Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

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

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

    Results information
    Results version number
    		 v1
    This version publication date
    02 May 2016
    First version publication date
    06 Mar 2015
    Other versions
    		 v2 , v3

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    109069
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00464815
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l'Institut 89, Rixensart, Belgium, 1330
    Public contact
    Clinical Disclosure Advisor, GlaxoSmithKline Biologicals, +44 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Disclosure Advisor, GlaxoSmithKline Biologicals, +44 2089904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000429-PIP01-08
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    24 Apr 2009
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Apr 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Sep 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    One month after vaccination: - To demonstrate the non-inferiority of the vaccine response induced by meningococcal vaccine GSK134612 compared to the licensed Mencevax ACWY measured by serum bactericidal antibodies using baby rabbit complement. - To demonstrate the non-inferiority of meningococcal vaccine GSK 134612 compared to the licensed Mencevax ACWY in terms of the incidence of any grade 3 systemic symptom within four days after vaccination based on the analysis of pooled safety and reactogenicity data of this present study and study 109067 (MenACWY-TT-035).
    Protection of trial subjects
    Vaccines were administered by qualified and trained personnel. Vaccines were administered only to eligible subjects that had no contraindications to any components of the vaccines.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 May 2007
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    India: 398
    Country: Number of subjects enrolled
    Philippines: 392
    Country: Number of subjects enrolled
    Taiwan: 235
    Worldwide total number of subjects
    1025
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    172
    Adolescents (12-17 years)
    853
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The study was planned to enrol 1024 healthy male and female subjects in India, Philippines and Taiwan from February 2007 to August 2007.

    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
    		 1025
    Number of subjects completed
    		 1025

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Nimenrix Group
    Arm description
    		 Subjects received 1 dose of meningococcal vaccine Nimenrix
    Arm type
    		 Experimental

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

    Arm title
    		 Mencevax ACWY Group
    Arm description
    		 Subjects received 1 dose of Mencevax™ ACWY vaccine
    Arm type
    		 Active comparator

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

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

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Nimenrix Group
    Reporting group description
    		 Subjects received 1 dose of meningococcal vaccine Nimenrix

    Reporting group title
    Mencevax ACWY Group
    Reporting group description
    		 Subjects received 1 dose of Mencevax™ ACWY vaccine

    Reporting group values
    		 Nimenrix Group Mencevax ACWY Group Total
    Number of subjects
    		 768 257 1025
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Healthy males and females aged 11 through 17 years who previously completed routine childhood immunizations to the best of parents'/guardians'knowledge and whose parents/guardians gave written informed consent. No previous vaccination with meningoccal polysaccharide vaccine of serogroups A, C, W-135 and/or Y within the last 5 years, or with meningococcal polysaccharide conjugate vaccine of serogroups A, C, W-135 and/or Y since birth. No previous vaccination with tetanus toxoid within the last month
    Units: years
        arithmetic mean (standard deviation)
    		 14.3 ( 1.97 ) 14.3 ( 1.97 ) -
    Gender categorical
    Units: Subjects
        Female
    		 414 135 549
        Male
    		 354 122 476
    Subject analysis sets

    Subject analysis set title
    Nimenrix Group (without subjects of excluded center)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects from the Nimenrix Group who had no GCP issues .

    Subject analysis set title
    Mencevax ACWY Group (without subjects of the excluded center)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects from the Mencevax ACWY Group who had no GCP issues.

    Subject analysis set title
    109067 Nimenrix Group
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Nimenrix Group from study MenACWY-TT-035 (109067).

    Subject analysis set title
    109067 Mencevax Group
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Mencevax Group from study MenACWY-TT-035 (109067).

    Subject analysis sets values
    		 Nimenrix Group (without subjects of excluded center) Mencevax ACWY Group (without subjects of the excluded center) 109067 Nimenrix Group 109067 Mencevax Group
    Number of subjects
    474
    159
    935
    312
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Healthy males and females aged 11 through 17 years who previously completed routine childhood immunizations to the best of parents'/guardians'knowledge and whose parents/guardians gave written informed consent. No previous vaccination with meningoccal polysaccharide vaccine of serogroups A, C, W-135 and/or Y within the last 5 years, or with meningococcal polysaccharide conjugate vaccine of serogroups A, C, W-135 and/or Y since birth. No previous vaccination with tetanus toxoid within the last month
    Units: years
        arithmetic mean (standard deviation)
    14.5 ( 1.92 )
    14.5 ( 1.93 )
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
    257
    84
        Male
    217
    75

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Nimenrix Group
    Reporting group description
    		 Subjects received 1 dose of meningococcal vaccine Nimenrix

    Reporting group title
    Mencevax ACWY Group
    Reporting group description
    		 Subjects received 1 dose of Mencevax™ ACWY vaccine

    Subject analysis set title
    Nimenrix Group (without subjects of excluded center)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects from the Nimenrix Group who had no GCP issues .

    Subject analysis set title
    Mencevax ACWY Group (without subjects of the excluded center)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects from the Mencevax ACWY Group who had no GCP issues.

    Subject analysis set title
    109067 Nimenrix Group
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Nimenrix Group from study MenACWY-TT-035 (109067).

    Subject analysis set title
    109067 Mencevax Group
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Mencevax Group from study MenACWY-TT-035 (109067).

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

    		 Close Top of page
    End point title
    		 Number of subjects with a vaccine response to MenA, MenC, MenY and MenW-135
    End point description
    End point type
    Primary
    End point timeframe
    One month after vaccination
    End point values
    		 Nimenrix Group Mencevax ACWY Group Nimenrix Group (without subjects of excluded center) Mencevax ACWY Group (without subjects of the excluded center)
    Number of subjects analysed
    657
    219
    378
    127
    Units: Subjects
        rSBA-MenA (N=553,191,314,108)
    472
    148
    273
    84
        rSBA-MenC (N=642,211,365,119)
    625
    204
    350
    115
        rSBA-MenW-135 (N=639,216,362,125)
    616
    189
    350
    115
        rSBA-MenY (N=657,219,378,127)
    616
    172
    359
    100
    Statistical analysis title
    		 Difference in % subjects with rSBA-MenA response
    Statistical analysis description
    To demonstrate the non-inferiority of Nimenrix vaccine versus Mencevax ACWY vaccine in term of rSBA vaccine response, the standardized asymptotic 95% CI for the difference in rSBA vaccine response rate for each of the meningococcal serogroups (Nimenrix Group rate minus Mencevax ACWY Group rate) one month after vaccination was computed.
    Comparison groups
    Nimenrix Group v Mencevax ACWY Group
    Number of subjects included in analysis
    876
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Rate difference
    Point estimate
    7.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.63
         upper limit
    		 14.87
    Notes
    [1] - Criterion for non-inferiority: the lower limit of the 2-sided standardized asymptotic 95% confidence interval for the group difference (Nimenrig Group minus Mencevax ACWY Group) in the percentage of subjects with bactericidal vaccine response was greater than or equal to the pre-defined clinical limit of -10%
    Statistical analysis title
    		 Difference in % subjects with rSBA-MenC response
    Statistical analysis description
    To demonstrate the non-inferiority of NImenriv vaccine versus Mencevax ACWY vaccine in term of rSBA vaccine response, the standardized asymptotic 95% CI for the difference in rSBA vaccine response rate for each of the meningococcal serogroups (Nimenrix Group rate minus Mencevax ACWY Group rate) one month after vaccination was computed.
    Comparison groups
    Nimenrix Group v Mencevax ACWY Group
    Number of subjects included in analysis
    876
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    Parameter type
    		 Rates Difference
    Point estimate
    0.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.65
         upper limit
    		 4.18
    Notes
    [2] - Criterion for non-inferiority: the lower limit of the 2-sided standardized asymptotic 95% confidence interval for the group difference [Nimenrix Group minus Mencevax ACWY Group] in the percentage of subjects with bactericidal vaccine response was greater than or equal to the pre-defined clinical limit of -10%
    Statistical analysis title
    		 Difference in % subjects with rSBA-MenW135response
    Statistical analysis description
    To demonstrate the non-inferiority of Nimenrix vaccine versus Mencevax ACWY vaccine in term of rSBA vaccine response, the standardized asymptotic 95% CI for the difference in rSBA vaccine response rate for each of the meningococcal serogroups (Nimenrix Group rate minus Mencevax ACWY Group rate) one month after vaccination was computed.
    Comparison groups
    Mencevax ACWY Group v Nimenrix Group
    Number of subjects included in analysis
    876
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    Method
    Parameter type
    		 Rate difference
    Point estimate
    8.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.78
         upper limit
    		 14.14
    Notes
    [3] - Criterion for non-inferiority: the lower limit of the 2-sided standardized asymptotic 95% confidence interval for the group difference [Nimenrix Group minus Mencevax ACWY Group] in the percentage of subjects with bactericidal vaccine response was greater than or equal to the pre-defined clinical limit of -10%
    Statistical analysis title
    		 Difference in % subjects with rSBA-MenY response
    Statistical analysis description
    To demonstrate the non-inferiority of Nimenrix vaccine versus Mencevax ACWY vaccine in term of rSBA vaccine response, the standardized asymptotic 95% CI for the difference in rSBA vaccine response rate for each of the meningococcal serogroups (Nimenrix Group rate minus Mencevax ACWY Group rate) one month after vaccination was computed.
    Comparison groups
    Nimenrix Group v Mencevax ACWY Group
    Number of subjects included in analysis
    876
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [4]
    Method
    Parameter type
    		 Rate difference
    Point estimate
    15.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 9.89
         upper limit
    		 21.37
    Notes
    [4] - Criterion for non-inferiority: the lower limit of the 2-sided standardized asymptotic 95% confidence interval for the group difference [Nimenrix Group minus Mencevax ACWY Group] in the percentage of subjects with bactericidal vaccine response was greater than or equal to the pre-defined clinical limit of -10%

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

    		 Close Top of page
    End point title
    		 Number of subjects with any Grade 3 general (solicited and unsolicited) symptoms
    End point description
    End point type
    Primary
    End point timeframe
    During the 4-day (Days 0 to 3) period after vaccination
    End point values
    		 Nimenrix Group Mencevax ACWY Group 109067 Nimenrix Group 109067 Mencevax Group
    Number of subjects analysed
    768
    257
    935
    312
    Units: Subjects
        Subjects with Grade 3 symptoms
    12
    1
    22
    7
    Statistical analysis title
    		 Ratio of % 109067 subjects with Grade 3 symptoms
    Statistical analysis description
    To demonstrate the non-inferiority of Nimenrix vaccine versus Mencevax vaccine in term of incidence of any Grade 3 general (solicited and unsolicited) symptom, the 2-sided standardised asymptotic 95% CI for the ratio between Nimenrix and Mencevax (Nimenrix over Mencevax) in the percentage of subjects with any grade 3 general symptom within 4 days after vaccination was computed for the safety analysis in study MenACWY-TT-035.
    Comparison groups
    109067 Nimenrix Group v 109067 Mencevax Group
    Number of subjects included in analysis
    1247
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [5]
    P-value
    		 = 0.9116
    Method
    		 Standardized asymptotic method
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.46
         upper limit
    		 2.38
    Notes
    [5] - Criterion for non-inferiority: the upper limit of the 2-sided standardized asymptotic 95% CI for the ratio of the percentages of subjects with any Grade 3 general symptom was lower than or equal to the pre-defined clinical limit of 3.0
    Statistical analysis title
    		 Ratio of % 109069 subjects with Grade 3 symptoms
    Statistical analysis description
    To demonstrate the non-inferiority of Nimenrix vaccine versus Mencevax vaccine in term of incidence of any Grade 3 general (solicited and unsolicited) symptom, the 2-sided standardised asymptotic 95% CI for the ratio between Nimenrix and Mencevax (Nimenrix over Mencevax) in the percentage of subjects with any grade 3 general symptom within 4 days after vaccination was computed for the safety analysis in study MenACWY-TT-036.
    Comparison groups
    Nimenrix Group v Mencevax ACWY Group
    Number of subjects included in analysis
    1025
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [6]
    P-value
    		 = 0.1456
    Method
    		 Standardized asymptotic method
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    4.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.68
         upper limit
    		 24.6
    Notes
    [6] - Criterion for non-inferiority: the upper limit of the 2-sided standardized asymptotic 95% CI for the ratio of the percentages of subjects with any Grade 3 general symptom was lower than or equal to the pre-defined clinical limit of 3.0
    Statistical analysis title
    		 Ratio of % pooled subjects with Grade 3 symptoms
    Statistical analysis description
    To demonstrate the non-inferiority of Nimenrix vaccine versus Mencevax vaccine in term of incidence of any Grade 3 general (solicited and unsolicited) symptom, the 2-sided standardised asymptotic 95% CI for the ratio between Nimenrix and Mencevax (Nimenrix over Mencevax) in the percentage of subjects with any grade 3 general symptom within 4 days after vaccination was computed for the safety analysis in studies MenACWY-TT-035 and MenACWY-TT-036.
    Comparison groups
    Nimenrix Group v Mencevax ACWY Group v 109067 Nimenrix Group v 109067 Mencevax Group
    Number of subjects included in analysis
    2272
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.3653 [7]
    Method
    		 Standardized asymptotic method
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.67
         upper limit
    		 3
    Notes
    [7] - Criterion for non-inferiority: the upper limit of the 2-sided standardized asymptotic 95% CI for the ratio of the percentages of subjects with any Grade 3 general symptom was lower than or equal to the pre-defined clinical limit of 3.0

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

    		 Close Top of page
    End point title
    		 Number of subjects with any Grade 3 general (solicited and unsolicited) symptoms
    End point description
    End point type
    Primary
    End point timeframe
    During the 4-day (Days 0 to 3) period after vaccination
    End point values
    		 Nimenrix Group (without subjects of excluded center) Mencevax ACWY Group (without subjects of the excluded center) 109067 Nimenrix Group 109067 Mencevax Group
    Number of subjects analysed
    474
    159
    935
    312
    Units: Subjects
        Subjects with Grade 3 symptoms
    9
    1
    22
    7
    Statistical analysis title
    		 Ratio of % 109067 subjects with Grade 3 symptoms
    Comparison groups
    109067 Nimenrix Group v 109067 Mencevax Group
    Number of subjects included in analysis
    1247
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.9116
    Method
    		 Standardized asymptotic method
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.46
         upper limit
    		 2.38
    Statistical analysis title
    		 Ration of % 109069 subjects with Grade 3 symptoms
    Comparison groups
    Nimenrix Group (without subjects of excluded center) v Mencevax ACWY Group (without subjects of the excluded center)
    Number of subjects included in analysis
    633
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.2665
    Method
    		 Standardized asymptotic method
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    3.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.5
         upper limit
    		 18.41
    Statistical analysis title
    		 Ratio of % pooled subjects with Grade 3 symptoms
    Comparison groups
    Mencevax ACWY Group (without subjects of the excluded center) v 109067 Mencevax Group v Nimenrix Group (without subjects of excluded center) v 109067 Nimenrix Group
    Number of subjects included in analysis
    1880
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.5085
    Method
    		 Standardized asymptotic method
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.61
         upper limit
    		 2.76

    Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titer ≥1:8

    		 Close Top of page
    End point title
    		 Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titer ≥1:8
    End point description
    End point type
    Secondary
    End point timeframe
    Prior to (PRE) and one month (M1) after vaccination
    End point values
    		 Nimenrix Group Mencevax ACWY Group Nimenrix Group (without subjects of excluded center) Mencevax ACWY Group (without subjects of the excluded center)
    Number of subjects analysed
    678
    224
    390
    128
    Units: Subjects
        rSBA-MenA, PRE (N=557,191,316,108)
    463
    148
    257
    83
        rSBA-MenA, M1 (N=674,224,388,128)
    674
    223
    388
    128
        rSBA-MenC, PRE (N=648,211,369,119)
    381
    121
    209
    71
        rSBA-MenC, M1 (N=673,224,387,128)
    673
    224
    387
    128
        rSBA- MenW-135, PRE (N=640,216,363,125)
    519
    176
    285
    99
        rSBA- MenW-135, M1 (N=678,224,390,128)
    677
    224
    389
    128
        rSBA-MenY, PRE (N=659,219,380,127)
    597
    186
    341
    105
        rSBA-MenY, M1 (N=677,224,389,128)
    677
    224
    389
    128
    No statistical analyses for this end point

    Secondary: rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titers

    		 Close Top of page
    End point title
    		 rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titers
    End point description
    End point type
    Secondary
    End point timeframe
    Prior to and one month after vaccination
    End point values
    		 Nimenrix Group Mencevax ACWY Group Nimenrix Group (without subjects of excluded center) Mencevax ACWY Group (without subjects of the excluded center)
    Number of subjects analysed
    678
    224
    390
    128
    Units: Titers
    geometric mean (confidence interval 95%)
        rSBA-MenA, PRE (N=557,191,316,108)
    208.1 (176.4 to 245.5)
    155.9 (113.8 to 213.7)
    187.7 (149.6 to 235.5)
    170.9 (110.8 to 263.6)
        rSBA-MenA, M1 (N=674,224,388,128)
    5928.5 (5557.4 to 6324.3)
    2947.2 (2611.7 to 3325.7)
    6688.5 (6162.7 to 7259.2)
    3401.4 (2964.6 to 3902.5)
        rSBA-MenC, PRE (N=648,211,369,119)
    44.1 (37.3 to 52.2)
    40.9 (30.2 to 55.3)
    43.2 (34.3 to 54.5)
    47.9 (31.5 to 73)
        rSBA-MenC, M1 (N=673,224,387,128)
    13109.8 (11939.1 to 14395.2)
    8222 (6807.5 to 9930.4)
    11184.2 (9781.6 to 12787.9)
    8459.6 (6483.5 to 11038.2)
        rSBA- MenW-135, PRE (N=640,216,363,125)
    109.4 (94.6 to 126.6)
    112.2 (87.2 to 144.3)
    96.9 (79.4 to 118.1)
    104.9 (74 to 148.7)
        rSBA- MenW-135, M1 (N=678,224,390,128)
    8246.6 (7638.8 to 8902.7)
    2632.7 (2299.3 to 3014.4)
    9538.9 (8589.4 to 10593.3)
    3303.4 (2790.6 to 3910.4)
        rSBA-MenY, PRE (N=659,219,380,127)
    348.3 (303.5 to 399.7)
    299 (225.2 to 397)
    319.9 (265 to 386.3)
    286 (193.1 to 423.5)
        rSBA-MenY, M1 (N=677,224,389,128)
    14086.5 (13168 to 15069)
    5066.3 (4463.1 to 5750.9)
    16379 (14958.3 to 17934.5)
    5772.9 (4856.6 to 6862.1)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-tetanus toxoid (Anti-TT) > 0.1 IU/mL

    		 Close Top of page
    End point title
    		 Number of subjects with anti-tetanus toxoid (Anti-TT) > 0.1 IU/mL
    End point description
    End point type
    Secondary
    End point timeframe
    Prior to and one month after vaccination
    End point values
    		 Nimenrix Group Mencevax ACWY Group Nimenrix Group (without subjects of excluded center) Mencevax ACWY Group (without subjects of the excluded center)
    Number of subjects analysed
    679
    224
    391
    128
    Units: Subjects
        Anti-TT, PRE (N=679,224,391,128)
    439
    155
    357
    120
        Anti-TT, M1 (N=679,224,391,128)
    662
    157
    389
    119
    No statistical analyses for this end point

    Secondary: Anti-TT antibody concentrations

    		 Close Top of page
    End point title
    		 Anti-TT antibody concentrations
    End point description
    End point type
    Secondary
    End point timeframe
    Prior to and one month after vaccination
    End point values
    		 Nimenrix Group Mencevax ACWY Group Nimenrix Group (without subjects of excluded center) Mencevax ACWY Group (without subjects of the excluded center)
    Number of subjects analysed
    679
    224
    391
    128
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-TT, PRE (N=679,224,391,128)
    0.367 (0.321 to 0.419)
    0.41 (0.326 to 0.516)
    1.035 (0.9 to 1.191)
    1.153 (0.907 to 1.464)
        Anti-TT, M1 (N=679,224,391,128)
    10.305 (9.131 to 11.631)
    0.459 (0.364 to 0.58)
    18.089 (16.314 to 20.058)
    1.212 (0.948 to 1.549)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-PSA, anti-PSC, anti-PSW-135, and anti-PSY concentrations ≥ 0.3 μg/mL and ≥ 2.0 μg/mL

    		 Close Top of page
    End point title
    		 Number of subjects with anti-PSA, anti-PSC, anti-PSW-135, and anti-PSY concentrations ≥ 0.3 μg/mL and ≥ 2.0 μg/mL
    End point description
    End point type
    Secondary
    End point timeframe
    Prior to and one month after vaccination
    End point values
    		 Nimenrix Group Mencevax ACWY Group Nimenrix Group (without subjects of excluded center) Mencevax ACWY Group (without subjects of the excluded center)
    Number of subjects analysed
    347
    114
    204
    68
    Units: Subjects
        Anti-PSA ≥ 0.3 ug/mL, PRE (N=322,102,189,59)
    235
    75
    130
    40
        Anti-PSA ≥ 0.3 ug/mL, M1 (N=341,107,194,59)
    341
    107
    194
    59
        Anti-PSC ≥ 0.3 ug/mL, PRE (N=335,108,190,60)
    50
    21
    25
    13
        Anti-PSC ≥ 0.3 ug/mL, M1 (N=331,107,188,60)
    331
    107
    188
    60
        Anti-PSW-135 ≥ 0.3 ug/mL, PRE (N=340,111,204,64)
    40
    8
    23
    6
        Anti-PSW-135 ≥ 0.3 ug/mL, M1 (N=344,114,205,66)
    340
    113
    203
    66
        Anti-PSY ≥ 0.3 ug/mL, PRE (N=347,114,206,68)
    49
    16
    28
    11
        Anti-PSY ≥ 0.3 ug/mL, M1 (N=342,114,201,66)
    342
    113
    201
    66
        Anti-PSA ≥ 2 ug/mL, PRE (N=322,102,189,59)
    130
    40
    78
    24
        Anti-PSA ≥ 2 ug/mL, M1 (N=341,107,194,59)
    341
    107
    194
    59
        Anti-PSC ≥ 2 ug/mL, PRE (N=335,108,190,60)
    17
    10
    8
    6
        Anti-PSC ≥ 2 ug/mL, M1 (N=331,107,188,60)
    324
    106
    181
    59
        Anti-PSW-135 ≥ 2 ug/mL, PRE (N=340,111,204,64)
    9
    3
    5
    2
        Anti-PSW-135 ≥ 2 ug/mL, M1 (N=344,114,205,66)
    327
    106
    192
    61
        Anti-PSY ≥ 2 ug/mL, PRE (N=347,114,206,68)
    12
    8
    5
    7
        Anti-PSY ≥ 2 ug/mL, M1 (N=342,114,201,66)
    336
    111
    195
    65
    No statistical analyses for this end point

    Secondary: Anti-PSA, anti-PSC, anti-PSW-135, and anti-PSY antibody concentrations

    		 Close Top of page
    End point title
    		 Anti-PSA, anti-PSC, anti-PSW-135, and anti-PSY antibody concentrations
    End point description
    End point type
    Secondary
    End point timeframe
    Prior to and one month after vaccination
    End point values
    		 Nimenrix Group Mencevax ACWY Group Nimenrix Group (without subjects of excluded center) Mencevax ACWY Group (without subjects of the excluded center)
    Number of subjects analysed
    347
    114
    206
    68
    Units: μg/mL
    geometric mean (confidence interval 95%)
        Anti-PSA, PRE (N=322,102,189,59)
    1.05 (0.88 to 1.24)
    1.04 (0.77 to 1.39)
    1 (0.79 to 1.28)
    1.04 (0.68 to 1.6)
        Anti-PSA, M1 (N=341,107,194,59)
    86.06 (75.35 to 98.29)
    44.06 (34.4 to 56.42)
    85.68 (71.24 to 103.04)
    51.87 (36.86 to 72.98)
        Anti-PSC, PRE (N=335,108,190,60)
    0.21 (0.19 to 0.24)
    0.25 (0.2 to 0.3)
    0.2 (0.18 to 0.23)
    0.26 (0.19 to 0.35)
        Anti-PSC, M1 (N=331,107,188,60)
    22.83 (20.42 to 25.52)
    43.24 (35.8 to 52.23)
    17.71 (15.13 to 20.72)
    40.09 (30.73 to 52.31)
        Anti-PSW-135, PRE (N=340,111,204,64)
    0.18 (0.17 to 0.2)
    0.18 (0.16 to 0.21)
    0.18 (0.17 to 0.18)
    0.19 (0.15 to 0.24)
        Anti-PSW-135, M1 (N=344,114,205,66)
    17.82 (15.34 to 20.7)
    13.22 (10.47 to 16.68)
    15.48 (12.73 to 18.82)
    14.5 (10.72 to 19.62)
        Anti-PSY, PRE (N=347,114,206,68)
    0.2 (0.18 to 0.22)
    0.22 (0.18 to 0.28)
    0.19 (0.17 to 0.22)
    0.25 (0.18 to 0.35)
        Anti-PSY, M1 (N=342,114,201,66)
    23.77 (20.95 to 26.98)
    17.97 (14.3 to 22.59)
    20.95 (17.61 to 24.94)
    18.79 (13.94 to 25.32)
    No statistical analyses for this end point

    Secondary: Number of subjects with any solicited local symptoms

    		 Close Top of page
    End point title
    		 Number of subjects with any solicited local symptoms
    End point description
    End point type
    Secondary
    End point timeframe
    During the 4-day (Day 0 to Day 3) period after vaccination
    End point values
    		 Nimenrix Group Mencevax ACWY Group Nimenrix Group (without subjects of excluded center) Mencevax ACWY Group (without subjects of the excluded center)
    Number of subjects analysed
    200
    68
    174
    49
    Units: Subjects
        Any Pain
    200
    68
    174
    49
        Any Redness
    94
    16
    75
    11
        Any Swelling
    71
    16
    61
    14
    No statistical analyses for this end point

    Secondary: Number of subjects with any solicited general symptoms

    		 Close Top of page
    End point title
    		 Number of subjects with any solicited general symptoms
    End point description
    End point type
    Secondary
    End point timeframe
    During the 4-day (Day 0 to Day 3) period after vaccination
    End point values
    		 Nimenrix Group Mencevax ACWY Group Nimenrix Group (without subjects of excluded center) Mencevax ACWY Group (without subjects of the excluded center)
    Number of subjects analysed
    109
    36
    75
    22
    Units: Subjects
        Any Fatigue
    109
    36
    75
    22
        Any Fever (Axillary)
    55
    13
    39
    10
        Any Gastrointestinal symptoms
    35
    11
    26
    8
        Any Headache
    102
    27
    58
    12
    No statistical analyses for this end point

    Secondary: Number of subjects with any unsolicited adverse events

    		 Close Top of page
    End point title
    		 Number of subjects with any unsolicited adverse events
    End point description
    End point type
    Secondary
    End point timeframe
    Up to one month after vaccination
    End point values
    		 Nimenrix Group Mencevax ACWY Group Nimenrix Group (without subjects of excluded center) Mencevax ACWY Group (without subjects of the excluded center)
    Number of subjects analysed
    72
    26
    38
    13
    Units: Subjects
        Any AEs
    72
    26
    38
    13
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Number of subjects with any serious adverse events (SAEs)
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 6 months after vaccination
    End point values
    		 Nimenrix Group Mencevax ACWY Group Nimenrix Group (without subjects of excluded center) Mencevax ACWY Group (without subjects of the excluded center)
    Number of subjects analysed
    3
    2
    2
    2
    Units: Subjects
        Any SAEs
    3
    2
    2
    2
    No statistical analyses for this end point

    Secondary: Number of subjects with specific adverse events

    		 Close Top of page
    End point title
    		 Number of subjects with specific adverse events
    End point description
    These events included the specific categories of adverse events (AEs) which included rash (e.g. hives, idiopathic thrombocytopenia purpura, petechiae), new onset of chronic illness(es) (NOCIs) (e.g. autoimmune disorders, asthma, type I diabetes and allergies), conditions prompting emergency room (ER) visits or non-routine physician office visits (i.e. office visits not related to well-being care, vaccination, injury or common acute illnesses such as upper respiratory tract infections, otitis media, pharyngitis, gastroenteritis), any events related to lack of meningococcal vaccine efficacy (i.e. meningococcal disease)*.
    End point type
    Secondary
    End point timeframe
    Up to 6 months after vaccination
    End point values
    		 Nimenrix Group Mencevax ACWY Group Nimenrix Group (without subjects of excluded center) Mencevax ACWY Group (without subjects of the excluded center)
    Number of subjects analysed
    6
    1
    5
    1
    Units: Subjects
        Any Rash
    6
    1
    5
    1
        Any NOCIs
    0
    0
    0
    0
        Any ER visits
    1
    0
    1
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titer ≥1:128

    		 Close Top of page
    End point title
    		 Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titer ≥1:128
    End point description
    End point type
    Secondary
    End point timeframe
    Prior to (PRE) and one month (M1) after vaccination
    End point values
    		 Nimenrix Group Mencevax ACWY Group Nimenrix Group (without subjects of excluded center) Mencevax ACWY Group (without subjects of the excluded center)
    Number of subjects analysed
    678
    224
    390
    128
    Units: Subjects
        rSBA-MenA, PRE (N=557,191,316,108)
    427
    128
    233
    74
        rSBA-MenA, M1 (N=674,224,388,128)
    674
    223
    388
    128
        rSBA-MenC, PRE (N=648,211,369,119)
    277
    79
    153
    45
        rSBA-MenC, M1 (N=673,224,387,128)
    672
    223
    386
    128
        rSBAMenW-135, PRE (N=640,216,363,125)
    373
    120
    199
    67
        rSBAMenW-135, M1 (N=678,224,390,128)
    677
    223
    389
    128
        rSBA-MenY, PRE (N=659,219,380,127)
    538
    167
    301
    96
        rSBA-MenY, M1 (N=677,224,389,128)
    677
    224
    389
    128
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Solicited local and general adverse events (AEs): during the 4-day (Day 0 to Day 3) period after vaccination Unsolicited AEs: up to one month after vaccination Serious AEs and specific AEs: up to 6 month after vaccination (study end)
    Adverse event reporting additional description
    Specific AEs include Rash, New onset of chronic illness, Conditions prompting ER visits and Any events related to lack of meningococcal vaccine efficacy
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.0
    Reporting groups
    Reporting group title
    MenACWY-TT
    Reporting group description
    		 Subjects received 1 dose of meningococcal vaccine GSK134612

    Reporting group title
    MenACWY
    Reporting group description
    		 Subject received 1 dose of Mencevax™ ACWY

    Reporting group title
    MenACWY-TT (without subjects of the excluded center)
    Reporting group description
    		 Subjects from the MenACWY-TT group who had not GCP issues

    Reporting group title
    MenACWY (without the subjects of the excluded center)
    Reporting group description
    		 Subjects from the MenACWY group who had not GCP issues

    Serious adverse events
    		 MenACWY-TT MenACWY MenACWY-TT (without subjects of the excluded center) MenACWY (without the subjects of the excluded center)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 768 (0.39%)
    2 / 257 (0.78%)
    2 / 474 (0.42%)
    2 / 159 (1.26%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Humerus fracture
         subjects affected / exposed
    0 / 768 (0.00%)
    1 / 257 (0.39%)
    0 / 474 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Peptic ulcer
         subjects affected / exposed
    2 / 768 (0.26%)
    0 / 257 (0.00%)
    2 / 474 (0.42%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Amoebic dysentery
         subjects affected / exposed
    1 / 768 (0.13%)
    0 / 257 (0.00%)
    0 / 474 (0.00%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 768 (0.00%)
    1 / 257 (0.39%)
    0 / 474 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritoneal abscess
         subjects affected / exposed
    0 / 768 (0.00%)
    1 / 257 (0.39%)
    0 / 474 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 768 (0.13%)
    0 / 257 (0.00%)
    0 / 474 (0.00%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 MenACWY-TT MenACWY MenACWY-TT (without subjects of the excluded center) MenACWY (without the subjects of the excluded center)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    200 / 768 (26.04%)
    68 / 257 (26.46%)
    174 / 474 (36.71%)
    49 / 159 (30.82%)
    General disorders and administration site conditions
    Pain
    alternative assessment type: Systematic
         subjects affected / exposed
    200 / 768 (26.04%)
    68 / 257 (26.46%)
    174 / 474 (36.71%)
    49 / 159 (30.82%)
         occurrences all number
    200
    68
    174
    49
    Redness
    alternative assessment type: Systematic
         subjects affected / exposed
    94 / 768 (12.24%)
    16 / 257 (6.23%)
    75 / 474 (15.82%)
    11 / 159 (6.92%)
         occurrences all number
    94
    16
    75
    11
    Swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    71 / 768 (9.24%)
    16 / 257 (6.23%)
    61 / 474 (12.87%)
    14 / 159 (8.81%)
         occurrences all number
    71
    16
    61
    14
    Fatigue
    alternative assessment type: Systematic
         subjects affected / exposed
    109 / 768 (14.19%)
    36 / 257 (14.01%)
    75 / 474 (15.82%)
    22 / 159 (13.84%)
         occurrences all number
    109
    36
    75
    22
    Fever
    alternative assessment type: Systematic
         subjects affected / exposed
    55 / 768 (7.16%)
    13 / 257 (5.06%)
    39 / 474 (8.23%)
    10 / 159 (6.29%)
         occurrences all number
    55
    13
    39
    10
    Gastrointestinal
    alternative assessment type: Systematic
         subjects affected / exposed
    35 / 768 (4.56%)
    11 / 257 (4.28%)
    26 / 474 (5.49%)
    8 / 159 (5.03%)
         occurrences all number
    35
    11
    26
    8
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed
    102 / 768 (13.28%)
    27 / 257 (10.51%)
    58 / 474 (12.24%)
    12 / 159 (7.55%)
         occurrences all number
    102
    27
    58
    12
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 768 (0.00%)
    0 / 257 (0.00%)
    13 / 474 (2.74%)
    8 / 159 (5.03%)
         occurrences all number
    0
    0
    13
    8

    More information

    		 Close Top of page

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

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sun May 05 21:47:58 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA