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    Clinical Trial Results:
    A phase III, open, controlled study to evaluate immunogenicity of GSK Biologicals’ MenACWY-TT conjugate vaccine administered intramuscularly to at risk subjects from 1 to less than 18 years and to an age-matched control group of healthy subjects

    Due to the EudraCT – Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines.
    Summary
    EudraCT number
    		 2011-002410-36
    Trial protocol
    		 CZ   Outside EU/EEA  
    Global end of trial date
    03 Mar 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 May 2016
    First version publication date
    27 May 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    115524
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01641042
    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, 44 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000429-PIP01-08
    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
    03 Mar 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Oct 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Mar 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the immunogenicity of 1 and 2 doses of MenACWY-TT administered to at risk subjects compared to age-matched healthy subjects in terms of rSBA and hSBA vaccine response rates for N. meningitidis serogroups A, C, W-135 and Y.
    Protection of trial subjects
    All subjects were supervised for 30 minutes 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 31 days after the last vaccination/product administration.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Sep 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Czech Republic: 62
    Country: Number of subjects enrolled
    United States: 24
    Worldwide total number of subjects
    86
    EEA total number of subjects
    62
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    36
    Adolescents (12-17 years)
    50
    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
    Overall Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Nimenrix™ At risk Group
    Arm description
    		 Subjects with an increased risk for meningococcal disease such as anatomic asplenia or some degree of functional asplenia received two doses of the MenACWY-TT vaccine at Visit 1 (Month 0) and Visit 3 (Month 2).
    Arm type
    		 Experimental

    Investigational medicinal product name
    NimenrixTM
    Investigational medicinal product code
    Other name
    Meningococcal vaccine GSK134612
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.

    Arm title
    		 Nimenrix™ Healthy Group
    Arm description
    		 Subjects age matched with the subjects in the At-risk Group received two doses of the MenACWY-TT vaccine at Visit 1 (Month 0) and Visit 3 (Month 2).
    Arm type
    		 Experimental

    Investigational medicinal product name
    NimenrixTM
    Investigational medicinal product code
    Other name
    Meningococcal vaccine GSK134612
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.

    Number of subjects in period 1
    		Nimenrix™ At risk Group Nimenrix™ Healthy Group
    Started
    43
    43
    Completed
    43
    43

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Nimenrix™ At risk Group
    Reporting group description
    		 Subjects with an increased risk for meningococcal disease such as anatomic asplenia or some degree of functional asplenia received two doses of the MenACWY-TT vaccine at Visit 1 (Month 0) and Visit 3 (Month 2).

    Reporting group title
    Nimenrix™ Healthy Group
    Reporting group description
    		 Subjects age matched with the subjects in the At-risk Group received two doses of the MenACWY-TT vaccine at Visit 1 (Month 0) and Visit 3 (Month 2).

    Reporting group values
    		 Nimenrix™ At risk Group Nimenrix™ Healthy Group Total
    Number of subjects
    		 43 43 86
    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: years
        arithmetic mean (standard deviation)
    		 12 ( 4.4 ) 11.5 ( 3.6 ) -
    Gender categorical
    Units: Subjects
        Female
    		 20 22 42
        Male
    		 23 21 44

    End points

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    End points reporting groups
    Reporting group title
    Nimenrix™ At risk Group
    Reporting group description
    		 Subjects with an increased risk for meningococcal disease such as anatomic asplenia or some degree of functional asplenia received two doses of the MenACWY-TT vaccine at Visit 1 (Month 0) and Visit 3 (Month 2).

    Reporting group title
    Nimenrix™ Healthy Group
    Reporting group description
    		 Subjects age matched with the subjects in the At-risk Group received two doses of the MenACWY-TT vaccine at Visit 1 (Month 0) and Visit 3 (Month 2).

    Primary: Number of subjects with a vaccine response to rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibodies

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    End point title
    		 Number of subjects with a vaccine response to rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibodies [1]
    End point description
    Vaccine response to rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY is defined as rSBA antibody titers ≥1:32, for initially seronegative subjects (i.e. pre-vaccination rSBA antibody titres <1:8) and at least a 4-fold increase in rSBA antibody titres from pre to post-vaccination for initially seropositive subjects (i.e. pre-vaccination rSBA antibody titres ≥1:8).
    End point type
    Primary
    End point timeframe
    At 1 month post first vaccine dose
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Nimenrix™ At risk Group Nimenrix™ Healthy Group
    Number of subjects analysed
    40
    40
    Units: Subjects
        rSBA-MenA
    40
    39
        rSBA-MenC
    37
    39
        rSBA-MenW-135
    40
    39
        rSBA-MenY
    39
    40
    No statistical analyses for this end point

    Primary: Number of subjects with a vaccine response to hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY antibodies

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    End point title
    		 Number of subjects with a vaccine response to hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY antibodies [2]
    End point description
    Vaccine response to hSBA-MenA, hSBA-MenC, rSBA-MenW-135 and hSBA-MenY is defined as hSBA antibody titers ≥1:8, for initially seronegative subjects (i.e. pre-vaccination hSBA antibody titres <1:4) and at least a 4-fold increase in hSBA antibody titres from pre to post-vaccination for initially seropositive subjects (i.e. pre-vaccination hSBA antibody titres ≥1:4).
    End point type
    Primary
    End point timeframe
    At 1 month post first vaccine dose
    Notes
    [2] - 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 scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Nimenrix™ At risk Group Nimenrix™ Healthy Group
    Number of subjects analysed
    38
    38
    Units: Subjects
        hSBA-MenA [N = 33, 33]
    23
    23
        hSBA-MenC [N = 35, 33]
    27
    20
        hSBA-MenW-135 [N = 36, 32]
    20
    21
        hSBA-MenY [N = 38, 38]
    23
    29
    No statistical analyses for this end point

    Primary: Number of subjects with a vaccine response to rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibodies

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    End point title
    		 Number of subjects with a vaccine response to rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibodies [3]
    End point description
    Vaccine response to rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY is defined as rSBA antibody titers ≥1:32, for initially seronegative subjects (i.e. pre-vaccination rSBA antibody titres <1:8) and at least a 4-fold increase in rSBA antibody titres from pre to post-vaccination for initially seropositive subjects (i.e. pre-vaccination rSBA antibody titres ≥1:8).
    End point type
    Primary
    End point timeframe
    At 1 month post second vaccine dose
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Nimenrix™ At risk Group Nimenrix™ Healthy Group
    Number of subjects analysed
    39
    39
    Units: Subjects
        rSBA-MenA
    39
    39
        rSBA-MenC
    39
    39
        rSBA-MenW-135
    39
    39
        rSBA-MenY
    39
    39
    No statistical analyses for this end point

    Primary: Number of subjects with a vaccine response to hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY antibodies

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    End point title
    		 Number of subjects with a vaccine response to hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY antibodies [4]
    End point description
    Vaccine response to hSBA-MenA, hSBA-MenC, rSBA-MenW-135 and hSBA-MenY is defined as hSBA antibody titers ≥1:8, for initially seronegative subjects (i.e. pre-vaccination hSBA antibody titres <1:4) and at least a 4-fold increase in hSBA antibody titres from pre to post-vaccination for initially seropositive subjects (i.e. pre-vaccination hSBA antibody titres ≥1:4).
    End point type
    Primary
    End point timeframe
    At 1 month post second vaccine dose
    Notes
    [4] - 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 scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Nimenrix™ At risk Group Nimenrix™ Healthy Group
    Number of subjects analysed
    37
    37
    Units: Subjects
        hSBA-MenA [N = 33, 32]
    28
    24
        hSBA-MenC [N = 34, 34]
    34
    29
        hSBA-MenW-135 [N = 36, 31]
    29
    24
        hSBA-MenY [N = 37, 37]
    27
    27
    No statistical analyses for this end point

    Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY titers equal to or above the cut-off values

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    End point title
    		 Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY titers equal to or above the cut-off values
    End point description
    Antibody titers equal to or above (≥) 1:8.
    End point type
    Secondary
    End point timeframe
    At pre, post first vaccine dose and post second vaccine dose
    End point values
    		 Nimenrix™ At risk Group Nimenrix™ Healthy Group
    Number of subjects analysed
    40
    40
    Units: Subjects
        rSBA-MenA; Month 0 [N = 40, 40]
    7
    2
        rSBA-MenA; Month 1 [N = 40, 40]
    40
    40
        rSBA-MenA; Month 3 [N = 39, 39]
    39
    39
        rSBA-MenC; Month 0 [N = 40, 40]
    10
    5
        rSBA-MenC; Month 1 [N = 40, 40]
    37
    39
        rSBA-MenC; Month 3 [N = 39, 39]
    39
    39
        rSBA-MenW-135; Month 0 [N = 40, 40]
    5
    3
        rSBA-MenW-135; Month 1 [N = 40, 40]
    40
    39
        rSBA-MenW-135; Month 3 [N = 39, 39]
    39
    39
        rSBA-MenY; Month 0 [N = 40, 40]
    9
    8
        rSBA-MenY; Month 1 [N = 40, 40]
    40
    40
        rSBA-MenY; Month 3 [N = 39, 39]
    39
    39
    No statistical analyses for this end point

    Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY titers equal to or above the cut-off values

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    End point title
    		 Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY titers equal to or above the cut-off values
    End point description
    Antibody titers equal to or above (≥) 1:128.
    End point type
    Secondary
    End point timeframe
    At pre, post first vaccine dose and post second vaccine dose
    End point values
    		 Nimenrix™ At risk Group Nimenrix™ Healthy Group
    Number of subjects analysed
    40
    40
    Units: Subjects
        rSBA-MenA; Month 0 [N = 40, 40]
    6
    1
        rSBA-MenA; Month 1 [N = 40, 40]
    40
    40
        rSBA-MenA; Month 3 [N = 39, 39]
    39
    39
        rSBA-MenC; Month 0 [N = 40, 40]
    3
    4
        rSBA-MenC; Month 1 [N = 40, 40]
    37
    39
        rSBA-MenC; Month 3 [N = 39, 39]
    38
    38
        rSBA-MenW-135; Month 0 [N = 40, 40]
    4
    2
        rSBA-MenW-135; Month 1 [N = 40, 40]
    40
    39
        rSBA-MenW-135; Month 3 [N = 39, 39]
    38
    39
        rSBA-MenY; Month 0 [N = 40, 40]
    8
    8
        rSBA-MenY; Month 1 [N = 40, 40]
    40
    40
        rSBA-MenY; Month 3 [N = 39, 39]
    39
    39
    No statistical analyses for this end point

    Secondary: Antibody titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY meningococcal antigens

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    End point title
    		 Antibody titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY meningococcal antigens
    End point description
    Antibody titers were measured in Geometric mean titers (GMTs).
    End point type
    Secondary
    End point timeframe
    At pre, post first vaccine dose and post second vaccine dose
    End point values
    		 Nimenrix™ At risk Group Nimenrix™ Healthy Group
    Number of subjects analysed
    40
    40
    Units: Titers
    geometric mean (confidence interval 95%)
        rSBA-MenA; Month 0 [N = 40, 40]
    8.6 (4.8 to 15.3)
    4.8 (3.6 to 6.3)
        rSBA-MenA; Month 1 [N = 40, 40]
    2012.8 (1414 to 2865.3)
    4025.6 (3065.1 to 5287.2)
        rSBA-MenA; Month 3 [N = 39, 39]
    2820.1 (1899 to 4187.9)
    3553.1 (2640.3 to 4781.5)
        rSBA-MenC; Month 0 [N = 40, 40]
    9 (5.4 to 15)
    6.3 (4.2 to 9.3)
        rSBA-MenC; Month 1 [N = 40, 40]
    1374.8 (693.4 to 2725.7)
    2233.4 (1197.4 to 4165.6)
        rSBA-MenC; Month 3 [N = 39, 39]
    1684.3 (1097.8 to 2584.1)
    1684.3 (1087.8 to 2608.1)
        rSBA-MenW-135; Month 0 [N = 40, 40]
    7 (4.2 to 11.7)
    5.1 (3.8 to 6.9)
        rSBA-MenW-135; Month 1 [N = 40, 40]
    3050.9 (2029.8 to 4585.5)
    4167.6 (2620 to 6629.2)
        rSBA-MenW-135; Month 3 [N = 39, 39]
    5844.3 (4046.3 to 8441.3)
    6981.1 (5467.9 to 8913)
        rSBA-MenY; Month 0 [N = 40, 40]
    10.6 (5.7 to 19.7)
    9.7 (5.4 to 17.3)
        rSBA-MenY; Month 1 [N = 40, 40]
    4624.2 (3125.5 to 6841.6)
    7009 (5175.6 to 9491.9)
        rSBA-MenY; Month 3 [N = 39, 39]
    5640.2 (4142.5 to 7679.5)
    6618.6 (4875.6 to 8984.6)
    No statistical analyses for this end point

    Secondary: Number of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY titers equal to or above the cut-off values

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    End point title
    		 Number of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY titers equal to or above the cut-off values
    End point description
    Antibody titers equal to or above (≥) 1:4.
    End point type
    Secondary
    End point timeframe
    At pre, post first vaccine dose and post second vaccine dose
    End point values
    		 Nimenrix™ At risk Group Nimenrix™ Healthy Group
    Number of subjects analysed
    40
    40
    Units: Subjects
        hSBA-MenA; Month 0 [N = 36, 35]
    14
    12
        hSBA-MenA; Month 1 [N = 35, 37]
    29
    28
        hSBA-MenA; Month 3 [N = 37, 36]
    35
    29
        hSBA-MenC; Month 0 [N = 36, 35]
    21
    23
        hSBA-MenC; Month 1 [N = 37, 38]
    34
    36
        hSBA-MenC; Month 3 [N = 38, 39]
    38
    39
        hSBA-MenW-135; Month 0 [N = 37, 33]
    20
    16
        hSBA-MenW-135; Month 1 [N = 37, 39]
    34
    39
        hSBA-MenW-135; Month 3 [N = 39, 38]
    39
    38
        hSBA-MenY; Month 0 [N = 38, 38]
    24
    25
        hSBA-MenY; Month 1 [N = 40, 40]
    37
    40
        hSBA-MenY; Month 3 [N = 39, 39]
    39
    39
    No statistical analyses for this end point

    Secondary: Number of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY titers equal to or above the cut-off values

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    End point title
    		 Number of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY titers equal to or above the cut-off values
    End point description
    Antibody titers equal to or above (≥) 1:8.
    End point type
    Secondary
    End point timeframe
    At pre, post first vaccine dose and post second vaccine dose
    End point values
    		 Nimenrix™ At risk Group Nimenrix™ Healthy Group
    Number of subjects analysed
    40
    40
    Units: Subjects
        hSBA-MenA; Month 0 [N = 36, 35]
    13
    12
        hSBA-MenA; Month 1 [N = 35, 37]
    29
    28
        hSBA-MenA; Month 3 [N = 37, 36]
    35
    29
        hSBA-MenC; Month 0 [N = 36, 35]
    20
    22
        hSBA-MenC; Month 1 [N = 37, 38]
    34
    36
        hSBA-MenC; Month 3 [N = 38, 39]
    38
    39
        hSBA-MenW-135; Month 0 [N = 37, 33]
    20
    16
        hSBA-MenW-135; Month 1 [N = 37, 39]
    34
    39
        hSBA-MenW-135; Month 3 [N = 39, 38]
    39
    38
        hSBA-MenY; Month 0 [N = 38, 38]
    24
    25
        hSBA-MenY; Month 1 [N = 40, 40]
    37
    40
        hSBA-MenY; Month 3 [N = 39, 39]
    39
    39
    No statistical analyses for this end point

    Secondary: Antibody titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY meningococcal antigens

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    End point title
    		 Antibody titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY meningococcal antigens
    End point description
    Antibody titers were measured in Geometric mean titers (GMTs).
    End point type
    Secondary
    End point timeframe
    At pre, post first vaccine dose and post second vaccine dose
    End point values
    		 Nimenrix™ At risk Group Nimenrix™ Healthy Group
    Number of subjects analysed
    40
    40
    Units: Titers
    geometric mean (confidence interval 95%)
        hSBA-MenA; Month 0 [N = 36, 35]
    5.5 (3.4 to 8.9)
    4.2 (2.9 to 6.1)
        hSBA-MenA; Month 1 [N = 35, 37]
    105.9 (47.6 to 235.6)
    68.7 (32.6 to 144.5)
        hSBA-MenA; Month 3 [N = 37, 36]
    235.1 (136.2 to 405.9)
    90.3 (44.8 to 182.1)
        hSBA-MenC; Month 0 [N = 36, 35]
    12.9 (6.5 to 25.7)
    10.9 (6.3 to 18.6)
        hSBA-MenC; Month 1 [N = 37, 38]
    812.9 (283.5 to 2330.9)
    196.7 (84.6 to 457.2)
        hSBA-MenC; Month 3 [N = 38, 39]
    1472.1 (733.6 to 2954)
    764.6 (404.8 to 1444.5)
        hSBA-MenW-135; Month 0 [N = 37, 33]
    21.7 (9.9 to 47.7)
    13.6 (6.4 to 28.5)
        hSBA-MenW-135; Month 1 [N = 37, 39]
    283.7 (137.4 to 585.6)
    263.7 (187.3 to 371.2)
        hSBA-MenW-135; Month 3 [N = 39, 38]
    884.5 (567.2 to 1379.2)
    590.8 (443 to 787.8)
        hSBA-MenY; Month 0 [N = 38, 38]
    37 (16.7 to 82.4)
    32 (15.5 to 65.8)
        hSBA-MenY; Month 1 [N = 40, 40]
    743.6 (352.9 to 1566.7)
    661.7 (460.2 to 951.6)
        hSBA-MenY; Month 3 [N = 39, 39]
    1415.1 (905.2 to 2212.2)
    800.7 (638.1 to 1004.7)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY antibody concentrations equal to or above the cut-off values

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    End point title
    		 Number of subjects with anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY antibody concentrations equal to or above the cut-off values
    End point description
    Antibody titers equal to or above (≥) 0.3 µg/mL.
    End point type
    Secondary
    End point timeframe
    At pre, post first vaccine dose and post second vaccine dose
    End point values
    		 Nimenrix™ At risk Group Nimenrix™ Healthy Group
    Number of subjects analysed
    33
    34
    Units: Subjects
        anti-PSA; Month 0 [N = 28, 30]
    28
    30
        anti-PSA; Month 1 [N = 29, 34]
    29
    34
        anti-PSA; Month 3 [N = 33, 32]
    33
    32
        anti-PSC; Month 0 [N = 33, 34]
    15
    4
        anti-PSC; Month 1 [N = 29, 34]
    29
    34
        anti-PSC; Month 3 [N = 33, 32]
    33
    32
        anti-PSW-135; Month 0 [N = 28, 30]
    21
    19
        anti-PSW-135; Month 1 [N = 29, 34]
    29
    34
        anti-PSW-135; Month 3 [N = 33, 32]
    33
    32
        anti-PSY; Month 0 [N = 7, 5]
    7
    5
        anti-PSY; Month 1 [N = 10, 13]
    10
    13
        anti-PSY; Month 3 [N = 10, 11]
    10
    11
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY antibody concentration equal to or above the cut-off values

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    End point title
    		 Number of subjects with anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY antibody concentration equal to or above the cut-off values
    End point description
    Antibody titers equal to or above (≥) 2.0 µg/mL.
    End point type
    Secondary
    End point timeframe
    At pre, post first vaccine dose and post second vaccine dose
    End point values
    		 Nimenrix™ At risk Group Nimenrix™ Healthy Group
    Number of subjects analysed
    33
    34
    Units: Subjects
        anti-PSA; Month 0 [N = 28, 30]
    12
    9
        anti-PSA; Month 1 [N = 29, 34]
    29
    34
        anti-PSA; Month 3 [N = 33, 32]
    33
    32
        anti-PSC; Month 0 [N = 33, 34]
    3
    2
        anti-PSC; Month 1 [N = 29, 34]
    26
    32
        anti-PSC; Month 3 [N = 33, 32]
    30
    27
        anti-PSW-135; Month 0 [N = 28, 30]
    4
    2
        anti-PSW-135; Month 1 [N = 29, 34]
    28
    33
        anti-PSW-135; Month 3 [N = 33, 32]
    33
    32
        anti-PSY; Month 0 [N = 7, 5]
    3
    3
        anti-PSY; Month 1 [N = 10, 13]
    10
    13
        anti-PSY; Month 3 [N = 10, 11]
    10
    11
    No statistical analyses for this end point

    Secondary: Antibody titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY meningococcal antigens

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    End point title
    		 Antibody titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY meningococcal antigens
    End point description
    Antibody titers were measured in Geometric mean concentrations (GMCs).
    End point type
    Secondary
    End point timeframe
    At pre, post first vaccine dose and post second vaccine dose
    End point values
    		 Nimenrix™ At risk Group Nimenrix™ Healthy Group
    Number of subjects analysed
    33
    34
    Units: Titers
    geometric mean (confidence interval 95%)
        anti-PSA; Month 0 [N = 28, 30]
    1.9 (1.5 to 2.4)
    1.4 (1.1 to 1.8)
        anti-PSA; Month 1 [N = 29, 34]
    17.4 (11.7 to 25.8)
    16.2 (11.3 to 23.3)
        anti-PSA; Month 3 [N = 33, 32]
    14.2 (10.5 to 19.3)
    10.7 (8 to 14.3)
        anti-PSC; Month 0 [N = 33, 34]
    0.4 (0.2 to 0.6)
    0.2 (0.1 to 0.3)
        anti-PSC; Month 1 [N = 29, 34]
    8.3 (5.6 to 12.5)
    8.4 (5.9 to 11.8)
        anti-PSC; Month 3 [N = 33, 32]
    6 (4.4 to 8.1)
    5.8 (4.2 to 8)
        anti-PSW-135; Month 0 [N = 28, 30]
    0.6 (0.3 to 1.1)
    0.4 (0.3 to 0.6)
        anti-PSW-135; Month 1 [N = 29, 34]
    14.9 (8.4 to 26.3)
    13.3 (9.2 to 19.4)
        anti-PSW-135; Month 3 [N = 33, 32]
    19 (12.8 to 28.2)
    14 (9.9 to 19.8)
        anti-PSY; Month 0 [N = 7, 5]
    2.9 (1.1 to 7.9)
    2.5 (1 to 6.1)
        anti-PSY; Month 1 [N = 10, 13]
    20.4 (6.3 to 66.2)
    17.3 (11.2 to 26.8)
        anti-PSY; Month 3 [N = 10, 11]
    30 (10.4 to 86.5)
    12.5 (9.4 to 16.7)
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any and grade 3 solicited local symptom at age stratum 1-5 years

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    End point title
    		 Number of subjects reporting any and grade 3 solicited local symptom at age stratum 1-5 years
    End point description
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-vaccination period following each dose and overall
    End point values
    		 Nimenrix™ At risk Group Nimenrix™ Healthy Group
    Number of subjects analysed
    3
    3
    Units: Subjects
        Any Pain; Dose 1 [N=3;3]
    2
    0
        Grade 3 Pain; Dose 1 [N=3;3]
    0
    0
        Any Redness; Dose 1 [N=3;3]
    2
    0
        Grade 3 Redness; Dose 1 [N=3;3]
    0
    0
        Any Swelling; Dose 1 [N=3;3]
    2
    0
        Grade 3 Swelling; Dose 1 [N=3;3]
    0
    0
        Any Pain; Dose 2 [N=3;2]
    1
    1
        Grade 3 Pain; Dose 2 [N=3;2]
    0
    0
        Any Redness; Dose 2 [N=3;2]
    0
    0
        Grade 3 Redness; Dose 2 [N=3;2]
    0
    0
        Any Swelling; Dose 2 [N=3;2]
    0
    0
        Grade 3 Swelling; Dose 2 [N=3;2]
    0
    0
        Any Pain Across Doses [N=3;3]
    2
    1
        Grade 3 Pain Across Doses [N=3;3]
    0
    0
        Any Redness Across Doses [N=3;3]
    2
    0
        Grade 3 Redness Across Doses [N=3;3]
    0
    0
        Any Swelling Across Doses [N=3;3]
    2
    0
        Grade 3 Swelling Across Doses [N=3;3]
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any and grade 3 solicited local symptom at age stratum 6-17 years

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    End point title
    		 Number of subjects reporting any and grade 3 solicited local symptom at age stratum 6-17 years
    End point description
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-vaccination period following each dose and overall
    End point values
    		 Nimenrix™ At risk Group Nimenrix™ Healthy Group
    Number of subjects analysed
    40
    39
    Units: Subjects
        Any Pain; Dose 1 [N=40; 39]
    28
    23
        Grade 3 Pain; Dose 1 [N=40; 39]
    2
    1
        Any Redness; Dose 1 [N=40; 39]
    7
    13
        Grade 3 Redness; Dose 1 [N=40; 39]
    0
    0
        Any Swelling; Dose 1 [N=40; 39]
    12
    8
        Grade 3 Swelling; Dose 1 [N=40; 39]
    2
    2
        Any Pain; Dose 2 [N=38; 38]
    29
    24
        Grade 3 Pain; Dose 2 [N=38; 38]
    3
    1
        Any Redness; Dose 2 [N=38; 38]
    12
    8
        Grade 3 Redness; Dose 2 [N=38; 38]
    1
    0
        Any Swelling; Dose 2 [N=38; 38]
    12
    10
        Grade 3 Swelling; Dose 2 [N=38; 38]
    3
    2
        Any Pain; Across Doses [N=40; 39]
    32
    28
        Grade 3 Pain; Across Doses [N=40; 39]
    4
    2
        Any Redness; Across Doses [N=40; 39]
    14
    14
        Grade 3 Redness; Across Doses [N=40; 39]
    1
    0
        Any Swelling; Across Doses [N=40; 39]
    18
    12
        Grade 3 Swelling; Across Doses [N=40; 39]
    4
    3
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any, grade 3 and related solicited general symptoms at age stratum 1-5 years

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    End point title
    		 Number of subjects reporting any, grade 3 and related solicited general symptoms at age stratum 1-5 years
    End point description
    Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptoms = symptoms which prevented normal everyday activities. Grade 3 fever = oral temperature >39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-vaccination period following each dose and overall
    End point values
    		 Nimenrix™ At risk Group Nimenrix™ Healthy Group
    Number of subjects analysed
    3
    3
    Units: Subjects
        Any Drowsiness; Dose 1 [N=3;3]
    3
    1
        Grade 3 Drowsiness; Dose 1 [N=3;3]
    1
    0
        Related Drowsiness; Dose 1 [N=3;3]
    3
    0
        Any Irritability; Dose 1 [N=3;3]
    2
    1
        Grade 3 Irritability; Dose 1 [N=3;3]
    1
    0
        Related Irritability; Dose 1 [N=3;3]
    2
    0
        Any Loss of appetite; Dose 1 [N=3;3]
    2
    0
        Grade 3 Loss of appetite; Dose 1 [N=3;3]
    0
    0
        Related Loss of appetite; Dose 1 [N=3;3]
    2
    0
        Any Fever; Dose 1 [N=3;3]
    0
    0
        Grade 3 Fever; Dose 1 [N=3;3]
    0
    0
        Related Fever; Dose 1 [N=3;3]
    0
    0
        Any Drowsiness; Dose 2 [N=3;2]
    0
    1
        Grade 3 Drowsiness; Dose 2 [N=3;2]
    0
    0
        Related Drowsiness; Dose 2 [N=3;2]
    0
    1
        Any Irritability; Dose 2 [N=3;2]
    0
    1
        Grade 3 Irritability; Dose 2 [N=3;2]
    0
    0
        Related Irritability; Dose 2 [N=3;2]
    0
    1
        Any Loss of appetite; Dose 2 [N=3;2]
    0
    0
        Grade 3 Loss of appetite; Dose 2 [N=3;2]
    0
    0
        Related Loss of appetite; Dose 2 [N=3;2]
    0
    0
        Any Fever; Dose 2 [N=3;2]
    0
    0
        Grade 3 Fever; Dose 2 [N=3;2]
    0
    0
        Related Fever; Dose 2 [N=3;2]
    0
    0
        Any Drowsiness; Across Doses [N=3;3]
    3
    2
        Grade 3 Drowsiness; Across Doses [N=3;3]
    1
    0
        Related Drowsiness; Across Doses [N=3;3]
    3
    1
        Any Irritability; Across Doses [N=3;3]
    2
    2
        Grade 3 Irritability; Across Doses [N=3;3]
    1
    0
        Related Irritability; Across Doses [N=3;3]
    2
    1
        Any Loss of appetite; Across Doses [N=3;3]
    2
    0
        Grade 3 Loss of appetite; Across Doses [N=3;3]
    0
    0
        Related Loss of appetite; Across Doses [N=3;3]
    2
    0
        Any Fever; Across Doses [N=3;3]
    0
    0
        Grade 3 Fever; Across Doses [N=3;3]
    0
    0
        Related Fever; Across Doses [N=3;3]
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any, grade 3 and related solicited general symptoms at age stratum 6-17 years

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    End point title
    		 Number of subjects reporting any, grade 3 and related solicited general symptoms at age stratum 6-17 years
    End point description
    Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache and fever. Gastrointestinal symptoms include nausea, vomiting, diarrhoea and/or abdominal pain. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptoms = symptoms which prevented normal everyday activities. Grade 3 fever = oral temperature >39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-vaccination period following each dose and overall
    End point values
    		 Nimenrix™ At risk Group Nimenrix™ Healthy Group
    Number of subjects analysed
    40
    39
    Units: Subjects
        Any Fatigue; Dose 1 [N=40; 39]
    18
    12
        Grade 3 Fatigue; Dose 1 [N=40; 39]
    1
    0
        Related Fatigue; Dose 1 [N=40; 39]
    17
    12
        Any Gastrointestinal; Dose 1 [N=40; 39]
    5
    3
        Grade 3 Gastrointestinal; Dose 1 [N=40; 39]
    0
    0
        Related Gastrointestinal; Dose 1 [N=40; 39]
    4
    3
        Any Headache; Dose 1 [N=40; 39]
    12
    9
        Grade 3 Headache; Dose 1 [N=40; 39]
    0
    0
        Related Headache; Dose 1 [N=40; 39]
    9
    9
        Any Fever; Dose 1 [N=40; 39]
    3
    0
        Grade 3 Fever; Dose 1 [N=40; 39]
    0
    0
        Related Fever; Dose 1 [N=40; 39]
    2
    0
        Any Fatigue; Dose 2 [N=38; 38]
    13
    7
        Grade 3 Fatigue; Dose 2 [N=38; 38]
    0
    1
        Related Fatigue; Dose 2 [N=38; 38]
    13
    6
        Any Gastrointestinal; Dose 2 [N=38; 38]
    1
    6
        Grade 3 Gastrointestinal; Dose 2 [N=38; 38]
    0
    2
        Related Gastrointestinal; Dose 2 [N=38; 38]
    1
    3
        Any Headache; Dose 2 [N=38; 38]
    7
    5
        Grade 3 Headache; Dose 2 [N=38; 38]
    0
    1
        Related Headache; Dose 2 [N=38; 38]
    6
    4
        Any Fever; Dose 2 [N=38; 38]
    1
    2
        Grade 3 Fever; Dose 2 [N=38; 38]
    0
    0
        Related Fever; Dose 2 [N=38; 38]
    1
    1
        Any Fatigue; Across Doses [N=40; 39]
    21
    14
        Grade 3 Fatigue; Across Doses [N=40; 39]
    1
    1
        Related Fatigue; Across Doses [N=40; 39]
    21
    14
        Any Gastrointestinal; Across Doses [N=40; 39]
    6
    8
        Grade 3 Gastrointestinal; Across Doses [N=40; 39]
    0
    2
        Related Gastrointestinal; Across Doses [N=40; 39]
    5
    5
        Any Headache; Across Doses [N=40; 39]
    16
    10
        Grade 3 Headache; Across Doses [N=40; 39]
    0
    1
        Related Headache; Across Doses [N=40; 39]
    14
    10
        Any Fever; Across Doses [N=40; 39]
    4
    2
        Grade 3 Fever; Across Doses [N=40; 39]
    0
    0
        Related Fever; Across Doses [N=40; 39]
    3
    1
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects reporting New Onset of Chronic Illnesses (NOCIs)
    End point description
    New Onset of Chronic Illnesses such as autoimmune disorders, asthma, type 1 diabetes and allergies.
    End point type
    Secondary
    End point timeframe
    From vaccination (dose 1) until the end of the Extended Safety Follow-Up (ESFU)
    End point values
    		 Nimenrix™ At risk Group Nimenrix™ Healthy Group
    Number of subjects analysed
    43
    43
    Units: Subjects
        Any NOCI(s)
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any unsolicited adverse events (AEs)

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    End point title
    		 Number of subjects reporting any unsolicited adverse events (AEs)
    End point description
    An unsolicited adverse event (AE) covers any untoward medical occurrence in a clinical subject investigation temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an AE reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE.
    End point type
    Secondary
    End point timeframe
    During the 31-day (Days 0-30) post first vaccination period
    End point values
    		 Nimenrix™ At risk Group Nimenrix™ Healthy Group
    Number of subjects analysed
    43
    43
    Units: Subjects
        Any AE(s)
    7
    7
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any unsolicited AEs

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    End point title
    		 Number of subjects reporting any unsolicited AEs
    End point description
    An unsolicited AE covers any untoward medical occurrence in a clinical subject investigation temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an AE reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE.
    End point type
    Secondary
    End point timeframe
    During the 31-day (Days 0-30) post second vaccination period
    End point values
    		 Nimenrix™ At risk Group Nimenrix™ Healthy Group
    Number of subjects analysed
    43
    43
    Units: Subjects
        Any AE(s)
    3
    8
    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)
    End point description
    End point type
    Secondary
    End point timeframe
    From vaccination (dose 1) until the end of ESFU.
    End point values
    		 Nimenrix™ At risk Group Nimenrix™ Healthy Group
    Number of subjects analysed
    43
    43
    Units: Subjects
        Any SAE(s)
    4
    1
    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 (Days 0-3) post-vaccination period, Unsolicited AEs during the 31 Day (Days 0-30) post-vaccination period, SAEs from Dose 1 up to the end of the Extended Safety Follow-Up (ESFU).
    Adverse event reporting additional description
    The number of occurrences reported for solicited symptoms, adverse events, and serious adverse events were not available for posting. The number of subjects affected by each specific event was indicated as the number of occurrences.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Nimenrix™At risk Group
    Reporting group description
    		 Subjects with an increased risk for meningococcal disease such as anatomic asplenia or some degree of functional asplenia received two doses of the MenACWY-TT vaccine at Visit 1 (Month 0) and Visit 3 (Month 2).

    Reporting group title
    Nimenrix™ Healthy Group
    Reporting group description
    		 Subjects age matched with the subjects in the At-risk Group received two doses of the MenACWY-TT vaccine at Visit 1 (Month 0) and Visit 3 (Month 2).

    Serious adverse events
    		 Nimenrix™At risk Group Nimenrix™ Healthy Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 43 (9.30%)
    1 / 43 (2.33%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Joint injury
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Sickle cell anaemia with crisis
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Cystitis escherichia
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumococcal bacteraemia
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salmonellosis
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Nimenrix™At risk Group Nimenrix™ Healthy Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    32 / 43 (74.42%)
    28 / 43 (65.12%)
    General disorders and administration site conditions
    Pain (1-5 years)
         subjects affected / exposed [1]
    2 / 3 (66.67%)
    1 / 3 (33.33%)
         occurrences all number
    2
    1
    Redness (1-5 years)
         subjects affected / exposed [2]
    2 / 3 (66.67%)
    0 / 3 (0.00%)
         occurrences all number
    2
    0
    Swelling (1-5 years)
         subjects affected / exposed [3]
    2 / 3 (66.67%)
    0 / 3 (0.00%)
         occurrences all number
    2
    0
    Pain (6-17 years)
         subjects affected / exposed [4]
    32 / 40 (80.00%)
    28 / 39 (71.79%)
         occurrences all number
    32
    28
    Redness (6-17 years)
         subjects affected / exposed [5]
    14 / 40 (35.00%)
    14 / 39 (35.90%)
         occurrences all number
    14
    14
    Swelling (6-17 years)
         subjects affected / exposed [6]
    18 / 40 (45.00%)
    12 / 39 (30.77%)
         occurrences all number
    18
    12
    Drowsiness (1-5 years)
         subjects affected / exposed [7]
    3 / 3 (100.00%)
    2 / 3 (66.67%)
         occurrences all number
    3
    2
    Irritability (1-5 years)
         subjects affected / exposed [8]
    2 / 3 (66.67%)
    2 / 3 (66.67%)
         occurrences all number
    2
    2
    Loss of appetite (1-5 years)
         subjects affected / exposed [9]
    2 / 3 (66.67%)
    0 / 3 (0.00%)
         occurrences all number
    2
    0
    Fatigue (6-17 years)
         subjects affected / exposed [10]
    21 / 40 (52.50%)
    14 / 39 (35.90%)
         occurrences all number
    21
    14
    Gastrointestinal Symptom (6-17 years)
         subjects affected / exposed [11]
    6 / 40 (15.00%)
    8 / 39 (20.51%)
         occurrences all number
    6
    8
    Headache (6-17 years)
         subjects affected / exposed [12]
    16 / 40 (40.00%)
    10 / 39 (25.64%)
         occurrences all number
    16
    10
    Fever (orally, ≥37.5) (6-17 years)
         subjects affected / exposed [13]
    4 / 40 (10.00%)
    2 / 39 (5.13%)
         occurrences all number
    4
    2
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [12] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [13] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Apr 2014
    Amendment 2 Interference had been observed when Menactra and the pneumococcal conjugate vaccine PCV7 were co-administered in subjects < 2 years of age. In order not to compromise the immunogenicity of PCV, the Advisory Committee on Immunization Practices (ACIP) had formulated vaccination recommendations for children aged 9 through 23 months. Following these recommendations, children < 2 years of age with functional or anatomic asplenia were not enrolled in the study. Only children < 2 years of age with complement component deficiencies were enrolled in the ‘At risk’ group in this study.
    01 Apr 2014
    Amendment 3 The physicochemical stability data on the reconstituted MenACWY-TT vaccine has been complemented by microbial stability data, simulating a contamination that may potentially happen during the reconstitution of the vaccine. These microbial data do not support the use of the vaccine up to 24 hours after reconstitution. Therefore, the storage condition of keeping the reconstituted MenACWY-TT vaccine in the refrigerator for up to 24 hours was removed from the protocol and a reference to the Study Procedures Manual was added for further details. In order to reflect this change, the Study Procedures Manual was modified as well.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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