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    Clinical Trial Results:
    A phase II, double-blind, multicentre study to evaluate the safety and immunogenicity of a booster dose of new formulations of GlaxoSmithKline Biologicals’ combined DTPa-HBV-IPV/Hib vaccine in healthy toddlers, previously primed with three doses of the same vaccine in study 113948 (DTPA-HBV-IPV-124 PRI).

    Summary
    EudraCT number
    		 2011-000876-33
    Trial protocol
    		 FI   Outside EU/EEA  
    Global end of trial date
    08 Aug 2013

    Results information
    Results version number
    		 v1
    This version publication date
    02 May 2016
    First version publication date
    01 Feb 2015
    Other versions
    		 v2 , v3

    Trial information

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    Trial identification
    Sponsor protocol code
    114843
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01453998
    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 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    14 Nov 2012
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Aug 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that the immunogenicity of at least one DTPa-HBV-IPV/Hib formulation is non-inferior to the licensed formulation in terms of seroprotection rates to diphtheria, tetanus, hepatitis B, poliovirus types 1, 2 and 3 and PRP antigens and in terms of antibody geometric mean concentrations (GMCs) for pertussis antigens one month after the booster dose.
    Protection of trial subjects
    As with all injectable vaccines, appropriate medical treatment was always readily available in case of anaphylactic reactions following the administration of the vaccine. For this reason, the vaccinee remained under medical supervision for 30 minutes after vaccination. DTPa vaccination was administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may have occured following an intramuscular administration to these subjects. DTPa vaccination was under no circumstances administered intravenously.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Oct 2011
    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
    Dominican Republic: 248
    Country: Number of subjects enrolled
    Finland: 409
    Worldwide total number of subjects
    657
    EEA total number of subjects
    409
    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)
    657
    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
    		 A total of 272 subjects were enrolled in the study before the second protocol amendment and total of 385 after the amendment. After amendment 2, all subjects yet to receive a booster dose of a GSK217744 formulation, were administered the Infanrix hexa™ vaccine.

    Pre-assignment
    Screening details
    		 A total of 272 subjects were enrolled in the study before the second protocol amendment and total of 385 after the amendment. After amendment 2, all subjects yet to receive a booster dose of a GSK217744 formulation, were administered the Infanrix hexa™ vaccine.

    Period 1
    Period 1 title
    Before Protocol Amendment 2
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 GSK217744 Group 1
    Arm description
    		 Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Prevenar 13®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.

    Investigational medicinal product name
    Biological: GSK217744
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively

    Arm title
    		 GSK217744 Group 2
    Arm description
    		 Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Prevenar 13®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.

    Investigational medicinal product name
    GSK217744
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.

    Arm title
    		 Infanrix hexa Group
    Arm description
    		 Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Infanrix hexa™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.

    Investigational medicinal product name
    Prevenar 13®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.

    Number of subjects in period 1
    		GSK217744 Group 1 GSK217744 Group 2 Infanrix hexa Group
    Started
    85
    88
    99
    Completed
    85
    88
    99
    Period 2
    Period 2 title
    After Protocol Amendment 2
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 GSK217744 Group 1
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    infanrix hexa™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose, licensed formulation, intramuscular into right

    Investigational medicinal product name
    Prevenar 13®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single co-administered dose, intramuscular into left thigh

    Investigational medicinal product name
    GSK217744
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose, licensed formulation, intramuscular into right

    Arm title
    		 GSK217744 Group 2
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Infanrix hexa™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose, licensed formulation, intramuscular into right

    Arm title
    		 Infanrix hexa Group
    Arm description
    		 -
    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
    Single dose, licensed formulation, intramuscular into right

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: More subjects were enrolled in period 2 therefore it was considered the baseline period.
    Number of subjects in period 2
    		GSK217744 Group 1 GSK217744 Group 2 Infanrix hexa Group
    Started
    103
    99
    183
    Completed
    102
    99
    183
    Not completed
    1
    0
    0
         Consent withdrawn by subject
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups [1]
    Reporting group title
    GSK217744 Group 1
    Reporting group description
    		 -

    Reporting group title
    GSK217744 Group 2
    Reporting group description
    		 -

    Reporting group title
    Infanrix hexa Group
    Reporting group description
    		 -

    Notes
    [1] - The number of subjects reported to be in the baseline period is not equal to the worldwide number of subjects enrolled in the trial. It is expected that these numbers will be the same.
    Justification: More subjects were enrolled in period 2 therefore it was considered the baseline period.
    Reporting group values
    		 GSK217744 Group 1 GSK217744 Group 2 Infanrix hexa Group Total
    Number of subjects
    		 103 99 183
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 14 ± 0.5 14 ± 0.46 14 ± 0.72 -
    Gender categorical
    Units: Subjects
        Female
    		 47 54 89 190
        Male
    		 56 45 94 195

    End points

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    End points reporting groups
    Reporting group title
    GSK217744 Group 1
    Reporting group description
    		 Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.

    Reporting group title
    GSK217744 Group 2
    Reporting group description
    		 Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.

    Reporting group title
    Infanrix hexa Group
    Reporting group description
    		 Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
    Reporting group title
    GSK217744 Group 1
    Reporting group description
    		 -

    Reporting group title
    GSK217744 Group 2
    Reporting group description
    		 -

    Reporting group title
    Infanrix hexa Group
    Reporting group description
    		 -

    Primary: Number of seroprotected subjects for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies.

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    End point title
    		 Number of seroprotected subjects for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies. [1]
    End point description
    A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).
    End point type
    Primary
    End point timeframe
    Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed
    End point values
    		 GSK217744 Group 1 GSK217744 Group 2 Infanrix hexa Group
    Number of subjects analysed
    81
    82
    90
    Units: Subjects
        Anti-D PRE [N=81;82;89]
    78
    80
    84
        Anti-D POST [N=81;82;90]
    81
    82
    90
        Anti-T PRE [N=81;82;89]
    76
    78
    85
        Anti-T POST [N=81;82;90]
    81
    82
    90
    No statistical analyses for this end point

    Primary: Concentrations for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies.

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    End point title
    		 Concentrations for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies. [2]
    End point description
    Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.
    End point type
    Primary
    End point timeframe
    Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed
    End point values
    		 GSK217744 Group 1 GSK217744 Group 2 Infanrix hexa Group
    Number of subjects analysed
    81
    82
    90
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-D PRE [N=81;82;89]
    0.357 (0.305 to 0.419)
    0.445 (0.381 to 0.52)
    0.401 (0.343 to 0.468)
        Anti-D POST [N=81;82;90]
    5.652 (4.985 to 6.408)
    5.494 (4.891 to 6.171)
    6.772 (5.897 to 7.777)
        Anti-T PRE [N=81;82;89]
    0.358 (0.301 to 0.427)
    0.362 (0.306 to 0.428)
    0.394 (0.337 to 0.459)
        Anti-T POST [N=81;82;90]
    5.015 (4.341 to 5.794)
    5.034 (4.366 to 5.803)
    5.571 (4.869 to 6.374)
    No statistical analyses for this end point

    Primary: Number of seroprotected subjects for anti-polyribosyl-ribitol phosphate (anti-PRP)

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    End point title
    		 Number of seroprotected subjects for anti-polyribosyl-ribitol phosphate (anti-PRP) [3]
    End point description
    A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).
    End point type
    Primary
    End point timeframe
    Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed
    End point values
    		 GSK217744 Group 1 GSK217744 Group 2 Infanrix hexa Group
    Number of subjects analysed
    81
    82
    90
    Units: Subjects
        Anti-PRP PRE [N=81;82;89]
    41
    45
    52
        Anti-PRP POST [N=81;82;90]
    81
    82
    90
    No statistical analyses for this end point

    Primary: Concentrations for anti-PRP antibodies

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    End point title
    		 Concentrations for anti-PRP antibodies [4]
    End point description
    Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.15 µg /mL.
    End point type
    Primary
    End point timeframe
    Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed
    End point values
    		 GSK217744 Group 1 GSK217744 Group 2 Infanrix hexa Group
    Number of subjects analysed
    81
    82
    90
    Units: Units:µg /mL
    geometric mean (confidence interval 95%)
        Anti-PRP PRE [N=81;82;89]
    0.173 (0.138 to 0.216)
    0.175 (0.142 to 0.216)
    0.236 (0.182 to 0.307)
        Anti-PRP POST [N=81;82;90]
    12.765 (9.3 to 17.52)
    15.904 (11.723 to 21.576)
    17.099 (12.966 to 22.55)
    No statistical analyses for this end point

    Primary: Number of seroprotected subjects for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies

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    End point title
    		 Number of seroprotected subjects for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies [5]
    End point description
    A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).
    End point type
    Primary
    End point timeframe
    Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed
    End point values
    		 GSK217744 Group 1 GSK217744 Group 2 Infanrix hexa Group
    Number of subjects analysed
    96
    95
    173
    Units: Subjects
        Anti-D PRE [N=96;95;170]
    84
    83
    159
        Anti-D POST [N=96;95;173]
    96
    95
    173
        Anti-T PRE [N=96;95;170]
    87
    87
    167
        Anti-T POST [N=96;95;173]
    96
    95
    173
    No statistical analyses for this end point

    Primary: Concentrations for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies

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    End point title
    		 Concentrations for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies [6]
    End point description
    Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.
    End point type
    Primary
    End point timeframe
    Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed
    End point values
    		 GSK217744 Group 1 GSK217744 Group 2 Infanrix hexa Group
    Number of subjects analysed
    96
    95
    173
    Units: Units:IU/mL
    geometric mean (confidence interval 95%)
        Anti-D PRE [N=96;95;170]
    0.26 (0.217 to 0.311)
    0.245 (0.206 to 0.292)
    0.306 (0.272 to 0.343)
        Anti-D POST [N=96;95;173]
    6.224 (5.411 to 7.159)
    6.549 (5.781 to 7.418)
    6.105 (5.641 to 6.607)
        Anti-T PRE [N=96;95;170]
    0.309 (0.259 to 0.369)
    0.306 (0.255 to 0.367)
    0.384 (0.346 to 0.425)
        Anti-T POST [N=96;95;173]
    5.713 (4.923 to 6.629)
    5.895 (5.01 to 6.937)
    5.649 (5.074 to 6.289)
    No statistical analyses for this end point

    Primary: Number of seroprotected subjects for anti-polyribosyl-ribitol phosphate (anti-PRP).

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    End point title
    		 Number of seroprotected subjects for anti-polyribosyl-ribitol phosphate (anti-PRP). [7]
    End point description
    A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).
    End point type
    Primary
    End point timeframe
    Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed
    End point values
    		 GSK217744 Group 1 GSK217744 Group 2 Infanrix hexa Group
    Number of subjects analysed
    96
    95
    173
    Units: Subjects
        Anti-PRP PRE [N=96;95;170]
    70
    70
    111
        Anti-PRP POST [N=96;95;173]
    96
    95
    171
    No statistical analyses for this end point

    Primary: Concentrations for anti-PRP antibodies.

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    End point title
    		 Concentrations for anti-PRP antibodies. [8]
    End point description
    Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.15 µg /mL.
    End point type
    Primary
    End point timeframe
    Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed
    End point values
    		 GSK217744 Group 1 GSK217744 Group 2 Infanrix hexa Group
    Number of subjects analysed
    96
    95
    173
    Units: Units:µg /mL
    geometric mean (confidence interval 95%)
        Anti-PRP PRE [N=96;95;170]
    0.357 (0.269 to 0.474)
    0.359 (0.271 to 0.475)
    0.273 (0.224 to 0.332)
        Anti-PRP POST [N=96;95;173]
    17.459 (12.846 to 23.727)
    18.576 (13.845 to 24.923)
    18.04 (14.522 to 22.41)
    No statistical analyses for this end point

    Secondary: Number of seropositive subjects for anti-pneumococcal (anti-PNE) serotypes.

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    End point title
    		 Number of seropositive subjects for anti-pneumococcal (anti-PNE) serotypes.
    End point description
    A seropositive subject was defined as a vaccinated subject who had anti- pneumococcal antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL). The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
    End point type
    Secondary
    End point timeframe
    1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
    End point values
    		 GSK217744 Group 1 GSK217744 Group 2 Infanrix hexa Group
    Number of subjects analysed
    50
    50
    53
    Units: Subjects
        Anti- PNE 1 [N=50;50;53]
    50
    50
    53
        Anti- PNE 3 [N=40;44;44]
    40
    43
    43
        Anti- PNE 4 [N=50;50;53]
    50
    50
    53
        Anti- PNE 5 [N=50;50;53]
    50
    50
    53
        Anti- PNE 6A [N=50;50;53]
    50
    50
    53
        Anti- PNE 6B [N=50;50;53]
    50
    49
    53
        Anti- PNE 7F [N=50;50;53]
    50
    50
    53
        Anti- PNE 9V [N=50;50;53]
    50
    50
    53
        Anti- PNE 14 [N=50;50;53]
    49
    50
    53
        Anti- PNE 18C [N=50;50;53]
    49
    50
    53
        Anti- PNE 19A [N=49;50;53]
    49
    50
    53
        Anti- PNE 19F [N=50;50;53]
    50
    50
    53
        Anti- PNE 23F [N=50;47;52]
    50
    47
    52
    No statistical analyses for this end point

    Secondary: Concentrations for anti-PNE antibodies.

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    End point title
    		 Concentrations for anti-PNE antibodies.
    End point description
    Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 0.15 µg /mL. The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
    End point type
    Secondary
    End point timeframe
    Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
    End point values
    		 GSK217744 Group 1 GSK217744 Group 2 Infanrix hexa Group
    Number of subjects analysed
    50
    50
    50
    Units: Units:µg /mL
    geometric mean (confidence interval 95%)
        Anti- PNE 1 [N=50;50;53]
    2.07 (1.69 to 2.53)
    2.16 (1.75 to 2.68)
    2.27 (1.84 to 2.8)
        Anti- PNE 3 [N=40;44;44]
    0.76 (0.62 to 0.93)
    0.87 (0.66 to 1.15)
    0.88 (0.69 to 1.14)
        Anti- PNE 4 [N=50;50;53]
    1.87 (1.51 to 2.32)
    1.83 (1.46 to 2.28)
    2.14 (1.72 to 2.66)
        Anti- PNE 5 [N=50;50;53]
    1.18 (0.97 to 1.42)
    1.1 (0.92 to 1.33)
    1.21 (0.99 to 1.49)
        Anti- PNE 6A [N=50;50;53]
    7.71 (6.49 to 9.16)
    6.92 (5.53 to 8.64)
    8.63 (6.79 to 10.96)
        Anti- PNE 6B [N=50;50;53]
    4.24 (3.39 to 5.3)
    4.21 (3.17 to 5.59)
    4.58 (3.45 to 6.08)
        Anti- PNE 7F [N=50;50;53]
    3.27 (2.75 to 3.89)
    3.42 (2.94 to 3.97)
    4.27 (3.58 to 5.08)
        Anti- PNE 9V [N=50;50;53]
    1.68 (1.33 to 2.11)
    1.52 (1.25 to 1.85)
    1.63 (1.29 to 2.06)
        Anti- PNE 14 [N=50;50;53]
    8.22 (6.27 to 10.77)
    8.8 (7.01 to 11.06)
    8.97 (7.29 to 11.02)
        Anti- PNE 18C [N=50;50;53]
    1.5 (1.13 to 1.99)
    1.63 (1.32 to 2.01)
    1.64 (1.33 to 2.02)
        Anti- PNE 19A [N=49;50;53]
    7 (5.76 to 8.51)
    8.05 (6.39 to 10.13)
    6.7 (5.14 to 8.73)
        Anti- PNE 19F [N=50;50;53]
    7.15 (5.86 to 8.74)
    7.34 (5.89 to 9.15)
    6.72 (5.32 to 8.48)
        Anti- PNE 23F [N=50;47;52]
    3.74 (2.87 to 4.88)
    4.54 (3.67 to 5.63)
    3.94 (2.97 to 5.23)
    No statistical analyses for this end point

    Secondary: Number of seropositive subjects for anti-pneumococcal (anti-PNE) serotypes

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    End point title
    		 Number of seropositive subjects for anti-pneumococcal (anti-PNE) serotypes
    End point description
    A seropositive subject was defined as a vaccinated subject who had anti- pneumococcal antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL). The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
    End point type
    Secondary
    End point timeframe
    1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
    End point values
    		 GSK217744 Group 1 GSK217744 Group 2 Infanrix hexa Group
    Number of subjects analysed
    9
    9
    46
    Units: Subjects
        Anti- PNE 1 [N=9;9;46]
    9
    9
    46
        Anti- PNE 3 [N=8;8;39]
    8
    8
    39
        Anti- PNE 4 [N=9;9;46]
    9
    9
    46
        Anti- PNE 5 [N=9;9;46]
    9
    9
    46
        Anti- PNE 6A [N=9;9;46]
    9
    9
    46
        Anti- PNE 6B [N=9;9;46]
    9
    9
    46
        Anti- PNE 7F [N=9;9;46]
    9
    9
    46
        Anti- PNE 9V [N=9;9;46]
    9
    9
    46
        Anti- PNE 14 [N=9;9;46]
    9
    9
    46
        Anti- PNE 18C [N=9;9;46]
    9
    9
    46
        Anti- PNE 19A [N=9;8;46]
    9
    9
    46
        Anti- PNE 19F [N=9;9;46]
    9
    9
    46
        Anti- PNE 23F [N=9;9;46]
    9
    9
    46
    No statistical analyses for this end point

    Secondary: Concentrations for anti-PNE antibodies.

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    End point title
    		 Concentrations for anti-PNE antibodies.
    End point description
    Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 0.15 µg /mL. The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
    End point type
    Secondary
    End point timeframe
    Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
    End point values
    		 GSK217744 Group 1 GSK217744 Group 2 Infanrix hexa Group
    Number of subjects analysed
    9
    9
    46
    Units: Units:µg /mL
    geometric mean (confidence interval 95%)
        Anti- PNE 1 [N=9;9;46]
    2.58 (1.11 to 6.03)
    2.92 (2.08 to 4.1)
    2.79 (2.24 to 3.48)
        Anti- PNE 3 [N=8;8;39]
    0.95 (0.45 to 1.99)
    0.98 (0.68 to 1.4)
    0.77 (0.65 to 0.92)
        Anti- PNE 4 [N=9;9;46]
    2.74 (1.18 to 6.38)
    1.85 (1.26 to 2.71)
    2.19 (1.78 to 2.7)
        Anti- PNE 5 [N=9;9;46]
    1.49 (0.75 to 2.94)
    1.14 (0.72 to 1.8)
    1.25 (1.05 to 1.48)
        Anti- PNE 6A [N=9;9;46]
    11.76 (6.26 to 22.09)
    6.92 (4.43 to 10.83)
    8.38 (6.73 to 10.42)
        Anti- PNE 6B [N=9;9;46]
    6.4 (2.14 to 19.16)
    5.84 (2.97 to 11.49)
    5.02 (4 to 6.31)
        Anti- PNE 7F [N=9;9;46]
    8.04 (4.56 to 14.16)
    3.74 (2.38 to 5.86)
    3.86 (3.26 to 4.57)
        Anti- PNE 9V [N=9;9;46]
    1.96 (1.07 to 3.58)
    1.87 (1.14 to 3.08)
    1.77 (1.42 to 2.21)
        Anti- PNE 14 [N=9;9;46]
    9.88 (5.23 to 18.67)
    6.78 (3.97 to 11.56)
    8.23 (6.67 to 10.16)
        Anti- PNE 18C [N=9;9;46]
    2.95 (1.42 to 6.11)
    1.52 (1.17 to 1.99)
    1.67 (1.34 to 2.07)
        Anti- PNE 19A [N=9;8;46]
    6.48 (3.08 to 13.61)
    12.89 (6.08 to 27.32)
    7.56 (6.06 to 9.44)
        Anti- PNE 19F [N=9;9;46]
    5.48 (2.29 to 13.1)
    5.97 (2.93 to 12.16)
    7.42 (5.78 to 9.54)
        Anti- PNE 23F [N=9;9;46]
    6.26 (2.67 to 14.66)
    6.4 (4.8 to 8.53)
    4.53 (3.68 to 5.58)
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any solicited local symptoms.

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    End point title
    		 Number of subjects reporting any solicited local symptoms.
    End point description
    Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled before protocol amendment 2)
    End point values
    		 GSK217744 Group 1 GSK217744 Group 2 Infanrix hexa Group
    Number of subjects analysed
    85
    88
    99
    Units: Subjects
        Any pain
    56
    67
    63
        Any redness
    55
    56
    59
        Any swelling
    45
    43
    48
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any solicited general symptoms.

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    End point title
    		 Number of subjects reporting any solicited general symptoms.
    End point description
    Solicited local symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever [axillary temperature above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any local symptom regardless of intensity grade.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled before protocol amendment 2)
    End point values
    		 GSK217744 Group 1 GSK217744 Group 2 Infanrix hexa Group
    Number of subjects analysed
    85
    88
    99
    Units: Subjects
        Any drowsiness
    54
    47
    47
        Any irritability/fussiness
    69
    73
    74
        Any loss of appetite
    43
    45
    46
        Any fever
    37
    41
    37
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects reporting any unsolicited adverse events (AEs).
    End point description
    An unsolicited AE is 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. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination.
    End point type
    Secondary
    End point timeframe
    Within the 31-day (Days 0-30) follow up period after vaccination. (subjects enrolled before protocol amendment 2)
    End point values
    		 GSK217744 Group 1 GSK217744 Group 2 Infanrix hexa Group
    Number of subjects analysed
    85
    88
    99
    Units: Subjects
        Any AEs [Units:Subjects]
    42
    39
    67
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects reporting any serious adverse events (SAEs).
    End point description
    SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Any SAE = any SAE regardless of assessment of relationship to study vaccination.
    End point type
    Secondary
    End point timeframe
    During the entire study period (Days 0-30). (subjects enrolled before protocol amendment 2)
    End point values
    		 GSK217744 Group 1 GSK217744 Group 2 Infanrix hexa Group
    Number of subjects analysed
    85
    88
    99
    Units: Subjects
        Any SAEs [Units:Subjects]
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any solicited local symptoms

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    End point title
    		 Number of subjects reporting any solicited local symptoms
    End point description
    Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled after protocol amendment 2)
    End point values
    		 GSK217744 Group 1 GSK217744 Group 2 Infanrix hexa Group
    Number of subjects analysed
    103
    99
    183
    Units: Subjects
        Any pain
    51
    57
    98
        Any redness
    24
    26
    73
        Any swelling
    29
    28
    58
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any solicited general symptoms

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    End point title
    		 Number of subjects reporting any solicited general symptoms
    End point description
    Solicited local symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever [axillary temperature above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any local symptom regardless of intensity grade.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled after protocol amendment 2)
    End point values
    		 GSK217744 Group 1 GSK217744 Group 2 Infanrix hexa Group
    Number of subjects analysed
    103
    99
    183
    Units: Subjects
        Any drowsiness
    30
    35
    67
        Any irritability/fussiness
    37
    47
    102
        Any loss of appetite
    27
    28
    58
        Any fever
    37
    40
    83
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects reporting any unsolicited adverse events (AEs)
    End point description
    An unsolicited AE is 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. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination.
    End point type
    Secondary
    End point timeframe
    Within the 31-day (Days 0-30) follow up period after vaccination. (subjects enrolled after protocol amendment 2)
    End point values
    		 GSK217744 Group 1 GSK217744 Group 2 Infanrix hexa Group
    Number of subjects analysed
    103
    99
    183
    Units: Subjects
        Any AEs [Units:Subjects]
    26
    24
    46
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects reporting any serious adverse events (SAEs)
    End point description
    SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Any SAE = any SAE regardless of assessment of relationship to study vaccination.
    End point type
    Secondary
    End point timeframe
    During the entire study period (Days 0-30). (subjects enrolled after protocol amendment 2)
    End point values
    		 GSK217744 Group 1 GSK217744 Group 2 Infanrix hexa Group
    Number of subjects analysed
    103
    99
    183
    Units: Subjects
        Any SAEs [Units:Subjects]
    1
    1
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).
    Adverse event reporting additional description
    As there were no SAEs reported before protocol amendment 2, the number of subjects at risk for each reported SAE was the total number of subjects enrolled after the protocol amendment. The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16
    Reporting groups
    Reporting group title
    GSK217744 Group 1
    Reporting group description
    		 Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.

    Reporting group title
    GSK217744 Group 2
    Reporting group description
    		 Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.

    Reporting group title
    Infanrix hexa Group
    Reporting group description
    		 Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.

    Serious adverse events
    		 GSK217744 Group 1 GSK217744 Group 2 Infanrix hexa Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 188 (0.53%)
    1 / 187 (0.53%)
    0 / 282 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Infections and infestations
    Pneumonia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 188 (0.53%)
    1 / 187 (0.53%)
    0 / 282 (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
    Metabolism and nutrition disorders
    Dehydration
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 188 (0.00%)
    1 / 187 (0.53%)
    0 / 282 (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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 GSK217744 Group 1 GSK217744 Group 2 Infanrix hexa Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    188 / 188 (100.00%)
    187 / 187 (100.00%)
    282 / 282 (100.00%)
    General disorders and administration site conditions
    Pain (Symptom reported in subjects enrolled after protocol amendment 2.)
    alternative assessment type: Systematic
         subjects affected / exposed
    51 / 188 (27.13%)
    57 / 187 (30.48%)
    98 / 282 (34.75%)
         occurrences all number
    51
    57
    98
    Redness (Symptom reported in subjects enrolled after protocol amendment 2.)
    alternative assessment type: Systematic
         subjects affected / exposed
    24 / 188 (12.77%)
    26 / 187 (13.90%)
    73 / 282 (25.89%)
         occurrences all number
    24
    26
    73
    Swelling (Symptom reported in subjects enrolled after protocol amendment 2.)
    alternative assessment type: Systematic
         subjects affected / exposed
    29 / 188 (15.43%)
    28 / 187 (14.97%)
    58 / 282 (20.57%)
         occurrences all number
    29
    28
    58
    Drowsiness (Symptom reported in subjects enrolled after protocol amendment 2.)
    alternative assessment type: Systematic
         subjects affected / exposed
    30 / 188 (15.96%)
    35 / 187 (18.72%)
    67 / 282 (23.76%)
         occurrences all number
    30
    35
    67
    Irritability/fussiness (Symptom reported in subjects enrolled after protocol amendment 2.)
    alternative assessment type: Systematic
         subjects affected / exposed
    37 / 188 (19.68%)
    47 / 187 (25.13%)
    102 / 282 (36.17%)
         occurrences all number
    37
    47
    102
    Loss of appetite (Symptom reported in subjects enrolled after protocol amendment 2.)
    alternative assessment type: Systematic
         subjects affected / exposed
    27 / 188 (14.36%)
    28 / 187 (14.97%)
    58 / 282 (20.57%)
         occurrences all number
    27
    28
    58
    Fever (Symptom reported in subjects enrolled after protocol amendment 2.)
    alternative assessment type: Systematic
         subjects affected / exposed
    37 / 188 (19.68%)
    40 / 187 (21.39%)
    83 / 282 (29.43%)
         occurrences all number
    37
    40
    83
    Diarrhoea (AE reported in subjects enrolled before protocol amendment 2.)
         subjects affected / exposed
    5 / 188 (2.66%)
    6 / 187 (3.21%)
    4 / 282 (1.42%)
         occurrences all number
    5
    6
    4
    Injection site induration (AE reported in subjects enrolled before protocol amendment 2)
         subjects affected / exposed
    7 / 188 (3.72%)
    3 / 187 (1.60%)
    5 / 282 (1.77%)
         occurrences all number
    7
    3
    5
    Pyrexia (AE reported in subjects enrolled before protocol amendment 2)
         subjects affected / exposed
    4 / 188 (2.13%)
    5 / 187 (2.67%)
    5 / 282 (1.77%)
         occurrences all number
    4
    5
    5
    Pain (Symptom reported in subjects enrolled before protocol amendment 2)
    alternative assessment type: Systematic
         subjects affected / exposed
    56 / 188 (29.79%)
    67 / 187 (35.83%)
    63 / 282 (22.34%)
         occurrences all number
    56
    67
    63
    Redness (Symptom reported in subjects enrolled before protocol amendment 2)
    alternative assessment type: Systematic
         subjects affected / exposed
    55 / 188 (29.26%)
    56 / 187 (29.95%)
    59 / 282 (20.92%)
         occurrences all number
    55
    56
    59
    Swelling (Symptom reported in subjects enrolled before protocol amendment 2)
    alternative assessment type: Systematic
         subjects affected / exposed
    45 / 188 (23.94%)
    43 / 187 (22.99%)
    48 / 282 (17.02%)
         occurrences all number
    45
    43
    48
    Drowsiness (Symptom reported in subjects enrolled before protocol amendment 2)
    alternative assessment type: Systematic
         subjects affected / exposed
    54 / 188 (28.72%)
    47 / 187 (25.13%)
    47 / 282 (16.67%)
         occurrences all number
    54
    47
    47
    Irritability/fussiness (Symptom reported in subjects enrolled before protocol amendment 2)
    alternative assessment type: Systematic
         subjects affected / exposed
    69 / 188 (36.70%)
    73 / 187 (39.04%)
    74 / 282 (26.24%)
         occurrences all number
    69
    73
    74
    Loss of appetite (Symptom reported in subjects enrolled before protocol amendment 2)
    alternative assessment type: Systematic
         subjects affected / exposed
    43 / 188 (22.87%)
    45 / 187 (24.06%)
    46 / 282 (16.31%)
         occurrences all number
    43
    45
    46
    Fever (Symptom reported in subjects enrolled before protocol amendment 2)
    alternative assessment type: Systematic
         subjects affected / exposed
    42 / 188 (22.34%)
    41 / 187 (21.93%)
    37 / 282 (13.12%)
         occurrences all number
    42
    41
    37
    Eye disorders
    Conjunctivitis (AE reported in subjects enrolled before protocol amendment 2.)
         subjects affected / exposed
    3 / 188 (1.60%)
    0 / 187 (0.00%)
    7 / 282 (2.48%)
         occurrences all number
    3
    0
    7
    Infections and infestations
    Nasopharyngitis (AE reported in subjects enrolled after protocol amendment 2)
         subjects affected / exposed
    9 / 188 (4.79%)
    11 / 187 (5.88%)
    10 / 282 (3.55%)
         occurrences all number
    9
    11
    10
    Otitis media (AE reported in subjects enrolled before protocol amendment 2)
         subjects affected / exposed
    6 / 188 (3.19%)
    11 / 187 (5.88%)
    11 / 282 (3.90%)
         occurrences all number
    6
    11
    11
    Upper respiratory tract infection (AE reported in subjects enrolled before protocol amendment 2)
         subjects affected / exposed
    6 / 188 (3.19%)
    7 / 187 (3.74%)
    9 / 282 (3.19%)
         occurrences all number
    6
    7
    9
    Nasopharyngitis (AE reported in subjects enrolled before protocol amendment 2)
         subjects affected / exposed
    4 / 188 (2.13%)
    2 / 187 (1.07%)
    5 / 282 (1.77%)
         occurrences all number
    4
    2
    5
    Gastroenteritis (AE reported in subjects enrolled before protocol amendment 2)
         subjects affected / exposed
    2 / 188 (1.06%)
    2 / 187 (1.07%)
    5 / 282 (1.77%)
         occurrences all number
    2
    2
    5

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Oct 2011
    1. At the discretion of GSK Biologicals, pneumococcal testing may be done at a GSK Biologicals laboratory or the World Health Organisation (WHO) reference laboratory. Since the 22F-inhibition ELISA assay used at the WHO reference laboratory has a different assay cut-off, different thresholds are mentioned in the statistical analysis description. The threshold for the 22F-inhibition non-GSK ELISA assay performed at the WHO reference laboratory is 0.35 µg/ml. 2. In order to simplify study management activities, the subjects will be given new treatment numbers in the present booster study. 3. Exploratory statistical comparisons will be based on 97.5% CI instead of 95% to be aligned with the study objective criteria.
    12 Apr 2012
    1. Due to the increased incidence of fever observed with the new formulations of the DTPa-HBV-IPV/Hib vaccine in the primary vaccination study 113948 (DTPa-HBV-IPV-124), all subjects yet to receive a booster dose in the present study will be administered the licensed formulation of Infanrix hexa. 2. Because the safety and immunogenicity of commercial vaccines administered after Formulation A or Formulation B is unknown, this study will continue to ensure the safety of the subjects and adequate immune responses to the booster dose of Infanrix hexa. 3. SBIR will be used to allocate new treatment numbers corresponding to Infanrix hexa vaccine to all newly enrolled subjects after amendment 2. 4. After amendment 2, all subjects will receive Infanrix hexa. Accordingly less than half of the subjects can contribute to the initial study objectives leading to a study power lower than 50%. For this reason, separate analyses of the cohort enrolled pre and post amendment will be performed. These analyses will be descriptive without study group comparisons.
    15 May 2012
    At the European Medicines Agency’s (EMA) request, GSK Biologicals has updated its procedure for emergency unblinding during the conduct of a clinical study. According to the revised procedure, the responsibility and the decision to break the treatment code in emergency situations resides solely with the investigator and consequently, the investigator will have full authority to break the treatment code.

    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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