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    Clinical Trial Results:
    A phase II, open, controlled, multi-center study to evaluate the long-term antibody persistence at 1 year, 3 years and 5 years after the administration of one dose of GlaxoSmithKline (GSK) Biologicals’ meningococcal serogroups A, C, W-135, Y-tetanus toxoid conjugate (MenACWY-TT) vaccine versus one dose of sanofi-pasteur’s meningococcal serogroups A, C, W-135 and Y-diphtheria toxoid conjugate vaccine (Menactra®) in healthy adolescents/adults aged 10-25 years and to evaluate the safety and immunogenicity of a booster response to MenACWY-TT vaccine administered at 5 years post-primary vaccination with MenACWY-TT or Menactra® and of a primary vaccination of MenACWY-TT in a newly enrolled group aged 15-<31 years.

    Summary
    EudraCT number
    		 2012-002718-38
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    20 Sep 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 May 2016
    First version publication date
    18 Jul 2015
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    111670
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00715910
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    15 Apr 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Apr 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Sep 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the long-term persistence of the immunogen-icity induced by MenACWY-TT vaccine as compared to Menactra at 11-25 years of age in terms of the percentage of subjects with N. meningitidis serogroup A (MenA), N. meningitidis serogroup C (MenC), N. meningitidis serogroup W-135 (MenW-135), and N. meningitidis serogroup Y (MenY) titers >= 1:8 as measured by a serum bactericidal assay using human complement (hSBA).
    Protection of trial subjects
    The vaccines were observed closely for at least 30 minutes following the administration of the vaccines, with appropriate medical treatment readily available in case of a rare anaphylactoid/anaphylactic reaction.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Jul 2008
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy, Safety
    Long term follow-up duration
    		 5 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 648
    Worldwide total number of subjects
    648
    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)
    68
    Adults (18-64 years)
    580
    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.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Nimenrix 1 Group
    Arm description
    		 Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nimenrix™
    Investigational medicinal product code
    Other name
    Meningococcal vaccine GSK134612 (MenACWY-TT)
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose, as intramuscular injection.

    Arm title
    		 Menactra Group
    Arm description
    		 Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra® vaccine at the time of vaccination.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Menactra®
    Investigational medicinal product code
    MenACWY-DT
    Other name
    Sanofi Pasteur’s meningococcal serogroups A, C, W-135 and Y diphtheria toxoid conjugate vaccine.
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose, as intramuscular injection.

    Arm title
    		 Nimenrix 2 Group
    Arm description
    		 Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nimenrix™
    Investigational medicinal product code
    Other name
    Meningococcal vaccine GSK134612 (MenACWY-TT)
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose, as intramuscular injection.

    Number of subjects in period 1
    		Nimenrix 1 Group Menactra Group Nimenrix 2 Group
    Started
    433
    147
    68
    Completed
    433
    147
    68
    Period 2
    Period 2 title
    Persistence Phase Year 3
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Nimenrix 1 Group
    Arm description
    		 Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nimenrix™
    Investigational medicinal product code
    Other name
    Meningococcal vaccine GSK134612 (MenACWY-TT)
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose, as intramuscular injection.

    Arm title
    		 Menactra Group
    Arm description
    		 Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra® vaccine at the time of vaccination.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Menactra®
    Investigational medicinal product code
    MenACWY-DT
    Other name
    Sanofi Pasteur’s meningococcal serogroups A, C, W-135 and Y diphtheria toxoid conjugate vaccine.
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose, as intramuscular injection.

    Arm title
    		 Nimenrix 2 Group
    Arm description
    		 Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nimenrix™
    Investigational medicinal product code
    Other name
    Meningococcal vaccine GSK134612 (MenACWY-TT)
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose, as intramuscular injection.

    Number of subjects in period 2 [1]
    		Nimenrix 1 Group Menactra Group Nimenrix 2 Group
    Started
    345
    86
    56
    Completed
    345
    86
    56
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Not all study participants returned in time for every study visit, but they were allowed to continue the study nonetheless. The number of participants who started each study period depends on the actual rate of return of the subjects.
    Period 3
    Period 3 title
    Persistence Phase Year 5
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Nimenrix 1 Group
    Arm description
    		 Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nimenrix™
    Investigational medicinal product code
    Other name
    Meningococcal vaccine GSK134612 (MenACWY-TT)
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose, as intramuscular injection.

    Arm title
    		 Menactra Group
    Arm description
    		 Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra® vaccine at the time of vaccination.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Menactra®
    Investigational medicinal product code
    MenACWY-DT
    Other name
    Sanofi Pasteur’s meningococcal serogroups A, C, W-135 and Y diphtheria toxoid conjugate vaccine.
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose, as intramuscular injection.

    Arm title
    		 Nimenrix 2 Group
    Arm description
    		 Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nimenrix™
    Investigational medicinal product code
    Other name
    Meningococcal vaccine GSK134612 (MenACWY-TT)
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose, as intramuscular injection.

    Number of subjects in period 3 [2]
    		Nimenrix 1 Group Menactra Group Nimenrix 2 Group
    Started
    218
    56
    38
    Completed
    218
    56
    38
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Not all study participants returned in time for every study visit, but they were allowed to continue the study nonetheless. The number of participants who started each study period depends on the actual rate of return of the subjects.
    Period 4
    Period 4 title
    Booster Phase
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Menactra Booster Group
    Arm description
    		 Subjects 11-25 years of age who had received 1 dose of Menactra vaccine in primary study (NCT00454909) and will receive 1 dose of Nimenrix vaccine in this current study.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Nimenrix™
    Investigational medicinal product code
    Other name
    Meningococcal vaccine GSK134612 (MenACWY-TT)
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose, as intramuscular injection.

    Number of subjects in period 4 [3]
    		Menactra Booster Group
    Started
    38
    Completed
    37
    Not completed
    1
         Lost to follow-up
    1
    Notes
    [3] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Not all study participants returned in time for every study visit, but they were allowed to continue the study nonetheless. The number of participants who started each study period depends on the actual rate of return of the subjects.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Nimenrix 1 Group
    Reporting group description
    		 Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination.

    Reporting group title
    Menactra Group
    Reporting group description
    		 Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra® vaccine at the time of vaccination.

    Reporting group title
    Nimenrix 2 Group
    Reporting group description
    		 Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination.

    Reporting group values
    		 Nimenrix 1 Group Menactra Group Nimenrix 2 Group Total
    Number of subjects
    		 433 147 68 648
    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)
    		 15.9 ( 2.79 ) 16 ( 2.83 ) 11.2 ( 0.42 ) -
    Gender categorical
    Units: Subjects
        Female
    		 213 78 41 332
        Male
    		 220 69 27 316

    End points

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    End points reporting groups
    Reporting group title
    Nimenrix 1 Group
    Reporting group description
    		 Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination.

    Reporting group title
    Menactra Group
    Reporting group description
    		 Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra® vaccine at the time of vaccination.

    Reporting group title
    Nimenrix 2 Group
    Reporting group description
    		 Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination.
    Reporting group title
    Nimenrix 1 Group
    Reporting group description
    		 Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination.

    Reporting group title
    Menactra Group
    Reporting group description
    		 Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra® vaccine at the time of vaccination.

    Reporting group title
    Nimenrix 2 Group
    Reporting group description
    		 Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination.
    Reporting group title
    Nimenrix 1 Group
    Reporting group description
    		 Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination.

    Reporting group title
    Menactra Group
    Reporting group description
    		 Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra® vaccine at the time of vaccination.

    Reporting group title
    Nimenrix 2 Group
    Reporting group description
    		 Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination.
    Reporting group title
    Menactra Booster Group
    Reporting group description
    		 Subjects 11-25 years of age who had received 1 dose of Menactra vaccine in primary study (NCT00454909) and will receive 1 dose of Nimenrix vaccine in this current study.

    Subject analysis set title
    Nimenrix Pooled Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Pooled group of subjects 10-25 years of age from Nimenrix 1 and Nimenrix 2 groups in the primary study (NCT00454909) who had received 1 dose of Nimenrix vaccine in that study and will receive a booster dose in this current study.

    Subject analysis set title
    Nimenrix Naïve Group
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subjects 15 to <31 years of age at the time of primary vaccination with 1 dose of Nimenrix vaccine at year 5 of the current study.

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

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    End point title
    		 Number of subjects with serum bactericidal assay (using human complement) (hSBA) titers equal to or above the cut-off values. [1]
    End point description
    hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:8.
    End point type
    Primary
    End point timeframe
    At year 1 persistence.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Nimenrix 1 Group Menactra Group Nimenrix 2 Group
    Number of subjects analysed
    356
    112
    58
    Units: Subjects
        hSBA-MenA [N=350;111;57]
    102
    35
    15
        hSBA-MenC [N=336;105;56]
    319
    77
    55
        hSBA-MenW-135 [N=327;107;54]
    322
    81
    53
        hSBA-MenY [N=356;112;58]
    348
    97
    58
    No statistical analyses for this end point

    Primary: Number of subjects with hSBA titers equal to or above the cut-off values.

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    End point title
    		 Number of subjects with hSBA titers equal to or above the cut-off values. [2]
    End point description
    hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:8.
    End point type
    Primary
    End point timeframe
    At year 3 persistence.
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Nimenrix 1 Group Menactra Group Nimenrix 2 Group
    Number of subjects analysed
    321
    80
    53
    Units: Subjects
        hSBA-MenA [N=314;78;51]
    117
    37
    22
        hSBA-MenC [N=317;80;53]
    295
    65
    51
        hSBA-MenW-135 [N=321;79;53]
    306
    67
    51
        hSBA-MenY [N=319;79;51]
    306
    70
    49
    No statistical analyses for this end point

    Primary: Number of subjects with hSBA titers equal to or above the cut-off values.

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    End point title
    		 Number of subjects with hSBA titers equal to or above the cut-off values. [3]
    End point description
    hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:8.
    End point type
    Primary
    End point timeframe
    At year 5 persistence.
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Nimenrix 1 Group Menactra Group Nimenrix 2 Group
    Number of subjects analysed
    142
    45
    26
    Units: Subjects
        hSBA-MenA [N=141;45;24]
    69
    20
    9
        hSBA-MenC [N=140;44;26]
    130
    35
    22
        hSBA-MenW-135 [N=138;44;26]
    120
    37
    24
        hSBA-MenY [N=142;44;26]
    134
    40
    24
    No statistical analyses for this end point

    Secondary: Number of subjects with hSBA titers equal to or above the cut-off values.

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    End point title
    		 Number of subjects with hSBA titers equal to or above the cut-off values.
    End point description
    hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:4.
    End point type
    Secondary
    End point timeframe
    At year 1 persistence
    End point values
    		 Nimenrix 1 Group Menactra Group Nimenrix 2 Group
    Number of subjects analysed
    356
    112
    58
    Units: Subjects
        hSBA-MenA [N=350;111;57]
    106
    35
    17
        hSBA-MenC [N=336;105;56]
    319
    77
    55
        hSBA-MenW-135 [N=327;107;54]
    322
    81
    54
        hSBA-MenY [N=356;112;58]
    348
    97
    58
    No statistical analyses for this end point

    Secondary: Number of subjects with hSBA titers equal to or above the cut-off values.

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    End point title
    		 Number of subjects with hSBA titers equal to or above the cut-off values.
    End point description
    hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:4.
    End point type
    Secondary
    End point timeframe
    At year 3 persistence.
    End point values
    		 Nimenrix 1 Group Menactra Group Nimenrix 2 Group
    Number of subjects analysed
    321
    80
    53
    Units: Subjects
        hSBA-MenA [N=314;78;51]
    123
    37
    23
        hSBA-MenC [N=317;80;53]
    295
    68
    51
        hSBA-MenW-135 [N=321;79;53]
    307
    67
    52
        hSBA-MenY [N=319;79;51]
    306
    70
    49
    No statistical analyses for this end point

    Secondary: Number of subjects with hSBA titers equal to or above the cut-off values.

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    End point title
    		 Number of subjects with hSBA titers equal to or above the cut-off values.
    End point description
    hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:4.
    End point type
    Secondary
    End point timeframe
    At year 5 persistence.
    End point values
    		 Nimenrix 1 Group Menactra Group Nimenrix 2 Group
    Number of subjects analysed
    142
    45
    26
    Units: Subjects
        hSBA-MenA [N=141;45;24]
    74
    20
    9
        hSBA-MenC [N=140;44;26]
    134
    39
    24
        hSBA-MenW-135 [N=138;44;26]
    122
    37
    24
        hSBA-MenY [N=142;44;26]
    134
    40
    24
    No statistical analyses for this end point

    Secondary: hSBA antibody titers.

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    End point title
    		 hSBA antibody titers.
    End point description
    Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY respectively.
    End point type
    Secondary
    End point timeframe
    At year 1 persistence.
    End point values
    		 Nimenrix 1 Group Menactra Group Nimenrix 2 Group
    Number of subjects analysed
    356
    112
    58
    Units: Titers
    geometric mean (confidence interval 95%)
        hSBA-MenA titers [N=350;111;57]
    5.4 (4.5 to 6.4)
    6 (4.3 to 8.5)
    5.2 (3.4 to 7.9)
        hSBA-MenC titers [N=336;105;56]
    172 (142.5 to 207.4)
    46.7 (30.2 to 72.1)
    238.3 (154 to 368.9)
        hSBA-MenW-135 titers [N=327;107;54]
    197.5 (173 to 225.5)
    48.9 (32.5 to 73.8)
    231.2 (174.5 to 306.2)
        hSBA-MenY titers [N=356;112;58]
    271.8 (237.5 to 311.2)
    100.8 (69.6 to 146.2)
    266.8 (205.1 to 347)
    No statistical analyses for this end point

    Secondary: hSBA antibody titers.

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    End point title
    		 hSBA antibody titers.
    End point description
    Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY respectively.
    End point type
    Secondary
    End point timeframe
    At year 3 persistence.
    End point values
    		 Nimenrix 1 Group Menactra Group Nimenrix 2 Group
    Number of subjects analysed
    321
    80
    53
    Units: Titers
    geometric mean (confidence interval 95%)
        hSBA-MenA titers [N=314;78;51]
    6.2 (5.2 to 7.3)
    9.3 (6.2 to 14)
    8.8 (5.3 to 14.9)
        hSBA-MenC titers [N=317;80;53]
    117.9 (94.3 to 147.4)
    54.8 (33.9 to 88.9)
    131.2 (79.8 to 215.7)
        hSBA-MenW-135 titers [N=321;79;53]
    141.6 (122.8 to 163.4)
    75.5 (48.7 to 117)
    137.6 (98.2 to 192.9)
        hSBA-MenY titers [N=319;79;51]
    206.6 (177.9 to 239.8)
    139 (93.8 to 206.2)
    186.6 (130.7 to 266.6)
    No statistical analyses for this end point

    Secondary: hSBA antibody titers.

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    End point title
    		 hSBA antibody titers.
    End point description
    Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY respectively.
    End point type
    Secondary
    End point timeframe
    At year 5 persistence.
    End point values
    		 Nimenrix 1 Group Menactra Group Nimenrix 2 Group
    Number of subjects analysed
    142
    45
    26
    Units: Titers
    geometric mean (confidence interval 95%)
        hSBA-MenA titers [N=141;45;24]
    8.9 (6.8 to 11.8)
    7.9 (4.8 to 13.2)
    6.3 (3.2 to 12.2)
        hSBA-MenC titers [N=140;44;26]
    94.6 (65.9 to 135.9)
    30.6 (17.3 to 54.4)
    92.9 (39.6 to 217.6)
        hSBA-MenW-135 titers [N=138;44;26]
    103.5 (76.3 to 140.5)
    70.4 (37.2 to 133.1)
    92.4 (50.5 to 168.8)
        hSBA-MenY titers [N=142;44;26]
    224.6 (173.9 to 290)
    129.3 (77.4 to 215.9)
    113.7 (58.4 to 221.3)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-polysaccharide A (Anti-PSA), anti-PSC, anti-PSY, and anti-PSW-135 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-PSC, anti-PSY, and anti-PSW-135 concentrations equal to or above the cut-off values.
    End point description
    The cut-off values were defined as a concentration ≥0.3 microgram per milliliter (μg/mL) and ≥ 2.0 μg/mL.
    End point type
    Secondary
    End point timeframe
    At year 1 persistence.
    End point values
    		 Nimenrix 1 Group Menactra Group Nimenrix 2 Group
    Number of subjects analysed
    366
    112
    59
    Units: Subjects
        Anti-PSA ≥ 0.3 µg/mL [N=355;112;56]
    340
    101
    55
        Anti-PSA ≥ 2.0 µg/mL [N=355;112;56]
    260
    66
    38
        Anti-PSC ≥ 0.3 µg/mL [N=366;112;58]
    302
    56
    51
        Anti-PSC ≥ 2.0 µg/mL [N=366;112;58]
    162
    31
    28
        Anti-PSW-135 ≥ 0.3 µg/mL [N=354;104;56]
    319
    65
    54
        Anti-PSW-135 ≥ 2.0 µg/mL [N=354;104;56]
    178
    27
    28
        Anti-PSY ≥ 0.3 µg/mL [N=358;112;59]
    342
    78
    55
        Anti-PSY ≥ 2.0 µg/mL [N=358;112;59]
    240
    38
    37
    No statistical analyses for this end point

    Secondary: Anti-polysaccharide A (Anti-PSA), anti-PSC, anti-PSY, and anti-PSW-135 antibody concentrations.

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    End point title
    		 Anti-polysaccharide A (Anti-PSA), anti-PSC, anti-PSY, and anti-PSW-135 antibody concentrations.
    End point description
    Antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in μg/mL.
    End point type
    Secondary
    End point timeframe
    At year 1 persistence.
    End point values
    		 Nimenrix 1 Group Menactra Group Nimenrix 2 Group
    Number of subjects analysed
    366
    112
    59
    Units: μg/mL
    geometric mean (confidence interval 95%)
        Anti-PSA [N=355;112;56]
    5 (4.2 to 5.9)
    3.7 (2.6 to 5.3)
    4.2 (2.9 to 6.1)
        Anti-PSC [N=366;112;58]
    1.8 (1.5 to 2.1)
    0.6 (0.5 to 0.9)
    2.1 (1.4 to 3.1)
        Anti-PSW-135 [N=354;104;56]
    2 (1.7 to 2.3)
    0.8 (0.6 to 1.1)
    2 (1.5 to 2.6)
        Anti-PSY [N=358;112;59]
    3.4 (3 to 4)
    1 (0.7 to 1.3)
    2.5 (1.8 to 3.4)
    No statistical analyses for this end point

    Secondary: Number of subjects with serious adverse events (SAEs) related to a concurrent GSK medication.

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    End point title
    		 Number of subjects with serious adverse events (SAEs) related to a concurrent GSK medication.
    End point description
    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
    End point type
    Secondary
    End point timeframe
    From 6 months up to 1 year following primary vaccination.
    End point values
    		 Nimenrix 1 Group Menactra Group Nimenrix 2 Group
    Number of subjects analysed
    433
    147
    68
    Units: Subjects
        Any SAE(s)
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with SAEs related to study participation or to a concurrent GSK medication.

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    End point title
    		 Number of subjects with SAEs related to study participation or to a concurrent GSK medication.
    End point description
    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
    End point type
    Secondary
    End point timeframe
    From 6 months up to 3 years following primary vaccination.
    End point values
    		 Nimenrix 1 Group Menactra Group Nimenrix 2 Group
    Number of subjects analysed
    345
    86
    56
    Units: Subjects
        Any SAE(s)
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with SAEs related to study participation or to a concurrent GSK medication.

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    End point title
    		 Number of subjects with SAEs related to study participation or to a concurrent GSK medication.
    End point description
    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
    End point type
    Secondary
    End point timeframe
    From 6 months up to 5 years following primary vaccination.
    End point values
    		 Nimenrix 1 Group Menactra Group Nimenrix 2 Group
    Number of subjects analysed
    218
    56
    38
    Units: Subjects
        Any SAE(s)
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY antibody titers equal to or above the cut-off values.

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    End point title
    		 Number of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY antibody titers equal to or above the cut-off values.
    End point description
    The cut-off values were defined as hSBA antibody titers ≥ 1:4 and ≥ 1:8.
    End point type
    Secondary
    End point timeframe
    1 month post primary (naïve control group) and booster vaccination.
    End point values
    		 Menactra Booster Group Nimenrix Pooled Group Nimenrix Naïve Group
    Number of subjects analysed
    29
    109
    84
    Units: Subjects
        hSBA-MenA ≥ 1:4 [N=28;106;79]
    28
    105
    61
        hSBA-MenA ≥ 1:8 [N=28;106;79]
    28
    105
    61
        hSBA-MenC ≥ 1:4 [N=29;109;81]
    29
    108
    78
        hSBA-MenC ≥ 1:8 [N=29;109;81]
    29
    108
    77
        hSBA-MenW-135 ≥ 1:4 [N=29;109;80]
    29
    109
    74
        hSBA-MenW-135 ≥ 1:8 [N=29;109;80]
    29
    109
    74
        hSBA-MenY ≥ 1:4 [N=29;109;84]
    29
    109
    82
        hSBA-MenY ≥ 1:8 [N=29;109;84]
    29
    109
    82
    No statistical analyses for this end point

    Secondary: hSBA antibody titers.

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    End point title
    		 hSBA antibody titers.
    End point description
    Titers are given as GMTs for the serogroups hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY respectively.
    End point type
    Secondary
    End point timeframe
    1 month post primary (naïve control group) and booster vaccination.
    End point values
    		 Menactra Booster Group Nimenrix Pooled Group Nimenrix Naïve Group
    Number of subjects analysed
    29
    109
    84
    Units: Titers
    geometric mean (confidence interval 95%)
        hSBA-MenA [N=28;106;79]
    952 (600.9 to 1508.2)
    783.8 (601.7 to 1020.9)
    79.7 (46.3 to 137.4)
        hSBA-MenC [N=29;109;81]
    6722.1 (3950.9 to 11437.2)
    5020.4 (3995.4 to 6308.4)
    534.7 (308 to 928.1)
        hSBA-MenW-135 [N=29;109;80]
    3729 (2415.4 to 5757.1)
    5517.6 (4573.6 to 6656.4)
    237.7 (150.4 to 375.8)
        hSBA-MenY [N=29;109;84]
    6546.4 (4312.3 to 9938)
    5664.3 (4590 to 6990.1)
    755.1 (522.4 to 1091.4)
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with vaccine response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY antibodies.
    End point description
    Vaccine response was defined as: For initially seronegative subjects: antibody titre ≥ 1:8 at one month after vaccination For initially seropositive subjects: antibody titre at one month after vaccination ≥ 4 fold the titres before vaccination.
    End point type
    Secondary
    End point timeframe
    1 month post primary (naïve control group) and booster vaccination.
    End point values
    		 Menactra Booster Group Nimenrix Pooled Group Nimenrix Naïve Group
    Number of subjects analysed
    29
    106
    78
    Units: Subjects
        hSBA-MenA [N=28;101;75]
    24
    98
    51
        hSBA-MenC [N=28;106;68]
    27
    97
    47
        hSBA-MenW-135 [N=28;105;76]
    24
    101
    51
        hSBA-MenY [N=29;106;78]
    27
    97
    53
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited local symptoms.

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    End point title
    		 Number of subjects with solicited local symptoms.
    End point description
    Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any solicited local symptom reported irrespective of intensity grade. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeter (mm).
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post primary (naïve control group) and booster vaccination.
    End point values
    		 Menactra Booster Group
    Number of subjects analysed
    37
    Units: Subjects
        Any Pain
    20
        Grade 3 Pain
    0
        Any Redness
    6
        Grade 3 Redness
    0
        Any Swelling
    5
        Grade 3 Swelling
    1
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited general symptoms.

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    End point title
    		 Number of subjects with solicited general symptoms.
    End point description
    Solicited general symptoms assessed were fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhea and/or abdominal pain), headache and temperature. Any = occurrence of any general symptoms reported irrespective of intensity grade and relationship to study vaccination. Any temperature = axillary temperature greater than or equal to (≥)37.5 degrees Celsius (°C). Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 temperature = axillary temperature above 39.0°C. Related = symptoms considered by the investigator to have a causal relationship to vaccination.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post primary (naïve control group) and booster vaccination.
    End point values
    		 Menactra Booster Group
    Number of subjects analysed
    37
    Units: Subjects
        Any Fatigue
    7
        Grade 3 Fatigue
    0
        Related Fatigue
    6
        Any Gastrointestinal symptoms
    8
        Grade 3 Gastrointestinal symptoms
    0
        Related Gastrointestinal symptoms
    8
        Any Headache
    10
        Grade 3 Headache
    0
        Related Headache
    10
        Any Temperature
    0
        Grade 3 Temperature
    0
        Related Temperature
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with unsolicited adverse events (AEs).

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    End point title
    		 Number of subjects with unsolicited adverse events (AEs).
    End point description
    Unsolicited AE covers any AE 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.
    End point type
    Secondary
    End point timeframe
    During the 31-day (Days 0-30) following primary (naïve control group) and booster vaccination.
    End point values
    		 Menactra Booster Group
    Number of subjects analysed
    38
    Units: Subjects
        Any AE(s)
    9
    No statistical analyses for this end point

    Secondary: Number of subjects reporting new onset chronic illness(es) (NOCIs).

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    End point title
    		 Number of subjects reporting new onset chronic illness(es) (NOCIs).
    End point description
    Examples of NOCIs include autoimmune disorders, asthma, type 1 diabetes and allergies.
    End point type
    Secondary
    End point timeframe
    During the 6-month period following the primary (naïve control group) and booster vaccination.
    End point values
    		 Menactra Booster Group
    Number of subjects analysed
    38
    Units: Subjects
        Any NOCI(s)
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with SAEs.

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    End point title
    		 Number of subjects with SAEs.
    End point description
    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
    End point type
    Secondary
    End point timeframe
    During the 6-month period following the primary (naïve control group) and booster vaccination.
    End point values
    		 Menactra Booster Group
    Number of subjects analysed
    38
    Units: Subjects
        Any SAE(s)
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    SAEs = From 6 months up to 5 years after primary vaccination and up to 6 months after vaccination in booster phase. Solicited and unsolicited symptoms during 4 days (Days 0-3) and 31-days (Days 0-30) after vaccination in booster phase respectively.
    Adverse event reporting additional description
    For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Nimenrix Pooled Group
    Reporting group description
    		 Pooled group of subjects 10-25 years of age from Nimenrix 1 and Nimenrix 2 groups in the primary study (NCT00454909) who had received 1 dose of Nimenrix vaccine in that study and will receive a booster dose in this current study.

    Reporting group title
    Menactra Booster Group
    Reporting group description
    		 Subjects 11-25 years of age who had received 1 dose of Menactra vaccine in primary study (NCT00454909) and received 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.

    Reporting group title
    Nimenrix Naïve Group
    Reporting group description
    		 Naïve control group of subjects 15 to <31 years at the time of primary vaccination with 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.

    Serious adverse events
    		 Nimenrix Pooled Group Menactra Booster Group Nimenrix Naïve Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 183 (1.64%)
    0 / 38 (0.00%)
    0 / 101 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 38 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 38 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Malaria
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 38 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Nimenrix Pooled Group Menactra Booster Group Nimenrix Naïve Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    100 / 183 (54.64%)
    20 / 38 (52.63%)
    55 / 101 (54.46%)
    General disorders and administration site conditions
    Pain
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    100 / 170 (58.82%)
    20 / 37 (54.05%)
    55 / 91 (60.44%)
         occurrences all number
    100
    20
    55
    Redness
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    39 / 170 (22.94%)
    6 / 37 (16.22%)
    17 / 91 (18.68%)
         occurrences all number
    39
    6
    17
    Swelling
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    27 / 170 (15.88%)
    5 / 37 (13.51%)
    14 / 91 (15.38%)
         occurrences all number
    27
    5
    14
    Fatigue
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    58 / 170 (34.12%)
    7 / 37 (18.92%)
    30 / 91 (32.97%)
         occurrences all number
    58
    7
    30
    Gastrointestinal symptoms
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    28 / 170 (16.47%)
    8 / 37 (21.62%)
    20 / 91 (21.98%)
         occurrences all number
    28
    8
    20
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    61 / 170 (35.88%)
    10 / 37 (27.03%)
    22 / 91 (24.18%)
         occurrences all number
    61
    10
    22
    Temperature/(Axillary)
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    4 / 170 (2.35%)
    0 / 37 (0.00%)
    3 / 91 (3.30%)
         occurrences all number
    4
    0
    3
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 183 (1.64%)
    2 / 38 (5.26%)
    0 / 101 (0.00%)
         occurrences all number
    3
    2
    0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total Vaccinated cohort, only on subjects with their symptom sheets completed.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total Vaccinated cohort, only on subjects with their symptom sheets completed.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total Vaccinated cohort, only on subjects with their symptom sheets completed.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total Vaccinated cohort, only on subjects with their symptom sheets completed.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total Vaccinated cohort, only on subjects with their symptom sheets completed.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total Vaccinated cohort, only on subjects with their symptom sheets completed.
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total Vaccinated cohort, only on subjects with their symptom sheets completed.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 May 2011
    The primary objective of the current study is to evaluate the long-term persistence of the immunogenicity induced by MenACWY-TT vaccine as compared to Menactra at 11-25 years of age in terms of the percentage of subjects with N. meningitidis serogroup A, C; W-135 and Y titers  1:8 as measured by a serum bactericidal assay using human complement (hSBA) at 1, 3 and 5 year after vaccine administration. In addition, to support the data obtained by hSBA testing, antibody concentrations against meningococcal polysaccharides are planned to be assessed by ELISA. The ELISA testing will be performed at 1 year after vaccine administration, but the sponsor decided not to perform the ELISA testing at 3 and 5 years after vaccine administration for the following reasons: - the World Health Organization (WHO) considers SBA the primary means of assessing immune response to meningococcal conjugate vaccines. - circulating bactericidal antibodies are more critical for persistent protection against meningococcal disease than non- functional antibodies against meningococcal polysaccharides.
    01 Dec 2011
    The instructions on reconstitution of the MenACWY-TT vaccine have been updated.
    16 Feb 2012
    The co-ordinating author and several contributing author’s names have been changed. The saline diluent to reconstitute the MenACWY-TT vaccine has been changed from vial presentation to a pre-filled syringe.
    02 May 2012
    The Interval for coming back for the Year 5 post-vaccination visit (Visit 3) has been extended 4 weeks, from 5 years + 16 weeks post-vaccination to 5 years + 20 week post-vaccination. This was done because a booster vaccination will also be administered at this visit, and the extension was needed to ensure that vaccine would be available at the study site.

    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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