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    Clinical Trial Results:
    A phase II, observer-blinded, multi-center, controlled study to assess the safety and immunogenicity of one dose of GlaxoSmithKline (GSK) Biologicals’ meningococcal serogroup ACWY tetanus toxoid conjugate vaccine (MenACWY-TT) versus one dose of sanofi pasteur’s meningococcal serogroups A, C, W-135 and Y vaccine (Menactra®) in healthy subjects aged 10 through 25 years.

    Summary
    EudraCT number
    		 2012-001305-25
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    29 Jul 2011

    Results information
    Results version number
    		 v1
    This version publication date
    11 May 2016
    First version publication date
    29 Jul 2015
    Other versions
    		 v2 , v3

    Trial information

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    Trial identification
    Sponsor protocol code
    114249
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01165242
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    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
    12 Jan 2012
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Feb 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Jul 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    • To demonstrate the non-inferiority of MenACWY-TT (Lot A) vaccine when compared to MenACWY-DT vaccine in terms of the percentage of subjects with serum bactericidal assay using human complement against Neisseria meningitides serogroup A (hSBA-MenA), serogroup C (hSBA-MenC), serogroup W-135 (hSBA-MenW-135) and serogroup Y (hSBA-MenY) vaccine response one month after vaccination.
    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
    19 Aug 2010
    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
    United States: 713
    Country: Number of subjects enrolled
    Canada: 300
    Worldwide total number of subjects
    1013
    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)
    1013
    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
    		 1013
    Number of subjects completed
    		 1011

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 No vaccination received: 2
    Period 1
    Period 1 title
    Overall (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor
    Blinding implementation details
    Data were collected in an observer-blind manner during this study. The blinding was observer-blind with respect to lots of MenACWY-TT and observer-blind with respect to MenACWY-TT or Menactra. By observer-blind, it was meant that during the course of the study, the vaccine recipient and those responsible for the evaluation of any study endpoint (e.g. safety and reactogenicity) were all unaware of which vaccine was administered.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Nimenrix™ A Group
    Arm description
    		 Subjects received 1 dose of Nimenrix™ Lot A vaccine.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nimenrix™
    Investigational medicinal product code
    Other name
    Meningococcal vaccine GSK 134612
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One intramuscular injection administered in the deltoid region of the non-dominant arm.

    Arm title
    		 Nimenrix™ B Group
    Arm description
    		 Subjects received 1 dose of Nimenrix™ Lot B vaccine.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nimenrix™
    Investigational medicinal product code
    Other name
    Meningococcal vaccine GSK 134612
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One intramuscular injection administered in the deltoid region of the non-dominant arm.

    Arm title
    		 Menactra®MenACWY-DT Group
    Arm description
    		 Subjects were vaccinated with Menactra®
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Menactra®
    Investigational medicinal product code
    Other name
    MenACWY-DT vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One intramuscular injection administered in the deltoid region of the non-dominant arm.

    Number of subjects in period 1 [1]
    		Nimenrix™ A Group Nimenrix™ B Group Menactra®MenACWY-DT Group
    Started
    337
    336
    338
    Completed
    327
    326
    324
    Not completed
    10
    10
    14
         Consent withdrawn by subject
    -
    2
    2
         'Subjects unreachable '
    1
    -
    -
         'Subject incarcerated '
    -
    1
    -
         Extended holiday
    -
    -
    1
         Lost to follow-up
    9
    7
    10
         Subject refuses visit 2
    -
    -
    1
    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: Out f the 1013 subjects enrolled in this study, 2 were assigned subject numbers but received no vaccination and were hence excluded from the study start.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Nimenrix™ A Group
    Reporting group description
    		 Subjects received 1 dose of Nimenrix™ Lot A vaccine.

    Reporting group title
    Nimenrix™ B Group
    Reporting group description
    		 Subjects received 1 dose of Nimenrix™ Lot B vaccine.

    Reporting group title
    Menactra®MenACWY-DT Group
    Reporting group description
    		 Subjects were vaccinated with Menactra®

    Reporting group values
    		 Nimenrix™ A Group Nimenrix™ B Group Menactra®MenACWY-DT Group Total
    Number of subjects
    		 337 336 338 1011
    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 ± 5.16 16.3 ± 5.16 16.2 ± 4.97 -
    Gender categorical
    Units: Subjects
        Female
    		 175 169 176 520
        Male
    		 162 167 162 491

    End points

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    End points reporting groups
    Reporting group title
    Nimenrix™ A Group
    Reporting group description
    		 Subjects received 1 dose of Nimenrix™ Lot A vaccine.

    Reporting group title
    Nimenrix™ B Group
    Reporting group description
    		 Subjects received 1 dose of Nimenrix™ Lot B vaccine.

    Reporting group title
    Menactra®MenACWY-DT Group
    Reporting group description
    		 Subjects were vaccinated with Menactra®

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

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    End point title
    		 Number of subjects with vaccine response to hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY antibodies [1] [2]
    End point description
    End point type
    Primary
    End point timeframe
    One month after the vaccination
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Reporting for hSBA results was done separately for the baseline groups.
    End point values
    		 Nimenrix™ A Group Menactra®MenACWY-DT Group
    Number of subjects analysed
    310
    297
    Units: Subjects
        hSBA-MenA
    281
    191
        hSBA-MenC
    217
    209
        hSBA-MenW-135
    198
    185
        hSBA-MenY
    150
    115
    No statistical analyses for this end point

    Secondary: Number of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY antibody titers ≥ 1:4

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    End point title
    		 Number of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY antibody titers ≥ 1:4
    End point description
    End point type
    Secondary
    End point timeframe
    One month after vaccination
    End point values
    		 Nimenrix™ A Group Nimenrix™ B Group Menactra®MenACWY-DT Group
    Number of subjects analysed
    315
    309
    305
    Units: Subjects
        hSBA-MenA (POST)
    253
    243
    223
        hSBA-MenC (POST)
    295
    293
    291
        hSBA-MenW-135 (POST)
    272
    262
    247
        hSBA-MenY (POST)
    307
    302
    287
    No statistical analyses for this end point

    Secondary: Number of subjects with vaccine response to hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY antibody titers ≥ 1:8

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    End point title
    		 Number of subjects with vaccine response to hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY antibody titers ≥ 1:8
    End point description
    End point type
    Secondary
    End point timeframe
    One month after vaccination
    End point values
    		 Nimenrix™ A Group Nimenrix™ B Group Menactra®MenACWY-DT Group
    Number of subjects analysed
    315
    309
    305
    Units: Subjects
        hSBA-MenA (POST)
    251
    242
    221
        hSBA-MenC (POST)
    295
    292
    291
        hSBA-MenW-135 (POST)
    272
    262
    247
        hSBA-MenY (POST)
    307
    302
    287
    No statistical analyses for this end point

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

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    End point title
    		 Concentration of hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY antibody titers
    End point description
    End point type
    Secondary
    End point timeframe
    One month after vaccination
    End point values
    		 Nimenrix™ A Group Nimenrix™ B Group Menactra®MenACWY-DT Group
    Number of subjects analysed
    315
    309
    305
    Units: Titers
    geometric mean (confidence interval 95%)
        hSBA-MenA (POST)
    54.2 (43.5 to 67.4)
    49.6 (39.6 to 62.1)
    41.3 (32.3 to 52.9)
        hSBA-MenC (POST)
    687.1 (510.5 to 924.9)
    755.8 (557.3 to 1025)
    543.3 (411.2 to 718)
        hSBA-MenW-135 (POST)
    174.5 (138.6 to 219.6)
    161.6 (128.3 to 203.5)
    101.7 (77.9 to 132.7)
        hSBA-MenY (POST)
    349.1 (298.1 to 408.8)
    387.4 (329.7 to 455.1)
    253.8 (204.9 to 314.5)
    No statistical analyses for this end point

    Secondary: Number of subjects with vaccine response for hSBA antibodies

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    End point title
    		 Number of subjects with vaccine response for hSBA antibodies [3]
    End point description
    End point type
    Secondary
    End point timeframe
    One month after vaccination
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Reporting for hSBA results was done separately for the baseline groups.
    End point values
    		 Nimenrix™ B Group
    Number of subjects analysed
    300
    Units: Subjects
        hSBA-MenA MenACWY-TT-B
    214
        hSBA-MenC MenACWY-TT-B
    226
        hSBA-MenW- 135 MenACWY-TT-B
    196
        hSBA-MenY MenACWY-TT-B
    150
    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
    End point type
    Secondary
    End point timeframe
    Within 4 days (Day 0 - Day 3) following vaccination.
    End point values
    		 Nimenrix™ A Group Nimenrix™ B Group Menactra®MenACWY-DT Group
    Number of subjects analysed
    329
    329
    325
    Units: Subjects
        Pain
    169
    167
    180
        Redness
    85
    60
    66
        Swelling
    63
    40
    44
    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
    End point type
    Secondary
    End point timeframe
    Within 4 days (Day 0 - Day 3) following vaccination.
    End point values
    		 Nimenrix™ A Group Nimenrix™ B Group Menactra®MenACWY-DT Group
    Number of subjects analysed
    329
    329
    326
    Units: Subjects
        Fatigue
    96
    94
    89
        Gastrointestinal
    43
    43
    44
        Headache
    86
    87
    83
        Temperature (Orally)
    17
    14
    16
    No statistical analyses for this end point

    Secondary: Occurrence of unsolicited non-serious adverse events

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    End point title
    		 Occurrence of unsolicited non-serious adverse events
    End point description
    End point type
    Secondary
    End point timeframe
    Within 31 days (Day 0 to 30) following vaccination
    End point values
    		 Nimenrix™ A Group Nimenrix™ B Group Menactra®MenACWY-DT Group
    Number of subjects analysed
    337
    336
    338
    Units: Subjects
        AE(s)
    105
    76
    85
    No statistical analyses for this end point

    Secondary: Number of subjects with occurrence of new onset of chronic illness(es) (NOCI)

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    End point title
    		 Number of subjects with occurrence of new onset of chronic illness(es) (NOCI)
    End point description
    End point type
    Secondary
    End point timeframe
    From Month 0 through Month 6
    End point values
    		 Nimenrix™ A Group Nimenrix™ B Group Menactra®MenACWY-DT Group
    Number of subjects analysed
    337
    336
    338
    Units: Subjects
        NOCIs
    3
    0
    0
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with serious adverse events (SAEs)
    End point description
    End point type
    Secondary
    End point timeframe
    From Month 0 through Month 6
    End point values
    		 Nimenrix™ A Group Nimenrix™ B Group Menactra®MenACWY-DT Group
    Number of subjects analysed
    337
    336
    338
    Units: Subjects
        All SAEs
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited symptoms during the 4-day post-vaccination period, Unsolicited AEs during the 31-day post-vaccination period, SAEs up to study end
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    MenACWY-TT-A Group
    Reporting group description
    		 -

    Reporting group title
    MenACWY-TT-B Group
    Reporting group description
    		 -

    Reporting group title
    MenACWY-DT Group
    Reporting group description
    		 -

    Serious adverse events
    		 MenACWY-TT-A Group MenACWY-TT-B Group MenACWY-DT Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 337 (0.30%)
    5 / 336 (1.49%)
    2 / 338 (0.59%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Jaw fracture
         subjects affected / exposed
    0 / 337 (0.00%)
    0 / 336 (0.00%)
    1 / 338 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post procedural haematoma
         subjects affected / exposed
    0 / 337 (0.00%)
    0 / 336 (0.00%)
    1 / 338 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 337 (0.30%)
    1 / 336 (0.30%)
    0 / 338 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 337 (0.00%)
    1 / 336 (0.30%)
    0 / 338 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 337 (0.00%)
    2 / 336 (0.60%)
    0 / 338 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 337 (0.00%)
    2 / 336 (0.60%)
    0 / 338 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 337 (0.00%)
    1 / 336 (0.30%)
    0 / 338 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tooth infection
         subjects affected / exposed
    0 / 337 (0.00%)
    1 / 336 (0.30%)
    0 / 338 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 MenACWY-TT-A Group MenACWY-TT-B Group MenACWY-DT Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    169 / 337 (50.15%)
    167 / 336 (49.70%)
    180 / 338 (53.25%)
    General disorders and administration site conditions
    Pain
    alternative assessment type: Systematic
         subjects affected / exposed
    169 / 337 (50.15%)
    167 / 336 (49.70%)
    180 / 338 (53.25%)
         occurrences all number
    169
    167
    180
    Redness
    alternative assessment type: Systematic
         subjects affected / exposed
    85 / 337 (25.22%)
    60 / 336 (17.86%)
    66 / 338 (19.53%)
         occurrences all number
    85
    60
    66
    Swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    63 / 337 (18.69%)
    40 / 336 (11.90%)
    44 / 338 (13.02%)
         occurrences all number
    63
    40
    44
    Fatigue
    alternative assessment type: Systematic
         subjects affected / exposed
    96 / 337 (28.49%)
    94 / 336 (27.98%)
    89 / 338 (26.33%)
         occurrences all number
    96
    94
    89
    Gastrointestinal
    alternative assessment type: Systematic
         subjects affected / exposed
    43 / 337 (12.76%)
    43 / 336 (12.80%)
    44 / 338 (13.02%)
         occurrences all number
    43
    43
    44
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed
    86 / 337 (25.52%)
    87 / 336 (25.89%)
    83 / 338 (24.56%)
         occurrences all number
    86
    87
    83
    Temperature (Orally)
    alternative assessment type: Systematic
         subjects affected / exposed
    17 / 337 (5.04%)
    14 / 336 (4.17%)
    16 / 338 (4.73%)
         occurrences all number
    17
    14
    16

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Mar 2010
    Amendment 3 The introduction was updated with the current licensing status of competitor vaccines and the current recommendations for meningococcal vaccines. The primary objective of the current study is to demonstrate the non-inferiority of MenACWY-TT (Lot A) when compared to Menactra at 10-25 years of age in terms of the percentage of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY vaccine response* one month after vaccination. *Vaccine response is defined as an hSBA titer of at least 1:8 in subjects initially seronegative (hSBA titer <1:4) and as a 4-fold increase in titer in subjects initially seropositive (hSBA titer 1:4). In addition, to support the data obtained by hSBA testing, antibody concentrations against meningococcal polysaccharides were planned to be assessed by ELISA. The sponsor decided not to perform the ELISA testing for the following reasons: • the World Health Organisation (WHO) considers SBA the primary means of assessing immune response to meningoccoccal 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 [CDC, 2011; WHO, 2006]. Section 6.2 (Storage and handling of study vaccines) has been modified in order to align the wording with the new version of SOP-BIO-CLIN-7055 v04 entitled “Management of the Cold Chain for GlaxoSmithKline Biologicals investigational human subject research” effective since 31 March 2010.
    06 Sep 2010
    • The MenA capsular polysaccharide O-acetylation in MenACWY-TT vaccine Lot A will be 68% instead of 61%. • Mencevax™ ACWY is not licensed in Canada. • Menveo® (Novartis’ meningococcal [groups A, C, Y and W-135] oligosaccharide diphtheria CRM197 conjugate vaccine) was recently licensed in Canada. • A new abbreviation was added to the List of Abbreviations. • For clarification, the word “days” was added after “180-210” in Table 3 Intervals between study visits. • For clarification, the 31-day post-vaccination reporting period for pregnancies was added to Figure 1. • New safety reporting telephone numbers replaced the old numbers. New study contact for emergency code break telephone numbers replaced the old numbers.

    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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