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    Clinical Trial Results:
    A phase II, partially double-blind, randomised, controlled, single-centre study to assess the immunogenicity and reactogenicity of three different formulations of GSK Biologicals’ DTPw-HBV-IPV/Hib candidate vaccine compared to the Zilbrix/Hib and Poliorix vaccines administered concomitantly, when administered as a single booster dose to poliovirus vaccine-primed healthy toddlers aged 12-24 months.

    Summary
    EudraCT number
    		 2016-000645-31
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    02 Sep 2010

    Results information
    Results version number
    		 v2(current)
    This version publication date
    18 May 2018
    First version publication date
    24 Aug 2016
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Minor corrections of the full study results.

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    113264
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01106092
    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, +44 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, +44 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
    07 Dec 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Sep 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Sep 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    •To demonstrate the non-inferiority of GSK Biologicals’ DTPw-HBV-IPV(3 doses)/Hib vaccine compared to Poliorix co-administered with Zilbrix/Hib, -(full dose): in terms of seroprotection rates to the 3 poliovirus types and to demonstrate that the formulation induces at least a 2-fold increase in the geometric mean (GM) of the individual ratios (post- over pre-booster titres) for anti-poliovirus antibodies (Abs), 1 month after booster vaccination -(1/2 dose): in terms of seroprotection rates to the 3 poliovirus types and to demonstrate that the formulation induces at least a 2-fold increase in the GM of the individual ratios (post- over pre-booster titres) for anti-poliovirus abs, 1 month after booster vaccination -(1/3 dose): in terms of seroprotection rates to the 3 poliovirus types and to demonstrate that the formulation induces at least a 2-fold increase in the GM of the individual ratios (post- over pre-booster titres) for anti-poliovirus Abs, 1month after booster vaccination.
    Protection of trial subjects
    The vaccinees were observed closely for at least 30 minutes following the administration of vaccines, with appropriate medical treatment readily available in case of a rare anaphylactic reaction.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 May 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Philippines: 312
    Worldwide total number of subjects
    312
    EEA total number of subjects
    0
    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)
    312
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

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

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Subject
    Blinding implementation details
    The study was conducted in a partially double blind manner: • The study was double blind [i.e. the investigator and parent(s)/LAR(s) of the subjects were unaware of the treatment administered] for the three groups receiving the three different DTPw-HBV-IPV/Hib formulations (Form groups). • The study was open-label with respect to the Control Group as subjects in this group received two injections.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 GSK2036874A Group 1
    Arm description
    		 Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK2036874A
    Investigational medicinal product code
    Other name
    DTPw-HBV-IPV/Hib
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one dose of the vaccine (formulation 1) in the anterolateral region of the left thigh, at Day 0.

    Arm title
    		 GSK2036874A Group 2
    Arm description
    		 Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK2036874A
    Investigational medicinal product code
    Other name
    DTPw-HBV-IPV/Hib
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one dose of the vaccine (formulation 2) in the anterolateral region of the left thigh, at Day 0.

    Arm title
    		 GSK2036874A Group 3
    Arm description
    		 Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK2036874A
    Investigational medicinal product code
    Other name
    DTPw-HBV-IPV/Hib
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one dose of the vaccine (formulation 3) in the anterolateral region of the left thigh, at Day 0.

    Arm title
    		 Zilbrix/HIB/Poliorix Group
    Arm description
    		 Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib and Poliorix vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Zilbrix/Hib
    Investigational medicinal product code
    Other name
    DTPw-HBV/Hib Kft.
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one dose of the vaccine in the anterolateral region of the left thigh, at Day 0.

    Investigational medicinal product name
    Poliorix
    Investigational medicinal product code
    Other name
    IPV
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one dose of the vaccine in the anterolateral region of the right thigh, at Day 0.

    Number of subjects in period 1
    		GSK2036874A Group 1 GSK2036874A Group 2 GSK2036874A Group 3 Zilbrix/HIB/Poliorix Group
    Started
    78
    78
    78
    78
    Completed
    78
    78
    78
    77
    Not completed
    0
    0
    0
    1
         Consent withdrawn by subject
    -
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GSK2036874A Group 1
    Reporting group description
    		 Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.

    Reporting group title
    GSK2036874A Group 2
    Reporting group description
    		 Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.

    Reporting group title
    GSK2036874A Group 3
    Reporting group description
    		 Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.

    Reporting group title
    Zilbrix/HIB/Poliorix Group
    Reporting group description
    		 Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib and Poliorix vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.

    Reporting group values
    		 GSK2036874A Group 1 GSK2036874A Group 2 GSK2036874A Group 3 Zilbrix/HIB/Poliorix Group Total
    Number of subjects
    		 78 78 78 78 312
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 17.4 ( 3.81 ) 18 ( 2.96 ) 17.7 ( 3.38 ) 17.5 ( 3.59 ) -
    Gender categorical
    Units: Subjects
        Female
    		 37 31 35 40 143
        Male
    		 41 47 43 38 169
    Race/Ethnicity
    Units: Subjects
        Asian-South East Asian heritage
    		 78 78 78 78 312

    End points

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    End points reporting groups
    Reporting group title
    GSK2036874A Group 1
    Reporting group description
    		 Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.

    Reporting group title
    GSK2036874A Group 2
    Reporting group description
    		 Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.

    Reporting group title
    GSK2036874A Group 3
    Reporting group description
    		 Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.

    Reporting group title
    Zilbrix/HIB/Poliorix Group
    Reporting group description
    		 Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib and Poliorix vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.

    Primary: NUMBER OF SUBJECTS SEROPROTECTED AGAINST ANTI-POLIOVIRUS (ANTI-POLIO) TYPES 1, 2 AND 3.

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    End point title
    		 NUMBER OF SUBJECTS SEROPROTECTED AGAINST ANTI-POLIOVIRUS (ANTI-POLIO) TYPES 1, 2 AND 3.
    End point description
    Seroprotection was defined as anti-polio types 1, 2 and 3 antibody titres ≥ 8 effective dose (ED50), for 50% of vaccinated subjects.
    End point type
    Primary
    End point timeframe
    At Month 1 (POST)
    End point values
    		 GSK2036874A Group 1 GSK2036874A Group 2 GSK2036874A Group 3 Zilbrix/HIB/Poliorix Group
    Number of subjects analysed
    78
    78
    78
    77
    Units: Subjects
        Anti-polio 1 POST [N=78;78;78;77]
    78
    77
    78
    77
        Anti-polio 2 POST [N=77;78;78;77]
    77
    78
    78
    77
        Anti-polio 3 POST [N=78;78;78;77]
    77
    77
    78
    77
    Statistical analysis title
    		 Difference in SPR rates for anti-polio 1 (F1)
    Statistical analysis description
    To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 1) compared to Poliorix™ vaccine co-administered with Zilbrix™/Hib vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 1 antibodies, one month after vaccination.
    Comparison groups
    Zilbrix/HIB/Poliorix Group v GSK2036874A Group 1
    Number of subjects included in analysis
    155
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Difference in seroprotection rate
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.78
         upper limit
    		 4.72
    Notes
    [1] - The upper limit (UL) of the standardized asymptotic 95% confidence interval (CI) on the group [Zilbrix/Hib Group - GSK2036874A Group 1] difference in percentage of seroprotected subjects ≤ 10%.
    Statistical analysis title
    		 Difference in SPR rates for anti-polio 1 (F2)
    Statistical analysis description
    To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 2) compared to Poliorix™ vaccine co-administered with ZilbrixTM/Hib vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 1 antibodies, one month after vaccination.
    Comparison groups
    Zilbrix/HIB/Poliorix Group v GSK2036874A Group 2
    Number of subjects included in analysis
    155
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    Parameter type
    		 Difference in seroprotection rate
    Point estimate
    1.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.53
         upper limit
    		 6.94
    Notes
    [2] - The upper limit (UL) of the standardized asymptotic 95% confidence interval (CI) on the group [Zilbrix/Hib Group - GSK2036874A Group 2] difference in percentage of seroprotected subjects ≤ 10%.
    Statistical analysis title
    		 Difference in SPR rates for anti-polio 1 (F3)
    Statistical analysis description
    To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 3) compared to Poliorix™ vaccine co-administered with ZilbrixTM/Hib vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 1 antibodies, one month after vaccination.
    Comparison groups
    GSK2036874A Group 3 v Zilbrix/HIB/Poliorix Group
    Number of subjects included in analysis
    155
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    Method
    Parameter type
    		 Difference in seroprotection rate
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.78
         upper limit
    		 4.72
    Notes
    [3] - The upper limit (UL) of the standardized asymptotic 95% confidence interval (CI) on the group [Zilbrix/Hib Group - GSK2036874A Group 3] difference in percentage of seroprotected subjects ≤ 10%.
    Statistical analysis title
    		 Difference in SPR rates for anti-polio 2 (F1)
    Statistical analysis description
    To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 1) compared to Poliorix™ vaccine co-administered with ZilbrixTM/Hib vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 2 antibodies, one month after vaccination.
    Comparison groups
    GSK2036874A Group 1 v Zilbrix/HIB/Poliorix Group
    Number of subjects included in analysis
    155
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [4]
    Method
    Parameter type
    		 Difference in seroprotection rate
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.78
         upper limit
    		 4.78
    Notes
    [4] - The upper limit (UL) of the standardized asymptotic 95% confidence interval (CI) on the group [Zilbrix/Hib Group - GSK2036874A Group 1] difference in percentage of seroprotected subjects ≤ 10%.
    Statistical analysis title
    		 Difference in SPR rates for anti-polio 2 (F2)
    Statistical analysis description
    To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 2) compared to Poliorix™ vaccine co-administered with ZilbrixTM/Hib vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 2 antibodies, one month after vaccination.
    Comparison groups
    GSK2036874A Group 2 v Zilbrix/HIB/Poliorix Group
    Number of subjects included in analysis
    155
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [5]
    Method
    Parameter type
    		 Difference in seroprotection rate
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.78
         upper limit
    		 4.72
    Notes
    [5] - The upper limit (UL) of the standardized asymptotic 95% confidence interval (CI) on the group [Zilbrix/Hib Group - GSK2036874A Group 2] difference in percentage of seroprotected subjects ≤ 10%.
    Statistical analysis title
    		 Difference in SPR rates for anti-polio 2 (F3)
    Statistical analysis description
    To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 3) compared to Poliorix™ vaccine co-administered with ZilbrixTM/Hib vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 2 antibodies, one month after vaccination.
    Comparison groups
    GSK2036874A Group 3 v Zilbrix/HIB/Poliorix Group
    Number of subjects included in analysis
    155
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [6]
    Method
    Parameter type
    		 Difference in seroprotection rate
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.78
         upper limit
    		 4.72
    Notes
    [6] - The upper limit (UL) of the standardized asymptotic 95% confidence interval (CI) on the group [Zilbrix/Hib Group - GSK2036874A Group 3] difference in percentage of seroprotected subjects ≤ 10%.
    Statistical analysis title
    		 Difference in SPR rates for anti-polio 3 (F1)
    Statistical analysis description
    To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 1) compared to Poliorix™ vaccine co-administered with ZilbrixTM/Hib vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 3 antibodies, one month after vaccination.
    Comparison groups
    GSK2036874A Group 1 v Zilbrix/HIB/Poliorix Group
    Number of subjects included in analysis
    155
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [7]
    Method
    Parameter type
    		 Difference in seroprotection rate
    Point estimate
    1.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.53
         upper limit
    		 6.94
    Notes
    [7] - The upper limit (UL) of the standardized asymptotic 95% confidence interval (CI) on the group [Zilbrix/Hib Group - GSK2036874A Group 1] difference in percentage of seroprotected subjects ≤ 10%.
    Statistical analysis title
    		 Difference in SPR rates for anti-polio 3 (F2)
    Statistical analysis description
    To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 2) compared to Poliorix™ vaccine co-administered with ZilbrixTM/Hib vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 3 antibodies, one month after vaccination.
    Comparison groups
    GSK2036874A Group 2 v Zilbrix/HIB/Poliorix Group
    Number of subjects included in analysis
    155
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [8]
    Method
    Parameter type
    		 Difference in seroprotection rate
    Point estimate
    1.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.53
         upper limit
    		 6.94
    Notes
    [8] - The upper limit (UL) of the standardized asymptotic 95% confidence interval (CI) on the group [Zilbrix/Hib Group - GSK2036874A Group 2] difference in percentage of seroprotected subjects ≤ 10%.
    Statistical analysis title
    		 Difference in SPR rates for anti-polio 3 (F3)
    Statistical analysis description
    To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 3) compared to Poliorix™ vaccine co-administered with ZilbrixTM/Hib vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 3 antibodies, one month after vaccination.
    Comparison groups
    GSK2036874A Group 3 v Zilbrix/HIB/Poliorix Group
    Number of subjects included in analysis
    155
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [9]
    Method
    Parameter type
    		 Difference in seroprotection rate
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.78
         upper limit
    		 4.72
    Notes
    [9] - The upper limit (UL) of the standardized asymptotic 95% confidence interval (CI) on the group [Zilbrix/Hib Group - GSK2036874A Group 3] difference in percentage of seroprotected subjects ≤ 10%.

    Primary: ANTI-POLIO TYPES 1, 2 AND 3 ANTIBODY TITERS

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    End point title
    		 ANTI-POLIO TYPES 1, 2 AND 3 ANTIBODY TITERS [10]
    End point description
    Antibody titers were presented as geometric mean titers (GMTs).
    End point type
    Primary
    End point timeframe
    At Month 1 (POST)
    Notes
    [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 GSK2036874A Group 1 GSK2036874A Group 2 GSK2036874A Group 3 Zilbrix/HIB/Poliorix Group
    Number of subjects analysed
    78
    78
    78
    77
    Units: Titers
    geometric mean (confidence interval 95%)
        Anti-polio 1 POST [N=78;78;78;77]
    2218.4 (1786.3 to 2755.1)
    1486.7 (1065.9 to 2073.5)
    1245.1 (1007.2 to 1539.2)
    3760.2 (2973.7 to 4754.7)
        Anti-polio 2 POST [N=77;78;78;77]
    1598.8 (1293.5 to 1976.3)
    1056.4 (841.5 to 1326.1)
    966.5 (779.5 to 1198.3)
    2883.2 (2275.2 to 3653.8)
        Anti-polio 3 POST [N=78;78;78;77]
    2820 (2129.9 to 3733.9)
    2217.7 (1654 to 2973.4)
    1915.8 (1498.1 to 2449.8)
    3626.4 (2618.2 to 5022.9)
    No statistical analyses for this end point

    Primary: ANTI-POLIO TYPES 1, 2 AND 3 ANTIBODY TITERS

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    End point title
    		 ANTI-POLIO TYPES 1, 2 AND 3 ANTIBODY TITERS [11]
    End point description
    Antibody titers were presented as geometric mean titers (GMTs).
    End point type
    Primary
    End point timeframe
    At Month 0 (PRE)
    Notes
    [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 GSK2036874A Group 1 GSK2036874A Group 2 GSK2036874A Group 3 Zilbrix/HIB/Poliorix Group
    Number of subjects analysed
    78
    78
    78
    77
    Units: Titers
    geometric mean (confidence interval 95%)
        Anti-polio 1 PRE [N=78;78;78;77]
    321.1 (231.2 to 446)
    219.1 (144 to 333.6)
    296.6 (205.1 to 428.8)
    296.9 (213.9 to 412.1)
        Anti-polio 2 PRE [N=78;78;78;77]
    186.8 (140.1 to 249.2)
    152.2 (111.8 to 207.3)
    183.4 (146.4 to 229.7)
    148 (112.4 to 194.9)
        Anti-polio 3 PRE [N=78;78;78;77]
    74.5 (56 to 99)
    82.1 (62.1 to 108.6)
    102.1 (77.6 to 134.4)
    79.1 (57.9 to 108.1)
    No statistical analyses for this end point

    Secondary: NUMBER OF SEROCONVERTED SUBJECTS FOR ANTI-POLIO TYPES 1, 2 AND 3

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    End point title
    		 NUMBER OF SEROCONVERTED SUBJECTS FOR ANTI-POLIO TYPES 1, 2 AND 3
    End point description
    Seroconversion was defined as: For initially seronegative subjects, antibody titre ≥ 8 ED50 one month after the booster dose; For initially seropositive subjects: antibody titre one month after the booster dose ≥ 4 fold the pre-booster antibody titre; For subjects with pre-booster antibody titre below the highest dilution tested (reciprocal < 8192 ED50): highest dilution tested one month after the booster dose (reciprocal > 8192 ED50).
    End point type
    Secondary
    End point timeframe
    At Month 1 (POST)
    End point values
    		 GSK2036874A Group 1 GSK2036874A Group 2 GSK2036874A Group 3 Zilbrix/HIB/Poliorix Group
    Number of subjects analysed
    78
    78
    78
    77
    Units: Subjects
        Anti-polio 1 POST [N=78;78;78;77]
    70
    64
    60
    69
        Anti-polio 2 POST [N=77;78;78;77]
    68
    66
    70
    72
        Anti-polio 3 POST [N=78;78;78;77]
    74
    74
    73
    75
    No statistical analyses for this end point

    Secondary: NUMBER OF SUBJECTS SEROPROTECTED AGAINST ANTI-POLIOVIRUS (ANTI-POLIO) TYPES 1, 2 AND 3.

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    End point title
    		 NUMBER OF SUBJECTS SEROPROTECTED AGAINST ANTI-POLIOVIRUS (ANTI-POLIO) TYPES 1, 2 AND 3.
    End point description
    Seroprotection was defined as anti-polio types 1, 2 and 3 antibody titres ≥ 8 effective dose (ED50), for 50% of vaccinated subjects.
    End point type
    Secondary
    End point timeframe
    At Month 0 (PRE)
    End point values
    		 GSK2036874A Group 1 GSK2036874A Group 2 GSK2036874A Group 3 Zilbrix/HIB/Poliorix Group
    Number of subjects analysed
    78
    78
    78
    77
    Units: Subjects
        Anti-polio 1 PRE [N=78;78;78;77]
    76
    70
    74
    75
        Anti-polio 2 PRE [N=78;78;78;77]
    77
    75
    78
    74
        Anti-polio 3 PRE [N=78;78;78;77]
    74
    76
    76
    70
    No statistical analyses for this end point

    Secondary: NUMBER OF SEROPROTECTED SUBJECTS FOR ANTI-DIPHTHERIA (ANTI-D) AND ANTI-TETANUS (ANTI-T)

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    End point title
    		 NUMBER OF SEROPROTECTED SUBJECTS FOR ANTI-DIPHTHERIA (ANTI-D) AND ANTI-TETANUS (ANTI-T)
    End point description
    Seroprotection was defined as anti-D and anti-T antibody concentration ≥ 0.1 International Units per milliliter (IU/mL).
    End point type
    Secondary
    End point timeframe
    At Month 0 (PRE) and Month 1 (POST)
    End point values
    		 GSK2036874A Group 1 GSK2036874A Group 2 GSK2036874A Group 3 Zilbrix/HIB/Poliorix Group
    Number of subjects analysed
    78
    78
    78
    77
    Units: Subjects
        Anti-D PRE
    69
    69
    69
    65
        Anti-D POST
    78
    78
    78
    77
        Anti-T PRE
    78
    77
    77
    76
        Anti-T POST
    78
    78
    78
    77
    No statistical analyses for this end point

    Secondary: ANTI-D AND ANTI-T CONCENTRATIONS

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    End point title
    		 ANTI-D AND ANTI-T CONCENTRATIONS
    End point description
    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.
    End point type
    Secondary
    End point timeframe
    At Month 0 (PRE) and Month 1 (POST)
    End point values
    		 GSK2036874A Group 1 GSK2036874A Group 2 GSK2036874A Group 3 Zilbrix/HIB/Poliorix Group
    Number of subjects analysed
    78
    78
    78
    77
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-D PRE
    0.301 (0.237 to 0.382)
    0.331 (0.258 to 0.424)
    0.33 (0.264 to 0.412)
    0.374 (0.276 to 0.508)
        Anti-D POST
    6.519 (5.46 to 7.783)
    7.687 (6.112 to 9.669)
    8.659 (7.132 to 10.514)
    6.807 (5.231 to 8.858)
        Anti-T PRE
    0.776 (0.639 to 0.942)
    0.766 (0.622 to 0.944)
    0.833 (0.668 to 1.038)
    0.932 (0.756 to 1.149)
        Anti-T POST
    26.12 (22.65 to 30.121)
    31.047 (25.954 to 37.139)
    31.054 (26.837 to 35.934)
    24.402 (21.042 to 28.298)
    No statistical analyses for this end point

    Secondary: NUMBER OF SEROPROTECTED AND SEROPOSITIVE SUBJECTS FOR ANTI-HEPATITIS B (ANTI-HBS)

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    End point title
    		 NUMBER OF SEROPROTECTED AND SEROPOSITIVE SUBJECTS FOR ANTI-HEPATITIS B (ANTI-HBS)
    End point description
    Seropositivity was defined as anti-HBs antibody concentration ≥ 3.3 milli-international units per milliliter (mIU/mL). Seprotection was defined as anti-HBs antibody concentration ≥ 10 mIU/mL. Note that percentage of subjects with concentration ≥ 10 mIU/mL was over-estimated due to the use of in-house assay overestimating concentrations between 10-100 mIU/mL. Accordingly GMCs were also overestimated. A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis. Some of the available blood samples initially tested with ELISA were re-tested using the new assay, CLIA.
    End point type
    Secondary
    End point timeframe
    At Month 0 (PRE) and Month 1 (POST)
    End point values
    		 GSK2036874A Group 1 GSK2036874A Group 2 GSK2036874A Group 3 Zilbrix/HIB/Poliorix Group
    Number of subjects analysed
    78
    78
    78
    77
    Units: Subjects
        Anti-HBs ≥ 3.3 mIU/mL PRE
    71
    70
    73
    73
        Anti-HBs ≥ 3.3 mIU/mL POST
    78
    77
    78
    77
        Anti-HBs ≥ 10 mIU/mL PRE
    64
    67
    62
    70
        Anti-HBs ≥ 10 mIU/mL POST
    77
    77
    78
    77
    No statistical analyses for this end point

    Secondary: ANTI-HBS CONCENTRATIONS

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    End point title
    		 ANTI-HBS CONCENTRATIONS
    End point description
    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.
    End point type
    Secondary
    End point timeframe
    At Month 0 (PRE) and Month 1 (POST)
    End point values
    		 GSK2036874A Group 1 GSK2036874A Group 2 GSK2036874A Group 3 Zilbrix/HIB/Poliorix Group
    Number of subjects analysed
    78
    78
    78
    77
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Anti-HBs PRE
    59.9 (40.3 to 89.1)
    46.9 (32.8 to 67.2)
    61.9 (42.2 to 91)
    88.5 (60.7 to 129)
        Anti-HBs POST
    2713.4 (1846.9 to 3986.2)
    2395.1 (1630 to 3519.4)
    3992.8 (2747.2 to 5803.1)
    3484.3 (2452.2 to 4950.8)
    No statistical analyses for this end point

    Secondary: NUMBER OF SEROPROTECTED SUBJECTS AGAINST ANTI-POLYRIBOSIL-RIBITOL-PHOSPHATE (ANTI-PRP)

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    End point title
    		 NUMBER OF SEROPROTECTED SUBJECTS AGAINST ANTI-POLYRIBOSIL-RIBITOL-PHOSPHATE (ANTI-PRP)
    End point description
    Seprotection was defined as anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (μg/mL).
    End point type
    Secondary
    End point timeframe
    At Month 0 (PRE) and Month 1 (POST)
    End point values
    		 GSK2036874A Group 1 GSK2036874A Group 2 GSK2036874A Group 3 Zilbrix/HIB/Poliorix Group
    Number of subjects analysed
    78
    78
    78
    77
    Units: Subjects
        Anti-PRP PRE
    28
    27
    30
    35
        Anti-PRP POST
    77
    76
    71
    76
    No statistical analyses for this end point

    Secondary: ANTI-PRP CONCENTRATIONS

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    End point title
    		 ANTI-PRP CONCENTRATIONS
    End point description
    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in μg/mL.
    End point type
    Secondary
    End point timeframe
    At Month 0 (PRE) and Month 1 (POST)
    End point values
    		 GSK2036874A Group 1 GSK2036874A Group 2 GSK2036874A Group 3 Zilbrix/HIB/Poliorix Group
    Number of subjects analysed
    78
    78
    78
    77
    Units: μg/mL
    geometric mean (confidence interval 95%)
        Anti-PRP PRE
    0.134 (0.109 to 0.166)
    0.137 (0.11 to 0.172)
    0.152 (0.118 to 0.197)
    0.171 (0.13 to 0.226)
        Anti-PRP POST
    2.871 (1.797 to 4.587)
    2.243 (1.52 to 3.31)
    1.575 (1.065 to 2.33)
    3.305 (2.373 to 4.603)
    No statistical analyses for this end point

    Secondary: NUMBER OF SEROPOSITIVE SUBJECTS FOR ANTI-BORDETELLA PERTUSSIS (ANTI-BPT)

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    End point title
    		 NUMBER OF SEROPOSITIVE SUBJECTS FOR ANTI-BORDETELLA PERTUSSIS (ANTI-BPT)
    End point description
    Sepositvity was defined as anti-BPT antibody concentration ≥15 ELISA units per milliliter (EL.U/mL).
    End point type
    Secondary
    End point timeframe
    At Month 0 (PRE) and Month 1 (POST)
    End point values
    		 GSK2036874A Group 1 GSK2036874A Group 2 GSK2036874A Group 3 Zilbrix/HIB/Poliorix Group
    Number of subjects analysed
    76
    78
    78
    77
    Units: Subjects
        Anti-BPT PRE [N=76;78;78;77]
    50
    50
    51
    49
        Anti-BPT POST [N=76;74;77;75]
    76
    73
    77
    75
    No statistical analyses for this end point

    Secondary: ANTI-BPT CONCENTRATIONS

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    End point title
    		 ANTI-BPT CONCENTRATIONS
    End point description
    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL
    End point type
    Secondary
    End point timeframe
    At Month 0 (PRE) and Month 1 (POST)
    End point values
    		 GSK2036874A Group 1 GSK2036874A Group 2 GSK2036874A Group 3 Zilbrix/HIB/Poliorix Group
    Number of subjects analysed
    76
    78
    78
    77
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-BPT PRE [N=76;78;78;77]
    19.6 (16.4 to 23.6)
    20.1 (16.5 to 24.5)
    18.9 (15.9 to 22.4)
    19.5 (16 to 23.9)
        Anti-BPT POST [N=76;74;77;75]
    161.8 (143.6 to 182.3)
    182.9 (158 to 211.9)
    211 (190.1 to 234.2)
    194.7 (170.6 to 222.4)
    No statistical analyses for this end point

    Secondary: NUMBER OF SUBJECTS WITH A BOOSTER RESPONSE FOR ANTI-BPT

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    End point title
    		 NUMBER OF SUBJECTS WITH A BOOSTER RESPONSE FOR ANTI-BPT
    End point description
    Booster response defined as: For initially seronegative subjects, antibody concentration ≥ 15 EL.U/mL one month after the booster dose; For initially seropositive subjects: antibody concentration one month after the booster dose ≥ 2 fold the pre-booster antibody concentration.
    End point type
    Secondary
    End point timeframe
    At Month 1 (POST)
    End point values
    		 GSK2036874A Group 1 GSK2036874A Group 2 GSK2036874A Group 3 Zilbrix/HIB/Poliorix Group
    Number of subjects analysed
    74
    74
    77
    75
    Units: Subjects
        Anti-BPT (POST)
    72
    72
    77
    72
    No statistical analyses for this end point

    Secondary: NUMBER OF SUBJECTS WITH ANY SOLICITED LOCAL SYMPTOMS

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    End point title
    		 NUMBER OF SUBJECTS WITH ANY SOLICITED LOCAL SYMPTOMS
    End point description
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
    End point type
    Secondary
    End point timeframe
    During the 8-day (Day 0-Day 7) follow-up period after vaccination.
    End point values
    		 GSK2036874A Group 1 GSK2036874A Group 2 GSK2036874A Group 3 Zilbrix/HIB/Poliorix Group
    Number of subjects analysed
    78
    78
    78
    78
    Units: Subjects
        Any Pain
    67
    65
    66
    68
        Any Redness
    28
    29
    35
    35
        Any Swelling
    33
    32
    36
    35
    No statistical analyses for this end point

    Secondary: NUMBER OF SUBJECTS WITH ANY UNSOLICITED ADVERSE EVENTS (AES)

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    End point title
    		 NUMBER OF SUBJECTS WITH ANY UNSOLICITED ADVERSE EVENTS (AES)
    End point description
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
    End point type
    Secondary
    End point timeframe
    During the 31-day (Day 0-Day 30) follow-up period after vaccination
    End point values
    		 GSK2036874A Group 1 GSK2036874A Group 2 GSK2036874A Group 3 Zilbrix/HIB/Poliorix Group
    Number of subjects analysed
    78
    78
    78
    78
    Units: Subjects
        AE(s)
    30
    44
    30
    40
    No statistical analyses for this end point

    Secondary: NUMBER OF SUBJECTS WITH SERIOUS ADVERSE EVENTS (SAES)

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    End point title
    		 NUMBER OF SUBJECTS WITH SERIOUS ADVERSE EVENTS (SAES)
    End point description
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
    End point type
    Secondary
    End point timeframe
    During the entire study period (from Month 0 to Month 1).
    End point values
    		 GSK2036874A Group 1 GSK2036874A Group 2 GSK2036874A Group 3 Zilbrix/HIB/Poliorix Group
    Number of subjects analysed
    78
    78
    78
    78
    Units: Subjects
        SAE(s)
    1
    3
    2
    1
    No statistical analyses for this end point

    Secondary: NUMBER OF SUBJECTS WITH ANY SOLICITED GENERAL SYMPTOMS

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    End point title
    		 NUMBER OF SUBJECTS WITH ANY SOLICITED GENERAL SYMPTOMS
    End point description
    Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.
    End point type
    Secondary
    End point timeframe
    During the 8-day (Day 0-Day 7) follow-up period after vaccination.
    End point values
    		 GSK2036874A Group 1 GSK2036874A Group 2 GSK2036874A Group 3 Zilbrix/HIB/Poliorix Group
    Number of subjects analysed
    78
    78
    78
    78
    Units: Subjects
        Any Drowsiness
    43
    42
    46
    41
        Any Irritability
    53
    60
    57
    65
        Any Loss of appetite
    33
    36
    36
    38
        Any Temperature (Axillary)
    59
    60
    57
    63
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited local/general symptoms: During the 8-day (Day 0-Day 7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Day 0-Day 30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1)
    Adverse event reporting additional description
    The number of occurrences reported for solicited symptoms, adverse events, and serious adverse events were not available for posting. The number of subjects affected by each specific event was indicated as the number of occurrences.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    GSK2036874A Group 1
    Reporting group description
    		 Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.

    Reporting group title
    GSK2036874A Group 2
    Reporting group description
    		 Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.

    Reporting group title
    GSK2036874A Group 3
    Reporting group description
    		 Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.

    Reporting group title
    Zilbrix/HIB/Poliorix Group
    Reporting group description
    		 Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.

    Serious adverse events
    		 GSK2036874A Group 1 GSK2036874A Group 2 GSK2036874A Group 3 Zilbrix/HIB/Poliorix Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 78 (1.28%)
    3 / 78 (3.85%)
    2 / 78 (2.56%)
    1 / 78 (1.28%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Nervous system disorders
    Febrile convulsion
         subjects affected / exposed
    0 / 78 (0.00%)
    3 / 78 (3.85%)
    1 / 78 (1.28%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 78 (1.28%)
    0 / 78 (0.00%)
    1 / 78 (1.28%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 78 (1.28%)
    0 / 78 (0.00%)
    0 / 78 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 GSK2036874A Group 1 GSK2036874A Group 2 GSK2036874A Group 3 Zilbrix/HIB/Poliorix Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    75 / 78 (96.15%)
    74 / 78 (94.87%)
    76 / 78 (97.44%)
    77 / 78 (98.72%)
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    67 / 78 (85.90%)
    65 / 78 (83.33%)
    66 / 78 (84.62%)
    68 / 78 (87.18%)
         occurrences all number
    67
    65
    66
    68
    Redness
         subjects affected / exposed
    28 / 78 (35.90%)
    29 / 78 (37.18%)
    35 / 78 (44.87%)
    35 / 78 (44.87%)
         occurrences all number
    28
    29
    35
    35
    Swelling
         subjects affected / exposed
    33 / 78 (42.31%)
    32 / 78 (41.03%)
    36 / 78 (46.15%)
    35 / 78 (44.87%)
         occurrences all number
    33
    32
    36
    35
    Drowsiness
         subjects affected / exposed
    43 / 78 (55.13%)
    42 / 78 (53.85%)
    46 / 78 (58.97%)
    41 / 78 (52.56%)
         occurrences all number
    43
    42
    46
    41
    Fever
         subjects affected / exposed
    59 / 78 (75.64%)
    60 / 78 (76.92%)
    57 / 78 (73.08%)
    63 / 78 (80.77%)
         occurrences all number
    59
    60
    57
    63
    Irritability
         subjects affected / exposed
    53 / 78 (67.95%)
    60 / 78 (76.92%)
    57 / 78 (73.08%)
    65 / 78 (83.33%)
         occurrences all number
    53
    60
    57
    65
    Loss of appetite
         subjects affected / exposed
    33 / 78 (42.31%)
    36 / 78 (46.15%)
    36 / 78 (46.15%)
    38 / 78 (48.72%)
         occurrences all number
    33
    36
    36
    38
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    5 / 78 (6.41%)
    10 / 78 (12.82%)
    9 / 78 (11.54%)
    8 / 78 (10.26%)
         occurrences all number
    5
    10
    9
    8
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    3 / 78 (3.85%)
    12 / 78 (15.38%)
    11 / 78 (14.10%)
    13 / 78 (16.67%)
         occurrences all number
    3
    12
    11
    13
    Upper respiratory tract infection
         subjects affected / exposed
    9 / 78 (11.54%)
    12 / 78 (15.38%)
    5 / 78 (6.41%)
    9 / 78 (11.54%)
         occurrences all number
    9
    12
    5
    9
    Conjunctivitis bacterial
         subjects affected / exposed
    1 / 78 (1.28%)
    4 / 78 (5.13%)
    0 / 78 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    1
    4
    0
    0

    More information

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

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

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