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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
    		 v2(current)
    This version publication date
    07 Apr 2016
    First version publication date
    17 Jul 2015
    Other versions
    		 v1
    Version creation reason
    • New data added to full data set
    • Correction of full data set
    Data for secondary endpoints have been added. Data for rSBA seropositivity and seroconversion primary and secondary endpoints were updated.

    Trial information

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    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
    Final
    Date of interim/final analysis
    30 Jun 2015
    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 Nimenrix™ or Mencevax™ ACWY vaccine: • To evaluate the persistence of meningococcal antibodies in terms of percentage of subjects with serum bactericidal antibodies using baby rabbit complement (rSBA) titres ≥ 1:8 for each of the 4 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
    Month 24 (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, in the primary study 109069 (NCT00464815).
    Arm type
    		 No Intervention

    Investigational medicinal product name
    Nimenrix™
    Investigational medicinal product code
    Other name
    MenACWY-TT
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    MenACWY-TT vaccine was administered by intramuscular injection in the deltoid region of the nondominant arm.

    Arm title
    		 Mencevax Group
    Arm description
    		 Subjects vaccinated with a single dose of MenACWY vaccine, in the primary study 109069 (NCT00464815).
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this 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: No vaccination was received for 8 subjects, hence they were excluded from the study.

    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, in the primary study 109069 (NCT00464815).

    Reporting group title
    Mencevax Group
    Reporting group description
    		 Subjects vaccinated with a single dose of MenACWY vaccine, in the primary study 109069 (NCT00464815).

    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, in the primary study 109069 (NCT00464815).

    Reporting group title
    Mencevax Group
    Reporting group description
    		 Subjects vaccinated with a single dose of MenACWY vaccine, in the primary study 109069 (NCT00464815).

    Primary: Number of subjects with Meningitis A antibody titres by serum bactericidal assay (using rabbit complement) (rSBA-MenA) ≥1:8

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    End point title
    		 Number of subjects with Meningitis A antibody titres by serum bactericidal assay (using rabbit complement) (rSBA-MenA) ≥1:8 [1]
    End point description
    These analyses were performed by the Public Health England (PHE) laboratory and by GSK Biologicals’ laboratory
    End point type
    Primary
    End point timeframe
    At months 24, 36, 48 and 60 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 scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    449
    150
    Units: Subjects
        rSBA-MenA M24 GSK laboratory [N=405;132]
    404
    132
        rSBA-MenA M36 PHE laboratory [N=449;150]
    417
    124
        rSBA-MenA M48 PHE laboratory [N=391;130]
    353
    105
        rSBA-MenA M60 PHE laboratory [N=236;86]
    230
    80
    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 Public Health England (PHE) laboratory and by GSK Biologicals’ laboratory
    End point type
    Primary
    End point timeframe
    At months 24, 36, 48 and 60 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 scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    449
    150
    Units: Subjects
        rSBA-MenC M24 GSK laboratory [N=407;132]
    404
    131
        rSBA-MenC M36 PHE laboratory [N=449;150]
    409
    129
        rSBA-MenC M48 PHE laboratory [N=390;130]
    367
    113
        rSBA-MenC M60 PHE laboratory [N=236;85]
    209
    74
    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 Public Health England (PHE) laboratory and by GSK Biologicals’ laboratory
    End point type
    Primary
    End point timeframe
    At months 24, 36, 48 and 60 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 scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    449
    150
    Units: Subjects
        rSBA-MenW-135 M24 GSK laboratory [N=407;131]
    405
    124
        rSBA-MenW-135 M36 PHE laboratory [N=449;150]
    368
    45
        rSBA-MenW-135 M48 PHE laboratory [N=390;130]
    301
    35
        rSBA-MenW-135 M60 PHE laboratory [N=236;86]
    203
    30
    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 Public Health England (PHE) laboratory and by GSK Biologicals’ laboratory
    End point type
    Primary
    End point timeframe
    At months 24, 36, 48 and 60 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 scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    449
    150
    Units: Subjects
        rSBA-MenY M24 GSK laboratory [N=407;130]
    407
    126
        rSBA-MenY M36 PHE laboratory [N=449;150]
    418
    87
        rSBA-MenY M48 PHE laboratory [N=389;130]
    348
    63
        rSBA-MenY M60 PHE laboratory [N=236;86]
    228
    57
    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 Public Health England (PHE) laboratory and by GSK Biologicals’ laboratory
    End point type
    Secondary
    End point timeframe
    At months 24, 36, 48 and 60 post primary dose
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    449
    150
    Units: Subjects
        rSBA-MenA M24 GSK laboratory [N=405;132]
    403
    128
        rSBA-MenA M36 PHE laboratory [N=449;150]
    398
    118
        rSBA-MenA M48 PHE laboratory [N=391;130]
    335
    99
        rSBA-MenA M60 PHE laboratory [N=236;86]
    219
    71
    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 Public Health England (PHE) laboratory and by GSK Biologicals’ laboratory
    End point type
    Secondary
    End point timeframe
    At months 24, 36, 48 and 60 post primary dose
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    449
    150
    Units: Subjects
        rSBA-MenC M24 GSK laboratory [N=407;132]
    396
    125
        rSBA-MenC M36 PHE laboratory [N=449;150]
    380
    117
        rSBA-MenC M48 PHE laboratory [N=390;130]
    347
    104
        rSBA-MenC M60 PHE laboratory [N=236;85]
    188
    68
    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 Public Health England (PHE) laboratory and by GSK Biologicals’ laboratory
    End point type
    Secondary
    End point timeframe
    At months 24, 36, 48 and 60 post primary dose
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    449
    150
    Units: Subjects
        rSBA-MenW-135 M24 GSK laboratory [N=407;131]
    403
    113
        rSBA-MenW-135 M36 PHE laboratory [N=449;150]
    350
    36
        rSBA-MenW-135 M48 PHE laboratory [N=390;130]
    284
    25
        rSBA-MenW-135 M60 PHE laboratory [N=236;86]
    195
    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 Public Health England (PHE) laboratory and by GSK Biologicals’ laboratory
    End point type
    Secondary
    End point timeframe
    At months 24, 36, 48 and 60 post primary dose
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    449
    150
    Units: Subjects
        rSBA-MenY M24 GSK laboratory [N=407;130]
    407
    123
        rSBA-MenY M36 PHE laboratory [N=449;150]
    401
    77
        rSBA-MenY M48 PHE laboratory [N=389;130]
    333
    60
        rSBA-MenY M60 PHE laboratory [N=236;86]
    225
    56
    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 Public Health England (PHE) laboratory and by GSK Biologicals’ laboratory
    End point type
    Secondary
    End point timeframe
    At months 24, 36, 48 and 60 post primary dose
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    449
    150
    Units: Titers
    geometric mean (confidence interval 95%)
        rSBA-MenA M24 GSK laboratory [N=405;132]
    1493.4 (1369 to 1629)
    780.3 (665.3 to 915.2)
        rSBA-MenA M36 PHE laboratory [N=449;150]
    448.3 (381.4 to 527.1)
    206 (147.4 to 288.1)
        rSBA-MenA M48 PHE laboratory [N=391;130]
    386.9 (321.2 to 466.2)
    174.4 (121.2 to 250.8)
        rSBA-MenA M60 PHE laboratory [N=236;86]
    643.8 (530.7 to 781)
    296 (202.4 to 432.9)
    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 Public Health England (PHE) laboratory and by GSK Biologicals’ laboratory
    End point type
    Secondary
    End point timeframe
    At months 24, 36, 48 and 60 post primary dose
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    449
    150
    Units: Titers
    geometric mean (confidence interval 95%)
        rSBA-MenC M24 GSK laboratory [N=407;132]
    1137.5 (1006.1 to 1286)
    1543 (1145.8 to 2077.7)
        rSBA-MenC M36 PHE laboratory [N=449;150]
    371.4 (309.4 to 445.8)
    389.8 (262 to 579.9)
        rSBA-MenC M48 PHE laboratory [N=390;130]
    378.5 (319.7 to 448.1)
    364 (242.7 to 545.9)
        rSBA-MenC M60 PHE laboratory [N=236;85]
    248.6 (194.2 to 318.2)
    366.5 (224.1 to 599.4)
    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 Public Health England (PHE) laboratory and by GSK Biologicals’ laboratory
    End point type
    Secondary
    End point timeframe
    At months 24, 36, 48 and 60 post primary dose
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    449
    150
    Units: Titers
    geometric mean (confidence interval 95%)
        rSBA-MenW-135 M24 GSK laboratory [N=407;131]
    1977.6 (1775 to 2203.4)
    418.2 (317.6 to 550.6)
        rSBA-MenW-135 M36 PHE laboratory [N=449;150]
    338 (268.4 to 425.6)
    16 (10.9 to 23.6)
        rSBA-MenW-135 M48 PHE laboratory [N=390;130]
    209.8 (163.9 to 268.6)
    11.7 (8.2 to 16.8)
        rSBA-MenW-135 M60 PHE laboratory [N=236;86]
    436.9 (324.4 to 588.4)
    19.7 (11.8 to 32.9)
    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 Public Health England (PHE) laboratory and by GSK Biologicals’ laboratory
    End point type
    Secondary
    End point timeframe
    At months 24, 36, 48 and 60 post primary dose
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    449
    150
    Units: Titer
    geometric mean (confidence interval 95%)
        rSBA-MenY M24 GSK laboratory [N=407;130]
    3502.5 (3203.2 to 3829.7)
    1028.3 (797.3 to 1326.1)
        rSBA-MenY M36 PHE laboratory [N=449;150]
    740.5 (620 to 884.3)
    69.6 (44.6 to 108.6)
        rSBA-MenY M48 PHE laboratory [N=389;130]
    533.4 (430 to 661.7)
    49.8 (30.7 to 80.9)
        rSBA-MenY M60 PHE laboratory [N=236;86]
    1000.2 (824.1 to 1214)
    124.9 (71.2 to 219.3)
    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 GSK Biologicals’ laboratory
    End point type
    Secondary
    End point timeframe
    At month 24
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    208
    66
    Units: Subjects
        Anti-PSA ≥ 0.3 µg/mL [N=196; 65]
    196
    65
        Anti-PSA ≥ 2.0 µg/mL [N=196; 65]
    179
    64
        Anti-PSC ≥ 0.3 µg/mL [N=192; 66]
    176
    66
        Anti-PSC ≥ 2.0 µg/mL [N=192; 66]
    96
    62
        Anti-PSW-135 ≥ 0.3 µg/mL [N=198; 62]
    187
    61
        Anti-PSW-135 ≥ 2.0 µg/mL [N=198; 62]
    127
    49
        Anti-PSY ≥ 0.3 µg/mL [N=208; 65]
    203
    63
        Anti-PSY ≥ 2.0 µg/mL [N=208; 65]
    130
    51
    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
    208
    66
    Units: μg/mL
    geometric mean (confidence interval 95%)
        Anti-PSA [N=196; 65]
    10.16 (8.47 to 12.2)
    18.17 (13.33 to 24.77)
        Anti-PSC [N=192; 66]
    1.95 (1.61 to 2.35)
    10.88 (8.22 to 14.41)
        Anti-PSW-135 [N=198; 62]
    3.29 (2.71 to 4)
    5.22 (3.74 to 7.27)
        Anti-PSY [N=208; 65]
    3.63 (3 to 4.4)
    6.99 (4.83 to 10.11)
    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, 48 and 60
    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
        SAEs Month 60 [N=356;122]
    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, 48 and 60.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Mencevax Group
    Reporting group description
    		 Subjects vaccinated with a single dose of MenACWY vaccine.

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

    Serious adverse events
    		 Mencevax Group Nimenrix Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 168 (0.00%)
    0 / 521 (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
    		 Mencevax Group Nimenrix Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 168 (0.00%)
    0 / 521 (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.

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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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