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:
    Persistence of antibodies after vaccination with a dose of GSK Biologicals’ meningococcal vaccine GSK134612 in healthy children and safety and immunogenicity of a booster dose at 68 months post-primary vaccination.

    Summary
    EudraCT number
    		 2010-018730-51
    Trial protocol
    		 FR   DE  
    Global end of trial date
    17 May 2014

    Results information
    Results version number
    		 v2
    This version publication date
    21 Apr 2016
    First version publication date
    24 May 2015
    Other versions
    		 v1 , v3
    Version creation reason
    • New data added to full data set
    Data for Month 56, 68 and 69 have been added.

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    113977
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01266993
    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
    27 May 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Mar 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    17 May 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Persistence At 32, 44, 56 and 68 months after primary vaccination with MenACWY-TT or MenC-CRM. •To evaluate the persistence of meningococcal antibodies in terms of the percentage of subjects with rSBAMenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY titres ≥1:8.
    Protection of trial subjects
    All subjects were supervised closely for at least 30 minutes following vaccination with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel. Vaccines/products were administered only to eligible subjects that had no contraindications to any components of the vaccines. Subjects were followed-up from the time the subject consents to participate in the study until she/he is discharged.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Jan 2011
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 37 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 97
    Country: Number of subjects enrolled
    Germany: 185
    Worldwide total number of subjects
    282
    EEA total number of subjects
    282
    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)
    282
    Adolescents (12-17 years)
    0
    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
    		 -

    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
    		 282
    Number of subjects completed
    		 271

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 No vaccination received: 11
    Period 1
    Period 1 title
    Month 32
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Nimenrix Month 32 Group
    Arm description
    		 Subjects who received Nimenrix™ (GSK134612 vaccine) in the primary study received a booster dose of the same vaccine in the current study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nimerix™
    Investigational medicinal product code
    Other name
    GSK134612 vaccine MenACWY-TT
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular administration, of 1 vaccine dose, in the non-dominant arm, deltoid/thigh region at Day 0.

    Arm title
    		 Menjugate Month 32 Group
    Arm description
    		 Subjects who received Menjugate® in the primary study received a booster dose of Nimenrix™ (GSK134612 vaccine) in the current study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nimerix™
    Investigational medicinal product code
    Other name
    GSK134612 vaccine MenACWY-TT
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular administration, of 1 vaccine dose, in the non-dominant arm, deltoid/thigh region at Day 0.

    Number of subjects in period 1 [1]
    		Nimenrix Month 32 Group Menjugate Month 32 Group
    Started
    199
    72
    Completed
    199
    72
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Not all subjects who completed a period entered in the next one . The number of subjects who started each period depends on the number of subjects available at the time.
    Period 2
    Period 2 title
    Month 44
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Nimenrix Month 44 Group
    Arm description
    		 Subjects who received Nimenrix™ (GSK134612 vaccine) in the primary study received a booster dose of the same vaccine in the current study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nimerix™
    Investigational medicinal product code
    Other name
    GSK134612 vaccine MenACWY-TT
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular administration, of 1 vaccine dose, in the non-dominant arm, deltoid/thigh region at Day 0.

    Arm title
    		 Menjugate Month 44 Group
    Arm description
    		 Subjects who received Menjugate® in the primary study received a booster dose of Nimenrix™ (GSK134612 vaccine) in the current study
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nimerix™
    Investigational medicinal product code
    Other name
    GSK134612 vaccine MenACWY-TT
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular administration, of 1 vaccine dose, in the non-dominant arm, deltoid/thigh region at Day 0.

    Number of subjects in period 2 [2]
    		Nimenrix Month 44 Group Menjugate Month 44 Group
    Started
    193
    68
    Completed
    193
    68
    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 subjects who completed a period entered in the next one . The number of subjects who started each period depends on the number of subjects available at the time.
    Period 3
    Period 3 title
    Month 56
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Nimenrix Month 56 Group
    Arm description
    		 Subjects who received Nimenrix™ (GSK134612 vaccine) in the primary study and a booster dose of the same vaccine in the current study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nimerix™
    Investigational medicinal product code
    Other name
    GSK134612 vaccine MenACWY-TT
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular administration, of 1 vaccine dose, in the non-dominant arm, deltoid/thigh region at Day 0.

    Arm title
    		 Menjugate Month 56 Group
    Arm description
    		 Subjects who received Menjugate® in the primary study and a booster dose of Nimenrix™ (GSK134612 vaccine) in the current study
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nimerix™
    Investigational medicinal product code
    Other name
    GSK134612 vaccine MenACWY-TT
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular administration, of 1 vaccine dose, in the non-dominant arm, deltoid/thigh region at Day 0.

    Number of subjects in period 3 [3]
    		Nimenrix Month 56 Group Menjugate Month 56 Group
    Started
    193
    67
    Completed
    193
    67
    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 subjects who completed a period entered in the next one . The number of subjects who started each period depends on the number of subjects available at the time.
    Period 4
    Period 4 title
    Month 68
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Nimenrix Month 68 Group
    Arm description
    		 Subjects who received Nimenrix™ (GSK134612 vaccine) in the primary study received a booster dose of the same vaccine in the current study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nimerix™
    Investigational medicinal product code
    Other name
    GSK134612 vaccine MenACWY-TT
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular administration, of 1 vaccine dose, in the non-dominant arm, deltoid/thigh region at Day 0.

    Arm title
    		 Menjugate Month 68 Group
    Arm description
    		 Subjects who received Menjugate® in the primary study received a booster dose of Nimenrix™ (GSK134612 vaccine) in the current study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nimerix™
    Investigational medicinal product code
    Other name
    GSK134612 vaccine MenACWY-TT
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular administration, of 1 vaccine dose, in the non-dominant arm, deltoid/thigh region at Day 0.

    Number of subjects in period 4 [4]
    		Nimenrix Month 68 Group Menjugate Month 68 Group
    Started
    179
    62
    Completed
    179
    62
    Notes
    [4] - 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 subjects who completed a period entered in the next one . The number of subjects who started each period depends on the number of subjects available at the time.
    Period 5
    Period 5 title
    Month 69 (Booster)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Nimenrix Month 69 Group
    Arm description
    		 Subjects who received Nimenrix™ (GSK134612 vaccine) in the primary study received a booster dose of the same vaccine in the current study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nimerix™
    Investigational medicinal product code
    Other name
    GSK134612 vaccine MenACWY-TT
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular administration, of 1 vaccine dose, in the non-dominant arm, deltoid/thigh region at Day 0.

    Arm title
    		 Menjugate Month 69 Group
    Arm description
    		 Subjects who received Menjugate® in the primary study received a booster dose of Nimenrix™ (GSK134612 vaccine) in the current study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nimerix™
    Investigational medicinal product code
    Other name
    GSK134612 vaccine MenACWY-TT
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular administration, of 1 vaccine dose, in the non-dominant arm, deltoid/thigh region at Day 0.

    Number of subjects in period 5
    		Nimenrix Month 69 Group Menjugate Month 69 Group
    Started
    179
    62
    Completed
    174
    60
    Not completed
    5
    2
         Consent withdrawn by subject
    -
    1
         Lost to follow-up
    5
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Nimenrix Month 32 Group
    Reporting group description
    		 Subjects who received Nimenrix™ (GSK134612 vaccine) in the primary study received a booster dose of the same vaccine in the current study.

    Reporting group title
    Menjugate Month 32 Group
    Reporting group description
    		 Subjects who received Menjugate® in the primary study received a booster dose of Nimenrix™ (GSK134612 vaccine) in the current study.

    Reporting group values
    		 Nimenrix Month 32 Group Menjugate Month 32 Group Total
    Number of subjects
    		 199 72 271
    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)
    		 8.4 ± 2.58 8.1 ± 2.42 -
    Gender categorical
    Units: Subjects
        Female
    		 103 34 137
        Male
    		 96 38 134

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Nimenrix Month 32 Group
    Reporting group description
    		 Subjects who received Nimenrix™ (GSK134612 vaccine) in the primary study received a booster dose of the same vaccine in the current study.

    Reporting group title
    Menjugate Month 32 Group
    Reporting group description
    		 Subjects who received Menjugate® in the primary study received a booster dose of Nimenrix™ (GSK134612 vaccine) in the current study.
    Reporting group title
    Nimenrix Month 44 Group
    Reporting group description
    		 Subjects who received Nimenrix™ (GSK134612 vaccine) in the primary study received a booster dose of the same vaccine in the current study.

    Reporting group title
    Menjugate Month 44 Group
    Reporting group description
    		 Subjects who received Menjugate® in the primary study received a booster dose of Nimenrix™ (GSK134612 vaccine) in the current study
    Reporting group title
    Nimenrix Month 56 Group
    Reporting group description
    		 Subjects who received Nimenrix™ (GSK134612 vaccine) in the primary study and a booster dose of the same vaccine in the current study.

    Reporting group title
    Menjugate Month 56 Group
    Reporting group description
    		 Subjects who received Menjugate® in the primary study and a booster dose of Nimenrix™ (GSK134612 vaccine) in the current study
    Reporting group title
    Nimenrix Month 68 Group
    Reporting group description
    		 Subjects who received Nimenrix™ (GSK134612 vaccine) in the primary study received a booster dose of the same vaccine in the current study.

    Reporting group title
    Menjugate Month 68 Group
    Reporting group description
    		 Subjects who received Menjugate® in the primary study received a booster dose of Nimenrix™ (GSK134612 vaccine) in the current study.
    Reporting group title
    Nimenrix Month 69 Group
    Reporting group description
    		 Subjects who received Nimenrix™ (GSK134612 vaccine) in the primary study received a booster dose of the same vaccine in the current study.

    Reporting group title
    Menjugate Month 69 Group
    Reporting group description
    		 Subjects who received Menjugate® in the primary study received a booster dose of Nimenrix™ (GSK134612 vaccine) in the current study.

    Primary: Number of subjects with serum bactericidal assay against Neisseria meningitides serogroup A, C, W-135, Y, using baby rabbit complement (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY) antibody titres ≥1:8

    		 Close Top of page
    End point title
    		 Number of subjects with serum bactericidal assay against Neisseria meningitides serogroup A, C, W-135, Y, using baby rabbit complement (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY) antibody titres ≥1:8 [1]
    End point description
    These analyses were performed by the Health Protection Agency (HPA) laboratory
    End point type
    Primary
    End point timeframe
    At month 32 after primary vaccination
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed
    End point values
    		 Nimenrix Month 32 Group Menjugate Month 32 Group
    Number of subjects analysed
    193
    69
    Units: Subjects
        rSBA-MenA [N=193;69]
    167
    15
        rSBA-MenC [N=192;69]
    124
    53
        rSBA-MenW-135 [N=193;69]
    149
    5
        rSBA-MenY [N=193;69]
    157
    10
    No statistical analyses for this end point

    Primary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY antibody titres ≥1:8

    		 Close Top of page
    End point title
    		 Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY antibody titres ≥1:8 [2]
    End point description
    These analyses were performed by the Health Protection Agency (HPA) laboratory
    End point type
    Primary
    End point timeframe
    At month 44 after primary vaccination
    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 Month 44 Group Menjugate Month 44 Group
    Number of subjects analysed
    189
    66
    Units: Subjects
        rSBA-MenA [N=189;66]
    162
    17
        rSBA-MenC [N=189;66]
    70
    30
        rSBA-MenW-135 [N=189;66]
    129
    7
        rSBA-MenY [N=189;66]
    118
    4
    No statistical analyses for this end point

    Primary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY antibody titres ≥1:8

    		 Close Top of page
    End point title
    		 Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY antibody titres ≥1:8 [3]
    End point description
    These analyses were performed by the GSK laboratory
    End point type
    Primary
    End point timeframe
    At 32 months after the primary vaccination
    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 Month 32 Group Menjugate Month 32 Group
    Number of subjects analysed
    192
    67
    Units: Subjects
        rSBA-MenA [N=191;57]
    191
    25
        rSBA-MenC [N=189;67]
    189
    67
        rSBA-MenW-135 [N=192;65]
    192
    52
        rSBA-MenY [N=191;65]
    191
    51
    No statistical analyses for this end point

    Primary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY antibody titres ≥1:8

    		 Close Top of page
    End point title
    		 Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY antibody titres ≥1:8 [4]
    End point description
    These analyses were performed by the GSK laboratory
    End point type
    Primary
    End point timeframe
    At 44 months after the primary vaccination
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed
    End point values
    		 Nimenrix Month 44 Group Menjugate Month 44 Group
    Number of subjects analysed
    188
    64
    Units: Subjects
        rSBA-MenA [N=187;55]
    187
    24
        rSBA-MenC [N=186;64]
    186
    64
        rSBA-MenW-135 [N=188;62]
    188
    49
        rSBA-MenY [N=187;62]
    187
    49
    No statistical analyses for this end point

    Primary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY antibody titres ≥1:8

    		 Close Top of page
    End point title
    		 Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY antibody titres ≥1:8 [5]
    End point description
    These analyses were performed by the Health Protection Agency (HPA) laboratory
    End point type
    Primary
    End point timeframe
    At 56 months after the primary vaccination
    Notes
    [5] - 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 Month 56 Group Menjugate Month 56 Group
    Number of subjects analysed
    186
    65
    Units: Subjects
        rSBA-MenA [N=186;65]
    161
    19
        rSBA-MenC [N=186;65]
    110
    42
        rSBA-MenW-135 [N=186;65]
    145
    17
        rSBA-MenY [N=186;64]
    149
    14
    No statistical analyses for this end point

    Primary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY antibody titres ≥1:8

    		 Close Top of page
    End point title
    		 Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY antibody titres ≥1:8 [6]
    End point description
    These analyses were performed by the Health Protection Agency (HPA) laboratory
    End point type
    Primary
    End point timeframe
    At 68 months after the primary vaccination
    Notes
    [6] - 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 Month 68 Group Menjugate Month 68 Group
    Number of subjects analysed
    178
    61
    Units: Subjects
        rSBA-MenA [N=178;61]
    154
    18
        rSBA-MenC [N=178;61]
    71
    38
        rSBA-MenW-135 [N=178;61]
    94
    9
        rSBA-MenY [N=178;61]
    127
    8
    No statistical analyses for this end point

    Primary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY antibody titres ≥1:8

    		 Close Top of page
    End point title
    		 Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY antibody titres ≥1:8 [7]
    End point description
    These analyses were performed by the GSK laboratory .
    End point type
    Primary
    End point timeframe
    At 56 months after the primary vaccination
    Notes
    [7] - 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 Month 56 Group Menjugate Month 56 Group
    Number of subjects analysed
    185
    63
    Units: Subjects
        rSBA-MenA [N=184;54]
    184
    24
        rSBA-MenC [N=182;63]
    182
    63
        rSBA-MenW-135 [N=185;61]
    185
    48
        rSBA-MenY [N=184;61]
    184
    49
    No statistical analyses for this end point

    Primary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY antibody titres ≥1:8

    		 Close Top of page
    End point title
    		 Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY antibody titres ≥1:8 [8]
    End point description
    These analyses were performed by the GSK laboratory
    End point type
    Primary
    End point timeframe
    At 68 months after the primary vaccination
    Notes
    [8] - 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 Month 68 Group Menjugate Month 68 Group
    Number of subjects analysed
    177
    59
    Units: Subjects
        rSBA-MenA [N=176;51]
    176
    24
        rSBA-MenC [N=174;59]
    174
    59
        rSBA-MenW-135 [N=177;58]
    177
    46
        rSBA-MenY [N=176;57]
    176
    47
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY antibody titres ≥1:128
    End point description
    These analyses were performed by the Health Protection Agency (HPA) laboratory
    End point type
    Secondary
    End point timeframe
    At 32 months after the primary vaccination
    End point values
    		 Nimenrix Month 32 Group Menjugate Month 32 Group
    Number of subjects analysed
    193
    69
    Units: Subjects
        rSBA-MenA [N=193;69]
    140
    9
        rSBA-MenC [N=192;69]
    69
    35
        rSBA-MenW-135 [N=193;69]
    136
    5
        rSBA-MenY [N=193;69]
    145
    8
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY antibody titres ≥1:128
    End point description
    These analyses were performed by the Health Protection Agency (HPA) laboratory
    End point type
    Secondary
    End point timeframe
    At 44 months after the primary vaccination
    End point values
    		 Nimenrix Month 44 Group Menjugate Month 44 Group
    Number of subjects analysed
    189
    66
    Units: Subject
        rSBA-MenA [N=189;66]
    151
    16
        rSBA-MenC [N=189;66]
    38
    23
        rSBA-MenW-135 [N=189;66]
    120
    5
        rSBA-MenY [N=189;66]
    107
    3
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY antibody titres ≥1:128
    End point description
    These analyses were performed by the GSK laboratory
    End point type
    Secondary
    End point timeframe
    At 32 months after the primary vaccination
    End point values
    		 Nimenrix Month 32 Group Menjugate Month 32 Group
    Number of subjects analysed
    192
    67
    Units: Subjects
        rSBA-MenA [N=191;57]
    191
    19
        rSBA-MenC [N=189;67]
    186
    67
        rSBA-MenW-135 [N=192;65]
    191
    30
        rSBA-MenY [N=191;65]
    191
    34
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY antibody titres ≥1:128
    End point description
    These analyses were performed by the GSK laboratory
    End point type
    Secondary
    End point timeframe
    At 44 months after the primary vaccination
    End point values
    		 Nimenrix Month 44 Group Menjugate Month 44 Group
    Number of subjects analysed
    188
    64
    Units: Subjects
        rSBA-MenA [N=187;55]
    187
    18
        rSBA-MenC [N=186;64]
    183
    64
        rSBA-MenW-135 [N=188;62]
    187
    29
        rSBA-MenY [N=187;62]
    187
    32
    No statistical analyses for this end point

    Secondary: Antibody titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY meningococcal antigens

    		 Close Top of page
    End point title
    		 Antibody titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY meningococcal antigens
    End point description
    These analyses were performed by the Health Protection Agency (HPA) laboratory
    End point type
    Secondary
    End point timeframe
    At 32 months after the primary vaccination
    End point values
    		 Nimenrix Month 32 Group Menjugate Month 32 Group
    Number of subjects analysed
    193
    69
    Units: Titers
    geometric mean (confidence interval 95%)
        rSBA-MenA [N=193;69]
    196.3 (144.1 to 267.2)
    8 (5.5 to 11.7)
        rSBA-MenC [N=192;69]
    34.8 (26 to 46.4)
    86.5 (47.3 to 158.1)
        rSBA-MenW-135 [193;69]
    213.9 (149.3 to 306.6)
    5.6 (4.2 to 7.6)
        rSBA-MenY [N=193;69]
    227.4 (164.8 to 313.7)
    7.2 (5 to 10.4)
    No statistical analyses for this end point

    Secondary: Antibody titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY meningococcal antigens

    		 Close Top of page
    End point title
    		 Antibody titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY meningococcal antigens
    End point description
    These analyses were performed by the Health Protection Agency (HPA) laboratory
    End point type
    Secondary
    End point timeframe
    At 44 months after the primary vaccination
    End point values
    		 Nimenrix Month 44 Group Menjugate Month 44 Group
    Number of subjects analysed
    189
    66
    Units: Titers
    geometric mean (confidence interval 95%)
        rSBA-MenA [N=189;66]
    307.5 (223.7 to 422.8)
    13.5 (8 to 23)
        rSBA-MenC [N=189;66]
    14.5 (10.9 to 19.2)
    31 (16.6 to 58)
        rSBA-MenW-135 [N=189;66]
    103.5 (72.5 to 147.6)
    5.9 (4.3 to 8.1)
        rSBA-MenY [N=189;66]
    78.9 (54.6 to 114)
    4.9 (3.9 to 6.2)
    No statistical analyses for this end point

    Secondary: Antibody titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY meningococcal antigens

    		 Close Top of page
    End point title
    		 Antibody titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY meningococcal antigens
    End point description
    These analyses were performed by the GSK laboratory
    End point type
    Secondary
    End point timeframe
    At 32 months after the primary vaccination
    End point values
    		 Nimenrix Month 32 Group Menjugate Month 32 Group
    Number of subjects analysed
    192
    67
    Units: Titers
    geometric mean (confidence interval 95%)
        rSBA-MenA [N=191;57]
    6733.3 (5927 to 7649.3)
    27.2 (14.4 to 51.1)
        rSBA-MenC [N=189;67]
    2588 (2124.5 to 3152.7)
    5135.3 (3436.5 to 7674.1)
        rSBA-MenW-135 [N=192;65]
    8959.1 (7828.9 to 10252.5)
    77.9 (49.4 to 122.9)
        rSBA-MenY [N=191;65]
    8543.9 (7405 to 9858.1)
    86.5 (54.5 to 137.3)
    No statistical analyses for this end point

    Secondary: Antibody titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY meningococcal antigens

    		 Close Top of page
    End point title
    		 Antibody titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY meningococcal antigens
    End point description
    These analyses were performed by the GSK laboratory
    End point type
    Secondary
    End point timeframe
    At 44 months after the primary vaccination
    End point values
    		 Nimenrix Month 44 Group Menjugate Month 44 Group
    Number of subjects analysed
    188
    64
    Units: Titers
    geometric mean (confidence interval 95%)
        rSBA-MenA [N=187;55]
    6633.2 (5830.3 to 7546.6)
    26.9 (14.1 to 51.3)
        rSBA-MenC [N=186;64]
    2609 (2134.9 to 3188.3)
    5120.1 (3432 to 7638.4)
        rSBA-MenW-135 [N=188;62]
    9158.4 (7975 to 10517.4)
    76.9 (47.9 to 123.6)
        rSBA-MenY [N=187;62]
    8520.4 (7362.2 to 9860.8)
    87.2 (54.4 to 139.6)
    No statistical analyses for this end point

    Secondary: Number of subjects with serum bactericidal assay against N. meningitides serogroup A, C, W-135, Y, using human complement (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) antibody titres ≥1:4

    		 Close Top of page
    End point title
    		 Number of subjects with serum bactericidal assay against N. meningitides serogroup A, C, W-135, Y, using human complement (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) antibody titres ≥1:4
    End point description
    This analysis was performed on 50% of the subjects in each group
    End point type
    Secondary
    End point timeframe
    At Month 32 after primary vaccination
    End point values
    		 Nimenrix Month 32 Group Menjugate Month 32 Group
    Number of subjects analysed
    91
    34
    Units: Subjects
        hSBA-MenA [N=90;34]
    24
    5
        hSBA-MenC [N=90;33]
    86
    30
        hSBA-MenW-135 [N=86;23]
    73
    4
        hSBA-MenY [N=91;28]
    74
    13
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Number of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY antibody titres ≥1:4
    End point description
    This analysis was performed on 50% of the subjects in each group
    End point type
    Secondary
    End point timeframe
    At Month 44 after primary vaccination
    End point values
    		 Nimenrix Month 44 Group Menjugate Month 44 Group
    Number of subjects analysed
    89
    31
    Units: Subjects
        hSBA-MenA [N=89;31]
    26
    5
        hSBA-MenC [N=82;31]
    63
    20
        hSBA-MenW-135 [N=87;30]
    70
    8
        hSBA-MenY [N=76;26]
    63
    12
    No statistical analyses for this end point

    Secondary: Number of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY antibody titres ≥1:8

    		 Close Top of page
    End point title
    		 Number of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY antibody titres ≥1:8
    End point description
    This analysis was performed on 50% of the subjects in each group
    End point type
    Secondary
    End point timeframe
    At Month 32 after primary vaccination
    End point values
    		 Nimenrix Month 32 Group Menjugate Month 32 Group
    Number of subjects analysed
    91
    34
    Units: Subjects
        hSBA-MenA [N=90;34]
    23
    5
        hSBA-MenC [N=90;33]
    86
    30
        hSBA-MenW-135 [N=86;23]
    73
    4
        hSBA-MenY [N=91;28]
    74
    13
    No statistical analyses for this end point

    Secondary: Number of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY antibody titres ≥1:8

    		 Close Top of page
    End point title
    		 Number of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY antibody titres ≥1:8
    End point description
    This analysis was performed on 50% of the subjects in each group
    End point type
    Secondary
    End point timeframe
    At Month 44 after primary vaccination
    End point values
    		 Nimenrix Month 44 Group Menjugate Month 44 Group
    Number of subjects analysed
    89
    31
    Units: Subjects
        hSBA-MenA [N=89;31]
    23
    5
        hSBA-MenC [N=82;31]
    63
    20
        hSBA-MenW-135 [N=87;30]
    70
    8
        hSBA-MenY [N=76;26]
    63
    12
    No statistical analyses for this end point

    Secondary: Antibody titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY meningococcal antigens

    		 Close Top of page
    End point title
    		 Antibody titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY meningococcal antigens
    End point description
    This analysis was performed on 50% of the subjects in each group
    End point type
    Secondary
    End point timeframe
    At Month 32 after primary vaccination
    End point values
    		 Nimenrix Month 32 Group Menjugate Month 32 Group
    Number of subjects analysed
    91
    34
    Units: Titers
    geometric mean (confidence interval 95%)
        hSBA-MenA [N=90;34]
    4.6 (3.3 to 6.3)
    2.7 (2.1 to 3.4)
        hSBA-MenC [N=90;33]
    75.9 (53.4 to 107.9)
    82.2 (34.6 to 195.8)
        hSBA-MenW-135 [N=86;23]
    69.9 (48.2 to 101.5)
    3.8 (2 to 7.1)
        hSBA-MenY [N=91;28]
    79.2 (52.5 to 119.3)
    15.1 (6.3 to 36.5)
    No statistical analyses for this end point

    Secondary: Antibody titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY meningococcal antigens

    		 Close Top of page
    End point title
    		 Antibody titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY meningococcal antigens
    End point description
    This analysis was performed on 50% of the subjects in each group
    End point type
    Secondary
    End point timeframe
    At Month 44 after primary vaccination
    End point values
    		 Nimenrix Month 44 Group Menjugate Month 44 Group
    Number of subjects analysed
    89
    31
    Units: Titers
    geometric mean (confidence interval 95%)
        hSBA-MenA [N=89;31]
    4.8 (3.4 to 6.7)
    2.8 (2.1 to 3.7)
        hSBA-MenC [N=82;31]
    36.4 (23.1 to 57.2)
    38.8 (13.3 to 113.2)
        hSBA-MenW-135 [N=87;30]
    64.3 (42.7 to 96.8)
    5.2 (2.8 to 9.5)
        hSBA-MenY [N=76;26]
    126.7 (78 to 205.7)
    16.8 (16.8 to 44.9)
    No statistical analyses for this end point

    Secondary: Number of subjects with any SAEs

    		 Close Top of page
    End point title
    		 Number of subjects with any 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.
    End point type
    Secondary
    End point timeframe
    Up to Month 32, 44, 56 and 68
    End point values
    		 Nimenrix Month 32 Group Nimenrix Month 44 Group Nimenrix Month 56 Group Menjugate Month 32 Group Menjugate Month 44 Group Menjugate Month 56 Group Nimenrix Month 68 Group Menjugate Month 68 Group
    Number of subjects analysed
    199
    193
    193
    72
    68
    67
    179
    62
    Units: Subjects
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY antibody titres ≥1:128
    End point description
    These analyses were performed by the Health Protection Agency (HPA) laboratory
    End point type
    Secondary
    End point timeframe
    At 56 months after the primary vaccination
    End point values
    		 Nimenrix Month 56 Group Menjugate Month 56 Group
    Number of subjects analysed
    186
    65
    Units: Subjects
        rSBA-MenA [N=186;65]
    107
    10
        rSBA-MenC [N=186;65]
    65
    32
        rSBA-MenW-135 [N=186;65]
    123
    10
        rSBA-MenY [N=186;64]
    139
    10
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY antibody titres ≥1:128
    End point description
    These analyses were performed by the Health Protection Agency (HPA) laboratory
    End point type
    Secondary
    End point timeframe
    At 68 months after the primary vaccination
    End point values
    		 Nimenrix Month 68 Group Menjugate Month 68 Group
    Number of subjects analysed
    178
    61
    Units: Subjects
        rSBA-MenA
    107
    12
        rSBA-MenC
    38
    25
        rSBA-MenW-135
    84
    8
        rSBA-MenY
    118
    6
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY antibody titres ≥1:128
    End point description
    These analyses were performed by the GSK laboratory
    End point type
    Secondary
    End point timeframe
    At 56 months after the primary vaccination
    End point values
    		 Nimenrix Month 56 Group Menjugate Month 56 Group
    Number of subjects analysed
    185
    63
    Units: Subjects
        rSBA-MenA [N=184;54]
    184
    18
        rSBA-MenC [N=182;63]
    179
    63
        rSBA-MenW-135 [N=185;61]
    184
    29
        rSBA-MenY [N=184;61]
    184
    34
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY antibody titres ≥1:128
    End point description
    These analyses were performed by the GSK laboratory
    End point type
    Secondary
    End point timeframe
    At 68 months after the primary vaccination
    End point values
    		 Nimenrix Month 68 Group Menjugate Month 68 Group
    Number of subjects analysed
    177
    59
    Units: Subjects
        rSBA-MenA [N=176;51]
    176
    19
        rSBA-MenC [N=174;59]
    172
    59
        rSBA-MenW-135 [N=177;58]
    176
    27
        rSBA-MenY [N=176;57]
    176
    32
    No statistical analyses for this end point

    Secondary: Antibody titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY meningococcal antigens

    		 Close Top of page
    End point title
    		 Antibody titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY meningococcal antigens
    End point description
    These analyses were performed by the Health Protection Agency (HPA) laboratory
    End point type
    Secondary
    End point timeframe
    At 56 months after the primary vaccination
    End point values
    		 Nimenrix Month 56 Group Menjugate Month 56 Group
    Number of subjects analysed
    181
    65
    Units: Titers
    geometric mean (confidence interval 95%)
        rSBA-MenA [N=181;65]
    120.1 (87 to 165.9)
    9.8 (6.4 to 15)
        rSBA-MenC [N=181;65]
    30.5 (22.6 to 41.1)
    69 (36.9 to 128.9)
        rSBA-MenW-135 [N=181;65]
    158.3 (112.4 to 222.9)
    10.3 (6.4 to 16.6)
        rSBA-MenY [N=181;64]
    233.2 (166 to 327.6)
    9 (6 to 13.6)
    No statistical analyses for this end point

    Secondary: Antibody titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY meningococcal antigens

    		 Close Top of page
    End point title
    		 Antibody titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY meningococcal antigens
    End point description
    These analyses were performed by the Health Protection Agency (HPA) laboratory
    End point type
    Secondary
    End point timeframe
    At 68 months after the primary vaccination
    End point values
    		 Nimenrix Month 68 Group Menjugate Month 68 Group
    Number of subjects analysed
    178
    61
    Units: Titers
    geometric mean (confidence interval 95%)
        rSBA-MenA [N=178;61]
    129.5 (93.5 to 179.3)
    11.1 (7 to 17.7)
        rSBA-MenC [N=178;61]
    14.2 (10.8 to 18.7)
    44.5 (23.7 to 83.6)
        rSBA-MenW-135 [N=178;61]
    59.2 (39.3 to 89.2)
    7.8 (5 to 12.1)
        rSBA-MenY [N=178;61]
    139.4 (96 to 202.5)
    6.8 (4.6 to 10.2)
    No statistical analyses for this end point

    Secondary: Antibody titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY meningococcal antigens

    		 Close Top of page
    End point title
    		 Antibody titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY meningococcal antigens
    End point description
    These analyses were performed by the GSK laboratory
    End point type
    Secondary
    End point timeframe
    At 56 months after the primary vaccination
    End point values
    		 Nimenrix Month 56 Group Menjugate Month 56 Group
    Number of subjects analysed
    185
    63
    Units: Titers
    geometric mean (confidence interval 95%)
        rSBA-MenA [N=184;54]
    6748.6 (5931.4 to 7678.5)
    27.9 (14.5 to 53.6)
        rSBA-MenC [N=182;63]
    2612.4 (2133.4 to 3199)
    5327.5 (3508.6 to 8089.4)
        rSBA-MenW-135 [N=185;61]
    9350.9 (8134 to 10749.9)
    78.1 (48.2 to 126.7)
        rSBA-MenY [N=184;61]
    8418.8 (7265.3 to 9755.5)
    94.7 (59.3 to 151.4)
    No statistical analyses for this end point

    Secondary: Antibody titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY meningococcal antigens

    		 Close Top of page
    End point title
    		 Antibody titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY meningococcal antigens
    End point description
    These analyses were performed by the GSK laboratory
    End point type
    Secondary
    End point timeframe
    At 68 months after the primary vaccination
    End point values
    		 Nimenrix Month 68 Group Menjugate Month 68 Group
    Number of subjects analysed
    177
    59
    Units: Titers
    geometric mean (confidence interval 95%)
        rSBA-MenA [N=176;51]
    6875.3 (6005.7 to 7870.9)
    31.9 (16.1 to 63.1)
        rSBA-MenC [N=174;59]
    2911.5 (2354.6 to 3600.2)
    5393 (3436.2 to 8464.2)
        rSBA-MenW-135 [N=177;58]
    9587.1 (8337.7 to 11023.7)
    77.4 (47.4 to 126.3)
        rSBA-MenY [N=176;57]
    8723 (7530.3 to 10104.7)
    95.8 (58.9 to 155.6)
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Number of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY antibody titres ≥1:4
    End point description
    This analysis was performed on 50% of the subjects in each group
    End point type
    Secondary
    End point timeframe
    At Month 56 after primary vaccination
    End point values
    		 Nimenrix Month 56 Group Menjugate Month 56 Group
    Number of subjects analysed
    89
    31
    Units: Subjects
        hSBA-MenA [N=89;33]
    53
    19
        hSBA-MenC [N=86;31]
    66
    21
        hSBA-MenW-135 [N=83;30]
    69
    13
        hSBA-MenY [N=89;31]
    79
    22
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Number of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY antibody titres ≥1:4
    End point description
    This analysis was performed on 50% of the subjects in each group
    End point type
    Secondary
    End point timeframe
    At Month 68 after primary vaccination
    End point values
    		 Nimenrix Month 68 Group Menjugate Month 68 Group
    Number of subjects analysed
    172
    59
    Units: Subjects
        hSBA-MenA [N=170;59]
    70
    23
        hSBA-MenC [N=172;57]
    134
    43
        hSBA-MenW-135 [N=159;52]
    125
    19
        hSBA-MenY [N=159;58]
    116
    24
    No statistical analyses for this end point

    Secondary: Antibody titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY meningococcal antigens

    		 Close Top of page
    End point title
    		 Antibody titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY meningococcal antigens
    End point description
    This analysis was performed on 50% of the subjects in each group
    End point type
    Secondary
    End point timeframe
    At Month 56 after primary vaccination
    End point values
    		 Nimenrix Month 56 Group Menjugate Month 56 Group
    Number of subjects analysed
    89
    31
    Units: Titers
    geometric mean (confidence interval 95%)
        hSBA-MenA [N=89;33]
    10.6 (7.6 to 14.9)
    7.6 (5 to 11.8)
        hSBA-MenC [N=86;31]
    20.6 (13.8 to 30.8)
    31.2 (11.5 to 85)
        hSBA-MenW-135 [N=83;30]
    59.3 (40.2 to 87.6)
    9.2 (4.7 to 18.2)
        hSBA-MenY [N=89;31]
    117.9 (80.8 to 171.9)
    35.7 (16.8 to 75.9)
    No statistical analyses for this end point

    Secondary: Antibody titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY meningococcal antigens

    		 Close Top of page
    End point title
    		 Antibody titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY meningococcal antigens
    End point description
    This analysis was performed on 50% of the subjects in each group
    End point type
    Secondary
    End point timeframe
    At Month 68 after primary vaccination
    End point values
    		 Nimenrix Month 68 Group Menjugate Month 68 Group
    Number of subjects analysed
    172
    59
    Units: Titers
    geometric mean (confidence interval 95%)
        hSBA-MenA [N=170;59]
    6.9 (5.4 to 8.9)
    4.5 (3.3 to 6)
        hSBA-MenC [N=172;57]
    28.4 (21.2 to 37.9)
    34.3 (19 to 61.9)
        hSBA-MenW-135 [N=159;52]
    56.7 (41.5 to 77.3)
    8.1 (4.7 to 13.8)
        hSBA-MenY [N=159;58]
    56.3 (39.5 to 80.3)
    13.3 (7 to 25.1)
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titres ≥1:8
    End point description
    End point type
    Secondary
    End point timeframe
    At Month 69 after primary vaccination (one month post-booster vaccination)
    End point values
    		 Nimenrix Month 69 Group Menjugate Month 69 Group
    Number of subjects analysed
    165
    55
    Units: Subjects
        rSBA-MenA
    165
    55
        rSBA-MenC
    165
    55
        rSBA-MenW-135
    165
    55
        rSBA-MenY
    165
    55
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titres ≥1:128
    End point description
    End point type
    Secondary
    End point timeframe
    At Month 69 after primary vaccination (one month post-booster vaccination)
    End point values
    		 Nimenrix Month 69 Group Menjugate Month 69 Group
    Number of subjects analysed
    165
    55
    Units: Subjects
        rSBA-MenA
    165
    55
        rSBA-MenC
    165
    55
        rSBA-MenW-135
    165
    55
        rSBA-MenY
    165
    55
    No statistical analyses for this end point

    Secondary: Antibody titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY meningococcal antigens

    		 Close Top of page
    End point title
    		 Antibody titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY meningococcal antigens
    End point description
    End point type
    Secondary
    End point timeframe
    At Month 69 after primary vaccination (one month post-booster vaccination)
    End point values
    		 Nimenrix Month 69 Group Menjugate Month 69 Group
    Number of subjects analysed
    165
    55
    Units: Titers
    geometric mean (confidence interval 95%)
        rSBA-MenA
    5613 (4946.3 to 6369.4)
    3521.1 (2912.5 to 4256.9)
        rSBA-MenC
    5314.6 (4596.2 to 6145.4)
    7042.2 (5317.4 to 9326.5)
        rSBA-MenW-135
    14750.6 (12779.6 to 17025.6)
    10540.4 (8455.2 to 13139.8)
        rSBA-MenY
    7954.6 (7167.8 to 8827.8)
    5829.2 (4725.6 to 7190.6)
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Number of subjects with a vaccine response to rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibodies
    End point description
    Vaccine response to rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY is defined as rSBA antibody titers ≥1:32, for initially seronegative subjects (i.e. pre-vaccination rSBA antibody titres <1:8) and at least a 4-fold increase in rSBA antibody titres from pre to post-vaccination for initially seropositive subjects (i.e. pre-vaccination rSBA antibody titres ≥1:8).
    End point type
    Secondary
    End point timeframe
    At Month 69 after primary vaccination (one month post-booster vaccination)
    End point values
    		 Nimenrix Month 69 Group Menjugate Month 69 Group
    Number of subjects analysed
    165
    55
    Units: Subjects
        rSBA-MenA-Post-booster status Total
    147
    54
        rSBA-MenC-Post-booster status Total
    161
    48
        rSBA-MenW-Post-booster status Total
    157
    54
        rSBA-MenY-Post-booster status Total
    156
    54
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Number of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY antibody titres ≥1:4
    End point description
    Vaccine response to hSBA-MenA, hSBA-MenC, rSBA-MenW-135 and hSBA-MenY is defined as hSBA antibody titers ≥1:8, for initially seronegative subjects (i.e. pre-vaccination hSBA antibody titres <1:4) and at least a 4-fold increase in hSBA antibody titres from pre to post-vaccination for initially seropositive subjects (i.e. pre-vaccination hSBA antibody titres ≥1:4).
    End point type
    Secondary
    End point timeframe
    At Month 69 after primary vaccination
    End point values
    		 Nimenrix Month 69 Group Menjugate Month 69 Group
    Number of subjects analysed
    163
    54
    Units: Subjects
        hSBA-MenA [N=163;53]
    163
    46
        hSBA-MenC [N=161;54]
    161
    54
        hSBA-MenW-135 [N=156;52]
    156
    50
        hSBA-MenY [N=160;54]
    160
    52
    No statistical analyses for this end point

    Secondary: Number of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY antibody titres ≥1:8

    		 Close Top of page
    End point title
    		 Number of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY antibody titres ≥1:8
    End point description
    Vaccine response to hSBA-MenA, hSBA-MenC, rSBA-MenW-135 and hSBA-MenY is defined as hSBA antibody titers ≥1:8, for initially seronegative subjects (i.e. pre-vaccination hSBA antibody titres <1:4) and at least a 4-fold increase in hSBA antibody titres from pre to post-vaccination for initially seropositive subjects (i.e. pre-vaccination hSBA antibody titres ≥1:4).
    End point type
    Secondary
    End point timeframe
    At Month 69 after primary vaccination (one month post-booster vaccination)
    End point values
    		 Nimenrix Month 69 Group Menjugate Month 69 Group
    Number of subjects analysed
    163
    54
    Units: Subjects
        hSBA-MenA [N=163;53]
    163
    46
        hSBA-MenC [N=161;54]
    161
    54
        hSBA-MenW-135 [N=156;52]
    156
    50
        hSBA-MenY [N=160;54]
    160
    52
    No statistical analyses for this end point

    Secondary: Antibody titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY meningococcal antigens

    		 Close Top of page
    End point title
    		 Antibody titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY meningococcal antigens
    End point description
    Vaccine response to hSBA-MenA, hSBA-MenC, rSBA-MenW-135 and hSBA-MenY is defined as hSBA antibody titers ≥1:8, for initially seronegative subjects (i.e. pre-vaccination hSBA antibody titres <1:4) and at least a 4-fold increase in hSBA antibody titres from pre to post-vaccination for initially seropositive subjects (i.e. pre-vaccination hSBA antibody titres ≥1:4).
    End point type
    Secondary
    End point timeframe
    At Month 69 after primary vaccination (one month post-booster vaccination)
    End point values
    		 Nimenrix Month 69 Group Menjugate Month 69 Group
    Number of subjects analysed
    163
    54
    Units: Titers
    geometric mean (confidence interval 95%)
        hSBA-MenA [N=163;53]
    1376.5 (1138.2 to 1664.6)
    101.2 (59.3 to 172.8)
        hSBA-MenC [N=161;54]
    11986.8 (10085.2 to 14247)
    13692.2 (10094.2 to 18572.8)
        hSBA-MenW-135 [N=156;52]
    14582.1 (12448.5 to 17081.5)
    235.7 (152 to 365.5)
        hSBA-MenY [N=160;54]
    12835.9 (11074.4 to 14877.5)
    527.3 (356.5 to 779.9)
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Number of subjects with a vaccine response to hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY antibodies
    End point description
    Vaccine response to hSBA-MenA, hSBA-MenC, rSBA-MenW-135 and hSBA-MenY is defined as hSBA antibody titers ≥1:8, for initially seronegative subjects (i.e. pre-vaccination hSBA antibody titres <1:4) and at least a 4-fold increase in hSBA antibody titres from pre to post-vaccination for initially seropositive subjects (i.e. pre-vaccination hSBA antibody titres ≥1:4).
    End point type
    Secondary
    End point timeframe
    At Month 69 after primary vaccination (one month post-booster vaccination)
    End point values
    		 Nimenrix Month 69 Group Menjugate Month 69 Group
    Number of subjects analysed
    159
    52
    Units: Subjects
        hSBA-MenA-Post-booster status Total [159;52]
    156
    43
        hSBA-MenC-Post-booster status Total [156;50]
    153
    46
        hSBA-MenW-Post-booster status Total [139;45]
    136
    34
        hSBA-MenY-Post-booster status Total [144;51]
    142
    35
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited local symptoms

    		 Close Top of page
    End point title
    		 Number of subjects with solicited local symptoms
    End point description
    Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 50 millimeters (mm). “Any” is defined as incidence of the specified symptom regardless of intensity.
    End point type
    Secondary
    End point timeframe
    During the 4-day period (Days 0-3) following the booster vaccination.
    End point values
    		 Nimenrix Month 69 Group Menjugate Month 69 Group
    Number of subjects analysed
    171
    60
    Units: Subjects
        Any Pain
    113
    35
        Grade 3 Pain
    7
    4
        Any Redness
    62
    25
        Grade 3 Redness
    8
    4
        Any Swelling
    52
    19
        Grade 3 Swelling
    4
    3
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited general symptoms

    		 Close Top of page
    End point title
    		 Number of subjects with solicited general symptoms
    End point description
    Assessed solicited general symptoms were Fatigue, Gastrointestinal symptoms (Gastro. symptoms), Headache and Temperature (axillary temperature higher than [≥] 37.5 degrees Celsius [°C]). Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Fatigue = Fatigue that prevented normal activity. Grade 3 Gastro. symptoms = Gastro. symptoms that prevented normal everyday activities. Grade 3 Headache = Headache that prevented normal acitivity. Grade 3 Fever = Rectal temperature higher than (>) 39.5°C.
    End point type
    Secondary
    End point timeframe
    During the 4-day period (Days 0-3) following the booster vaccination.
    End point values
    		 Nimenrix Month 69 Group Menjugate Month 69 Group
    Number of subjects analysed
    169
    58
    Units: Subjects
        Any Fatigue
    38
    12
        Grade 3 Fatigue
    3
    0
        Related Fatigue
    28
    10
        Any Gastro. Symptoms
    19
    7
        Grade 3 Gastro. Symptoms
    2
    1
        Related Gastro. Symptoms
    10
    3
        Any Headache
    43
    10
        Grade 3 Headache
    7
    0
        Related Headache
    27
    8
        Any Temperature/Axillary
    11
    5
        Grade 3 Temperature/Axillary
    0
    0
        Related Temperature/Axillary
    9
    3
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Number of subjects with any unsolicited adverse events (AEs)
    End point description
    An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
    End point type
    Secondary
    End point timeframe
    During the 31-day period (Days 0-30) following the booster vaccination.
    End point values
    		 Nimenrix Month 69 Group Menjugate Month 69 Group
    Number of subjects analysed
    179
    62
    Units: Subjects
        Any AEs
    26
    8
    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
    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity.
    End point type
    Secondary
    End point timeframe
    During the 31-day period (Days 0-30) post booster vaccination
    End point values
    		 Nimenrix Month 69 Group Menjugate Month 69 Group
    Number of subjects analysed
    179
    62
    Units: Subjects
        Any SAEs
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with any new onset of chronic illnesses (NOCIs)

    		 Close Top of page
    End point title
    		 Number of subjects with any new onset of chronic illnesses (NOCIs)
    End point description
    New onset of chronic illnesses (NOCIs) included: autoimmune disorders, asthma, type I diabetes and allergies.
    End point type
    Secondary
    End point timeframe
    During the 31-day period (Days 0-30) following the booster vaccination.
    End point values
    		 Nimenrix Month 69 Group Menjugate Month 69 Group
    Number of subjects analysed
    179
    62
    Units: Subjects
        Any NOCIs
    0
    0
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Solicited symptoms during the 4-day post-vaccination period, Unsolicited AEs during the 31-day post-vaccination period, SAEs during the entire study period.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Nimenrix Month 32 Group
    Reporting group description
    		 -

    Reporting group title
    Nimenrix Month 44 Group
    Reporting group description
    		 -

    Reporting group title
    Menjugate Month 32 Group
    Reporting group description
    		 -

    Reporting group title
    Menjugate Month 44 Group
    Reporting group description
    		 -

    Reporting group title
    Nimenrix Month 56 Group
    Reporting group description
    		 -

    Reporting group title
    Menjugate Month 56 Group
    Reporting group description
    		 -

    Reporting group title
    Nimenrix Month 68 Group
    Reporting group description
    		 -

    Reporting group title
    Menjugate Month 68 Group
    Reporting group description
    		 -

    Reporting group title
    Nimenrix Month 69 Group
    Reporting group description
    		 -

    Reporting group title
    Menjugate Month 68 Group
    Reporting group description
    		 -

    Serious adverse events
    		 Nimenrix Month 32 Group Nimenrix Month 44 Group Menjugate Month 32 Group Menjugate Month 44 Group Nimenrix Month 56 Group Menjugate Month 56 Group Nimenrix Month 68 Group Menjugate Month 68 Group Nimenrix Month 69 Group Menjugate Month 68 Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 193 (0.00%)
    0 / 72 (0.00%)
    0 / 68 (0.00%)
    0 / 193 (0.00%)
    0 / 67 (0.00%)
    0 / 193 (0.00%)
    0 / 67 (0.00%)
    0 / 179 (0.00%)
    0 / 62 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Nimenrix Month 32 Group Nimenrix Month 44 Group Menjugate Month 32 Group Menjugate Month 44 Group Nimenrix Month 56 Group Menjugate Month 56 Group Nimenrix Month 68 Group Menjugate Month 68 Group Nimenrix Month 69 Group Menjugate Month 68 Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 193 (0.00%)
    0 / 72 (0.00%)
    0 / 68 (0.00%)
    0 / 193 (0.00%)
    0 / 67 (0.00%)
    0 / 193 (0.00%)
    0 / 67 (0.00%)
    113 / 179 (63.13%)
    35 / 62 (56.45%)
    General disorders and administration site conditions
    Pain
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    0 / 192 (0.00%)
    0 / 193 (0.00%)
    0 / 72 (0.00%)
    0 / 68 (0.00%)
    0 / 193 (0.00%)
    0 / 67 (0.00%)
    0 / 193 (0.00%)
    0 / 67 (0.00%)
    113 / 171 (66.08%)
    35 / 60 (58.33%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    113
    35
    Redness
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    0 / 192 (0.00%)
    0 / 193 (0.00%)
    0 / 72 (0.00%)
    0 / 68 (0.00%)
    0 / 193 (0.00%)
    0 / 67 (0.00%)
    0 / 193 (0.00%)
    0 / 67 (0.00%)
    62 / 171 (36.26%)
    25 / 60 (41.67%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    62
    25
    Swelling
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    0 / 192 (0.00%)
    0 / 193 (0.00%)
    0 / 72 (0.00%)
    0 / 68 (0.00%)
    0 / 193 (0.00%)
    0 / 67 (0.00%)
    0 / 193 (0.00%)
    0 / 67 (0.00%)
    52 / 171 (30.41%)
    19 / 60 (31.67%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    52
    19
    Fatigue
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    0 / 192 (0.00%)
    0 / 193 (0.00%)
    0 / 72 (0.00%)
    0 / 68 (0.00%)
    0 / 193 (0.00%)
    0 / 67 (0.00%)
    0 / 193 (0.00%)
    0 / 67 (0.00%)
    38 / 169 (22.49%)
    12 / 58 (20.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    38
    12
    Gastrointestinal symptoms
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    0 / 192 (0.00%)
    0 / 193 (0.00%)
    0 / 72 (0.00%)
    0 / 68 (0.00%)
    0 / 193 (0.00%)
    0 / 67 (0.00%)
    0 / 193 (0.00%)
    0 / 67 (0.00%)
    19 / 169 (11.24%)
    7 / 58 (12.07%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    19
    7
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    0 / 192 (0.00%)
    0 / 193 (0.00%)
    0 / 72 (0.00%)
    0 / 68 (0.00%)
    0 / 193 (0.00%)
    0 / 67 (0.00%)
    0 / 193 (0.00%)
    0 / 67 (0.00%)
    43 / 169 (25.44%)
    10 / 58 (17.24%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    43
    10
    Temperature/(Axillary)
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    0 / 192 (0.00%)
    0 / 193 (0.00%)
    0 / 72 (0.00%)
    0 / 68 (0.00%)
    0 / 193 (0.00%)
    0 / 67 (0.00%)
    0 / 193 (0.00%)
    0 / 67 (0.00%)
    11 / 169 (6.51%)
    5 / 58 (8.62%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    11
    5
    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

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Aug 2010
    This amendment has been done to answer the requests of the French and German ethics committees to not use Menjugate as a booster vaccination since Menjugate has no booster indication in France and also to not use Menveo as a booster vaccination since Menveo is currently not licensed for the age group in this study and has no booster indication.
    15 Dec 2011
    The primary objective of the study was to evaluate the persistence of meningococcal antibodies in terms of the percentage of subjects with rabbit serum bactericidal assay (rSBA)-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY titres ≥1:8 at 32, 44, 56 and 68 months after primary vaccination with MenACWY-TT or Menjugate. In addition, to support the data obtained by rSBA testing, antibody titres and concentrations against meningococcal polysaccharides were planned to be assessed by human (h)SBA testing and ELISA (anti-polysaccharides [PS] testing) at 32, 44, 56 and 68 months after primary vaccination with MenACWY-TT or Menjugate and at Month 69, one month after the MenACWY-TT booster vaccination. The sponsor decided not to perform the ELISA testing at all time points for the following reasons: • the World Health Organisation (WHO) considers SBA the primary means of assessing immune response to meningococcal conjugate vaccines [WHO, 2006; WHO, 1999]. • circulating bactericidal antibodies are more critical for persistent protection against meningococcal disease than non-functional antibodies against meningococcal polysaccharides [CDC, 2011; WHO, 2006]. Although antibody concentrations will not be determined by ELISA at 32, 44, 56 and 68 months after primary vaccination with MenACWY-TT or Menjugate and at Month 69, one month after the MenACWY-TT booster vaccination, all subjects will be informed of their rSBA and hSBA antibody titres at each immunogenicity time point when statistical analyses at that time point have been completed. In addition: • The protocol amendment clarifies in which laboratory the different assays will be performed. • The introduction has been updated with the current licensing status of competitor meningococcal vaccines. • The list of abbreviations and reference list have been updated according to changes made throughout the protocol. The authors list has been updated according to changes in the clinical study team.

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    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-Sat May 04 07:21:56 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA