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    Clinical Trial Results:
    A phase III, randomized, open, controlled, multicenter primary vaccination study to demonstrate the non inferiority of the immunogenicity of meningococcal vaccine GSK134612 given intramuscularly versus Mencevax ACWY given subcutaneously to healthy subjects aged 11 through 17 years

    Summary
    EudraCT number
    		 2012-000282-20
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    10 Sep 2008

    Results information
    Results version number
    		 v3(current)
    This version publication date
    09 Aug 2022
    First version publication date
    06 Mar 2015
    Other versions
    		 v1 , v2
    Version creation reason
    • Correction of full data set
    Correction of full data set and alignment between registries.

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    109069
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00464815
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l'Institut 89, Rixensart, Belgium, 1330
    Public contact
    Clinical Disclosure Advisor, GlaxoSmithKline Biologicals, +44 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Disclosure Advisor, 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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    24 Apr 2009
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Apr 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Sep 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    One month after vaccination: - To demonstrate the non-inferiority of the vaccine response induced by meningococcal vaccine GSK134612 compared to the licensed Mencevax ACWY measured by serum bactericidal antibodies using baby rabbit complement. - To demonstrate the non-inferiority of meningococcal vaccine GSK 134612 compared to the licensed Mencevax ACWY in terms of the incidence of any grade 3 systemic symptom within four days after vaccination based on the analysis of pooled safety and reactogenicity data of this present study and study 109067 (MenACWY-TT-035).
    Protection of trial subjects
    Vaccines were administered by qualified and trained personnel. Vaccines were administered only to eligible subjects that had no contraindications to any components of the vaccines.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 May 2007
    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
    Philippines: 392
    Country: Number of subjects enrolled
    Taiwan: 235
    Country: Number of subjects enrolled
    India: 398
    Worldwide total number of subjects
    1025
    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)
    172
    Adolescents (12-17 years)
    853
    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
    		 The target sample size was 1024 enrolled subjects, but a total of 1025 subjects (in all age strata) were actually enrolled and vaccinated in seven study centres in India, Taiwan and the Philippines.

    Period 1
    Period 1 title
    Overall (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Nimenrix Group
    Arm description
    		 Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Nimenrix (GSK134612) vaccine, administered intramuscularly into the deltoid region of the non-dominant arm.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nimenrix
    Investigational medicinal product code
    GSK134612
    Other name
    Meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose by intramuscular injection in the deltoid region of the non-dominant arm.

    Arm title
    		 Mencevax ACWY Group
    Arm description
    		 Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Mencevax ACWY vaccine, administered subcutaneously into the non-dominant upper arm.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Mencevax ACWY
    Investigational medicinal product code
    Other name
    Meningococcal serogroups A, C, W-135, Y plain polysaccharide vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1 dose subcutaneously in the non-dominant upper arm.

    Number of subjects in period 1
    		Nimenrix Group Mencevax ACWY Group
    Started
    768
    257
    Completed
    762
    254
    Not completed
    6
    3
         Consent withdrawn by subject
    6
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Nimenrix Group
    Reporting group description
    		 Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Nimenrix (GSK134612) vaccine, administered intramuscularly into the deltoid region of the non-dominant arm.

    Reporting group title
    Mencevax ACWY Group
    Reporting group description
    		 Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Mencevax ACWY vaccine, administered subcutaneously into the non-dominant upper arm.

    Reporting group values
    		 Nimenrix Group Mencevax ACWY Group Total
    Number of subjects
    		 768 257 1025
    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
    Healthy males and females aged 11 through 17 years who previously completed routine childhood immunizations to the best of parents'/guardians'knowledge and whose parents/guardians gave written informed consent. No previous vaccination with meningoccal polysaccharide vaccine of serogroups A, C, W-135 and/or Y within the last 5 years, or with meningococcal polysaccharide conjugate vaccine of serogroups A, C, W-135 and/or Y since birth. No previous vaccination with tetanus toxoid within the last month
    Units: years
        arithmetic mean (standard deviation)
    		 14.3 ( 1.97 ) 14.3 ( 1.97 ) -
    Gender categorical
    Units: Subjects
        Female
    		 414 135 549
        Male
    		 354 122 476

    End points

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    End points reporting groups
    Reporting group title
    Nimenrix Group
    Reporting group description
    		 Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Nimenrix (GSK134612) vaccine, administered intramuscularly into the deltoid region of the non-dominant arm.

    Reporting group title
    Mencevax ACWY Group
    Reporting group description
    		 Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Mencevax ACWY vaccine, administered subcutaneously into the non-dominant upper arm.

    Primary: Number of subjects with vaccine response to meningococcal antigens

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    End point title
    		 Number of subjects with vaccine response to meningococcal antigens
    End point description
    Vaccine response induced by Neisseria meningitidis serogroups A, C, W-135 and Y (MenA, MenC, MenW-135 and menY) as measured by serum bactericidal antibodies using baby rabbit complement (rSBA), was defined as an rSBA titer of at least 1:32 in subjects initially seronegative [rSBA titer below (<) 1:8] and as a 4-fold increase in titer in subjects initially seropositive [rSBA titer greater than or equal to (≥) 1:8]. The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
    End point type
    Primary
    End point timeframe
    One month after vaccination (At Month 1)
    End point values
    		 Nimenrix Group Mencevax ACWY Group
    Number of subjects analysed
    657
    219
    Units: Subjects
        rSBA-MenA (N=553,191,314,108)
    472
    148
        rSBA-MenC (N=642,211,365,119)
    625
    204
        rSBA-MenW-135 (N=639,216,362,125)
    616
    189
        rSBA-MenY (N=657,219,378,127)
    616
    172
    Statistical analysis title
    		 Difference in % subjects with rSBA-MenA response
    Statistical analysis description
    To demonstrate the non-inferiority of Nimenrix vaccine versus Mencevax ACWY vaccine in term of rSBA-MenA vaccine response, the standardized asymptotic 95% CI for the difference in rSBA vaccine response rate for each of the meningococcal serogroup A (Nimenrix Group rate minus Mencevax ACWY Group rate) one month after vaccination was computed.
    Comparison groups
    Nimenrix Group v Mencevax ACWY Group
    Number of subjects included in analysis
    876
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Rate difference
    Point estimate
    7.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.63
         upper limit
    		 14.87
    Notes
    [1] - Criterion for non-inferiority: the lower limit of the 2-sided standardized asymptotic 95% confidence interval for the group difference (Nimenrig Group minus Mencevax ACWY Group) in the percentage of subjects with bactericidal vaccine response was greater than or equal to the pre-defined clinical limit of -10%
    Statistical analysis title
    		 Difference in % subjects with rSBA-MenC response
    Statistical analysis description
    To demonstrate the non-inferiority of NImenriv vaccine versus Mencevax ACWY vaccine in term of rSBA-MenC vaccine response, the standardized asymptotic 95% CI for the difference in rSBA vaccine response rate for each of the meningococcal serogroup C (Nimenrix Group rate minus Mencevax ACWY Group rate) one month after vaccination was computed.
    Comparison groups
    Nimenrix Group v Mencevax ACWY Group
    Number of subjects included in analysis
    876
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    Parameter type
    		 Rates Difference
    Point estimate
    0.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.65
         upper limit
    		 4.18
    Notes
    [2] - Criterion for non-inferiority: the lower limit of the 2-sided standardized asymptotic 95% confidence interval for the group difference [Nimenrix Group minus Mencevax ACWY Group] in the percentage of subjects with bactericidal vaccine response was greater than or equal to the pre-defined clinical limit of -10%
    Statistical analysis title
    		 Difference in % subjects with rSBA-MenW135response
    Statistical analysis description
    To demonstrate the non-inferiority of Nimenrix vaccine versus Mencevax ACWY vaccine in term of rSBA-MenW-135 vaccine response, the standardized asymptotic 95% CI for the difference in rSBA vaccine response rate for each of the meningococcal serogroup W-135 (Nimenrix Group rate minus Mencevax ACWY Group rate) one month after vaccination was computed.
    Comparison groups
    Mencevax ACWY Group v Nimenrix Group
    Number of subjects included in analysis
    876
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    Method
    Parameter type
    		 Rate difference
    Point estimate
    8.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.78
         upper limit
    		 14.14
    Notes
    [3] - Criterion for non-inferiority: the lower limit of the 2-sided standardized asymptotic 95% confidence interval for the group difference [Nimenrix Group minus Mencevax ACWY Group] in the percentage of subjects with bactericidal vaccine response was greater than or equal to the pre-defined clinical limit of -10%
    Statistical analysis title
    		 Difference in % subjects with rSBA-MenY response
    Statistical analysis description
    To demonstrate the non-inferiority of Nimenrix vaccine versus Mencevax ACWY vaccine in term of rSBA-MenY vaccine response, the standardized asymptotic 95% CI for the difference in rSBA vaccine response rate for each of the meningococcal serogroup Y (Nimenrix Group rate minus Mencevax ACWY Group rate) one month after vaccination was computed.
    Comparison groups
    Nimenrix Group v Mencevax ACWY Group
    Number of subjects included in analysis
    876
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [4]
    Method
    Parameter type
    		 Rate difference
    Point estimate
    15.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 9.89
         upper limit
    		 21.37
    Notes
    [4] - Criterion for non-inferiority: the lower limit of the 2-sided standardized asymptotic 95% confidence interval for the group difference [Nimenrix Group minus Mencevax ACWY Group] in the percentage of subjects with bactericidal vaccine response was greater than or equal to the pre-defined clinical limit of -10%

    Primary: Number of subjects with any Grade 3 general (solicited and unsolicited) symptoms

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    End point title
    		 Number of subjects with any Grade 3 general (solicited and unsolicited) symptoms
    End point description
    General symptoms assessed included fatigue, fever (defined as axillary temperature), gastrointestinal symptoms and headache. Grade 3 symptom= event that prevented normal activities. Grade 3 fever= temperature above (>) 39.5 degrees Celsius (°C). The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.
    End point type
    Primary
    End point timeframe
    During the 4-day (Days 0 to 3) period after vaccination
    End point values
    		 Nimenrix Group Mencevax ACWY Group
    Number of subjects analysed
    768
    257
    Units: Subjects
        Subjects with Grade 3 symptoms
    12
    1
    Statistical analysis title
    		 Ratio of % 109069 subjects with Grade 3 symptoms
    Statistical analysis description
    To demonstrate the non-inferiority of Nimenrix vaccine versus Mencevax vaccine in term of incidence of any Grade 3 general (solicited and unsolicited) symptom, the 2-sided standardised asymptotic 95% CI for the ratio between Nimenrix and Mencevax groups (Nimenrix over Mencevax) in the percentage of subjects with any grade 3 general symptom within 4 days after vaccination was computed for the safety analysis in study MenACWY-TT-036.
    Comparison groups
    Nimenrix Group v Mencevax ACWY Group
    Number of subjects included in analysis
    1025
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [5]
    P-value
    		 = 0.1456
    Method
    		 Chi-squared
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    4.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.68
         upper limit
    		 24.6
    Notes
    [5] - Criterion for non-inferiority: the upper limit of the 2-sided standardized asymptotic 95% CI for the ratio of the percentages of subjects with any Grade 3 general symptom was lower than or equal to the pre-defined clinical limit of 3.0

    Secondary: Number of subjects with rSBA-Men antibody titers ≥ the cut-off values

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    End point title
    		 Number of subjects with rSBA-Men antibody titers ≥ the cut-off values
    End point description
    Neisseria meningitidis serogroups A, C, W-135 and Y were measured by serum bactericidal assay using baby rabbit complement (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY). The cut-off values for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128. The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures and assay results were available for antibodies against at least one study vaccine antigen component.
    End point type
    Secondary
    End point timeframe
    Prior to (Month 0) and one month after vaccination (Month 1)
    End point values
    		 Nimenrix Group Mencevax ACWY Group
    Number of subjects analysed
    678
    224
    Units: Subjects
        rSBA-MenA, Month 0 ≥ 1:8 (N=557,191)
    463
    148
        rSBA-MenA, Month 0 ≥ 1:128 (N=557,191)
    427
    128
        rSBA-MenA, Month 1 ≥ 1:8 (N=674,224)
    674
    223
        rSBA-MenA, Month 1 ≥ 1:128 (N=674,224)
    674
    223
        rSBA-MenC, Month 0 ≥ 1:8 (N=648,211)
    381
    121
        rSBA-MenC, Month 0 ≥ 1:128 (N=648,211)
    277
    79
        rSBA-MenC, Month 1 ≥ 1:8 (N=673,224)
    673
    224
        rSBA-MenC, Month 1 ≥ 1:128 (N=673,224)
    672
    223
        rSBA- MenW-135, Month 0 ≥ 1:8 (N=640,216)
    519
    176
        rSBA- MenW-135, Month 0 ≥ 1:128 (N=640,216)
    373
    120
        rSBA- MenW-135, Month 1 ≥ 1:8 (N=678,224)
    677
    224
        rSBA- MenW-135, Month 1 ≥ 1:128 (N=678,224)
    677
    223
        rSBA-MenY, Month 0 ≥ 1:8 (N=659,219)
    597
    186
        rSBA-MenY, Month 0 ≥ 1:128 (N=659,219)
    538
    167
        rSBA-MenY, Month 1 ≥ 1:8 (N=677,224)
    677
    224
        rSBA-MenY, Month 1 ≥ 1:128 (N=677,224)
    677
    224
    No statistical analyses for this end point

    Secondary: Meningococcal rSBA antibody titers

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    End point title
    		 Meningococcal rSBA antibody titers
    End point description
    rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers are presented as geometric mean titers (GMTs). The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures and assay results were available for antibodies against at least one study vaccine antigen component.
    End point type
    Secondary
    End point timeframe
    Prior to (Month 0) and one month after vaccination (Month 1)
    End point values
    		 Nimenrix Group Mencevax ACWY Group
    Number of subjects analysed
    678
    224
    Units: Titers
    geometric mean (confidence interval 95%)
        rSBA-MenA, Month 0 (N=557,191,316,108)
    208.1 (176.4 to 245.5)
    155.9 (113.8 to 213.7)
        rSBA-MenA, Month 1 (N=674,224,388,128)
    5928.5 (5557.4 to 6324.3)
    2947.2 (2611.7 to 3325.7)
        rSBA-MenC, Month 0 (N=648,211,369,119)
    44.1 (37.3 to 52.2)
    40.9 (30.2 to 55.3)
        rSBA-MenC, Month 1 (N=673,224,387,128)
    13109.8 (11939.1 to 14395.2)
    8222 (6807.5 to 9930.4)
        rSBA- MenW-135, Month 0 (N=640,216,363,125)
    109.4 (94.6 to 126.6)
    112.2 (87.2 to 144.3)
        rSBA- MenW-135, Month 1 (N=678,224,390,128)
    8246.6 (7638.8 to 8902.7)
    2632.7 (2299.3 to 3014.4)
        rSBA-MenY, Month 0 (N=659,219,380,127)
    348.3 (303.5 to 399.7)
    299 (225.2 to 397)
        rSBA-MenY, Month 1 (N=677,224,389,128)
    14086.5 (13168 to 15069)
    5066.3 (4463.1 to 5750.9)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-tetanus toxoid (Anti-TT) greater than (>) the cut-off value

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    End point title
    		 Number of subjects with anti-tetanus toxoid (Anti-TT) greater than (>) the cut-off value
    End point description
    The cut-off value of the assay was an anti-tetanus toxoid antibody titer greater than (>) 0.1 international units per milliliter (IU/mL). The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures and assay results were available for antibodies against at least one study vaccine antigen component.
    End point type
    Secondary
    End point timeframe
    Prior to (Month 0) and one month after vaccination (Month 1)
    End point values
    		 Nimenrix Group Mencevax ACWY Group
    Number of subjects analysed
    679
    224
    Units: Subjects
        Anti-TT, Month 0 (N=679,224,391,128)
    439
    155
        Anti-TT, Month 1 (N=679,224,391,128)
    662
    157
    No statistical analyses for this end point

    Secondary: Anti-TT antibody concentrations

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    End point title
    		 Anti-TT antibody concentrations
    End point description
    Antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL). The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures and assay results were available for antibodies against at least one study vaccine antigen component.
    End point type
    Secondary
    End point timeframe
    Prior to (Month 0) and one month (Month 1) after vaccination
    End point values
    		 Nimenrix Group Mencevax ACWY Group
    Number of subjects analysed
    679
    224
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-TT, Month 0 (N=679,224,391,128)
    0.367 (0.321 to 0.419)
    0.41 (0.326 to 0.516)
        Anti-TT, Month 1 (N=679,224,391,128)
    10.305 (9.131 to 11.631)
    0.459 (0.364 to 0.58)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-meningococcal polysaccharides (PS) antibody concentrations ≥ the cut-off values

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    End point title
    		 Number of subjects with anti-meningococcal polysaccharides (PS) antibody concentrations ≥ the cut-off values
    End point description
    The cut-off values of the assay was an anti-PS concentration greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and ≥ 2.0 μg/mL. The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures and assay results were available for antibodies against at least one study vaccine antigen component.
    End point type
    Secondary
    End point timeframe
    Prior to (Month 0) and one month after vaccination (Month 1)
    End point values
    		 Nimenrix Group Mencevax ACWY Group
    Number of subjects analysed
    347
    114
    Units: Subjects
        Anti-PSA ≥ 0.3 ug/mL, Month 0 (N=322,102,189,59)
    235
    75
        Anti-PSA ≥ 0.3 ug/mL, Month 1 (N=341,107,194,59)
    341
    107
        Anti-PSC ≥ 0.3 ug/mL, Month 0 (N=335,108,190,60)
    50
    21
        Anti-PSC ≥ 0.3 ug/mL, Month 1 (N=331,107,188,60)
    331
    107
        Anti-PSW-135 ≥0.3 ug/mL,Month 0 (N=340,111,204,64)
    40
    8
        Anti-PSW-135 ≥0.3ug/mL, Month 1 (N=344,114,205,66)
    340
    113
        Anti-PSY ≥ 0.3 ug/mL, Month 0 (N=347,114,206,68)
    49
    16
        Anti-PSY ≥ 0.3 ug/mL, Month 1 (N=342,114,201,66)
    342
    113
        Anti-PSA ≥ 2 ug/mL, Month 0 (N=322,102,189,59)
    130
    40
        Anti-PSA ≥ 2 ug/mL, Month 1 (N=341,107,194,59)
    341
    107
        Anti-PSC ≥ 2 ug/mL, Month 0 (N=335,108,190,60)
    17
    10
        Anti-PSC ≥ 2 ug/mL, Month 1 (N=331,107,188,60)
    324
    106
        Anti-PSW-135 ≥ 2 ug/mL, Month 0 (N=340,111,204,64)
    9
    3
        Anti-PSW-135 ≥ 2 ug/mL, Month 1 (N=344,114,205,66)
    327
    106
        Anti-PSY ≥ 2 ug/mL, Month 0 (N=347,114,206,68)
    12
    8
        Anti-PSY ≥ 2 ug/mL, Month 1 (N=342,114,201,66)
    336
    111
    No statistical analyses for this end point

    Secondary: Anti-meningococcal polysaccharide concentrations

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    End point title
    		 Anti-meningococcal polysaccharide concentrations
    End point description
    Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures and assay results were available for antibodies against at least one study vaccine antigen component.
    End point type
    Secondary
    End point timeframe
    Prior to (Month 0) and one month (Month 1) after vaccination
    End point values
    		 Nimenrix Group Mencevax ACWY Group
    Number of subjects analysed
    347
    114
    Units: μg/mL
    geometric mean (confidence interval 95%)
        Anti-PSA, Month 0 (N=322,102,189,59)
    1.05 (0.88 to 1.24)
    1.04 (0.77 to 1.39)
        Anti-PSA, Month 1 (N=341,107,194,59)
    86.06 (75.35 to 98.29)
    44.06 (34.4 to 56.42)
        Anti-PSC, Month 0 (N=335,108,190,60)
    0.21 (0.19 to 0.24)
    0.25 (0.2 to 0.3)
        Anti-PSC, Month 1 (N=331,107,188,60)
    22.83 (20.42 to 25.52)
    43.24 (35.8 to 52.23)
        Anti-PSW-135, Month 0 (N=340,111,204,64)
    0.18 (0.17 to 0.2)
    0.18 (0.16 to 0.21)
        Anti-PSW-135, Month 1 (N=344,114,205,66)
    17.82 (15.34 to 20.7)
    13.22 (10.47 to 16.68)
        Anti-PSY, Month 0 (N=347,114,206,68)
    0.2 (0.18 to 0.22)
    0.22 (0.18 to 0.28)
        Anti-PSY, Month 1 (N=342,114,201,66)
    23.77 (20.95 to 26.98)
    17.97 (14.3 to 22.59)
    No statistical analyses for this end point

    Secondary: Number of subjects with any and Grade 3 solicited local symptoms

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    End point title
    		 Number of subjects with any and Grade 3 solicited local symptoms
    End point description
    Solicited local symptoms assessed included pain, redness and swelling. Any= incidence of a particular symptom regardless of intensity. Grade 3 symptoms= symptoms that prevented normal activity. Grade 3 swelling= swelling spreading beyond 50 millimeters (mm). The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had the symptoms sheet filled in.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Day 0 to Day 3) period after vaccination
    End point values
    		 Nimenrix Group Mencevax ACWY Group
    Number of subjects analysed
    763
    254
    Units: Subjects
        Any Pain
    200
    68
        Grade 3 Pain
    6
    0
        Any Redness
    94
    16
        Grade 3 Redness
    2
    0
        Any Swelling
    71
    16
        Grade 3 Swelling
    9
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with any, grade 3 and related solicited general symptoms

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    End point title
    		 Number of subjects with any, grade 3 and related solicited general symptoms
    End point description
    Solicited general symptoms assessed included fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any= incidence of a particular symptom regardless of intensity or relationship to vaccination. Grade 3= event that prevented normal activities. Grade 3 fever= fever > 39.5 °C. Related= general symptom assessed by the investigator as causally related to the study vaccination. The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had the symptoms sheet filled in.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Day 0 to Day 3) period after vaccination
    End point values
    		 Nimenrix Group Mencevax ACWY Group
    Number of subjects analysed
    763
    254
    Units: Subjects
        Any Fatigue
    109
    36
        Grade 3 Fatigue
    7
    1
        Related Fatigue
    83
    26
        Any Fever (Axillary)
    55
    13
        Grade 3 Fever
    3
    0
        Related Fever
    42
    10
        Any Gastrointestinal symptoms
    35
    11
        Grade 3 Gastrointestinal symptoms
    0
    1
        Related Gastrointestinal symptoms
    24
    9
        Any Headache
    102
    27
        Grade 3 Headache
    5
    1
        Related Headache
    81
    19
    No statistical analyses for this end point

    Secondary: Number of subjects with any unsolicited adverse events

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    End point title
    		 Number of subjects with any unsolicited adverse events
    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. The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
    End point type
    Secondary
    End point timeframe
    During the 31-day (Days 0-30) post-vaccination period
    End point values
    		 Nimenrix Group Mencevax ACWY Group
    Number of subjects analysed
    768
    257
    Units: Subjects
        Any AEs
    72
    26
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with any serious adverse events (SAEs)
    End point description
    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
    End point type
    Secondary
    End point timeframe
    Up to study end (Month 6)
    End point values
    		 Nimenrix Group Mencevax ACWY Group
    Number of subjects analysed
    768
    257
    Units: Subjects
        Any SAEs
    3
    2
    No statistical analyses for this end point

    Secondary: Number of subjects with specific adverse events

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    End point title
    		 Number of subjects with specific adverse events
    End point description
    These events included the specific categories of adverse events (AEs) which included rash (e.g. hives, idiopathic thrombocytopenia purpura, petechiae), new onset of chronic illness(es) (NOCIs) (e.g. autoimmune disorders, asthma, type I diabetes and allergies), conditions prompting emergency room (ER) visits or non-routine physician office visits (i.e. office visits not related to well-being care, vaccination, injury or common acute illnesses such as upper respiratory tract infections, otitis media, pharyngitis, gastroenteritis), any events related to lack of meningococcal vaccine efficacy (i.e. meningococcal disease). The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
    End point type
    Secondary
    End point timeframe
    Up to study end (Month 6)
    End point values
    		 Nimenrix Group Mencevax ACWY Group
    Number of subjects analysed
    768
    257
    Units: Subjects
        Any Rash
    6
    1
        Any NOCIs
    0
    0
        Any ER visits
    1
    0
    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 adverse events (AEs): during the 4-day (Days 0-3) period after vaccination. Unsolicited AEs: up to one month after vaccination (Month 1). SAEs and specific AEs: up to study end (Month 6).
    Adverse event reporting additional description
    The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.0
    Reporting groups
    Reporting group title
    Nimenrix Group
    Reporting group description
    		 Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Nimenrix (GSK134612) vaccine, administered intramuscularly into the deltoid region of the non-dominant arm.

    Reporting group title
    Mencevax ACWY Group
    Reporting group description
    		 Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Mencevax ACWY vaccine, administered subcutaneously into the non-dominant upper arm.

    Serious adverse events
    		 Nimenrix Group Mencevax ACWY Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 768 (0.39%)
    2 / 257 (0.78%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Humerus fracture
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 768 (0.00%)
    1 / 257 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Peptic ulcer
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 768 (0.26%)
    0 / 257 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Amoebic dysentery
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 768 (0.13%)
    0 / 257 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 768 (0.00%)
    1 / 257 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritoneal abscess
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 768 (0.00%)
    1 / 257 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 768 (0.13%)
    0 / 257 (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 Group Mencevax ACWY Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    311 / 768 (40.49%)
    99 / 257 (38.52%)
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    200 / 768 (26.04%)
    68 / 257 (26.46%)
         occurrences all number
    200
    68
    Redness
         subjects affected / exposed
    94 / 768 (12.24%)
    16 / 257 (6.23%)
         occurrences all number
    94
    16
    Swelling
         subjects affected / exposed
    71 / 768 (9.24%)
    16 / 257 (6.23%)
         occurrences all number
    71
    16
    Fatigue
         subjects affected / exposed
    109 / 768 (14.19%)
    36 / 257 (14.01%)
         occurrences all number
    109
    36
    Fever
         subjects affected / exposed
    55 / 768 (7.16%)
    13 / 257 (5.06%)
         occurrences all number
    55
    13
    Headache
         subjects affected / exposed
    102 / 768 (13.28%)
    27 / 257 (10.51%)
         occurrences all number
    102
    27

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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