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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
    12 Nov 2012

    Results information
    Results version number
    		 v3(current)
    This version publication date
    06 Sep 2020
    First version publication date
    01 Feb 2015
    Other versions
    		 v1 , v2
    Version creation reason

    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
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    GSK Response Center, GlaxoSmithKline, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 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
    02 May 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Nov 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Nov 2012
    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
    		 -

    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
    After Protocol Amendment 2.
    Is this the baseline period?
    		 Yes
    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
    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 the right side of the thigh

    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
    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 the right side of the thigh

    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
    		 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 the right side of the thigh

    Number of subjects in period 1 [1]
    		GSK217744 Group 1 GSK217744 Group 2 Infanrix hexa Group
    Started
    131
    130
    124
    Completed
    130
    130
    124
    Not completed
    1
    0
    0
         Consent withdrawn by subject
    1
    -
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: A total of 272 subjects were enrolled in the study before the second protocol amendment and total of 385 were enrolled after the amendment, hence the second period was the baseline.
    Period 2
    Period 2 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
    Single dose, licensed formulation, intramuscular into the right side of the thigh

    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
    Single dose, licensed formulation, intramuscular into the right side of the thigh

    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
    Single dose, licensed formulation, intramuscular into the right side of the thigh

    Number of subjects in period 2 [2]
    		GSK217744 Group 1 GSK217744 Group 2 Infanrix hexa Group
    Started
    85
    88
    99
    Completed
    85
    88
    99
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: A total of 272 subjects were enrolled in the study before the second protocol amendment and total of 385 were enrolled after the amendment, hence the second period was the baseline.

    Baseline characteristics

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    Baseline characteristics 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 values
    		 GSK217744 Group 1 GSK217744 Group 2 Infanrix hexa Group Total
    Number of subjects
    		 131 130 124 385
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 131 130 124 385
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 0 0 0 0
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age Continuous
    Baseline measure for subjects enrolled before protocol amendment 2.
    Units: Months
        arithmetic mean (standard deviation)
    		 14.1 ± 0.6 13.9 ± 0.6 14 ± 0.6 -
    Sex: Female, Male
    Baseline measure for subjects enrolled before protocol amendment 2.
    Units: Participants
        Female
    		 61 76 53 190
        Male
    		 70 54 71 195

    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
    		 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.

    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
    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: Statistical analysis not applicable for this endpoint
    End point values
    		 GSK217744 Group 1 GSK217744 Group 2 Infanrix hexa Group
    Number of subjects analysed
    81
    82
    90
    Units: Participants
        Anti-D, POST (N=81, 82, 90)
    81
    82
    90
        Anti-T, POST (N=81, 82, 90)
    81
    82
    90
    No statistical analyses for this end point

    Primary: Number of seroprotected subjects for anti-diptheria and anti-T antibody

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    End point title
    		 Number of seroprotected subjects for anti-diptheria and anti-T antibody [2]
    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
    1 month post booster vaccination (POST) (subjects enrolled after 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: Statistical analysis not applicable for this endpoint
    End point values
    		 GSK217744 Group 1 GSK217744 Group 2 Infanrix hexa Group
    Number of subjects analysed
    123
    122
    118
    Units: Participants
        Anti-D, POST (N=123, 122, 118)
    123
    122
    118
        Anti-T, POST (N=123, 122, 118)
    123
    122
    118
    No statistical analyses for this end point

    Primary: Number of seroprotected subjects against anti-Hepatitis B (anti-HBs) antigens

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    End point title
    		 Number of seroprotected subjects against anti-Hepatitis B (anti-HBs) antigens [3]
    End point description
    A seroprotected subject was a subject whose antibody concentration was greater than or equal to the level defining clinical protection of 10 milli-international units per millilitre (mIU/mL).
    End point type
    Primary
    End point timeframe
    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: Statistical analysis not applicable for this endpoint
    End point values
    		 GSK217744 Group 1 GSK217744 Group 2 Infanrix hexa Group
    Number of subjects analysed
    79
    79
    84
    Units: Participants
    78
    78
    84
    No statistical analyses for this end point

    Primary: Number of seroprotected subjects against anti-HBs antigens

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    End point title
    		 Number of seroprotected subjects against anti-HBs antigens [4]
    End point description
    A seroprotected subject was a subject whose antibody concentration was greater than or equal to the level defining clinical protection of 10 milli-international units per millilitre (mIU/mL).
    End point type
    Primary
    End point timeframe
    1 month post booster vaccination (POST) (subjects enrolled after 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: Statistical analysis not applicable for this endpoint
    End point values
    		 GSK217744 Group 1 GSK217744 Group 2 Infanrix hexa Group
    Number of subjects analysed
    123
    115
    115
    Units: Participants
    121
    113
    114
    No statistical analyses for this end point

    Primary: Number of Seroprotected Subjects for anti-poliovirus types 1, 2 and 3

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    End point title
    		 Number of Seroprotected Subjects for anti-poliovirus types 1, 2 and 3 [5]
    End point description
    A seroprotected subject was a subject whose antibody titre was greater than or equal to the level defining clinical protection of 8.
    End point type
    Primary
    End point timeframe
    1 month post booster vaccination (POST) (subjects enrolled before 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: Statistical analysis not applicable for this endpoint
    End point values
    		 GSK217744 Group 1 GSK217744 Group 2 Infanrix hexa Group
    Number of subjects analysed
    77
    72
    85
    Units: Participants
        Anti-Polio 1, POST (N= 77, 72, 85)
    76
    72
    85
        Anti-Polio 2, POST (N= 62, 61, 76)
    62
    60
    76
        Anti-Polio 3, POST (N= 64, 63, 73)
    64
    63
    71
    No statistical analyses for this end point

    Primary: Number of Seroprotected Subjects for anti-poliovirus (type 1, 2 and 3)

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    End point title
    		 Number of Seroprotected Subjects for anti-poliovirus (type 1, 2 and 3) [6]
    End point description
    A seroprotected subject was a subject whose antibody titre was greater than or equal to the level defining clinical protection of 8.
    End point type
    Primary
    End point timeframe
    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: Statistical analysis not applicable for this endpoint
    End point values
    		 GSK217744 Group 1 GSK217744 Group 2 Infanrix hexa Group
    Number of subjects analysed
    113
    107
    103
    Units: Participants
        Anti-Polio 1, POST (N= 111, 107, 103)
    111
    107
    102
        Anti-Polio 2, POST (N= 96, 97, 87)
    96
    96
    87
        Anti-Polio 3, POST (N= 113, 103, 98)
    113
    103
    98
    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
    1 month post booster vaccination (POST) (subjects enrolled before 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: Statistical analysis not applicable for this endpoint
    End point values
    		 GSK217744 Group 1 GSK217744 Group 2 Infanrix hexa Group
    Number of subjects analysed
    81
    82
    90
    Units: Participants
    81
    82
    90
    No statistical analyses for this end point

    Primary: Number of seroprotected subjects for anti-PRP

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    End point title
    		 Number of seroprotected subjects for anti-PRP [8]
    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
    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: Statistical analysis not applicable for this endpoint
    End point values
    		 GSK217744 Group 1 GSK217744 Group 2 Infanrix hexa Group
    Number of subjects analysed
    123
    122
    118
    Units: Participants
        Anti-PRP seroprotected subjects (N= 123, 122, 117)
    122
    122
    117
    No statistical analyses for this end point

    Primary: Concentrations for anti-Pertussis toxoid (anti-PT), anti-Filamentous haemagglutinin (anti-FHA), anti-Pertactin (anti-PRN)

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    End point title
    		 Concentrations for anti-Pertussis toxoid (anti-PT), anti-Filamentous haemagglutinin (anti-FHA), anti-Pertactin (anti-PRN) [9]
    End point description
    Concentrations were expressed as geometric mean concentrations (GMCs). Seropositivity cut-off assay was 5 EL.U/mL.
    End point type
    Primary
    End point timeframe
    1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis not applicable for this endpoint
    End point values
    		 GSK217744 Group 1 GSK217744 Group 2 Infanrix hexa Group
    Number of subjects analysed
    81
    82
    90
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PT, POST (N= 79, 81, 89)
    76.1 (66.1 to 87.6)
    74.3 (62.6 to 88.1)
    96.0 (83.5 to 110.3)
        Anti-FHA, POST (N= 81, 82, 90)
    393.7 (346.4 to 447.6)
    372.4 (332.7 to 416.7)
    423.0 (368.1 to 485.9)
        Anti-PRN, POST (N= 81, 81, 89)
    213.0 (178.1 to 254.7)
    180.0 (154.2 to 210.1)
    372.9 (309.3 to 449.5)
    No statistical analyses for this end point

    Primary: Concentrations for anti-PT, anti-FHA, anti-PRN

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    End point title
    		 Concentrations for anti-PT, anti-FHA, anti-PRN [10]
    End point description
    Concentrations were expressed as geometric mean concentrations (GMCs). Seropositivity cut-off assay was 5 EL.U/mL.
    End point type
    Primary
    End point timeframe
    1 month post booster vaccination (subjects enrolled after protocol amendment 2)
    Notes
    [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis not applicable for this endpoint
    End point values
    		 GSK217744 Group 1 GSK217744 Group 2 Infanrix hexa Group
    Number of subjects analysed
    123
    122
    117
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PT, POST (N= 118, 121, 116)
    92.4 (80.6 to 106.0)
    93.6 (83.1 to 105.5)
    132.6 (114.9 to 153.0)
        Anti-FHA, POST (N=123, 122, 117)
    467.3 (417.3 to 523.3)
    446.2 (402.3 to 494.9)
    582.9 (517.1 to 657.1)
        Anti-PRN, POST (N= 122, 122, 117)
    253.2 (216.9 to 295.6)
    181.0 (154.8 to 211.7)
    401.1 (342.2 to 470.0)
    No statistical analyses for this end point

    Secondary: 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
    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
    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
    81
    82
    90
    Units: IU/mL
    geometric mean (confidence interval 95%)
        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, 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)
        Anti-D, PRE (N= 81, 82, 89)
    0.357 (0.305 to 0.419)
    0.445 (0.381 to 0.520)
    0.401 (0.343 to 0.468)
        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)
    No statistical analyses for this end point

    Secondary: Concentrations for anti-D and anti-T antibodies

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    End point title
    		 Concentrations for anti-D and anti-T antibodies
    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
    Secondary
    End point timeframe
    Before (PRE) 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
    123
    122
    118
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-D, POST (N= 123, 122, 118)
    6.327 (5.698 to 7.025)
    5.452 (4.956 to 5.998)
    7.192 (6.419 to 8.059)
        Anti-T, POST (N= 123, 122, 118)
    5.986 (5.204 to 6.885)
    5.316 (4.716 to 5.992)
    5.993 (5.222 to 6.878)
        Anti-D, PRE (N= 123, 121, 117)
    0.247 (0.213 to 0.287)
    0.278 (0.244 to 0.317)
    0.304 (0.258 to 0.360)
        Anti-T, PRE (N= 123, 121, 117)
    0.364 (0.313 to 0.422)
    0.332 (0.289 to 0.380)
    0.331 (0.285 to 0.383)
    No statistical analyses for this end point

    Secondary: Number of seroprotected subjects for anti-D and anti-T antibodies

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    End point title
    		 Number of seroprotected subjects for anti-D and anti-T antibodies
    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
    Secondary
    End point timeframe
    Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
    End point values
    		 GSK217744 Group 1 GSK217744 Group 2 Infanrix hexa Group
    Number of subjects analysed
    81
    82
    90
    Units: Participants
        Anti-D, PRE (N= 81, 82, 90)
    78
    80
    84
        Anti-T, PRE (N= 81, 82, 90)
    76
    78
    85
    No statistical analyses for this end point

    Secondary: Number of seroprotected subjects for anti-diptheria and anti-T antibodies

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    End point title
    		 Number of seroprotected subjects for anti-diptheria and anti-T antibodies
    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
    Secondary
    End point timeframe
    Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
    End point values
    		 GSK217744 Group 1 GSK217744 Group 2 Infanrix hexa Group
    Number of subjects analysed
    123
    121
    117
    Units: Participants
        Anti-D, PRE (N= 123, 121, 117)
    107
    114
    104
        Anti-T, PRE (N= 123, 121, 117)
    116
    114
    111
    No statistical analyses for this end point

    Secondary: Concentrations for anti-Pertussis toxoid (anti-PT), anti-Filamentous haemagglutinin (anti-FHA), anti-Pertactin

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    End point title
    		 Concentrations for anti-Pertussis toxoid (anti-PT), anti-Filamentous haemagglutinin (anti-FHA), anti-Pertactin
    End point description
    Concentrations were expressed as geometric mean concentrations (GMCs). Seropositivity cut-off assay was 5 EL.U/mL.
    End point type
    Secondary
    End point timeframe
    Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
    End point values
    		 GSK217744 Group 1 GSK217744 Group 2 Infanrix hexa Group
    Number of subjects analysed
    81
    82
    89
    Units: EL.U/mL.
    geometric mean (confidence interval 95%)
        Anti-PT, PRE (N= 80, 80, 87)
    10.5 (8.8 to 12.6)
    9.5 (7.9 to 11.4)
    12.7 (10.8 to 15.0)
        Anti-FHA, PRE (N= 81, 82, 88)
    41.7 (35.4 to 49.2)
    36.9 (31.5 to 43.3)
    47.1 (40.3 to 55.1)
        Anti-PRN, PRE (N= 81, 81, 89)
    12.8 (10.4 to 15.7)
    10.8 (8.9 to 13.1)
    18.2 (15.0 to 22.1)
    No statistical analyses for this end point

    Secondary: Concentrations for anti-PT, anti-FHA and anti-PRN

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    End point title
    		 Concentrations for anti-PT, anti-FHA and anti-PRN
    End point description
    Concentrations were expressed as geometric mean concentrations (GMCs). Seropositivity cut-off assay was 5 EL.U/mL.
    End point type
    Secondary
    End point timeframe
    Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
    End point values
    		 GSK217744 Group 1 GSK217744 Group 2 Infanrix hexa Group
    Number of subjects analysed
    123
    121
    117
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PT, PRE (N= 123, 121, 117)
    8.3 (7.2 to 9.7)
    7.9 (6.8 to 9.1)
    9.9 (8.5 to 11.5)
        Anti-FHA, PRE (N= 123, 118, 116)
    37.6 (32.5 to 43.4)
    34.0 (28.7 to 40.4)
    45.7 (38.8 to 53.9)
        Anti-PRN, PRE (N= 123, 121, 117)
    11.6 (9.7 to 13.9)
    9.7 (8.1 to 11.7)
    15.6 (13.0 to 18.7)
    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 a subject whose antibody concentration was greater than or equal to (≥) the assay cut-off of 5 ELISA units per milliliter (EL.U/mL).
    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
    81
    82
    90
    Units: Participants
        Anti-PT, POST (N= 79, 81, 89)
    79
    81
    89
        Anti-FHA, POST (N= 81, 82, 90)
    81
    82
    90
        Anti-PRN, POST (N= 81, 81, 89)
    81
    81
    89
    No statistical analyses for this end point

    Secondary: Number of seropositive subjects for anti-PT, anti-FHA, anti-PRN

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    End point title
    		 Number of seropositive subjects for anti-PT, anti-FHA, anti-PRN
    End point description
    A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the assay cut-off of 5 ELISA units per milliliter (EL.U/mL).
    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
    123
    122
    117
    Units: Participants
        Anti-PT, POST (N= 118, 121, 116)
    118
    121
    116
        Anti-FHA, POST (N= 123, 122, 117)
    123
    122
    117
        Anti-PRN, POST (N= 122, 122, 117)
    122
    122
    117
    No statistical analyses for this end point

    Secondary: Anti-Hepatitis B (anti-HBs) antibody concentrations

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    End point title
    		 Anti-Hepatitis B (anti-HBs) antibody concentrations
    End point description
    Concentrations were expressed as geometric mean concentrations (GMCs). Seroprotection cut-off assay was 10 mIU/mL.
    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
    79
    79
    84
    Units: mIU/mL
        geometric mean (confidence interval 95%)
    2233.3 (1479.7 to 3370.8)
    2026.3 (1389.4 to 2955.2)
    2685.7 (1868.8 to 3859.7)
    No statistical analyses for this end point

    Secondary: Anti-HBs antibody concentration

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    End point title
    		 Anti-HBs antibody concentration
    End point description
    Concentrations were expressed as geometric mean concentrations (GMCs). Seroprotection cut-off assay was 10 mIU/mL.
    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
    123
    115
    115
    Units: mIU/mL
        geometric mean (confidence interval 95%)
    2229.3 (1625.5 to 3057.5)
    1729.8 (1240.6 to 2411.9)
    3711.4 (2729.7 to 5046.1)
    No statistical analyses for this end point

    Secondary: Anti-Hepatitis B (anti-HBs) antibody concentration

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    End point title
    		 Anti-Hepatitis B (anti-HBs) antibody concentration
    End point description
    Concentrations were expressed as geometric mean concentrations (GMCs). Seroprotection cut-off assay was 10 mIU/mL.
    End point type
    Secondary
    End point timeframe
    Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
    End point values
    		 GSK217744 Group 1 GSK217744 Group 2 Infanrix hexa Group
    Number of subjects analysed
    74
    79
    84
    Units: mIU/mL
        geometric mean (confidence interval 95%)
    130.3 (91.2 to 186.0)
    124.4 (89.5 to 173.0)
    166.4 (112.8 to 245.5)
    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 expressed as geometric mean concentrations (GMCs). Seroprotection cut-off assay was 10 mIU/mL.
    End point type
    Secondary
    End point timeframe
    Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
    End point values
    		 GSK217744 Group 1 GSK217744 Group 2 Infanrix hexa Group
    Number of subjects analysed
    120
    119
    115
    Units: mIU/mL
        geometric mean (confidence interval 95%)
    94.9 (72.2 to 124.8)
    61.8 (45.7 to 83.5)
    125.9 (94.6 to 167.7)
    No statistical analyses for this end point

    Secondary: Number of seroprotected subjects against anti-Hepatitis B antigens

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    End point title
    		 Number of seroprotected subjects against anti-Hepatitis B antigens
    End point description
    A seroprotected subject was a subject whose antibody concentration was greater than or equal to the level defining clinical protection of 10 milli-international units per millilitre (mIU/mL).
    End point type
    Secondary
    End point timeframe
    Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
    End point values
    		 GSK217744 Group 1 GSK217744 Group 2 Infanrix hexa Group
    Number of subjects analysed
    74
    79
    84
    Units: Participants
    68
    74
    78
    No statistical analyses for this end point

    Secondary: Number of seroprotected subjects against anti-HBs antigen

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    End point title
    		 Number of seroprotected subjects against anti-HBs antigen
    End point description
    A seroprotected subject was a subject whose antibody concentration was greater than or equal to the level defining clinical protection of 10 milli-international units per millilitre (mIU/mL).
    End point type
    Secondary
    End point timeframe
    Before (PRE) booaster vaccination (subjects enrolled after protocol amendment 2)
    End point values
    		 GSK217744 Group 1 GSK217744 Group 2 Infanrix hexa Group
    Number of subjects analysed
    120
    119
    115
    Units: Participants
    108
    100
    106
    No statistical analyses for this end point

    Secondary: Concentrations for anti-poliovirus types 1, 2, 3

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    End point title
    		 Concentrations for anti-poliovirus types 1, 2, 3
    End point description
    Concentrations were expressed as geometric mean titers (GMTs). The seroprotection cut-off of the assay was 8.
    End point type
    Secondary
    End point timeframe
    Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
    End point values
    		 GSK217744 Group 1 GSK217744 Group 2 Infanrix hexa Group
    Number of subjects analysed
    73
    74
    80
    Units: Titers
    geometric mean (confidence interval 95%)
        Anti-Polio 1, PRE (N= 69, 74, 71)
    18.2 (13.7 to 24.1)
    17.8 (13.5 to 23.5)
    22.4 (16.8 to 29.9)
        Anti-Polio 2, PRE (N= 69, 72, 69)
    12.7 (9.5 to 16.9)
    17.1 (12.3 to 23.8)
    16.6 (12.0 to 22.8)
        Anti-Polio, 3 PRE (N= 73, 73, 80)
    24.7 (17.1 to 35.8)
    16.8 (12.0 to 23.5)
    26.6 (19.2 to 36.9)
    No statistical analyses for this end point

    Secondary: Concentration for anti-poliovirus types 1, 2, 3

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    End point title
    		 Concentration for anti-poliovirus types 1, 2, 3
    End point description
    Concentrations were expressed as geometric mean titers (GMTs). The seroprotection cut-off of the assay was 8.
    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
    77
    72
    85
    Units: Titers
    geometric mean (confidence interval 95%)
        Anti-Polio 1, POST (N= 77, 72, 85)
    572.9 (435.5 to 753.6)
    558.3 (422.0 to 738.8)
    902.1 (698.4 to 1165.0)
        Anti-Polio 2, POST (N= 62, 61, 76)
    629.7 (452.6 to 876.1)
    668.7 (489.9 to 912.7)
    1184.9 (901.1 to 1558.1)
        Anti-Polio 3, POST (N= 64, 63, 73)
    1147.5 (846.2 to 1556.0)
    614.0 (453.9 to 830.6)
    1120.7 (793.0 to 1583.9)
    No statistical analyses for this end point

    Secondary: Concentrations for anti-poliovirus types 1, 2 and 3

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    End point title
    		 Concentrations for anti-poliovirus types 1, 2 and 3
    End point description
    Concentrations were expressed as geometric mean titers (GMTs). The seroprotection cut-off of the assay was 8.
    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
    113
    107
    103
    Units: Titers
    geometric mean (confidence interval 95%)
        Anti-Polio 1, POST (N= 111, 107, 103)
    1121.0 (904.2 to 1389.8)
    1099.6 (905.2 to 1335.8)
    1386.2 (1091.8 to 1760.0)
        Anti-Polio 2, POST (N= 96, 97, 87)
    1485.3 (1182.4 to 1865.8)
    1215.6 (973.8 to 1517.4)
    1537.2 (1191.0 to 1984.1)
        Anti-Polio 3, POST (N= 113, 103, 98)
    1851.2 (1473.2 to 2326.1)
    1960.4 (1574.0 to 2441.5)
    2376.4 (1874.2 to 3013.2)
    No statistical analyses for this end point

    Secondary: Concentration for anti-poliovirus type 1, 2 and 3

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    End point title
    		 Concentration for anti-poliovirus type 1, 2 and 3
    End point description
    Concentrations were expressed as geometric mean titers (GMTs). The seroprotection cut-off of the assay was 8.
    End point type
    Secondary
    End point timeframe
    Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
    End point values
    		 GSK217744 Group 1 GSK217744 Group 2 Infanrix hexa Group
    Number of subjects analysed
    108
    109
    104
    Units: Titers
    geometric mean (confidence interval 95%)
        Anti-Polio 1, PRE (N=106, 105, 99)
    53.5 (39.6 to 72.4)
    50.7 (37.2 to 69.2)
    70.8 (52.4 to 95.8)
        Anti-Polio 2, PRE (N= 90, 93, 85)
    76.6 (50.3 to 116.7)
    55.0 (38.2 to 79.3)
    82.7 (55.6 to 122.9)
        Anti-Polio, 3 PRE (N= 108, 109, 104)
    67.8 (47.3 to 97.2)
    73.8 (52.2 to 104.2)
    93.9 (64.4 to 136.8)
    No statistical analyses for this end point

    Secondary: Number of Seroprotected Subjects for anti-poliovirus type 1, 2 and 3

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    End point title
    		 Number of Seroprotected Subjects for anti-poliovirus type 1, 2 and 3
    End point description
    A seroprotected subject was a subject whose antibody titre was greater than or equal to the level defining clinical protection of 8.
    End point type
    Secondary
    End point timeframe
    Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
    End point values
    		 GSK217744 Group 1 GSK217744 Group 2 Infanrix hexa Group
    Number of subjects analysed
    73
    74
    80
    Units: Participants
        Anti-Polio 1, PRE (N= 69, 74, 71)
    50
    54
    56
        Anti-Polio 2, PRE (N= 69, 72, 69)
    38
    44
    44
        Anti-Polio, 3 PRE (N= 73, 73, 80)
    51
    43
    61
    No statistical analyses for this end point

    Secondary: Number of seroprotected subjects against anti-Poliovirus type 1, 2 and 3

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    End point title
    		 Number of seroprotected subjects against anti-Poliovirus type 1, 2 and 3
    End point description
    A seroprotected subject was a subject whose antibody titre was greater than or equal to the level defining clinical protection of 8.
    End point type
    Secondary
    End point timeframe
    Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
    End point values
    		 GSK217744 Group 1 GSK217744 Group 2 Infanrix hexa Group
    Number of subjects analysed
    108
    109
    104
    Units: Participants
        Anti-Polio 1, PRE (N= 106, 105, 99)
    95
    91
    92
        Anti-Polio 2, PRE (n= 90, 93, 85)
    78
    81
    74
        Anti-Polio, 3 PRE (n= 108, 109, 104)
    96
    99
    91
    No statistical analyses for this end point

    Secondary: Concentrations for anti-PRP antibodies

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    End point title
    		 Concentrations for anti-PRP antibodies
    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
    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
    81
    82
    90
    Units: µg /mL
        geometric mean (confidence interval 95%)
    12.765 (9.300 to 17.520)
    15.904 (11.723 to 21.576)
    17.099 (12.966 to 22.550)
    No statistical analyses for this end point

    Secondary: Concentrations for anti-PRP antibody

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    End point title
    		 Concentrations for anti-PRP antibody
    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
    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
    123
    122
    118
    Units: µg /mL
        geometric mean (confidence interval 95%)
    21.462 (16.650 to 27.664)
    15.903 (12.132 to 20.848)
    17.429 (13.429 to 22.620)
    No statistical analyses for this end point

    Secondary: Concentrations for anti-polyribosyl-ribitol phosphate (anti-PRP) antibodies

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    End point title
    		 Concentrations for anti-polyribosyl-ribitol phosphate (anti-PRP) antibodies
    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
    Secondary
    End point timeframe
    Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
    End point values
    		 GSK217744 Group 1 GSK217744 Group 2 Infanrix hexa Group
    Number of subjects analysed
    81
    82
    89
    Units: µg /mL
        geometric mean (confidence interval 95%)
    0.173 (0.138 to 0.216)
    0.175 (0.142 to 0.216)
    0.236 (0.182 to 0.307)
    No statistical analyses for this end point

    Secondary: Concentrations for anti-polyribosyl-ribitol phosphate antibodies

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    End point title
    		 Concentrations for anti-polyribosyl-ribitol phosphate antibodies
    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
    Secondary
    End point timeframe
    Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2))
    End point values
    		 GSK217744 Group 1 GSK217744 Group 2 Infanrix hexa Group
    Number of subjects analysed
    123
    121
    117
    Units: µg /mL
        geometric mean (confidence interval 90%)
    0.328 (0.262 to 0.409)
    0.288 (0.227 to 0.365)
    0.334 (0.254 to 0.439)
    No statistical analyses for this end point

    Secondary: Number of seropositive subjects for anti-Pertussis toxoid (anti-PT), anti-FHA, anti-PRN

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    End point title
    		 Number of seropositive subjects for anti-Pertussis toxoid (anti-PT), anti-FHA, anti-PRN
    End point description
    A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the assay cut-off of 5 ELISA units per milliliter (EL.U/mL).
    End point type
    Secondary
    End point timeframe
    Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
    End point values
    		 GSK217744 Group 1 GSK217744 Group 2 Infanrix hexa Group
    Number of subjects analysed
    81
    82
    89
    Units: Participants
        Anti-PT, PRE (N= 80, 80, 87)
    68
    65
    78
        Anti-FHA, PRE (N= 81, 82, 88)
    81
    81
    88
        Anti-PRN, PRE (N= 81, 81, 89)
    68
    69
    83
    No statistical analyses for this end point

    Secondary: Number of seropositive subjects for anti-PT, anti-FHA and anti-PRN

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    End point title
    		 Number of seropositive subjects for anti-PT, anti-FHA and anti-PRN
    End point description
    A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the assay cut-off of 5 ELISA units per milliliter (EL.U/mL).
    End point type
    Secondary
    End point timeframe
    Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
    End point values
    		 GSK217744 Group 1 GSK217744 Group 2 Infanrix hexa Group
    Number of subjects analysed
    123
    121
    117
    Units: Participants
        Anti-PT, PRE (N= 123, 121, 117)
    95
    94
    97
        Anti-FHA, PRE (N= 123, 118, 116)
    122
    117
    116
        Anti-PRN, PRE (N= 123, 121, 117)
    98
    92
    105
    No statistical analyses for this end point

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

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    End point title
    		 Number of seroprotected subjects for anti-PRP (anti-polyribosyl-ribitol phosphate)
    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
    Secondary
    End point timeframe
    Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
    End point values
    		 GSK217744 Group 1 GSK217744 Group 2 Infanrix hexa Group
    Number of subjects analysed
    81
    82
    89
    Units: Participants
    41
    45
    52
    No statistical analyses for this end point

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

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    End point title
    		 Number of seroprotected subjects for anti-polyribosyl-ribitol phosphate (PRP)
    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
    Secondary
    End point timeframe
    Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
    End point values
    		 GSK217744 Group 1 GSK217744 Group 2 Infanrix hexa Group
    Number of subjects analysed
    123
    121
    117
    Units: Participants
    92
    78
    81
    No statistical analyses for this end point

    Secondary: Concentrations for anti-pneumococcal (anti-PNE) antibodies

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    End point title
    		 Concentrations for anti-pneumococcal (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
    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: 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 2.80)
        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)
    1.10 (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 5.30)
    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)
    8.80 (7.01 to 11.06)
    8.97 (7.29 to 11.02)
        Anti- PNE 18C (N= 50, 50, 53)
    1.50 (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)
    7.00 (5.76 to 8.51)
    8.05 (6.39 to 10.13)
    6.70 (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: 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
    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
    23
    21
    20
    Units: µg /mL
    geometric mean (confidence interval 95%)
        Anti- PNE 1 (N= 23, 21, 20)
    2.54 (1.93 to 3.34)
    2.47 (1.83 to 3.35)
    3.47 (2.23 to 5.41)
        Anti- PNE 3 (N= 21, 18, 16)
    0.76 (0.59 to 0.96)
    0.82 (0.60 to 1.13)
    0.92 (0.66 to 1.30)
        Anti-PNE 4 (N= 23, 21, 20)
    2.03 (1.53 to 2.68)
    2.10 (1.59 to 2.79)
    2.57 (1.65 to 4.01)
        Anti-PNE 5 (N= 23, 21, 20)
    1.26 (0.97 to 1.63)
    1.24 (0.98 to 1.57)
    1.29 (0.89 to 1.87)
        Anti-PNE 6A (N= 23, 21, 20)
    10.64 (7.94 to 14.25)
    7.67 (6.18 to 9.53)
    7.47 (4.76 to 11.70)
        Anti-PNE 6B (N= 23, 21, 20)
    5.04 (3.74 to 6.79)
    4.56 (3.16 to 6.59)
    6.62 (3.90 to 11.24)
        Anti-PNE 7F (N= 23, 21, 20)
    4.20 (3.45 to 5.11)
    3.97 (2.98 to 5.29)
    4.67 (3.16 to 6.89)
        Anti-PNE 9V (N= 23, 21, 20)
    2.20 (1.66 to 2.93)
    1.42 (1.10 to 1.85)
    1.85 (1.21 to 2.83)
        Anti-PNE 14 (N= 23, 21, 20)
    7.47 (5.68 to 9.83)
    8.12 (6.04 to 10.93)
    9.28 (6.15 to 14.01)
        Anti-PNE 18C (N= 23, 21, 20)
    1.80 (1.34 to 2.40)
    1.52 (1.09 to 2.11)
    2.09 (1.41 to 3.11)
        Anti-PNE 19A (N= 23, 21, 20)
    8.79 (6.53 to 11.82)
    6.22 (4.99 to 7.76)
    9.10 (5.23 to 15.84)
        Anti-PNE 19F (N= 23, 21, 20)
    8.09 (5.48 to 11.95)
    7.11 (5.21 to 9.70)
    5.56 (3.38 to 9.14)
        Anti-PNE 23F (N= 23, 21, 20)
    5.31 (4.29 to 6.57)
    4.00 (3.05 to 5.24)
    5.82 (3.59 to 9.44)
    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: Participants
        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: Number of seropositive subjects for anti-PNE serotypes

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    End point title
    		 Number of seropositive subjects for 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
    23
    21
    20
    Units: Participants
        Anti- PNE 1 (N= 23, 21, 20)
    23
    21
    20
        Anti- PNE 3 (N= 21, 18, 16)
    21
    18
    16
        Anti-PNE 4 (N= 23, 21, 20)
    23
    21
    20
        Anti-PNE 5 (N= 23, 21, 20)
    23
    21
    20
        Anti-PNE 6A (N= 23, 21, 20)
    23
    21
    20
        Anti-PNE 6B (N= 23, 21, 20)
    23
    21
    20
        Anti-PNE 7F (N= 23, 21, 20)
    23
    21
    20
        Anti-PNE 9V (N= 23, 21, 20)
    23
    21
    20
        Anti-PNE 14 (N= 23, 21, 20)
    23
    21
    20
        Anti-PNE 18C (N= 23, 21, 20)
    23
    21
    20
        Anti-PNE 19A (N= 23, 21, 19)
    23
    21
    19
        Anti-PNE 19F (N= 23, 21, 20)
    23
    21
    20
        Anti-PNE 23F (N= 23, 21, 20)
    23
    21
    20
    No statistical analyses for this end point

    Secondary: Number of subjects with booster response to anti-pertussis antigens (anti-PT, anti-FHA and anti-PRN)

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    End point title
    		 Number of subjects with booster response to anti-pertussis antigens (anti-PT, anti-FHA and anti-PRN)
    End point description
    Booster response defined as : – For initially seronegative subjects, antibody concentration ≥ 5 EL.U/mL one month after booster vaccination – For initially seropositive subjects, antibody concentration at Post-booster ≥ 2 fold the pre-vaccination antibody concentration
    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
    81
    82
    88
    Units: Participants
        Anti-PT (N= 78, 79, 86)
    72
    77
    86
        Anti-FHA (N= 81, 82, 88)
    79
    81
    87
        Anti-PRN (N= 81, 80, 88)
    81
    80
    87
    No statistical analyses for this end point

    Secondary: Number of subjects with booster response to anti-pertussis antigens

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    End point title
    		 Number of subjects with booster response to anti-pertussis antigens
    End point description
    Booster response defined as : – For initially seronegative subjects, antibody concentration ≥ 5 EL.U/mL one month after booster vaccination – For initially seropositive subjects, antibody concentration at Post-booster ≥ 2 fold the pre-vaccination antibody concentration
    End point type
    Secondary
    End point timeframe
    1 month poste 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
    123
    121
    116
    Units: Subjects
        Anti-PT (N= 118, 121, 115)
    118
    119
    110
        Anti-FHA (N= 123, 118, 115)
    120
    115
    113
        Anti-PRN (N= 122, 121, 116)
    121
    120
    115
    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: Participants
        Any pain (N= 85, 88, 99)
    56
    67
    63
        Any redness (N= 85, 88, 99)
    55
    56
    59
        Any swelling (N= 85, 88, 99)
    45
    43
    48
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any solicited local symptom

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    End point title
    		 Number of subjects reporting any solicited local symptom
    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
    131
    130
    124
    Units: Participants
        Any pain (N= 131, 130, 124)
    76
    66
    64
        Any redness (N= 131, 130, 124)
    47
    36
    40
        Any swelling (N= 131, 130, 124)
    43
    34
    38
    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: Participants
        Any drowsiness (N= 85, 88, 99)
    54
    47
    47
        Any irritability/fussiness (N= 85, 88, 99)
    69
    73
    74
        Any loss of appetite (N= 85, 88, 99)
    43
    45
    46
        Any fever (N= 85, 88, 99)
    42
    41
    37
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any solicited general symptom

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    End point title
    		 Number of subjects reporting any solicited general symptom
    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
    131
    130
    124
    Units: Participants
        Any drowsiness (N= 131, 130, 124)
    52
    40
    40
        Any irritability/fussiness (N= 131, 130, 124)
    66
    58
    62
        Any loss of appetite (N= 131, 130, 124)
    42
    37
    34
        Any fever (N= 131, 130, 124)
    58
    50
    52
    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: Participants
    42
    39
    67
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any unsolicited AEs

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    End point title
    		 Number of subjects reporting any unsolicited 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
    131
    130
    124
    Units: Participants
    38
    27
    31
    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: Participants
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any SAEs

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    End point title
    		 Number of subjects reporting any 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
    131
    130
    124
    Units: Participants
    0
    2
    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
    The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    GSK217744 Group 1(Before protocol amendment 2)
    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 GSK217744 formulation A vaccine (for subjects vaccinated before 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(Before Protocol Amendment2)
    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 GSK217744 formulation B vaccine (for subjects vaccinated before 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(Before Protocol Amendment2)
    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(After Protocol Amendment2)
    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 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(After Protocol Amendment2)
    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 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(After Protocol Amendment2)
    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(Before protocol amendment 2) GSK217744 Group 2(Before Protocol Amendment2) Infanrix hexa Group(Before Protocol Amendment2) GSK217744 Group 1(After Protocol Amendment2) GSK217744 Group 2(After Protocol Amendment2) Infanrix hexa Group(After Protocol Amendment2)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 85 (0.00%)
    0 / 88 (0.00%)
    0 / 99 (0.00%)
    0 / 131 (0.00%)
    2 / 130 (1.54%)
    0 / 124 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Infections and infestations
    Pneumonia
    Additional description: SAE reported in subjects enrolled after protocol amendment 2.
         subjects affected / exposed
    0 / 85 (0.00%)
    0 / 88 (0.00%)
    0 / 99 (0.00%)
    0 / 131 (0.00%)
    2 / 130 (1.54%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
    Additional description: SAE reported in subjects enrolled after protocol amendment 2.
         subjects affected / exposed
    0 / 85 (0.00%)
    0 / 88 (0.00%)
    0 / 99 (0.00%)
    0 / 131 (0.00%)
    1 / 130 (0.77%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 GSK217744 Group 1(Before protocol amendment 2) GSK217744 Group 2(Before Protocol Amendment2) Infanrix hexa Group(Before Protocol Amendment2) GSK217744 Group 1(After Protocol Amendment2) GSK217744 Group 2(After Protocol Amendment2) Infanrix hexa Group(After Protocol Amendment2)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    85 / 85 (100.00%)
    85 / 88 (96.59%)
    96 / 99 (96.97%)
    118 / 131 (90.08%)
    103 / 130 (79.23%)
    104 / 124 (83.87%)
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    54 / 85 (63.53%)
    47 / 88 (53.41%)
    47 / 99 (47.47%)
    52 / 131 (39.69%)
    40 / 130 (30.77%)
    40 / 124 (32.26%)
         occurrences all number
    54
    47
    47
    52
    40
    40
    General disorders and administration site conditions
    Injection site induration
         subjects affected / exposed
    7 / 85 (8.24%)
    3 / 88 (3.41%)
    5 / 99 (5.05%)
    4 / 131 (3.05%)
    0 / 130 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    7
    3
    5
    4
    0
    0
    Pain
         subjects affected / exposed
    56 / 85 (65.88%)
    67 / 88 (76.14%)
    63 / 99 (63.64%)
    76 / 131 (58.02%)
    66 / 130 (50.77%)
    64 / 124 (51.61%)
         occurrences all number
    56
    67
    63
    76
    66
    64
    Swelling
         subjects affected / exposed
    45 / 85 (52.94%)
    43 / 88 (48.86%)
    48 / 99 (48.48%)
    43 / 131 (32.82%)
    34 / 130 (26.15%)
    38 / 124 (30.65%)
         occurrences all number
    45
    43
    48
    43
    34
    38
    Pyrexia
         subjects affected / exposed
    44 / 85 (51.76%)
    45 / 88 (51.14%)
    39 / 99 (39.39%)
    59 / 131 (45.04%)
    51 / 130 (39.23%)
    52 / 124 (41.94%)
         occurrences all number
    44
    45
    39
    59
    51
    52
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    5 / 85 (5.88%)
    6 / 88 (6.82%)
    4 / 99 (4.04%)
    2 / 131 (1.53%)
    2 / 130 (1.54%)
    4 / 124 (3.23%)
         occurrences all number
    5
    6
    4
    2
    2
    4
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    55 / 85 (64.71%)
    56 / 88 (63.64%)
    59 / 99 (59.60%)
    47 / 131 (35.88%)
    36 / 130 (27.69%)
    40 / 124 (32.26%)
         occurrences all number
    55
    56
    59
    47
    36
    40
    Psychiatric disorders
    Irritability/fussiness
         subjects affected / exposed
    69 / 85 (81.18%)
    73 / 88 (82.95%)
    74 / 99 (74.75%)
    66 / 131 (50.38%)
    58 / 130 (44.62%)
    62 / 124 (50.00%)
         occurrences all number
    69
    73
    74
    66
    58
    62
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    3 / 85 (3.53%)
    1 / 88 (1.14%)
    7 / 99 (7.07%)
    0 / 131 (0.00%)
    0 / 130 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    3
    1
    7
    0
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    4 / 85 (4.71%)
    2 / 88 (2.27%)
    5 / 99 (5.05%)
    13 / 131 (9.92%)
    9 / 130 (6.92%)
    8 / 124 (6.45%)
         occurrences all number
    4
    2
    5
    13
    9
    8
    Otitis media
         subjects affected / exposed
    6 / 85 (7.06%)
    11 / 88 (12.50%)
    11 / 99 (11.11%)
    3 / 131 (2.29%)
    3 / 130 (2.31%)
    2 / 124 (1.61%)
         occurrences all number
    6
    11
    11
    3
    3
    2
    Upper respiratory tract infection
         subjects affected / exposed
    6 / 85 (7.06%)
    7 / 88 (7.95%)
    9 / 99 (9.09%)
    1 / 131 (0.76%)
    1 / 130 (0.77%)
    4 / 124 (3.23%)
         occurrences all number
    6
    7
    9
    1
    1
    4
    Gastroenteritis
         subjects affected / exposed
    2 / 85 (2.35%)
    2 / 88 (2.27%)
    5 / 99 (5.05%)
    1 / 131 (0.76%)
    1 / 130 (0.77%)
    1 / 124 (0.81%)
         occurrences all number
    2
    2
    5
    1
    1
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    43 / 85 (50.59%)
    45 / 88 (51.14%)
    46 / 99 (46.46%)
    42 / 131 (32.06%)
    37 / 130 (28.46%)
    34 / 124 (27.42%)
         occurrences all number
    43
    45
    46
    42
    37
    34

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Apr 2012
    After protocol amendment 2, all subjects yet to receive a booster dose in the present study will be administered the licensed formulation of Infanrix hexa.

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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