 0.15)
    0.16 (0.14 to 0.18)
        Anti-PSY (PI[M1]) [N=135;24]
    10.22 (8.96 to 11.67)
    0.15 (0.15 to 0.15)
        Anti-PSY (PI[M12]) [N=144;35]
    1.95 (1.67 to 2.27)
    0.15 (0.15 to 0.17)
        Anti-PSY (PI[M24]) [N=161;33]
    1.12 (0.96 to 1.3)
    0.16 (0.14 to 0.19)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-PS antibodies concentrations ≥ 0.3 µg/mL

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    End point title
    Number of subjects with anti-PS antibodies concentrations ≥ 0.3 µg/mL
    End point description
    End point type
    Secondary
    End point timeframe
    Persistence Year 2
    End point values
    Nimenrix™ 2-11 years of age Group Mencevax™ 2-11 years of age Group
    Number of subjects analysed
    210
    59
    Units: Subjects
        Anti-PSA (PRE) [N=203;59]
    24
    11
        Anti-PSA (PI[M1]) [N=208;59]
    208
    58
        Anti-PSA (PI[M12]) [N=205;57]
    201
    54
        Anti-PSA (PI[M24]) [N=199;56]
    187
    54
        Anti-PSC (PRE) [N=210;58]
    29
    6
        Anti-PSC (PI[M1]) [N=208;59]
    208
    59
        Anti-PSC (PI[M12]) [N=208;59]
    163
    58
        Anti-PSC (PI[M24]) [N=208;59]
    131
    57
        Anti-PSW-135 (PRE) [N=210;59]
    3
    1
        Anti-PSW-135 (PI[M1]) [N=208;59]
    208
    57
        Anti-PSW-135 (PI[M12]) [N=202;57]
    198
    52
        Anti-PSW-135 (PI[M24]) [N=204;58]
    181
    52
        Anti-PSY (PRE) [N=209;58]
    5
    0
        Anti-PSY (PI[M1]) [N=209;58]
    209
    56
        Anti-PSY (PI[M12]) [N=207;59]
    205
    56
        Anti-PSY (PI[M24]) [N=205;54]
    198
    50
    No statistical analyses for this end point

    Secondary: Anti-PS antibodies concentrations

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    End point title
    Anti-PS antibodies concentrations
    End point description
    End point type
    Secondary
    End point timeframe
    Persistence Year 2
    End point values
    Nimenrix™ 2-11 years of age Group Mencevax™ 2-11 years of age Group
    Number of subjects analysed
    210
    59
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PSA (PRE) [N=203;59]
    0.18 (0.17 to 0.2)
    0.21 (0.17 to 0.26)
        Anti-PSA (PI[M1]) [N=208;59]
    34.76 (30.83 to 39.19)
    11.2 (8.1 to 15.47)
        Anti-PSA (PI[M12]) [N=205;57]
    2.27 (1.9 to 2.71)
    4.62 (3.13 to 6.82)
        Anti-PSA (PI[M24]) [N=199;56]
    1.52 (1.28 to 1.81)
    2.93 (2.07 to 4.14)
        Anti-PSC (PRE) [N=210;58]
    0.2 (0.18 to 0.23)
    0.2 (0.16 to 0.25)
        Anti-PSC (PI[M1]) [N=208;59]
    12.94 (11.37 to 14.72)
    15.28 (11.24 to 20.77)
        Anti-PSC (PI[M12]) [N=208;59]
    0.75 (0.63 to 0.9)
    4.98 (3.51 to 7.06)
        Anti-PSC (PI[M24]) [N=208;59]
    0.54 (0.45 to 0.64)
    2.81 (2.02 to 3.91)
        Anti-PSW-135 (PRE) [N=210;59]
    0.15 (0.15 to 0.16)
    0.15 (0.15 to 0.16)
        Anti-PSW-135 (PI[M1]) [N=208;59]
    6.16 (5.34 to 7.11)
    4.5 (3.13 to 6.47)
        Anti-PSW-135 (PI[M12]) [N=202;57]
    1.9 (1.66 to 2.17)
    2.28 (1.53 to 3.4)
        Anti-PSW-135 (PI[M24]) [N=204;58]
    1.15 (0.99 to 1.34)
    1.32 (0.92 to 1.9)
        Anti-PSY (PRE) [N=209;58]
    0.16 (0.15 to 0.16)
    0.15 (0.15 to 0.15)
        Anti-PSY (PI[M1]) [N=209;58]
    11.1 (9.76 to 12.63)
    14.91 (10.45 to 21.28)
        Anti-PSY (PI[M12]) [N=207;59]
    2.73 (2.39 to 3.11)
    5.8 (4.01 to 8.39)
        Anti-PSY (PI[M24]) [N=205;54]
    1.72 (1.49 to 1.98)
    2.9 (1.98 to 4.26)
    No statistical analyses for this end point

    Secondary: Number of subjects with rSBA antibodies titers ≥ 1:8

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    End point title
    Number of subjects with rSBA antibodies titers ≥ 1:8
    End point description
    This analysis was performed by the GSK Biologicals’ laboratory.
    End point type
    Secondary
    End point timeframe
    Persistence Year 3
    End point values
    Nimenrix™ 1-2 years of age Group Meningitec™ 1-2 years of age Group
    Number of subjects analysed
    177
    37
    Units: Subjects
        rSBA-MenA (PRE) [N=151;35]
    65
    15
        rSBA-MenA (PI[M1]) [N=177;32]
    177
    10
        rSBA-MenA (PI[M12]) [N=174;22]
    172
    7
        rSBA-MenA (PI[M24]) [N=165;30]
    164
    21
        rSBA-MenA (PI[M36]) [N=170;32]
    168
    27
        rSBA-MenC (PRE) [N=163;34]
    71
    12
        rSBA-MenC (PI[M1]) [N=175;36]
    175
    36
        rSBA-MenC (PI[M12]) [N=169;35]
    169
    35
        rSBA-MenC (PI[M24]) [N=171;36]
    171
    36
        rSBA-MenC (PI[M36]) [N=174;37]
    158
    36
        rSBA-MenW-135 (PRE) [N=167;33]
    50
    11
        rSBA-MenW-135 (PI[M1]) [N=177;36]
    177
    14
        rSBA-MenW-135 (PI[M12]) [N=176;35]
    176
    22
        rSBA-MenW-135 (PI[M24]) [N=173;30]
    172
    15
        rSBA-MenW-135 (PI[M36]) [N=174;33]
    172
    24
        rSBA-MenY (PRE) [N=166;36]
    96
    24
        rSBA-MenY (PI[M1]) [N=177;36]
    177
    29
        rSBA-MenY (PI[M12]) [N=176;35]
    175
    24
        rSBA-MenY (PI[M24]) [N=171;35]
    168
    27
        rSBA-MenY (PI[M36]) [N=177;36]
    174
    33
    No statistical analyses for this end point

    Secondary: rSBA antibodies titers

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    End point title
    rSBA antibodies titers
    End point description
    This analysis was performed by the GSK Biologicals’ laboratory.
    End point type
    Secondary
    End point timeframe
    Persistence Year 3
    End point values
    Nimenrix™ 1-2 years of age Group Meningitec™ 1-2 years of age Group
    Number of subjects analysed
    177
    37
    Units: Titers
    geometric mean (confidence interval 95%)
        rSBA-MenA (PRE) [N=151;35]
    23 (16.4 to 32.2)
    21.8 (10.8 to 44.1)
        rSBA-MenA (PI[M1]) [N=177;32]
    3787.4 (3353.2 to 4277.8)
    14.4 (7 to 29.4)
        rSBA-MenA (PI[M12]) [N=174;22]
    974.4 (831 to 1142.4)
    17.6 (6.5 to 47.6)
        rSBA-MenA (PI[M24]) [N=165;30]
    575.2 (494 to 669.9)
    56.5 (28.5 to 112.2)
        rSBA-MenA (PI[M36]) [N=170;32]
    518.6 (447.6 to 600.8)
    117.1 (65 to 211.2)
        rSBA-MenC (PRE) [N=163;34]
    15.5 (11.9 to 20)
    12 (6.9 to 20.9)
        rSBA-MenC (PI[M1]) [N=175;36]
    887 (770.4 to 1021.2)
    727.6 (478.7 to 1105.8)
        rSBA-MenC (PI[M12]) [N=169;35]
    223.5 (192.2 to 259.8)
    218.3 (157.9 to 301.8)
        rSBA-MenC (PI[M24]) [N=171;36]
    141.2 (120.3 to 165.6)
    158.6 (103.8 to 242.2)
        rSBA-MenC (PI[M36]) [N=174;37]
    125.1 (96.7 to 162)
    185.7 (118.3 to 291.5)
        rSBA-MenW-135 (PRE) [N=167;33]
    11.7 (9 to 15.1)
    12.6 (6.8 to 23.5)
        rSBA-MenW-135 (PI[M1]) [N=177;36]
    5563.5 (4976.9 to 6219.4)
    17.5 (9.2 to 33.6)
        rSBA-MenW-135 (PI[M12]) [N=176;35]
    904.9 (792.5 to 1033.2)
    37.9 (20.1 to 71.3)
        rSBA-MenW-135 (PI[M24]) [N=173;30]
    439.3 (379 to 509.4)
    22.9 (11.6 to 45.1)
        rSBA-MenW-135 (PI[M36]) [N=174;33]
    439.8 (370.5 to 522)
    64.5 (33.5 to 124.3)
        rSBA-MenY (PRE) [N=166;36]
    37.4 (27.4 to 51)
    52.5 (26.7 to 103.3)
        rSBA-MenY (PI[M1]) [N=177;36]
    2875.6 (2540 to 3255.6)
    101.5 (54.3 to 189.7)
        rSBA-MenY (PI[M12]) [N=176;35]
    799.2 (683.3 to 934.7)
    75.7 (36.2 to 158.3)
        rSBA-MenY (PI[M24]) [N=171;35]
    532.8 (439.7 to 645.6)
    100.6 (50.6 to 200)
        rSBA-MenY (PI[M36]) [N=177;36]
    583.2 (479 to 709.9)
    176 (97.6 to 317.3)
    No statistical analyses for this end point

    Secondary: Number of subjects with rSBA antibodies titers ≥ 1:8

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    End point title
    Number of subjects with rSBA antibodies titers ≥ 1:8
    End point description
    This analysis was performed by the GSK Biologicals’ laboratory.
    End point type
    Secondary
    End point timeframe
    Persistence Year 3
    End point values
    Nimenrix™ 2-11 years of age Group Mencevax™ 2-11 years of age Group
    Number of subjects analysed
    196
    37
    Units: Subjects
        rSBA-MenA (PRE) [N=162;31]
    109
    20
        rSBA-MenA (PI[M1]) [N=196;37]
    196
    37
        rSBA-MenA (PI[M12]) [N=196;36]
    195
    34
        rSBA-MenA (PI[M24]) [N=193;35]
    193
    33
        rSBA-MenA (PI[M36]) [N=192;34]
    192
    31
        rSBA-MenC (PRE) [N=184;35]
    118
    26
        rSBA-MenC (PI[M1]) [N=196;37]
    196
    37
        rSBA-MenC (PI[M12]) [N=195;34]
    195
    34
        rSBA-MenC (PI[M24]) [N=195;37]
    195
    37
        rSBA-MenC (PI[M36]) [N=192;37]
    189
    31
        rSBA-MenW-135 (PRE) [N=173;33]
    107
    22
        rSBA-MenW-135 (PI[M1]) [N=196;37]
    196
    37
        rSBA-MenW-135 (PI[M12]) [N=196;37]
    196
    37
        rSBA-MenW-135 (PI[M24]) [N=195;34]
    194
    30
        rSBA-MenW-135 (PI[M36]) [N=196;35]
    196
    29
        rSBA-MenY (PRE) [N=192;34]
    127
    19
        rSBA-MenY (PI[M1]) [N=196;37]
    196
    37
        rSBA-MenY (PI[M12]) [N=196;34]
    196
    32
        rSBA-MenY (PI[M24]) [N=195;37]
    195
    30
        rSBA-MenY (PI[M36]) [N=195;37]
    195
    30
    No statistical analyses for this end point

    Secondary: rSBA antibodies titers

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    End point title
    rSBA antibodies titers
    End point description
    This analysis was performed by the GSK Biologicals’ laboratory.
    End point type
    Secondary
    End point timeframe
    Persistence Year 3
    End point values
    Nimenrix™ 2-11 years of age Group Mencevax™ 2-11 years of age Group
    Number of subjects analysed
    196
    37
    Units: Titers
    geometric mean (confidence interval 95%)
        rSBA-MenA (PRE) [N=162;31]
    58.4 (42.8 to 79.6)
    69.8 (30.6 to 158.8)
        rSBA-MenA (PI[M1]) [N=196;37]
    7513.7 (6740.4 to 8375.7)
    2244.3 (1737.7 to 2898.6)
        rSBA-MenA (PI[M12]) [N=196;36]
    2533.4 (2211.6 to 2902.1)
    576.2 (334.8 to 991.7)
        rSBA-MenA (PI[M24]) [N=193;35]
    1352.7 (1191.4 to 1535.7)
    240.1 (149.5 to 385.7)
        rSBA-MenA (PI[M36]) [N=192;34]
    1184.2 (1054.2 to 1330.3)
    218.8 (128.9 to 371.5)
        rSBA-MenC (PRE) [N=184;35]
    36.5 (27.8 to 48)
    61.3 (31.4 to 119.7)
        rSBA-MenC (PI[M1]) [N=196;37]
    2524.9 (2162.1 to 2948.5)
    1433.7 (939.4 to 2188)
        rSBA-MenC (PI[M12]) [N=195;34]
    509.4 (439.4 to 590.6)
    437.6 (282.9 to 676.8)
        rSBA-MenC (PI[M24]) [N=195;37]
    273.1 (229.3 to 325.1)
    237.9 (144 to 393)
        rSBA-MenC (PI[M36]) [N=192;37]
    244.3 (200.8 to 297.3)
    163.5 (83.8 to 319.2)
        rSBA-MenW-135 (PRE) [N=173;33]
    45.4 (33.5 to 61.5)
    57.4 (27.6 to 119.4)
        rSBA-MenW-135 (PI[M1]) [N=196;37]
    12158.8 (10949.9 to 13501.1)
    2602.6 (1795.6 to 3772.4)
        rSBA-MenW-135 (PI[M12]) [N=196;37]
    3064.7 (2692.8 to 3488)
    587 (411.3 to 837.9)
        rSBA-MenW-135 (PI[M24]) [N=195;34]
    1324.4 (1154.4 to 1519.4)
    182.8 (104 to 321.2)
        rSBA-MenW-135 (PI[M36]) [N=196;35]
    1737.1 (1503.8 to 2006.7)
    112.9 (59.9 to 212.6)
        rSBA-MenY (PRE) [N=192;34]
    55.4 (41.3 to 74.3)
    37.2 (17.3 to 80.4)
        rSBA-MenY (PI[M1]) [N=196;37]
    6655.7 (6009.1 to 7372)
    1813.8 (1235.6 to 2662.5)
        rSBA-MenY (PI[M12]) [N=196;34]
    2164 (1924.2 to 2433.6)
    467.5 (261.3 to 836.5)
        rSBA-MenY (PI[M24]) [N=195;37]
    1556.4 (1355.9 to 1786.6)
    116.2 (59.3 to 227.7)
        rSBA-MenY (PI[M36]) [N=195;37]
    1551.6 (1381.2 to 1743.1)
    103.8 (54.3 to 198.3)
    No statistical analyses for this end point

    Secondary: Number of subjects with rSBA antibodies titers ≥ 1:8

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    End point title
    Number of subjects with rSBA antibodies titers ≥ 1:8
    End point description
    This analysis was performed by the GSK Biologicals’ laboratory.
    End point type
    Secondary
    End point timeframe
    Persistence Year 4
    End point values
    Nimenrix™ 1-2 years of age Group Meningitec™ 1-2 years of age Group
    Number of subjects analysed
    152
    31
    Units: Subjects
        rSBA-MenA (PRE) [N=130;30]
    62
    11
        rSBA-MenA (PI[M1]) [N=152;26]
    152
    7
        rSBA-MenA (PI[M12]) [N=150;19]
    148
    6
        rSBA-MenA (PI[M24]) [N=143;28]
    142
    19
        rSBA-MenA (PI[M36]) [N=144;26]
    143
    22
        rSBA-MenA (PI[M48]) [N=136;24]
    133
    21
        rSBA-MenC (PRE) [N=138;30]
    57
    13
        rSBA-MenC (PI[M1]) [N=150;29]
    150
    29
        rSBA-MenC (PI[M12]) [N=146;29]
    146
    29
        rSBA-MenC (PI[M24]) [N=148;31]
    148
    31
        rSBA-MenC (PI[M36]) [N=148;30]
    147
    30
        rSBA-MenC (PI[M48]) [N=137;30]
    125
    27
        rSBA-MenW-135 (PRE) [N=143;28]
    44
    8
        rSBA-MenW-135 (PI[M1]) [N=152;29]
    152
    12
        rSBA-MenW-135 (PI[M12]) [N=152;29]
    152
    17
        rSBA-MenW-135 (PI[M24]) [N=149;25]
    148
    12
        rSBA-MenW-135 (PI[M36]) [N=147;28]
    146
    20
        rSBA-MenW-135 (PI[M48]) [N=138;27]
    133
    18
        rSBA-MenY (PRE) [N=143;31]
    83
    21
        rSBA-MenY (PI[M1]) [N=152;29]
    152
    25
        rSBA-MenY (PI[M12]) [N=152;30]
    151
    22
        rSBA-MenY (PI[M24]) [N=147;30]
    146
    23
        rSBA-MenY (PI[M36]) [N=150;29]
    148
    27
        rSBA-MenY (PI[M48]) [N=138;29]
    134
    23
    No statistical analyses for this end point

    Secondary: rSBA antibodies titers

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    End point title
    rSBA antibodies titers
    End point description
    This analysis was performed by the GSK Biologicals’ laboratory.
    End point type
    Secondary
    End point timeframe
    Persistence Year 4
    End point values
    Nimenrix™ 1-2 years of age Group Meningitec™ 1-2 years of age Group
    Number of subjects analysed
    152
    31
    Units: Titers
    geometric mean (confidence interval 95%)
        rSBA-MenA (PRE) [N=130;30]
    27.9 (19.2 to 40.4)
    18.1 (8.3 to 39.3)
        rSBA-MenA (PI[M1]) [N=152;26]
    3911.7 (3443.2 to 4444)
    12.4 (5.6 to 27.4)
        rSBA-MenA (PI[M12]) [N=150;19]
    938.4 (790.3 to 1114.3)
    15.9 (5.6 to 45)
        rSBA-MenA (PI[M24]) [N=143;28]
    533 (451.6 to 629)
    53.8 (25.9 to 112)
        rSBA-MenA (PI[M36]) [N=144;26]
    503 (432.3 to 585.3)
    129.3 (65.9 to 254)
        rSBA-MenA (PI[M48]) [N=136;24]
    623.9 (507.1 to 767.6)
    157.4 (79.1 to 313)
        rSBA-MenC (PRE) [N=138;30]
    14.9 (11.2 to 19.9)
    15.4 (8.3 to 28.5)
        rSBA-MenC (PI[M1]) [N=150;29]
    922.5 (794.7 to 1070.8)
    846.2 (537.3 to 1332.8)
        rSBA-MenC (PI[M12]) [N=146;29]
    236.8 (199.7 to 280.7)
    233.9 (160.3 to 341.5)
        rSBA-MenC (PI[M24]) [N=148;31]
    162.5 (138.2 to 191.1)
    185.3 (116.9 to 293.6)
        rSBA-MenC (PI[M36]) [N=148;30]
    176.1 (138.6 to 223.9)
    210.3 (139.6 to 316.8)
        rSBA-MenC (PI[M48]) [N=137;30]
    141.9 (103.8 to 194)
    150.5 (73.4 to 308.6)
        rSBA-MenW-135 (PRE) [N=143;28]
    11.9 (9 to 15.7)
    10.9 (5.6 to 21.3)
        rSBA-MenW-135 (PI[M1]) [N=152;29]
    5495.6 (4864.5 to 6208.6)
    19.8 (9.3 to 41.8)
        rSBA-MenW-135 (PI[M12]) [N=152;29]
    900.8 (782.6 to 1036.8)
    36.5 (17.5 to 76.1)
        rSBA-MenW-135 (PI[M24]) [N=149;25]
    426.3 (364 to 499.3)
    24.1 (10.8 to 54.1)
        rSBA-MenW-135 (PI[M36]) [N=147;28]
    454.9 (382.7 to 540.7)
    62.8 (30.4 to 129.5)
        rSBA-MenW-135 (PI[M48]) [N=138;27]
    400.9 (316.6 to 507.7)
    59.8 (26.5 to 135.1)
        rSBA-MenY (PRE) [N=143;31]
    37.9 (27.1 to 53.1)
    52.7 (25.7 to 108.3)
        rSBA-MenY (PI[M1]) [N=152;29]
    2839.7 (2497.7 to 3228.4)
    123.9 (66.4 to 231.4)
        rSBA-MenY (PI[M12]) [N=152;30]
    776.5 (655 to 920.5)
    87.8 (40.7 to 189.5)
        rSBA-MenY (PI[M24]) [N=147;30]
    539.2 (444.7 to 653.7)
    100 (47 to 212.5)
        rSBA-MenY (PI[M36]) [N=150;29]
    581.5 (472.5 to 715.6)
    220.9 (117.8 to 414.2)
        rSBA-MenY (PI[M48]) [N=138;29]
    524.2 (417 to 658.9)
    174.1 (74.6 to 406.6)
    No statistical analyses for this end point

    Secondary: Number of subjects with rSBA antibodies titers ≥ 1:8

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    End point title
    Number of subjects with rSBA antibodies titers ≥ 1:8
    End point description
    This analysis was performed by the GSK Biologicals’ laboratory.
    End point type
    Secondary
    End point timeframe
    Persistence Year 4
    End point values
    Nimenrix™ 2-11 years of age Group Mencevax™ 2-11 years of age Group
    Number of subjects analysed
    188
    29
    Units: Subjects
        rSBA-MenA (PRE) [N=155;24]
    105
    14
        rSBA-MenA (PI[M1]) [N=187;29]
    187
    29
        rSBA-MenA (PI[M12]) [N=188;28]
    188
    26
        rSBA-MenA (PI[M24]) [N=185;27]
    185
    25
        rSBA-MenA (PI[M36]) [N=182;27]
    182
    24
        rSBA-MenA (PI[M48]) [N=188;28]
    188
    24
        rSBA-MenC (PRE) [N=176;28]
    112
    22
        rSBA-MenC (PI[M1]) [N=187;29]
    187
    29
        rSBA-MenC (PI[M12]) [N=187;28]
    187
    28
        rSBA-MenC (PI[M24]) [N=186;29]
    186
    29
        rSBA-MenC (PI[M36]) [N=181;29]
    181
    27
        rSBA-MenC (PI[M48]) [N=188;29]
    182
    26
        rSBA-MenW-135 (PRE) [N=165;27]
    104
    19
        rSBA-MenW-135 (PI[M1]) [N=187;29]
    187
    29
        rSBA-MenW-135 (PI[M12]) [N=188;29]
    188
    29
        rSBA-MenW-135 (PI[M24]) [N=186;26]
    185
    22
        rSBA-MenW-135 (PI[M36]) [N=185;28]
    185
    22
        rSBA-MenW-135 (PI[M48]) [N=188;29]
    188
    22
        rSBA-MenY (PRE) [N=183;26]
    123
    14
        rSBA-MenY (PI[M1]) [N=187;29]
    187
    29
        rSBA-MenY (PI[M12]) [N=188;27]
    188
    26
        rSBA-MenY (PI[M24]) [N=186;29]
    186
    23
        rSBA-MenY (PI[M36]) [N=185;29]
    185
    24
        rSBA-MenY (PI[M48]) [N=188;29]
    188
    24
    No statistical analyses for this end point

    Secondary: rSBA antibodies titers

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    End point title
    rSBA antibodies titers
    End point description
    End point type
    Secondary
    End point timeframe
    Persistence Year 4
    End point values
    Nimenrix™ 2-11 years of age Group Mencevax™ 2-11 years of age Group
    Number of subjects analysed
    188
    29
    Units: Titers
    geometric mean (confidence interval 95%)
        rSBA-MenA (PRE) [N=155;24]
    59.5 (43.4 to 81.7)
    58.3 (21.1 to 160.9)
        rSBA-MenA (PI[M1]) [N=187;29]
    7593.9 (6848.5 to 8420.4)
    2075.1 (1544.1 to 2788.7)
        rSBA-MenA (PI[M12]) [N=188;28]
    2556.2 (2260.3 to 2890.9)
    488.7 (246.6 to 968.3)
        rSBA-MenA (PI[M24]) [N=185;27]
    1317.2 (1155.9 to 1500.9)
    203.2 (112.6 to 366.5)
        rSBA-MenA (PI[M36]) [N=182;27]
    1154.1 (1026.8 to 1297.2)
    193.8 (102.1 to 367.9)
        rSBA-MenA (PI[M48]) [N=188;28]
    1932.3 (1684.9 to 2216.1)
    182.8 (85.5 to 390.9)
        rSBA-MenC (PRE) [N=176;28]
    35.8 (27 to 47.4)
    69.7 (34 to 142.9)
        rSBA-MenC (PI[M1]) [N=187;29]
    2578.5 (2221.9 to 2992.3)
    1371.7 (837.1 to 2247.7)
        rSBA-MenC (PI[M12]) [N=187;28]
    510.1 (439.3 to 592.4)
    444.8 (271.1 to 729.9)
        rSBA-MenC (PI[M24]) [N=186;29]
    278.5 (234.3 to 330.9)
    307.4 (179.2 to 527.4)
        rSBA-MenC (PI[M36]) [N=181;29]
    255.7 (211.3 to 309.4)
    260 (136.9 to 493.8)
        rSBA-MenC (PI[M48]) [N=188;29]
    203.6 (162.9 to 254.6)
    211.9 (104.8 to 428.7)
        rSBA-MenW-135 (PRE) [N=165;27]
    47.4 (34.8 to 64.6)
    63.7 (28.7 to 141.5)
        rSBA-MenW-135 (PI[M1]) [N=187;29]
    12275.6 (11099.2 to 13576.7)
    2428 (1565 to 3767.1)
        rSBA-MenW-135 (PI[M12]) [N=188;29]
    3083.8 (2712.1 to 3506.3)
    564.2 (366 to 869.7)
        rSBA-MenW-135 (PI[M24]) [N=186;26]
    1324.2 (1150.3 to 1524.3)
    149.4 (72.4 to 308.1)
        rSBA-MenW-135 (PI[M36]) [N=185;28]
    1748.3 (1508.7 to 2025.9)
    95.7 (44.5 to 205.8)
        rSBA-MenW-135 (PI[M48]) [N=188;29]
    1807.5 (1568.9 to 2082.5)
    93.4 (44.2 to 197.5)
        rSBA-MenY (PRE) [N=183;26]
    56.8 (42.2 to 76.6)
    34.7 (14 to 86)
        rSBA-MenY (PI[M1]) [N=187;29]
    6801.4 (6206.1 to 7453.9)
    1696.6 (1103.1 to 2609.4)
        rSBA-MenY (PI[M12]) [N=188;27]
    2169.8 (1930.4 to 2438.9)
    480.4 (260.9 to 884.9)
        rSBA-MenY (PI[M24]) [N=186;29]
    1550.8 (1352.6 to 1778)
    106.6 (48.5 to 234.1)
        rSBA-MenY (PI[M36]) [N=185;29]
    1551.5 (1378.9 to 1745.7)
    101.6 (50 to 206.5)
        rSBA-MenY (PI[M48]) [N=188;29]
    1545.5 (1356.6 to 1760.6)
    113.1 (55.1 to 232.3)
    No statistical analyses for this end point

    Secondary: Number of subjects with rSBA antibodies titers ≥ 1:8 (HPA laboratory assay)

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    End point title
    Number of subjects with rSBA antibodies titers ≥ 1:8 (HPA laboratory assay)
    End point description
    End point type
    Secondary
    End point timeframe
    Persistence Year 4
    End point values
    Nimenrix™ 1-2 years of age Group Meningitec™ 1-2 years of age Group
    Number of subjects analysed
    152
    31
    Units: Subjects
        rSBA-MenA (PI[M48]) [N=152;31]
    93
    0
        rSBA-MenC (PI[M48]) [N=152;31]
    46
    8
        rSBA-MenW-135 (PI[M48]) [N=152;31]
    78
    0
        rSBA-MenY (PI[M48]) [N=152;31]
    84
    9
    No statistical analyses for this end point

    Secondary: rSBA antibodies titers (HPA laboratory assay)

    Close Top of page
    End point title
    rSBA antibodies titers (HPA laboratory assay)
    End point description
    End point type
    Secondary
    End point timeframe
    Persistence Year 4
    End point values
    Nimenrix™ 1-2 years of age Group Meningitec™ 1-2 years of age Group
    Number of subjects analysed
    152
    31
    Units: Titers
    geometric mean (confidence interval 95%)
        rSBA-MenA (PI[M48]) [N=152;31]
    25.7 (19.1 to 34.7)
    4 (4 to 4)
        rSBA-MenC (PI[M48]) [N=152;31]
    11.2 (8.3 to 15.1)
    11.4 (5.2 to 25)
        rSBA-MenW-135 (PI[M48]) [N=152;31]
    31.3 (21.4 to 45.6)
    4 (4 to 4)
        rSBA-MenY (PI[M48]) [N=152;31]
    29.9 (21.5 to 41.6)
    12.5 (6 to 26.1)
    No statistical analyses for this end point

    Secondary: Number of subjects with rSBA antibodies titers ≥ 1:8 (HPA laboratory assay)

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    End point title
    Number of subjects with rSBA antibodies titers ≥ 1:8 (HPA laboratory assay)
    End point description
    End point type
    Secondary
    End point timeframe
    Persistence Year 4
    End point values
    Nimenrix™ 2-11 years of age Group Mencevax™ 2-11 years of age Group
    Number of subjects analysed
    188
    29
    Units: Subjects
        rSBA-MenA (PI[M48]) [N=188;29]
    157
    5
        rSBA-MenC (PI[M48]) [N=188;29]
    94
    12
        rSBA-MenW-135 (PI[M48]) [N=187;29]
    169
    4
        rSBA-MenY (PI[M48]) [N=187;29]
    151
    2
    No statistical analyses for this end point

    Secondary: rSBA antibodies titers (HPA laboratory assay)

    Close Top of page
    End point title
    rSBA antibodies titers (HPA laboratory assay)
    End point description
    End point type
    Secondary
    End point timeframe
    Persistence Year 4
    End point values
    Nimenrix™ 2-11 years of age Group Mencevax™ 2-11 years of age Group
    Number of subjects analysed
    188
    29
    Units: Titers
    geometric mean (confidence interval 95%)
        rSBA-MenA (PI[M48]) [N=188;29]
    77.5 (59.3 to 101.3)
    7.3 (4.3 to 12.4)
        rSBA-MenC (PI[M48]) [N=188;29]
    21.7 (16.2 to 29.1)
    23.5 (9.8 to 56.3)
        rSBA-MenW-135 (PI[M48]) [N=187;29]
    671.1 (500.8 to 899.4)
    7.6 (4 to 14.4)
        rSBA-MenY (PI[M48]) [N=187;29]
    134.8 (99.1 to 183.5)
    4.7 (3.5 to 6.4)
    No statistical analyses for this end point

    Secondary: Number of subjects with rSBA antibodies titers ≥ 1:8

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    End point title
    Number of subjects with rSBA antibodies titers ≥ 1:8
    End point description
    This analysis was performed by the GSK Biologicals’ laboratory.
    End point type
    Secondary
    End point timeframe
    Persistence Year 4
    End point values
    Nimenrix™ 1-2 years of age Group Meningitec™ 1-2 years of age Group
    Number of subjects analysed
    49
    11
    Units: Subjects
        rSBA-MenA (PRE) [N=41;8]
    17
    5
        rSBA-MenA (PI[M1]) [N=49;9]
    49
    3
        rSBA-MenA (PI[M12]) [N=48;6]
    48
    1
        rSBA-MenA (PI[M24]) [N=48;8]
    48
    7
        rSBA-MenA (PI[M36]) [N=45;9]
    45
    9
        rSBA-MenA (PI[M48]) [N=40;7]
    40
    7
        rSBA-MenC (PRE) [N=45;10]
    15
    3
        rSBA-MenC (PI[M1]) [N=48;11]
    48
    11
        rSBA-MenC (PI[M12]) [N=47;10]
    47
    10
        rSBA-MenC (PI[M24]) [N=49;11]
    49
    11
        rSBA-MenC (PI[M36]) [N=46;10]
    46
    10
        rSBA-MenC (PI[M48]) [N=43;10]
    43
    9
        rSBA-MenW-135 (PRE) [N=45;11]
    14
    3
        rSBA-MenW-135 (PI[M1]) [N=49;11]
    49
    3
        rSBA-MenW-135 (PI[M12]) [N=48;10]
    48
    7
        rSBA-MenW-135 (PI[M24]) [N=49;8]
    48
    4
        rSBA-MenW-135 (PI[M36]) [N=46;8]
    45
    5
        rSBA-MenW-135 (PI[M48]) [N=40;9]
    37
    5
        rSBA-MenY (PRE) [N=48;10]
    30
    8
        rSBA-MenY (PI[M1]) [N=49;10]
    49
    8
        rSBA-MenY (PI[M12]) [N=48;10]
    48
    8
        rSBA-MenY (PI[M24]) [N=48;11]
    48
    10
        rSBA-MenY (PI[M36]) [N=47;9]
    47
    8
        rSBA-MenY (PI[M48]) [N=40;10]
    39
    8
    No statistical analyses for this end point

    Secondary: rSBA antibodies titers

    Close Top of page
    End point title
    rSBA antibodies titers
    End point description
    This analysis was performed by the GSK Biologicals’ laboratory
    End point type
    Secondary
    End point timeframe
    Persistence Year 4
    End point values
    Nimenrix™ 1-2 years of age Group Meningitec™ 1-2 years of age Group
    Number of subjects analysed
    49
    11
    Units: Titers
    geometric mean (confidence interval 95%)
        rSBA-MenA (PRE) [N=41;8]
    22.6 (11.4 to 44.4)
    45.7 (7.3 to 287.7)
        rSBA-MenA (PI[M1]) [N=49;9]
    4931.9 (4071.9 to 5973.6)
    16.7 (3.1 to 89.8)
        rSBA-MenA (PI[M12]) [N=48;6]
    1224.2 (958.4 to 1563.8)
    7.8 (1.4 to 43.7)
        rSBA-MenA (PI[M24]) [N=48;8]
    668.3 (511.6 to 873)
    119.5 (34.5 to 414.8)
        rSBA-MenA (PI[M36]) [N=45;9]
    578.5 (445.8 to 750.7)
    210.8 (128.8 to 345.2)
        rSBA-MenA (PI[M48]) [N=40;7]
    782.4 (551.3 to 1110.2)
    392 (192.7 to 797.6)
        rSBA-MenC (PRE) [N=45;10]
    10.7 (6.7 to 17.1)
    9.4 (3.2 to 27.9)
        rSBA-MenC (PI[M1]) [N=48;11]
    1115.3 (878.3 to 1416.3)
    536.8 (278.6 to 1034.1)
        rSBA-MenC (PI[M12]) [N=47;10]
    352.4 (251.3 to 494.2)
    249.3 (128.8 to 482.4)
        rSBA-MenC (PI[M24]) [N=49;11]
    229.5 (169 to 311.6)
    215.6 (77.6 to 599)
        rSBA-MenC (PI[M36]) [N=46;10]
    472.4 (285.2 to 782.3)
    229.5 (82 to 642.1)
        rSBA-MenC (PI[M48]) [N=43;10]
    729.9 (468.4 to 1137.4)
    332 (61.2 to 1802)
        rSBA-MenW-135 (PRE) [N=45;11]
    12.8 (7.4 to 22.2)
    8.4 (3.1 to 22.7)
        rSBA-MenW-135 (PI[M1]) [N=49;11]
    6805 (5432.2 to 8524.7)
    12.2 (3.4 to 43.8)
        rSBA-MenW-135 (PI[M12]) [N=48;10]
    956.5 (710.1 to 1288.3)
    49.4 (13 to 188)
        rSBA-MenW-135 (PI[M24]) [N=49;8]
    408.5 (287.2 to 581.1)
    25.9 (4.5 to 148.3)
        rSBA-MenW-135 (PI[M36]) [N=46;8]
    486 (316.5 to 746.5)
    52.9 (8.2 to 342.5)
        rSBA-MenW-135 (PI[M48]) [N=40;9]
    419 (235.1 to 746.7)
    31.3 (5.8 to 167.9)
        rSBA-MenY (PRE) [N=48;10]
    43.7 (24.5 to 78)
    99.6 (23 to 431)
        rSBA-MenY (PI[M1]) [N=49;10]
    3555.6 (2928.3 to 4317.3)
    138.7 (29.8 to 645.6)
        rSBA-MenY (PI[M12]) [N=48;10]
    976.8 (716.8 to 1331.2)
    148 (30.5 to 717.9)
        rSBA-MenY (PI[M24]) [N=48;11]
    703 (500.8 to 986.9)
    185.1 (59.5 to 576.3)
        rSBA-MenY (PI[M36]) [N=47;9]
    684 (468.3 to 998.9)
    242.2 (45.3 to 1294.5)
        rSBA-MenY (PI[M48]) [N=40;10]
    601.5 (365.1 to 991)
    189 (35.8 to 998.1)
    No statistical analyses for this end point

    Secondary: Number of subjects with rSBA antibodies titers ≥ 1:8

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    End point title
    Number of subjects with rSBA antibodies titers ≥ 1:8
    End point description
    This analysis was performed by the GSK Biologicals’ laboratory
    End point type
    Secondary
    End point timeframe
    Persistence Year 4
    End point values
    Nimenrix™ 2-11 years of age Group Mencevax™ 2-11 years of age Group
    Number of subjects analysed
    98
    13
    Units: Subjects
        rSBA-MenA (PRE) [N=81;10]
    57
    4
        rSBA-MenA (PI[M1]) [N=98;13]
    98
    13
        rSBA-MenA (PI[M12]) [N=98;13]
    98
    12
        rSBA-MenA (PI[M24]) [N=97;12]
    97
    11
        rSBA-MenA (PI[M36]) [N=95;13]
    95
    12
        rSBA-MenA (PI[M48]) [N=97;13]
    97
    11
        rSBA-MenC (PRE) [N=94;13]
    65
    12
        rSBA-MenC (PI[M1]) [N=98;13]
    98
    13
        rSBA-MenC (PI[M12]) [N=97;12]
    97
    12
        rSBA-MenC (PI[M24]) [N=98;13]
    98
    13
        rSBA-MenC (PI[M36]) [N=96;13]
    96
    13
        rSBA-MenC (PI[M48]) [N=97;13]
    97
    13
        rSBA-MenW-135 (PRE) [N=86;12]
    55
    10
        rSBA-MenW-135 (PI[M1]) [N=98;13]
    98
    13
        rSBA-MenW-135 (PI[M12]) [N=98;13]
    98
    13
        rSBA-MenW-135 (PI[M24]) [N=98;12]
    98
    10
        rSBA-MenW-135 (PI[M36]) [N=98;12]
    98
    10
        rSBA-MenW-135 (PI[M48]) [N=97;13]
    97
    11
        rSBA-MenY (PRE) [N=94;13]
    62
    6
        rSBA-MenY (PI[M1]) [N=98;13]
    98
    13
        rSBA-MenY (PI[M12]) [N=98;13]
    98
    12
        rSBA-MenY (PI[M24]) [N=98;13]
    98
    11
        rSBA-MenY (PI[M36]) [N=97;13]
    97
    11
        rSBA-MenY (PI[M48]) [N=97;13]
    97
    11
    No statistical analyses for this end point

    Secondary: rSBA antibodies titers

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    End point title
    rSBA antibodies titers
    End point description
    This analysis was performed by the GSK Biologicals’ laboratory.
    End point type
    Secondary
    End point timeframe
    Persistence Year 4
    End point values
    Nimenrix™ 2-11 years of age Group Mencevax™ 2-11 years of age Group
    Number of subjects analysed
    98
    13
    Units: Titers
    geometric mean (confidence interval 95%)
        rSBA-MenA (PRE) [N=81;10]
    64.3 (41.9 to 98.7)
    35.7 (4.6 to 277.8)
        rSBA-MenA (PI[M1]) [N=98;13]
    9195.5 (8097.2 to 10442.6)
    2319 (1337.7 to 4019.9)
        rSBA-MenA (PI[M12]) [N=98;13]
    3031.2 (2569.8 to 3575.5)
    491 (157.4 to 1531.1)
        rSBA-MenA (PI[M24]) [N=97;12]
    1641.7 (1375.5 to 1959.3)
    187.9 (61.2 to 576.6)
        rSBA-MenA (PI[M36]) [N=95;13]
    1318.4 (1124.3 to 1545.9)
    219.9 (87 to 555.5)
        rSBA-MenA (PI[M48]) [N=97;13]
    2365 (1957.2 to 2857.7)
    135.4 (37.6 to 487.1)
        rSBA-MenC (PRE) [N=94;13]
    44.7 (30.2 to 66.2)
    114 (41.5 to 313.6)
        rSBA-MenC (PI[M1]) [N=98;13]
    3604.6 (2921.3 to 4447.7)
    2361.1 (1010.1 to 5518.9)
        rSBA-MenC (PI[M12]) [N=97;12]
    777.4 (633.7 to 953.7)
    1002 (520 to 1931)
        rSBA-MenC (PI[M24]) [N=98;13]
    502.5 (402 to 628.1)
    627.1 (248.2 to 1584.1)
        rSBA-MenC (PI[M36]) [N=96;13]
    514.4 (409.4 to 646.4)
    865.2 (475.5 to 1574)
        rSBA-MenC (PI[M48]) [N=97;13]
    495.2 (386.7 to 634.1)
    742.7 (356.7 to 1546.6)
        rSBA-MenW-135 (PRE) [N=86;12]
    50.5 (32.4 to 78.8)
    86.8 (29.7 to 253.8)
        rSBA-MenW-135 (PI[M1]) [N=98;13]
    13562 (11976.3 to 15357.6)
    2601 (1301.1 to 5199.6)
        rSBA-MenW-135 (PI[M12]) [N=98;13]
    3794.4 (3232 to 4454.6)
    462.2 (235.5 to 907.5)
        rSBA-MenW-135 (PI[M24]) [N=98;12]
    1637.9 (1385.7 to 1936)
    137.4 (42.5 to 443.9)
        rSBA-MenW-135 (PI[M36]) [N=98;12]
    2098.3 (1783.7 to 2468.3)
    96.6 (28.5 to 327.6)
        rSBA-MenW-135 (PI[M48]) [N=97;13]
    2178.4 (1843.2 to 2574.4)
    100.6 (37.9 to 267)
        rSBA-MenY (PRE) [N=94;13]
    54.3 (35.4 to 83.2)
    15.7 (5.5 to 44.7)
        rSBA-MenY (PI[M1]) [N=98;13]
    7167.2 (6324.9 to 8121.8)
    2085.3 (1028.6 to 4227.2)
        rSBA-MenY (PI[M12]) [N=98;13]
    2502.4 (2125.3 to 2946.3)
    322.7 (113.1 to 920.9)
        rSBA-MenY (PI[M24]) [N=98;13]
    1907.1 (1574.2 to 2310.4)
    112.3 (32 to 394)
        rSBA-MenY (PI[M36]) [N=97;13]
    1670.6 (1413.6 to 1974.3)
    92.2 (31.9 to 266.4)
        rSBA-MenY (PI[M48]) [N=97;13]
    1736 (1430.4 to 2106.8)
    83.3 (29.3 to 236.3)
    No statistical analyses for this end point

    Secondary: Number of subjects with rSBA antibodies titers ≥ 1:8 (HPA laboratory assay)

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    End point title
    Number of subjects with rSBA antibodies titers ≥ 1:8 (HPA laboratory assay)
    End point description
    End point type
    Secondary
    End point timeframe
    Persistence Year 5
    End point values
    Nimenrix™ 1-2 years of age Group Meningitec™ 1-2 years of age Group
    Number of subjects analysed
    49
    11
    Units: Subjects
        rSBA-MenA (PI[M48]) [N=45;10]
    29
    0
        rSBA-MenA (PI[M60]) [N=49;11]
    36
    0
        rSBA-MenC (PI[M48]) [N=45;10]
    44
    8
        rSBA-MenC (PI[M60]) [N=49;11]
    38
    7
        rSBA-MenW-135 (PI[M48]) [N=45;10]
    27
    0
        rSBA-MenW-135 (PI[M60]) [N=49;11]
    17
    2
        rSBA-MenY (PI[M48]) [N=45;10]
    28
    3
        rSBA-MenY (PI[M60]) [N=49;11]
    21
    2
    No statistical analyses for this end point

    Secondary: rSBA antibodies titers (HPA laboratory assay)

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    End point title
    rSBA antibodies titers (HPA laboratory assay)
    End point description
    End point type
    Secondary
    End point timeframe
    Persistence Year 5
    End point values
    Nimenrix™ 1-2 years of age Group Meningitec™ 1-2 years of age Group
    Number of subjects analysed
    49
    11
    Units: Titers
    geometric mean (confidence interval 95%)
        rSBA-MenA (PI[M48]) [N=45;10]
    35.1 (19.4 to 63.4)
    4 (4 to 4)
        rSBA-MenA (PI[M60]) [N=49;11]
    37.4 (22.1 to 63.2)
    4 (4 to 4)
        rSBA-MenC (PI[M48]) [N=45;10]
    109.7 (62.7 to 192)
    137.2 (22.6 to 831.8)
        rSBA-MenC (PI[M60]) [N=49;11]
    48.9 (28.5 to 84)
    26.5 (6.5 to 107.2)
        rSBA-MenW-135 (PI[M48]) [N=45;10]
    50.8 (24 to 107.6)
    4 (4 to 4)
        rSBA-MenW-135 (PI[M60]) [N=49;11]
    18.2 (9.3 to 35.3)
    7.1 (2.6 to 19.1)
        rSBA-MenY (PI[M48]) [N=45;10]
    44.9 (22.6 to 89.3)
    12.1 (2.3 to 63.5)
        rSBA-MenY (PI[M60]) [N=49;11]
    20.6 (10.9 to 39.2)
    11.7 (2.3 to 59.7)
    No statistical analyses for this end point

    Secondary: Number of subjects with rSBA antibodies titers ≥ 1:8 (HPA laboratory assay)

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    End point title
    Number of subjects with rSBA antibodies titers ≥ 1:8 (HPA laboratory assay)
    End point description
    End point type
    Secondary
    End point timeframe
    Persistence Year 5
    End point values
    Nimenrix™ 2-11 years of age Group Mencevax™ 2-11 years of age Group
    Number of subjects analysed
    98
    13
    Units: Subjects
        rSBA-MenA (PI[M48]) [N=97;13]
    86
    1
        rSBA-MenA (PI[M60]) [N=98;13]
    89
    2
        rSBA-MenC (PI[M48]) [N=97;13]
    96
    12
        rSBA-MenC (PI[M60]) [N=98;13]
    89
    13
        rSBA-MenW-135 (PI[M48]) [N=96;13]
    92
    2
        rSBA-MenW-135 (PI[M60]) [N=98;13]
    77
    0
        rSBA-MenY (PI[M48]) [N=96;13]
    85
    1
        rSBA-MenY (PI[M60]) [N=98;13]
    77
    1
    No statistical analyses for this end point

    Secondary: rSBA antibodies titers (HPA laboratory assay)

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    End point title
    rSBA antibodies titers (HPA laboratory assay)
    End point description
    End point type
    Secondary
    End point timeframe
    Persistence Year 5
    End point values
    Nimenrix™ 2-11 years of age Group Mencevax™ 2-11 years of age Group
    Number of subjects analysed
    98
    13
    Units: Titers
    geometric mean (confidence interval 95%)
        rSBA-MenA (PI[M48]) [N=97;13]
    123.5 (85.4 to 178.6)
    5 (3.1 to 7.9)
        rSBA-MenA (PI[M60]) [N=98;13]
    141.3 (98.2 to 203.4)
    4.7 (3.7 to 6)
        rSBA-MenC (PI[M48]) [N=97;13]
    118.3 (86 to 162.8)
    206.8 (71.7 to 596.7)
        rSBA-MenC (PI[M60]) [N=98;13]
    79.7 (56 to 113.3)
    128 (56.4 to 290.7)
        rSBA-MenW-135 (PI[M48]) [N=96;13]
    1031.4 (731 to 1455.4)
    8.4 (2.8 to 25.7)
        rSBA-MenW-135 (PI[M60]) [N=98;13]
    208.5 (127.9 to 340)
    4 (4 to 4)
        rSBA-MenY (PI[M48]) [N=96;13]
    216.8 (147.3 to 319.1)
    4.2 (3.8 to 4.7)
        rSBA-MenY (PI[M60]) [N=98;13]
    143.3 (88 to 233.4)
    5.5 (2.7 to 11.1)
    No statistical analyses for this end point

    Secondary: Number of subjects with hSBA antibodies titers ≥ 1:4

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    End point title
    Number of subjects with hSBA antibodies titers ≥ 1:4
    End point description
    End point type
    Secondary
    End point timeframe
    Persistence Year 1
    End point values
    Nimenrix™ 1-2 years of age Group Meningitec™ 1-2 years of age Group
    Number of subjects analysed
    215
    68
    Units: Subjects
        hSBA-MenA (PRE) [N=209;66]
    3
    3
        hSBA-MenA (PI[M1]) [N=211;63]
    196
    3
        hSBA-MenA (PI[M12]) [N=201;63]
    47
    3
        hSBA-MenC (PRE) [N=208;65]
    3
    1
        hSBA-MenC (PI[M1]) [N=215;66]
    213
    48
        hSBA-MenC (PI[M12]) [N=200;64]
    192
    34
        hSBA-MenW-135 (PRE) [N=199;62]
    2
    3
        hSBA-MenW-135 (PI[M1]) [N=173;56]
    141
    1
        hSBA-MenW-135 (PI[M12]) [N=175;62]
    172
    3
        hSBA-MenY (PRE) [N=182;55]
    7
    2
        hSBA-MenY (PI[M1]) [N=196;57]
    131
    3
        hSBA-MenY (PI[M12]) [N=214;68]
    200
    8
    No statistical analyses for this end point

    Secondary: hSBA antibodies titers

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    End point title
    hSBA antibodies titers
    End point description
    End point type
    Secondary
    End point timeframe
    Persistence Year 1
    End point values
    Nimenrix™ 1-2 years of age Group Meningitec™ 1-2 years of age Group
    Number of subjects analysed
    215
    68
    Units: Titers
    geometric mean (confidence interval 95%)
        hSBA-MenA (PRE) [N=209;66]
    2 (2 to 2.1)
    2.2 (2 to 2.4)
        hSBA-MenA (PI[M1]) [N=211;63]
    57.6 (47.9 to 69.3)
    2.2 (1.9 to 2.5)
        hSBA-MenA (PI[M12]) [N=201;63]
    3.6 (3.1 to 4.2)
    2.2 (2 to 2.4)
        hSBA-MenC (PRE) [N=208;65]
    2.1 (2 to 2.2)
    2.1 (1.9 to 2.3)
        hSBA-MenC (PI[M1]) [N=215;66]
    187 (161.6 to 216.5)
    22 (14.3 to 33.8)
        hSBA-MenC (PI[M12]) [N=200;64]
    88.7 (73.8 to 106.5)
    12.2 (7.6 to 19.5)
        hSBA-MenW-135 (PRE) [N=199;62]
    2.1 (2 to 2.2)
    2.2 (2 to 2.4)
        hSBA-MenW-135 (PI[M1]) [N=173;56]
    38.5 (29.3 to 50.5)
    2.1 (2 to 2.2)
        hSBA-MenW-135 (PI[M12]) [N=175;62]
    225.1 (184.5 to 274.7)
    2.4 (1.9 to 3)
        hSBA-MenY (PRE) [N=182;55]
    2.2 (2 to 2.3)
    2.1 (2 to 2.2)
        hSBA-MenY (PI[M1]) [N=196;57]
    23.8 (18.1 to 31.4)
    2.5 (1.9 to 3.2)
        hSBA-MenY (PI[M12]) [N=214;68]
    105.1 (85.2 to 129.7)
    3.2 (2.3 to 4.4)
    No statistical analyses for this end point

    Secondary: Number of subjects with hSBA antibodies titers ≥ 1:4

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    End point title
    Number of subjects with hSBA antibodies titers ≥ 1:4
    End point description
    End point type
    Secondary
    End point timeframe
    Persistence Year 2
    End point values
    Nimenrix™ 1-2 years of age Group Meningitec™ 1-2 years of age Group
    Number of subjects analysed
    198
    51
    Units: Subjects
        hSBA-MenA (PRE) [N=193;51]
    3
    3
        hSBA-MenA (PI[M1]) [N=194;48]
    180
    2
        hSBA-MenA (PI[M24]) [N=180;50]
    73
    6
        hSBA-MenC (PRE) [N=192;49]
    2
    1
        hSBA-MenC (PI[M1]) [N=198;50]
    196
    38
        hSBA-MenC (PI[M24]) [N=191;51]
    179
    28
        hSBA-MenW-135 (PRE) [N=183;47]
    2
    2
        hSBA-MenW-135 (PI[M1]) [N=158;45]
    130
    1
        hSBA-MenW-135 (PI[M24]) [N=178;51]
    171
    5
        hSBA-MenY (PRE) [N=168;42]
    6
    2
        hSBA-MenY (PI[M1]) [N=181;44]
    121
    3
        hSBA-MenY (PI[M24]) [N=173;43]
    157
    13
    No statistical analyses for this end point

    Secondary: hSBA antibodies titers

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    End point title
    hSBA antibodies titers
    End point description
    End point type
    Secondary
    End point timeframe
    Persistence Year 2
    End point values
    Nimenrix™ 1-2 years of age Group Meningitec™ 1-2 years of age Group
    Number of subjects analysed
    198
    51
    Units: Titers
    geometric mean (confidence interval 95%)
        hSBA-MenA (PRE) [N=193;51]
    2 (2 to 2.1)
    2.2 (2 to 2.5)
        hSBA-MenA (PI[M1]) [N=194;48]
    58.8 (48.5 to 71.3)
    2.2 (1.9 to 2.7)
        hSBA-MenA (PI[M24]) [N=180;50]
    5.1 (4.2 to 6.1)
    2.3 (2 to 2.5)
        hSBA-MenC (PRE) [N=192;49]
    2.1 (2 to 2.1)
    2.1 (1.9 to 2.4)
        hSBA-MenC (PI[M1]) [N=198;50]
    185.4 (159.3 to 215.9)
    26.7 (16.1 to 44.3)
        hSBA-MenC (PI[M24]) [N=191;51]
    55.6 (45.1 to 68.5)
    11.8 (6.8 to 20.6)
        hSBA-MenW-135 (PRE) [N=183;47]
    2.1 (2 to 2.2)
    2.1 (2 to 2.3)
        hSBA-MenW-135 (PI[M1]) [N=158;45]
    38.7 (29.2 to 51.2)
    2.1 (1.9 to 2.2)
        hSBA-MenW-135 (PI[M24]) [N=178;51]
    111.4 (90.9 to 136.5)
    2.9 (2.1 to 4)
        hSBA-MenY (PRE) [N=168;42]
    2.1 (2 to 2.3)
    2.1 (2 to 2.2)
        hSBA-MenY (PI[M1]) [N=181;44]
    23.1 (17.4 to 30.8)
    2.6 (1.9 to 3.7)
        hSBA-MenY (PI[M24]) [N=173;43]
    72.5 (57 to 92.4)
    5 (3.1 to 7.9)
    No statistical analyses for this end point

    Secondary: Number of subjects with hSBA antibodies titers ≥ 1:4

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    End point title
    Number of subjects with hSBA antibodies titers ≥ 1:4
    End point description
    End point type
    Secondary
    End point timeframe
    Persistence Year 3
    End point values
    Nimenrix™ 1-2 years of age Group Meningitec™ 1-2 years of age Group
    Number of subjects analysed
    176
    37
    Units: Subjects
        hSBA-MenA (PRE) [N=172;37]
    1
    3
        hSBA-MenA (PI[M1]) [N=172;36]
    159
    3
        hSBA-MenA (PI[M36]) [N=170;36]
    37
    2
        hSBA-MenC (PRE) [N=170;35]
    2
    0
        hSBA-MenC (PI[M1]) [N=176;36]
    174
    31
        hSBA-MenC (PI[M36]) [N=166;33]
    147
    25
        hSBA-MenW-135 (PRE) [N=163;34]
    2
    2
        hSBA-MenW-135 (PI[M1]) [N=138;33]
    112
    1
        hSBA-MenW-135 (PI[M36]) [N=164;35]
    131
    3
        hSBA-MenY (PRE) [N=149;31]
    5
    2
        hSBA-MenY (PI[M1]) [N=161;34]
    110
    3
        hSBA-MenY (PI[M36]) [N=159;33]
    117
    9
    No statistical analyses for this end point

    Secondary: hSBA antibodies titers

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    End point title
    hSBA antibodies titers
    End point description
    End point type
    Secondary
    End point timeframe
    Persistence Year 3
    End point values
    Nimenrix™ 1-2 years of age Group Meningitec™ 1-2 years of age Group
    Number of subjects analysed
    176
    37
    Units: Titers
    geometric mean (confidence interval 95%)
        hSBA-MenA (PRE) [N=172;37]
    2 (2 to 2)
    2.3 (2 to 2.7)
        hSBA-MenA (PI[M1]) [N=172;36]
    56.9 (46.4 to 69.9)
    2.4 (1.9 to 3)
        hSBA-MenA (PI[M36]) [N=170;36]
    3.3 (2.8 to 3.8)
    2.2 (1.9 to 2.6)
        hSBA-MenC (PRE) [N=170;35]
    2.1 (2 to 2.2)
    2 (2 to 2)
        hSBA-MenC (PI[M1]) [N=176;36]
    182.7 (154.6 to 215.8)
    44.1 (25.2 to 77.3)
        hSBA-MenC (PI[M36]) [N=166;33]
    65.1 (49.6 to 85.5)
    32.5 (16 to 65.9)
        hSBA-MenW-135 (PRE) [N=163;34]
    2.1 (2 to 2.2)
    2.2 (1.9 to 2.6)
        hSBA-MenW-135 (PI[M1]) [N=138;33]
    39.1 (28.8 to 53.1)
    2.1 (1.9 to 2.3)
        hSBA-MenW-135 (PI[M36]) [N=164;35]
    40.8 (31.1 to 53.6)
    3 (1.9 to 4.7)
        hSBA-MenY (PRE) [N=149;31]
    2.1 (2 to 2.2)
    2.1 (1.9 to 2.3)
        hSBA-MenY (PI[M1]) [N=161;34]
    24.8 (18.3 to 33.5)
    2.8 (1.8 to 4.4)
        hSBA-MenY (PI[M36]) [N=159;33]
    37.3 (27.2 to 51.2)
    6 (3 to 11.9)
    No statistical analyses for this end point

    Secondary: Number of subjects with hSBA antibodies titers ≥ 1:4

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    End point title
    Number of subjects with hSBA antibodies titers ≥ 1:4
    End point description
    End point type
    Secondary
    End point timeframe
    Persistence Year 4
    End point values
    Nimenrix™ 1-2 years of age Group Meningitec™ 1-2 years of age Group
    Number of subjects analysed
    151
    31
    Units: Subjects
        hSBA-MenA (PRE) [N=148;30]
    0
    2
        hSBA-MenA (PI[M1]) [N=148;30]
    137
    1
        hSBA-MenA (PI[M48]) [N=140;31]
    57
    8
        hSBA-MenC (PRE) [N=146;28]
    2
    0
        hSBA-MenC (PI[M1]) [N=151;29]
    149
    25
        hSBA-MenC (PI[M48]) [N=147;31]
    126
    24
        hSBA-MenW-135 (PRE) [N=141;27]
    2
    1
        hSBA-MenW-135 (PI[M1]) [N=119;28]
    100
    1
        hSBA-MenW-135 (PI[M48]) [N=143;31]
    117
    3
        hSBA-MenY (PRE) [N=127;26]
    5
    1
        hSBA-MenY (PI[M1]) [N=139;28]
    93
    2
        hSBA-MenY (PI[M48]) [N=129;26]
    100
    12
    No statistical analyses for this end point

    Secondary: hSBA antibodies titers

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    End point title
    hSBA antibodies titers
    End point description
    End point type
    Secondary
    End point timeframe
    Persistence Year 4
    End point values
    Nimenrix™ 1-2 years of age Group Meningitec™ 1-2 years of age Group
    Number of subjects analysed
    151
    31
    Units: Titers
    geometric mean (confidence interval 95%)
        hSBA-MenA (PRE) [N=148;30]
    2 (2 to 2)
    2.2 (1.9 to 2.5)
        hSBA-MenA (PI[M1]) [N=148;30]
    57.7 (46.1 to 72.1)
    2.3 (1.8 to 2.9)
        hSBA-MenA (PI[M48]) [N=140;31]
    6 (4.7 to 7.7)
    3.1 (2.3 to 4)
        hSBA-MenC (PRE) [N=146;28]
    2.1 (2 to 2.2)
    2 (2 to 2)
        hSBA-MenC (PI[M1]) [N=151;29]
    192.5 (160.7 to 230.7)
    45 (23.3 to 86.9)
        hSBA-MenC (PI[M48]) [N=147;31]
    51.4 (36.9 to 71.7)
    32.4 (14.8 to 71.1)
        hSBA-MenW-135 (PRE) [N=141;27]
    2.1 (2 to 2.2)
    2.1 (1.9 to 2.3)
        hSBA-MenW-135 (PI[M1]) [N=119;28]
    41.7 (30.4 to 57.3)
    2.1 (1.9 to 2.3)
        hSBA-MenW-135 (PI[M48]) [N=143;31]
    48.3 (36.2 to 64.4)
    2.8 (1.9 to 4.2)
        hSBA-MenY (PRE) [N=127;26]
    2.1 (2 to 2.2)
    2.1 (1.9 to 2.3)
        hSBA-MenY (PI[M1]) [N=139;28]
    22.5 (16.3 to 31.1)
    2.6 (1.7 to 4.1)
        hSBA-MenY (PI[M48]) [N=129;26]
    42.1 (30.6 to 58.1)
    13.5 (5.6 to 32.3)
    No statistical analyses for this end point

    Secondary: Number of subjects with hSBA antibodies titers ≥ 1:4

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    End point title
    Number of subjects with hSBA antibodies titers ≥ 1:4
    End point description
    End point type
    Secondary
    End point timeframe
    Persistence Year 5
    End point values
    Nimenrix™ 1-2 years of age Group Meningitec™ 1-2 years of age Group
    Number of subjects analysed
    49
    11
    Units: Subjects
        hSBA-MenA (PRE) [N=47;11]
    0
    0
        hSBA-MenA (PI[M1]) [N=49;11]
    48
    0
        hSBA-MenA (PI[M60]) [N=45;11]
    16
    3
        hSBA-MenC (PRE) [N=45;10]
    0
    0
        hSBA-MenC (PI[M1]) [N=48;11]
    48
    9
        hSBA-MenC (PI[M60]) [N=48;11]
    45
    10
        hSBA-MenW-135 (PRE) [N=44;9]
    1
    1
        hSBA-MenW-135 (PI[M1]) [N=41;11]
    37
    0
        hSBA-MenW-135 (PI[M60]) [N=46;9]
    38
    2
        hSBA-MenY (PRE) [N=45;8]
    2
    2
        hSBA-MenY (PI[M1]) [N=48;10]
    40
    0
        hSBA-MenY (PI[M60]) [N=45;10]
    36
    4
    No statistical analyses for this end point

    Secondary: hSBA antibodies titers

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    End point title
    hSBA antibodies titers
    End point description
    End point type
    Secondary
    End point timeframe
    Persistence Year 5
    End point values
    Nimenrix™ 1-2 years of age Group Meningitec™ 1-2 years of age Group
    Number of subjects analysed
    49
    11
    Units: Titers
    geometric mean (confidence interval 95%)
        hSBA-MenA (PRE) [N=47;11]
    2 (2 to 2)
    2 (2 to 2)
        hSBA-MenA (PI[M1]) [N=49;11]
    78.5 (55.7 to 110.4)
    2 (2 to 2)
        hSBA-MenA (PI[M60]) [N=45;11]
    5.2 (3.4 to 7.8)
    3.6 (1.8 to 7.2)
        hSBA-MenC (PRE) [N=45;10]
    2 (2 to 2)
    2 (2 to 2)
        hSBA-MenC (PI[M1]) [N=48;11]
    252 (193.2 to 328.6)
    38.7 (10.5 to 142.9)
        hSBA-MenC (PI[M60]) [N=48;11]
    216.5 (123.6 to 379.1)
    108.7 (21.2 to 557.2)
        hSBA-MenW-135 (PRE) [N=44;9]
    2.2 (1.8 to 2.5)
    2.3 (1.6 to 3.3)
        hSBA-MenW-135 (PI[M1]) [N=41;11]
    81.3 (45.4 to 145.7)
    2 (2 to 2)
        hSBA-MenW-135 (PI[M60]) [N=46;9]
    59.7 (35.1 to 101.4)
    5.1 (1.2 to 20.9)
        hSBA-MenY (PRE) [N=45;8]
    2.1 (1.9 to 2.4)
    2.6 (1.7 to 3.8)
        hSBA-MenY (PI[M1]) [N=48;10]
    46.1 (27.4 to 77.5)
    2 (2 to 2)
        hSBA-MenY (PI[M60]) [N=45;10]
    70.6 (38.7 to 128.8)
    11.6 (2.2 to 59.4)
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited local symptoms

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    End point title
    Number of subjects with solicited local symptoms
    End point description
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) (1 - < 2 years of age and 2 - < 6 years of age groups) and 50 mm (6 - < 11 years of age groups) of injection site, respectively. Relationship analysis was not performed.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Day 0-3) follow-up period
    End point values
    Nimenrix™ 1-2 years of age Group Nimenrix™ 2-6 years of age Group Nimenrix™ 6-11 years of age Group Meningitec™ 1-2 years of age Group Mencevax™ 2-6 years of age Group Mencevax™ 6-11 years of age Group
    Number of subjects analysed
    228
    113
    117
    73
    39
    39
    Units: Subjects
        Any Pain
    76
    51
    84
    20
    28
    32
        Grade 3 Pain
    3
    2
    7
    0
    1
    1
        Any Redness
    84
    44
    53
    24
    8
    15
        Grade 3 Redness
    8
    12
    19
    1
    0
    0
        Any Swelling
    36
    29
    42
    11
    3
    6
        Grade 3 Swelling
    3
    9
    14
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited general symptoms

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    End point title
    Number of subjects with solicited general symptoms
    End point description
    Assessed solicited general symptoms were drowsiness, fever [defined as rectal temperature equal to or above 38.0 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Day 0-3) follow-up period
    End point values
    Nimenrix™ 1-2 years of age Group Nimenrix™ 2-6 years of age Group Nimenrix™ 6-11 years of age Group Meningitec™ 1-2 years of age Group Mencevax™ 2-6 years of age Group Mencevax™ 6-11 years of age Group
    Number of subjects analysed
    228
    113
    117
    73
    39
    39
    Units: Subjects
        Any Drowsiness
    63
    30
    45
    25
    5
    8
        Grade 3 Drowsiness
    2
    0
    1
    0
    0
    0
        Related Drowsiness
    61
    29
    45
    25
    5
    8
        Any Fever
    36
    7
    11
    9
    2
    1
        Grade 3 Fever >40.0˚C
    2
    0
    0
    0
    0
    0
        Related Fever
    32
    7
    11
    9
    2
    0
        Any Irritability
    88
    18
    23
    29
    11
    5
        Grade 3 Irritability
    2
    0
    3
    0
    0
    1
        Related Irritability
    85
    18
    21
    29
    10
    4
        Any Loss of appetite
    54
    16
    31
    17
    6
    6
        Grade 3 Loss of appetite
    2
    0
    1
    0
    0
    0
        Related Loss of appetite
    52
    16
    29
    17
    5
    5
    No statistical analyses for this end point

    Secondary: Number of subjects with rash

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    End point title
    Number of subjects with rash [13]
    End point description
    End point type
    Secondary
    End point timeframe
    From administration of the vaccine dose until 6 months later
    Notes
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    Nimenrix™ 1-2 years of age Group Meningitec™ 1-2 years of age Group Nimenrix™ 2-11 years of age Primary Phase Group Mencevax™ 2-11 years of age Primary Phase Group
    Number of subjects analysed
    229
    75
    231
    78
    Units: Subjects
        At least one symptom
    10
    6
    9
    1
    No statistical analyses for this end point

    Secondary: Number of subjects with New Onset of Chronic Illnesses (NOCIs)

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    End point title
    Number of subjects with New Onset of Chronic Illnesses (NOCIs) [14]
    End point description
    NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
    End point type
    Secondary
    End point timeframe
    From administration of the vaccine dose until 6 months later
    Notes
    [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    Nimenrix™ 1-2 years of age Group Meningitec™ 1-2 years of age Group Nimenrix™ 2-11 years of age Primary Phase Group Mencevax™ 2-11 years of age Primary Phase Group
    Number of subjects analysed
    229
    75
    231
    78
    Units: Subjects
        At least one symptom
    1
    0
    2
    4
    No statistical analyses for this end point

    Secondary: Number of subjects with Adverse Events (AEs) resulting in an Emergency Room (ER) visit

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    End point title
    Number of subjects with Adverse Events (AEs) resulting in an Emergency Room (ER) visit [15]
    End point description
    End point type
    Secondary
    End point timeframe
    From administration of the vaccine dose until 6 months later
    Notes
    [15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    Nimenrix™ 1-2 years of age Group Meningitec™ 1-2 years of age Group Nimenrix™ 2-11 years of age Primary Phase Group Mencevax™ 2-11 years of age Primary Phase Group
    Number of subjects analysed
    229
    75
    231
    78
    Units: Subjects
        At least one symptom
    21
    8
    15
    5
    No statistical analyses for this end point

    Secondary: Number of subjects with unsolicited AEs

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    End point title
    Number of subjects with unsolicited AEs [16]
    End point description
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
    End point type
    Secondary
    End point timeframe
    During the 31-day (Days 0-30) post-vaccination period
    Notes
    [16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    Nimenrix™ 1-2 years of age Group Meningitec™ 1-2 years of age Group Nimenrix™ 2-11 years of age Primary Phase Group Mencevax™ 2-11 years of age Primary Phase Group
    Number of subjects analysed
    229
    75
    231
    78
    Units: Subjects
        Any AE(s)
    121
    38
    83
    24
    No statistical analyses for this end point

    Secondary: Number of subjects with Serious Adverse Events (SAEs)

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    End point title
    Number of subjects with Serious Adverse Events (SAEs) [17]
    End point description
    SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
    End point type
    Secondary
    End point timeframe
    Up to 6 Months after vaccination
    Notes
    [17] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    Nimenrix™ 1-2 years of age Group Meningitec™ 1-2 years of age Group Nimenrix™ 2-11 years of age Primary Phase Group Mencevax™ 2-11 years of age Primary Phase Group
    Number of subjects analysed
    229
    75
    231
    78
    Units: Subjects
        Any SAE(s)
    5
    7
    2
    1
    No statistical analyses for this end point

    Secondary: Number of subjects with SAE(s)

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    End point title
    Number of subjects with SAE(s)
    End point description
    SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
    End point type
    Secondary
    End point timeframe
    From 6 Months after vaccination up to Year 1
    End point values
    Nimenrix™ 1-2 years of age Group Nimenrix™ 2-11 years of age Group Meningitec™ 1-2 years of age Group Mencevax™ 2-11 years of age Group
    Number of subjects analysed
    222
    221
    71
    78
    Units: Subjects
        Any SAE(s)
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with SAE(s)

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    End point title
    Number of subjects with SAE(s)
    End point description
    SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
    End point type
    Secondary
    End point timeframe
    From 6 Months after vaccination up to Year 2
    End point values
    Nimenrix™ 1-2 years of age Group Nimenrix™ 2-11 years of age Group Meningitec™ 1-2 years of age Group Mencevax™ 2-11 years of age Group
    Number of subjects analysed
    208
    215
    53
    61
    Units: Subjects
        Any SAE(s)
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with SAE(s)

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    End point title
    Number of subjects with SAE(s)
    End point description
    SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
    End point type
    Secondary
    End point timeframe
    From 6 Months following vaccination up to Year 3
    End point values
    Nimenrix™ 1-2 years of age Group Nimenrix™ 2-11 years of age Group Meningitec™ 1-2 years of age Group Mencevax™ 2-11 years of age Group
    Number of subjects analysed
    185
    201
    38
    38
    Units: Subjects
        Any SAE(s)
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with SAE(s)

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    End point title
    Number of subjects with SAE(s)
    End point description
    SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
    End point type
    Secondary
    End point timeframe
    From 6 Months following vaccination up to Year 4
    End point values
    Nimenrix™ 1-2 years of age Group Nimenrix™ 2-11 years of age Group Meningitec™ 1-2 years of age Group Mencevax™ 2-11 years of age Group
    Number of subjects analysed
    165
    192
    34
    32
    Units: Subjects
        Any SAE(s)
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with SAE(s)

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    End point title
    Number of subjects with SAE(s)
    End point description
    SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
    End point type
    Secondary
    End point timeframe
    From 6 Months following vaccination up to Year 5
    End point values
    Nimenrix™ 1-2 years of age Group Nimenrix™ 2-11 years of age Group Meningitec™ 1-2 years of age Group Mencevax™ 2-11 years of age Group
    Number of subjects analysed
    52
    99
    12
    13
    Units: Subjects
        Any SAE(s)
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-PS antibodies concentrations ≥ 0.3 µg/mL and ≥ 2.0 µg/mL

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    End point title
    Number of subjects with anti-PS antibodies concentrations ≥ 0.3 µg/mL and ≥ 2.0 µg/mL
    End point description
    End point type
    Secondary
    End point timeframe
    Prior to (PRE) and one month after vaccination [PI(M1)]
    End point values
    Nimenrix™ 2-11 years of age Primary Phase Group Mencevax™ 2-11 years of age Primary Phase Group
    Number of subjects analysed
    225
    75
    Units: Subjects
        Anti-PSA ≥0.3µg/mL, PRE [N=218,75]
    29
    12
        Anti-PSA ≥0.3µg/mL, PI(M1) [N=224,74]
    224
    73
        Anti-PSA ≥2.0µg/mL, PRE [N=218,75]
    9
    2
        Anti-PSA ≥2.0µg/mL, PI(M1) [N=224,74]
    224
    68
        Anti-PSC ≥0.3µg/mL , PRE [N=225,74]
    28
    6
        Anti-PSC ≥0.3µg/mL, PI(M1) [N=224,74]
    224
    74
        Anti-PSC ≥2.0µg/mL, PRE [N=225,74]
    9
    2
        Anti-PSC ≥2.0µg/mL, PI(M1) [N=224,74]
    223
    71
        Anti-PSW-135 ≥0.3µg/mL , PRE [N=225,75]
    3
    1
        Anti-PSW-135 ≥0.3µg/mL , PI(M1) [N=224,74]
    224
    72
        Anti-PSW-135 ≥2.0µg/mL , PRE [N=225,75]
    0
    0
        Anti-PSW-135 ≥2.0µg/mL , PI(M1) [N=224,74]
    197
    54
        Anti-PSY ≥0.3µg/mL, PRE [N=224,74]
    6
    0
        Anti-PSY ≥0.3µg/mL, PI(M1) [N=225,74]
    225
    72
        Anti-PSY ≥2.0µg/mL, PRE [N=224,74]
    1
    0
        Anti-PSY ≥2.0µg/mL, PI(M1) [N=225,74]
    217
    71
    No statistical analyses for this end point

    Secondary: Anti-PS antibodies concentrations

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    End point title
    Anti-PS antibodies concentrations
    End point description
    End point type
    Secondary
    End point timeframe
    Prior to (PRE) and one month post vaccination [PI(M1)]
    End point values
    Nimenrix™ 2-11 years of age Primary Phase Group Mencevax™ 2-11 years of age Primary Phase Group
    Number of subjects analysed
    225
    75
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PSA, PRE [N=218,75]
    0.19 (0.17 to 0.21)
    0.2 (0.16 to 0.23)
        Anti-PSA, PI(M1) [N=224,74]
    36.35 (32.3 to 40.91)
    10.34 (7.79 to 13.72)
        Anti-PSC, PRE [N=225,74]
    0.2 (0.18 to 0.22)
    0.19 (0.15 to 0.22)
        Anti-PSC, PI(M1) [N=224,74]
    13.33 (11.75 to 15.12)
    14.53 (11.13 to 18.95)
        Anti-PSW-135, PRE [N=225,75]
    0.15 (0.15 to 0.15)
    0.15 (0.15 to 0.16)
        Anti-PSW-135, PI(M1) [N=224,74]
    6.35 (5.53 to 7.29)
    4.62 (3.37 to 6.35)
        Anti-PSY, PRE [N=224,74]
    0.16 (0.15 to 0.16)
    0.15 (0.15 to 0.15)
        Anti-PSY, PI(M1) [N=225,74]
    11.35 (10.01 to 12.87)
    15.45 (11.42 to 20.91)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-TT antibody concentrations ≥ 0.1 IU/mL

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    End point title
    Number of subjects with anti-TT antibody concentrations ≥ 0.1 IU/mL
    End point description
    End point type
    Secondary
    End point timeframe
    Prior to (PRE) and one month after vaccination [PI(M1)]
    End point values
    Nimenrix™ 2-11 years of age Primary Phase Group Mencevax™ 2-11 years of age Primary Phase Group
    Number of subjects analysed
    32
    7
    Units: Subjects
        Anti-TT, PRE [N=19,4]
    19
    4
        Anti-TT, PI(M1) [N=32,7]
    32
    7
    No statistical analyses for this end point

    Secondary: Anti-TT antibody concentrations

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    End point title
    Anti-TT antibody concentrations
    End point description
    End point type
    Secondary
    End point timeframe
    Prior to (PRE) and one month after vaccination [PI(M1)]
    End point values
    Nimenrix™ 2-11 years of age Primary Phase Group Mencevax™ 2-11 years of age Primary Phase Group
    Number of subjects analysed
    32
    7
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-TT, PRE [N=19,4]
    1.541 (0.856 to 2.775)
    2.103 (0.129 to 34.398)
        Anti-TT, PI(M1) [N=32,7]
    20.951 (14.656 to 29.949)
    1.74 (0.536 to 5.642)
    No statistical analyses for this end point

    Secondary: Number of subjects with hSBA antibodies titers ≥ 1:4

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    End point title
    Number of subjects with hSBA antibodies titers ≥ 1:4 [18]
    End point description
    End point type
    Secondary
    End point timeframe
    Prior to (PRE) and one month after vaccination [PI(M1)]
    Notes
    [18] - 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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    Nimenrix™ 1-2 years of age Group Meningitec™ 1-2 years of age Group
    Number of subjects analysed
    221
    68
    Units: Subjects
        hSBA-MenA, PRE [N=215,68]
    3
    3
        hBA-MenA, PI(M1) [N=217,65]
    203
    4
        hSBA-MenC, PRE [N=214,67]
    3
    1
        hSBA-MenC, PI(M1) [N=221,68]
    219
    49
        hSBA-MenW-135, PRE [N=205,64]
    2
    3
        hSBA-MenW-135, PI(M1) [N=177,58]
    145
    1
        hSBA-MenY, PRE [N=189,57]
    7
    2
        hSBA-MenY, PI(M1) [N=201,59]
    135
    3
    No statistical analyses for this end point

    Secondary: hSBA antibodies titers

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    End point title
    hSBA antibodies titers [19]
    End point description
    End point type
    Secondary
    End point timeframe
    Prior to (PRE) and one month after vaccination [PI(M1)]
    Notes
    [19] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    Nimenrix™ 1-2 years of age Group Meningitec™ 1-2 years of age Group
    Number of subjects analysed
    221
    68
    Units: Titers
    geometric mean (confidence interval 95%)
        hSBA-MenA, PRE [N=215,68]
    2 (2 to 2.1)
    2.2 (2 to 2.3)
        hBA-MenA, PI(M1) [N=217,65]
    59 (49.3 to 70.6)
    2.3 (2 to 2.6)
        hSBA-MenC, PRE [N=214,67]
    2.1 (2 to 2.2)
    2.1 (1.9 to 2.3)
        hSBA-MenC, PI(M1) [N=221,68]
    190 (164.7 to 219.2)
    21.2 (13.9 to 32.3)
        hSBA-MenW-135, PRE [N=205,64]
    2.1 (2 to 2.1)
    2.2 (2 to 2.4)
        hSBA-MenW-135, PI(M1) [N=177,58]
    38.8 (29.7 to 50.6)
    2 (2 to 2.1)
        hSBA-MenY, PRE [N=189,57]
    2.2 (2 to 2.3)
    2.1 (2 to 2.2)
        hSBA-MenY, PI(M1) [N=201,59]
    24.4 (18.6 to 32.1)
    2.4 (1.9 to 3.1)
    No statistical analyses for this end point

    Secondary: Number of subjects with rSBA antibodies titers ≥ 1:128

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    End point title
    Number of subjects with rSBA antibodies titers ≥ 1:128 [20]
    End point description
    End point type
    Secondary
    End point timeframe
    Prior to (PRE) and one month after vaccination [PI(M1)]
    Notes
    [20] - 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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    Nimenrix™ 1-2 years of age Group Meningitec™ 1-2 years of age Group
    Number of subjects analysed
    222
    68
    Units: Subjects
        rSBA-MenA, PRE [N=191,65]
    59
    20
        rSBA-MenA, PI(M1) [N=222,63]
    222
    16
        rSBA-MenC, PRE [N=203,61]
    29
    4
        rSBA-MenC, PI(M1) [N=220,68]
    218
    56
        rSBA-MenW-135, PRE [N=208,62]
    38
    16
        rSBA-MenW-135, PI(M1) [N=222,63]
    222
    18
        rSBA-MenY, PRE [N=208,67]
    77
    28
        rSBA-MenY, PI(M1) [N=222,66]
    221
    31
    No statistical analyses for this end point

    Secondary: rSBA antibodies titers

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    End point title
    rSBA antibodies titers [21]
    End point description
    End point type
    Secondary
    End point timeframe
    Prior to (PRE) and one month after vaccination [PI(M1)]
    Notes
    [21] - 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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    Nimenrix™ 1-2 years of age Group Meningitec™ 1-2 years of age Group
    Number of subjects analysed
    222
    68
    Units: Titers
    geometric mean (confidence interval 95%)
        rSBA-MenA, PRE [N=191,65]
    21.6 (16.1 to 29)
    20.2 (12.1 to 33.8)
        rSBA-MenA, PI(M1) [N=222,63]
    3706.5 (3327.2 to 4128.9)
    17.1 (10.1 to 29)
        rSBA-MenC, PRE [N=203,61]
    13.9 (11 to 17.5)
    9.7 (6.8 to 13.9)
        rSBA-MenC, PI(M1) [N=220,68]
    878.7 (779.4 to 990.7)
    415 (296.9 to 580)
        rSBA-MenW-135, PRE [N=208,62]
    11.3 (8.9 to 14.3)
    16.5 (10.2 to 26.7)
        rSBA-MenW-135, PI(M1) [N=222,63]
    5394.6 (4869.9 to 5975.7)
    20.3 (12.5 to 33.2)
        rSBA-MenY, PRE [N=208,67]
    33.8 (25.6 to 44.6)
    45.3 (27 to 75.8)
        rSBA-MenY, PI(M1) [N=222,66]
    2823.8 (2529 to 3153.1)
    77.1 (46.3 to 128.2)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited symptoms during the 4-day (Day 0-3) follow-up vaccination period, Unsolicited AEs during the 31-day (Days 0-30) post-vaccination period, SAEs during the entire study periods.
    Adverse event reporting additional description
    The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    11.1
    Reporting groups
    Reporting group title
    Nimenrix™ 1-2 years of age Group
    Reporting group description
    -

    Reporting group title
    Nimenrix™ 2-11 years of age Group
    Reporting group description
    -

    Reporting group title
    Meningitec™ 1-2 years of age Group
    Reporting group description
    -

    Reporting group title
    Mencevax™ 2-11 years of age Group
    Reporting group description
    -

    Serious adverse events
    Nimenrix™ 1-2 years of age Group Nimenrix™ 2-11 years of age Group Meningitec™ 1-2 years of age Group Mencevax™ 2-11 years of age Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 229 (2.18%)
    2 / 231 (0.87%)
    7 / 75 (9.33%)
    1 / 78 (1.28%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Lower limb fracture
         subjects affected / exposed
    1 / 229 (0.44%)
    0 / 231 (0.00%)
    0 / 75 (0.00%)
    0 / 78 (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
    Bronchitis chronic
         subjects affected / exposed
    1 / 229 (0.44%)
    0 / 231 (0.00%)
    2 / 75 (2.67%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Stomatitis
         subjects affected / exposed
    1 / 229 (0.44%)
    0 / 231 (0.00%)
    0 / 75 (0.00%)
    0 / 78 (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
    Testicular torsion
         subjects affected / exposed
    0 / 229 (0.00%)
    0 / 231 (0.00%)
    0 / 75 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperglycemia
         subjects affected / exposed
    0 / 229 (0.00%)
    1 / 231 (0.43%)
    0 / 75 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations