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    Clinical Trial Results:
    A phase II, open, multi-center study to evaluate the long-term anti-body persistence at 1 year, 3 years and 5 years after the administration of one or two doses of GlaxoSmithKline (GSK) Biologicals’ meningococcal serogroups A, C, W-135, Y-tetanus toxoid conjugate (MenACWY-TT) vaccine in healthy toddlers at 9-12 months of age, and to evaluate the safety and immunogenicity of a booster dose of MenACWY-TT administered 5 years post-primary vaccination and of a primary vaccination of MenACWY-TT in a newly enrolled group, aged 5-6 years, as a naïve control.

    Summary
    EudraCT number
    		 2012-002719-24
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    28 Mar 2014

    Results information
    Results version number
    		 v3(current)
    This version publication date
    31 Mar 2023
    First version publication date
    02 Jul 2015
    Other versions
    		 v1 , v2
    Version creation reason
    • Correction of full data set
    Correction of full data set and alignment between registries.

    Trial information

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    Trial identification
    Sponsor protocol code
    112021
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00718666
    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
    15 Oct 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Nov 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Mar 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the long-term persistence of the immunogenicity induced by one or two doses of MenACWY-TT vaccine administered at 12 months or 9 and 12 months of age in terms of the percentage of subjects with N. meningitidis serogroup A (MenA), N. meningitidis serogroup C (MenC), N. meningitidis serogroup W-135 (MenW-135), and N. meningitidis serogroup Y (MenY) antibody titers ≥ 1:8 as measured by a serum bactericidal assay using human complement (hSBA).
    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
    20 Oct 2008
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    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
    United States: 387
    Worldwide total number of subjects
    387
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    387
    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
    		 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.

    Pre-assignment
    Screening details
    		 Out of 387 subjects originally enrolled in the study, only 248 subjects received vaccination.

    Period 1
    Period 1 title
    Persistence Phase Year 1
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Nimenrix 1 Group Y1
    Arm description
    		 Subjects who received 1 dose of Nimenrix vaccine at 12 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nimenrix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One intramuscular injection in the deltoid of non-dominant arm.

    Arm title
    		 Nimenrix 2 Group Y1
    Arm description
    		 Subjects who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Nimenrix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One intramuscular injection in the deltoid of non-dominant arm.

    Number of subjects in period 1 [1]
    		Nimenrix 1 Group Y1 Nimenrix 2 Group Y1
    Started
    118
    130
    Completed
    118
    130
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    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 2
    Period 2 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 Group Y3
    Arm description
    		 Subjects who received 1 dose of Nimenrix vaccine at 12 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nimenrix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One intramuscular injection in the deltoid of non-dominant arm.

    Arm title
    		 Nimenrix 2 Group Y3
    Arm description
    		 Subjects who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Nimenrix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One intramuscular injection in the deltoid of non-dominant arm.

    Number of subjects in period 2 [2]
    		Nimenrix 1 Group Y3 Nimenrix 2 Group Y3
    Started
    98
    104
    Completed
    98
    104
    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 3
    Period 3 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 Group Y5
    Arm description
    		 Subjects who received 1 dose of Nimenrix vaccine at 12 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nimenrix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One intramuscular injection in the deltoid of non-dominant arm.

    Arm title
    		 Nimenrix 2 Group Y5
    Arm description
    		 Subjects who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Nimenrix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One intramuscular injection in the deltoid of non-dominant arm.

    Number of subjects in period 3 [3]
    		Nimenrix 1 Group Y5 Nimenrix 2 Group Y5
    Started
    70
    82
    Completed
    70
    82
    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 4
    Period 4 title
    Booster 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 Booster Group
    Arm description
    		 Subjects who received 1 dose of Nimenrix vaccine at 12 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nimenrix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One intramuscular injection in the deltoid of non-dominant arm.

    Arm title
    		 Nimenrix 2 Booster Group
    Arm description
    		 Subjects who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Nimenrix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One intramuscular injection in the deltoid of non-dominant arm.

    Arm title
    		 Nimenrix Naive Group
    Arm description
    		 Vaccine-naive subjects aged 5-6 years were enrolled to receive Nimenrix vaccine as primary vaccination at Year 5.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nimenrix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One intramuscular injection in the deltoid of non-dominant arm.

    Number of subjects in period 4
    		Nimenrix 1 Booster Group Nimenrix 2 Booster Group Nimenrix Naive Group
    Started
    38
    46
    68
    Completed
    36
    46
    94
    Not completed
    2
    0
    6
         Consent withdrawn by subject
    -
    -
    1
         No active participation request
    -
    -
    1
         Lost to follow-up
    1
    -
    4
         Declined v-4 serology
    1
    -
    -
    Joined
    0
    0
    32
         Harmonization of subject numbers between periods
    -
    -
    32

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Nimenrix 1 Group Y1
    Reporting group description
    		 Subjects who received 1 dose of Nimenrix vaccine at 12 months of age.

    Reporting group title
    Nimenrix 2 Group Y1
    Reporting group description
    		 Subjects who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.

    Reporting group values
    		 Nimenrix 1 Group Y1 Nimenrix 2 Group Y1 Total
    Number of subjects
    		 118 130 248
    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)
    		 24.5 ( 0.97 ) 24.6 ( 1 ) -
    Gender categorical
    Units: Subjects
        Female
    		 56 66 122
        Male
    		 62 64 126

    End points

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    End points reporting groups
    Reporting group title
    Nimenrix 1 Group Y1
    Reporting group description
    		 Subjects who received 1 dose of Nimenrix vaccine at 12 months of age.

    Reporting group title
    Nimenrix 2 Group Y1
    Reporting group description
    		 Subjects who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.
    Reporting group title
    Nimenrix 1 Group Y3
    Reporting group description
    		 Subjects who received 1 dose of Nimenrix vaccine at 12 months of age.

    Reporting group title
    Nimenrix 2 Group Y3
    Reporting group description
    		 Subjects who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.
    Reporting group title
    Nimenrix 1 Group Y5
    Reporting group description
    		 Subjects who received 1 dose of Nimenrix vaccine at 12 months of age.

    Reporting group title
    Nimenrix 2 Group Y5
    Reporting group description
    		 Subjects who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.
    Reporting group title
    Nimenrix 1 Booster Group
    Reporting group description
    		 Subjects who received 1 dose of Nimenrix vaccine at 12 months of age.

    Reporting group title
    Nimenrix 2 Booster Group
    Reporting group description
    		 Subjects who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.

    Reporting group title
    Nimenrix Naive Group
    Reporting group description
    		 Vaccine-naive subjects aged 5-6 years were enrolled to receive Nimenrix vaccine as primary vaccination at Year 5.

    Primary: Number of subjects with serum bactericidal assay (using human complement) (hSBA) titers equal to or above the cut-off values

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    End point title
    		 Number of subjects with serum bactericidal assay (using human complement) (hSBA) titers equal to or above the cut-off values [1]
    End point description
    hSBA antibody titers were assessed for the MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above (≥) 1:8.
    End point type
    Primary
    End point timeframe
    At Year 1 (12 months post primary vaccination)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Nimenrix 1 Group Y1 Nimenrix 2 Group Y1
    Number of subjects analysed
    110
    120
    Units: Subjects
        hSBA-MenA, M12, ≥ 1:8 (N=102; 108)
    21
    28
        hSBA-MenC, M12 ≥ 1:8 (N=104; 113)
    91
    103
        hSBA-MenW-135, M12 ≥ 1:8 (N=104; 112)
    93
    111
        hSBA-MenY, M12 ≥ 1:8 (N=110; 120)
    88
    111
    No statistical analyses for this end point

    Primary: Number of subjects with serum bactericidal assay (using human complement) (hSBA) titers ≥ the cut-off value

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    End point title
    		 Number of subjects with serum bactericidal assay (using human complement) (hSBA) titers ≥ the cut-off value [2]
    End point description
    hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was ≥ 1:8.
    End point type
    Primary
    End point timeframe
    At Year 3 (36 months post primary vaccination)
    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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Nimenrix 1 Group Y3 Nimenrix 2 Group Y3
    Number of subjects analysed
    86
    97
    Units: Subjects
        hSBA-MenA, M36, ≥ 1:8 (N=82; 96)
    14
    16
        hSBA-MenC, M36 ≥ 1:8 (N=81; 94)
    57
    68
        hSBA-MenW-135, M36 ≥ 1:8 (N=86; 97)
    54
    82
        hSBA-MenY, M36 ≥ 1:8 (N=85; 95)
    53
    59
    No statistical analyses for this end point

    Primary: Number of subjects with serum bactericidal assay (using human complement) (hSBA) titers ≥ the cut-off value

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    End point title
    		 Number of subjects with serum bactericidal assay (using human complement) (hSBA) titers ≥ the cut-off value [3]
    End point description
    hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was ≥ 1:8.
    End point type
    Primary
    End point timeframe
    At Year 5 (60 months post primary vaccination)
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Nimenrix 1 Group Y5 Nimenrix 2 Group Y5
    Number of subjects analysed
    63
    72
    Units: Subjects
        hSBA-MenA, M60, ≥ 1:8 (N=63; 71)
    20
    27
        hSBA-MenC, M60 ≥ 1:8 (N=60; 71)
    45
    53
        hSBA-MenW-135, M60 ≥ 1:8 (N=61; 72)
    40
    62
        hSBA-MenY, M60 ≥ 1:8 (N=50; 63)
    32
    49
    No statistical analyses for this end point

    Secondary: Number of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY titers ≥ the cut-off value

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    End point title
    		 Number of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY titers ≥ the cut-off value
    End point description
    hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was ≥ 1:4.
    End point type
    Secondary
    End point timeframe
    At Year 1 (12 months post vaccination)
    End point values
    		 Nimenrix 1 Group Y1 Nimenrix 2 Group Y1
    Number of subjects analysed
    110
    120
    Units: Subjects
        hSBA-MenA, M12, ≥ 1:4 (N=102; 108)
    23
    29
        hSBA-MenC, M12 ≥ 1:4 (N=104; 113)
    91
    103
        hSBA-MenW-135, M12 ≥ 1:4 (N=104; 112)
    93
    111
        hSBA-MenY, M12 ≥ 1:4 (N=110; 120)
    89
    111
    No statistical analyses for this end point

    Secondary: Number of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY titers ≥ the cut-off value

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    End point title
    		 Number of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY titers ≥ the cut-off value
    End point description
    hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was ≥ 1:4.
    End point type
    Secondary
    End point timeframe
    At Year 3 (36 months post primary vaccination)
    End point values
    		 Nimenrix 1 Group Y3 Nimenrix 2 Group Y3
    Number of subjects analysed
    86
    97
    Units: Subjects
        hSBA-MenA, M36, ≥ 1:4 (N=82; 96)
    14
    19
        hSBA-MenC, M36 ≥ 1:4 (N=81; 94)
    59
    69
        hSBA-MenW-135, M36 ≥ 1:4 (N=86; 97)
    54
    82
        hSBA-MenY, M36 ≥ 1:4 (N=85; 95)
    53
    59
    No statistical analyses for this end point

    Secondary: Number of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY titers ≥ the cut-off value

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    End point title
    		 Number of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY titers ≥ the cut-off value
    End point description
    hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was ≥ 1:4.
    End point type
    Secondary
    End point timeframe
    At Year 5 (60 months post primary vaccination)
    End point values
    		 Nimenrix 1 Group Y5 Nimenrix 2 Group Y5
    Number of subjects analysed
    63
    72
    Units: Subjects
        hSBA-MenA, M60, ≥ 1:4 (N=63; 71)
    20
    27
        hSBA-MenC, M60 ≥ 1:4 (N=60; 71)
    47
    56
        hSBA-MenW-135, M60 ≥ 1:4 (N=61; 72)
    40
    62
        hSBA-MenY, M60 ≥ 1:4 (N=50; 63)
    32
    49
    No statistical analyses for this end point

    Secondary: hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY antibody titers

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    End point title
    		 hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY antibody titers
    End point description
    Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBAMenW-135, and hSBA-MenY respectively, calculated on all subjects.
    End point type
    Secondary
    End point timeframe
    At Year 1 (12 months post primary vaccination)
    End point values
    		 Nimenrix 1 Group Y1 Nimenrix 2 Group Y1
    Number of subjects analysed
    110
    120
    Units: Titers
    geometric mean (confidence interval 95%)
        hSBA-MenA, M12 (N=102; 108)
    3.7 (2.9 to 4.8)
    4.1 (3.2 to 5.2)
        hSBA-MenC, M12 (N=104; 113)
    70.5 (50.4 to 98.5)
    72.4 (53.3 to 98.4)
        hSBA-MenW-135, M12 (N=104; 112)
    127.9 (87.3 to 187.3)
    204.6 (163.6 to 255.9)
        hSBA-MenY, M12 (N=110; 120)
    55.6 (38.1 to 81.1)
    86.2 (65.8 to 112.9)
    No statistical analyses for this end point

    Secondary: hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY antibody titers

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    End point title
    		 hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY antibody titers
    End point description
    Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBAMenW-135, and hSBA-MenY respectively, calculated on all subjects.
    End point type
    Secondary
    End point timeframe
    At Year 3 (36 months post primary vaccination)
    End point values
    		 Nimenrix 1 Group Y3 Nimenrix 2 Group Y3
    Number of subjects analysed
    86
    97
    Units: Titers
    geometric mean (confidence interval 95%)
        hSBA-MenA, M36 (N=82; 96)
    3.5 (2.6 to 4.6)
    3.4 (2.7 to 4.3)
        hSBA-MenC, M36 (N=81; 94)
    31.2 (18.9 to 51.6)
    29.8 (18.9 to 47)
        hSBA-MenW-135, M36 (N=86; 97)
    29 (18 to 46.9)
    63.9 (44 to 92.8)
        hSBA-MenY, M36 (N=85; 95)
    22 (14 to 34.5)
    20.5 (13.6 to 30.8)
    No statistical analyses for this end point

    Secondary: hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY antibody titers

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    End point title
    		 hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY antibody titers
    End point description
    Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBAMenW-135, and hSBA-MenY respectively, calculated on all subjects.
    End point type
    Secondary
    End point timeframe
    At Year 5 (60 months post primary vaccination)
    End point values
    		 Nimenrix 1 Group Y5 Nimenrix 2 Group Y5
    Number of subjects analysed
    63
    72
    Units: Titers
    geometric mean (confidence interval 95%)
        hSBA-MenA, M60 (N=63; 71)
    4.6 (3.3 to 6.3)
    6.6 (4.5 to 9.8)
        hSBA-MenC, M60 (N=60; 71)
    40.7 (22.7 to 73.1)
    38.2 (22.5 to 64.9)
        hSBA-MenW-135, M60 (N=61; 72)
    24.2 (14.4 to 40.7)
    53.7 (35.8 to 80.4)
        hSBA-MenY, M60 (N=50; 63)
    26 (14.1 to 47.8)
    37.9 (24.3 to 59.2)
    No statistical analyses for this end point

    Secondary: Number of subjects with titers ≥ the cut-off for meningococcal polysaccharides A , C, W-135 and Y serum bactericidal antibodies, using baby rabbit complement for assay

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    End point title
    		 Number of subjects with titers ≥ the cut-off for meningococcal polysaccharides A , C, W-135 and Y serum bactericidal antibodies, using baby rabbit complement for assay
    End point description
    rSBA antibody titers were assessed for the rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY serogroups respectively. The antibody cut-off value assessed was ≥ 1:8 and 1:128. The analysis was performed by GSK Biologicals' laboratory assay.
    End point type
    Secondary
    End point timeframe
    At Year 1 (12 months post primary vaccination)
    End point values
    		 Nimenrix 1 Group Y1 Nimenrix 2 Group Y1
    Number of subjects analysed
    101
    114
    Units: Subjects
        rSBA-MenA, M12 ≥ 1:8 (N=95; 104)
    90
    101
        rSBA-MenA, M12 ≥ 1:128 (N=95; 104)
    71
    80
        rSBA-MenC, M12 ≥ 1:8 (N=95; 112)
    83
    96
        rSBA-MenC, M12 ≥ 1:128 (N=95; 112)
    46
    54
        rSBA-MenW-135, M12 ≥ 1:8 (N=101;114)
    97
    114
        rSBA-MenW-135, M12 ≥ 1:128 (N=101;114)
    82
    89
        rSBA-MenY, M12 ≥ 1:8 (N=101; 113)
    96
    113
        rSBA-MenY, M12 ≥ 1:128 (N=101; 113)
    85
    100
    No statistical analyses for this end point

    Secondary: Number of subjects with titers ≥ the cut-off for meningococcal polysaccharides A , C, W-135 and Y serum bactericidal antibodies, using baby rabbit complement for assay

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    End point title
    		 Number of subjects with titers ≥ the cut-off for meningococcal polysaccharides A , C, W-135 and Y serum bactericidal antibodies, using baby rabbit complement for assay
    End point description
    rSBA antibody titers were assessed for the rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY serogroups respectively. The antibody cut-off value assessed was ≥ 1:8 and 1:128. The analysis was performed by GSK Biologicals' laboratory assay.
    End point type
    Secondary
    End point timeframe
    At Year 3 (36 months post primary vaccination)
    End point values
    		 Nimenrix 1 Group Y3 Nimenrix 2 Group Y3
    Number of subjects analysed
    73
    89
    Units: Subjects
        rSBA-MenA, M12 ≥ 1:8 (N=69;84)
    65
    82
        rSBA-MenA, M12 ≥ 1:128 (N=69;84)
    51
    65
        rSBA-MenC, M12 ≥ 1:8 (N=68;89)
    60
    75
        rSBA-MenC, M12 ≥ 1:128 (N=68;89)
    32
    40
        rSBA-MenW-135, M12 ≥ 1:8 (N=72;88)
    68
    88
        rSBA-MenW-135, M12 ≥ 1:128 (N=72;88)
    56
    69
        rSBA-MenY, M12 ≥ 1:8 (N=73;89)
    69
    89
        rSBA-MenY, M12 ≥ 1:128 (N=73;89)
    62
    78
    No statistical analyses for this end point

    Secondary: rSBA antibody titers

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    End point title
    		 rSBA antibody titers
    End point description
    Titers are given as geometric mean titers (GMTs) for the serogroups rSBA-MenA, rSBA-MenC, rSBAMenW-135, and rSBA-MenY respectively, as performed by by GSK Biologicals’ laboratory assay.
    End point type
    Secondary
    End point timeframe
    At Year 1 (12 months post primary vaccination)
    End point values
    		 Nimenrix 1 Group Y1 Nimenrix 2 Group Y1
    Number of subjects analysed
    101
    114
    Units: Titers
    geometric mean (confidence interval 95%)
        rSBA-MenA, M12 (N=95; 104)
    259.7 (191.4 to 352.3)
    237.2 (187 to 301)
        rSBA-MenC, M12 (N=95; 112)
    94.1 (67.1 to 131.9)
    90.3 (65.5 to 124.4)
        rSBA-MenW-135, M12 (N=101; 114)
    385.2 (286.4 to 518.1)
    345.3 (280.1 to 425.8)
        rSBA-MenY, M12 (N=101; 113)
    364.5 (273.7 to 485.4)
    342.2 (284.5 to 411.8)
    No statistical analyses for this end point

    Secondary: rSBA antibody titers

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    End point title
    		 rSBA antibody titers
    End point description
    Titers are given as geometric mean titers (GMTs) for the serogroups rSBA-MenA, rSBA-MenC, rSBAMenW-135, and rSBA-MenY respectively, as performed by GSK Biologicals’ laboratory assay.
    End point type
    Secondary
    End point timeframe
    At Year 3 (36 months post-primary vaccination)
    End point values
    		 Nimenrix 1 Group Y3 Nimenrix 2 Group Y3
    Number of subjects analysed
    73
    89
    Units: Titers
    geometric mean (confidence interval 95%)
        rSBA-MenA, M12 (N=69; 84)
    247.9 (173.8 to 353.7)
    241.8 (185.6 to 315)
        rSBA-MenC, M12 (N=68; 89)
    87 (59.3 to 127.8)
    76.4 (53.5 to 109)
        rSBA-MenW-135, M12 (N=72; 88)
    353.3 (240 to 520.1)
    358 (282.8 to 453.3)
        rSBA-MenY, M12 (N=73; 89)
    360.5 (253.4 to 512.9)
    341.4 (276.9 to 421.1)
    No statistical analyses for this end point

    Secondary: Number of subjects with titers ≥ the cut-off for meningococcal polysaccharides A , C, W-135 and Y serum bactericidal antibodies, using baby rabbit complement for assay

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    End point title
    		 Number of subjects with titers ≥ the cut-off for meningococcal polysaccharides A , C, W-135 and Y serum bactericidal antibodies, using baby rabbit complement for assay
    End point description
    rSBA antibody titers were assessed for the rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY serogroups respectively. The antibody cut-off value assessed was ≥ 1:8 and 1:128 Titers were determined by Public Health England (PHE) laboratory assay.
    End point type
    Secondary
    End point timeframe
    At Year 3 (36 months post primary vaccination)
    End point values
    		 Nimenrix 1 Group Y3 Nimenrix 2 Group Y3
    Number of subjects analysed
    83
    98
    Units: Subjects
        rSBA-MenA, M36, ≥ 1:8 (N=83; 97)
    38
    44
        rSBA-MenA, M36, ≥ 1:128 (N=83; 97)
    23
    24
        rSBA-MenC, M36, ≥ 1:8 (N=83; 97)
    27
    30
        rSBA-MenC, M36, ≥ 1:128 (N=83; 97)
    18
    15
        rSBA-MenW-135, M36, ≥ 1:8 (N=83; 95)
    36
    35
        rSBA-MenW-135, M36, ≥ 1:128 (N=83; 95)
    24
    23
        rSBA-MenY, M36, ≥ 1:8 (N=83; 98)
    39
    45
        rSBA-MenY, M36, ≥ 1:128 (N=83; 98)
    21
    24
    No statistical analyses for this end point

    Secondary: rSBA antibody titers

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    End point title
    		 rSBA antibody titers
    End point description
    Titers are given as geometric mean titers (GMTs) for the serogroups rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY respectively. Titers were determined by Public Health England (PHE) laboratory assay.
    End point type
    Secondary
    End point timeframe
    At Year 3 (36 months following primary vaccination)
    End point values
    		 Nimenrix 1 Group Y3 Nimenrix 2 Group Y3
    Number of subjects analysed
    83
    98
    Units: Titers
    geometric mean (confidence interval 95%)
        rSBA-MenA, M36 (N=83; 97)
    18.4 (12 to 28.3)
    16.6 (11.3 to 24.3)
        rSBA-MenC, M36 (N=83; 97)
    13.2 (8.6 to 20.2)
    10.6 (7.4 to 15)
        rSBA-MenW-135, M36 (N=83; 95)
    19.4 (12.3 to 30.6)
    14.6 (9.7 to 21.8)
        rSBA-MenY, M36 (N=83; 98)
    19.6 (12.7 to 30.1)
    16.7 (11.5 to 24.3)
    No statistical analyses for this end point

    Secondary: Antibody to Polysacccharide N. meningitidis Serogroup A, C, W-135 and Y (anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY) antibody concentrations

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    End point title
    		 Antibody to Polysacccharide N. meningitidis Serogroup A, C, W-135 and Y (anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY) antibody concentrations
    End point description
    Results were tabulated as geometric mean antibody concentration (GMC) calculated on all subjects, expressed in microgram per milliliter (μg/ml).
    End point type
    Secondary
    End point timeframe
    At Year 1 (12 months post primary vaccination)
    End point values
    		 Nimenrix 1 Group Y1 Nimenrix 2 Group Y1
    Number of subjects analysed
    103
    120
    Units: μg/ml
    geometric mean (confidence interval 95%)
        Anti-PSA, M12 (N=103; 120)
    0.45 (0.36 to 0.58)
    0.33 (0.28 to 0.4)
        Anti-PSC, M12 (N=102; 114)
    0.27 (0.22 to 0.32)
    0.25 (0.22 to 0.3)
        Anti-PSW-135, M12 (N=99; 113)
    0.96 (0.74 to 1.25)
    1.2 (1 to 1.44)
        Anti-PSY, M12 (N=98; 117)
    1.41 (1.07 to 1.85)
    1.7 (1.43 to 2.03)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY ≥ the cut-off value

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    End point title
    		 Number of subjects with anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY ≥ the cut-off value
    End point description
    The cut-off values for the assay were 0.3 μg/ml and 2.0 μg/ml respectively.
    End point type
    Secondary
    End point timeframe
    At Year 1 (12 months post primary vaccination)
    End point values
    		 Nimenrix 1 Group Y1 Nimenrix 2 Group Y1
    Number of subjects analysed
    103
    120
    Units: Subjects
        Anti-PSA, M12, ≥0.3 μg/ml (N=103; 120)
    60
    59
        Anti-PSA, M12, ≥2.0 μg/ml (N=103; 120)
    12
    6
        Anti-PSC, M12, ≥0.3 μg/ml (N=102; 114)
    36
    39
        Anti-PSC, M12, ≥2.0 μg/ml (N=102; 114)
    3
    4
        Anti-PSW-135, M12, ≥0.3 μg/ml (N=99; 113)
    78
    104
        Anti-PSW-135, M12, ≥2.0 μg/ml (N=99; 113)
    28
    29
        Anti-PSY, M12, ≥0.3 μg/ml (N=98; 117)
    84
    114
        Anti-PSY, M12, ≥2.0 μg/ml (N=98; 117)
    45
    50
    No statistical analyses for this end point

    Secondary: Number of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY titers ≥ the cut-off value

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    End point title
    		 Number of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY titers ≥ the cut-off value
    End point description
    hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenYserogroups respectively. The antibody cut-off values assessed were ≥ 1:4 or 1:8. This outcome measure only concerns the Nimenrix Naive Group.
    End point type
    Secondary
    End point timeframe
    At Month 60 (pre-primary vaccination with Nimenrix vaccine)
    End point values
    		 Nimenrix Naive Group
    Number of subjects analysed
    79
    Units: Subjects
        hSBA-MenA, PRE(M60), ≥ 1:4
    16
        hSBA-MenA, PRE(M60), ≥ 1:8
    16
        hSBA-MenC, PRE(M60), ≥ 1:4
    28
        hSBA-MenC, PRE(M60), ≥ 1:8
    24
        hSBA-MenW-135, PRE(M60), ≥ 1:4
    28
        hSBA-MenW-135, PRE(M60), ≥ 1:8
    28
        hSBA-MenY, PRE(M60), ≥ 1:4
    29
        hSBA-MenY, PRE(M60), ≥ 1:8
    29
    No statistical analyses for this end point

    Secondary: hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY titers

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    End point title
    		 hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY titers
    End point description
    Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBAMenW-135, and hSBA-MenY respectively. This outcome measure only concerns the Nimenrix Naive Group.
    End point type
    Secondary
    End point timeframe
    At Month 60 (pre-vaccination with Nimenrix vaccine)
    End point values
    		 Nimenrix Naive Group
    Number of subjects analysed
    79
    Units: Titers
    geometric mean (confidence interval 95%)
        hSBA-MenA, PRE(M60)
    3.3 (2.6 to 4.1)
        hSBA-MenC, PRE(M60)
    5.3 (3.9 to 7.3)
        hSBA-MenW-135, PRE(M60)
    7 (4.7 to 10.4)
        hSBA-MenY, PRE(M60)
    9.5 (5.9 to 15.1)
    No statistical analyses for this end point

    Secondary: Number of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY titers ≥ the cut-off value

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    End point title
    		 Number of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY titers ≥ the cut-off value
    End point description
    hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off values assessed were ≥ 1:4 or 1:8.
    End point type
    Secondary
    End point timeframe
    At Month 61, one month post-primary vaccination for Nimenrix Naive Group; one month post-booster for Nimenrix 1 and Nimenrix 2 Groups
    End point values
    		 Nimenrix 1 Booster Group Nimenrix 2 Booster Group Nimenrix Naive Group
    Number of subjects analysed
    32
    38
    79
    Units: Subjects
        hSBA-MenA ≥1:4 (N=31; 38; 79)
    31
    38
    62
        hSBA-MenA ≥1:8 (N=31; 38; 79)
    31
    38
    62
        hSBA-MenC ≥1:4 (N=32; 37; 77)
    32
    37
    68
        hSBA-MenC ≥1:8 (N=32; 37; 77)
    32
    37
    66
        hSBA-MenW-135 ≥1:4 (N=32; 38; 78)
    32
    38
    70
        hSBA-MenW-135 ≥1:8 (N=32; 38; 78)
    32
    38
    70
        hSBA-MenY ≥1:4 (N=32; 38; 70)
    32
    38
    66
        hSBA-MenY ≥1:8 (N=32; 38; 70)
    32
    38
    66
    No statistical analyses for this end point

    Secondary: hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY titers

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    End point title
    		 hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY titers
    End point description
    Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC,hSBAMenW-135, and hSBA-MenY respectively, calculated on all subjects.
    End point type
    Secondary
    End point timeframe
    At Month 61, one month post-primary vaccination for Nimenrix Naive Group; one month post-booster for Nimenrix 1 and Nimenrix 2 Groups
    End point values
    		 Nimenrix 1 Booster Group Nimenrix 2 Booster Group Nimenrix Naive Group
    Number of subjects analysed
    32
    38
    79
    Units: Titers
    geometric mean (confidence interval 95%)
        hSBA-MenA (N= 31, 38, 79)
    1395.9 (926.0 to 2104.4)
    1590.1 (1157.4 to 2184.6)
    38.3 (25.4 to 57.9)
        hSBA-MenC (N= 32, 37, 77)
    8185.7 (4736.9 to 14145.4)
    12881.2 (8549.1 to 19408.4)
    95.3 (56.5 to 160.9)
        hSBA-MenW-135 (N= 32, 38, 78)
    15800.9 (12975.8 to 19241.0)
    20495.9 (16080.2 to 26124.3)
    98.1 (65.8 to 146)
        hSBA-MenY (N= 32, 38, 70)
    8809.1 (6926.3 to 11203.9)
    10513.8 (7933.6 to 13933.2)
    198.7 (137.6 to 287)
    No statistical analyses for this end point

    Secondary: Number of subjects with vaccine response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY antibody titers

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    End point title
    		 Number of subjects with vaccine response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY antibody titers
    End point description
    Vaccine response was defines as: for initially seronegative subjects (pre-vaccination titer < 1:4): hSBA post-vaccination antibody titers ≥ 1:8 and for seropositive subjects (pre-vaccination titers ≥ 1:4): hSBA antibody titers at least four times the pre-vaccination antibody titers.
    End point type
    Secondary
    End point timeframe
    At Month 61, one month post-primary vaccination for Nimenrix Naive Group; one month post-booster for Nimenrix 1 and Nimenrix 2 Groups
    End point values
    		 Nimenrix 1 Booster Group Nimenrix 2 Booster Group Nimenrix Naive Group
    Number of subjects analysed
    31
    35
    77
    Units: Subjects
        hSBA-MenA, (N=31; 35; 77)
    31
    35
    56
        hSBA-MenC, (N=30; 34; 68)
    28
    31
    48
        hSBA-MenW-135, (N=31; 35; 74)
    31
    35
    48
        hSBA-MenY, (N=26; 31; 61)
    26
    31
    48
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any and grade 3 solicited local symptom

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    End point title
    		 Number of subjects reporting any and grade 3 solicited local symptom
    End point description
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness/swelling was defined as redness/swelling spreading beyond 50 millimeters (mm) of injection site.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-primary vaccination for Nimenrix Naive Group and post-booster for Nimenrix 1 and Nimenrix 2 Groups
    End point values
    		 Nimenrix 1 Booster Group Nimenrix 2 Booster Group Nimenrix Naive Group
    Number of subjects analysed
    36
    45
    89
    Units: Subjects
        Any Pain
    18
    21
    46
        Any Redness
    10
    15
    22
        Any Swelling
    8
    9
    21
        Grade 3 Pain
    0
    1
    1
        Grade 3 Redness
    1
    0
    1
        Grade 3 Swelling
    1
    0
    2
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any, grade 3 and related solicited general symptom

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    End point title
    		 Number of subjects reporting any, grade 3 and related solicited general symptom
    End point description
    Assessed solicited general symptoms were fatigue, fever (defined as axillary temperature ≥ 37.5 °C), headache and gastrointestinal. Any was defined as occurrence of the symptom regardless of their intensity grade or relationship to study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever higher than (>) 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-primary vaccination for Nimenrix Naive Group and post-booster for Nimenrix 1 and Nimenrix 2 Groups
    End point values
    		 Nimenrix 1 Booster Group Nimenrix 2 Booster Group Nimenrix Naive Group
    Number of subjects analysed
    36
    45
    89
    Units: Subjects
        Any Fatigue
    10
    7
    18
        Grade 3 Fatigue
    0
    0
    1
        Related Fatigue
    8
    6
    15
        Any Gastrointestinal
    4
    5
    7
        Grade 3 Gastrointestinal
    1
    2
    0
        Related Gastrointestinal
    3
    4
    5
        Any Headache
    4
    5
    11
        Grade 3 Headache
    1
    1
    1
        Related Headache
    4
    4
    8
        Any Fever (Axillary)
    1
    2
    5
        Fever (Axillary) >39.5°C
    9
    0
    0
        Related Fever (Axillary)
    0
    1
    3
    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 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.
    End point type
    Secondary
    End point timeframe
    During the 31-day (Days 0-30) post-primary vaccination for Nimenrix Naive Group and post-booster for Nimenrix 1 and Nimenrix 2 Groups
    End point values
    		 Nimenrix 1 Booster Group Nimenrix 2 Booster Group Nimenrix Naive Group
    Number of subjects analysed
    38
    46
    100
    Units: Subjects
        Any AE(s)
    9
    6
    29
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any serious adverse events (SAEs)

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    End point title
    		 Number of subjects reporting any serious adverse events (SAEs)
    End point description
    Serious adverse events (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
    During the 181-day (Days 0-180) post primary vaccination for Nimenrix Naive Group and post booster for Nimenrix 1 and Nimenrix 2 Groups
    End point values
    		 Nimenrix 1 Booster Group Nimenrix 2 Booster Group Nimenrix Naive Group
    Number of subjects analysed
    38
    46
    100
    Units: Subjects
        Any SAE(s)
    0
    0
    1
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any new onset of chronic illnesses (NOCIs)

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    End point title
    		 Number of subjects reporting any new onset of chronic illnesses (NOCIs)
    End point description
    NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
    End point type
    Secondary
    End point timeframe
    During the 181-day (Days 0-180) post primary vaccination for Nimenrix Naive Group and post booster for Nimenrix 1 and Nimenrix 2 Groups
    End point values
    		 Nimenrix 1 Booster Group Nimenrix 2 Booster Group Nimenrix Naive Group
    Number of subjects analysed
    38
    46
    100
    Units: Subjects
        Any NOCI(s)
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with titers ≥ the cut-off, for meningococcal polysaccharides A , C, W-135 and Y serum bactericidal antibodies, using baby rabbit complement for assay

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    End point title
    		 Number of subjects with titers ≥ the cut-off, for meningococcal polysaccharides A , C, W-135 and Y serum bactericidal antibodies, using baby rabbit complement for assay
    End point description
    rSBA antibody titers were assessed for the rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY serogroups respectively. The antibody cut-off values assessed were ≥ 1:8 and 1:128. The analysis was performed by GSK Biologicals' laboratory assay.
    End point type
    Secondary
    End point timeframe
    At Year 5 (60 months post-primary vacccination)
    End point values
    		 Nimenrix 1 Group Y5 Nimenrix 2 Group Y5
    Number of subjects analysed
    53
    64
    Units: Subjects
        rSBA-MenA, M12, ≥ 1:8 (N=51;59)
    51
    57
        rSBA-MenA, M12, ≥ 1:128 (N=51;59)
    38
    49
        rSBA-MenC, M12, ≥ 1:8 (N=51;63)
    43
    53
        rSBA-MenC, M12, ≥ 1:128 (N=51;63)
    23
    31
        rSBA-MenW-135, M12, ≥ 1:8 (N=52;64)
    51
    64
        rSBA-MenW-135, M12, ≥ 1:128 (N=52;64)
    41
    53
        rSBA-MenY, M12, ≥ 1:8 (N=53;64)
    50
    64
        rSBA-MenY, M12, ≥ 1:128 (N=53;64)
    43
    58
    No statistical analyses for this end point

    Secondary: rSBA antibody titers

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    End point title
    		 rSBA antibody titers
    End point description
    Titers are given as geometric mean titers (GMTs), calculated on all subjects for the serogroups rSBA-MenA, rSBA-MenC, rSBAMenW-135, and rSBA-MenY respectively by GSK Biologicals’ laboratory assay.
    End point type
    Secondary
    End point timeframe
    At Year 5 (60 months post-primary vacccination)
    End point values
    		 Nimenrix 1 Group Y5 Nimenrix 2 Group Y5
    Number of subjects analysed
    53
    64
    Units: Titers
    geometric mean (confidence interval 95%)
        rSBA-MenA, M12 (N=51;59)
    311.6 (221.8 to 437.6)
    277.5 (200.4 to 384.1)
        rSBA-MenC, M12, (N=51;63)
    88.6 (54.2 to 144.8)
    85.5 (55.1 to 132.5)
        rSBA-MenW-135, M12, (N=52;64)
    339.4 (235.2 to 489.8)
    404.2 (308.5 to 529.7)
        rSBA-MenY, M12, (N=53;64)
    347.6 (223.9 to 539.6)
    367.7 (287.8 to 469.9)
    No statistical analyses for this end point

    Secondary: Number of subjects with titers ≥ the cut-off for meningococcal polysaccharides A , C, W-135 and Y serum bactericidal antibodies, using baby rabbit complement for assay

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    End point title
    		 Number of subjects with titers ≥ the cut-off for meningococcal polysaccharides A , C, W-135 and Y serum bactericidal antibodies, using baby rabbit complement for assay
    End point description
    rSBA antibody titers were assessed for the rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:8 and 1:128 by Public Health England [PHE] laboratory assay.
    End point type
    Secondary
    End point timeframe
    At Year 5 (60 months post-primary vacccination)
    End point values
    		 Nimenrix 1 Group Y5 Nimenrix 2 Group Y5
    Number of subjects analysed
    62
    72
    Units: Subjects
        rSBA-MenA, M60, ≥ 1:8 (N=61;72)
    38
    42
        rSBA-MenA, M60, ≥ 1:128 (N=61;72)
    22
    26
        rSBA-MenC, M60, ≥ 1:8 (N=62;71)
    29
    29
        rSBA-MenC, M60, ≥ 1:128 (N=62;71)
    16
    19
        rSBA-MenW-135, M60, ≥ 1:8 (N=62;72)
    15
    22
        rSBA-MenW-135, M60, ≥ 1:128 (N=62;72)
    9
    14
        rSBA-MenY, M60, ≥ 1:8 (N=61;72)
    33
    36
        rSBA-MenY, M60, ≥ 1:128 (N=61;72)
    23
    26
    No statistical analyses for this end point

    Secondary: rSBA antibody titers

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    End point title
    		 rSBA antibody titers
    End point description
    Titers are given as geometric mean titers (GMTs), calculated for all subjects for the serogroups rSBA-MenA, rSBA-MenC, rSBAMenW-135, and rSBA-MenY respectively. Titers were determined by Public Health England (PHE) laboratory assay.
    End point type
    Secondary
    End point timeframe
    At Year 5 (60 months following primary vaccination)
    End point values
    		 Nimenrix 1 Group Y5 Nimenrix 2 Group Y5
    Number of subjects analysed
    62
    72
    Units: Titers
    geometric mean (confidence interval 95%)
        rSBA-MenA, M60, (N=61;72)
    32.4 (18.7 to 56)
    32.3 (19.1 to 54.7)
        rSBA-MenC, M60, (N=62;71)
    20 (12 to 33.4)
    16.5 (10.2 to 26.6)
        rSBA-MenW-135, M60, (N=62;72)
    8.9 (5.9 to 13.6)
    11.8 (7.5 to 18.5)
        rSBA-MenY, M60, (N=61;72)
    32 (17.8 to 57.4)
    26.9 (16.2 to 44.7)
    No statistical analyses for this end point

    Secondary: Number of subjects with vaccine response with hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY antibody titers

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    End point title
    		 Number of subjects with vaccine response with hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY antibody titers
    End point description
    Vaccine response was defined as: for initially seronegative subjects: antibody titer ≥ 1:32 at post-vaccination; and for initially seropositive subjects: antibody titer at post-vaccination ≥ 4 fold the pre-vaccination antibody titer. Titers were determined by Public Health England (PHE) laboratory assay.
    End point type
    Secondary
    End point timeframe
    At Month 61 (one month post-primary vaccination for Nimenrix Naive Group; one month post-booster for Nimenrix 1 and Nimenrix 2 Groups)
    End point values
    		 Nimenrix 1 Booster Group Nimenrix 2 Booster Group Nimenrix Naive Group
    Number of subjects analysed
    30
    37
    78
    Units: Subjects
        hSBA-MenA, (N=29; 37; 78)
    28
    36
    75
        hSBA-MenC, (N=30; 37; 77)
    26
    32
    70
        hSBA-MenW-135, (N=30; 37; 78)
    30
    37
    77
        hSBA-MenY, (N=29; 37; 78)
    29
    36
    78
    No statistical analyses for this end point

    Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titers ≥ the cut-off values

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    End point title
    		 Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titers ≥ the cut-off values
    End point description
    The cut-off values for the assay were ≥1:8 and ≥1:128. Titers were determined by Public Health England (PHE) laboratory assay.
    End point type
    Secondary
    End point timeframe
    At Month 60 and 61 (just prior to and one month post-primary vaccination for Nimenrix Naive Group; one month post-booster vaccination for Nimenrix 1 and Nimenrix 2 Groups)
    End point values
    		 Nimenrix 1 Booster Group Nimenrix 2 Booster Group Nimenrix Naive Group
    Number of subjects analysed
    31
    38
    82
    Units: Subjects
        rSBA-MenA, PRE[M60], ≥1:8 (N=30;37; 78)
    21
    23
    20
        rSBA-MenA, PRE[M60], ≥1:128 (N=30;37; 78)
    11
    14
    9
        rSBA-MenA, POST[M61], ≥1:8 (N=31;38; 81)
    31
    38
    81
        rSBA-MenA, POST[M61], ≥1:128 (N=31;38; 81)
    31
    38
    81
        rSBA-MenC, PRE[M60], ≥1:8 (N=31;37; 77)
    15
    18
    5
        rSBA-MenC, PRE[M60], ≥1:128 (N=31;37; 77)
    6
    12
    4
        rSBA-MenC, POST[M61], ≥1:8 (N=31;38; 82)
    31
    38
    80
        rSBA-MenC, POST[M61], ≥1:128 (N=31;38; 82)
    31
    38
    72
        rSBA-MenW-135, PRE[M60], ≥1:8 (N=31; 37; 78)
    7
    10
    3
        rSBA-MenW-135, PRE[M60], ≥1:128 (N=31; 37; 78)
    4
    7
    3
        rSBA-MenW-135, POST[M61], ≥1:8 (N=31; 38; 82)
    31
    38
    82
        rSBA-MenW-135, POST[M61], ≥1:128 (N=31; 38; 82)
    31
    38
    81
        rSBA-MenY, PRE[M60], ≥1:8 (N=30;37; 78)
    16
    18
    23
        rSBA-MenY, PRE[M60], ≥1:128 (N=30;37; 78)
    10
    12
    23
        rSBA-MenY, POST[M61], ≥1:8 (N=31;38; 82)
    31
    38
    82
        rSBA-MenY, POST[M61], ≥1:128 (N=31;38; 82)
    31
    38
    82
    No statistical analyses for this end point

    Secondary: rSBA antibody titers

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    End point title
    		 rSBA antibody titers
    End point description
    Titers are given as geometric mean titers (GMTs) for the serogroups rSBA-MenA, rSBA-MenC, rSBAMenW-135, and rSBA-MenY respectively, determined by Public Health England [PHE] laboratory assay.
    End point type
    Secondary
    End point timeframe
    At Month 60 and 61 (just prior to and one month post-primary vaccination for Nimenrix Naive Group; one month post-booster for Nimenrix 1 and Nimenrix 2 Groups)
    End point values
    		 Nimenrix 1 Booster Group Nimenrix 2 Booster Group Nimenrix Naive Group
    Number of subjects analysed
    31
    38
    82
    Units: Titers
    geometric mean (confidence interval 95%)
        rSBA-MenA, PRE[M60], (N=30;37; 78)
    35.9 (16.8 to 76.8)
    35.8 (17.1 to 75)
    8.1 (5.7 to 11.5)
        rSBA-MenA, POST[M61], (N=31;38; 81)
    5238.1 (3835.3 to 7154.1)
    5287.7 (4212.4 to 6637.4)
    2970.7 (2282.6 to 3866.1)
        rSBA-MenC, PRE[M60], (N=31;37; 77)
    16 (8.5 to 30)
    20 (10.1 to 39.7)
    5.2 (4.1 to 6.7)
        rSBA-MenC, POST[M61], (N=31;38; 82)
    2738.9 (1707.8 to 4392.5)
    3605 (2401.2 to 5412.4)
    525.1 (365.2 to 755.2)
        rSBA-MenW-135, PRE[M60], (N=31; 37; 78)
    8.7 (4.9 to 15.5)
    10 (5.7 to 17.7)
    4.7 (3.9 to 5.6)
        rSBA-MenW-135, POST[M61], (N=31; 38; 82)
    10713.2 (7632.4 to 15037.4)
    11585.2 (8901.4 to 15078.2)
    5792.6 (4591.7 to 7307.6)
        rSBA-MenY, PRE[M60], (N=30;37; 78)
    29.2 (12.8 to 66.3)
    22 (10.8 to 44.9)
    16.6 (9.9 to 27.7)
        rSBA-MenY, POST[M61], (N=31;38; 82)
    5601.6 (4181.4 to 7504)
    5098.3 (4044.6 to 6426.5)
    4027.3 (3159 to 5134.4)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Month 54).
    Adverse event reporting additional description
    Unsolicitied AEs and SAEs were assessed on the Total Vaccinated Cohort. Solicited symptoms were assessed on those subjects from the Total Vaccinated Cohort who returned their symptom sheet.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Nimenrix Naive Group
    Reporting group description
    		 Vaccine-naive subjects aged 5-6 years were enrolled to receive Nimenrix vaccine as primary vaccination at Year 5.

    Reporting group title
    Nimenrix 2 Group Y1
    Reporting group description
    		 Subjects who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age.

    Reporting group title
    Nimenrix 1 Group Y1
    Reporting group description
    		 Subjects who received 1 dose of Nimenrix vaccine at 12 months of age.

    Serious adverse events
    		 Nimenrix Naive Group Nimenrix 2 Group Y1 Nimenrix 1 Group Y1
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 46 (0.00%)
    0 / 38 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Humerus fracture
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 46 (0.00%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Nimenrix Naive Group Nimenrix 2 Group Y1 Nimenrix 1 Group Y1
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    67 / 100 (67.00%)
    43 / 46 (93.48%)
    31 / 38 (81.58%)
    General disorders and administration site conditions
    Pain
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    46 / 89 (51.69%)
    21 / 45 (46.67%)
    18 / 36 (50.00%)
         occurrences all number
    46
    21
    18
    Redness
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    22 / 89 (24.72%)
    15 / 45 (33.33%)
    10 / 36 (27.78%)
         occurrences all number
    22
    15
    10
    Swelling
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    21 / 89 (23.60%)
    9 / 45 (20.00%)
    8 / 36 (22.22%)
         occurrences all number
    21
    9
    8
    Fatigue
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    18 / 89 (20.22%)
    7 / 45 (15.56%)
    10 / 36 (27.78%)
         occurrences all number
    18
    7
    10
    Gastrointestinal
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    7 / 89 (7.87%)
    5 / 45 (11.11%)
    4 / 36 (11.11%)
         occurrences all number
    7
    5
    4
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    11 / 89 (12.36%)
    5 / 45 (11.11%)
    4 / 36 (11.11%)
         occurrences all number
    11
    5
    4
    Fever (Axillary)
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    5 / 89 (5.62%)
    2 / 45 (4.44%)
    1 / 36 (2.78%)
         occurrences all number
    5
    2
    1
    Injection site bruising
         subjects affected / exposed
    2 / 100 (2.00%)
    1 / 46 (2.17%)
    2 / 38 (5.26%)
         occurrences all number
    2
    1
    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: Only subjects who completed their symptom reporting sheets were taken in consideration for solicited adverse events.
    [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: Only subjects who completed their symptom reporting sheets were taken in consideration for solicited adverse events.
    [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: Only subjects who completed their symptom reporting sheets were taken in consideration for solicited adverse events.
    [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: Only subjects who completed their symptom reporting sheets were taken in consideration for solicited adverse events.
    [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: Only subjects who completed their symptom reporting sheets were taken in consideration for solicited adverse events.
    [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: Only subjects who completed their symptom reporting sheets were taken in consideration for solicited adverse events.
    [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: Only subjects who completed their symptom reporting sheets were taken in consideration for solicited adverse events.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Nov 2010
    A new cohort of subjects (naïve control group), aged 5-6 years, will be administered a dose of MenACWY-TT vaccine at the same time as the booster vaccination given to ACWY1 and ACWY2 groups to allow for evaluation of the safety and immunogenicity of a primary (naïve control group) and a booster dose (groups ACWY1 and ACWY2) within the same study.
    14 Dec 2011
    The primary objective of this study is to evaluate the antibody persistence at approximately 1 year, 3 years and 5 years post-administration of one or two doses of MenACWY-TT conjugate vaccine when given to healthy toddlers at 9-12 months of age. This study will generate antibody persistence data following administration of MenACWY-TT. In addition, the safety and immunogenicity of a booster dose of MenACWY-TT, administered at 5 years post-primary vaccination will be evaluated. Another cohort of subjects (naïve control group) 5-6 years of age will be administered a dose of MenACWY-TT vaccine at the same time to allow for evaluation of a primary (naïve control group) and booster dose within the same study.

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

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