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    Clinical Trial Results:
    A phase IIb, open, randomised, controlled primary vaccination study to evaluate the non-inferiority and the persistence of the immune response of GSK Biologicals’ meningococcal serogroup ACWY conjugate vaccine given intramuscularly versus Mencevax ACWY given subcutaneously to healthy subjects aged 11 to 55 years of age

    Summary
    EudraCT number
    		 2012-002722-75
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    16 Feb 2013

    Results information
    Results version number
    		 v3(current)
    This version publication date
    24 Jun 2022
    First version publication date
    18 Jul 2015
    Other versions
    		 v1 (removed from public view) , v2
    Version creation reason
    • Correction of full data set
    Correction of full data set and alignment between registries.

    Trial information

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    Trial identification
    Sponsor protocol code
    107386
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00356369
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 107392: eTrack number, 107398: eTrack number, 107402: eTrack number, 107404: eTrack number, 107406: eTrack number
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l'Institut 89, Rixensart, Belgium, B-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)
    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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    12 Jun 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Feb 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    One month after vaccination: • To evaluate the non-inferiority of the vaccine response induced by the MenACWY TT conjugate vaccine when compared to the licensed Mencevax ACWY. • To evaluate the non-inferiority of the MenACWY-TT conjugate vaccine when compared to the licensed Mencevax ACWY in terms of the incidence of any grade 3 systemic symptom within 4 days after vaccination.
    Protection of trial subjects
    Vaccines were administered by qualified and trained personnel. Vaccines were administered only to eligible subjects that had no contraindications to any components of the vaccines.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Dec 2006
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 5 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Philippines: 400
    Country: Number of subjects enrolled
    Saudi Arabia: 100
    Worldwide total number of subjects
    500
    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)
    43
    Adolescents (12-17 years)
    258
    Adults (18-64 years)
    199
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

    Period 1
    Period 1 title
    Active Phase
    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 who received one dose of Nimenrix vaccine, administrated intramuscularly (IM) by injection in the non-dominant deltoid region.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nimenrix
    Investigational medicinal product code
    Other name
    GlaxoSmithKline (GSK) Biologicals’ meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate vaccine, MenACWY-TT
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose administered intramuscularly in the non-dominant deltoid region.

    Arm title
    		 Mencevax Group
    Arm description
    		 Subjects who received one dose of Mencevax ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Mencevax
    Investigational medicinal product code
    Other name
    GSK Biologicals’ meningococcal serogroups A, C, W-135, Y plain polysaccharide vaccine, MenACWY
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    One dose administered subcutaneously into the non-dominant upper arm.

    Number of subjects in period 1
    		Nimenrix Group Mencevax Group
    Started
    374
    126
    Completed
    372
    125
    Not completed
    2
    1
         Consent withdrawn by subject
    2
    1
    Period 2
    Period 2 title
    Year 1
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Nimenrix Group
    Arm description
    		 Subjects who received one dose of Nimenrix vaccine, administrated intramuscularly (IM) by injection in the non-dominant deltoid region.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nimenrix
    Investigational medicinal product code
    Other name
    GlaxoSmithKline (GSK) Biologicals’ meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose administered intramuscularly in the non-dominant deltoid region.

    Arm title
    		 Mencevax Group
    Arm description
    		 Subjects who received one dose of Mencevax ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Mencevax
    Investigational medicinal product code
    Other name
    GSK Biologicals’ meningococcal serogroups A, C, W-135, Y plain polysaccharide vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    One dose administered subcutaneously into the non-dominant upper arm.

    Number of subjects in period 2 [1]
    		Nimenrix Group Mencevax Group
    Started
    364
    121
    Completed
    364
    121
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Not all study participants returned in time for every study visit, but they were allowed to continue the study nonetheless. The number of participants who started each study period depends on the actual rate of return of the subjects.
    Period 3
    Period 3 title
    Year 2
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Nimenrix Group
    Arm description
    		 Subjects who received one dose of Nimenrix vaccine, administrated intramuscularly (IM) by injection in the non-dominant deltoid region.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nimenrix
    Investigational medicinal product code
    Other name
    GlaxoSmithKline (GSK) Biologicals’ meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose administered intramuscularly in the non-dominant deltoid region.

    Arm title
    		 Mencevax Group
    Arm description
    		 Subjects who received one dose of Mencevax ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Mencevax
    Investigational medicinal product code
    Other name
    GSK Biologicals’ meningococcal serogroups A, C, W-135, Y plain polysaccharide vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    One dose administered subcutaneously into the non-dominant upper arm.

    Number of subjects in period 3 [2]
    		Nimenrix Group Mencevax Group
    Started
    354
    117
    Completed
    354
    117
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Not all study participants returned in time for every study visit, but they were allowed to continue the study nonetheless. The number of participants who started each study period depends on the actual rate of return of the subjects.
    Period 4
    Period 4 title
    Year 3
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Nimenrix Group
    Arm description
    		 Subjects who received one dose of Nimenrix vaccine, administrated intramuscularly (IM) by injection in the non-dominant deltoid region.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nimenrix
    Investigational medicinal product code
    Other name
    GlaxoSmithKline (GSK) Biologicals’ meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose administered intramuscularly in the non-dominant deltoid region.

    Arm title
    		 Mencevax Group
    Arm description
    		 Subjects who received one dose of Mencevax ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Mencevax
    Investigational medicinal product code
    Other name
    GSK Biologicals’ meningococcal serogroups A, C, W-135, Y plain polysaccharide vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    One dose administered subcutaneously into the non-dominant upper arm.

    Number of subjects in period 4 [3]
    		Nimenrix Group Mencevax Group
    Started
    344
    116
    Completed
    344
    116
    Notes
    [3] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Not all study participants returned in time for every study visit, but they were allowed to continue the study nonetheless. The number of participants who started each study period depends on the actual rate of return of the subjects.
    Period 5
    Period 5 title
    Year 4
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Nimenrix Group
    Arm description
    		 Subjects who received one dose of Nimenrix vaccine, administrated intramuscularly (IM) by injection in the non-dominant deltoid region.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nimenrix
    Investigational medicinal product code
    Other name
    GlaxoSmithKline (GSK) Biologicals’ meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose administered intramuscularly in the non-dominant deltoid region.

    Arm title
    		 Mencevax Group
    Arm description
    		 Subjects who received one dose of Mencevax ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Mencevax
    Investigational medicinal product code
    Other name
    GSK Biologicals’ meningococcal serogroups A, C, W-135, Y plain polysaccharide vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    One dose administered subcutaneously into the non-dominant upper arm.

    Number of subjects in period 5 [4]
    		Nimenrix Group Mencevax Group
    Started
    317
    109
    Completed
    317
    109
    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 study participants returned in time for every study visit, but they were allowed to continue the study nonetheless. The number of participants who started each study period depends on the actual rate of return of the subjects.
    Period 6
    Period 6 title
    Year 5
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Nimenrix Group
    Arm description
    		 Subjects who received one dose of Nimenrix vaccine, administrated intramuscularly (IM) by injection in the non-dominant deltoid region.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nimenrix
    Investigational medicinal product code
    Other name
    GlaxoSmithKline (GSK) Biologicals’ meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose administered intramuscularly in the non-dominant deltoid region.

    Arm title
    		 Mencevax Group
    Arm description
    		 Subjects who received one dose of Mencevax ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Mencevax
    Investigational medicinal product code
    Other name
    GSK Biologicals’ meningococcal serogroups A, C, W-135, Y plain polysaccharide vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    One dose administered subcutaneously into the non-dominant upper arm.

    Number of subjects in period 6 [5]
    		Nimenrix Group Mencevax Group
    Started
    299
    105
    Completed
    299
    105
    Notes
    [5] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Not all study participants returned in time for every study visit, but they were allowed to continue the study nonetheless. The number of participants who started each study period depends on the actual rate of return of the subjects.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Nimenrix Group
    Reporting group description
    		 Subjects who received one dose of Nimenrix vaccine, administrated intramuscularly (IM) by injection in the non-dominant deltoid region.

    Reporting group title
    Mencevax Group
    Reporting group description
    		 Subjects who received one dose of Mencevax ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.

    Reporting group values
    		 Nimenrix Group Mencevax Group Total
    Number of subjects
    		 374 126 500
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 374 126 500
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 18.6 ± 7.62 19.3 ± 8.58 -
    Gender categorical
    Units: Subjects
        Female
    		 168 60 228
        Male
    		 206 66 272

    End points

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    End points reporting groups
    Reporting group title
    Nimenrix Group
    Reporting group description
    		 Subjects who received one dose of Nimenrix vaccine, administrated intramuscularly (IM) by injection in the non-dominant deltoid region.

    Reporting group title
    Mencevax Group
    Reporting group description
    		 Subjects who received one dose of Mencevax ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.
    Reporting group title
    Nimenrix Group
    Reporting group description
    		 Subjects who received one dose of Nimenrix vaccine, administrated intramuscularly (IM) by injection in the non-dominant deltoid region.

    Reporting group title
    Mencevax Group
    Reporting group description
    		 Subjects who received one dose of Mencevax ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.
    Reporting group title
    Nimenrix Group
    Reporting group description
    		 Subjects who received one dose of Nimenrix vaccine, administrated intramuscularly (IM) by injection in the non-dominant deltoid region.

    Reporting group title
    Mencevax Group
    Reporting group description
    		 Subjects who received one dose of Mencevax ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.
    Reporting group title
    Nimenrix Group
    Reporting group description
    		 Subjects who received one dose of Nimenrix vaccine, administrated intramuscularly (IM) by injection in the non-dominant deltoid region.

    Reporting group title
    Mencevax Group
    Reporting group description
    		 Subjects who received one dose of Mencevax ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.
    Reporting group title
    Nimenrix Group
    Reporting group description
    		 Subjects who received one dose of Nimenrix vaccine, administrated intramuscularly (IM) by injection in the non-dominant deltoid region.

    Reporting group title
    Mencevax Group
    Reporting group description
    		 Subjects who received one dose of Mencevax ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.
    Reporting group title
    Nimenrix Group
    Reporting group description
    		 Subjects who received one dose of Nimenrix vaccine, administrated intramuscularly (IM) by injection in the non-dominant deltoid region.

    Reporting group title
    Mencevax Group
    Reporting group description
    		 Subjects who received one dose of Mencevax ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.

    Primary: Vaccine response to meningococcal antigens for serum bactericidal assay using rabbit complement (rSBA)

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    End point title
    		 Vaccine response to meningococcal antigens for serum bactericidal assay using rabbit complement (rSBA)
    End point description
    Response to vaccine antigen was defined as: for initially seronegative subjects [subjects with serum bactericidal assay using rabbit complement (rSBA) titer lower than (<) 1:8], post-vaccination rSBA titer greater than or equal to (≥) 1:32 and for initially seropositive (subjects with rSBA titer ≥ 1:8), at least 4-fold increase in rSBA titer from pre to post vaccination.
    End point type
    Primary
    End point timeframe
    One Month post vaccination
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    329
    113
    Units: percentage of subjects
    number (confidence interval 95%)
        rSBA-MenA [N=289;99]
    82.7 (77.8 to 86.9)
    69.7 (59.6 to 78.5)
        rSBA-MenC [N=324;113]
    94.4 (91.4 to 96.7)
    90.3 (83.2 to 95)
        rSBA-MenW-135 [N=326;109]
    96.3 (93.7 to 98.1)
    91.7 (84.9 to 96.2)
        rSBA-MenY [N=329;113]
    93 (89.7 to 95.5)
    85 (77 to 91)
    Statistical analysis title
    		 Difference in % for rSBA-MenA antibodies
    Statistical analysis description
    To evaluate the non-inferiority of the vaccine response induced by the MenACWY-TT vaccine when compared to the licensed MenACWY vaccine.
    Comparison groups
    Nimenrix Group v Mencevax Group
    Number of subjects included in analysis
    442
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Difference in % for rSBA-MenA antibodies
    Point estimate
    13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.52
         upper limit
    		 23.5
    Notes
    [1] - Criterion indicative of non-inferiority: Lower limit of the standardized asymptotic 95% confidence interval (CI) for the difference between MenACWY-TT and (minus) MenACWY in the percentage of subjects with bactericidal vaccine response was greater than (>) -15%.
    Statistical analysis title
    		 Difference in % for rSBA-MenC antibodies
    Statistical analysis description
    To evaluate the non-inferiority of the vaccine response induced by the MenACWY-TT vaccine when compared to the licensed MenACWY vaccine.
    Comparison groups
    Nimenrix Group v Mencevax Group
    Number of subjects included in analysis
    442
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    Parameter type
    		 Difference in % for rSBA-MenC antibodies
    Point estimate
    4.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.03
         upper limit
    		 11.36
    Notes
    [2] - Criterion indicative of non-inferiority: Lower limit of the standardized asymptotic 95% confidence interval (CI) for the difference between MenACWY-TT and (minus) MenACWY in the percentage of subjects with bactericidal vaccine response was ≥ -12%.
    Statistical analysis title
    		 Difference in % for rSBA-MenW antibodies
    Statistical analysis description
    To evaluate the non-inferiority of the vaccine response induced by the MenACWY-TT vaccine when compared to the licensed MenACWY vaccine.
    Comparison groups
    Nimenrix Group v Mencevax Group
    Number of subjects included in analysis
    442
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    Method
    Parameter type
    		 Difference in % for rSBA-MenW-135 antibo
    Point estimate
    4.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.07
         upper limit
    		 11.49
    Notes
    [3] - Criterion indicative of non-inferiority: Lower limit of the standardized asymptotic 95% confidence interval (CI) for the difference between MenACWY-TT and (minus) MenACWY in the percentage of subjects with bactericidal vaccine response was ≥ -12%.
    Statistical analysis title
    		 Difference in % for rSBA-MenY antibodies
    Statistical analysis description
    To evaluate the non-inferiority of the vaccine response induced by the MenACWY-TT vaccine when compared to the licensed MenACWY vaccine.
    Comparison groups
    Nimenrix Group v Mencevax Group
    Number of subjects included in analysis
    442
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [4]
    Method
    Parameter type
    		 Difference in % for rSBA-MenY antibodies
    Point estimate
    8.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.72
         upper limit
    		 16.17
    Notes
    [4] - Criterion indicative of non-inferiority: Lower limit of the standardized asymptotic 95% confidence interval (CI) for the difference between MenACWY-TT and (minus) MenACWY in the percentage of subjects with bactericidal vaccine response was ≥ -12%.

    Primary: Number of subjects with Grade 3 symptoms

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    End point title
    		 Number of subjects with Grade 3 symptoms
    End point description
    Local symptom, Grade 3 = pain that prevented normal activity and redness/ swelling spreading beyond (>) 50 millimeters (mm). General symptom, Grade 3 = any general symptom that prevented normal activity including fever (orally) >39.5 °C.
    End point type
    Primary
    End point timeframe
    During the 4-day (Days 0-3) post-vaccination period
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    374
    126
    Units: Subjects
        Any Grade 3 unsolicited
    12
    1
        Grade 3 solicited general
    5
    0
        Grade 3 solicited local
    9
    1
    Statistical analysis title
    		 Difference in % Grade 3 general symptoms
    Statistical analysis description
    To evaluate the non-inferiority of the MenACWY-TT conjugate vaccine when compared to the licensed MenACWY vaccine in terms of the incidence of any Grade 3 systemic symptom within 4 days after vaccination.
    Comparison groups
    Nimenrix Group v Mencevax Group
    Number of subjects included in analysis
    500
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [5]
    Method
    Parameter type
    		 Difference in % Grade 3 general symptoms
    Point estimate
    1.34
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.64
         upper limit
    		 3.09
    Notes
    [5] - Criterion indicative of non-inferiority: Upper limit of the standardized asymptotic 95% CI on the difference between MenACWY- TT and (minus) MenACWY in the incidence of Grade 3 systemic symptoms was below 5%.

    Secondary: Number of subjects with serum bactericidal assay using rabbit complement against Neisseria meningitidis serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) antibody titers ≥ the cut-off value

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    End point title
    		 Number of subjects with serum bactericidal assay using rabbit complement against Neisseria meningitidis serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) antibody titers ≥ the cut-off value
    End point description
    The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and (≥) 1:128.
    End point type
    Secondary
    End point timeframe
    At pre-vaccination at Day 0 (PRE) and post-vaccination at Month 1 (PI[M1])
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    341
    114
    Units: Subjects
        rSBA-MenA (PRE) ≥ 1:8 [N=305;101]
    290
    88
        rSBA-MenA (PI [M1]) ≥ 1:8 [N=323;112]
    323
    112
        rSBA-MenA (PRE) ≥ 1:128 [N=305;101]
    273
    81
        rSBA-MenA (PI [M1]) ≥ 1:128 [N=323;112]
    322
    112
        rSBA-MenC (PRE) ≥ 1:8 [N=324;113]
    253
    96
        rSBA-MenC (PI [M1]) ≥ 1:8 [N=341;114]
    340
    114
        rSBA-MenC (PRE) ≥ 1:128 [N=324;113]
    172
    56
        rSBA-MenC (PI [M1]) ≥ 1:128 [N=341;114]
    340
    112
        rSBA-MenW-135 (PRE) ≥ 1:8 [N=327;109]
    247
    89
        rSBA-MenW-135 (PI [M1]) ≥ 1:8 [N=340;114]
    339
    114
        rSBA-MenW-135 (PRE) ≥ 1:128 [N=327;109]
    191
    67
        rSBA-MenW-135 (PI [M1]) ≥ 1:128 [N=340;114]
    338
    114
        rSBA-MenY (PRE) ≥ 1:8 [N=330;113]
    306
    105
        rSBA-MenY (PI [M1]) ≥ 1:8 [N=340;114]
    340
    114
        rSBA-MenY (PRE) ≥ 1:128 [N=330;113]
    264
    88
        rSBA-MenY (PI [M1]) ≥ 1:128 [N=340;114]
    339
    114
    No statistical analyses for this end point

    Secondary: rSBA antibody titres

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    End point title
    		 rSBA antibody titres
    End point description
    Antibody titers are presented as Geometric Mean Titers (GMTs).
    End point type
    Secondary
    End point timeframe
    At pre-vaccination at Day 0 (PRE) and post-vaccination at Month 1 (PI[M1])
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    341
    114
    Units: titre
    geometric mean (confidence interval 95%)
        rSBA-MenA (PRE) [N=305;101]
    330.7 (285.8 to 382.7)
    227.8 (162.1 to 320.2)
        rSBA-MenA (PI [M1]) [N=323;112]
    4944.6 (4451.5 to 5492.5)
    2190.1 (1857.5 to 2582.2)
        rSBA-MenC (PRE) [N=324;113]
    84.1 (68.5 to 103.4)
    114.1 (80.3 to 162)
        rSBA-MenC (PI [M1]) [N=341;114]
    10073.7 (8699.9 to 11664.5)
    6545.6 (5047.5 to 8488.4)
        rSBA-MenW-135 (PRE) [N=327;109]
    93 (74.6 to 116)
    115.3 (81.6 to 162.9)
        rSBA-MenW-135 (PI [M1]) [N=340;114]
    8576.5 (7614.9 to 9659.5)
    2969.5 (2439.4 to 3614.9)
        rSBA-MenY (PRE) [N=330;113]
    310 (261.2 to 367.9)
    282.8 (209.9 to 380.8)
        rSBA-MenY (PI [M1]) [N=340;114]
    10315.2 (9317.1 to 11420.2)
    4573.7 (3863.9 to 5413.9)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-Polysaccharide (anti-PS) antibodies

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    End point title
    		 Number of subjects with anti-Polysaccharide (anti-PS) antibodies
    End point description
    The cut-off value for the anti-PS concentration was greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and ≥ 2.0 μg/mL.
    End point type
    Secondary
    End point timeframe
    At pre-vaccination at Day 0 (PRE) and post-vaccination at Month 1 (PI[M1])
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    341
    114
    Units: Subjects
        Anti-PSA (PRE) ≥ 0.3 µg/mL [N=316;107]
    255
    90
        Anti-PSA (PI [M1]) ≥ 0.3 µg/mL [N=340;113]
    339
    113
        Anti-PSA (PRE) ≥ 2.0 µg/mL [N=316;107]
    137
    53
        Anti-PSA (PI [M1]) ≥ 2.0 µg/mL [N=340;113]
    339
    113
        Anti-PSC (PRE) ≥ 0.3 µg/mL [N=334;110]
    71
    27
        Anti-PSC (PI M1]) ≥ 0.3 µg/mL [N=341;114]
    340
    114
        Anti-PSC (PRE) ≥ 2.0 µg/mL [N=334;110]
    30
    16
        Anti-PSC (PI [M1]) ≥ 2.0 µg/mL [N=341;114]
    333
    113
        Anti-PSW-135 (PRE) ≥ 0.3 µg/mL [N=332;106]
    41
    17
        Anti-PSW-135 (PI M1]) ≥ 0.3 µg/mL [N=339;114]
    335
    113
        Anti-PSW-135 (PRE) ≥ 2.0 µg/mL [N=332;106]
    11
    4
        Anti-PSW-135 (PI [M1]) ≥ 2.0 µg/mL [N=339;114]
    314
    106
        Anti-PSY (PRE) ≥ 0.3 µg/mL [N=329;110]
    55
    23
        Anti-PSY (PI M1]) ≥ 0.3 µg/mL [N=339;112]
    338
    112
        Anti-PSY (PRE) ≥ 2.0 µg/mL [N=329;110]
    25
    8
        Anti-PSY (PI [M1]) ≥ 2.0 µg/mL [N=339;112]
    328
    109
    No statistical analyses for this end point

    Secondary: Concentration of anti-PS antibodies

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    End point title
    		 Concentration of anti-PS antibodies
    End point description
    Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) and measured in micrograms/milliliter (μg/mL).
    End point type
    Secondary
    End point timeframe
    At pre-vaccination at Day 0 (PRE) and post-vaccination at Month 1 (PI[M1])
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    341
    114
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PSA (PRE) [N=316;107]
    1.4 (1.2 to 1.7)
    1.7 (1.3 to 2.3)
        Anti-PSA (PI [M1]) [N=340;113]
    107.3 (92.7 to 124.1)
    53.6 (41.9 to 68.5)
        Anti-PSC (PRE) [N=334;110]
    0.3 (0.2 to 0.3)
    0.3 (0.2 to 0.4)
        Anti-PSC (PI M1]) [N=341;114]
    23.9 (21 to 27.2)
    43.9 (35.6 to 54.1)
        Anti-PSW-135 (PRE) [N=332;106]
    0.2 (0.2 to 0.2)
    0.2 (0.2 to 0.3)
        Anti-PSW-135 (PI M1]) [N=339;114]
    18.6 (15.8 to 21.8)
    15.8 (12.1 to 20.7)
        Anti-PSY (PRE) [N=329;110]
    0.2 (0.2 to 0.3)
    0.2 (0.2 to 0.3)
        Anti-PSY (PI M1]) [N=339;112]
    23.2 (19.9 to 26.9)
    23.6 (18.4 to 30.2)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-Tetanus (anti-TT) antibodies ≥ the cut-off value

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    End point title
    		 Number of subjects with anti-Tetanus (anti-TT) antibodies ≥ the cut-off value
    End point description
    Cut-off values assessed were ≥ 0.1 international units per milliliter (IU/mL).
    End point type
    Secondary
    End point timeframe
    At pre-vaccination at Day 0 (PRE) and post-vaccination at Month 1 (PI[M1])
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    341
    113
    Units: Subjects
        Anti-TT (PRE) [N=331;110]
    223
    110
        Anti-TT (PI [M1]) [N=341;113]
    326
    113
    No statistical analyses for this end point

    Secondary: Concentration of anti-TT antibodies

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    End point title
    		 Concentration of anti-TT antibodies
    End point description
    Concentrations were presented as GMCs expressed in international units per milliliter.
    End point type
    Secondary
    End point timeframe
    At pre-vaccination at Day 0 (PRE) and post-vaccination at Month 1 (PI[M1])
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    341
    113
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-TT (PRE) [N=331;110]
    0.35 (0.29 to 0.43)
    0.28 (0.2 to 0.39)
        Anti-TT (PI [M1]) [N=341;113]
    10.01 (8.34 to 12.03)
    0.27 (0.19 to 0.38)
    No statistical analyses for this end point

    Secondary: Number of subjects with rSBA antibody titers ≥ the cut-off value

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    End point title
    		 Number of subjects with rSBA antibody titers ≥ the cut-off value
    End point description
    The cut-off value for the rSBA titres was greater than or equal to (≥) 1:8 and ≥ 1:128.
    End point type
    Secondary
    End point timeframe
    At Year 1 (PI[M12])
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    356
    117
    Units: Subjects
        rSBA-MenA (PI [M12]) ≥ 1:8 [N=354;113]
    353
    113
        rSBA-MenA (PI [M12]) ≥ 1:128 [N=354;113]
    352
    112
        rSBA-MenC (PI [M12]) ≥ 1:8 [N=353;115]
    352
    114
        rSBA-MenC (PI [M12]) ≥ 1:128 [N=353;115]
    343
    110
        rSBA-MenW-135 (PI [M12]) ≥ 1:8 [N=356;117]
    355
    117
        rSBA-MenW-135 (PI [M12]) ≥ 1:128 [N=356;117]
    354
    111
        rSBA-MenY (PI [M12]) ≥ 1:8 [N=355;116]
    355
    116
        rSBA-MenY (PI [M12]) ≥ 1:128 [N=355;116]
    354
    114
    No statistical analyses for this end point

    Secondary: rSBA antibody titres

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    End point title
    		 rSBA antibody titres
    End point description
    Antibody titers are presented as Geometric Mean Titers (GMTs).
    End point type
    Secondary
    End point timeframe
    At Year 1 (PI[M12])
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    356
    117
    Units: titre
    geometric mean (confidence interval 95%)
        rSBA-MenA (PI [M12]) [N=354;113]
    2084.9 (1888.3 to 2302)
    1099.1 (931.6 to 1296.7)
        rSBA-MenC (PI [M12]) [N=353;115]
    1848.6 (1620.3 to 2109.2)
    1876.5 (1400.7 to 2514)
        rSBA-MenW-135 (PI [M12]) [N=356;117]
    2993.5 (2618.8 to 3421.9)
    699.9 (569.3 to 860.4)
        rSBA-MenY (PI [M12]) [N=355;116]
    4207.1 (3767.3 to 4698.3)
    1386.5 (1104.2 to 1740.9)
    No statistical analyses for this end point

    Secondary: Number of subjects with rSBA antibody titers ≥ the cut-off value

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    End point title
    		 Number of subjects with rSBA antibody titers ≥ the cut-off value
    End point description
    The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128.
    End point type
    Secondary
    End point timeframe
    At Year 2 (PI[M24])
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    346
    112
    Units: Subjects
        rSBA-MenA (PI [M24]) ≥ 1:8 [N=338;102]
    337
    101
        rSBA-MenA (PI [M24]) ≥ 1:128 [N=338;102]
    335
    98
        rSBA-MenC (PI [M24]) ≥ 1:8 [N=345;112]
    343
    110
        rSBA-MenC (PI [M24]) ≥ 1:128 [N=345;112]
    332
    103
        rSBA-MenW-135 (PI [M24]) ≥ 1:8 [N=346;111]
    344
    100
        rSBA-MenW-135 (PI [M24]) ≥ 1:128 [N=346;111]
    341
    90
        rSBA-MenY (PI [M24]) ≥ 1:8 [N=345;111]
    344
    110
        rSBA-MenY (PI [M24]) ≥ 1:128 [N=345;111]
    342
    105
    No statistical analyses for this end point

    Secondary: rSBA antibody titres

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    End point title
    		 rSBA antibody titres
    End point description
    Antibody titers are presented as Geometric Mean Titers.
    End point type
    Secondary
    End point timeframe
    At Year 2 (PI[M24])
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    346
    112
    Units: titre
    geometric mean (confidence interval 95%)
        rSBA-MenA (PI [M24]) [N=338;102]
    1326.8 (1197.7 to 1469.7)
    698.9 (561.2 to 870.4)
        rSBA-MenC (PI [M24]) [N=345;112]
    1162 (1013.1 to 1332.9)
    1229.4 (876.4 to 1724.7)
        rSBA-MenW-135 (PI [M24]) [N=346;111]
    1984.6 (1757.1 to 2241.4)
    319.1 (228 to 446.5)
        rSBA-MenY (PI [M24]) [N=345;111]
    3042.1 (2692.2 to 3437.5)
    850.2 (667.5 to 1082.9)
    No statistical analyses for this end point

    Secondary: Number of subjects with rSBA antibody titers ≥ the cut-off value

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    End point title
    		 Number of subjects with rSBA antibody titers ≥ the cut-off value
    End point description
    The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128.
    End point type
    Secondary
    End point timeframe
    At Year 3 (PI[M36])
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    338
    109
    Units: Subjects
        rSBA-MenA (PI [M36]) ≥ 1:8 [N=322;104]
    322
    104
        rSBA-MenA (PI [M36]) ≥ 1:128 [N=322;104]
    319
    98
        rSBA-MenC (PI [M36]) ≥ 1:8 [N=337;109]
    334
    108
        rSBA-MenC (PI [M36]) ≥ 1:128 [N=337;109]
    313
    102
        rSBA-MenW-135 (PI [M36]) ≥ 1:8 [N=336;105]
    335
    91
        rSBA-MenW-135 (PI [M36]) ≥ 1:128 [N=336;105]
    332
    84
        rSBA-MenY (PI [M36]) ≥ 1:8 [N=338;108]
    337
    107
        rSBA-MenY (PI [M36]) ≥ 1:128 [N=338;108]
    336
    105
    No statistical analyses for this end point

    Secondary: rSBA antibody titres

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    End point title
    		 rSBA antibody titres
    End point description
    Antibody titers are presented as Geometric Mean Titers.
    End point type
    Secondary
    End point timeframe
    At Year 3 (PI[M36])
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    338
    109
    Units: titre
    geometric mean (confidence interval 95%)
        rSBA-MenA (PI [M36]) [N=322;104]
    1238.4 (1126 to 1361.9)
    596.9 (488.5 to 729.3)
        rSBA-MenC (PI [M36]) [N=337;109]
    870.3 (757.1 to 1000.4)
    1124.8 (812.3 to 1557.6)
        rSBA-MenW-135 (PI [M36]) [N=336;105]
    2109.2 (1842.5 to 2414.5)
    332.8 (224.4 to 493.8)
        rSBA-MenY (PI [M36]) [N=338;108]
    2567.3 (2288.6 to 2879.8)
    848 (682.6 to 1053.5)
    No statistical analyses for this end point

    Secondary: Number of subjects with rSBA antibody titers ≥ the cut-off value

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    End point title
    		 Number of subjects with rSBA antibody titers ≥ the cut-off value
    End point description
    The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128.
    End point type
    Secondary
    End point timeframe
    At Year 4 (PI[M48])
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    312
    107
    Units: Subjects
        rSBA-MenA (PI [M48]) ≥ 1:8 [N=312;107]
    270
    79
        rSBA-MenA (PI [M48]) ≥ 1:128 [N=312;107]
    245
    66
        rSBA-MenC (PI [M48]) ≥ 1:8 [N=312;107]
    276
    90
        rSBA-MenC (PI [M48]) ≥ 1:128 [N=312;107]
    254
    79
        rSBA-MenW-135 (PI [M48]) ≥ 1:8 [N=312;107]
    231
    27
        rSBA-MenW-135 (PI [M48]) ≥ 1:128 [N=312;107]
    214
    22
        rSBA-MenY (PI [M48]) ≥ 1:8 [N=309;107]
    256
    47
        rSBA-MenY (PI [M48]) ≥ 1:128 [N=309;107]
    243
    37
    No statistical analyses for this end point

    Secondary: rSBA antibody titres

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    End point title
    		 rSBA antibody titres
    End point description
    Antibody titers are presented as Geometric Mean Titers.
    End point type
    Secondary
    End point timeframe
    At Year 4 (PI[M48])
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    312
    107
    Units: titre
    geometric mean (confidence interval 95%)
        rSBA-MenA (PI [M48]) [N=312;107]
    278.6 (219.7 to 353.2)
    105.4 (67.6 to 164.4)
        rSBA-MenC (PI [M48]) [N=312;107]
    273.6 (220.6 to 339.4)
    315 (196.8 to 504.1)
        rSBA-MenW-135 (PI [M48]) [N=312;107]
    175.1 (131.5 to 233)
    11.3 (7.8 to 16.3)
        rSBA-MenY (PI [M48]) [N=309;107]
    350.5 (268.9 to 456.7)
    26 (16.6 to 40.7)
    No statistical analyses for this end point

    Secondary: Number of subjects with rSBA antibody titers ≥ the cut-off value

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    End point title
    		 Number of subjects with rSBA antibody titers ≥ the cut-off value
    End point description
    The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128.
    End point type
    Secondary
    End point timeframe
    At Year 5 (PI[M60])
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    51
    19
    Units: Subjects
        rSBA-MenA (PI [M60]) ≥ 1:8 [N=51;19]
    43
    11
        rSBA-MenA (PI [M60]) ≥ 1:128 [N=51;19]
    39
    9
        rSBA-MenC (PI [M60]) ≥ 1:8 [N=51;18]
    37
    7
        rSBA-MenC (PI [M60]) ≥ 1:128 [N=51;18]
    28
    5
        rSBA-MenW-135 (PI [M60]) ≥ 1:8 [N=51;19]
    44
    6
        rSBA-MenW-135 (PI [M60]) ≥ 1:128 [N=51;19]
    38
    6
        rSBA-MenY (PI [M60]) ≥ 1:8 [N=51;19]
    47
    12
        rSBA-MenY (PI [M60]) ≥ 1:128 [N=51;19]
    47
    11
    No statistical analyses for this end point

    Secondary: rSBA antibody titres

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    End point title
    		 rSBA antibody titres
    End point description
    Antibody titers are presented as Geometric Mean Titers.
    End point type
    Secondary
    End point timeframe
    At Year 5 (PI[M60])
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    51
    19
    Units: titre
    geometric mean (confidence interval 95%)
        rSBA-MenA (PI [M60]) [N=51;19]
    189.8 (107.7 to 334.6)
    37 (12.6 to 108.7)
        rSBA-MenC (PI [M60]) [N=51;18]
    78.5 (41.8 to 147.4)
    17.3 (6 to 49.7)
        rSBA-MenW-135 (PI [M60]) [N=51;19]
    281.6 (145.9 to 543.2)
    15.4 (5.7 to 41.9)
        rSBA-MenY (PI [M60]) [N=51;19]
    769.7 (438.6 to 1351)
    74.1 (21.9 to 250.3)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-PS antibodies

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    End point title
    		 Number of subjects with anti-PS antibodies
    End point description
    The cut-off value for the anti-PS concentration was greater than or equal to (≥) 0.3 μg/mL and ≥ 2.0 μg/mL.
    End point type
    Secondary
    End point timeframe
    At Year 1 (PI[M12])
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    354
    117
    Units: Subjects
        Anti-PSA (PI [M12]) ≥ 0.3 µg/mL [N=352;116]
    351
    116
        Anti-PSA (PI [M12]) ≥ 2.0 µg/mL [N=352;116]
    332
    115
        Anti-PSC (PI [M12]) ≥ 0.3 µg/mL [N=354;117]
    349
    117
        Anti-PSC (PI [M12]) ≥ 2.0 µg/mL [N=354;117]
    262
    113
        Anti-PSW-135 (PI [M12]) ≥ 0.3 µg/mL [N=348;115]
    342
    112
        Anti-PSW-135 (PI [M12]) ≥ 2.0 µg/mL [N=348;115]
    264
    102
        Anti-PSY (PI [M12]) ≥ 0.3 µg/mL [N=354;116]
    350
    116
        Anti-PSY (PI [M12]) ≥ 2.0 µg/mL [N=354;116]
    289
    110
    No statistical analyses for this end point

    Secondary: Concentration of anti-PS antibodies

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    End point title
    		 Concentration of anti-PS antibodies
    End point description
    Antibody concentrations were expressed as Geometric Mean Concentrations and measured in µg/mL.
    End point type
    Secondary
    End point timeframe
    At Year 1 (PI[M12])
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    354
    117
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PSA (PI [M12]) [N=352;116]
    23.25 (19.78 to 27.32)
    31.72 (24.77 to 40.63)
        Anti-PSC (PI [M12]) [N=354;117]
    4.67 (4.08 to 5.33)
    24.53 (19.92 to 30.2)
        Anti-PSW-135 (PI [M12]) [N=348;115]
    5.48 (4.68 to 6.4)
    10.39 (7.8 to 13.85)
        Anti-PSY (PI [M12]) [N=354;116]
    6.68 (5.69 to 7.85)
    16.7 (12.9 to 21.62)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-PS antibodies

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    End point title
    		 Number of subjects with anti-PS antibodies
    End point description
    The cut-off value for the anti-PS concentration was greater than or equal to (≥) 0.3 μg/mL and ≥ 2.0 μg/mL.
    End point type
    Secondary
    End point timeframe
    At Year 2 (PI[M24])
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    343
    112
    Units: Subjects
        Anti-PSA (PI [M24]) ≥ 0.3 µg/mL [N=336;105]
    335
    105
        Anti-PSA (PI [M24]) ≥ 2.0 µg/mL [N=336;105]
    301
    103
        Anti-PSC (PI [M24]) ≥ 0.3 µg/mL [N=340;111]
    323
    111
        Anti-PSC (PI [M24]) ≥ 2.0 µg/mL [N=340;111]
    196
    107
        Anti-PSW-135 (PI [M24]) ≥ 0.3 µg/mL [N=336;110]
    316
    108
        Anti-PSW-135 (PI [M24]) ≥ 2.0 µg/mL [N=336;110]
    226
    93
        Anti-PSY (PI [M24]) ≥ 0.3 µg/mL [N=343;112]
    325
    110
        Anti-PSY (PI [M24]) ≥ 2.0 µg/mL [N=343;112]
    237
    97
    No statistical analyses for this end point

    Secondary: Concentration of anti-PS antibodies

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    End point title
    		 Concentration of anti-PS antibodies
    End point description
    Antibody concentrations were expressed as Geometric Mean Concentrations and measured in µg/mL.
    End point type
    Secondary
    End point timeframe
    At Year 2 (PI[M24])
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    343
    112
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PSA (PI [M24]) [N=336;105]
    15.15 (12.76 to 17.98)
    24.85 (19.08 to 32.36)
        Anti-PSC (PI [M24]) [N=340;111]
    2.62 (2.27 to 3.03)
    15.74 (12.56 to 19.72)
        Anti-PSW-135 (PI [M24]) [N=336;110]
    3.51 (2.98 to 4.15)
    6.76 (5.08 to 9.01)
        Anti-PSY (PI [M24]) [N=343;112]
    4.44 (3.73 to 5.3)
    11.11 (8.39 to 14.71)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-PS antibodies

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    End point title
    		 Number of subjects with anti-PS antibodies
    End point description
    The cut-off value for the anti-PS concentration was greater than or equal to (≥) 0.3 μg/mL and ≥ 2.0 μg/mL.
    End point type
    Secondary
    End point timeframe
    At Year 3 (PI[M36])
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    331
    110
    Units: Subjects
        Anti-PSA (PI [M36]) ≥ 0.3 µg/mL [N=330;109]
    328
    109
        Anti-PSA (PI [M36]) ≥ 2.0 µg/mL [N=330;109]
    300
    108
        Anti-PSC (PI [M36]) ≥ 0.3 µg/mL [N=331;110]
    318
    110
        Anti-PSC (PI [M36]) ≥ 2.0 µg/mL [N=331;110]
    200
    106
        Anti-PSW-135 (PI [M36]) ≥ 0.3 µg/mL [N=328;108]
    303
    105
        Anti-PSW-135 (PI [M36]) ≥ 2.0 µg/mL [N=328;108]
    204
    87
        Anti-PSY (PI [M36]) ≥ 0.3 µg/mL [N=323;110]
    299
    108
        Anti-PSY (PI [M36]) ≥ 2.0 µg/mL [N=323;110]
    213
    92
    No statistical analyses for this end point

    Secondary: Concentration of anti-PS antibodies

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    End point title
    		 Concentration of anti-PS antibodies
    End point description
    Antibody concentrations were expressed as Geometric Mean Concentrations and measured in µg/mL.
    End point type
    Secondary
    End point timeframe
    At Year 3 (PI[M36])
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    331
    110
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PSA (PI [M36]) N=330;109]
    12.5 (10.7 to 14.6)
    19.8 (15.7 to 24.9)
        Anti-PSC (PI [M36]) [N=331;110]
    2.7 (2.3 to 3)
    13.9 (11.2 to 17.2)
        Anti-PSW-135 (PI [M36]) [N=328;108]
    2.9 (2.5 to 3.4)
    5.5 (4.2 to 7.2)
        Anti-PSY (PI [M36]) [N=323;110]
    3.8 (3.2 to 4.5)
    8.2 (6.2 to 10.8)
    No statistical analyses for this end point

    Secondary: Number of subjects with any and Grade 3 solicited local symptoms

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    End point title
    		 Number of subjects with any and Grade 3 solicited local symptoms
    End point description
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 Pain = pain that prevented normal activity. Grade 3 Redness/Swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-vaccination
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    370
    124
    Units: Subjects
        Any Pain
    143
    40
        Grade 3 Pain
    7
    1
        Any Redness
    57
    8
        Grade 3 Redness
    1
    0
        Any Swelling
    42
    4
        Grade 3 Swelling
    1
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with any, Grade 3 and related solicited general symptoms

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    End point title
    		 Number of subjects with any, Grade 3 and related solicited general symptoms
    End point description
    Assessed solicited general symptoms were fatigue, fever [defined as oral temperature equal to or above 37.5 degrees Celsius (°C)], gastrointestinal and headache. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-vaccination
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    371
    125
    Units: Subjects
        Any Fatigue
    55
    13
        Grade 3 Fatigue
    1
    0
        Related Fatigue
    35
    8
        ≥ 37.5 ˚C Fever
    16
    4
        >39.5 ˚C Fever
    0
    0
        Related Fever
    10
    2
        Any Gastrointestinal
    13
    5
        Grade 3 Gastrointestinal
    2
    0
        Related Gastrointestinal
    6
    0
        Any Headache
    65
    15
        Grade 3 Headache
    3
    0
        Related Headache
    41
    8
    No statistical analyses for this end point

    Secondary: Number of subjects with New Onset of Chronic Illnesses (NOCIs)

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    End point title
    		 Number of subjects with New Onset of Chronic Illnesses (NOCIs)
    End point description
    NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
    End point type
    Secondary
    End point timeframe
    From Day 0 up to 6 Months after vaccination
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    374
    126
    Units: Subjects
    1
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with rash

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    End point title
    		 Number of subjects with rash
    End point description
    End point type
    Secondary
    End point timeframe
    From Day 0 up to 6 Months after vaccination
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    374
    126
    Units: Subjects
    0
    1
    No statistical analyses for this end point

    Secondary: Number of subjects with AEs resulting in emergency rooms visits

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    End point title
    		 Number of subjects with AEs resulting in emergency rooms visits
    End point description
    End point type
    Secondary
    End point timeframe
    From Day 0 up to 6 Months after vaccination
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    374
    126
    Units: Subjects
        Any AE(s)
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with unsolicited AEs

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    End point title
    		 Number of subjects with unsolicited AEs
    End point description
    An unsolicited AE covers 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 and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
    End point type
    Secondary
    End point timeframe
    Up to 31 Days after vaccination
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    374
    126
    Units: Subjects
        Any (AE)s
    18
    8
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with serious adverse events (SAEs)
    End point description
    SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
    End point type
    Secondary
    End point timeframe
    From Day 0 up to 6 Months after vaccination
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    374
    126
    Units: Subjects
        Any (SAE)s
    1
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with SAEs

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    End point title
    		 Number of subjects with SAEs
    End point description
    SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
    End point type
    Secondary
    End point timeframe
    At Year 1, Year 2, Year 3, Year 4 and Year 5
    End point values
    		 Nimenrix Group Mencevax Group
    Number of subjects analysed
    364
    121
    Units: Subjects
        Any (SAE)s Year 1
    0
    0
        Any (SAE)s Year 2
    0
    0
        Any (SAE)s Year 3
    0
    0
        Any (SAE)s Year 4
    0
    0
        Any (SAE)s Year 5
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Occurrence of solicited local and general symptoms during the 4-day (Days 0-3) post vaccination period; Occurrence of unsolicited AE(s) up to 31 days after vaccination; Occurrence of SAE(s) from Day 0 up to 6 months after vaccination.
    Adverse event reporting additional description
    The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    Nimenrix Group
    Reporting group description
    		 Subjects who received one dose of Nimenrix vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.

    Reporting group title
    Mencevax Group
    Reporting group description
    		 Subjects who received one dose of Mencevax ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.

    Serious adverse events
    		 Nimenrix Group Mencevax Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 374 (0.27%)
    0 / 126 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Psychiatric disorders
    Mental disorder
         subjects affected / exposed
    1 / 374 (0.27%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Costochondritis
         subjects affected / exposed
    1 / 374 (0.27%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Nimenrix Group Mencevax Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    143 / 374 (38.24%)
    40 / 126 (31.75%)
    General disorders and administration site conditions
    Any Pain
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    143 / 370 (38.65%)
    40 / 124 (32.26%)
         occurrences all number
    143
    40
    Any Redness
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    57 / 370 (15.41%)
    8 / 124 (6.45%)
         occurrences all number
    57
    8
    Any Swelling
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    42 / 370 (11.35%)
    4 / 124 (3.23%)
         occurrences all number
    42
    4
    Any Fatigue
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    55 / 371 (14.82%)
    13 / 125 (10.40%)
         occurrences all number
    55
    13
    Any Headache
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    65 / 371 (17.52%)
    15 / 125 (12.00%)
         occurrences all number
    65
    15
    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.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Dec 2011
    Amendment 1 To support the data obtained by serum bactericidal assay (SBA) testing, antibody concentrations against meningococcal polysaccharides (PSs) were planned to be assessed by enzyme-linked immunosorbent assay (ELISA). The ELISA testing was performed prior to and one month after vaccination, and one, two and three years after vaccine administration, but the sponsor decided not to perform the ELISA testing at four and five years after vaccine administration for the following reasons: • the World Health Organisation (WHO) considers SBA the primary means of assessing immune response to meningococcal conjugate vaccines [WHO, 2006; WHO,1999]. • circulating bactericidal antibodies are more critical for persistent protection against meningococcal disease than non-functional antibodies against meningococcal PSs [Centers for Disease Control (CDC), 2011; WHO, 2006].

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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