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    Clinical Trial Results:
    A phase IV, open, multicenter, multicountry study to assess the long-term antibody persistence of a booster dose of GlaxoSmithKline (GSK) Biologicals’ Haemophilus influenzae type b – meningococcal serogroup C conjugate (Hib-MenC) vaccine given at 12-15 months of age to subjects who were primed in primary study 103974 (HIB-MENC-TT-012) and boosted in study 104056 (HIB-MENC-TT-013 BST:012).

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2006-006460-32
    Trial protocol
    		 GB  
    Global end of trial date
    18 May 2010

    Results information
    Results version number
    		 v2(current)
    This version publication date
    17 Jun 2016
    First version publication date
    29 May 2015
    Other versions
    		 v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    Data correction due to a system error in EudraCT – Results

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    109664,109666,109668
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00454987
    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
    10 Mar 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 May 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    In all evaluable subjects of groups HibMenC and LicMenC at 12 months after the booster vaccination; in all evaluable subjects of groups HibMenC and LicMenC at 24 months after the booster vaccination; in all evaluable subjects of group NoBoost at 40-43 months of age; and in all evaluable subjects of groups HibMenC and LicMenC at 48 months after the booster vaccination: • To evaluate the persistence of meningococcal C antibodies • To evaluate the persistence of Haemophilus influenzae type b antibodies. In all UK evaluable subjects* of groups HibMenC and LicMenC: • To evaluate the persistence of anti-pertussis antibodies prior to Infanrix-IPV preschool booster and the response to Infanrix-IPV preschool booster 24 months later. * UK pediatric vaccination schedule recommends a DTP booster at the moment of Visit 2 (24 months after study booster vaccination) of our study; the Polish pediatric vaccination schedule recommends a DTP booster before Visit 1 of our study.
    Protection of trial subjects
    Vaccines were administered by qualified and trained personnel. Vaccines were administered only to eligible subjects that had no contraindications to any components of the vaccines.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 May 2007
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 4 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 192
    Country: Number of subjects enrolled
    Poland: 286
    Worldwide total number of subjects
    478
    EEA total number of subjects
    478
    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)
    478
    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
    		 -

    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
    Booster phase
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    Partially double-blind: The primary phase of the study will be open with respect to the treatment administered, but double-blind with respect to the Hib-MenC and DTPa-IPV lots. The booster phase will be double-blind with respect to the Hib-MenC lots.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Menitorix Group
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Menitorix™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Menitorix co-administered with Priorix. Menitorix was administered intramuscularly in the deltoid region of the right arm.

    Investigational medicinal product name
    Priorix-Tetra™
    Investigational medicinal product code
    Other name
    Priorix TM
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    One dose of Priorix was co-administered with Menitorix. Priorix was administered subcutaneously in the left arm.

    Arm title
    		 Meningitec Group
    Arm description
    		 -
    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
    Meningitec, 0.5 ml, was administered intramuscularly in the right thigh.

    Investigational medicinal product name
    Pediacel™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Pediacel, 0.5 ml, was administered intramuscularly, in the left thigh.

    Investigational medicinal product name
    Menitorix™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Menitorix was co-administered with Priorix. One dose of Menitorix was administered in the deltoid region of the right arm.

    Investigational medicinal product name
    Priorix-Tetra™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    One dose of Priorix was co-administered with Menitorix. Priorix was administered subcutaneously in the left arm.

    Number of subjects in period 1 [1]
    		Menitorix Group Meningitec Group
    Started
    359
    117
    Completed
    357
    116
    Not completed
    2
    1
         Consent withdrawn by subject
    1
    1
         Adverse event, non-fatal
    1
    -
    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: Subjects were taken into account even if they missed study visits. The number of subjects started depends on the actual rate of return.
    Period 2
    Period 2 title
    Year 1
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Menitorix Group
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Menitorix™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Menitorix was co-administered with Priorix. One dose of Menitorix was administered in the deltoid region of the right arm.

    Investigational medicinal product name
    Infanrix™ IPV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Infanrix IPV was administered according to the manufacturer's instructions to UK subjects at 40 to 43 months of age.

    Investigational medicinal product name
    Priorix-Tetra™
    Investigational medicinal product code
    Other name
    Priorix TM
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Priorix, 0.5 ml, was administered in opposite limbs (right or left arm) subcutaneously.

    Arm title
    		 Meningitec Group
    Arm description
    		 -
    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
    Meningitec, 0.5 ml, was administered intramuscularly in the right thigh.

    Investigational medicinal product name
    Pediacel™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Pediacel, 0.5 ml, was administered intramuscularly, in the left thigh.

    Investigational medicinal product name
    Menitorix™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Menitorix was only administered to subjects of the group NoBoost at 40 to 43 months of age.

    Investigational medicinal product name
    Priorix-Tetra™
    Investigational medicinal product code
    Other name
    Priorix TM
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Priorix, 0.5 ml, was administered in opposite limbs (right or left arm) subcutaneously.

    Number of subjects in period 2 [2]
    		Menitorix Group Meningitec Group
    Started
    221
    67
    Completed
    221
    67
    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: Subjects were taken into account even if they missed study visits. The number of subjects started depends on the actual rate of return.
    Period 3
    Period 3 title
    Year 2
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Menitorix Group
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Menitorix™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Menitorix was only administered to subjects of the group NoBoost at 40 to 43 months of age.

    Investigational medicinal product name
    Infanrix™ IPV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Infanrix IPV was administered according to the manufacturer's instructions to UK subjects at 40 to 43 months of age.

    Investigational medicinal product name
    Priorix-Tetra™
    Investigational medicinal product code
    Other name
    Priorix TM
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Priorix, 0.5 ml, was administered in opposite limbs (right or left arm) subcutaneously.

    Arm title
    		 Meningitec Group
    Arm description
    		 -
    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
    Meningitec, 0.5 ml, was administered intramuscularly in the right thigh.

    Investigational medicinal product name
    Pediacel™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Pediacel, 0.5 ml, was administered intramuscularly, in the left thigh.

    Investigational medicinal product name
    Menitorix™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Menitorix was only administered to subjects of the group NoBoost at 40 to 43 months of age.

    Investigational medicinal product name
    Priorix-Tetra™
    Investigational medicinal product code
    Other name
    Priorix TM
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Priorix, 0.5 ml, was administered in opposite limbs (right or left arm) subcutaneously.

    Number of subjects in period 3
    		Menitorix Group Meningitec Group
    Started
    221
    67
    Completed
    235
    77
    Joined
    14
    10
         Late return for study visit
    14
    10
    Period 4
    Period 4 title
    Year 4
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Menitorix Group
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Menitorix™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Menitorix was only administered to subjects of the group NoBoost at 40 to 43 months of age.

    Investigational medicinal product name
    Infanrix™ IPV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Infanrix IPV was administered according to the manufacturer's instructions to UK subjects at 40 to 43 months of age.

    Investigational medicinal product name
    Priorix-Tetra™
    Investigational medicinal product code
    Other name
    Priorix TM
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Priorix, 0.5 ml, was administered in opposite limbs (right or left arm) subcutaneously.

    Arm title
    		 Meningitec Group
    Arm description
    		 -
    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
    Meningitec, 0.5 ml, was administered intramuscularly in the right thigh.

    Investigational medicinal product name
    Pediacel™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Pediacel, 0.5 ml, was administered intramuscularly, in the left thigh.

    Investigational medicinal product name
    Menitorix™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Menitorix was only administered to subjects of the group NoBoost at 40 to 43 months of age.

    Investigational medicinal product name
    Priorix-Tetra™
    Investigational medicinal product code
    Other name
    Priorix TM
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Priorix, 0.5 ml, was administered in opposite limbs (right or left arm) subcutaneously.

    Number of subjects in period 4 [3]
    		Menitorix Group Meningitec Group
    Started
    206
    62
    Completed
    206
    62
    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: Subjects were taken into account even if they missed study visits. The number of subjects started depends on the actual rate of return.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Menitorix Group
    Reporting group description
    		 -

    Reporting group title
    Meningitec Group
    Reporting group description
    		 -

    Reporting group values
    		 Menitorix Group Meningitec Group Total
    Number of subjects
    		 359 117 476
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 12.8 ( 0.75 ) 12.8 ( 0.78 ) -
    Gender categorical
    Units: Subjects
        Female
    		 179 62 241
        Male
    		 180 55 235

    End points

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    End points reporting groups
    Reporting group title
    Menitorix Group
    Reporting group description
    		 -

    Reporting group title
    Meningitec Group
    Reporting group description
    		 -
    Reporting group title
    Menitorix Group
    Reporting group description
    		 -

    Reporting group title
    Meningitec Group
    Reporting group description
    		 -
    Reporting group title
    Menitorix Group
    Reporting group description
    		 -

    Reporting group title
    Meningitec Group
    Reporting group description
    		 -
    Reporting group title
    Menitorix Group
    Reporting group description
    		 -

    Reporting group title
    Meningitec Group
    Reporting group description
    		 -

    Subject analysis set title
    NoBoost Group
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects enrolled only in the UK (at Visit 2), primed (according to the routine UK immunization schedule) with 3 doses of a MenC conjugate vaccine and a Hib containing vaccine before the age of 8 months without booster dose at 12 months of age. Those subjects received a catch-up dose of Hib-MenC in study 109666.

    Primary: Number of subjects with rSBA-MenC antibody titers ≥1:8

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    End point title
    		 Number of subjects with rSBA-MenC antibody titers ≥1:8 [1]
    End point description
    End point type
    Primary
    End point timeframe
    Up to Year 1
    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 primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Menitorix Group Meningitec Group
    Number of subjects analysed
    204
    64
    Units: Subjects
        rSBS-MenC (Pre-Primary) [N=204;60]
    12
    3
        rSBS-MenC (Post-Primary) [N=202;63]
    200
    63
        rSBS-MenC (Pre-Booster) [N=202;62]
    163
    39
        rSBS-MenC (Post-Booster) [N=203;64]
    201
    61
        rSBS-MenC PIV (M12) [N=200;59]
    178
    41
    No statistical analyses for this end point

    Primary: Number of subjects with rSBA-MenC antibody titers ≥1:128

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    End point title
    		 Number of subjects with rSBA-MenC antibody titers ≥1:128 [2]
    End point description
    End point type
    Primary
    End point timeframe
    Up to Year 1
    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 primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Menitorix Group Meningitec Group
    Number of subjects analysed
    204
    64
    Units: Subjects
        rSBS-MenC (Pre-Primary) [N=204;60]
    3
    0
        rSBS-MenC (Post-Primary) [N=202;63]
    189
    63
        rSBS-MenC (Pre-Booster) [N=202;62]
    94
    19
        rSBS-MenC (Post-Booster) [N=203;64]
    199
    56
        rSBS-MenC PIV (M12) [N=200;59]
    109
    17
    No statistical analyses for this end point

    Primary: rSBA-MenC antibody titres

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    End point title
    		 rSBA-MenC antibody titres [3]
    End point description
    End point type
    Primary
    End point timeframe
    Up to Year 1
    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 primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Menitorix Group Meningitec Group
    Number of subjects analysed
    204
    64
    Units: Titre
    geometric mean (confidence interval 95%)
        rSBS-MenC (Pre-Primary) [N=204;60]
    4.8 (4.3 to 5.3)
    4.3 (3.9 to 4.8)
        rSBS-MenC (Post-Primary) [N=202;63]
    624.7 (530.7 to 735.4)
    1000 (778.8 to 1284.2)
        rSBS-MenC (Pre-Booster) [N=202;62]
    67.1 (52.8 to 85.3)
    32.4 (20.3 to 51.6)
        rSBS-MenC (Post-Booster) [N=203;64]
    2540.3 (2058 to 3135.5)
    517.4 (346.7 to 772)
        rSBS-MenC PIV (M12) [N=200;59]
    123 (98.9 to 153)
    35.7 (23.4 to 54.5)
    No statistical analyses for this end point

    Primary: Number of subjects with rSBA-MenC antibody titers ≥ 1:8

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    End point title
    		 Number of subjects with rSBA-MenC antibody titers ≥ 1:8 [4]
    End point description
    End point type
    Primary
    End point timeframe
    Up to Year 2
    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 primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Menitorix Group Meningitec Group
    Number of subjects analysed
    228
    76
    Units: Subjects
        rSBS-MenC (Pre-Primary) [N=227;70]
    16
    2
        rSBS-MenC (Post-Primary) [N=224;73]
    222
    73
        rSBS-MenC (Pre-Booster) [N=226;72]
    175
    48
        rSBS-MenC (Post-Booster M1) [N=228;76]
    227
    73
        rSBS-MenC (Post-Booster M12) [N=184;53]
    164
    37
        rSBS-MenC (Post-Booster M24) [N=219;74]
    147
    30
    No statistical analyses for this end point

    Primary: Number of subjects with rSBA-MenC antibody titers ≥ 1:8

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    End point title
    		 Number of subjects with rSBA-MenC antibody titers ≥ 1:8 [5]
    End point description
    End point type
    Primary
    End point timeframe
    Up to Year 2
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 NoBoost Group
    Number of subjects analysed
    68
    Units: Subjects
        Subjects with no booster administered
    30
    No statistical analyses for this end point

    Primary: Number of subjects with rSBA-MenC antibody titers ≥ 1:128

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    End point title
    		 Number of subjects with rSBA-MenC antibody titers ≥ 1:128 [6]
    End point description
    End point type
    Primary
    End point timeframe
    Up to Year 2
    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 primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Menitorix Group Meningitec Group
    Number of subjects analysed
    228
    76
    Units: Subjects
        rSBS-MenC (Pre-Primary) [N=227;70]
    5
    0
        rSBS-MenC (Post-Primary) [N=224;73]
    208
    73
        rSBS-MenC (Pre-Booster) [N=226;72]
    96
    22
        rSBS-MenC (Post-Booster M1) [N=228;76]
    225
    66
        rSBS-MenC (Post-Booster M12) [N=184;53]
    98
    15
        rSBS-MenC (Post-Booster M24) [N=219;74]
    86
    10
    No statistical analyses for this end point

    Primary: Number of subjects with rSBA-MenC antibody titers ≥ 1:128

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    End point title
    		 Number of subjects with rSBA-MenC antibody titers ≥ 1:128 [7]
    End point description
    End point type
    Primary
    End point timeframe
    Up to Year 2
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 NoBoost Group
    Number of subjects analysed
    68
    Units: Subjects
        Subjects with no booster administered
    11
    No statistical analyses for this end point

    Primary: rSBA-MenC antibody titres

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    End point title
    		 rSBA-MenC antibody titres [8]
    End point description
    End point type
    Primary
    End point timeframe
    Up to Year 2
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Menitorix Group Meningitec Group
    Number of subjects analysed
    228
    76
    Units: Titre
    geometric mean (confidence interval 95%)
        rSBS-MenC (Pre-Primary) [N=227;70]
    5 (4.4 to 5.6)
    4.2 (3.9 to 4.5)
        rSBS-MenC (Post-Primary) [N=224;73]
    592.3 (507.3 to 691.5)
    1075.6 (859.8 to 1345.5)
        rSBS-MenC (Pre-Booster) [N=226;72]
    58.6 (46.4 to 73.9)
    35 (23.1 to 53)
        rSBS-MenC (Post-Booster M1) [N=228;76]
    2320.8 (1926.2 to 2796.2)
    520.9 (367.9 to 737.6)
        rSBS-MenC (Post-Booster M12) [N=184;53]
    122.3 (97.5 to 153.4)
    35.9 (22.9 to 56)
        rSBS-MenC (Post-Booster M24) [N=219;74]
    48 (36.8 to 62.6)
    14.4 (9.7 to 21.6)
    No statistical analyses for this end point

    Primary: rSBA-MenC antibody titres

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    End point title
    		 rSBA-MenC antibody titres [9]
    End point description
    End point type
    Primary
    End point timeframe
    Up to Year 2
    Notes
    [9] - 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 primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 NoBoost Group
    Number of subjects analysed
    68
    Units: Titre
    geometric mean (confidence interval 95%)
        Subjects with no booster administered
    15.9 (10.3 to 24.3)
    No statistical analyses for this end point

    Primary: Number of subjects with rSBA-MenC antibody titers ≥1:8

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    End point title
    		 Number of subjects with rSBA-MenC antibody titers ≥1:8 [10]
    End point description
    End point type
    Primary
    End point timeframe
    Up to Year 4
    Notes
    [10] - 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 primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Menitorix Group Meningitec Group
    Number of subjects analysed
    195
    58
    Units: Subjects
        rSBS-MenC (Pre-Primary) [N=194;53]
    10
    2
        rSBS-MenC (Post-Primary) [N=194;55]
    192
    55
        rSBS-MenC (Pre-Boost) [N=195;55]
    156
    34
        rSBS-MenC (Post-Boost M1) [N=195;58]
    194
    56
        rSBS-MenC (Post-Boost M12) [N=166;45]
    148
    30
        rSBS-MenC (Post-Boost M24) [N=187;56]
    123
    20
        rSBS-MenC (Post-Boost M48) [N=194;58]
    115
    26
    No statistical analyses for this end point

    Primary: Number of subjects with rSBA-MenC antibody titers ≥1:128

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    End point title
    		 Number of subjects with rSBA-MenC antibody titers ≥1:128 [11]
    End point description
    End point type
    Primary
    End point timeframe
    Up to Year 4
    Notes
    [11] - 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 primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Menitorix Group Meningitec Group
    Number of subjects analysed
    195
    58
    Units: Subjects
        rSBS-MenC (Pre-Primary) [N=194;53]
    2
    0
        rSBS-MenC (Post-Primary) [N=194;55]
    182
    55
        rSBS-MenC (Pre-Boost) [N=195;55]
    87
    17
        rSBS-MenC (Post-Boost M1) [N=195;58]
    193
    50
        rSBS-MenC (Post-Boost M12) [N=166;45]
    88
    11
        rSBS-MenC (Post-Boost M24) [N=187;56]
    78
    6
        rSBS-MenC (Post-Boost M48) [N=194;58]
    58
    5
    No statistical analyses for this end point

    Primary: rSBA-MenC antibody titers

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    End point title
    		 rSBA-MenC antibody titers [12]
    End point description
    End point type
    Primary
    End point timeframe
    Up to Year 4
    Notes
    [12] - 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 primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Menitorix Group Meningitec Group
    Number of subjects analysed
    195
    58
    Units: Titre
    geometric mean (confidence interval 95%)
        rSBS-MenC (Pre-Primary) [N=194;53]
    4.7 (4.2 to 5.2)
    4.2 (3.9 to 4.6)
        rSBS-MenC (Post-Primary) [N=194;55]
    616.1 (521.3 to 728.2)
    983.9 (742.6 to 1303.7)
        rSBS-MenC (Pre-Boost) [N=195;55]
    64.3 (50.3 to 82.4)
    30.8 (18.8 to 50.4)
        rSBS-MenC (Post-Boost M1) [N=195;58]
    2537 (2071.9 to 3106.5)
    507 (338.3 to 759.8)
        rSBS-MenC (Post-Boost M12) [N=166;45]
    124.1 (97.5 to 158)
    30.6 (18.7 to 50.1)
        rSBS-MenC (Post-Boost M24) [N=187;56]
    47.9 (35.7 to 64.3)
    12.1 (7.7 to 18.8)
        rSBS-MenC (Post-Boost M48) [N=194;58]
    30.4 (22.9 to 40.4)
    11.3 (7.7 to 16.5)
    No statistical analyses for this end point

    Primary: Number of subjects with anti-polyribosylribitol phosphate (anti-PRP) antibodies ≥0.15 µg/mL and ≥1 µg/mL

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    End point title
    		 Number of subjects with anti-polyribosylribitol phosphate (anti-PRP) antibodies ≥0.15 µg/mL and ≥1 µg/mL [13]
    End point description
    End point type
    Primary
    End point timeframe
    Up to Year 1
    Notes
    [13] - 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 primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Menitorix Group Meningitec Group
    Number of subjects analysed
    206
    64
    Units: Subjects
        Anti-PRP ≥0.15 µg/mL (Pre-Primary) [N=206;63]
    84
    25
        Anti-PRP ≥1.0 µg/mL (Pre-Primary) [N=206;63]
    20
    11
        Anti-PRP ≥0.15 µg/mL (Post-Primary) [N=204;63]
    204
    58
        Anti-PRP ≥1.0 µg/mL (Post-Primary) [N=204;63]
    198
    43
        Anti-PRP≥0.15 µg/mL (Pre-Boost) [N=204;64]
    199
    45
        Anti-PRP ≥1.0 µg/mL (Pre-Boost) [N=204;64]
    120
    19
        Anti-PRP ≥0.15 µg/mL (Post-Boost) [N=203;63]
    203
    63
        Anti-PRP≥1.0 µg/mL (Post-Boost) [N=203;63]
    203
    63
        Anti-PRP ≥0.15 µg/mL PIV (M12) [N=198;63]
    198
    63
        Anti-PRP ≥1.0 µg/mL PIV (M12) [N=198;63]
    188
    52
    No statistical analyses for this end point

    Primary: Concentration of anti-PRP antibodies

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    End point title
    		 Concentration of anti-PRP antibodies [14]
    End point description
    End point type
    Primary
    End point timeframe
    Up to Year 1
    Notes
    [14] - 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 primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Menitorix Group Meningitec Group
    Number of subjects analysed
    206
    64
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PRP (Pre-Primary) [N=206;63]
    0.16 (0.137 to 0.186)
    0.178 (0.13 to 0.243)
        Anti-PRP (Post-Primary) [N=204;63]
    12.413 (10.688 to 14.417)
    2.473 (1.557 to 3.928)
        Anti-PRP (Pre-Boost) [N=204;64]
    1.293 (1.095 to 1.528)
    0.441 (0.309 to 0.627)
        Anti-PRP (Post-Boost) [N=203;63]
    88.667 (74.609 to 105.373)
    39.024 (30.588 to 49.786)
        Anti-PRP PIV (M12) [N=198;63]
    7.153 (6.029 to 8.486)
    3.162 (2.316 to 4.318)
    No statistical analyses for this end point

    Primary: Number of subjects with anti-polyribosylribitol phosphate (anti-PRP) antibodies ≥0.15 µg/mL and ≥1 µg/mL

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    End point title
    		 Number of subjects with anti-polyribosylribitol phosphate (anti-PRP) antibodies ≥0.15 µg/mL and ≥1 µg/mL [15]
    End point description
    End point type
    Primary
    End point timeframe
    Up to Year 2
    Notes
    [15] - 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 primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Menitorix Group Meningitec Group
    Number of subjects analysed
    230
    75
    Units: Subjects
        Anti-PRP ≥0.15 µg/mL (Pre-Primary) [N=230;73]
    93
    30
        Anti-PRP ≥1.0 µg/mL (Pre-Primary) [N=230;73]
    18
    9
        Anti-PRP ≥0.15 µg/mL (Post-Primary) [N=227;73]
    227
    66
        Anti-PRP ≥1.0 µg/mL (Post-Primary) [N=227;73]
    222
    52
        Anti-PRP ≥0.15 µg/mL (Pre-Boost) [N=229;74]
    222
    53
        Anti-PRP ≥1.0 µg/mL (Pre-Boost) [N=229;74]
    134
    21
        Anti-PRP ≥0.15 µg/mL (Post-Boost M1) [N=228;75]
    228
    75
        Anti-PRP≥1.0 µg/mL (Post-Boost M1) [N=228;75]
    228
    75
        Anti-PRP ≥0.15 µg/mL (Post-Boost M12) [N=182;57]
    182
    57
        Anti-PRP ≥1.0 µg/mL (Post-Boost M12) [N=182;57]
    172
    48
        Anti-PRP ≥0.15 µg/mL (Post-Boost M24) [N=228;75]
    227
    74
        Anti-PRP ≥1.0 µg/mL (Post-Boost M24) [N=228;75]
    203
    56
    No statistical analyses for this end point

    Primary: Number of subjects with anti-polyribosylribitol phosphate (anti-PRP) antibodies ≥0.15 µg/mL and ≥1 µg/mL

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    End point title
    		 Number of subjects with anti-polyribosylribitol phosphate (anti-PRP) antibodies ≥0.15 µg/mL and ≥1 µg/mL [16]
    End point description
    End point type
    Primary
    End point timeframe
    Up to Year 2
    Notes
    [16] - 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 primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 NoBoost Group
    Number of subjects analysed
    72
    Units: Subjects
        Anti-PRP≥0.15 µg/mL (Subjects with no booster)
    62
        Anti-PRP≥1.0 µg/mL (Subjects with no booster )
    28
    No statistical analyses for this end point

    Primary: Concentration of anti-PRP antibodies

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    End point title
    		 Concentration of anti-PRP antibodies [17]
    End point description
    End point type
    Primary
    End point timeframe
    Up to Year 2
    Notes
    [17] - 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 primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Menitorix Group Meningitec Group
    Number of subjects analysed
    230
    75
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PRP (Pre-Primary) [N=230;73]
    0.153 (0.134 to 0.176)
    0.163 (0.125 to 0.213)
        Anti-PRP (Post-Primary) [N=227;73]
    12.794 (11.159 to 14.669)
    2.396 (1.58 to 3.635)
        Anti-PRP (Pre-Boost) [N=229;74]
    1.26 (1.08 to 1.469)
    0.425 (0.31 to 0.582)
        Anti-PRP (Post-Boost M1) [N=228;75]
    91.981 (78.7 to 107.503)
    44.002 (34.546 to 56.048)
        Anti-PRP (Post-Boost M12) [N=182;57]
    7.107 (5.931 to 8.516)
    3.456 (2.488 to 4.799)
        Anti-PRP (Post-Boost M24) [N=228;75]
    4.79 (4.065 to 5.644)
    2.339 (1.798 to 3.042)
    No statistical analyses for this end point

    Primary: Concentration of anti-PRP antibodies

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    End point title
    		 Concentration of anti-PRP antibodies [18]
    End point description
    End point type
    Primary
    End point timeframe
    Up to Year 2
    Notes
    [18] - 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 primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 NoBoost Group
    Number of subjects analysed
    72
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PRP (Subjects with no booster)
    0.668 (0.467 to 0.956)
    No statistical analyses for this end point

    Primary: Number of subjects with anti-polyribosylribitol phosphate (anti-PRP) antibodies ≥0.15 µg/mL and ≥1 µg/mL

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    End point title
    		 Number of subjects with anti-polyribosylribitol phosphate (anti-PRP) antibodies ≥0.15 µg/mL and ≥1 µg/mL [19]
    End point description
    End point type
    Primary
    End point timeframe
    Up to Year 4
    Notes
    [19] - 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 primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Menitorix Group Meningitec Group
    Number of subjects analysed
    197
    58
    Units: Subjects
        Anti-PRP ≥0.15 µg/mL (Pre-Primary) [N=197;56]
    77
    24
        Anti-PRP ≥1.0 µg/mL (Pre-Primary) [N=197;56]
    14
    9
        Anti-PRP ≥0.15 µg/mL (Post-Primary) [N=196;55]
    196
    48
        Anti-PRP ≥1.0 µg/mL (Post-Primary) [N=196;55]
    191
    33
        Anti-PRP ≥0.15 µg/mL (Pre-Boost) [N=197;57]
    191
    38
        Anti-PRP ≥1.0 µg/mL (Pre-Boost) [N=197;57]
    119
    14
        Anti-PRP ≥0.15 µg/mL (Post-Boost M1) [N=195;57]
    195
    57
        Anti-PRP ≥1.0 µg/mL (Post-Boost M1) [N=195;57]
    195
    57
        Anti-PRP ≥0.15 µg/mL (Post-Boost M12) [N=164;48]
    164
    48
        Anti-PRP ≥1.0 µg/mL (Post-Boost M12) [N=164;48]
    157
    40
        Anti-PRP ≥0.15 µg/mL (Post-Boost M24) [N=194;56]
    193
    55
        Anti-PRP ≥1.0 µg/mL (Post-Boost M24) [N=194;56]
    174
    40
        Anti-PRP ≥0.15 µg/mL (Post-Boost M48) [N=197;58]
    197
    58
        Anti-PRP ≥1.0 µg/mL (Post-Boost M48) [N=197;58]
    171
    36
    No statistical analyses for this end point

    Primary: Concentration of anti-PRP antibodies

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    End point title
    		 Concentration of anti-PRP antibodies [20]
    End point description
    End point type
    Primary
    End point timeframe
    Up to Year 4
    Notes
    [20] - 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 primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Menitorix Group Meningitec Group
    Number of subjects analysed
    197
    58
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PRP (Pre-Primary) [N=197;56]
    0.149 (0.129 to 0.173)
    0.18 (0.13 to 0.25)
        Anti-PRP (Post-Primary) [N=196;55]
    12.715 (10.945 to 14.771)
    1.776 (1.058 to 2.979)
        Anti-PRP (Pre-Boost) [N=197;57]
    1.276 (1.08 to 1.508)
    0.38 (0.263 to 0.55)
        Anti-PRP (Post-Boost M1) [N=195;57]
    90.101 (76.087 to 106.697)
    39.105 (29.506 to 51.825)
        Anti-PRP (Post-Boost M12) [N=164;48]
    7.455 (6.176 to 8.998)
    3.557 (2.45 to 5.165)
        Anti-PRP (Post-Boost M24) [N=194;56]
    4.928 (4.135 to 5.873)
    2.083 (1.524 to 2.847)
        Anti-PRP (Post-Boost M48) [N=197;58]
    3.824 (3.218 to 4.543)
    1.673 (1.215 to 2.305)
    No statistical analyses for this end point

    Primary: Number of subjects with anti-serogroup C polysaccharide (anti-PSC) antibody concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL

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    End point title
    		 Number of subjects with anti-serogroup C polysaccharide (anti-PSC) antibody concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL [21]
    End point description
    End point type
    Primary
    End point timeframe
    Up to Year 1
    Notes
    [21] - 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 primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Menitorix Group Meningitec Group
    Number of subjects analysed
    206
    64
    Units: Subjects
        Anti-PSC≥0.3 µg/mL (Pre-Primary) [N=206;63]
    19
    4
        Anti-PSC≥2 µg/mL (Pre-Primary) [N=206;63]
    8
    1
        Anti-PSC≥0.3 µg/mL (Post-Primary) [N=202;63]
    202
    63
        Anti-PSC ≥2 µg/mL (Post-Primary) [N=202;63]
    201
    63
        Anti-PSC≥0.3 µg/mL (Pre-Booster) [N=201;64]
    170
    56
        Anti-PSC≥2 µg/mL (Pre-Booster) [N=201;64]
    27
    10
        Anti-PSC≥0.3 µg/mL (Post-Booster) [N=205;64]
    205
    64
        Anti-PSC≥2 µg/mL (Post-Booster) [N=205;64]
    183
    47
        Anti-PSC≥0.3 µg/mL (PIV [M12]) [N=193;59]
    119
    29
        Anti-PSC≥2µg/mL (PIV [M12]) [N=193;59]
    19
    2
    No statistical analyses for this end point

    Primary: Concentration of anti-PSC antibodies

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    End point title
    		 Concentration of anti-PSC antibodies [22]
    End point description
    End point type
    Primary
    End point timeframe
    Up to Year 1
    Notes
    [22] - 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 primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Menitorix Group Meningitec Group
    Number of subjects analysed
    206
    64
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PSC (Pre-Primary) [N=206;63]
    0.18 (0.17 to 0.2)
    0.17 (0.15 to 0.18)
        Anti-PSC (Post-Primary) [N=202;63]
    9.52 (8.68 to 10.45)
    11.2 (9.42 to 13.33)
        Anti-PSC (Pre-Booster) [N=201;64]
    0.77 (0.67 to 0.88)
    0.84 (0.66 to 1.06)
        Anti-PSC (Post-Booster) [N=205;64]
    7.36 (6.46 to 8.39)
    3.51 (2.84 to 4.32)
        Anti-PSC (PIV [M12]) [N=193;59]
    0.47 (0.4 to 0.55)
    0.32 (0.26 to 0.4)
    No statistical analyses for this end point

    Primary: Number of subjects with anti-serogroup C polysaccharide (anti-PSC) antibody concentrations ≥0.3 µg/mL and ≥2 µg/mL

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    End point title
    		 Number of subjects with anti-serogroup C polysaccharide (anti-PSC) antibody concentrations ≥0.3 µg/mL and ≥2 µg/mL [23]
    End point description
    End point type
    Primary
    End point timeframe
    Up to Year 2
    Notes
    [23] - 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 primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Menitorix Group Meningitec Group
    Number of subjects analysed
    230
    76
    Units: Subjects
        Anti-PSC≥0.3 µg/mL (Pre-Primary) [N=229;73]
    26
    6
        Anti-PSC≥2 µg/mL (Pre-Primary) [N=229;73]
    12
    1
        Anti-PSC≥0.3 µg/mL (Post-Primary) [N=225;72]
    225
    72
        Anti-PSC≥2 µg/mL (Post-Primary) [N=225;72]
    224
    72
        Anti-PSC≥0.3 µg/mL (Pre-Booster) [N=226;74]
    188
    66
        Anti-PSC≥2 µg/mL (Pre-Booster) [N=226;74]
    27
    13
        Anti-PSC≥0.3 µg/mL (Post-Booster [M1]) [N=230;76]
    230
    76
        Anti-PSC≥2 µg/mL (Post-Booster [M1]) [N=230;76]
    210
    59
        Anti-PSC≥0.3 µg/mL (Post-Booster [M12]) [N=178;54]
    110
    26
        Anti-PSC≥2 µg/mL (Post-Booster [M12]) [N=178;54]
    16
    2
        Anti-PSC≥0.3 µg/mL (Post-Booster [M24]) [N=226;75
    76
    17
        Anti-PSC≥2 µg/mL (Post-Booster [M24]) [N=226;75]
    5
    0
    No statistical analyses for this end point

    Primary: Number of subjects with anti-serogroup C polysaccharide (anti-PSC) antibody concentrations ≥0.3 µg/mL and ≥2 µg/mL

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    End point title
    		 Number of subjects with anti-serogroup C polysaccharide (anti-PSC) antibody concentrations ≥0.3 µg/mL and ≥2 µg/mL [24]
    End point description
    End point type
    Primary
    End point timeframe
    Up to Year 2
    Notes
    [24] - 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 primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 NoBoost Group
    Number of subjects analysed
    72
    Units: Subjects
        Anti-PSC≥0.3 µg/mL (Subjects with no booster)
    4
        Anti-PSC≥2 µg/mL (Subjects with no booster)
    0
    No statistical analyses for this end point

    Primary: Concentration of anti-PSC antibodies

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    End point title
    		 Concentration of anti-PSC antibodies [25]
    End point description
    End point type
    Primary
    End point timeframe
    Up to Year 2
    Notes
    [25] - 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 primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Menitorix Group Meningitec Group
    Number of subjects analysed
    230
    76
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PSC (Pre-Primary) [N=229;73]
    0.2 (0.18 to 0.22)
    0.17 (0.15 to 0.18)
        Anti-PSC (Post-Primary) [N=225;72]
    9.35 (8.56 to 10.22)
    12.29 (10.5 to 14.39)
        Anti-PSC (Pre-Booster) [N=226;74]
    0.74 (0.65 to 0.84)
    0.87 (0.69 to 1.1)
        Anti-PSC (Post-Booster [M1]) [N=230;76]
    7.41 (6.59 to 8.33)
    3.91 (3.19 to 4.79)
        Anti-PSC (Post-Booster [M12]) [N=178;54]
    0.47 (0.4 to 0.55)
    0.32 (0.25 to 0.4)
        Anti-PSC (Post-Booster [M24]) [N=226;75]
    0.25 (0.23 to 0.28)
    0.21 (0.18 to 0.24)
    No statistical analyses for this end point

    Primary: Concentration of anti-PSC antibodies

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    End point title
    		 Concentration of anti-PSC antibodies [26]
    End point description
    End point type
    Primary
    End point timeframe
    Up to Year 2
    Notes
    [26] - 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 primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 NoBoost Group
    Number of subjects analysed
    72
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PSC (Subjecs with no booster)
    0.16 (0.15 to 0.18)
    No statistical analyses for this end point

    Primary: Number of subjects with anti-serogroup C polysaccharide (anti-PSC) antibody concentrations ≥0.3 µg/mL and ≥2 µg/mL

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    End point title
    		 Number of subjects with anti-serogroup C polysaccharide (anti-PSC) antibody concentrations ≥0.3 µg/mL and ≥2 µg/mL [27]
    End point description
    End point type
    Primary
    End point timeframe
    Up to Year 4
    Notes
    [27] - 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 primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Menitorix Group Meningitec Group
    Number of subjects analysed
    197
    58
    Units: Subjects
        Anti-PSC≥0.3 µg/mL (Pre-Primary) [N=197;56]
    19
    3
        Anti-PSC≥2 µg/mL (Pre-Primary) [N=197;56]
    7
    1
        Anti-PSC≥0.3 µg/mL (Post-Primary) [N=194;54]
    194
    54
        Anti-PSC≥2 µg/mL (Post-Primary) [N=194;54]
    193
    54
        Anti-PSC≥0.3 µg/mL (Pre-Boost) [N=194;57]
    163
    52
        Anti-PSC≥2 µg/mL (Pre-Boost) [N=194;57]
    24
    9
        Anti-PSC≥0.3 µg/mL (Post-Boost [M1]) [N=197;58]
    197
    58
        Anti-PSC≥2 µg/mL (Post-Boost [M1]) [N=197;58]
    179
    43
        Anti-PSC≥0.3µg/mL (Post-Boost [M12]) [N=161;45]
    101
    22
        Anti-PSC≥2 µg/mL (Post-Boost [M12]) [N=161;45]
    15
    2
        Anti-PSC≥0.3 µg/mL (Post-Boost [M24]) [N=193;56]
    69
    10
        Anti-PSC≥2 µg/mL (Post-Boost [M24]) [N=193;56]
    5
    0
        Anti-PSC≥0.3µg/mL (Post-Boost [M48]) [N=192;56]
    38
    4
        Anti-PSC≥2µ g/mL (Post-Boost [M48]) [N=192;56]
    6
    0
    No statistical analyses for this end point

    Primary: Concentration of anti-PSC antibodies

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    End point title
    		 Concentration of anti-PSC antibodies [28]
    End point description
    End point type
    Primary
    End point timeframe
    Up to Year 4
    Notes
    [28] - 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 primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Menitorix Group Meningitec Group
    Number of subjects analysed
    197
    58
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PSC (Pre-Primary) [N=197;56]
    0.19 (0.17 to 0.21)
    0.16 (0.15 to 0.18)
        Anti-PSC (Post-Primary) [N=194;54]
    9.41 (8.55 to 10.36)
    11.88 (9.75 to 14.46)
        Anti-PSC (Pre-Boost) [N=194;57]
    0.76 (0.66 to 0.87)
    0.85 (0.66 to 1.09)
        Anti-PSC (Post-Boost [M1]) [N=197;58]
    7.46 (6.55 to 8.49)
    3.76 (2.94 to 4.8)
        Anti-PSC (Post-Boost [M12]) [N=161;45]
    0.48 (0.41 to 0.57)
    0.34 (0.26 to 0.45)
        Anti-PSC (Post-Boost [M24]) [N=193;56]
    0.27 (0.23 to 0.3)
    0.19 (0.16 to 0.22)
        Anti-PSC (Post-Boost [M48]) [N=192;56]
    0.21 (0.19 to 0.23)
    0.17 (0.15 to 0.19)
    No statistical analyses for this end point

    Primary: Number of subjects with anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) antibody concentrations ≥ 5.0 EL.U/mL

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    End point title
    		 Number of subjects with anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) antibody concentrations ≥ 5.0 EL.U/mL [29]
    End point description
    Up to Year 2
    End point type
    Primary
    End point timeframe
    Up to Year 2
    Notes
    [29] - 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 primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Menitorix Group Meningitec Group
    Number of subjects analysed
    67
    23
    Units: Subjects
        Anti-PT Pre-Primary [N=64;18]
    11
    3
        Anti-PT Post-Primary (M3) [N=63;20]
    63
    20
        Anti-PT Post-Primary (M10) [N=66;21]
    34
    10
        Anti-PT Pre-Boost [N=67;23]
    8
    3
        Anti-FHA Pre-Primary [N=65;19]
    40
    12
        Anti-FHA Post-Primary (M3) [N=63;20]
    63
    20
        Anti-FHA Post-Primary (M10) [N=65;21]
    65
    21
        Anti-FHA Pre-Boost [N=64;22]
    47
    13
        Anti-PRN Pre-Primary [N=64;19]
    22
    4
        Anti-PRN Post-Primary (M3) [N=63;20]
    63
    20
        Anti-PRN Post-Primary (M10) [N=66;21]
    53
    14
        Anti-PRN Pre-Boost [N=67;23]
    34
    7
    No statistical analyses for this end point

    Primary: Concentration of anti-PT, anti-FHA and anti-PRN antibodies

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    End point title
    		 Concentration of anti-PT, anti-FHA and anti-PRN antibodies [30]
    End point description
    End point type
    Primary
    End point timeframe
    Up toYear 2
    Notes
    [30] - 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 primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Menitorix Group Meningitec Group
    Number of subjects analysed
    67
    23
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PT Pre-Primary [N=64;18]
    3.2 (2.8 to 3.7)
    3.3 (2.4 to 4.6)
        Anti-PT Post-Primary (M3) [N=63;20]
    44.8 (39.1 to 51.2)
    40.1 (31.7 to 50.8)
        Anti-PT Post-Primary (M10) [N=66;21]
    4.9 (4.1 to 5.9)
    4.5 (3.3 to 6.1)
        Anti-PT Pre-Boost [N=67;23]
    2.9 (2.6 to 3.2)
    3 (2.4 to 3.6)
        Anti-FHA Pre-Primary [N=65;19]
    6.5 (5.2 to 8.2)
    7.8 (4.7 to 13)
        Anti-FHA Post-Primary (M3) [N=63;20]
    223.5 (194.6 to 256.7)
    160.2 (123.1 to 208.6)
        Anti-FHA Post-Primary (M10) [N=65;21]
    30.4 (25.7 to 35.9)
    25.8 (19 to 34.9)
        Anti-FHA Pre-Boost [N=64;22]
    15.1 (9.5 to 24)
    20.3 (8 to 51.8)
        Anti-PRN Pre-Primary [N=64;19]
    4.2 (3.4 to 5.2)
    3.1 (2.5 to 3.9)
        Anti-PRN Post-Primary (M3) [N=63;20]
    116.3 (93.7 to 144.5)
    46.1 (31 to 68.5)
        Anti-PRN Post-Primary (M10) [N=66;21]
    12.5 (9.5 to 16.2)
    6.6 (4.4 to 9.9)
        Anti-PRN Pre-Boost [N=67;23]
    5.9 (4.5 to 7.7)
    4.3 (2.8 to 6.5)
    No statistical analyses for this end point

    Primary: Number of subjects with anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) antibody concentrations ≥ 5.0 EL.U/mL

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    End point title
    		 Number of subjects with anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) antibody concentrations ≥ 5.0 EL.U/mL [31]
    End point description
    End point type
    Primary
    End point timeframe
    Up to Year 4
    Notes
    [31] - 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 primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Menitorix Group Meningitec Group
    Number of subjects analysed
    44
    14
    Units: Subjects
        Anti-PT Pre-Primary [N=41;12]
    9
    2
        Anti-PT Post-Primary (M3) [N=42;11]
    42
    11
        Anti-PT Post-Primary (M10) [N=44;13]
    24
    5
        Anti-PT Pre-Boost ( M32) [N=43;14]
    6
    2
        Anti-PT Post-Boost ( M24) [N=44;13]
    30
    9
        Anti-FHA Pre-Primary [N=42;12]
    27
    9
        Anti-FHA Post-Primary (M3) [N=42;11]
    42
    11
        Anti-FHA Post-Primary (M10) [N=44;13]
    43
    13
        Anti-FHA Pre-Boost ( M32) [N=41;13]
    29
    10
        Anti-FHA Post-Boost ( M24) [N=41;14]
    41
    14
        Anti-PRN Pre-Primary [N=41;12]
    13
    3
        Anti-PRN Post-Primary (M3) [N=42;11]
    42
    11
        Anti-PRN Post-Primary (M10) [N=44;13]
    36
    8
        Anti-PRN Pre-Boost ( M32) [N=43;14]
    25
    4
        Anti-PRN Post-Boost ( M24) [N=44;14]
    43
    14
    No statistical analyses for this end point

    Primary: Concentration of anti-PT, anti-FHA and anti-PRN antibodies

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    End point title
    		 Concentration of anti-PT, anti-FHA and anti-PRN antibodies [32]
    End point description
    End point type
    Primary
    End point timeframe
    Up to Year 4
    Notes
    [32] - 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 primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Menitorix Group Meningitec Group
    Number of subjects analysed
    44
    14
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PT Pre-Primary [N=41;12]
    3.4 (2.8 to 4.1)
    3.4 (2.1 to 5.5)
        Anti-PT Post-Primary (M3) [N=42;11]
    45.2 (37.2 to 54.8)
    36.5 (26.1 to 51.1)
        Anti-PT Post-Primary (M10) [N=44;13]
    5.1 (4.1 to 6.4)
    3.9 (2.7 to 5.6)
        Anti-PT Pre-Boost ( M32) [N=43;14]
    3 (2.5 to 3.5)
    3.1 (2.3 to 4.1)
        Anti-PT Post-Boost ( M24) [N=44;13]
    8.2 (6.1 to 10.9)
    7.2 (3.9 to 13.4)
        Anti-FHA Pre-Primary [N=42;12]
    7.2 (5.2 to 10)
    9.1 (4.7 to 17.6)
        Anti-FHA Post-Primary (M3) [N=42;11]
    229.9 (188.5 to 280.4)
    169.8 (127 to 227)
        Anti-FHA Post-Primary (M10) [N=44;13]
    27.2 (22.1 to 33.5)
    22.8 (15.6 to 33.3)
        Anti-FHA Pre-Boost ( M32) [N=41;13]
    16.7 (9 to 30.9)
    33.1 (9.6 to 113.8)
        Anti-FHA Post-Boost ( M24) [N=41;14]
    164.7 (119.4 to 227.1)
    66.8 (43.8 to 101.7)
        Anti-PRN Pre-Primary [N=41;12]
    3.9 (3.1 to 4.9)
    3.1 (2.4 to 4.1)
        Anti-PRN Post-Primary (M3) [N=42;11]
    135.6 (106 to 173.4)
    50.4 (26 to 97.6)
        Anti-PRN Post-Primary (M10) [N=44;13]
    12.2 (8.9 to 16.7)
    5.6 (3.6 to 8.8)
        Anti-PRN Pre-Boost ( M32) [N=43;14]
    6.6 (4.5 to 9.5)
    4.9 (2.4 to 9.8)
        Anti-PRN Post-Boost ( M24) [N=44;14]
    102.8 (67.1 to 157.3)
    23.4 (15.1 to 36.2)
    No statistical analyses for this end point

    Primary: Number of subjects with Serious Adverse Events (SAEs)

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    End point title
    		 Number of subjects with Serious Adverse Events (SAEs) [33]
    End point description
    End point type
    Primary
    End point timeframe
    Up to Month 12 (Booster vaccination)
    Notes
    [33] - 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 primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Menitorix Group Meningitec Group
    Number of subjects analysed
    359
    117
    Units: Subjects
        Any SAE(s)
    0
    0
    No statistical analyses for this end point

    Primary: Number of subjects with SAEs

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    End point title
    		 Number of subjects with SAEs [34]
    End point description
    End point type
    Primary
    End point timeframe
    Up to Month 24 (Booster vaccination)
    Notes
    [34] - 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 primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Menitorix Group Meningitec Group
    Number of subjects analysed
    359
    117
    Units: Subjects
        Any SAE(s)
    0
    0
    No statistical analyses for this end point

    Primary: Number of subjects with SAEs

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    End point title
    		 Number of subjects with SAEs [35]
    End point description
    End point type
    Primary
    End point timeframe
    Up to Month 48 (Booster vaccination)
    Notes
    [35] - 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 primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Menitorix Group Meningitec Group
    Number of subjects analysed
    359
    117
    Units: Subjects
        Any SAE(s)
    1
    0
    No statistical analyses for this end point

    Primary: Number of UK subjects with SAEs

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    End point title
    		 Number of UK subjects with SAEs [36]
    End point description
    End point type
    Primary
    End point timeframe
    Within (31-Days) post vaccination at Year 2
    Notes
    [36] - 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 primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Menitorix Group Meningitec Group NoBoost Group
    Number of subjects analysed
    70
    23
    72
    Units: Subjects
        Any SAE(s)
    1
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Serious adverse events (SAEs) occurring from the last study contact of the booster study until the end of the persistence study. Serious adverse events (SAEs) occurring within 31 days of administration of the DTPa-IPV and Hib-MenC vaccines in UK.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.1
    Reporting groups
    Reporting group title
    Menitorix Group (Booster)
    Reporting group description
    		 -

    Reporting group title
    Meningitec Group (Booster)
    Reporting group description
    		 -

    Reporting group title
    Menitorix Group (Year 2)
    Reporting group description
    		 -

    Reporting group title
    Meningitec Group (Year 2)
    Reporting group description
    		 -

    Reporting group title
    NoBoost Group
    Reporting group description
    		 -

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No information about unsolicited adverse events was collected during this study.
    Serious adverse events
    		 Menitorix Group (Booster) Meningitec Group (Booster) Menitorix Group (Year 2) Meningitec Group (Year 2) NoBoost Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 359 (0.28%)
    0 / 117 (0.00%)
    1 / 70 (1.43%)
    0 / 23 (0.00%)
    0 / 72 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 359 (0.28%)
    0 / 117 (0.00%)
    0 / 70 (0.00%)
    0 / 23 (0.00%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 359 (0.00%)
    0 / 117 (0.00%)
    1 / 70 (1.43%)
    0 / 23 (0.00%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Menitorix Group (Booster) Meningitec Group (Booster) Menitorix Group (Year 2) Meningitec Group (Year 2) NoBoost Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 359 (0.00%)
    0 / 117 (0.00%)
    0 / 70 (0.00%)
    0 / 23 (0.00%)
    0 / 72 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Oct 2009
    Amendment 3. The protocol was amended to enlarge the age window at Visit 3 from 60-64 months of age to 56-64 months of age. About 40% of the subjects of groups HibMenC and LicMenC had a Hib and/or MenC suboptimal response at 2 years after administration of the Hib-MenC booster dose (i.e. blood sample taken in study 109666 Hib-MenC-TT-028 EXT:013 M24) and will be offered an extra dose of a Hib and/or MenC licensed vaccine. Since administration of an extra dose of Hib and/or MenC vaccine since the previous long term persistence visit is an exclusion criterion for the ATP cohort for persistence Year 4, 40% of the subjects would be lost for the analysis on that cohort. To allow administration of an extra dose of Hib and/or MenC vaccine as soon as possible after the blood sampling of study 109668 (Hib-MenC-TT-029 EXT: 013 M48) this protocol amendment allows Visit 3 to take place 4 months earlier than originally planned (at 56-64 months of age instead of at 60- 64 months of age). In addition, an error was detected in the study vaccine number for GlaxoSmithKline (GSK) Biologicals. Haemophilus influenzae type b (Hib) - meningococcal serogroup C (MenC) - tetanus toxoid conjugate (Hib-MenC) vaccine mentioned in Protocol Amendment 2. The correct vaccine number is 811936. The reference to Edition 3 of the Hib-MenC-TT Investigator Brochure was removed since a more recent version is available.

    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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