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    Clinical Trial Results:
    A phase II, open-label, multicentre study to evaluate the safety and immunogenicity of GSK Biologicals’ DTPa-HBV-IPV/Hib-MenC-TT vaccine as a booster dose in children aged 12 to 18 months, previously primed with the same vaccine in the primary vaccination study DTPa-HBV-IPV=Hib-MenC-TT-002 (112157).

    Summary
    EudraCT number
    		 2010-019253-18
    Trial protocol
    		 PL  
    Global end of trial date
    03 Dec 2010

    Results information
    Results version number
    		 v3(current)
    This version publication date
    18 May 2018
    First version publication date
    03 Jan 2015
    Other versions
    		 v1 (removed from public view) , v2
    Version creation reason
    • Correction of full data set
    Minor corrections of the full study results.

    Trial information

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    Trial identification
    Sponsor protocol code
    113978
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01171989
    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
    25 Mar 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Dec 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Dec 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Note: Objectives are conditional to having met all the primary and secondary objectives in study DTPa-HBV-IPV=Hib-MenC-TT-002 (112157). - To demonstrate that GSK Biologicals’ DTPa-HBV-IPV/Hib-MenC-TT vaccine is non-inferior to Menjugate co-administered with Infanrix hexa in terms of seroprotection to MenC one month after the booster dose. - To demonstrate that GSK Biologicals’ DTPa-HBV-IPV/Hib-MenC-TT vaccine is non-inferior to Infanrix hexa co-administered with NeisVac-C in terms of seroprotection to PRP and MenC, one month after the booster dose.
    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
    18 Aug 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 391
    Worldwide total number of subjects
    391
    EEA total number of subjects
    391
    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)
    391
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    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
    Overall Study Period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 GSK2202083A + Synflorix Group
    Arm description
    		 Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK2202083A
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose at Day 0 in the anterolateral side of the right thigh

    Investigational medicinal product name
    Synflorix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose at Month 1 in the anterolateral side of the left thigh

    Arm title
    		 Infanrix Hexa/Menjugate Group
    Arm description
    		 Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa vaccine and 2 doses of Menjugate vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa vaccine co-administered with Menjugate vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Infanrix hexa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose at Day 0 in the anterolateral side of the right thigh.

    Investigational medicinal product name
    Menjugate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose at Day 0 in the anterolateral side of the left thigh.

    Arm title
    		 Infanrix hexa/NeisVac-C + Synflorix Group
    Arm description
    		 Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa vaccine and Synflorix vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa vaccine co-administered with NeisVac-C vaccine at Day 0 and 1 dose of Synflorix vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Infanrix hexa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose at Day 0 in the anterolateral side of the right thigh.

    Investigational medicinal product name
    Synflorix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose at Month 1 in the anterolateral side of the left thigh

    Investigational medicinal product name
    NeisVac-C
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose at Day 0 in the anterolateral side of the left thigh.

    Number of subjects in period 1
    		GSK2202083A + Synflorix Group Infanrix Hexa/Menjugate Group Infanrix hexa/NeisVac-C + Synflorix Group
    Started
    137
    133
    121
    Completed
    137
    133
    120
    Not completed
    0
    0
    1
         Lost to follow-up
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GSK2202083A + Synflorix Group
    Reporting group description
    		 Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.

    Reporting group title
    Infanrix Hexa/Menjugate Group
    Reporting group description
    		 Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa vaccine and 2 doses of Menjugate vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa vaccine co-administered with Menjugate vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.

    Reporting group title
    Infanrix hexa/NeisVac-C + Synflorix Group
    Reporting group description
    		 Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa vaccine and Synflorix vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa vaccine co-administered with NeisVac-C vaccine at Day 0 and 1 dose of Synflorix vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.

    Reporting group values
    		 GSK2202083A + Synflorix Group Infanrix Hexa/Menjugate Group Infanrix hexa/NeisVac-C + Synflorix Group Total
    Number of subjects
    		 137 133 121 391
    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)
    		 13.7 ± 0.71 13.8 ± 0.73 13.7 ± 0.76 -
    Gender categorical
    Units: Subjects
        Female
    		 71 82 56 209
        Male
    		 66 51 65 182
    Race/Ethnicity
    Units: Subjects
        White-Caucasian/European heritage
    		 137 133 121 391

    End points

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    End points reporting groups
    Reporting group title
    GSK2202083A + Synflorix Group
    Reporting group description
    		 Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.

    Reporting group title
    Infanrix Hexa/Menjugate Group
    Reporting group description
    		 Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa vaccine and 2 doses of Menjugate vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa vaccine co-administered with Menjugate vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.

    Reporting group title
    Infanrix hexa/NeisVac-C + Synflorix Group
    Reporting group description
    		 Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa vaccine and Synflorix vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa vaccine co-administered with NeisVac-C vaccine at Day 0 and 1 dose of Synflorix vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.

    Primary: Number of seroprotected subjects against Polyribosyl-Ribitol-Phosphate (PRP)

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    End point title
    		 Number of seroprotected subjects against Polyribosyl-Ribitol-Phosphate (PRP)
    End point description
    A seroprotected subject was defined as a subject with anti-PRP antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (μg/mL).
    End point type
    Primary
    End point timeframe
    At one Month post (Post) booster dose
    End point values
    		 GSK2202083A + Synflorix Group Infanrix Hexa/Menjugate Group Infanrix hexa/NeisVac-C + Synflorix Group
    Number of subjects analysed
    132
    126
    114
    Units: Subjects
        Anti-PRP, Post (N=132, 126, 114)
    132
    126
    114
    Statistical analysis title
    		 Difference in percentage anti-PRP ≥ 0.15 μg/mL
    Comparison groups
    Infanrix hexa/NeisVac-C + Synflorix Group v GSK2202083A + Synflorix Group
    Number of subjects included in analysis
    246
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.27
         upper limit
    		 2.84
    Notes
    [1] - Criterion for evaluation of Non-inferiority: the upper limit of Standardised asymptotic 95% confidence interval lower or equal to 10%

    Primary: Number of seroprotected subjects against Neisseria meningitidis serogroup C using baby rabbit completent (rSBA-MenC)

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    End point title
    		 Number of seroprotected subjects against Neisseria meningitidis serogroup C using baby rabbit completent (rSBA-MenC)
    End point description
    A seroprotected subject was defined as a subject with anti-rSBA-MenC titers greater than or equal to (≥) 1:8.
    End point type
    Primary
    End point timeframe
    At 1 Month post (Post) booster dose.
    End point values
    		 GSK2202083A + Synflorix Group Infanrix Hexa/Menjugate Group Infanrix hexa/NeisVac-C + Synflorix Group
    Number of subjects analysed
    131
    124
    114
    Units: Subject
        Anti-rSBA-MenC, Post (N=131, 124, 114)
    131
    124
    114
    Statistical analysis title
    		 Difference between groups for rSBA-MenC ≥1:8
    Statistical analysis description
    The difference between Infanrix hexa/NeisVac-C and GSK2202083A + Synflorix groups in the percentage of subjects with rSBA-MenC titres equal to or above the cut-off value of 1:8 was assessed.
    Comparison groups
    Infanrix hexa/NeisVac-C + Synflorix Group v GSK2202083A + Synflorix Group
    Number of subjects included in analysis
    245
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.27
         upper limit
    		 2.86
    Statistical analysis title
    		 Difference between groups for rSBA-MenC ≥1:8 (2)
    Statistical analysis description
    The difference between Infanrix hexa/Menjugate and GSK2202083A + Synflorix groups in the percentage of subjects with rSBA-MenC titres equal to or above the cut-off value of 1:8 was assessed.
    Comparison groups
    GSK2202083A + Synflorix Group v Infanrix Hexa/Menjugate Group
    Number of subjects included in analysis
    255
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.02
         upper limit
    		 2.86

    Secondary: Number of seropositive subjects for anti-rSBA-MenC

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    End point title
    		 Number of seropositive subjects for anti-rSBA-MenC
    End point description
    A seropositive subject for anti-rSBA-MenC was defined as a subject with antibody titers greater than or equal to (≥) 1:128.
    End point type
    Secondary
    End point timeframe
    Before (Pre) and 1 Month post (Post) booster dose
    End point values
    		 GSK2202083A + Synflorix Group Infanrix Hexa/Menjugate Group Infanrix hexa/NeisVac-C + Synflorix Group
    Number of subjects analysed
    131
    124
    114
    Units: Subjects
        Anti-rSBA-MenC, Pre (N=127, 119, 104)
    87
    46
    3
        Anti-rSBA-MenC, Post (N=131, 124, 114)
    130
    124
    114
    No statistical analyses for this end point

    Secondary: Anti-rSBA-MenC antibody titres

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    End point title
    		 Anti-rSBA-MenC antibody titres
    End point description
    Antibody titres were expressed as geometric mean titres (GMTs) for the seroprotection cut-off value of ≥ 1:8.
    End point type
    Secondary
    End point timeframe
    Before (Pre) and 1 Month post (Post) booster dose
    End point values
    		 GSK2202083A + Synflorix Group Infanrix Hexa/Menjugate Group Infanrix hexa/NeisVac-C + Synflorix Group
    Number of subjects analysed
    131
    124
    114
    Units: Titers
    geometric mean (confidence interval 95%)
        Anti-rSBA-MenC, Pre (N=127, 119, 104)
    148.8 (114.4 to 193.5)
    55.6 (40.8 to 75.6)
    5.4 (4.5 to 6.6)
        Anti-rSBA-MenC, Post (N=131, 124, 114)
    2703.4 (2289.6 to 3192.1)
    7701.8 (6511.9 to 9109)
    2320.4 (2040.3 to 2638.8)
    No statistical analyses for this end point

    Secondary: Number of subjects with polysaccharide N. meningitidis serogroup C antibody (anti-PSC) antibody concentrations equal to or above the cut-off values

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    End point title
    		 Number of subjects with polysaccharide N. meningitidis serogroup C antibody (anti-PSC) antibody concentrations equal to or above the cut-off values
    End point description
    The cut-off values assessed were ≥ 0.3 μg/mL and ≥ 2 μg/mL.
    End point type
    Secondary
    End point timeframe
    Before (Pre) and 1 Month post (Post) booster dose
    End point values
    		 GSK2202083A + Synflorix Group Infanrix Hexa/Menjugate Group Infanrix hexa/NeisVac-C + Synflorix Group
    Number of subjects analysed
    134
    126
    114
    Units: Subjects
        Anti-PSC ≥ 0.3 mg/mL, Pre (N=134, 126, 114)
    133
    101
    0
        Anti-PSC ≥ 0.3 mg/mL, Post (N=134, 125, 114)
    134
    125
    114
        Anti-PSC ≥ 2 mg/mL, Pre (N=134, 126, 114)
    72
    21
    0
        Anti-PSC ≥ 2 mg/mL, Post (N=134, 125, 114)
    129
    125
    114
    No statistical analyses for this end point

    Secondary: Anti-PSC antibody concentrations

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    End point title
    		 Anti-PSC antibody concentrations
    End point description
    Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 0.3 μg/mL.
    End point type
    Secondary
    End point timeframe
    Before (Pre) and 1 Month post (Post) booster dose
    End point values
    		 GSK2202083A + Synflorix Group Infanrix Hexa/Menjugate Group Infanrix hexa/NeisVac-C + Synflorix Group
    Number of subjects analysed
    134
    126
    114
    Units: μg/mL
    geometric mean (confidence interval 95%)
        Anti-PSC, Pre (N=134, 126, 114)
    1.98 (1.69 to 2.31)
    0.76 (0.63 to 0.91)
    0.15 (0.15 to 0.15)
        Anti-PSC, Post (N=134, 125, 114)
    6.91 (6.21 to 7.69)
    21.75 (18.9 to 25.04)
    17.7 (15.97 to 19.61)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-PRP antibody concentrations ≥ the cut-off

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    End point title
    		 Number of subjects with anti-PRP antibody concentrations ≥ the cut-off
    End point description
    The cut-off value of the assay was an anti-PRP antibody concentration ≥ 1 μg/mL.
    End point type
    Secondary
    End point timeframe
    Before (Pre) and 1 Month post (Post) booster dose
    End point values
    		 GSK2202083A + Synflorix Group Infanrix Hexa/Menjugate Group Infanrix hexa/NeisVac-C + Synflorix Group
    Number of subjects analysed
    134
    126
    114
    Units: Subjects
        Anti-PRP, Pre (N=134, 125, 113)
    32
    22
    15
        Anti-PRP, Post (N=132, 126, 114)
    132
    126
    114
    No statistical analyses for this end point

    Secondary: Anti-PRP antibody concentrations

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    End point title
    		 Anti-PRP antibody concentrations
    End point description
    Concentrations were expressed as geometric mean concentrations (GMCs) for the cut-off value of ≥ 0.15 μg/mL.
    End point type
    Secondary
    End point timeframe
    Before (Pre) and 1 Month post (Post) booster dose
    End point values
    		 GSK2202083A + Synflorix Group Infanrix Hexa/Menjugate Group Infanrix hexa/NeisVac-C + Synflorix Group
    Number of subjects analysed
    134
    126
    114
    Units: μg/mL
    geometric mean (confidence interval 95%)
        Anti-PRP, Pre (N=134, 125, 113)
    0.601 (0.502 to 0.719)
    0.315 (0.252 to 0.394)
    0.368 (0.302 to 0.449)
        Anti-PRP, Post (N=132, 126, 114)
    25.449 (21.797 to 29.712)
    24.862 (20.188 to 30.619)
    25.943 (21.363 to 31.504)
    No statistical analyses for this end point

    Secondary: Number of seropositive subjects for anti-diphteria (anti-D) and anti-tetanus (anti-T)

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    End point title
    		 Number of seropositive subjects for anti-diphteria (anti-D) and anti-tetanus (anti-T)
    End point description
    A seropositive subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).
    End point type
    Secondary
    End point timeframe
    Before (Pre) and 1 Month post (Post) booster dose
    End point values
    		 GSK2202083A + Synflorix Group Infanrix Hexa/Menjugate Group Infanrix hexa/NeisVac-C + Synflorix Group
    Number of subjects analysed
    134
    126
    114
    Units: Subjects
        Anti-D, Pre (N=134, 125, 113)
    129
    115
    108
        Anti-D, Post (N=132, 126, 114)
    132
    126
    114
        Anti-T, Pre (N=134, 125, 112)
    133
    118
    111
        Anti-T, Post (N=132, 126, 114)
    132
    126
    114
    No statistical analyses for this end point

    Secondary: Anti-D and anti-T antibody concentrations

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    End point title
    		 Anti-D and anti-T antibody concentrations
    End point description
    Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 0.1 IU/mL.
    End point type
    Secondary
    End point timeframe
    Before (Pre) and 1 Month post (Post) booster dose
    End point values
    		 GSK2202083A + Synflorix Group Infanrix Hexa/Menjugate Group Infanrix hexa/NeisVac-C + Synflorix Group
    Number of subjects analysed
    134
    126
    114
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-D, Pre (N=134, 125, 113)
    0.349 (0.308 to 0.395)
    0.316 (0.27 to 0.37)
    0.311 (0.274 to 0.354)
        Anti-D, Post (N=132, 126, 114)
    6.166 (5.47 to 6.951)
    7.351 (6.63 to 8.15)
    6.02 (5.367 to 6.752)
        Anti-T, Pre (N=134, 125, 112)
    0.895 (0.808 to 0.992)
    0.316 (0.275 to 0.365)
    0.567 (0.5 to 0.643)
        Anti-T, Post (N=132, 126, 114)
    11.945 (10.898 to 13.094)
    5.351 (4.752 to 6.027)
    11.638 (10.398 to 13.025)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-hepatitis B (Anti-HBs) antibody concentrations equal to or above the cut-off values

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    End point title
    		 Number of subjects with anti-hepatitis B (Anti-HBs) antibody concentrations equal to or above the cut-off values
    End point description
    The cut-off values assessed were 3.3 milli-international units per milliliter (mIU/mL), 10 mIU/mL and 100 mIU/mL.
    End point type
    Secondary
    End point timeframe
    Before (Pre) and 1 Month post (Post) booster dose
    End point values
    		 GSK2202083A + Synflorix Group Infanrix Hexa/Menjugate Group Infanrix hexa/NeisVac-C + Synflorix Group
    Number of subjects analysed
    125
    122
    111
    Units: Subjects
        Anti-HBs ≥ 3.3 mIU/mL, Pre (N=124; 122; 105)
    123
    120
    104
        Anti-HBs ≥ 10 mIU/mL, Pre (N=124; 122; 105)
    121
    119
    102
        Anti-HBs ≥ 100 mIU/mL, Pre (N=124; 122; 105)
    99
    108
    90
        Anti-HBs ≥ 3.3 mIU/mL, Post (N=125; 114; 111)
    125
    114
    111
        Anti-HBs ≥ 10 mIU/mL, Post (N=125; 114; 111)
    125
    114
    109
        Anti-HBs ≥ 100 mIU/mL, Post (N=125; 114; 111)
    123
    113
    109
    No statistical analyses for this end point

    Secondary: Anti-HBs antibody concentrations

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    End point title
    		 Anti-HBs antibody concentrations
    End point description
    Concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.
    End point type
    Secondary
    End point timeframe
    Before (Pre) and 1 Month post (Post) booster dose
    End point values
    		 GSK2202083A + Synflorix Group Infanrix Hexa/Menjugate Group Infanrix hexa/NeisVac-C + Synflorix Group
    Number of subjects analysed
    125
    122
    111
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Anti-HBs, Pre (N=124; 122; 105)
    295.1 (234 to 372.1)
    387.6 (302.6 to 496.3)
    330.4 (256.5 to 425.5)
        Anti-HBs, Post (N=125; 114; 111)
    6390.7 (5171.5 to 7897.2)
    8465 (6827 to 10496.1)
    6840.3 (5235.8 to 8936.6)
    No statistical analyses for this end point

    Secondary: Number of seropositive subjects for anti-poliovirus types 1, 2 and 3

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    End point title
    		 Number of seropositive subjects for anti-poliovirus types 1, 2 and 3
    End point description
    A seropositive subject was defined as a subject with anti-polio type 1, 2 or 3 ≥ 1:8.
    End point type
    Secondary
    End point timeframe
    Before (Pre) and 1 Month post (Post) booster dose
    End point values
    		 GSK2202083A + Synflorix Group Infanrix Hexa/Menjugate Group Infanrix hexa/NeisVac-C + Synflorix Group
    Number of subjects analysed
    113
    102
    95
    Units: Subjects
        Anti-polio 1, Pre (N=103; 101; 88)
    96
    96
    79
        Anti-polio 1, Post (N=113; 99; 94)
    113
    99
    94
        Anti-polio 2, Pre (N=104; 100; 88)
    93
    95
    80
        Anti-polio 2, Post (N=113; 100; 94)
    113
    100
    94
        Anti-polio 3, Pre (N=102; 102; 88)
    94
    94
    80
        Anti-polio 3, Post (N=113; 100; 95)
    113
    100
    95
    No statistical analyses for this end point

    Secondary: Anti-poliovirus types 1, 2 and 3 antibody titres

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    End point title
    		 Anti-poliovirus types 1, 2 and 3 antibody titres
    End point description
    Titers were expressed as geometric mean titters (GMTs) for the seropositivity cut-off value of ≥ 1:8.
    End point type
    Secondary
    End point timeframe
    Before (Pre) and 1 Month post (Post) booster dose
    End point values
    		 GSK2202083A + Synflorix Group Infanrix Hexa/Menjugate Group Infanrix hexa/NeisVac-C + Synflorix Group
    Number of subjects analysed
    113
    102
    95
    Units: Titers
    geometric mean (confidence interval 95%)
        Anti-polio 1, Pre (N=103; 101; 88)
    35.1 (27.8 to 44.4)
    48.3 (37.3 to 62.6)
    37 (28.5 to 48)
        Anti-polio 1, Post (N=113; 99; 94)
    870.5 (721.5 to 1050.2)
    1203 (982.3 to 1473.2)
    896.7 (739.1 to 1088)
        Anti-polio 2, Pre (N=104; 100; 88)
    34.9 (27.6 to 44.2)
    46.2 (35.2 to 60.8)
    38.2 (29.2 to 50.1)
        Anti-polio 2, Post (N=113; 100; 94)
    1179.1 (979.3 to 1419.7)
    1483.6 (1217.2 to 1808.5)
    1143.8 (929.7 to 1407.1)
        Anti-polio 3, Pre (N=102; 102; 88)
    43.7 (34 to 56.1)
    51.6 (39.6 to 67.1)
    48.5 (36.3 to 64.7)
        Anti-polio 3, Post (N=113; 100; 95)
    1493.3 (1195 to 1866)
    1832.9 (1507.9 to 2228.1)
    1416.8 (1157.1 to 1734.8)
    No statistical analyses for this end point

    Secondary: Number of seropositive subjects for anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN)

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    End point title
    		 Number of seropositive subjects for anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN)
    End point description
    A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
    End point type
    Secondary
    End point timeframe
    Before (Pre) and 1 Month post (Post) booster
    End point values
    		 GSK2202083A + Synflorix Group Infanrix Hexa/Menjugate Group Infanrix hexa/NeisVac-C + Synflorix Group
    Number of subjects analysed
    133
    126
    114
    Units: Subjects
        Anti-PT, Pre (N=133, 125, 112)
    98
    97
    84
        Anti-PT, Post (N=133, 126, 114)
    133
    126
    114
        Anti-FHA, Pre (N=132, 125, 112)
    131
    122
    111
        Anti-FHA, Post (N=132, 126, 114)
    132
    126
    114
        Anti-PRN, Pre (N=133, 126, 113)
    100
    109
    94
        Anti-PRN, Post (N=132, 126, 113)
    132
    126
    113
    No statistical analyses for this end point

    Secondary: Anti-PT, anti-FHA and anti-PRN antibody concentrations

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    End point title
    		 Anti-PT, anti-FHA and anti-PRN antibody concentrations
    End point description
    Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value ≥ 5 EL.U/mL.
    End point type
    Secondary
    End point timeframe
    Before (Pre) and 1 Month post (Post) booster
    End point values
    		 GSK2202083A + Synflorix Group Infanrix Hexa/Menjugate Group Infanrix hexa/NeisVac-C + Synflorix Group
    Number of subjects analysed
    133
    126
    114
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PT, Pre (N=133, 125, 112)
    7.7 (6.7 to 8.8)
    8.9 (7.7 to 10.2)
    7.1 (6.2 to 8.1)
        Anti-PT, Post (N=133, 126, 114)
    50.6 (45.1 to 56.7)
    66.3 (58.6 to 75)
    61.8 (53.7 to 71.1)
        Anti-FHA, Pre (N=132, 125, 112)
    24.3 (21 to 28.2)
    30.4 (26.2 to 35.4)
    25.7 (22.1 to 29.7)
        Anti-FHA, Post (N=132, 126, 114)
    265.3 (235.3 to 299)
    339.6 (300.2 to 384.1)
    325.2 (284.7 to 371.4)
        Anti-PRN, Pre (N=133, 126, 113)
    8.8 (7.5 to 10.3)
    12.7 (10.9 to 14.9)
    11 (9.3 to 13)
        Anti-PRN, Post (N=132, 126, 113)
    216.8 (183.7 to 255.8)
    319.8 (275.6 to 371.2)
    277.9 (233.1 to 331.4)
    No statistical analyses for this end point

    Secondary: Number of subjects with any solicited local symptoms

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    End point title
    		 Number of subjects with any solicited local symptoms
    End point description
    Solicited local symptoms assessed included pain, redness and swelling. Any= all reports of the speecified symptom irrespective of intensity grade.
    End point type
    Secondary
    End point timeframe
    During the 8-day (Days 0-7) follow-up period following the booster dose
    End point values
    		 GSK2202083A + Synflorix Group Infanrix Hexa/Menjugate Group Infanrix hexa/NeisVac-C + Synflorix Group
    Number of subjects analysed
    136
    133
    120
    Units: Subjects
        Any Pain
    44
    68
    58
        Any Redness
    69
    77
    69
        Any Swelling
    50
    58
    50
    No statistical analyses for this end point

    Secondary: Number of subjects with any solicited general symptoms

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    End point title
    		 Number of subjects with any solicited general symptoms
    End point description
    Solicited general symptoms assessed included drowsiness, irritability, loss of appetite and fever (defined as axillary temperature ≥ 37.5º C). Any= all reports of the specified symptom irrespective of intensity grade and relationship to vaccination.
    End point type
    Secondary
    End point timeframe
    During the 8-day (Days 0-7) follow-up period following the booster dose
    End point values
    		 GSK2202083A + Synflorix Group Infanrix Hexa/Menjugate Group Infanrix hexa/NeisVac-C + Synflorix Group
    Number of subjects analysed
    136
    133
    120
    Units: Subjects
        Any Drowsiness
    40
    39
    39
        Any Irritability
    65
    65
    66
        Any Loss of appetite
    31
    32
    43
        Any Temperature (Axillary)
    34
    30
    31
    No statistical analyses for this end point

    Secondary: Number of subjects with unsolicited Adverse events (AEs)

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    End point title
    		 Number of subjects with unsolicited Adverse events (AEs)
    End point description
    An unsolicited AE was any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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.
    End point type
    Secondary
    End point timeframe
    During the 31-day (Days 0-30) follow-up period following the booster dose
    End point values
    		 GSK2202083A + Synflorix Group Infanrix Hexa/Menjugate Group Infanrix hexa/NeisVac-C + Synflorix Group
    Number of subjects analysed
    137
    133
    121
    Units: Subjects
        Any AEs
    45
    29
    35
    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 were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
    End point type
    Secondary
    End point timeframe
    After the booster dose of the study vaccine up to the study end
    End point values
    		 GSK2202083A + Synflorix Group Infanrix Hexa/Menjugate Group Infanrix hexa/NeisVac-C + Synflorix Group
    Number of subjects analysed
    137
    133
    121
    Units: Subjects
        Any SAEs
    3
    2
    2
    No statistical analyses for this end point

    Secondary: Number of seropositive subjects for anti-PRP

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    End point title
    		 Number of seropositive subjects for anti-PRP
    End point description
    A seropositive subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 μg/mL.
    End point type
    Secondary
    End point timeframe
    Be fore (Pre) booster dose
    End point values
    		 GSK2202083A + Synflorix Group Infanrix Hexa/Menjugate Group Infanrix hexa/NeisVac-C + Synflorix Group
    Number of subjects analysed
    134
    125
    113
    Units: Subjects
        Anti-PRP, Pre (N=134, 125, 113)
    131
    89
    88
    No statistical analyses for this end point

    Secondary: Number of seroprotected subjects against Neisseria meningitidis serogroup C using baby rabbit completent (rSBA-MenC)

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    End point title
    		 Number of seroprotected subjects against Neisseria meningitidis serogroup C using baby rabbit completent (rSBA-MenC)
    End point description
    A seroprotected subject was defined as a subject with anti-rSBA-MenC titers greater than or equal to (≥) 1:8.
    End point type
    Secondary
    End point timeframe
    Before (Pre) booster dose
    End point values
    		 GSK2202083A + Synflorix Group Infanrix Hexa/Menjugate Group Infanrix hexa/NeisVac-C + Synflorix Group
    Number of subjects analysed
    127
    119
    104
    Units: Subjects
        Anti-rSBA-MenC, Pre (N=127, 119, 104)
    117
    92
    10
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited local and general symptoms: during the 8-day (Days 0- 7) post-booster vaccination. Unsolicited adverse events: during the 31-day (Days 0- 30) post-booster vaccination. Serious adverse events: entire booster period (from Month 0 up to Month 1).
    Adverse event reporting additional description
    The number of occurrences reported for solicited symptoms, adverse events, and serious adverse events were not available for posting. The number of subjects affected by each specific event was indicated as the number of occurrences.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.1
    Reporting groups
    Reporting group title
    Infanrix hexa/NeisVac-C + Synflorix Group
    Reporting group description
    		 Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa vaccine and Synflorix vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa vaccine co-administered with NeisVac-C vaccine at Day 0 and 1 dose of Synflorix vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.

    Reporting group title
    GSK2202083A + Synflorix Group
    Reporting group description
    		 Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.

    Reporting group title
    Infanrix Hexa/Menjugate Group
    Reporting group description
    		 Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa vaccine and 2 doses of Menjugate vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa vaccine co-administered with Menjugate vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.

    Serious adverse events
    		 Infanrix hexa/NeisVac-C + Synflorix Group GSK2202083A + Synflorix Group Infanrix Hexa/Menjugate Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 121 (1.65%)
    3 / 137 (2.19%)
    2 / 133 (1.50%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Thermal burn
         subjects affected / exposed
    0 / 121 (0.00%)
    2 / 137 (1.46%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 121 (0.83%)
    1 / 137 (0.73%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 137 (0.00%)
    1 / 133 (0.75%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 137 (0.00%)
    1 / 133 (0.75%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 137 (0.73%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 137 (0.73%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 137 (0.00%)
    1 / 133 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Infanrix hexa/NeisVac-C + Synflorix Group GSK2202083A + Synflorix Group Infanrix Hexa/Menjugate Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    102 / 121 (84.30%)
    114 / 137 (83.21%)
    114 / 133 (85.71%)
    General disorders and administration site conditions
    Pain
         subjects affected / exposed [1]
    58 / 121 (47.93%)
    44 / 136 (32.35%)
    68 / 133 (51.13%)
         occurrences all number
    58
    44
    68
    Redness
         subjects affected / exposed [2]
    69 / 120 (57.50%)
    69 / 136 (50.74%)
    77 / 133 (57.89%)
         occurrences all number
    69
    69
    77
    Swelling
         subjects affected / exposed [3]
    50 / 120 (41.67%)
    50 / 136 (36.76%)
    58 / 133 (43.61%)
         occurrences all number
    50
    50
    58
    Drowsiness
         subjects affected / exposed [4]
    39 / 120 (32.50%)
    40 / 136 (29.41%)
    39 / 133 (29.32%)
         occurrences all number
    39
    40
    39
    Irritability
         subjects affected / exposed [5]
    66 / 120 (55.00%)
    65 / 136 (47.79%)
    65 / 133 (48.87%)
         occurrences all number
    66
    65
    65
    Loss of appetite
         subjects affected / exposed [6]
    43 / 120 (35.83%)
    31 / 136 (22.79%)
    32 / 133 (24.06%)
         occurrences all number
    43
    31
    32
    Fever
         subjects affected / exposed [7]
    31 / 120 (25.83%)
    34 / 136 (25.00%)
    30 / 133 (22.56%)
         occurrences all number
    31
    34
    30
    Infections and infestations
    Upper respiratory tract infection (unsolicited)
         subjects affected / exposed
    6 / 121 (4.96%)
    6 / 137 (4.38%)
    11 / 133 (8.27%)
         occurrences all number
    6
    6
    11
    Rhinitis
         subjects affected / exposed
    8 / 121 (6.61%)
    9 / 137 (6.57%)
    4 / 133 (3.01%)
         occurrences all number
    8
    9
    4
    Nasopharyngitis
         subjects affected / exposed
    4 / 121 (3.31%)
    7 / 137 (5.11%)
    2 / 133 (1.50%)
         occurrences all number
    4
    7
    2
    Pharyngitis
         subjects affected / exposed
    6 / 121 (4.96%)
    3 / 137 (2.19%)
    3 / 133 (2.26%)
         occurrences all number
    6
    3
    3
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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