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    Clinical Trial Results:
    A phase II, open-label, randomized, multicentre study to evaluate the feasibility of GSK Biologicals’ DTPa-IPV/Hib-MenC-TT vaccine co-administered with Prevenar compared with Pediacel co-administered with Menjugate and Prevenar, when given in healthy infants as a three-dose primary vaccination course at 2, 3 and 4 months of age and to evaluate Menitorix given to these children as a booster dose at 12 months of age

    Summary
    EudraCT number
    		 2008-003741-87
    Trial protocol
    		 GB  
    Global end of trial date
    09 Dec 2010

    Results information
    Results version number
    		 v2(current)
    This version publication date
    20 Nov 2018
    First version publication date
    30 Oct 2014
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Data (typos and numbers) were corrected.

    Trial information

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    Trial identification
    Sponsor protocol code
    111709
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00871338
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    19 May 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Mar 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Dec 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    •To demonstrate that GSK Biologicals’ DTPa IPV/Hib-MenC-TT vaccine co-administered with Prevenar (MenC-Combo group) is non-inferior to Pediacel co-administered with Prevenar and Menjugate (Control group), in terms of immune response to Hib and MenC, one month after the third dose of primary vaccination. Criteria for non-inferiority: Non-inferiority in terms of response to PRP will be demonstrated if the upper limit of the 95% confidence interval (CI) on the group difference (Control minus MenC-Combo group) in percentage of subjects with anti-PRP concentrations >= 0.15 micrograms/ml is <=10%. Non-inferiority in terms of response to MenC will be demonstrated if the upper limit of the 95% CI on the group difference (Control minus MenC-Combo group) in percentage of subjects with SBA-MenC titres >= 8 is <=10%.
    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
    24 Jun 2009
    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
    United Kingdom: 284
    Worldwide total number of subjects
    284
    EEA total number of subjects
    284
    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)
    284
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 284 subjects were enrolled in the study.

    Pre-assignment
    Screening details
    		 Out of the 284 subjects who enrolled in the study, 5 didn't complete the first period. Furthermore not all of the subjects who completed period 1 (Prior to Booster) started period 2 (After Booster).

    Period 1
    Period 1 title
    Prior to booster
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 GSK2197870A Group
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK2197870A
    Investigational medicinal product code
    Other name
    GSK’s combined diphtheria, tetanus, acellular pertussis, polio, Haemophilus influenzae type b and Neisseria meningitidis serogroup C tetanus toxoid conjugate.
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses given at 2, 3 and 4 months of age in the right upper anterolateral thigh.

    Investigational medicinal product name
    Prevenar™
    Investigational medicinal product code
    Other name
    Pfizer’s 7-valent pneumococcal polysaccharide conjugate vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 co-administered doses, intramuscular in the left upper anterolateral thigh, at 2 and 4 months of age, respectively.

    Arm title
    		 Pediacel Group
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Pediacel™
    Investigational medicinal product code
    Other name
    Sanofi-Pasteur-MSD’s combined DTPa-inactivated polio-Haemophilus influenzae type b vaccine.
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses given at 2, 3 and 4 months of age intramuscularly in the right upper anterolateral thigh.

    Investigational medicinal product name
    Menjugate™
    Investigational medicinal product code
    Other name
    Novartis’ meningococcal serogroup C CRM197 protein conjugated vaccine.
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses given at 3 and 4 months of age, intramuscularly in the left lower anterolateral thigh.

    Investigational medicinal product name
    Prevenar™
    Investigational medicinal product code
    Other name
    Pfizer’s 7-valent pneumococcal polysaccharide conjugate vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 co-administered doses, intramuscular in the left upper anterolateral thigh, at 2 and 4 months of age, respectively.

    Number of subjects in period 1
    		GSK2197870A Group Pediacel Group
    Started
    142
    142
    Completed
    140
    139
    Not completed
    2
    3
         Consent withdrawn by subject
    1
    3
         Lost to follow-up
    1
    -
    Period 2
    Period 2 title
    After Booster
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 GSK2197870A Group
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK2197870A
    Investigational medicinal product code
    Other name
    GSK’s combined diphtheria, tetanus, acellular pertussis, polio, Haemophilus influenzae type b and Neisseria meningitidis serogroup C tetanus toxoid conjugate.
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses given at 2, 3 and 4 months of age in the right upper anterolateral thigh.

    Investigational medicinal product name
    Prevenar™
    Investigational medicinal product code
    Other name
    Pfizer’s 7-valent pneumococcal polysaccharide conjugate vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 co-administered doses, intramuscular in the left upper anterolateral thigh, at 2 and 4 months of age, respectively.

    Investigational medicinal product name
    Menitorix™
    Investigational medicinal product code
    Other name
    GSK Biologicals’ combined Haemophilus influenzae type b and Neisseria meningitidis serogroup C tetanus toxoid conjugate vaccine.
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 booster dose at 12 months of age was administered in the right upper anterolateral thigh

    Arm title
    		 Pediacel Group
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Menitorix™
    Investigational medicinal product code
    Other name
    GSK Biologicals’ combined Haemophilus influenzae type b and Neisseria meningitidis serogroup C tetanus toxoid conjugate vaccine.
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 booster dose at 12 months of age was administered in the right upper anterolateral thigh

    Investigational medicinal product name
    Prevenar™
    Investigational medicinal product code
    Other name
    Pfizer’s 7-valent pneumococcal polysaccharide conjugate vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 co-administered doses, intramuscular in the left upper anterolateral thigh, at 2 and 4 months of age, respectively.

    Investigational medicinal product name
    Pediacel™
    Investigational medicinal product code
    Other name
    Sanofi-Pasteur-MSD’s combined DTPa-inactivated polio-Haemophilus influenzae type b vaccine.
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses given at 2, 3 and 4 months of age intramuscularly in the right upper anterolateral thigh.

    Investigational medicinal product name
    Menjugate™
    Investigational medicinal product code
    Other name
    Novartis’ meningococcal serogroup C CRM197 protein conjugated vaccine.
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses given at 3 and 4 months of age, intramuscularly in the left lower anterolateral thigh.

    Number of subjects in period 2 [1]
    		GSK2197870A Group Pediacel Group
    Started
    139
    135
    Completed
    139
    135
    Notes
    [1] - 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: The number of subjects enrolled in the booster phase was smaller than the one in the primary phase.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GSK2197870A Group
    Reporting group description
    		 -

    Reporting group title
    Pediacel Group
    Reporting group description
    		 -

    Reporting group values
    		 GSK2197870A Group Pediacel Group Total
    Number of subjects
    		 142 142 284
    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: weeks
        arithmetic mean (standard deviation)
    		 8.2 ( 0.69 ) 8.1 ( 0.74 ) -
    Gender categorical
    Units: Subjects
        Female
    		 59 78 137
        Male
    		 83 64 147

    End points

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    End points reporting groups
    Reporting group title
    GSK2197870A Group
    Reporting group description
    		 -

    Reporting group title
    Pediacel Group
    Reporting group description
    		 -
    Reporting group title
    GSK2197870A Group
    Reporting group description
    		 -

    Reporting group title
    Pediacel Group
    Reporting group description
    		 -

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

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    End point title
    		 Number of seroprotected subjects for anti-polyribosylribitol phosphate (anti-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
    Primary
    End point timeframe
    At Month 3
    End point values
    		 GSK2197870A Group Pediacel Group
    Number of subjects analysed
    108
    119
    Units: Subjects
        Anti-PRP
    108
    111
    Statistical analysis title
    		 Seroprotection in terms of anti-PRP antibodies
    Statistical analysis description
    To demonstrate that GSK2197870A vaccine co-administered with Prevenar™ vaccine is non-inferior to Pediacel™ vaccine co-administered with Prevenar™ and Menjugate™ vaccines (Pediacel Group), in terms of immune response to Hib and MenC, one month after the third dose of primary vaccination.
    Comparison groups
    GSK2197870A Group v Pediacel Group
    Number of subjects included in analysis
    227
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Difference in seroprotection rate
    Point estimate
    -6.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.72
         upper limit
    		 -3.16
    Notes
    [1] - Criterion for non-inferiority: upper limit of the standardized asymptotic 95% CI for the between-group differences in percentage of seroprotected or seropositive subjects ≤ 10%.

    Primary: Number of seropositive subjects against Neisseria meningitidis using baby rabbit complement (rSBA-MenC)

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    End point title
    		 Number of seropositive subjects against Neisseria meningitidis using baby rabbit complement (rSBA-MenC)
    End point description
    A seropositive subject was defined as a vaccinated subject who had rSBA-MenC ≥ 1:8. Month 3 results are the primary outcome variable.
    End point type
    Primary
    End point timeframe
    At Month 2 and Month 3.
    End point values
    		 GSK2197870A Group Pediacel Group
    Number of subjects analysed
    109
    113
    Units: Subjects
        rSBA-MenC at Month 2 [N=109;111]
    104
    109
        rSBA-MenC at Month 3 [N=105;113]
    101
    113
    Statistical analysis title
    		 Seropositivity in terms of rSBA-MenC antibodies
    Statistical analysis description
    To demonstrate that GSK2197870A vaccine co-administered with Prevenar™ vaccine is non-inferior to Pediacel™ vaccine co-administered with Prevenar™ and Menjugate™ vaccines (Pediacel Group), in terms of immune response to Hib and MenC, one month after the third dose of primary vaccination.
    Comparison groups
    Pediacel Group v GSK2197870A Group
    Number of subjects included in analysis
    222
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    3.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.44
         upper limit
    		 9.41
    Notes
    [2] - Criterion for non-inferiority: upper limit of the standardized asymptotic 95% CI for the between-group differences in percentage of seroprotected or seropositive subjects ≤ 10%.

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

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    End point title
    		 Number of subjects with anti-PRP concentrations antibody above the cut-off.
    End point description
    The reference cut-off was ≥ 1.0 micrograms per milliliter (µg/mL).
    End point type
    Secondary
    End point timeframe
    At Month 3
    End point values
    		 GSK2197870A Group Pediacel Group
    Number of subjects analysed
    108
    119
    Units: Subjects
        Anti-PRP
    96
    98
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-polysaccharide C (anti-PSC ) antibody concentrations above the cut-offs.

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    End point title
    		 Number of subjects with anti-polysaccharide C (anti-PSC ) antibody concentrations above the cut-offs.
    End point description
    The reference cut-offs were ≥ 0.3 µg/mL and ≥ 2 µg/mL.
    End point type
    Secondary
    End point timeframe
    At Month 2 and Month 3.
    End point values
    		 GSK2197870A Group Pediacel Group
    Number of subjects analysed
    113
    115
    Units: Subjects
        Anti-PSC ≥ 0.3 µg/mL at Month 2 [N=113;115]
    113
    115
        Anti-PSC ≥ 0.3 µg/mL at Month 3 [N=108;114]
    108
    114
        Anti-PSC ≥ 2.0 µg/mL at Month 2 [N=113;115]
    113
    113
        Anti-PSC ≥ 2.0 µg/mL at Month 3 [N=108;114]
    107
    144
    No statistical analyses for this end point

    Secondary: 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.
    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
    At Month 3.
    End point values
    		 GSK2197870A Group Pediacel Group
    Number of subjects analysed
    108
    119
    Units: Subjects
        Anti-T
    108
    119
        Anti-D
    108
    119
    No statistical analyses for this end point

    Secondary: Number of seropositive subjects against 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 against anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN).
    End point description
    A seropositive subject was defined as a vaccinated subject who had anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliters (EL.U/mL).
    End point type
    Secondary
    End point timeframe
    At Month 3.
    End point values
    		 GSK2197870A Group Pediacel Group
    Number of subjects analysed
    108
    120
    Units: Subjects
        Anti-PT [N=107;117]
    107
    117
        Anti-FHA [N=106;119]
    106
    119
        Anti-PRN [N=108;120]
    108
    119
    No statistical analyses for this end point

    Secondary: Number of seroprotected subjects for anti-poliovirus (anti-polio) types 1, 2 and 3.

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    End point title
    		 Number of seroprotected subjects for anti-poliovirus (anti-polio) types 1, 2 and 3.
    End point description
    A seroprotected subject was defined as a vaccinated subject who had anti-polio 1, 2 and 3 antibody concentrations ≥ 1:8.
    End point type
    Secondary
    End point timeframe
    At Month 3.
    End point values
    		 GSK2197870A Group Pediacel Group
    Number of subjects analysed
    89
    94
    Units: Subjects
        Anti-polio 1
    89
    93
        Anti-polio 2
    88
    92
        Anti-polio 3
    89
    94
    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 ≥ 0.2 micrograms per milliliter (µg/mL). The anti-PNE serotypes assessed were 4, 6B, 9V, 14, 18C, 19F and 23F.
    End point type
    Secondary
    End point timeframe
    At Month 3
    End point values
    		 GSK2197870A Group Pediacel Group
    Number of subjects analysed
    108
    112
    Units: Subjects
        Anti- PNE 4 [N=47;52]
    47
    52
        Anti- PNE 6B [N=46;52]
    14
    13
        Anti- PNE 9V [N=47;51]
    46
    49
        Anti- PNE 14 [N=47;52]
    47
    50
        Anti- PNE 18C [N=46;52]
    45
    51
        Anti- PNE 19F [N=47;52]
    46
    52
        Anti- PNE 23F [N=47;52]
    37
    49
    No statistical analyses for this end point

    Secondary: Concentrations for anti-PRP.

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    End point title
    		 Concentrations for anti-PRP.
    End point description
    Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.15 µg/mL.
    End point type
    Secondary
    End point timeframe
    At Month 3.
    End point values
    		 GSK2197870A Group Pediacel Group
    Number of subjects analysed
    108
    119
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PRP
    4.347 (3.507 to 5.389)
    3.043 (2.212 to 4.185)
    No statistical analyses for this end point

    Secondary: Titers for rSBA-MenC.

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    End point title
    		 Titers for rSBA-MenC.
    End point description
    Titers were expressed as geometric mean titers (GMTs). The seropositivity reference cut-off value was ≥ 1:8.
    End point type
    Secondary
    End point timeframe
    At Month 2 and Month 3.
    End point values
    		 GSK2197870A Group Pediacel Group
    Number of subjects analysed
    109
    113
    Units: Titers
    geometric mean (confidence interval 95%)
        rSBA-MenC at Month 2 [N=109;111]
    339.4 (254.5 to 452.7)
    257 (204.5 to 323)
        rSBA-MenC at Month 3 [N=105;113]
    393.2 (292.5 to 528.7)
    3110.5 (2612 to 3704.2)
    No statistical analyses for this end point

    Secondary: Concentrations for anti-PSC.

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    End point title
    		 Concentrations for anti-PSC.
    End point description
    Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.3 µg/mL.
    End point type
    Secondary
    End point timeframe
    At Month 2 and Month 3.
    End point values
    		 GSK2197870A Group Pediacel Group
    Number of subjects analysed
    113
    115
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PSC at Month 2 [N=113;115]
    18.2 (15.91 to 20.82)
    10.77 (9.61 to 12.08)
        Anti-PSC at Month 3 [N=108;114]
    15.1 (13 to 17.55)
    17.29 (15.53 to 19.25)
    No statistical analyses for this end point

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

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    End point title
    		 Concentrations for anti-T and anti-D.
    End point description
    Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.1 IU/mL.
    End point type
    Secondary
    End point timeframe
    At Month 3.
    End point values
    		 GSK2197870A Group Pediacel Group
    Number of subjects analysed
    108
    119
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-T
    2.694 (2.394 to 3.032)
    1.034 (0.895 to 1.195)
        Anti-D
    1.767 (1.548 to 2.019)
    1.817 (1.589 to 2.078)
    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). The seropositivity reference cut-off value was ≥ 5 EL.U/mL.
    End point type
    Secondary
    End point timeframe
    At Month 3.
    End point values
    		 GSK2197870A Group Pediacel Group
    Number of subjects analysed
    108
    120
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PT [N=107;117]
    45.4 (40 to 51.4)
    45.1 (39.8 to 51.2)
        Anti-FHA [N=106;119]
    234.4 (203.7 to 269.6)
    204.9 (178.2 to 235.6)
        Anti-PRN [N=108;120]
    121.6 (103.6 to 142.7)
    49.9 (41.4 to 60.1)
    No statistical analyses for this end point

    Secondary: Titers for anti-polio 1, 2 and 3.

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    End point title
    		 Titers for anti-polio 1, 2 and 3.
    End point description
    Titers were expressed as geometric mean titers (GMTs). The seropositivity reference cut-off value was ≥ 1:8.
    End point type
    Secondary
    End point timeframe
    At Month 3.
    End point values
    		 GSK2197870A Group Pediacel Group
    Number of subjects analysed
    89
    94
    Units: Titers
    geometric mean (confidence interval 95%)
        Anti-polio 1
    169.4 (127 to 226)
    89.3 (71.1 to 112.2)
        Anti-polio 2
    90.2 (68.5 to 118.7)
    77.7 (59.7 to 101.1)
        Anti-polio 3
    367.9 (288.1 to 469.9)
    250.5 (195.9 to 320.2)
    No statistical analyses for this end point

    Secondary: Concentrations for anti-PNE serotypes.

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    End point title
    		 Concentrations for anti-PNE serotypes.
    End point description
    Concentrations were expressed as geometric mean concentreations (GMCs). The seropositivity reference cut-off value was ≥ 0.2 µg/mL.
    End point type
    Secondary
    End point timeframe
    At Month 3.
    End point values
    		 GSK2197870A Group Pediacel Group
    Number of subjects analysed
    89
    94
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti- PNE 4 [N=47;52]
    2.56 (2.13 to 3.07)
    2.18 (1.87 to 2.53)
        Anti- PNE 6B [N=46;52]
    0.12 (0.08 to 0.17)
    0.12 (0.08 to 0.16)
        Anti- PNE 9V [N=47;51]
    2.56 (1.92 to 3.43)
    1.85 (1.43 to 2.39)
        Anti- PNE 14 [N=47;52]
    3.78 (2.7 to 5.28)
    2.71 (2 to 3.67)
        Anti- PNE 18C [N=46;52]
    2.26 (1.59 to 3.2)
    2.74 (2.12 to 3.56)
        Anti- PNE 19F [N=47;52]
    3 (2.21 to 4.06)
    3.15 (2.51 to 3.95)
        Anti- PNE 23F [N=47;52]
    0.58 (0.4 to 0.82)
    0.89 (0.69 to 1.14)
    No statistical analyses for this end point

    Secondary: Number of seroprotected subjects for anti-PRP.

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    End point title
    		 Number of seroprotected subjects for anti-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). Number of subjects with anti-PRP antibody concentrations ≥ 1 μg/mL were also reported.
    End point type
    Secondary
    End point timeframe
    At Month 10 and Month 11.
    End point values
    		 GSK2197870A Group Pediacel Group
    Number of subjects analysed
    98
    112
    Units: Subjects
        Month 10 ≥ 0.15 [N=89;98]
    76
    81
        Month 11 ≥ 0.15 [N=98;112]
    98
    112
        Month 10 ≥ 1 [N=89;98]
    15
    32
        Month 11 ≥ 1 [N=98;112]
    98
    112
    No statistical analyses for this end point

    Secondary: Number of seropositive subjects against rSBA-MenC.

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    End point title
    		 Number of seropositive subjects against rSBA-MenC.
    End point description
    A seropositive subject was defined as a vaccinated subject who had rSBA-MenC ≥ 1:8.
    End point type
    Secondary
    End point timeframe
    At Month 10 and Month 11.
    End point values
    		 GSK2197870A Group Pediacel Group
    Number of subjects analysed
    93
    109
    Units: Subjects
        rSBA-MenC at Month 10 [N=87;94]
    70
    78
        rSBA-MenC at Month 11 [N=93;109]
    93
    109
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-PSC antibody concentrations above the cut-offs.

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    End point title
    		 Number of subjects with anti-PSC antibody concentrations above the cut-offs.
    End point description
    The reference cut-offs were ≥ 0.3 µg/mL and ≥ 2 µg/mL.
    End point type
    Secondary
    End point timeframe
    At Month 10 and Month 11.
    End point values
    		 GSK2197870A Group Pediacel Group
    Number of subjects analysed
    100
    111
    Units: Subjects
        Anti-PSC ≥ 0.3 µg/mL at Month 10 [N=86;97]
    81
    89
        Anti-PSC ≥ 0.3 µg/mL at Month 11 [N=100;111]
    100
    111
        Anti-PSC ≥ 2.0 µg/mL at Month 10 [N=86;97]
    22
    14
        Anti-PSC ≥ 2.0 µg/mL at Month 11 [N=100;111]
    92
    80
    No statistical analyses for this end point

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

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    End point title
    		 Number of seroprotive subjects for anti-D and anti-T antibodies.
    End point description
    A seropositive subject was defined as a vaccinated subject who had anti-D (ELISA) and anti-T antibody concentrations ≥ 0.1 IU/mL. Seropositivity for anti-D was also defined with the ≥ 0.016 IU/mL cut-off (Neutralisation assay).
    End point type
    Secondary
    End point timeframe
    At Month 10.
    End point values
    		 GSK2197870A Group Pediacel Group
    Number of subjects analysed
    89
    98
    Units: Subjects
        Anti-T ≥ 0.1 IU/mL [N=89;98]
    86
    87
        Anti-D ≥ 0.1 IU/mL [N=89;98]
    72
    94
        Anti-D ≥ 0.016 IU/mL [N=16;3]
    11
    3
    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 defined as a vaccinated subject who had anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliters (EL.U/mL).
    End point type
    Secondary
    End point timeframe
    At Month 10.
    End point values
    		 GSK2197870A Group Pediacel Group
    Number of subjects analysed
    89
    100
    Units: Subjects
        Anti-PT [N=89;100]
    60
    88
        Anti-FHA [N=89;99]
    89
    98
        Anti-PRN [N=89;100]
    75
    72
    No statistical analyses for this end point

    Secondary: Number of seroprotected subjects for anti-polio types 1, 2 and 3.

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    End point title
    		 Number of seroprotected subjects for anti-polio types 1, 2 and 3.
    End point description
    A seroprotected subject was defined as a vaccinated subject who had anti-polio 1, 2 and 3 antibody concentrations ≥ 1:8.
    End point type
    Secondary
    End point timeframe
    At Month 10.
    End point values
    		 GSK2197870A Group Pediacel Group
    Number of subjects analysed
    78
    86
    Units: Subjects
        Anti-polio 1 [N=78;86]
    68
    62
        Anti-polio 2 [N=78;85]
    63
    69
        Anti-polio 3 [N=78;86]
    74
    76
    No statistical analyses for this end point

    Secondary: Concentrations for anti-PRP.

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    End point title
    		 Concentrations for anti-PRP.
    End point description
    Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.15 µg/mL.
    End point type
    Secondary
    End point timeframe
    At Month 10 and Month 11.
    End point values
    		 GSK2197870A Group Pediacel Group
    Number of subjects analysed
    98
    112
    Units: µg /mL
    geometric mean (confidence interval 95%)
        Anti-PRP at Month 10 [N=89;98]
    0.423 (0.339 to 0.528)
    0.574 (0.436 to 0.756)
        Anti-PRP at Month 11 [N=98;112]
    66.697 (53.271 to 83.507)
    26.899 (20.931 to 34.569)
    No statistical analyses for this end point

    Secondary: Titers for rSBA-MenC.

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    End point title
    		 Titers for rSBA-MenC.
    End point description
    Titers were expressed as geometric mean titers (GMTs). The seropositivity reference cut-off value was ≥ 1:8.
    End point type
    Secondary
    End point timeframe
    At Month 10 and Month 11.
    End point values
    		 GSK2197870A Group Pediacel Group
    Number of subjects analysed
    93
    109
    Units: Titers
    geometric mean (confidence interval 95%)
        rSBA-MenC at Month 10 [N=87;94]
    62.1 (43.3 to 89.1)
    67.1 (48.5 to 92.7)
        rSBA-MenC at Month 11 [N=93;109]
    3062.9 (2421.2 to 3874.6)
    954 (761.3 to 1195.5)
    No statistical analyses for this end point

    Secondary: Concentrations for anti-PSC.

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    End point title
    		 Concentrations for anti-PSC.
    End point description
    Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.3 µg/mL.
    End point type
    Secondary
    End point timeframe
    At Month 10 and Month 11.
    End point values
    		 GSK2197870A Group Pediacel Group
    Number of subjects analysed
    100
    111
    Units: µg /mL
    geometric mean (confidence interval 95%)
        Anti-PSC at Month 10 [N=86;97]
    0.94 (0.76 to 1.15)
    0.87 (0.74 to 1.04)
        Anti-PSC at Month 11 [N=100;111]
    6.15 (5.24 to 7.22)
    2.88 (2.49 to 3.32)
    No statistical analyses for this end point

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

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    End point title
    		 Concentrations for anti-T and anti-D.
    End point description
    Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.1 IU/mL. Seropositivity for anti-D was also defined with the ≥ 0.016 IU/mL cut-off (Neutralisation assay).
    End point type
    Secondary
    End point timeframe
    At Month 10.
    End point values
    		 GSK2197870A Group Pediacel Group
    Number of subjects analysed
    89
    98
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-T ≥ 0.1 IU/mL [N=89;98]
    0.428 (0.361 to 0.508)
    0.26 (0.217 to 0.311)
        Anti-D ≥ 0.1 IU/mL [N=89;98]
    0.249 (0.202 to 0.307)
    0.385 (0.33 to 0.448)
        Anti-D ≥ 0.016 IU/mL [N=16;3]
    0.015 (0.012 to 0.02)
    0.02 (0.008 to 0.052)
    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). The seropositivity reference cut-off value was ≥ 5 EL.U/mL.
    End point type
    Secondary
    End point timeframe
    At Month 10.
    End point values
    		 GSK2197870A Group Pediacel Group
    Number of subjects analysed
    89
    100
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PT [N=89;100]
    7.3 (6.1 to 8.8)
    9.8 (8.5 to 11.4)
        Anti-FHA [N=89;99]
    35.3 (28.3 to 44)
    48.8 (40.4 to 58.9)
        Anti-PRN [N=89;100]
    15 (11.8 to 19)
    9.6 (7.7 to 11.9)
    No statistical analyses for this end point

    Secondary: Titers for anti-polio 1, 2 and 3.

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    End point title
    		 Titers for anti-polio 1, 2 and 3.
    End point description
    Titers were expressed as geometric mean titers (GMTs). The seroprotection reference cut-off value was ≥ 1:8.
    End point type
    Secondary
    End point timeframe
    At Month 10.
    End point values
    		 GSK2197870A Group Pediacel Group
    Number of subjects analysed
    78
    89
    Units: Titers
    geometric mean (confidence interval 95%)
        Anti-polio 1 [N=78;86]
    36.3 (26.5 to 49.8)
    18.8 (14.4 to 24.7)
        Anti-polio 2 [N=78;85]
    28.5 (20.9 to 39)
    24.5 (18.8 to 32)
        Anti-polio 3 [N=78;86]
    70.1 (51 to 96.3)
    50.7 (37 to 69.4)
    No statistical analyses for this end point

    Secondary: Number of subjects with a booster response to rSBA-MenC antibodies.

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    End point title
    		 Number of subjects with a booster response to rSBA-MenC antibodies.
    End point description
    Booster response defined as: for initially seronegative subjects, antibody titre ≥ 1:32 at post-booster (Month 11); for initially seropositive subjects, antibody titres at post-booster ≥ 4 fold the pre-booster.
    End point type
    Secondary
    End point timeframe
    At Month 11
    End point values
    		 GSK2197870A Group Pediacel Group
    Number of subjects analysed
    71
    79
    Units: Subjects
        rSBA-MenC
    68
    61
    No statistical analyses for this end point

    Secondary: Number of subjects with a booster response to anti-PRP antibodies.

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    End point title
    		 Number of subjects with a booster response to anti-PRP antibodies.
    End point description
    Booster response defined as: for initially seronegative subjects, antibody concentration ≥ 0.6 µg/mL at post-booster (Month 11); for initially seropositive subjects, antibody concentrations at post-booster ≥ 4 fold the pre-booster.
    End point type
    Secondary
    End point timeframe
    At Month 11
    End point values
    		 GSK2197870A Group Pediacel Group
    Number of subjects analysed
    75
    87
    Units: Subjects
        Anti-PRP
    75
    85
    No statistical analyses for this end point

    Secondary: Number of subjects with a booster response to anti-PSC antibodies.

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    End point title
    		 Number of subjects with a booster response to anti-PSC antibodies.
    End point description
    Booster response defined as: for initially seronegative subjects, antibody concentration ≥ 1.2 µg/mL at post-booster (Month 11); for initially seropositive subjects, antibody concentrations at post-booster ≥ 4 fold the pre-booster.
    End point type
    Secondary
    End point timeframe
    At Month 11
    End point values
    		 GSK2197870A Group Pediacel Group
    Number of subjects analysed
    75
    83
    Units: Subjects
        Anti-PSC
    48
    27
    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 8-day (Days 0-7) after primary vaccination.
    End point values
    		 GSK2197870A Group Pediacel Group
    Number of subjects analysed
    142
    141
    Units: Subjects
        Any pain
    57
    57
        Any redness
    86
    77
        Any swelling
    60
    48
    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 8-day (Days 0-7) after booster vaccination.
    End point values
    		 GSK2197870A Group Pediacel Group
    Number of subjects analysed
    136
    134
    Units: Subjects
        Any pain
    24
    11
        Any redness
    74
    56
        Any swelling
    35
    20
    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 general symptoms assessed were drowsiness, irritability, 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 8-day (Days 0-7) after primary vaccination.
    End point values
    		 GSK2197870A Group Pediacel Group
    Number of subjects analysed
    142
    141
    Units: Subjects
        Any drowsiness
    103
    103
        Any irritability
    122
    117
        Any loss of appetite
    79
    77
        Any fever
    59
    49
    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 general symptoms assessed were drowsiness, irritability, 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 8-day (Days 0-7) after booster vaccination.
    End point values
    		 GSK2197870A Group Pediacel Group
    Number of subjects analysed
    136
    134
    Units: Subjects
        Any drowsiness
    43
    40
        Any irritability
    75
    66
        Any loss of appetite
    41
    40
        Any fever
    18
    20
    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 primary vaccination.
    End point values
    		 GSK2197870A Group Pediacel Group
    Number of subjects analysed
    142
    142
    Units: Subjects
        Any AEs
    114
    112
    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 booster vaccination.
    End point values
    		 GSK2197870A Group Pediacel Group
    Number of subjects analysed
    139
    135
    Units: Subjects
        Any AEs
    75
    66
    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 or results in disability/incapacity 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 (Month 0 to Month 11)
    End point values
    		 GSK2197870A Group Pediacel Group
    Number of subjects analysed
    142
    142
    Units: Subjects
        Any SAEs
    9
    6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
    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
    13.1
    Reporting groups
    Reporting group title
    GSK2197870A Group
    Reporting group description
    		 Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.

    Reporting group title
    Pediacel Group
    Reporting group description
    		 Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.

    Serious adverse events
    		 GSK2197870A Group Pediacel Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 142 (6.34%)
    6 / 142 (4.23%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Vascular disorders
    Hypertension
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral atrophy
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral infarction
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Developmental delay
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Intussusception
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Aspiration
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Eczema
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthropathy
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Lymph node abscess
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiolitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 142 (0.70%)
    2 / 142 (1.41%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 142 (1.41%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral upper respiratory tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 GSK2197870A Group Pediacel Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    122 / 142 (85.92%)
    117 / 142 (82.39%)
    General disorders and administration site conditions
    Rash (Symptom reported during the booster phase.)
    alternative assessment type: Non-systematic
         subjects affected / exposed [1]
    7 / 139 (5.04%)
    9 / 135 (6.67%)
         occurrences all number
    7
    9
    Pain (Symptom reported during the primary phase.)
         subjects affected / exposed [2]
    57 / 142 (40.14%)
    57 / 141 (40.43%)
         occurrences all number
    57
    57
    Redness (Symptom reported during the primary phase.)
         subjects affected / exposed [3]
    86 / 142 (60.56%)
    77 / 141 (54.61%)
         occurrences all number
    86
    77
    Swelling (Symptom reported during the primary phase.)
         subjects affected / exposed [4]
    60 / 142 (42.25%)
    48 / 141 (34.04%)
         occurrences all number
    60
    48
    Pain (Symptom reported during the booster phase.)
         subjects affected / exposed [5]
    24 / 136 (17.65%)
    11 / 134 (8.21%)
         occurrences all number
    24
    11
    Redness (Symptom reported during the booster phase.)
         subjects affected / exposed [6]
    76 / 136 (55.88%)
    56 / 134 (41.79%)
         occurrences all number
    76
    56
    Swelling (Symptom reported during the booster phase.)
         subjects affected / exposed [7]
    35 / 136 (25.74%)
    20 / 134 (14.93%)
         occurrences all number
    35
    20
    Drowsiness (Symptom reported during the primary phase.)
         subjects affected / exposed [8]
    103 / 142 (72.54%)
    103 / 141 (73.05%)
         occurrences all number
    103
    103
    Irritability (Symptom reported during the primary phase.)
         subjects affected / exposed [9]
    122 / 142 (85.92%)
    117 / 141 (82.98%)
         occurrences all number
    122
    117
    Loss of appetite (Symptom reported during the primary phase.)
         subjects affected / exposed [10]
    79 / 142 (55.63%)
    77 / 141 (54.61%)
         occurrences all number
    79
    77
    Fever (Symptom reported during the primary phase.)
         subjects affected / exposed [11]
    59 / 142 (41.55%)
    49 / 141 (34.75%)
         occurrences all number
    59
    49
    Drowsiness (Symptom reported during the booster phase.)
         subjects affected / exposed [12]
    43 / 136 (31.62%)
    40 / 134 (29.85%)
         occurrences all number
    43
    40
    Irritability (Symptom reported during the booster phase.)
         subjects affected / exposed [13]
    75 / 136 (55.15%)
    66 / 134 (49.25%)
         occurrences all number
    75
    66
    Loss of appetite (Symptom reported during the booster phase.)
         subjects affected / exposed [14]
    41 / 136 (30.15%)
    40 / 134 (29.85%)
         occurrences all number
    41
    40
    Fever (Symptom reported during the booster phase.)
         subjects affected / exposed [15]
    18 / 136 (13.24%)
    20 / 134 (14.93%)
         occurrences all number
    18
    20
    Pyrexia (Symptom reported during the booster phase.)
         subjects affected / exposed [16]
    7 / 139 (5.04%)
    3 / 135 (2.22%)
         occurrences all number
    7
    3
    Gastrointestinal disorders
    Teething (Symptom reported during the primary phase.)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    31 / 142 (21.83%)
    29 / 142 (20.42%)
         occurrences all number
    31
    29
    Diarrhoea (Symptom reported during the primary phase.)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    19 / 142 (13.38%)
    18 / 142 (12.68%)
         occurrences all number
    19
    18
    Vomiting (Symptom reported during the primary phase.)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    21 / 142 (14.79%)
    14 / 142 (9.86%)
         occurrences all number
    21
    14
    Teething (Symptom reported during the booster phase.)
    alternative assessment type: Non-systematic
         subjects affected / exposed [17]
    28 / 139 (20.14%)
    23 / 135 (17.04%)
         occurrences all number
    28
    23
    Diarrhoea (Symptom reported during the booster phase.)
    alternative assessment type: Non-systematic
         subjects affected / exposed [18]
    5 / 139 (3.60%)
    7 / 135 (5.19%)
         occurrences all number
    5
    7
    Respiratory, thoracic and mediastinal disorders
    Cough (Symptom reported during the primary phase.)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    7 / 142 (4.93%)
    15 / 142 (10.56%)
         occurrences all number
    7
    15
    Skin and subcutaneous tissue disorders
    Eczema (Symptom reported during the primary phase.)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    7 / 142 (4.93%)
    14 / 142 (9.86%)
         occurrences all number
    7
    14
    Infections and infestations
    Rhinitis (Symptom reported during the primary phase.)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    42 / 142 (29.58%)
    35 / 142 (24.65%)
         occurrences all number
    42
    35
    Nasopharyngitis (Symptom reported during the primary phase.)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    13 / 142 (9.15%)
    18 / 142 (12.68%)
         occurrences all number
    13
    18
    Upper respiratory tract infection (Symptom reported during the primary phase.)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    6 / 142 (4.23%)
    8 / 142 (5.63%)
         occurrences all number
    6
    8
    Nasopharyngitis (Symptom reported during the booster phase.)
    alternative assessment type: Non-systematic
         subjects affected / exposed [19]
    11 / 139 (7.91%)
    2 / 135 (1.48%)
         occurrences all number
    11
    2
    Upper respiratory tract infection (Symptom reported during the booster phase.)
    alternative assessment type: Non-systematic
         subjects affected / exposed [20]
    5 / 139 (3.60%)
    7 / 135 (5.19%)
         occurrences all number
    5
    7
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The number of subjects enrolled in the booster phase was smaller than the one in the primary phase.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Solicited local/general symptoms were reported only for subjects with a symptom sheet completed.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Solicited local/general symptoms were reported only for subjects with a symptom sheet completed.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Solicited local/general symptoms were reported only for subjects with a symptom sheet completed.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Solicited local/general symptoms were reported only for subjects with a symptom sheet completed.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Solicited local/general symptoms were reported only for subjects with a symptom sheet completed.
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Solicited local/general symptoms were reported only for subjects with a symptom sheet completed.
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Solicited local/general symptoms were reported only for subjects with a symptom sheet completed.
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Solicited local/general symptoms were reported only for subjects with a symptom sheet completed.
    [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Solicited local/general symptoms were reported only for subjects with a symptom sheet completed.
    [11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Solicited local/general symptoms were reported only for subjects with a symptom sheet completed.
    [12] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Solicited local/general symptoms were reported only for subjects with a symptom sheet completed.
    [13] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Solicited local/general symptoms were reported only for subjects with a symptom sheet completed.
    [14] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Solicited local/general symptoms were reported only for subjects with a symptom sheet completed.
    [15] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Solicited local/general symptoms were reported only for subjects with a symptom sheet completed.
    [16] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The number of subjects enrolled in the booster phase was smaller than the one in the primary phase.
    [17] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The number of subjects enrolled in the booster phase was smaller than the one in the primary phase.
    [18] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Solicited local/general symptoms were reported only for subjects with a symptom sheet completed.
    [19] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The number of subjects enrolled in the booster phase was smaller than the one in the primary phase.
    [20] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The number of subjects enrolled in the booster phase was smaller than the one in the primary phase.

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Feb 2010
    • This amendment reflects the recommendation of the Department of Health issued on 19 January 2010 to immunise babies with a 13-valent pneumococcal vaccine, rather than the 7-valent pneumococcal vaccine as foreseen in the original protocol. Since this recommendation was made during the course of the trial and since the 13-valent vaccine is not yet in routine use at the time of the amendment, the amended protocol will allow for the use of the 13-valent pneumococcal vaccine at the last visit of the study after finishing all study related procedures and will therefore not have an effect on the study endpoints. • An interim analysis on immunogenicity data in terms of rSBA MenC and anti-PRP response after the primary series was added. • Additionally, updated information on back-up contact for reporting of SAEs has been provided.

    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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