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

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

    Results information
    Results version number
    		 v3(current)
    This version publication date
    10 Dec 2020
    First version publication date
    24 May 2015
    Other versions
    		 v1 , v2
    Version creation reason

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    113977
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    27 May 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Mar 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    17 May 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Persistence At 32, 44, 56 and 68 months after primary vaccination with MenACWY-TT or MenC-CRM. To evaluate the persistence of meningococcal antibodies in terms of the percentage of subjects with rSBAMenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY titres ≥1:8.
    Protection of trial subjects
    All subjects were supervised closely for at least 30 minutes following vaccination with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel. Vaccines/products were administered only to eligible subjects that had no contraindications to any components of the vaccines. Subjects were followed-up from the time the subject consents to participate in the study until she/he is discharged.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Jan 2011
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 37 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 97
    Country: Number of subjects enrolled
    Germany: 185
    Worldwide total number of subjects
    282
    EEA total number of subjects
    282
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    282
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Out of 282 subjects participating to the study, 271 participated to Month 32-44 period, 261 to Month 44-56, 260 to Month 56-68, and 282 to Month 68-69 booster period. Out of 282 subjects participating to Month 68-69 booster period, 41 subjects had a subject number allocated but received no vaccine dose, hence only 241 started this phase.

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

    Period 1
    Period 1 title
    Persistence Phase (Month 32-44)
    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
    		 Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Nimenrix vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.
    Arm type
    		 Experimental

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

    Arm title
    		 Menjugate Group
    Arm description
    		 Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Menjugate vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.
    Arm type
    		 Experimental

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

    Number of subjects in period 1 [1]
    		Nimenrix Group Menjugate Group
    Started
    199
    72
    Completed
    199
    72
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Among the 282 subjects participating to the study, 271 subjects started the Persistence epoch Month 32 starting Month 32 and ending Month 44.
    Period 2
    Period 2 title
    Persistence Phase (Month 44-56)
    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
    		 Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Nimenrix vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.
    Arm type
    		 Experimental

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

    Arm title
    		 Menjugate Group
    Arm description
    		 Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Menjugate vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.
    Arm type
    		 Experimental

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

    Number of subjects in period 2 [2]
    		Nimenrix Group Menjugate Group
    Started
    193
    68
    Completed
    193
    68
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: The number of subjects who started each period depends on the number of subjects available at the time.
    Period 3
    Period 3 title
    Persistence Phase (Month 56-68)
    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
    		 Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Nimenrix vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.
    Arm type
    		 Experimental

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

    Arm title
    		 Menjugate Group
    Arm description
    		 Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Menjugate vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.
    Arm type
    		 Experimental

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

    Number of subjects in period 3 [3]
    		Nimenrix Group Menjugate Group
    Started
    193
    67
    Completed
    193
    67
    Notes
    [3] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: The number of subjects who started each period depends on the number of subjects available at the time.
    Period 4
    Period 4 title
    Booster Phase (Month 68-69)
    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
    		 Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Nimenrix vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.
    Arm type
    		 Experimental

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

    Arm title
    		 Menjugate Group
    Arm description
    		 Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Menjugate vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.
    Arm type
    		 Experimental

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

    Number of subjects in period 4 [4]
    		Nimenrix Group Menjugate Group
    Started
    179
    62
    Completed
    174
    60
    Not completed
    5
    2
         Consent withdrawn by subject
    -
    1
         Lost to follow-up
    5
    1
    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: The number of subjects who started each period depends on the number of subjects available at the time.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Nimenrix Group
    Reporting group description
    		 Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Nimenrix vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.

    Reporting group title
    Menjugate Group
    Reporting group description
    		 Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Menjugate vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.

    Reporting group values
    		 Nimenrix Group Menjugate Group Total
    Number of subjects
    		 199 72 271
    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)
    		 199 72 271
        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: Years
        arithmetic mean (standard deviation)
    		 8.4 ( 2.58 ) 8.1 ( 2.42 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 103 34 137
        Male
    		 96 38 134
    Race/Ethnicity, Customized
    Units: Subjects
        White - Caucasian/European Heritage
    		 169 61 230
        Other
    		 8 2 10
        African heritage / African American
    		 7 2 9
        American Indian or Alaskan native
    		 0 0 0
        Asian - Central/South Asian heritage
    		 1 0 1
        Asian - East Asian heritage
    		 1 1 2
        Asian - Japanese heritage
    		 0 0 0
        Asian - South East Asian heritage
    		 1 0 1
        Native Hawaiian or other pacific islander
    		 0 0 0
        White - Arabic / North African heritage
    		 12 6 18

    End points

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    End points reporting groups
    Reporting group title
    Nimenrix Group
    Reporting group description
    		 Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Nimenrix vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.

    Reporting group title
    Menjugate Group
    Reporting group description
    		 Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Menjugate vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.
    Reporting group title
    Nimenrix Group
    Reporting group description
    		 Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Nimenrix vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.

    Reporting group title
    Menjugate Group
    Reporting group description
    		 Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Menjugate vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.
    Reporting group title
    Nimenrix Group
    Reporting group description
    		 Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Nimenrix vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.

    Reporting group title
    Menjugate Group
    Reporting group description
    		 Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Menjugate vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.
    Reporting group title
    Nimenrix Group
    Reporting group description
    		 Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Nimenrix vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.

    Reporting group title
    Menjugate Group
    Reporting group description
    		 Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Menjugate vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.

    Primary: Number of subjects with serum bactericidal assay, using baby rabbit complement, against Neisseria meningitides serogroup A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) antibody titers was greater than or equal to (≥) 1:8, at Month 32.

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    End point title
    		 Number of subjects with serum bactericidal assay, using baby rabbit complement, against Neisseria meningitides serogroup A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) antibody titers was greater than or equal to (≥) 1:8, at Month 32. [1]
    End point description
    The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:8. These analyses have been performed by the Health Protection Agency (HPA) laboratory.
    End point type
    Primary
    End point timeframe
    At Month 32, 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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Nimenrix Group Menjugate Group
    Number of subjects analysed
    193
    69
    Units: Participants
        rSBA-MenA [N=193;69]
    167
    15
        rSBA-MenC [N=192;69]
    124
    53
        rSBA-MenW-135 [N=193;69]
    149
    5
        rSBA-MenY [N=193;69]
    157
    10
    No statistical analyses for this end point

    Primary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers ≥ 1:8, at Month 44.

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    End point title
    		 Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers ≥ 1:8, at Month 44. [2]
    End point description
    The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:8. These analyses have been performed by the Health Protection Agency (HPA) laboratory.
    End point type
    Primary
    End point timeframe
    At Month 44, 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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Nimenrix Group Menjugate Group
    Number of subjects analysed
    189
    66
    Units: Participants
        rSBA-MenA
    162
    17
        rSBA-MenC
    70
    30
        rSBA-MenW-135
    129
    7
        rSBA-MenY
    118
    4
    No statistical analyses for this end point

    Primary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers ≥ 1:8, at Month 56.

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    End point title
    		 Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers ≥ 1:8, at Month 56. [3]
    End point description
    The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:8. These analyses have been performed by the Health Protection Agency (HPA) laboratory.
    End point type
    Primary
    End point timeframe
    At Month 56, 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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Nimenrix Group Menjugate Group
    Number of subjects analysed
    186
    65
    Units: Participants
        rSBA-MenA [N=186;65]
    161
    19
        rSBA-MenC [N=186;65]
    110
    42
        rSBA-MenW-135 [N=186;65]
    145
    17
        rSBA-MenY [N=186;64]
    149
    14
    No statistical analyses for this end point

    Primary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers ≥ 1:8, at Month 68.

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    End point title
    		 Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers ≥ 1:8, at Month 68. [4]
    End point description
    The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:8. These analyses have been performed by the Health Protection Agency (HPA) laboratory.
    End point type
    Primary
    End point timeframe
    At Month 68, 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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Nimenrix Group Menjugate Group
    Number of subjects analysed
    178
    61
    Units: Participants
        rSBA-MenA
    154
    18
        rSBA-MenC
    71
    38
        rSBA-MenW-135
    94
    9
        rSBA-MenY
    127
    8
    No statistical analyses for this end point

    Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers ≥ 1:128, at Month 32.

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    End point title
    		 Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers ≥ 1:128, at Month 32.
    End point description
    The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:128. These analyses have been performed by the Health Protection Agency (HPA) laboratory.
    End point type
    Secondary
    End point timeframe
    At Month 32, post-primary vaccination
    End point values
    		 Nimenrix Group Menjugate Group
    Number of subjects analysed
    193
    69
    Units: Participants
        rSBA-MenA [N=193;69]
    140
    9
        rSBA-MenC [N=192;69]
    69
    35
        rSBA-MenW-135 [N=193;69]
    136
    5
        rSBA-MenY [N=193;69]
    145
    8
    No statistical analyses for this end point

    Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers ≥ 1:128, at Month 44.

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    End point title
    		 Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers ≥ 1:128, at Month 44.
    End point description
    The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:128. These analyses have been performed by the Health Protection Agency (HPA) laboratory.
    End point type
    Secondary
    End point timeframe
    At Month 44, post-primary vaccination
    End point values
    		 Nimenrix Group Menjugate Group
    Number of subjects analysed
    189
    66
    Units: Participants
        rSBA-MenA
    151
    16
        rSBA-MenC
    38
    23
        rSBA-MenW-135
    120
    5
        rSBA-MenY
    107
    3
    No statistical analyses for this end point

    Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers ≥ 1:128, at Month 56.

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    End point title
    		 Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers ≥ 1:128, at Month 56.
    End point description
    The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:128. These analyses have been performed by the Health Protection Agency (HPA) laboratory.
    End point type
    Secondary
    End point timeframe
    At Month 56, post-primary vaccination
    End point values
    		 Nimenrix Group Menjugate Group
    Number of subjects analysed
    186
    65
    Units: Participants
        rSBA-MenA [N=186;65]
    107
    10
        rSBA-MenC [N=186;65]
    65
    32
        rSBA-MenW-135 [N=186;65]
    123
    10
        rSBA-MenY [N=186;64]
    139
    10
    No statistical analyses for this end point

    Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers ≥ 1:128, at Month 68.

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    End point title
    		 Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers ≥ 1:128, at Month 68.
    End point description
    The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:128. These analyses have been performed by the Health Protection Agency (HPA) laboratory.
    End point type
    Secondary
    End point timeframe
    At Month 68, post-primary vaccination
    End point values
    		 Nimenrix Group Menjugate Group
    Number of subjects analysed
    178
    61
    Units: Participants
        rSBA-MenA
    107
    12
        rSBA-MenC
    38
    25
        rSBA-MenW-135
    84
    8
        rSBA-MenY
    118
    6
    No statistical analyses for this end point

    Secondary: Antibody titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 32.

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

    Secondary: Antibody titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 44.

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

    Secondary: Antibody titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 56.

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    End point title
    		 Antibody titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 56.
    End point description
    Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed by the Health Protection Agency (HPA) laboratory.
    End point type
    Secondary
    End point timeframe
    At Month 56, post-primary vaccination
    End point values
    		 Nimenrix Group Menjugate Group
    Number of subjects analysed
    186
    65
    Units: Titers
    geometric mean (confidence interval 95%)
        rSBA-MenA [N=186;65]
    120.1 (87.0 to 165.9)
    9.8 (6.4 to 15.0)
        rSBA-MenC [N=186;65]
    30.5 (22.6 to 41.1)
    69.0 (36.9 to 128.9)
        rSBA-MenW-135 [N=186;65]
    158.3 (112.4 to 222.9)
    10.3 (6.4 to 16.6)
        rSBA-MenY [N=186;64]
    233.2 (166.0 to 327.6)
    9.0 (6.0 to 13.6)
    No statistical analyses for this end point

    Secondary: Antibody titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 68.

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    End point title
    		 Antibody titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 68.
    End point description
    Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed by the Health Protection Agency (HPA) laboratory.
    End point type
    Secondary
    End point timeframe
    At Month 68, post-primary vaccination
    End point values
    		 Nimenrix Group Menjugate Group
    Number of subjects analysed
    178
    61
    Units: Titers
    geometric mean (confidence interval 95%)
        rSBA-MenA
    129.5 (93.5 to 179.3)
    11.1 (7.0 to 17.7)
        rSBA-MenC
    14.2 (10.8 to 18.7)
    44.5 (23.7 to 83.6)
        rSBA-MenW-135
    59.2 (39.3 to 89.2)
    7.8 (5.0 to 12.1)
        rSBA-MenY
    139.4 (96.0 to 202.5)
    6.8 (4.6 to 10.2)
    No statistical analyses for this end point

    Secondary: Number of subjects with serum bactericidal assay, using human complement, against N. meningitides serogroup A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) antibody titers ≥ 1:4 and ≥ 1:8, at Month 32.

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    End point title
    		 Number of subjects with serum bactericidal assay, using human complement, against N. meningitides serogroup A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) antibody titers ≥ 1:4 and ≥ 1:8, at Month 32.
    End point description
    The pre-defined cut-off values of the assay for the hSBA titers were greater than or equal to (≥) 1:4 and ≥ 1:8. These analyses have been performed on 50% of the subjects in each group, by the Health Protection Agency (HPA) laboratory.
    End point type
    Secondary
    End point timeframe
    At Month 32, post-primary vaccination
    End point values
    		 Nimenrix Group Menjugate Group
    Number of subjects analysed
    91
    34
    Units: Participants
        hSBA-MenA, ≥ 1:4 [N=90;34]
    24
    5
        hSBA-MenC, ≥ 1:4 [N=90;33]
    86
    30
        hSBA-MenW-135, ≥ 1:4 [N=86;23]
    73
    4
        hSBA-MenY, ≥ 1:4 [N=91;28]
    74
    13
        hSBA-MenA, ≥ 1:8 [N=90;34]
    23
    5
        hSBA-MenC, ≥ 1:8 [N=90;33]
    86
    30
        hSBA-MenW-135, ≥ 1:8 [N=86;23]
    73
    4
        hSBA-MenY, ≥ 1:8 [N=91;28]
    74
    13
    No statistical analyses for this end point

    Secondary: Number of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY antibody titers ≥ 1:4 and ≥ 1:8, at Month 44.

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    End point title
    		 Number of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY antibody titers ≥ 1:4 and ≥ 1:8, at Month 44.
    End point description
    The pre-defined cut-off values of the assay for the hSBA titers were greater than or equal to (≥) 1:4 and ≥ 1:8. These analyses have been performed on 50% of the subjects in each group, by the Health Protection Agency (HPA) laboratory.
    End point type
    Secondary
    End point timeframe
    At Month 44, post-primary vaccination
    End point values
    		 Nimenrix Group Menjugate Group
    Number of subjects analysed
    89
    31
    Units: Participants
        hSBA-MenA, ≥ 1:4 [N=89;31]
    26
    5
        hSBA-MenC, ≥ 1:4 [N=82;31]
    63
    20
        hSBA-MenW-135, ≥ 1:4 [N=87;30]
    70
    8
        hSBA-MenY, ≥ 1:4 [N=76;26]
    63
    12
        hSBA-MenA, ≥ 1:8 [N=89;31]
    23
    5
        hSBA-MenC, ≥ 1:8 [N=82;31]
    63
    20
        hSBA-MenW-135, ≥ 1:8 [N=87;30]
    70
    8
        hSBA-MenY, ≥ 1:8 [N=76;26]
    63
    12
    No statistical analyses for this end point

    Secondary: Number of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY antibody titers ≥ 1:4 and ≥ 1:8, at Month 56.

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    End point title
    		 Number of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY antibody titers ≥ 1:4 and ≥ 1:8, at Month 56.
    End point description
    The pre-defined cut-off values of the assay for the hSBA titers were greater than or equal to (≥) 1:4 and ≥ 1:8. These analyses have been performed on 50% of the subjects in each group, by the Health Protection Agency (HPA) laboratory.
    End point type
    Secondary
    End point timeframe
    At Month 56, post-primary vaccination
    End point values
    		 Nimenrix Group Menjugate Group
    Number of subjects analysed
    89
    33
    Units: Participants
        hSBA-MenA, ≥ 1:4 [N=89;33]
    53
    19
        hSBA-MenC, ≥ 1:4 [N=86;31]
    66
    21
        hSBA-MenW-135, ≥ 1:4 [N=83;30]
    69
    13
        hSBA-MenY, ≥ 1:4 [N=89;31]
    79
    22
        hSBA-MenA, ≥ 1:8 [N=89;33]
    53
    19
        hSBA-MenC, ≥ 1:8 [N=86;31]
    64
    21
        hSBA-MenW-135, ≥ 1:8 [N=83;30]
    69
    13
        hSBA-MenY, ≥ 1:8 [N=89;31]
    79
    22
    No statistical analyses for this end point

    Secondary: Number of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY antibody titers ≥ 1:4 and ≥ 1:8, at Month 68.

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    End point title
    		 Number of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY antibody titers ≥ 1:4 and ≥ 1:8, at Month 68.
    End point description
    The pre-defined cut-off values of the assay for the hSBA titers were greater than or equal to (≥) 1:4 and ≥ 1:8. These analyses have been performed in all subjects, by the Health Protection Agency (HPA) laboratory.
    End point type
    Secondary
    End point timeframe
    At Month 68, post-primary vaccination
    End point values
    		 Nimenrix Group Menjugate Group
    Number of subjects analysed
    172
    59
    Units: Participants
        hSBA-MenA, ≥ 1:4 [N=170;59]
    70
    23
        hSBA-MenC, ≥ 1:4 [N=172;57]
    134
    43
        hSBA-MenW-135, ≥ 1:4 [N=159;52]
    125
    19
        hSBA-MenY, ≥ 1:4 [N=159;58]
    116
    24
        hSBA-MenA, ≥ 1:8 [N=170;59]
    69
    21
        hSBA-MenC, ≥ 1:8 [N=172;57]
    130
    43
        hSBA-MenW-135, ≥ 1:8 [N=159;52]
    125
    19
        hSBA-MenY, ≥ 1:8 [N=159;58]
    116
    24
    No statistical analyses for this end point

    Secondary: Antibody titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 32.

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    End point title
    		 Antibody titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 32.
    End point description
    Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed on 50% of the subjects in each group, by the Health Protection Agency (HPA) laboratory.
    End point type
    Secondary
    End point timeframe
    At Month 32, post-primary vaccination
    End point values
    		 Nimenrix Group Menjugate Group
    Number of subjects analysed
    91
    34
    Units: Titers
    geometric mean (confidence interval 95%)
        hSBA-MenA [N=90;34]
    4.6 (3.3 to 6.3)
    2.7 (2.1 to 3.4)
        hSBA-MenC [N=90;33]
    75.9 (53.4 to 107.9)
    82.2 (34.6 to 195.8)
        hSBA-MenW-135 [N=86;23]
    69.9 (48.2 to 101.5)
    3.8 (2 to 7.1)
        hSBA-MenY [N=91;28]
    79.2 (52.5 to 119.3)
    15.1 (6.3 to 36.5)
    No statistical analyses for this end point

    Secondary: Antibody titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 44.

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    End point title
    		 Antibody titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 44.
    End point description
    Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed on 50% of the subjects in each group, by the Health Protection Agency (HPA) laboratory.
    End point type
    Secondary
    End point timeframe
    At Month 44, post-primary vaccination
    End point values
    		 Nimenrix Group Menjugate Group
    Number of subjects analysed
    89
    31
    Units: Titers
    geometric mean (confidence interval 95%)
        hSBA-MenA [N=89;31]
    4.8 (3.4 to 6.7)
    2.8 (2.1 to 3.7)
        hSBA-MenC [N=82;31]
    36.4 (23.1 to 57.2)
    38.8 (13.3 to 113.2)
        hSBA-MenW-135 [N=87;30]
    64.3 (42.7 to 96.8)
    5.2 (2.8 to 9.5)
        hSBA-MenY [N=76;26]
    126.7 (78 to 205.7)
    16.8 (16.8 to 44.9)
    No statistical analyses for this end point

    Secondary: Antibody titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 56.

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    End point title
    		 Antibody titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 56.
    End point description
    Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed on 50% of the subjects in each group, by the Health Protection Agency (HPA) laboratory.
    End point type
    Secondary
    End point timeframe
    At Month 56, post-primary vaccination
    End point values
    		 Nimenrix Group Menjugate Group
    Number of subjects analysed
    89
    33
    Units: Titers
    geometric mean (confidence interval 95%)
        hSBA-MenA [N=89;33]
    10.6 (7.6 to 14.9)
    7.6 (5.0 to 11.8)
        hSBA-MenC [N=86;31]
    20.6 (13.8 to 30.8)
    31.2 (11.5 to 85.0)
        hSBA-MenW-135 [N=83;30]
    59.3 (40.2 to 87.6)
    9.2 (4.7 to 18.2)
        hSBA-MenY [N=89;31]
    117.9 (80.8 to 171.9)
    35.7 (16.8 to 75.9)
    No statistical analyses for this end point

    Secondary: Antibody titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 68.

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    End point title
    		 Antibody titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 68.
    End point description
    Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed by the Health Protection Agency (HPA) laboratory.
    End point type
    Secondary
    End point timeframe
    At Month 68, post-primary vaccination
    End point values
    		 Nimenrix Group Menjugate Group
    Number of subjects analysed
    172
    59
    Units: Titers
    geometric mean (confidence interval 95%)
        hSBA-MenA [N=170;59]
    6.9 (5.4 to 8.9)
    4.5 (3.3 to 6.0)
        hSBA-MenC [N=172;57]
    28.4 (21.2 to 37.9)
    34.3 (19.0 to 61.0)
        hSBA-MenW-135 [N=159;52]
    56.7 (41.5 to 77.3)
    8.1 (4.7 to 13.8)
        hSBA-MenY [N=159;58]
    56.3 (39.5 to 80.3)
    13.3 (7.0 to 25.1)
    No statistical analyses for this end point

    Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers ≥ 1:128 and 1:8.

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    End point title
    		 Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers ≥ 1:128 and 1:8.
    End point description
    The pre-defined cut-off values of the assay for the rSBA titers were greater than or equal to (≥) 1:128 and ≥ 1:8. These analyses have been performed by the Health Protection Agency (HPA) laboratory.
    End point type
    Secondary
    End point timeframe
    At Month 69, one month post-booster vaccination
    End point values
    		 Nimenrix Group Menjugate Group
    Number of subjects analysed
    165
    55
    Units: Participants
        rSBA-MenA, ≥ 1:8
    165
    55
        rSBA-MenC, ≥ 1:8
    165
    55
        rSBA-MenW-135, ≥ 1:8
    165
    55
        rSBA-MenY, ≥ 1:8
    165
    55
        rSBA-MenA, ≥ 1:128
    165
    55
        rSBA-MenC, ≥ 1:128
    165
    55
        rSBA-MenW-135, ≥ 1:128
    165
    55
        rSBA-MenY, ≥ 1:128
    165
    55
    No statistical analyses for this end point

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

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    End point title
    		 Antibody titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY
    End point description
    Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed by the Health Protection Agency (HPA) laboratory.
    End point type
    Secondary
    End point timeframe
    At Month 69, one month post-booster vaccination
    End point values
    		 Nimenrix Group Menjugate Group
    Number of subjects analysed
    165
    55
    Units: Titers
    geometric mean (confidence interval 95%)
        rSBA-MenA
    5613.0 (4946.3 to 6369.4)
    3521.1 (2912.5 to 4256.9)
        rSBA-MenC
    5314.6 (4596.2 to 6145.4)
    7042.2 (5317.4 to 9326.5)
        rSBA-MenW-135
    14750.6 (12779.6 to 17025.6)
    10540.4 (8455.2 to 13139.8)
        rSBA-MenY
    7954.6 (7167.8 to 8827.8)
    5829.2 (4725.6 to 7190.6)
    No statistical analyses for this end point

    Secondary: Number of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY antibody titers ≥ 1:4 and 1:8.

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    End point title
    		 Number of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY antibody titers ≥ 1:4 and 1:8.
    End point description
    The pre-defined cut-off values of the assay for the hSBA titers were greater than or equal to (≥) 1:4 and ≥ 1:8. These analyses have been performed by the Health Protection Agency (HPA) laboratory.
    End point type
    Secondary
    End point timeframe
    At Month 69, one month post-booster vaccination
    End point values
    		 Nimenrix Group Menjugate Group
    Number of subjects analysed
    163
    54
    Units: Participants
        hSBA-MenA, ≥ 1:4 [N=163;53]
    163
    46
        hSBA-MenC, ≥ 1:4 [N=161;54]
    161
    54
        hSBA-MenW-135, ≥ 1:4 [N=156;52]
    156
    50
        hSBA-MenY, ≥ 1:4 [N=160;54]
    160
    52
        hSBA-MenA, ≥ 1:8 [N=163;53]
    163
    46
        hSBA-MenC, ≥ 1:8 [N=161;54]
    161
    54
        hSBA-MenW-135, ≥ 1:8 [N=156;52]
    156
    50
        hSBA-MenY, ≥ 1:8 [N=160;54]
    160
    52
    No statistical analyses for this end point

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

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    End point title
    		 Antibody titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY
    End point description
    Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed by the Health Protection Agency (HPA) laboratory.
    End point type
    Secondary
    End point timeframe
    At Month 69, one month post-booster vaccination
    End point values
    		 Nimenrix Group Menjugate Group
    Number of subjects analysed
    163
    54
    Units: Titers
    geometric mean (confidence interval 95%)
        hSBA-MenA [N=163;53]
    1376.5 (1138.2 to 1664.6)
    101.2 (59.3 to 172.8)
        hSBA-MenC [N=161;54]
    11986.8 (10085.2 to 14247.0)
    13692.2 (10094.2 to 18572.8)
        hSBA-MenW-135 [N=156;52]
    14582.1 (12448.5 to 17081.5)
    235.7 (152.0 to 365.5)
        hSBA-MenY [N=160;54]
    12835.9 (11074.4 to 14877.5)
    527.3 (356.5 to 779.9)
    No statistical analyses for this end point

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

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

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

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    End point title
    		 Number of subjects with a vaccine response to hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY antibodies
    End point description
    Vaccine response to hSBA-MenA, hSBA-MenC, rSBA-MenW-135 and hSBA-MenY was defined as hSBA antibody titers ≥ 1:8, for initially seronegative subjects (i.e. pre-vaccination hSBA antibody titers <1:4) and at least a 4-fold increase in hSBA antibody titers from pre to post-vaccination for initially seropositive subjects (i.e. pre-vaccination hSBA antibody titers ≥1:4).
    End point type
    Secondary
    End point timeframe
    At Month 69, one month post-booster vaccination
    End point values
    		 Nimenrix Group Menjugate Group
    Number of subjects analysed
    159
    52
    Units: Participants
        hSBA-MenA [N=159;52]
    156
    43
        hSBA-MenC [N=156;50]
    153
    46
        hSBA-MenW-135 [N=139;45]
    136
    34
        hSBA-MenY [N=144;51]
    142
    35
    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
    Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 50 millimeters (mm). “Any” was defined as incidence of the specified symptom regardless of intensity.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) period following the booster vaccination
    End point values
    		 Nimenrix Group Menjugate Group
    Number of subjects analysed
    171
    60
    Units: Participants
        Any Pain
    113
    35
        Grade 3 Pain
    7
    4
        Any Redness
    62
    25
        Grade 3 Redness
    8
    4
        Any Swelling
    52
    19
        Grade 3 Swelling
    4
    3
    No statistical analyses for this end point

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

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

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

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    End point title
    		 Number of subjects with any unsolicited adverse events (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.
    End point type
    Secondary
    End point timeframe
    During the 31-day (Days 0-30) period following the booster vaccination
    End point values
    		 Nimenrix Group Menjugate Group
    Number of subjects analysed
    179
    62
    Units: Participants
    26
    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
    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
    During the 31-day (Days 0-30) period following the booster vaccination
    End point values
    		 Nimenrix Group Menjugate Group
    Number of subjects analysed
    179
    62
    Units: Participants
    0
    0
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with any new onset of chronic illnesses (NOCIs)
    End point description
    New onset of chronic illnesses (NOCIs) included: autoimmune disorders, asthma, type I diabetes and allergies.
    End point type
    Secondary
    End point timeframe
    During the 31-day (Days 0-30) period following the booster vaccination
    End point values
    		 Nimenrix Group Menjugate Group
    Number of subjects analysed
    179
    62
    Units: Participants
    0
    0
    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, result in disability/incapacity.
    End point type
    Secondary
    End point timeframe
    Up to Month 32, 44, 56 and 68
    End point values
    		 Nimenrix Group Menjugate Group
    Number of subjects analysed
    199
    72
    Units: Participants
        Up to Month 32 [N=199;72]
    0
    0
        Up to Month 44 [N=193;68]
    0
    0
        Up to Month 56 [N=193;67]
    0
    0
        Up to Month 68 [N=179;62]
    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 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (Month 32 up to Month 69).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Menjugate Group
    Reporting group description
    		 Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Menjugate vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.

    Reporting group title
    Nimenrix Group
    Reporting group description
    		 Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Nimenrix vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.

    Serious adverse events
    		 Menjugate Group Nimenrix Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 179 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Menjugate Group Nimenrix Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    48 / 62 (77.42%)
    130 / 179 (72.63%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    10 / 62 (16.13%)
    43 / 179 (24.02%)
         occurrences all number
    10
    49
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    12 / 62 (19.35%)
    38 / 179 (21.23%)
         occurrences all number
    12
    38
    Pain
         subjects affected / exposed
    35 / 62 (56.45%)
    113 / 179 (63.13%)
         occurrences all number
    35
    113
    Pyrexia
         subjects affected / exposed
    8 / 62 (12.90%)
    17 / 179 (9.50%)
         occurrences all number
    8
    17
    Swelling
         subjects affected / exposed
    19 / 62 (30.65%)
    52 / 179 (29.05%)
         occurrences all number
    19
    52
    Gastrointestinal disorders
    Gastrointestinal disorder
         subjects affected / exposed
    7 / 62 (11.29%)
    19 / 179 (10.61%)
         occurrences all number
    7
    19
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    25 / 62 (40.32%)
    62 / 179 (34.64%)
         occurrences all number
    25
    62

    More information

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

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

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