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    Clinical Trial Results:
    A phase III, open, multi-centre, controlled study to evaluate the long-term antibody persistence at 2 years, 3 years and 4 years after a single dose of GlaxoSmithKline (GSK) Biologicals’ meningococcal serogroup A, C, W-135, Y- tetanus toxoid conjugate (MenACWY-TT) vaccine versus one dose of Meningitec administered in healthy 12 through 23-month old children who were primed in study MenACWY-TT-039 (109670) and to evaluate the immunogenicity and safety of a booster dose of the same meningococcal conjugate vaccine as given in the primary study, 4 years after priming.

    Summary
    EudraCT number
    		 2008-003824-51
    Trial protocol
    		 FI  
    Global end of trial date
    09 Sep 2012

    Results information
    Results version number
    		 v3(current)
    This version publication date
    08 Mar 2023
    First version publication date
    13 Jun 2015
    Other versions
    		 v1 , v2
    Version creation reason

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    112036
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00955682
    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)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000429-PIP01-08
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Interim
    Date of interim/final analysis
    30 May 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Dec 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Sep 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Immunogenicity Persistence At 24, 36, and 48 months after primary vaccination of toddlers with MenACWY-TT or Meningitec •To evaluate the persistence of meningococcal antibodies in terms of the percentage of subjects with rSBA antibody titres greater than or equal to (≥) 1:8 for each of the four serogroups.
    Protection of trial subjects
    All subjects were supervised for 30 min after vaccination/product administration with appropriate medical treatment readily available. Vaccines/products 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/products. Subjects were followed-up for 30 days after the last vaccination/product administration.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Aug 2009
    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
    Finland: 342
    Worldwide total number of subjects
    342
    EEA total number of subjects
    342
    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)
    342
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 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.

    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
    		 342
    Number of subjects completed
    		 295

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Not fulfilling protocol criteria: 47
    Period 1
    Period 1 title
    Year 2 Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Nimenrix Group Y2
    Arm description
    		 Subjects vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nimenrix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One intramuscular injection in the deltoid of non-dominant arm. Vaccination administered in the 109670 study.

    Investigational medicinal product name
    Priorix-Tetra
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses administered subcutaneously into the deltoid region of the dominant arm. Vaccination administered in the 109670 study.

    Arm title
    		 Meningitec Group Y2
    Arm description
    		 Subjects who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Priorix-Tetra
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses administered subcutaneously into the deltoid region of the dominant arm. Vaccination administered in the 109670 study.

    Investigational medicinal product name
    Meningitec
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One intramuscular injection in the deltoid of non-dominant arm. Vaccination administered in the 109670 study.

    Number of subjects in period 1 [1]
    		Nimenrix Group Y2 Meningitec Group Y2
    Started
    253
    42
    Completed
    253
    42
    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: The number of subjects reported in the baseline period are number vaccinated, as compared to worldwide number enrolled in the trial.
    Period 2
    Period 2 title
    Year 3 Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Nimenrix Group Y3
    Arm description
    		 Subjects vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Priorix-Tetra
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses administered subcutaneously into the deltoid region of the dominant arm. Vaccination administered in the 109670 study.

    Investigational medicinal product name
    Nimenrix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One intramuscular injection in the deltoid of non-dominant arm. Vaccination administered in the 109670 study.

    Arm title
    		 Meningitec Group Y3
    Arm description
    		 Subjects who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Meningitec
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One intramuscular injection in the deltoid of non-dominant arm. Vaccination administered in the 109670 study.

    Investigational medicinal product name
    Priorix-Tetra
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses administered subcutaneously into the deltoid region of the dominant arm. Vaccination administered in the 109670 study.

    Number of subjects in period 2
    		Nimenrix Group Y3 Meningitec Group Y3
    Started
    253
    42
    Completed
    273
    47
    Joined
    20
    5
         Late return to study visit
    20
    5
    Period 3
    Period 3 title
    Year 4 Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Nimenrix Group Y4
    Arm description
    		 Subjects vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nimenrix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One intramuscular injection in the deltoid of non-dominant arm. Vaccination administered in the 109670 study.

    Investigational medicinal product name
    Priorix-Tetra
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses administered subcutaneously into the deltoid region of the dominant arm. Vaccination administered in the 109670 study.

    Arm title
    		 Meningitec Group Y4
    Arm description
    		 Subjects who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Priorix-Tetra
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses administered subcutaneously into the deltoid region of the dominant arm. Vaccination administered in the 109670 study.

    Investigational medicinal product name
    Meningitec
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One intramuscular injection in the deltoid of non-dominant arm. Vaccination administered in the 109670 study.

    Number of subjects in period 3 [2]
    		Nimenrix Group Y4 Meningitec Group Y4
    Started
    246
    48
    Completed
    246
    48
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Not all study participants returned in time for every study visit, but they were allowed to continue the study nonetheless. The number of participants who started each study period depends on the actual rate of return of the subjects.
    Period 4
    Period 4 title
    Booster Period (Month 48- 49)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Nimenrix Group Booster (Month 49)
    Arm description
    		 Subjects vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Priorix-Tetra
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses administered subcutaneously into the deltoid region of the dominant arm. Vaccination administered in the 109670 study.

    Investigational medicinal product name
    Nimenrix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One intramuscular injection in the deltoid of non-dominant arm, vaccination administered in the 109670 study. Subjects are boosted with one dose of Nimenrix four years after the primary vaccination.

    Arm title
    		 Meningitec Group Booster (Month 49)
    Arm description
    		 Subjects who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Meningitec
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One intramuscular injection in the deltoid of non-dominant arm. Vaccination administered in the 109670 study.

    Investigational medicinal product name
    Priorix-Tetra
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses administered subcutaneously into the deltoid region of the dominant arm. Vaccination administered in the 109670 study. Subjects are boosted with one dose of Priorix-Tetra four years after the primary vaccination.

    Number of subjects in period 4 [3]
    		Nimenrix Group Booster (Month 49) Meningitec Group Booster (Month 49)
    Started
    245
    48
    Completed
    244
    47
    Not completed
    1
    1
         Lost to follow-up
    1
    1
    Notes
    [3] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Not all study participants returned in time for every study visit, but they were allowed to continue the study nonetheless. The number of participants who started each study period depends on the actual rate of return of the subjects.
    Period 5
    Period 5 title
    Year 5 Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Nimenrix Group Y5
    Arm description
    		 Subjects vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nimenrix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses administered subcutaneously into the deltoid region of the dominant arm.

    Investigational medicinal product name
    Priorix-Tetra
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One intramuscular injection in the deltoid of non-dominant arm.

    Arm title
    		 Meningitec Group Y5
    Arm description
    		 Subjects who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Priorix-Tetra
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses administered subcutaneously into the deltoid region of the dominant arm.

    Investigational medicinal product name
    Meningitec
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One intramuscular injection in the deltoid of non-dominant arm.

    Number of subjects in period 5 [4]
    		Nimenrix Group Y5 Meningitec Group Y5
    Started
    239
    47
    Completed
    239
    47
    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.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Nimenrix Group Y2
    Reporting group description
    		 Subjects vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.

    Reporting group title
    Meningitec Group Y2
    Reporting group description
    		 Subjects who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.

    Reporting group values
    		 Nimenrix Group Y2 Meningitec Group Y2 Total
    Number of subjects
    		 253 42 295
    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)
    		 253 42 295
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 40.7 ± 1.87 41.1 ± 1.74 -
    Gender categorical
    Units: Subjects
        Female
    		 120 20 140
        Male
    		 133 22 155

    End points

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    End points reporting groups
    Reporting group title
    Nimenrix Group Y2
    Reporting group description
    		 Subjects vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.

    Reporting group title
    Meningitec Group Y2
    Reporting group description
    		 Subjects who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
    Reporting group title
    Nimenrix Group Y3
    Reporting group description
    		 Subjects vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.

    Reporting group title
    Meningitec Group Y3
    Reporting group description
    		 Subjects who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
    Reporting group title
    Nimenrix Group Y4
    Reporting group description
    		 Subjects vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.

    Reporting group title
    Meningitec Group Y4
    Reporting group description
    		 Subjects who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
    Reporting group title
    Nimenrix Group Booster (Month 49)
    Reporting group description
    		 Subjects vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.

    Reporting group title
    Meningitec Group Booster (Month 49)
    Reporting group description
    		 Subjects who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.
    Reporting group title
    Nimenrix Group Y5
    Reporting group description
    		 Subjects vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.

    Reporting group title
    Meningitec Group Y5
    Reporting group description
    		 Subjects who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.

    Primary: Number of subjects with serum bactericidal assay/activity (rSBA) against Neisseria meningitidis serogroup A, C, W-135 and Y (using baby rabbit complement) titres ≥ the cut-off

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    End point title
    		 Number of subjects with serum bactericidal assay/activity (rSBA) against Neisseria meningitidis serogroup A, C, W-135 and Y (using baby rabbit complement) titres ≥ the cut-off [1]
    End point description
    The cut-off value for the assay was greater than or equal to (≥) 1:8, as measured at the GlaxoSmithKline (GSK) laboratory.
    End point type
    Primary
    End point timeframe
    At Month 24 post 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 scope of this endpoint was descriptive analysis.
    End point values
    		 Nimenrix Group Y2 Meningitec Group Y2
    Number of subjects analysed
    188
    30
    Units: Subjects
        rSBA-MenA [M24] (N=181; 28)
    177
    23
        rSBA-MenC [M24] (N=186; 29)
    164
    20
        rSBA-MenW-135 [M24] (N=188; 29)
    186
    17
        rSBA-MenY [M24] (N=188; 30)
    184
    24
    No statistical analyses for this end point

    Primary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥ the cut-off

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    End point title
    		 Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥ the cut-off [2]
    End point description
    The cut-off value for the assay was ≥ 1:8. The analysis of this endpoint was performed by GSK.
    End point type
    Primary
    End point timeframe
    At Month 36 post 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 scope of this endpoint was descriptive analysis.
    End point values
    		 Nimenrix Group Y3 Meningitec Group Y3
    Number of subjects analysed
    237
    40
    Units: Subjects
        rSBA-MenA [M36] (N=228; 38)
    224
    32
        rSBA-MenC [M36] (N=235; 39)
    210
    28
        rSBA-MenW-135 [M36] (N=236; 39)
    232
    22
        rSBA-MenY [M36] (N=237; 40)
    231
    33
    No statistical analyses for this end point

    Primary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥ the cut-off

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    End point title
    		 Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥ the cut-off [3]
    End point description
    The cut-off value for the assay was ≥ 1:8. The analysis of this endpoint was performed by GSK.
    End point type
    Primary
    End point timeframe
    At Month 48 post 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 scope of this endpoint was descriptive analysis.
    End point values
    		 Nimenrix Group Y4 Meningitec Group Y4
    Number of subjects analysed
    195
    37
    Units: Subjects
        rSBA-MenA [M48] (N=188; 35)
    185
    29
        rSBA-MenC [M48] (N=194; 36)
    175
    24
        rSBA-MenW-135 [M48] (N=194; 36)
    192
    22
        rSBA-MenY [M48] (N=195; 37)
    190
    31
    No statistical analyses for this end point

    Primary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres

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    End point title
    		 Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres [4]
    End point description
    The cut-off value for the assay was ≥ 1:8. The rSBA-MenA results for the Year 3 time point were obtained by re-testing the samples in parallel at Public Health England (PHE).
    End point type
    Primary
    End point timeframe
    At Month 36 post-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 scope of this endpoint was descriptive analysis.
    End point values
    		 Nimenrix Group Y3 Meningitec Group Y3
    Number of subjects analysed
    262 [5]
    46
    Units: Subjects
        rSBA-MenA [M36] (N=262; 46)
    157
    3
        rSBA-MenC [M36] (N=262; 46)
    94
    6
        rSBA-MenW-135 [M36] (N=261; 46)
    130
    2
        rSBA-MenY [M36] (N=262; 46)
    141
    6
    Notes
    [5] - Number of subjects analyzed is greater due to addition of subjects after they started the arm
    No statistical analyses for this end point

    Primary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres

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    End point title
    		 Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres [6]
    End point description
    The cut-off value for the aasay was ≥ 1:8. The rSBA-MenA results for the Year 4 time point were obtained by re-testing the samples in parallel at Public Health England (PHE).
    End point type
    Primary
    End point timeframe
    At Month 48 post-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 scope of this endpoint was descriptive analysis.
    End point values
    		 Nimenrix Group Y4 Meningitec Group Y4
    Number of subjects analysed
    225
    45
    Units: Subjects
        rSBA-MenA [M48] (N=224; 45)
    166
    13
        rSBA-MenC [M48] (N=225; 45)
    91
    16
        rSBA-MenW-135 [M48] (N=225; 45)
    111
    7
        rSBA-MenY [M48] (N=225; 45)
    131
    11
    No statistical analyses for this end point

    Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥ the cut-off

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    End point title
    		 Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥ the cut-off
    End point description
    The cut-off value for the assay was ≥ 1:128, as measured at the GlaxoSmithKline (GSK) laboratory.
    End point type
    Secondary
    End point timeframe
    At Month 24 post primary vaccination
    End point values
    		 Nimenrix Group Y2 Meningitec Group Y2
    Number of subjects analysed
    188
    30
    Units: Subjects
        rSBA-MenA [M24] (N=181; 28)
    166
    16
        rSBA-MenC [M24] (N=186; 29)
    90
    14
        rSBA-MenW-135 [M24] (N=188; 29)
    171
    12
        rSBA-MenY [M24] (N=188; 30)
    154
    20
    No statistical analyses for this end point

    Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥ the cut-off

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    End point title
    		 Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥ the cut-off
    End point description
    The cut-off value for the assay was ≥ 1:128. The analysis of this endpoint was performed by GSK.
    End point type
    Secondary
    End point timeframe
    At Month 36 post primary vaccination
    End point values
    		 Nimenrix Group Y3 Meningitec Group Y3
    Number of subjects analysed
    237
    40
    Units: Subjects
        rSBA-MenA [M36] (N=228; 38)
    207
    23
        rSBA-MenC [M36] (N=235; 39)
    115
    19
        rSBA-MenW-135 [M36] (N=236; 39)
    211
    16
        rSBA-MenY [M36] (N=237; 40)
    195
    26
    No statistical analyses for this end point

    Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥ the cut-off

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    End point title
    		 Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥ the cut-off
    End point description
    The cut-off value for the assay was ≥ 1:128. The analysis of this endpoint was performed by GSK.
    End point type
    Secondary
    End point timeframe
    At Month 48 post primary vaccination
    End point values
    		 Nimenrix Group Y4 Meningitec Group Y4
    Number of subjects analysed
    195
    37
    Units: Subjects
        rSBA-MenA [M48] (N=188; 35)
    175
    22
        rSBA-MenC [M48] (N=194; 36)
    97
    18
        rSBA-MenW-135 [M48] (N=194; 36)
    177
    17
        rSBA-MenY [M48] (N=195; 37)
    163
    25
    No statistical analyses for this end point

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

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    End point title
    		 rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres
    End point description
    The results for the assay were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres, as measured at the GlaxoSmithKline (GSK) laboratory.
    End point type
    Secondary
    End point timeframe
    At Month 24 post primary vaccination
    End point values
    		 Nimenrix Group Y2 Meningitec Group Y2
    Number of subjects analysed
    188
    30
    Units: Titres
    geometric mean (confidence interval 95%)
        rSBA-MenA [M24] (N=181; 28)
    420.3 (356.1 to 495.9)
    90.6 (46.2 to 177.9)
        rSBA-MenC [M24] (N=186; 29)
    98.1 (77.7 to 123.8)
    53.5 (25.5 to 112)
        rSBA-MenW-135 [M24] (N=188; 29)
    396.9 (342 to 460.5)
    42.2 (18.5 to 96.4)
        rSBA-MenY [M24] (N=188; 30)
    396.6 (324 to 485.5)
    151.3 (69.2 to 330.6)
    No statistical analyses for this end point

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

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    End point title
    		 rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres
    End point description
    Results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres. The analysis of this endpoint was performed by GSK.
    End point type
    Secondary
    End point timeframe
    At Month 36 post primary vaccination
    End point values
    		 Nimenrix Group Y3 Meningitec Group Y3
    Number of subjects analysed
    237
    40
    Units: Titres
    geometric mean (confidence interval 95%)
        rSBA-MenA [M36] (N=228; 38)
    415.3 (360.9 to 478)
    102.3 (59.6 to 175.4)
        rSBA-MenC [M36] (N=235; 39)
    104.2 (84.7 to 128.2)
    58.5 (31.7 to 107.9)
        rSBA-MenW-135 [M36] (N=236; 39)
    372.4 (323.4 to 428.9)
    39.7 (19.5 to 80.5)
        rSBA-MenY [M36] (N=237; 40)
    405.4 (337.4 to 487.1)
    169.1 (89.6 to 319.1)
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres
    End point description
    Results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres. The analysis of this endpoint was performed by GSK.
    End point type
    Secondary
    End point timeframe
    At Month 48 post primary vaccination
    End point values
    		 Nimenrix Group Y4 Meningitec Group Y4
    Number of subjects analysed
    195
    37
    Units: Titres
    geometric mean (confidence interval 95%)
        rSBA-MenA [M48] (N=188; 35)
    437.1 (376.6 to 507.4)
    106.4 (58.8 to 192.4)
        rSBA-MenC [M48] (N=194; 36)
    105.4 (84.6 to 131.3)
    53.6 (27.1 to 105.8)
        rSBA-MenW-135 [M48] (N=194; 36)
    398.2 (343.1 to 462.1)
    49.1 (23.5 to 102.5)
        rSBA-MenY [M48] (N=195; 37)
    411.1 (336.1 to 502.9)
    186.9 (98.1 to 355.8)
    No statistical analyses for this end point

    Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥ the cut-off

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    End point title
    		 Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥ the cut-off
    End point description
    The cut-off for the assay was ≥ 1:128. rSBA-MenA, MenC, MenW-135 and MenY results for the Year 3 time point obtained by re-testing the samples in parallel at Public Health England (PHE).
    End point type
    Secondary
    End point timeframe
    At Month 36 post-primary vaccination
    End point values
    		 Nimenrix Group Y3 Meningitec Group Y3
    Number of subjects analysed
    262
    46
    Units: Subjects
        rSBA-MenA [M36] (N=262; 46)
    60
    3
        rSBA-MenC [M36] (N=262; 46)
    23
    3
        rSBA-MenW-135 [M36] (N=261; 46)
    87
    2
        rSBA-MenY [M36] (N=262; 46)
    75
    2
    No statistical analyses for this end point

    Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥ the cut-off

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    End point title
    		 Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥ the cut-off
    End point description
    The cut-off for the assay was ≥ 1:128. rSBA-MenA, MenC, MenW-135, MenY results for the Year 4 time point obtained by re-testing the samples in parallel at Public Health England (PHE).
    End point type
    Secondary
    End point timeframe
    At Month 48 post-primary vaccination
    End point values
    		 Nimenrix Group Y4 Meningitec Group Y4
    Number of subjects analysed
    225
    45
    Units: Subjects
        rSBA-MenA [M48] (N=224; 45)
    134
    12
        rSBA-MenC [M48] (N=225; 45)
    34
    10
        rSBA-MenW-135 [M48] (N=225; 45)
    88
    7
        rSBA-MenY [M48] (N=225; 45)
    91
    9
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres
    End point description
    Results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres. rSBA-MenA, MenC, MenW and MenY results for the Year 3 time point obtained by re-testing the samples in parallel at Public Health England (PHE).
    End point type
    Secondary
    End point timeframe
    At Month 36 post-primary vaccination
    End point values
    		 Nimenrix Group Y3 Meningitec Group Y3
    Number of subjects analysed
    262
    46
    Units: Titres
    geometric mean (confidence interval 95%)
        rSBA-MenA [M36] (N=262; 46)
    19.3 (15.7 to 23.6)
    5.2 (3.8 to 6.9)
        rSBA-MenC [M36] (N=262; 46)
    9.8 (8.1 to 11.7)
    5.7 (4.2 to 7.7)
        rSBA-MenW-135 [M36] (N=261; 46)
    24.9 (19.2 to 32.4)
    4.9 (3.7 to 6.7)
        rSBA-MenY [M36] (N=262; 46)
    22.3 (17.6 to 28.4)
    5.7 (4.2 to 7.8)
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres
    End point description
    Results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres. rSBA-MenA, MenC, MenW and MenY results for the Year 4 time point obtained by re-testing the samples in parallel at Public Health England (PHE).
    End point type
    Secondary
    End point timeframe
    At Month 48 post-primary vaccination
    End point values
    		 Nimenrix Group Y4 Meningitec Group Y4
    Number of subjects analysed
    225
    45
    Units: Titres
    geometric mean (confidence interval 95%)
        rSBA-MenA [M48] (N=224; 45)
    107.3 (77.6 to 148.3)
    18.4 (8.5 to 39.7)
        rSBA-MenC [M48] (N=225; 45)
    12.3 (9.8 to 15.3)
    13.5 (7.4 to 24.5)
        rSBA-MenW-135 [M48] (N=225; 45)
    30.5 (22.4 to 41.5)
    8 (4.8 to 13.3)
        rSBA-MenY [M48] (N=225; 45)
    36.2 (27.1 to 48.4)
    10.4 (6 to 18)
    No statistical analyses for this end point

    Secondary: Number of subjects with serum bactericidal assay/activity against Neisseria meningitidis serogroup A, C, W-135 and Y (using human complement) titres ≥ the cut-off

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    End point title
    		 Number of subjects with serum bactericidal assay/activity against Neisseria meningitidis serogroup A, C, W-135 and Y (using human complement) titres ≥ the cut-off
    End point description
    The cut-off values for the assay were ≥ 1:4 and 1:8, respectively. The analysis of this endpoint was performed by GSK.
    End point type
    Secondary
    End point timeframe
    At Month 24 post primary vaccination
    End point values
    		 Nimenrix Group Y2 Meningitec Group Y2
    Number of subjects analysed
    183
    23
    Units: Subjects
        hSBA-MenA [M24], ≥ 1:4 (N=183; 23)
    46
    2
        hSBA-MenA [M24], ≥ 1:8 (N=183; 23)
    42
    0
        hSBA-MenC [M24], ≥ 1:4 (N=175; 19)
    154
    11
        hSBA-MenC [M24], ≥ 1:8 (N=175; 19)
    152
    10
        hSBA-MenW-135 [M24], ≥ 1:4 (N=180; 23)
    167
    0
        hSBA-MenW-135 [M24], ≥ 1:8 (N=180; 23)
    164
    0
        hSBA-MenY [M24], ≥ 1:4 (N=154; 22)
    134
    5
        hSBA-MenY [M24], ≥ 1:8 (N=154; 22)
    134
    5
    No statistical analyses for this end point

    Secondary: Number of subjects with serum bactericidal assay/activity against Neisseria meningitidis serogroup A, C, W-135 and Y (using human complement) titres ≥ the cut-off

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    End point title
    		 Number of subjects with serum bactericidal assay/activity against Neisseria meningitidis serogroup A, C, W-135 and Y (using human complement) titres ≥ the cut-off
    End point description
    The cut-off for the assay were ≥ 1:4 and 1:8. The analysis of this endpoint was performed by GSK.
    End point type
    Secondary
    End point timeframe
    At Month 36 post primary vaccination
    End point values
    		 Nimenrix Group Y3 Meningitec Group Y3
    Number of subjects analysed
    258
    35
    Units: Subjects
        hSBA-MenA [M36], ≥ 1:4 (N=251; 31)
    95
    5
        hSBA-MenA [M36], ≥ 1:8 (N=251; 31)
    90
    4
        hSBA-MenC [M36], ≥ 1:4 (N=253; 31)
    204
    13
        hSBA-MenC [M36], ≥ 1:8 (N=253; 31)
    198
    13
        hSBA-MenW-135 [M36], ≥ 1:4 (N=254; 33)
    209
    2
        hSBA-MenW-135 [M36], ≥ 1:8 (N=254; 33)
    209
    2
        hSBA-MenY [M36], ≥ 1:4 (N=250; 33)
    184
    6
        hSBA-MenY [M36], ≥ 1:8 (N=250; 33)
    180
    6
    No statistical analyses for this end point

    Secondary: Number of subjects with serum bactericidal assay/activity against Neisseria meningitidis serogroup A, C, W-135 and Y (using human complement) titres ≥ the cut-off

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    End point title
    		 Number of subjects with serum bactericidal assay/activity against Neisseria meningitidis serogroup A, C, W-135 and Y (using human complement) titres ≥ the cut-off
    End point description
    The cut-off for the assay were ≥ 1:4 and 1:8, as assessed by the GSK laboratory.
    End point type
    Secondary
    End point timeframe
    At Month 48 post primary vaccination
    End point values
    		 Nimenrix Group Y4 Meningitec Group Y4
    Number of subjects analysed
    209
    32
    Units: Subjects
        hSBA-MenA [M48], ≥ 1:4 (N=198; 28)
    58
    4
        hSBA-MenA [M48], ≥ 1:8 (N=198; 28)
    57
    4
        hSBA-MenC [M48], ≥ 1:4 (N=209; 32)
    154
    15
        hSBA-MenC [M48], ≥ 1:8 (N=209; 32)
    153
    15
        hSBA-MenW-135 [M48], ≥ 1:4 (N=165; 26)
    134
    2
        hSBA-MenW-135 [M48], ≥ 1:8 (N=165; 26)
    133
    2
        hSBA-MenY [M48], ≥ 1:4 (N=130; 27)
    85
    6
        hSBA-MenY [M48], ≥ 1:8 (N=130; 27)
    85
    6
    No statistical analyses for this end point

    Secondary: hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY titres

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    End point title
    		 hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY titres
    End point description
    The results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres, as assessed by the GSK laboratory.
    End point type
    Secondary
    End point timeframe
    At Month 24 post primary vaccination
    End point values
    		 Nimenrix Group Y2 Meningitec Group Y2
    Number of subjects analysed
    183
    23
    Units: Titres
    geometric mean (confidence interval 95%)
        hSBA-MenA [M24] (N=183; 23)
    3.8 (3.2 to 4.5)
    2.2 (1.9 to 2.4)
        hSBA-MenC [M24] (N=175; 19)
    50.2 (38.7 to 65.1)
    10.4 (4.7 to 22.8)
        hSBA-MenW-135 [M24] (N=180; 23)
    77.7 (61.8 to 97.6)
    2 (2 to 2)
        hSBA-MenY [M24] (N=154; 22)
    58.1 (44.5 to 75.8)
    5 (2.2 to 11.1)
    No statistical analyses for this end point

    Secondary: hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY titres

    		 Close Top of page
    End point title
    		 hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY titres
    End point description
    The results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres, as assessed by the GSK laboratory.
    End point type
    Secondary
    End point timeframe
    At Month 36 post primary vaccination
    End point values
    		 Nimenrix Group Y3 Meningitec Group Y3
    Number of subjects analysed
    254
    33
    Units: Titres
    geometric mean (confidence interval 95%)
        hSBA-MenA [M36] (N=31, 251)
    5.8 (4.8 to 7)
    2.6 (2.1 to 3.3)
        hSBA-MenC [M36] (N=31, 253)
    37.8 (29.4 to 48.6)
    6.2 (3.7 to 10.3)
        hSBA-MenW-135 [M36] (N=33, 254)
    52 (41.4 to 65.2)
    2.4 (1.8 to 3.1)
        hSBA-MenY [M36] (N=33, 250)
    33.2 (25.9 to 42.5)
    4.1 (2.4 to 7.1)
    No statistical analyses for this end point

    Secondary: hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY titres

    		 Close Top of page
    End point title
    		 hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY titres
    End point description
    The results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres, as measured by GSK.
    End point type
    Secondary
    End point timeframe
    At Month 48 post primary vaccination
    End point values
    		 Nimenrix Group Y4 Meningitec Group Y4
    Number of subjects analysed
    209
    32
    Units: Titres
    geometric mean (confidence interval 95%)
        hSBA-MenA [M48] (N=198; 28)
    4.9 (4 to 6)
    2.9 (2 to 4)
        hSBA-MenC [M48] (N=209; 32)
    32 (23.8 to 43)
    11.3 (4.9 to 25.6)
        hSBA-MenW-135 [M48] (N=165; 26)
    47.1 (35.7 to 62.2)
    2.6 (1.8 to 3.8)
        hSBA-MenY [M48] (N=130; 27)
    29.8 (20.2 to 44.1)
    4.4 (2.4 to 8.1)
    No statistical analyses for this end point

    Secondary: Number of subjects with Anti-polysaccharide A (anti-PSA), anti-PSC, anti-PSW, and anti-PSY ≥ the cut-off values

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    End point title
    		 Number of subjects with Anti-polysaccharide A (anti-PSA), anti-PSC, anti-PSW, and anti-PSY ≥ the cut-off values
    End point description
    The cut-off values for the assay were ≥ 0.3 microgram per milliliter (μg/mL) and ≥ 2.0 μg/mL, respectively, as measured at the GlaxoSmithKline (GSK) laboratory.
    End point type
    Secondary
    End point timeframe
    At Month 24 post primary vaccination
    End point values
    		 Nimenrix Group Y2 Meningitec Group Y2
    Number of subjects analysed
    92
    17
    Units: Subjects
        Anti-PSA [24], ≥ 0.3 (N=92; 17)
    50
    5
        Anti-PSA [24], ≥ 2.0 (N=92; 17)
    8
    2
        Anti-PSC [24], ≥ 0.3 (N=89; 16)
    25
    3
        Anti-PSC [24], ≥ 2.0 (N=89; 16)
    0
    0
        Anti-PSW-135 [24], ≥ 0.3 (N=86; 16)
    56
    0
        Anti-PSW-135 [24], ≥ 2.0 (N=86; 16)
    8
    0
        Anti-PSY [24], ≥ 0.3 (N=89; 17)
    72
    0
        Anti-PSY [24], ≥ 2.0 (N=89; 17)
    25
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with Anti-polysaccharide A (anti-PSA), anti-PSC, anti-PSW, and anti-PSY ≥ the cut-off values

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    End point title
    		 Number of subjects with Anti-polysaccharide A (anti-PSA), anti-PSC, anti-PSW, and anti-PSY ≥ the cut-off values
    End point description
    The cut-off values for the assay were ≥ 0.3 μg/mL and ≥ 2.0 μg/mL, respectively, as measured by the GSK laboratory.
    End point type
    Secondary
    End point timeframe
    At Month 36 post primary vaccination
    End point values
    		 Nimenrix Group Y3 Meningitec Group Y3
    Number of subjects analysed
    114
    21
    Units: Subjects
        Anti-PSA [36], ≥ 0.3 (N=114; 21)
    61
    6
        Anti-PSA [36], ≥ 2.0 (N=114; 21)
    10
    2
        Anti-PSC [36], ≥ 0.3 (N=111; 20)
    28
    4
        Anti-PSC [36], ≥ 2.0 (N=111; 20)
    0
    0
        Anti-PSW-135 [36], ≥ 0.3 (N=106; 20)
    68
    0
        Anti-PSW-135 [36], ≥ 2.0 (N=106; 20)
    11
    0
        Anti-PSY [36], ≥ 0.3 (N=110; 21)
    89
    1
        Anti-PSY [36], ≥ 2.0 (N=110; 21)
    33
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with Anti-polysaccharide A (anti-PSA), anti-PSC, anti-PSW, and anti-PSY ≥ the cut-off values

    		 Close Top of page
    End point title
    		 Number of subjects with Anti-polysaccharide A (anti-PSA), anti-PSC, anti-PSW, and anti-PSY ≥ the cut-off values
    End point description
    The cut-off values for the assay were ≥ 0.3 μg/mL and ≥ 2.0 μg/mL, respectively, as measured by GSK.
    End point type
    Secondary
    End point timeframe
    At Month 48 post primary vaccination
    End point values
    		 Nimenrix Group Y4 Meningitec Group Y4
    Number of subjects analysed
    93
    20
    Units: Subjects
        Anti-PSA [48], ≥ 0.3 (N=93; 20)
    50
    5
        Anti-PSA [48], ≥ 2.0 (N=93; 20)
    9
    2
        Anti-PSC [48], ≥ 0.3 (N=91; 19)
    21
    3
        Anti-PSC [48], ≥ 2.0 (N=91; 19)
    0
    0
        Anti-PSW-135 [48], ≥ 0.3 (N=86; 19)
    55
    0
        Anti-PSW-135 [48], ≥ 2.0 (N=86; 19)
    8
    0
        Anti-PSY [48], ≥ 0.3 (N=90; 20)
    73
    1
        Anti-PSY [48], ≥ 2.0 (N=90; 20)
    26
    0
    No statistical analyses for this end point

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

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    End point title
    		 Anti-PSA, anti-PSC, anti-PSW, and anti-PSY antibody concentrations
    End point description
    The results were tabulated as geometric mean antibody concentration calculated on all subjects, expressed in μg/mL, as measured at the GlaxoSmithKline (GSK) laboratory.
    End point type
    Secondary
    End point timeframe
    At Month 24 post primary vaccination
    End point values
    		 Nimenrix Group Y2 Meningitec Group Y2
    Number of subjects analysed
    92
    17
    Units: μg/mL
    geometric mean (confidence interval 95%)
        Anti-PSA [24] (N=92; 17)
    0.4 (0.32 to 0.5)
    0.28 (0.16 to 0.49)
        Anti-PSC [24] (N=89; 16)
    0.22 (0.19 to 0.25)
    0.19 (0.14 to 0.27)
        Anti-PSW-135 [24] (N=86; 16)
    0.47 (0.37 to 0.59)
    0.15 (0.15 to 0.15)
        Anti-PSY [24] (N=89; 17)
    0.85 (0.65 to 1.12)
    0.15 (0.15 to 0.15)
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Anti-PSA, anti-PSC, anti-PSW, and anti-PSY antibody concentrations
    End point description
    The results were tabulated as geometric mean antibody concentration calculated on all subjects, expressed in μg/mL, as measured by GSK.
    End point type
    Secondary
    End point timeframe
    At Month 36 post primary vaccination
    End point values
    		 Nimenrix Group Y3 Meningitec Group Y3
    Number of subjects analysed
    114
    21
    Units: μg/mL
    geometric mean (confidence interval 95%)
        Anti-PSA [24] (N=114; 21)
    0.39 (0.32 to 0.48)
    0.27 (0.17 to 0.43)
        Anti-PSC [24] (N=111; 20)
    0.21 (0.19 to 0.24)
    0.19 (0.15 to 0.25)
        Anti-PSW-135 [24] (N=106; 20)
    0.48 (0.39 to 0.59)
    0.15 (0.15 to 0.15)
        Anti-PSY [24] (N=110; 21)
    0.89 (0.7 to 1.14)
    0.16 (0.14 to 0.17)
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Anti-PSA, anti-PSC, anti-PSW, and anti-PSY antibody concentrations
    End point description
    The results were tabulated as geometric mean antibody concentration calculated on all subjects, expressed in μg/mL, as measured by GSK.
    End point type
    Secondary
    End point timeframe
    At Month 48 post primary dose
    End point values
    		 Nimenrix Group Y4 Meningitec Group Y4
    Number of subjects analysed
    93
    20
    Units: μg/mL
    geometric mean (confidence interval 95%)
        Anti-PSA [48] (N=93; 20)
    0.39 (0.31 to 0.5)
    0.26 (0.16 to 0.42)
        Anti-PSC [48] (N=91; 19)
    0.2 (0.18 to 0.23)
    0.19 (0.14 to 0.25)
        Anti-PSW-135 [48] (N=86; 19)
    0.46 (0.37 to 0.58)
    0.15 (0.15 to 0.15)
        Anti-PSY [48] (N=90; 20)
    0.89 (0.68 to 1.15)
    0.16 (0.14 to 0.17)
    No statistical analyses for this end point

    Secondary: Number of subjects with Anti-polysaccharide A (anti-PSA), anti-PSC, anti-PSW, and anti-PSY ≥ the cut-off values

    		 Close Top of page
    End point title
    		 Number of subjects with Anti-polysaccharide A (anti-PSA), anti-PSC, anti-PSW, and anti-PSY ≥ the cut-off values
    End point description
    The cut-off values for the assay were ≥ 0.3 μg/mL and ≥ 0.2 μg/mL. Anti-PS results for the Year 3 time point were obtained by re-testing the samples in parallel at Public Health England (PHE).
    End point type
    Secondary
    End point timeframe
    At Month 36 post-primary vaccination
    End point values
    		 Nimenrix Group Y3 Meningitec Group Y3
    Number of subjects analysed
    130
    26
    Units: Subjects
        Anti-PSA [36], ≥ 0.3 (N=130; 26)
    128
    20
        Anti-PSA [36], ≥ 2.0 (N=130; 26)
    27
    3
        Anti-PSC [36], ≥ 0.3 (N=119; 25)
    37
    5
        Anti-PSC [36], ≥ 2.0 (N=119; 25)
    2
    1
        Anti-PSW-135 [36], ≥ 0.3 (N=122; 25)
    117
    11
        Anti-PSW-135 [36], ≥ 2.0 (N=122; 25)
    13
    0
        Anti-PSY [36], ≥ 0.3 (N=104; 22)
    102
    19
        Anti-PSY [36], ≥ 2.0 (N=104; 22)
    19
    1
    No statistical analyses for this end point

    Secondary: Number of subjects with Anti-polysaccharide A (anti-PSA), anti-PSC, anti-PSW, and anti-PSY ≥ the cut-off values

    		 Close Top of page
    End point title
    		 Number of subjects with Anti-polysaccharide A (anti-PSA), anti-PSC, anti-PSW, and anti-PSY ≥ the cut-off values
    End point description
    The cut-off values for the assay were ≥ 0.3 μg/mL and ≥ 2.0 μg/mL, respectively. Anti-PS results for the Year 4 time point were obtained by re-testing the samples in parallel at Public Health England (PHE).
    End point type
    Secondary
    End point timeframe
    At Month 48 post-primary vaccination
    End point values
    		 Nimenrix Group Y4 Meningitec Group Y4
    Number of subjects analysed
    56
    22
    Units: Subjects
        Anti-PSA [48], ≥ 0.3 (N=53; 22)
    53
    20
        Anti-PSA [48], ≥ 2.0 (N=53; 22)
    26
    9
        Anti-PSC [48], ≥ 0.3 (N=56; 21)
    16
    7
        Anti-PSC [48], ≥ 2.0 (N=56; 21)
    3
    3
        Anti-PSW-135 [48], ≥ 0.3 (N=56; 22)
    56
    17
        Anti-PSW-135 [48], ≥ 2.0 (N=56; 22)
    5
    0
        Anti-PSY [48], ≥ 0.3 (N=50; 20)
    48
    18
        Anti-PSY [48], ≥ 2.0 (N=50; 20)
    7
    3
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Anti-polysaccharide A (anti-PSA), anti-PSC, anti-PSW, and anti-PSY antibody concentrations
    End point description
    The results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in μg/mL. Anti-PS results for the Year 3 time point were obtained by re-testing the samples in parallel at Public Health England (PHE). Results were tabulated as geometric mean antibody concentration calculated on all subjects, expressed in μg/mL.
    End point type
    Secondary
    End point timeframe
    At Month 36 post-primary vaccination
    End point values
    		 Nimenrix Group Y3 Meningitec Group Y3
    Number of subjects analysed
    130
    26
    Units: μg/mL
    geometric mean (confidence interval 95%)
        Anti-PSA [36] (N=130; 26)
    1.16 (1.01 to 1.34)
    0.69 (0.45 to 1.06)
        Anti-PSC [36] (N=119; 25)
    0.22 (0.2 to 0.25)
    0.19 (0.15 to 0.25)
        Anti-PSW-135 [36] (N=122; 25)
    0.78 (0.69 to 0.89)
    0.24 (0.19 to 0.3)
        Anti-PSY [36] (N=104; 22)
    1.12 (0.97 to 1.29)
    0.52 (0.37 to 0.72)
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Anti-polysaccharide A (anti-PSA), anti-PSC, anti-PSW, and anti-PSY antibody concentrations
    End point description
    The results were tabulated as geometric mean antibody concentration calculated on all subjects, expressed in μg/mL. Anti-PS results for the Year 4 time point obtained by re-testing the samples in parallel at Public Health England (PHE).
    End point type
    Secondary
    End point timeframe
    At Month 48 post-primary vaccination
    End point values
    		 Nimenrix Group Y4 Meningitec Group Y4
    Number of subjects analysed
    56
    22
    Units: μg/mL
    geometric mean (confidence interval 95%)
        Anti-PSA [48] (N=53; 22)
    2.05 (1.61 to 2.61)
    1.65 (0.97 to 2.83)
        Anti-PSC [48] (N=56; 21)
    0.25 (0.19 to 0.33)
    0.31 (0.18 to 0.54)
        Anti-PSW-135 [48] (N=56; 22)
    0.85 (0.73 to 0.98)
    0.35 (0.28 to 0.46)
        Anti-PSY [48] (N=50; 20)
    0.77 (0.63 to 0.93)
    0.83 (0.54 to 1.28)
    No statistical analyses for this end point

    Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥ the cut-off values

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    End point title
    		 Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥ the cut-off values
    End point description
    The cut-off values for the assay were 1:8 and 1:128, as measured by the PHE laboratory.
    End point type
    Secondary
    End point timeframe
    At one month (Month 49) post booster dose
    End point values
    		 Nimenrix Group Booster (Month 49) Meningitec Group Booster (Month 49)
    Number of subjects analysed
    215
    43
    Units: Subjects
        rSBA-MenA [M49], ≥ 1:8 (N=214; 43)
    214
    9
        rSBA-MenA [M49], ≥ 1:128 (N=214; 43)
    214
    8
        rSBA-MenC [M49], ≥ 1:8 (N=215; 43)
    215
    43
        rSBA-MenC [M49], ≥ 1:128 (N=215; 43)
    215
    43
        rSBA-MenW-135 [M49], ≥ 1:8 (N=215; 43)
    215
    8
        rSBA-MenW-135 [M49], ≥ 1:128 (N=215; 43)
    215
    7
        rSBA-MenY [M49], ≥ 1:8 (N=215; 43)
    215
    14
        rSBA-MenY [M49], ≥ 1:128 (N=215; 43)
    215
    14
    No statistical analyses for this end point

    Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥ the cut-off values

    		 Close Top of page
    End point title
    		 Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥ the cut-off values
    End point description
    The cut off values for the assay were 1:8 and 1:128, as measured by the PHE laboratory.
    End point type
    Secondary
    End point timeframe
    At 12 months (Month 60) post booster dose
    End point values
    		 Nimenrix Group Y5 Meningitec Group Y5
    Number of subjects analysed
    231
    46
    Units: Subjects
        rSBA-MenA [M60], ≥ 1:8 (N=231; 46)
    231
    3
        rSBA-MenA [M60], ≥ 1:128 (N=231; 46)
    229
    3
        rSBA-MenC [M60], ≥ 1:8 (N=231; 46)
    225
    45
        rSBA-MenC [M60], ≥ 1:128 (N=231; 46)
    181
    40
        rSBA-MenW-135 [M60], ≥ 1:8 (N=231; 46)
    231
    2
        rSBA-MenW-135 [M60], ≥ 1:128 (N=231; 46)
    229
    2
        rSBA-MenY [M60], ≥ 1:8 (N=231; 46)
    231
    11
        rSBA-MenY [M60], ≥ 1:128 (N=231; 46)
    229
    11
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres
    End point description
    Results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres, as measured by the PHE laboratory.
    End point type
    Secondary
    End point timeframe
    At one month (Month 49) post booster dose
    End point values
    		 Nimenrix Group Booster (Month 49) Meningitec Group Booster (Month 49)
    Number of subjects analysed
    215
    43
    Units: Titres
    geometric mean (confidence interval 95%)
        rSBA-MenA [M49] (N=214; 43)
    7173.3 (6389.2 to 8053.5)
    10.7 (5.6 to 20.4)
        rSBA-MenC [M49] (N=215; 43)
    4511.9 (3935.9 to 5172.3)
    3718.4 (2596 to 5326)
        rSBA-MenW-135 [M49] (N=215; 43)
    10949.7 (9531.4 to 12579.1)
    9.6 (5.3 to 17.3)
        rSBA-MenY [M49] (N=215; 43)
    4585.3 (4128.6 to 5092.5)
    15 (8 to 28)
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres
    End point description
    Results were tabulated as geometric mean antibody titre (GMT) calculated on all subjects, as measured by the PHE laboratory.
    End point type
    Secondary
    End point timeframe
    At 12 months (Month 60) post booster dose
    End point values
    		 Nimenrix Group Y5 Meningitec Group Y5
    Number of subjects analysed
    231
    46
    Units: Titres
    geometric mean (confidence interval 95%)
        rSBA-MenA [M60] (N=231; 46)
    978.9 (860.2 to 1114)
    5.4 (3.8 to 7.6)
        rSBA-MenC [M60] (N=231; 46)
    226.4 (183.7 to 279)
    320.9 (201.1 to 512.2)
        rSBA-MenW-135 [M60] (N=231; 46)
    1390.7 (1203.2 to 1607.3)
    4.7 (3.8 to 5.7)
        rSBA-MenY [M60] (N=231; 46)
    1071.1 (924.9 to 1240.5)
    13.4 (6.9 to 25.8)
    No statistical analyses for this end point

    Secondary: Number of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY titres ≥ the cut-off values

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    End point title
    		 Number of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY titres ≥ the cut-off values
    End point description
    The cut off values for the assay were ≥ 1:4 and ≥ 1:8 respectively, as measured by GSK.
    End point type
    Secondary
    End point timeframe
    At one month (Month 49) post booster dose
    End point values
    		 Nimenrix Group Booster (Month 49) Meningitec Group Booster (Month 49)
    Number of subjects analysed
    209
    33
    Units: Subjects
        hSBA-MenA [M49], ≥ 1:4 (N=28, 202)
    201
    4
        hSBA-MenA [M49], ≥ 1:8 (N=28, 202)
    201
    4
        hSBA-MenC [M49], ≥ 1:4 (N=33, 209)
    209
    33
        hSBA-MenC [M49], ≥ 1:8 (N=33, 209)
    209
    33
        hSBA-MenW-135 [M49], ≥ 1:4 (N=25,192)
    192
    1
        hSBA-MenW-135 [M49], ≥ 1:8 (N=25,192)
    192
    1
        hSBA-MenY [M49], ≥ 1:4 (N=25,173)
    173
    6
        hSBA-MenY [M49], ≥ 1:8 (N=25,173)
    173
    6
    No statistical analyses for this end point

    Secondary: Number of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY titres ≥ the cut-off values

    		 Close Top of page
    End point title
    		 Number of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY titres ≥ the cut-off values
    End point description
    The cut off values for the assay were ≥ 1:4 and ≥ 1:8, respectively, as measured by GSK.
    End point type
    Secondary
    End point timeframe
    At 12 months (Month 60) post booster dose
    End point values
    		 Nimenrix Group Y5 Meningitec Group Y5
    Number of subjects analysed
    228
    33
    Units: Subjects
        hSBA-MenA [M60], ≥ 1:4 (N=221; 28)
    211
    3
        hSBA-MenA [M60], ≥ 1:8 (N=221; 28)
    211
    3
        hSBA-MenC [M60], ≥ 1:4 (N=228; 33)
    228
    33
        hSBA-MenC [M60], ≥ 1:8 (N=228; 33)
    228
    33
        hSBA-MenW-135 [M60], ≥ 1:4 (N=218; 31)
    218
    5
        hSBA-MenW-135 [M60], ≥ 1:8 (N=218; 31)
    218
    5
        hSBA-MenY [M60], ≥ 1:4 (N=206; 31)
    206
    10
        hSBA-MenY [M60], ≥ 1:8 (N=206; 31)
    206
    10
    No statistical analyses for this end point

    Secondary: hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY titres

    		 Close Top of page
    End point title
    		 hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY titres
    End point description
    The results were tabulated as geometric mean antibody titre (GMT) calculated on all subjects, expressed in titres, as measured by GSK.
    End point type
    Secondary
    End point timeframe
    At one month (Month 49) post booster dose
    End point values
    		 Nimenrix Group Booster (Month 49) Meningitec Group Booster (Month 49)
    Number of subjects analysed
    209
    33
    Units: Titres
    geometric mean (confidence interval 95%)
        hSBA-MenA [M49] (N=202; 28)
    1343.2 (1119.3 to 1612)
    2.8 (2 to 3.8)
        hSBA-MenC [M49] (N=209; 33)
    15831.4 (13625.8 to 18394)
    8646.1 (5886.6 to 12699.3)
        hSBA-MenW-135 [M49] (N=192; 25)
    14411.2 (12971.8 to 16010.2)
    2.3 (1.7 to 3.3)
        hSBA-MenY [M49] (N=173; 25)
    6775.5 (5961.3 to 7700.9)
    4.9 (2.4 to 9.8)
    No statistical analyses for this end point

    Secondary: hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY titres

    		 Close Top of page
    End point title
    		 hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY titres
    End point description
    The results were tabulated as geometric mean antibody titre (GMT) calculated on all subjects, expressed in titres, as measured by GSK.
    End point type
    Secondary
    End point timeframe
    At 12 months (Month 60) post booster dose
    End point values
    		 Nimenrix Group Y5 Meningitec Group Y5
    Number of subjects analysed
    228
    33
    Units: Titres
    geometric mean (confidence interval 95%)
        hSBA-MenA [M60] (N=221; 28)
    88 (73.6 to 105.1)
    2.5 (1.9 to 3.2)
        hSBA-MenC [M60] (N=228; 33)
    1342.3 (1134.6 to 1588.1)
    931.1 (572.8 to 1513.4)
        hSBA-MenW-135 [M60] (N=218; 31)
    2196.6 (1955.7 to 2467.2)
    3.4 (2.2 to 5.4)
        hSBA-MenY [M60] (N=206; 31)
    1110.8 (987.5 to 1249.6)
    7.5 (3.6 to 15.7)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-PSA, anti-PSC, anti-PSW, and anti-PSY ≥ the cut-off values

    		 Close Top of page
    End point title
    		 Number of subjects with anti-PSA, anti-PSC, anti-PSW, and anti-PSY ≥ the cut-off values
    End point description
    The cut-off values for the assay were 0.3 μg/mL and 2.0 μg/mL, as measured by the PHE laboratory.
    End point type
    Secondary
    End point timeframe
    At one month (Month 49) post booster dose
    End point values
    		 Nimenrix Group Booster (Month 49) Meningitec Group Booster (Month 49)
    Number of subjects analysed
    70
    19
    Units: Subjects
        Anti-PSA [49], ≥ 0.3 (N=67; 15)
    67
    15
        Anti-PSA [49], ≥ 2.0 (N=67; 15)
    66
    6
        Anti-PSC [49], ≥ 0.3 (N=70; 18)
    70
    18
        Anti-PSC [49], ≥ 2.0 (N=70; 18)
    67
    18
        Anti-PSW-135 [49], ≥ 0.3 (N=69; 19)
    69
    13
        Anti-PSW-135 [49], ≥ 2.0 (N=69; 19)
    69
    0
        Anti-PSY [49], ≥ 0.3 (N=64; 10)
    63
    9
        Anti-PSY [49], ≥ 2.0 (N=64; 10)
    63
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-PSA, anti-PSC, anti-PSW, and anti-PSY ≥ the cut-off values

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    End point title
    		 Number of subjects with anti-PSA, anti-PSC, anti-PSW, and anti-PSY ≥ the cut-off values
    End point description
    The cut-off for the assay were 0.3 μg/mL and 2.0 μg/mL, as measured by the PHE laboratory.
    End point type
    Secondary
    End point timeframe
    At 12 months (Month 60) post booster dose
    End point values
    		 Nimenrix Group Y5 Meningitec Group Y5
    Number of subjects analysed
    98
    22
    Units: Subjects
        Anti-PSA [60], ≥ 0.3 (N=98; 22)
    98
    22
        Anti-PSA [60], ≥ 2.0 (N=98; 22)
    82
    5
        Anti-PSC [60], ≥ 0.3 (N=85; 14)
    85
    13
        Anti-PSC [60], ≥ 2.0 (N=85; 14)
    38
    10
        Anti-PSW-135 [60], ≥ 0.3 (N=98; 22)
    98
    8
        Anti-PSW-135 [60], ≥ 2.0 (N=98; 22)
    98
    0
        Anti-PSY [60], ≥ 0.3 (N=86; 12)
    85
    12
        Anti-PSY [60], ≥ 2.0 (N=86; 12)
    85
    6
    No statistical analyses for this end point

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

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    End point title
    		 Anti-PSA, anti-PSC, anti-PSW, and anti-PSY antibody concentrations
    End point description
    The results were tabulated as geometric mean antibody concentration calculated on all subjects, expressed in μg/mL, as measured by the PHE laboratory.
    End point type
    Secondary
    End point timeframe
    At one month (Month 49) post booster dose
    End point values
    		 Nimenrix Group Booster (Month 49) Meningitec Group Booster (Month 49)
    Number of subjects analysed
    70
    19
    Units: μg/mL
    geometric mean (confidence interval 95%)
        Anti-PSA [49] (N=67; 15)
    12.61 (10.39 to 15.29)
    1.76 (1.1 to 2.81)
        Anti-PSC [49] (N=70; 18)
    8.64 (7.18 to 10.4)
    13.07 (9.09 to 18.8)
        Anti-PSW-135 [49] (N=69; 19)
    59.06 (49.26 to 70.81)
    0.34 (0.24 to 0.48)
        Anti-PSY [49] (N=64; 10)
    38.85 (30.2 to 49.98)
    0.56 (0.35 to 0.89)
    No statistical analyses for this end point

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

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    End point title
    		 Anti-PSA, anti-PSC, anti-PSW, and anti-PSY antibody concentrations
    End point description
    The results were tabulated as geometric mean antibody concentration calculated on all subjects, expressed in μg/mL, as measured by the PHE laboratory.
    End point type
    Secondary
    End point timeframe
    At 12 months (Month 60) post booster dose
    End point values
    		 Nimenrix Group Y5 Meningitec Group Y5
    Number of subjects analysed
    98
    22
    Units: μg/mL
    geometric mean (confidence interval 95%)
        Anti-PSA [60] (N=98; 22)
    4.22 (3.64 to 4.88)
    1.41 (1.09 to 1.82)
        Anti-PSC [60] (N=85; 14)
    1.81 (1.56 to 2.11)
    2.93 (1.47 to 5.86)
        Anti-PSW-135 [60] (N=98; 22)
    9.44 (8.29 to 10.74)
    0.26 (0.18 to 0.37)
        Anti-PSY [60] (N=86; 12)
    10.31 (8.64 to 12.29)
    2.24 (1.25 to 4.02)
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any solicited local symptoms

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    End point title
    		 Number of subjects reporting any solicited local symptoms
    End point description
    Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any local symptom regardless of intensity grade.
    End point type
    Secondary
    End point timeframe
    During the 8-day period (Days 0-7) after booster vaccination
    End point values
    		 Nimenrix Group Booster (Month 49) Meningitec Group Booster (Month 49)
    Number of subjects analysed
    244
    47
    Units: Subjects
        Any pain
    149
    23
        Any Redness
    90
    17
        Any Swelling
    70
    11
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any solicited general symptoms

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    End point title
    		 Number of subjects reporting any solicited general symptoms
    End point description
    Solicited general symptoms assessed were drowsiness, irritability, loss of appetite, temperature (measured orally). Any was defined as occurrence of any general symptoms, regardless of their intensity grade or their relationship to vaccination.
    End point type
    Secondary
    End point timeframe
    During the 8-day period (Days 0-7) after the booster vaccination
    End point values
    		 Nimenrix Group Booster (Month 49) Meningitec Group Booster (Month 49)
    Number of subjects analysed
    244
    47
    Units: Subjects
        Any drowsiness (N=244;47)
    41
    10
        Any irritability (N=243;47)
    40
    11
        Any loss of appetite (N=243;47)
    31
    8
        Any temperature (orally, ≥ 37.5°C) (N=243;47)
    16
    1
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any adverse events (AEs)

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    End point title
    		 Number of subjects reporting any adverse events (AEs)
    End point description
    Any was defined as the occurrence of any adverse event regardless of intensity grade or relation to vaccination. 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.
    End point type
    Secondary
    End point timeframe
    During the 31-day period (Days 0-30) after booster vaccination
    End point values
    		 Nimenrix Group Booster (Month 49) Meningitec Group Booster (Month 49)
    Number of subjects analysed
    245
    48
    Units: Subjects
        Any AE(s)
    106
    18
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects reporting any serious adverse events (SAEs)
    End point description
    Serious adverse events (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 Month 24 post primary dose
    End point values
    		 Nimenrix Group Y2 Meningitec Group Y2
    Number of subjects analysed
    253
    42
    Units: Subjects
        Any SAE(s) M24
    0
    0
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects reporting any serious adverse events (SAEs)
    End point description
    Serious adverse events (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 Month 36
    End point values
    		 Nimenrix Group Y3 Meningitec Group Y3
    Number of subjects analysed
    273
    47
    Units: Subjects
        Any SAE(s) M36
    0
    0
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects reporting any serious adverse events (SAEs)
    End point description
    Serious adverse events (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 Month 48
    End point values
    		 Nimenrix Group Y4 Meningitec Group Y4
    Number of subjects analysed
    246
    48
    Units: Subjects
        Any SAE(s) M48
    0
    0
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects reporting any serious adverse events (SAEs)
    End point description
    Serious adverse events (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 month 48 to month 49 (post booster follow up period)
    End point values
    		 Nimenrix Group Booster (Month 49) Meningitec Group Booster (Month 49)
    Number of subjects analysed
    245
    48
    Units: Subjects
        Any SAE(s)
    2
    0
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects reporting any serious adverse events (SAEs)
    End point description
    Serious adverse events (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 month 49 to month 60
    End point values
    		 Nimenrix Group Y5 Meningitec Group Y5
    Number of subjects analysed
    239
    47
    Units: Subjects
        Any SAE(s) M60
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited local and general symptoms: during the 8-day period (Days 0-7) after booster vaccination. Unsolicited symptoms: during the 31-day period (Days 0-30) after booster vaccination. SAEs: during the 31-day period (Days 0-30) following vaccination.
    Adverse event reporting additional description
    The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Nimenrix Group
    Reporting group description
    		 Subjects vaccinated with Nimenrix vaccine in the primary study 109670 [NCT00474266] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study.

    Reporting group title
    Meningitec Group
    Reporting group description
    		 Subjects who received Meningitec vaccine in the primary vaccination study 109670 [NCT00474266] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study.

    Serious adverse events
    		 Nimenrix Group Meningitec Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 245 (0.82%)
    0 / 48 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Limb injury
         subjects affected / exposed
    1 / 245 (0.41%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Hypersensitivity
         subjects affected / exposed
    1 / 245 (0.41%)
    0 / 48 (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 Meningitec Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    190 / 245 (77.55%)
    39 / 48 (81.25%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    5 / 245 (2.04%)
    3 / 48 (6.25%)
         occurrences all number
    6
    4
    Somnolence
         subjects affected / exposed
    41 / 245 (16.73%)
    10 / 48 (20.83%)
         occurrences all number
    41
    10
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    149 / 245 (60.82%)
    23 / 48 (47.92%)
         occurrences all number
    149
    23
    Pyrexia
         subjects affected / exposed
    23 / 245 (9.39%)
    4 / 48 (8.33%)
         occurrences all number
    23
    4
    Swelling
         subjects affected / exposed
    70 / 245 (28.57%)
    11 / 48 (22.92%)
         occurrences all number
    70
    11
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    15 / 245 (6.12%)
    2 / 48 (4.17%)
         occurrences all number
    15
    2
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    90 / 245 (36.73%)
    17 / 48 (35.42%)
         occurrences all number
    90
    17
    Psychiatric disorders
    Irritability
         subjects affected / exposed
    40 / 245 (16.33%)
    11 / 48 (22.92%)
         occurrences all number
    40
    11
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    13 / 245 (5.31%)
    1 / 48 (2.08%)
         occurrences all number
    14
    1
    Upper respiratory tract infection
         subjects affected / exposed
    15 / 245 (6.12%)
    2 / 48 (4.17%)
         occurrences all number
    15
    2
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    31 / 245 (12.65%)
    8 / 48 (16.67%)
         occurrences all number
    31
    8

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Apr 2010
    • At the time of writing of protocol MenACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (112036) it was decided to test a subset of 75% of the enrolled subjects at each time point for hSBA. This was in accordance with what was initially decided for hSBA testing in the primary study MenACWY-TT-039 (109670). However, later on, it was decided to perform hSBA testing on the blood samples taken 42 days after Visit 1 in study MenACWY-TT-039 (109670) of the subjects vaccinated with MenACWY-TT (alone or co-administered with Priorix-Tetra) or Meningitec at Visit 1. Protocol MenACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (112036) is amended to have the same subset of subjects tested for hSBA in this follow-up study.

    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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