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    Clinical Trial Results:
    A phase III, open, controlled study to assess the persistence of antibodies after one dose of GlaxoSmithKline Biologicals’ meningococcal serogroup ACWY conjugate vaccine (MenACWY-TT) given intramuscularly versus one dose of Mencevax™ ACWY given subcutaneously to healthy subjects aged 11 through 17 years in the primary study 109069 (MenACWY-TT-036)

    Summary
    EudraCT number
    		 2012-005641-21
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    17 May 2013

    Results information
    Results version number
    		 v1
    This version publication date
    10 Mar 2016
    First version publication date
    17 Jul 2015
    Other versions
    		 v2

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    112148
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00974363
    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
    Interim
    Date of interim/final analysis
    20 Jun 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 May 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    17 May 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    At 24, 36, 48, and 60 months after primary vaccination of adolescents with MenACWY-TT or Mencevax™ ACWY vaccine, to evaluate the persistence of meningococcal antibodies in terms of percentage of subjects with rSBA titres ≥ 8 for each of the four serogroups.
    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
    08 Sep 2009
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 5 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Philippines: 388
    Country: Number of subjects enrolled
    India: 309
    Worldwide total number of subjects
    697
    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)
    0
    Adolescents (12-17 years)
    697
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

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

    Pre-assignment period milestones
    Number of subjects started
    		 697
    Number of subjects completed
    		 689

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 No vaccination received: 8
    Period 1
    Period 1 title
    Overall Study (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
    		 Subjects vaccinated with a single dose of MenACWY-TT vaccine.
    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
    MenACWY-TT vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.

    Arm title
    		 Mencevax Group
    Arm description
    		 Subjects vaccinated with a single dose of MenACWY vaccine.
    Arm type
    		 Experimental

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

    Number of subjects in period 1 [1]
    		Nimenrix Group Mencevax Group
    Started
    521
    168
    Completed
    521
    168
    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.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Nimenrix Group
    Reporting group description
    		 Subjects vaccinated with a single dose of MenACWY-TT vaccine.

    Reporting group title
    Mencevax Group
    Reporting group description
    		 Subjects vaccinated with a single dose of MenACWY vaccine.

    Reporting group values
    		 Nimenrix Group Mencevax Group Total
    Number of subjects
    		 521 168 689
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 16.4 ± 1.94 16.4 ± 2 -
    Gender categorical
    Units: Subjects
        Female
    		 273 86 359
        Male
    		 248 82 330

    End points

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    End points reporting groups
    Reporting group title
    Nimenrix Group
    Reporting group description
    		 Subjects vaccinated with a single dose of MenACWY-TT vaccine.

    Reporting group title
    Mencevax Group
    Reporting group description
    		 Subjects vaccinated with a single dose of MenACWY vaccine.

    Primary: Number of subjects with rSBA-MenA antibody titres ≥1:8.

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    End point title
    		 Number of subjects with rSBA-MenA antibody titres ≥1:8. [1]
    End point description
    These analyses were performed by the Health Protection Agency (HPA) laboratory and by GSK Biologicals’ laboratory.
    End point type
    Primary
    End point timeframe
    At months 24, 36 and 48 post primary dose.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    472
    154
    Units: Subjects
        rSBA-MenA Month 24 GSK laboratory [N=445;144]
    444
    144
        rSBA-MenA Month 36 GSK laboratory [N=465;149]
    465
    149
        rSBA-MenA Month 36 HPA laboratory [N=472;154]
    440
    128
        rSBA-MenA Month 48 GSK laboratory [N=399;130]
    399
    130
        rSBA-MenA Month 48 HPA laboratory [N=403;133]
    363
    107
    No statistical analyses for this end point

    Primary: Number of subjects with rSBA-MenC antibody titres ≥1:8.

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    End point title
    		 Number of subjects with rSBA-MenC antibody titres ≥1:8. [2]
    End point description
    These analyses were performed by the Health Protection Agency (HPA) laboratory and by GSK Biologicals’ laboratory.
    End point type
    Primary
    End point timeframe
    At months 24, 36 and 48 post primary dose.
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    472
    154
    Units: Subjects
        rSBA-MenC Month 24 GSK laboratory [N=447;145]
    444
    143
        rSBA-MenC Month 36 GSK laboratory [N=468;150]
    465
    149
        rSBA-MenC Month 36 HPA laboratory [N=472;154]
    432
    133
        rSBA-MenC Month 48 GSK laboratory [N=401;130]
    398
    128
        rSBA-MenC Month 48 HPA laboratory [N=402;133]
    379
    116
    No statistical analyses for this end point

    Primary: Number of subjects with rSBA-MenW-135 antibody titres ≥1:8.

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    End point title
    		 Number of subjects with rSBA-MenW-135 antibody titres ≥1:8. [3]
    End point description
    These analyses were performed by the Health Protection Agency (HPA) laboratory and by GSK Biologicals’ laboratory.
    End point type
    Primary
    End point timeframe
    At months 24, 36 and 48 post primary dose.
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    472
    154
    Units: Subjects
        rSBA-MenW-135 Month 24 GSK laboratory [N=447;143]
    445
    136
        rSBA-MenW-135 Month 36 GSK laboratory [N=468;147]
    467
    140
        rSBA-MenW-135 Month 36 HPA laboratory [N=472;154]
    389
    47
        rSBA-MenW-135 Month 48 GSK laboratory [N=401;129]
    400
    122
        rSBA-MenW-135 Month 48 HPA laboratory [N=402;132]
    311
    36
    No statistical analyses for this end point

    Primary: Number of subjects with rSBA-MenY antibody titres ≥1:8.

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    End point title
    		 Number of subjects with rSBA-MenY antibody titres ≥1:8. [4]
    End point description
    These analyses were performed by the Health Protection Agency (HPA) laboratory and by GSK Biologicals’ laboratory.
    End point type
    Primary
    End point timeframe
    At months 24, 36 and 48 post primary dose.
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    472
    154
    Units: Subjects
        rSBA-MenY Month 24 GSK laboratory [N=447;142]
    447
    138
        rSBA-MenY Month 36 GSK laboratory [N=468;147]
    468
    143
        rSBA-MenY Month 36 HPA laboratory [N=472;154]
    441
    89
        rSBA-MenY Month 48 GSK laboratory [N=401;128]
    401
    124
        rSBA-MenY Month 48 HPA laboratory [N=400;132]
    358
    64
    No statistical analyses for this end point

    Secondary: Number of subjects with rSBA-MenA antibody titres ≥1:128.

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    End point title
    		 Number of subjects with rSBA-MenA antibody titres ≥1:128.
    End point description
    These analyses were performed by the Health Protection Agency (HPA) laboratory and by GSK Biologicals’ laboratory.
    End point type
    Secondary
    End point timeframe
    At months 24, 36 and 48 post primary dose.
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    472
    154
    Units: Subjects
        rSBA-MenA Month 24 GSK laboratory [N=445;144]
    443
    140
        rSBA-MenA Month 36 GSK laboratory [N=465;149]
    464
    145
        rSBA-MenA Month 36 HPA laboratory [N=472;154]
    421
    122
        rSBA-MenA Month 48 GSK laboratory [N=399;130]
    398
    126
        rSBA-MenA Month 48 HPA laboratory [N=403;133]
    344
    101
    No statistical analyses for this end point

    Secondary: Number of subjects with rSBA-MenC antibody titres ≥1:128.

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    End point title
    		 Number of subjects with rSBA-MenC antibody titres ≥1:128.
    End point description
    These analyses were performed by the Health Protection Agency (HPA) laboratory and by GSK Biologicals’ laboratory.
    End point type
    Secondary
    End point timeframe
    At months 24, 36 and 48 post primary dose.
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    472
    154
    Units: Subjects
        rSBA-MenC Month 24 GSK laboratory [N=447;145]
    434
    137
        rSBA-MenC Month 36 GSK laboratory [N=468;150]
    452
    143
        rSBA-MenC Month 36 HPA laboratory [N=472;154]
    401
    121
        rSBA-MenC Month 48 GSK laboratory [N=401;130]
    387
    122
        rSBA-MenC Month 48 HPA laboratory [N=402;133]
    359
    107
    No statistical analyses for this end point

    Secondary: Number of subjects with rSBA-MenW-135 antibody titres ≥1:128.

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    End point title
    		 Number of subjects with rSBA-MenW-135 antibody titres ≥1:128.
    End point description
    These analyses were performed by the Health Protection Agency (HPA) laboratory and by GSK Biologicals’ laboratory.
    End point type
    Secondary
    End point timeframe
    At months 24, 36 and 48 post primary dose.
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    472
    154
    Units: Subjects
        rSBA-MenW-135 Month 24 GSK laboratory [N=447;143]
    443
    124
        rSBA-MenW-135 Month 36 GSK laboratory [N=468;147]
    465
    129
        rSBA-MenW-135 Month 36 HPA laboratory [N=472;154]
    371
    38
        rSBA-MenW-135 Month 48 GSK laboratory [N=401;129]
    398
    111
        rSBA-MenW-135 Month 48 HPA laboratory [N=402;132]
    292
    26
    No statistical analyses for this end point

    Secondary: Number of subjects with rSBA-MenY antibody titres ≥1:128.

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    End point title
    		 Number of subjects with rSBA-MenY antibody titres ≥1:128.
    End point description
    These analyses were performed by the Health Protection Agency (HPA) laboratory and by GSK Biologicals’ laboratory.
    End point type
    Secondary
    End point timeframe
    At months 24, 36 and 48 post primary dose.
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    472
    154
    Units: Subjects
        rSBA-MenY Month 24 GSK laboratory [N=447;142]
    447
    135
        rSBA-MenY Month 36 GSK laboratory [N=468;147]
    468
    140
        rSBA-MenY Month 36 HPA laboratory [N=472;154]
    422
    79
        rSBA-MenY Month 48 GSK laboratory [N=401;128]
    401
    121
        rSBA-MenY Month 48 HPA laboratory [N=400;132]
    343
    61
    No statistical analyses for this end point

    Secondary: Antibody titers for rSBA-MenA.

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    End point title
    		 Antibody titers for rSBA-MenA.
    End point description
    These analyses were performed by the Health Protection Agency (HPA) laboratory and by GSK Biologicals’ laboratory.
    End point type
    Secondary
    End point timeframe
    At months 24, 36 and 48 post primary dose.
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    472
    154
    Units: Titers
    geometric mean (confidence interval 95%)
        rSBA-MenA Month 24 GSK laboratory [N=445;144]
    1517.4 (1399.7 to 1645.1)
    810.6 (695.9 to 944.3)
        rSBA-MenA Month 36 GSK laboratory [N=465;149]
    1531.6 (1421.7 to 1650)
    821.9 (710.5 to 950.9)
        rSBA-MenA Month 36 HPA laboratory [N=472;154]
    470.2 (402.1 to 549.8)
    211.9 (152.7 to 294.1)
        rSBA-MenA Month 48 GSK laboratory [N=399;130]
    1484.8 (1370 to 1609.3)
    756.9 (652.3 to 878.2)
        rSBA-MenA Month 48 HPA laboratory [N=403;133]
    375.7 (312.4 to 451.7)
    171.4 (119.6 to 245.6)
    No statistical analyses for this end point

    Secondary: Antibody titers for rSBA-MenC.

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    End point title
    		 Antibody titers for rSBA-MenC.
    End point description
    These analyses were performed by the Health Protection Agency (HPA) laboratory and by GSK Biologicals’ laboratory.
    End point type
    Secondary
    End point timeframe
    At months 24, 36 and 48 post primary dose.
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    472
    154
    Units: Titers
    geometric mean (confidence interval 95%)
        rSBA-MenC Month 24 GSK laboratory [N=447;145]
    1121.9 (996.9 to 1262.6)
    1499 (1119.6 to 2006.8)
        rSBA-MenC Month 36 GSK laboratory [N=468;150]
    1111.2 (990.4 to 1246.6)
    1577.2 (1204.1 to 2065.8)
        rSBA-MenC Month 36 HPA laboratory [N=472;154]
    375.6 (314.8 to 448.1)
    407 (275.7 to 600.8)
        rSBA-MenC Month 48 GSK laboratory [N=401;130]
    1063.6 (940.2 to 1203.2)
    1316.9 (970.9 to 1786.1)
        rSBA-MenC Month 48 HPA laboratory [N=402;133]
    376.7 (319.6 to 444)
    368.7 (248 to 548.2)
    No statistical analyses for this end point

    Secondary: Antibody titers for rSBA-MenW-135.

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    End point title
    		 Antibody titers for rSBA-MenW-135.
    End point description
    These analyses were performed by the Health Protection Agency (HPA) laboratory and by GSK Biologicals’ laboratory.
    End point type
    Secondary
    End point timeframe
    At months 24, 36 and 48 post primary dose.
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    472
    154
    Units: Titers
    geometric mean (confidence interval 95%)
        rSBA-MenW-135 Month 24 GSK laboratory [N=447;143]
    2070.6 (1869.8 to 2293)
    442.6 (341.8 to 573)
        rSBA-MenW-135 Month 36 GSK laboratory [N=468;147]
    2091.8 (1899.7 to 2303.4)
    443.2 (344.9 to 569.5)
        rSBA-MenW-135 Month 36 HPA laboratory [N=472;154]
    352.6 (282 to 440.9)
    16.4 (11.2 to 24.1)
        rSBA-MenW-135 Month 48 GSK laboratory [N=401;129]
    1999.5 (1802.4 to 2218.1)
    393.5 (301.2 to 514.1)
        rSBA-MenW-135 Month 48 HPA laboratory [N=402;132]
    208.2 (163.3 to 265.3)
    12 (8.4 to 17.2)
    No statistical analyses for this end point

    Secondary: Antibody titers for rSBA-MenY.

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    End point title
    		 Antibody titers for rSBA-MenY.
    End point description
    These analyses were performed by the Health Protection Agency (HPA) laboratory and by GSK Biologicals’ laboratory.
    End point type
    Secondary
    End point timeframe
    At months 24, 36 and 48 post primary dose.
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    472
    154
    Units: Titers
    geometric mean (confidence interval 95%)
        rSBA-MenY Month 24 GSK laboratory [N=447;142]
    3715.9 (3409.3 to 4049.9)
    1090.3 (857.7 to 1386.1)
        rSBA-MenY Month 36 GSK laboratory [N=468;147]
    3701.8 (3401.9 to 4028)
    1122.4 (886.4 to 1421.3)
        rSBA-MenY Month 36 HPA laboratory [N=472;154]
    752.3 (633.3 to 893.6)
    68.5 (44.2 to 106.1)
        rSBA-MenY Month 48 GSK laboratory [N=401;128]
    3406.2 (3114.9 to 3724.7)
    999 (780.8 to 1278.2)
        rSBA-MenY Month 48 HPA laboratory [N=400;132]
    545 (440.7 to 673.9)
    49.5 (30.6 to 79.9)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-polysaccharide A (anti-PSA), anti-polysaccharide C (anti-PSC), anti-polysaccharide W-135 (anti-PSW-135) and anti-polysaccharide Y (anti-PSY) antibody concentrations equal to or above the cut-off values.

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    End point title
    		 Number of subjects with anti-polysaccharide A (anti-PSA), anti-polysaccharide C (anti-PSC), anti-polysaccharide W-135 (anti-PSW-135) and anti-polysaccharide Y (anti-PSY) antibody concentrations equal to or above the cut-off values.
    End point description
    These analyses were performed by the Health Protection Agency (HPA) laboratory and by GSK Biologicals’ laboratory.
    End point type
    Secondary
    End point timeframe
    At month 24.
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    226
    73
    Units: Subjects
        Anti-PSA ≥ 0.3 µg/mL [N=217;72]
    217
    72
        Anti-PSA ≥ 2.0 µg/mL [N=217;72]
    199
    71
        Anti-PSC ≥ 0.3 µg/mL [N=212;73]
    195
    73
        Anti-PSC ≥ 2.0 µg/mL [N=212;73]
    103
    68
        Anti-PSW-135 ≥ 0.3 µg/mL [N=216;68]
    204
    67
        Anti-PSW-135 ≥ 2.0 µg/mL [N=216;68]
    135
    54
        Anti-PSY ≥ 0.3 µg/mL [N=226;71]
    220
    69
        Anti-PSY ≥ 2.0 µg/mL [N=226;71]
    140
    56
    No statistical analyses for this end point

    Secondary: Concentrations of anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY antibodies.

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    End point title
    		 Concentrations of anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY antibodies.
    End point description
    End point type
    Secondary
    End point timeframe
    At month 24.
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    226
    73
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PSA [N=217;72]
    10.68 (8.97 to 12.72)
    18.47 (13.79 to 24.74)
        Anti-PSC [N=212;73]
    1.96 (1.63 to 2.34)
    10.76 (8.25 to 14.02)
        Anti-PSW-135 [N=216;68]
    3.15 (2.62 to 3.79)
    5.51 (4.01 to 7.58)
        Anti-PSY [N=226;71]
    3.51 (2.93 to 4.21)
    7.37 (5.2 to 10.45)
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with serious adverse events (SAEs).
    End point description
    End point type
    Secondary
    End point timeframe
    At months 24, 36 and 48.
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    521
    168
    Units: Subjects
        SAEs Month 24 [N=521;168]
    0
    0
        SAEs Month 36 [N=488;155]
    0
    0
        SAEs Month 48 [N=407;134]
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Serious adverse events (SAEs): up to Month 24, 36 an 48.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.1
    Reporting groups
    Reporting group title
    Nimenrix Group
    Reporting group description
    		 Subjects vaccinated with a single dose of MenACWY-TT vaccine.

    Reporting group title
    Mencevax Group
    Reporting group description
    		 Subjects vaccinated with a single dose of MenACWY vaccine.

    Serious adverse events
    		 Nimenrix Group Mencevax Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 521 (0.00%)
    0 / 168 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Nimenrix Group Mencevax Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 521 (0.00%)
    0 / 168 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No information about unsolicited AEs was collected during this study as no product was administered.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Dec 2011
    The primary objective of the study was to evaluate the persistence of meningococcal antibodies in terms of the percentage of subjects with rabbit serum bactericidal assay (rSBA) titres ≥1:8 for each of the four serogroups (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY) at 24, 36, 48 and 60 months after primary vaccination of adolescents with MenACWY-TT or Mencevax™ ACWY vaccine. To support the data obtained by rSBA testing, antibody concentrations against meningococcal polysaccharides are planned to be assessed by ELISA (anti-polysaccharides [PS] testing) at 24, 36, 48 and 60 months after primary vaccination with MenACWY-TT. The anti-PS testing will be performed at 24 months after vaccine administration, but the sponsor decided not to perform the anti-PS testing at 36, 48 and 60 months after vaccine administration for the following reasons: •the World Health Organisation (WHO) considers SBA the primary means of assessing immune response to meningococcal conjugate vaccines [WHO, 2006; WHO, 1999]. •circulating bactericidal antibodies are more critical for persistent protection against meningococcal disease than non-functional antibodies against meningococcal polysaccharides [Centres for Disease Control (CDC), 2011; WHO, 2006]. Although antibody concentrations will not be determined by ELISA at 36, 48 and 60 months after primary vaccination with MenACWY-TT or, all subjects will be informed of their rSBA antibody titres at each immunogenicity time point when statistical analyses at that time point have been completed. In addition: •The protocol amendment clarifies in which laboratory the different assays will be performed. •The introduction has been updated with the current licensing status of competitor vaccines and the current recommendations for meningococcal vaccines. The rationale for the study has been updated according to this new information. •The list of abbreviations and reference list have been updated according to changes in the clinical study team.

    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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