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    Clinical Trial Results:
    A phase III, randomized, single-blind, controlled study to assess the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine as a 3-dose primary immunization course at 6, 10 and 14 weeks of age in India, co-administered with GSK Biologicals’ Tritanrix-HepB/Hib (DTPw-HBV/Hib) vaccine.

    Summary
    EudraCT number
    		 2011-004644-22
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    13 Nov 2009

    Results information
    Results version number
    		 v1
    This version publication date
    01 Apr 2016
    First version publication date
    23 Jul 2015
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    111188
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00814710
    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
    13 Apr 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Nov 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Nov 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the immunogenicity of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine in India, one month post dose 3.
    Protection of trial subjects
    All subjects were supervised closely for at least 30 minutes following vaccination with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel. Vaccines were administered only to eligible subjects that had no contraindications to any components of the vaccines. Subjects were followed-up for one month (minimum 30 days) following administration of the last dose of study vaccines.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Mar 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
    India: 360
    Worldwide total number of subjects
    360
    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)
    360
    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
    		 Single blind
    Roles blinded
    		 Subject
    Blinding implementation details
    This study was conducted in a single-blind manner meaning that the investigator and the study staff are aware of the treatment assignment but the subject’s parent(s)/guardian(s) are not.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Synflorix & Tritanrix-HepB/Hib Group
    Arm description
    		 Subjects received Pneumococcal conjugate vaccine GSK1024850A intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pneumococcal conjugate vaccine GSK1024850A
    Investigational medicinal product code
    Other name
    10Pn-PD-DiT
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses at 6-10-14 weeks of age (=study month 0, 1, 2) administered in the right thigh

    Investigational medicinal product name
    Tritanrix™-HepB/Hib
    Investigational medicinal product code
    Other name
    DTPw-HBV/Hib
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses at 6-10-14 weeks of age (=study month 0, 1, 2) administered in the left thigh

    Arm title
    		 Hiberix group & Tritanrix-HepB Group
    Arm description
    		 Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Hiberix™
    Investigational medicinal product code
    Other name
    Hib
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses at 6-10-14 weeks of age (=study month 0, 1, 2) administered in the right thigh

    Investigational medicinal product name
    Tritanrix™-HepB
    Investigational medicinal product code
    Other name
    DTPw-HBV
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses at 6-10-14 weeks of age (=study month 0, 1, 2) administered in the left thigh

    Number of subjects in period 1
    		Synflorix & Tritanrix-HepB/Hib Group Hiberix group & Tritanrix-HepB Group
    Started
    240
    120
    Completed
    232
    117
    Not completed
    8
    3
         Adverse event, serious fatal
    1
    -
         Lost to follow-up
    7
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Synflorix & Tritanrix-HepB/Hib Group
    Reporting group description
    		 Subjects received Pneumococcal conjugate vaccine GSK1024850A intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)

    Reporting group title
    Hiberix group & Tritanrix-HepB Group
    Reporting group description
    		 Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2).

    Reporting group values
    		 Synflorix & Tritanrix-HepB/Hib Group Hiberix group & Tritanrix-HepB Group Total
    Number of subjects
    		 240 120 360
    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)
    		 6.7 ± 1.08 6.7 ± 1.05 -
    Gender categorical
    Units: Subjects
        Female
    		 109 66 175
        Male
    		 131 54 185

    End points

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    End points reporting groups
    Reporting group title
    Synflorix & Tritanrix-HepB/Hib Group
    Reporting group description
    		 Subjects received Pneumococcal conjugate vaccine GSK1024850A intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)

    Reporting group title
    Hiberix group & Tritanrix-HepB Group
    Reporting group description
    		 Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2).

    Primary: Concentrations of antibodies against vaccine pneumococcal serotypes.

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    End point title
    		 Concentrations of antibodies against vaccine pneumococcal serotypes. [1]
    End point description
    Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL
    End point type
    Primary
    End point timeframe
    One month after primary immunization (month 3).
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Synflorix & Tritanrix-HepB/Hib Group Hiberix group & Tritanrix-HepB Group
    Number of subjects analysed
    229
    116
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-1
    3.27 (2.91 to 3.67)
    0.03 (0.03 to 0.04)
        Anti-4
    3.8 (3.33 to 4.33)
    0.04 (0.03 to 0.05)
        Anti-5
    4.17 (3.72 to 4.67)
    0.05 (0.04 to 0.05)
        Anti-6B
    0.71 (0.59 to 0.86)
    0.05 (0.04 to 0.06)
        Anti-7F
    3.87 (3.47 to 4.31)
    0.06 (0.05 to 0.07)
        Anti-9V
    4.21 (3.71 to 4.78)
    0.06 (0.05 to 0.08)
        Anti-14
    5.21 (4.51 to 6.01)
    0.26 (0.2 to 0.34)
        Anti-18C
    15.23 (12.96 to 17.9)
    0.07 (0.05 to 0.08)
        Anti-19F
    11.78 (10.26 to 13.53)
    0.12 (0.1 to 0.16)
        Anti-23F
    1.18 (0.98 to 1.42)
    0.05 (0.04 to 0.05)
    No statistical analyses for this end point

    Primary: Concentration of antibody against protein D (PD).

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    End point title
    		 Concentration of antibody against protein D (PD). [2]
    End point description
    ANTI-PD concentrations are expressed as geometric mean concentrations (GMCs), in enzyme-linked immunosorbent assay (ELISA) unit per milliliter (EL.U/mL). Seropositivity status is defined as Anti-PD antibody concentrations ≥ 100 EL.U/mL.
    End point type
    Primary
    End point timeframe
    One month after primary immunization (month 3).
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Synflorix & Tritanrix-HepB/Hib Group Hiberix group & Tritanrix-HepB Group
    Number of subjects analysed
    227
    116
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PD, M3
    2981.7 (2703 to 3289.2)
    63.9 (55.8 to 73.1)
    No statistical analyses for this end point

    Secondary: Number of subjects with opsonophagocytic activity against pneumococcal serotypes.

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    End point title
    		 Number of subjects with opsonophagocytic activity against pneumococcal serotypes.
    End point description
    Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Cross-reactive pneumococcal serotypes included 6A and 19A. Opsonophagocytic activity was defined as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay was an opsonic titer equal to or greater than 8.
    End point type
    Secondary
    End point timeframe
    One month after primary immunization (month 3).
    End point values
    		 Synflorix & Tritanrix-HepB/Hib Group Hiberix group & Tritanrix-HepB Group
    Number of subjects analysed
    116
    57
    Units: Subjects
        Opsono-1 (N=116; 57)
    105
    3
        Opsono-4 (N=116; 55)
    114
    24
        Opsono-5 (N= 116; 56)
    111
    2
        Opsono-6B (N=116; 54)
    98
    5
        Opsono-7F (N=116; 53)
    116
    35
        Opsono-9V (N=115; 56)
    113
    9
        Opsono-14 (N=115; 56)
    110
    14
        Opsono-18C (N=115; 55)
    113
    2
        Opsono-19F (N=116; 56)
    114
    7
        Opsono-23F (N=116; 54)
    113
    9
        Opsono-6A (N=110;57)
    54
    7
        Opsono-19A (N=109;57)
    35
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with antibody concentrations against pneumococcal serotypes equal to or above cut-off value.

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    End point title
    		 Number of subjects with antibody concentrations against pneumococcal serotypes equal to or above cut-off value.
    End point description
    Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Cross-reactive pneumococcal serotypes included 6A and 19A. The cut-off was defined as 0.20 microgram per milliliter (µg/mL).
    End point type
    Secondary
    End point timeframe
    One month after primary immunization.
    End point values
    		 Synflorix & Tritanrix-HepB/Hib Group Hiberix group & Tritanrix-HepB Group
    Number of subjects analysed
    229
    116
    Units: Subjects
        Anti-1
    228
    2
        Anti-4
    225
    10
        Anti-5
    226
    10
        Anti-6B
    178
    9
        Anti-7F
    228
    16
        Anti-9V
    227
    21
        Anti-14
    229
    66
        Anti-18C
    227
    20
        Anti-19F
    227
    40
        Anti-23F
    205
    12
        Anti-6A (N=229;115)
    95
    12
        Anti-19A
    146
    21
    No statistical analyses for this end point

    Secondary: Concentrations of antibodies against pneumococcal cross-reactive serotypes.

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    End point title
    		 Concentrations of antibodies against pneumococcal cross-reactive serotypes.
    End point description
    Antibodies assessed for this outcome measure were those against the vaccine pneumococcal cross-reactive serotypes 6A and 19A (ANTI6A and -19A). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL
    End point type
    Secondary
    End point timeframe
    One month after primary immunization (month 3).
    End point values
    		 Synflorix & Tritanrix-HepB/Hib Group Hiberix group & Tritanrix-HepB Group
    Number of subjects analysed
    229
    116
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-6A (N=229;115)
    0.15 (0.13 to 0.18)
    0.06 (0.05 to 0.08)
        Anti-19A
    0.33 (0.27 to 0.39)
    0.08 (0.06 to 0.09)
    No statistical analyses for this end point

    Secondary: Number of subjects seropositive for pneumococcal serotypes.

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    End point title
    		 Number of subjects seropositive for pneumococcal serotypes.
    End point description
    Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Cross-reactive pneumococcal serotypes included 6A and 19A. Seropositivity was defined as a titer equal to or greater than 0.05 µg/mL.
    End point type
    Secondary
    End point timeframe
    One month after primary immunization (month 3).
    End point values
    		 Synflorix & Tritanrix-HepB/Hib Group Hiberix group & Tritanrix-HepB Group
    Number of subjects analysed
    229
    116
    Units: Subjects
        Anti-1
    228
    19
        Anti-4
    228
    24
        Anti-5
    229
    46
        Anti-6B
    215
    40
        Anti-7F
    229
    52
        Anti-9V
    228
    49
        Anti-14
    229
    101
        Anti-18C
    227
    56
        Anti-19F
    229
    90
        Anti-23F
    220
    37
        Anti-6A (N=229;115)
    188
    62
        Anti-19A
    207
    71
    No statistical analyses for this end point

    Secondary: Number of subjects seropositive for protein D (PD).

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    End point title
    		 Number of subjects seropositive for protein D (PD).
    End point description
    Seropositivity for PD was defined greater than or equal to 100 EL.U/mL.
    End point type
    Secondary
    End point timeframe
    One month after primary immunization (month 3).
    End point values
    		 Synflorix & Tritanrix-HepB/Hib Group Hiberix group & Tritanrix-HepB Group
    Number of subjects analysed
    227
    116
    Units: Subjects
        Anti-PD, M3
    226
    16
    No statistical analyses for this end point

    Secondary: Concentration of antibody against polyribosyl-ribitol phosphate (PRP).

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    End point title
    		 Concentration of antibody against polyribosyl-ribitol phosphate (PRP).
    End point description
    Concentration is expressed as GMC in µg/mL. Seroprotection status, defined as Anti-PRP antibody concentration equal to or greater than 0.15 µg/mL.
    End point type
    Secondary
    End point timeframe
    One month after primary immunization (month 3).
    End point values
    		 Synflorix & Tritanrix-HepB/Hib Group Hiberix group & Tritanrix-HepB Group
    Number of subjects analysed
    113
    116
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PRP
    31.367 (26.417 to 37.246)
    34.415 (26.847 to 44.116)
    No statistical analyses for this end point

    Secondary: Concentration of antibodies against diphteria (anti-DT) and tetanus (anti-TT).

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    End point title
    		 Concentration of antibodies against diphteria (anti-DT) and tetanus (anti-TT).
    End point description
    Concentrations were expressed as GMCs in International Units per milliliter (IU/mL). Seroprotection status, defined as Anti-DT or Anti-TT antibody concentration equal to or greater than 0.1 IU/mL.
    End point type
    Secondary
    End point timeframe
    One month after primary immunization (month 3).
    End point values
    		 Synflorix & Tritanrix-HepB/Hib Group Hiberix group & Tritanrix-HepB Group
    Number of subjects analysed
    113
    116
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-DT
    2.58 (2.146 to 3.102)
    2.065 (1.736 to 2.457)
        Anti-TT
    3.726 (3.182 to 4.363)
    1.542 (1.316 to 1.807)
    No statistical analyses for this end point

    Secondary: Concentration of antibody against Bordetella pertussis (BPT).

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    End point title
    		 Concentration of antibody against Bordetella pertussis (BPT).
    End point description
    Concentration was expressed as GMC in EL.U/mL. Seropositivity status, defined as Anti-BPT antibody concentration equal to or greater than 15 EL.U/mL
    End point type
    Secondary
    End point timeframe
    One month after primary immunization (month 3).
    End point values
    		 Synflorix & Tritanrix-HepB/Hib Group Hiberix group & Tritanrix-HepB Group
    Number of subjects analysed
    113
    116
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-BPT
    90.3 (80.3 to 101.6)
    114.5 (101.2 to 129.5)
    No statistical analyses for this end point

    Secondary: Concentration of antibody against hepatitis B (anti-HBs) by Enzyme-Linked ImmunoSorbent Assay (ELISA).

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    End point title
    		 Concentration of antibody against hepatitis B (anti-HBs) by Enzyme-Linked ImmunoSorbent Assay (ELISA).
    End point description
    Concentration was expressed as GMC in milli international units per milliliter (mIU/mL). As a decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL), the table shows results following partial or complete retesting/reanalysis.
    End point type
    Secondary
    End point timeframe
    One month after primary immunization (month 3).
    End point values
    		 Synflorix & Tritanrix-HepB/Hib Group Hiberix group & Tritanrix-HepB Group
    Number of subjects analysed
    92
    89
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Anti-HBS
    1970.5 (1614.9 to 2404.5)
    1378.2 (1115.6 to 1702.6)
    No statistical analyses for this end point

    Secondary: Number of subjects seropostive for B. pertussis (BPT)

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    End point title
    		 Number of subjects seropostive for B. pertussis (BPT)
    End point description
    Seropositivity was defined as and antibody concentration equal to or greater than 15 EL.U/mL.
    End point type
    Secondary
    End point timeframe
    One month after primary immunization (month 3).
    End point values
    		 Synflorix & Tritanrix-HepB/Hib Group Hiberix group & Tritanrix-HepB Group
    Number of subjects analysed
    113
    116
    Units: Subjects
        Anti-BPT
    113
    116
    No statistical analyses for this end point

    Secondary: Number of seroprotected subjects (anti-DT, anti-TT, anti-PRP, anti-HBs).

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    End point title
    		 Number of seroprotected subjects (anti-DT, anti-TT, anti-PRP, anti-HBs).
    End point description
    Seroprotection was defined as: Anti-DT antibody concentration equal to or greater than 0.1 IU/mL. Anti-TT antibody concentration equal to or greater than 0.1 IU/mL. Anti-PRP antibody concentration equal to or greater than 0.15 µg/mL Anti-HBs antibody concentration greater than or equal to 10 mIU/mL.
    End point type
    Secondary
    End point timeframe
    One month after primary immunization (month 3).
    End point values
    		 Synflorix & Tritanrix-HepB/Hib Group Hiberix group & Tritanrix-HepB Group
    Number of subjects analysed
    113
    116
    Units: Subjects
        Anti-DT
    113
    116
        Anti-TT
    113
    116
        Anti-PRP 0.15
    113
    116
        Anti-HBs (N=92,89)
    92
    89
    No statistical analyses for this end point

    Secondary: Number of seroprotected subjects (anti-PRP above the cut-off of 1.0 µg/mL).

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    End point title
    		 Number of seroprotected subjects (anti-PRP above the cut-off of 1.0 µg/mL).
    End point description
    Anti-PRP antibody concentration equal to or greater than 1.0 µg/mL.
    End point type
    Secondary
    End point timeframe
    One month after primary immunization (month 3).
    End point values
    		 Synflorix & Tritanrix-HepB/Hib Group Hiberix group & Tritanrix-HepB Group
    Number of subjects analysed
    113
    116
    Units: Subjects
        Anti-PRP
    113
    114
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited local symptoms (any and grade 3).

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    End point title
    		 Number of subjects with solicited local symptoms (any and grade 3).
    End point description
    Solicited local symptoms included pain, redness and swelling.Any = Occurrence of the local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = at injection site larger than (>) 30 millimeters (mm).
    End point type
    Secondary
    End point timeframe
    Within 4 days (day 0-3) after each vaccination.
    End point values
    		 Synflorix & Tritanrix-HepB/Hib Group Hiberix group & Tritanrix-HepB Group
    Number of subjects analysed
    238
    119
    Units: Subjects
        Any Pain dose 1 (N=238,119)
    188
    93
        Grade 3 Pain dose 1 (N=238,119)
    85
    33
        Any Redness dose 1 (N=238,119)
    82
    52
        Grade 3 Redness dose 1 (N=238,119)
    6
    1
        Any Swelling dose 1 (N=238,119)
    125
    70
        Grade 3 Swelling dose 1 (N=238,119)
    31
    16
        Any Pain dose 2 (N=237,118)
    167
    83
        Grade 3 Pain dose 2 (N=237,118)
    57
    25
        Any Redness dose 2 (N=237,118)
    75
    39
        Grade 3 Redness dose 2 (N=237,118)
    2
    0
        Any Swelling dose 2 (N=237,118)
    107
    51
        Grade 3 Swelling dose 2 (N=237,118)
    14
    9
        Any Pain dose 3 (N=233,117)
    148
    74
        Grade 3 Pain dose 3 (N=233,117)
    54
    30
        Any Redness dose 3 (N=233,117)
    75
    38
        Grade 3 Redness dose 3 (N=233,117)
    1
    2
        Any Swelling dose 3 (N=233,117)
    104
    48
        Grade 3 Swelling dose 3 (N=233,117)
    15
    6
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with unsolicited adverse events (AEs).
    End point description
    An AE is 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. Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
    End point type
    Secondary
    End point timeframe
    Within 31 days (day 0-30) after vaccination.
    End point values
    		 Synflorix & Tritanrix-HepB/Hib Group Hiberix group & Tritanrix-HepB Group
    Number of subjects analysed
    240
    120
    Units: Subjects
        Any AE(s)
    38
    17
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with serious adverse events (SAEs).
    End point description
    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
    End point type
    Secondary
    End point timeframe
    Following first vaccination (Month 0) throughout the entire study period (month 3).
    End point values
    		 Synflorix & Tritanrix-HepB/Hib Group Hiberix group & Tritanrix-HepB Group
    Number of subjects analysed
    240
    120
    Units: Subjects
        Any SAE(s)
    5
    1
    No statistical analyses for this end point

    Secondary: Number/percentage of subjects with any and grade 3 solicited general symptoms

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    End point title
    		 Number/percentage of subjects with any and grade 3 solicited general symptoms
    End point description
    Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness (Irr./Fuss.), Loss of appetite (Loss Appet.) and Fever (rectal temperature higher than [≥] 38.0 and > 39.0 degrees Celsius [°C]),. Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal everyday activities. Grade 3 Irr./Fuss. = Crying that could not be comforted/prevented normal everyday activities. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = Rectal temperature higher than (>) 40.0°C
    End point type
    Secondary
    End point timeframe
    Within 4 days (day 0-3) after each vaccination
    End point values
    		 Synflorix & Tritanrix-HepB/Hib Group Hiberix group & Tritanrix-HepB Group
    Number of subjects analysed
    238
    119
    Units: Subjects
        Any Drowsiness dose 1 (N=238,119)
    53
    26
        Grade 3 Drowsiness dose 1 (N=238,119)
    7
    4
        Fever ≥38°C dose 1 (N=238,119)
    140
    63
        Fever >39°C dose 1 (N=238,119)
    11
    2
        Fever >40°C dose 1 (N=238,119)
    1
    0
        Any Irritablity dose 1 (N=238,119)
    142
    74
        Grade 3 Irritability dose 1 (N=238,119)
    13
    6
        Any Loss Appet. dose 1 (N=238,119)
    63
    31
        Grade 3 Loss Appet. dose 1 (N=238,119)
    3
    0
        Any Drowsiness dose 2 (N=237,118)
    42
    22
        Grade 3 Drowsiness dose 2 (N=237,118)
    8
    4
        Fever ≥38°C dose 2 (N=237,118)
    108
    43
        Fever >39°C dose 2 (N=237,118)
    7
    1
        Fever >40°C dose 2 (N=237,118)
    0
    0
        Any Irritablity dose 2 (N=237,118)
    123
    54
        Grade 3 Irritability dose 2 (N=237,118)
    26
    5
        Any Loss Appet. dose 2 (N=237,118)
    57
    27
        Grade 3 Loss Appet. dose 2 (N=237,118)
    3
    0
        Any Drowsiness dose 3 (N=233,117)
    37
    15
        Grade 3 Drowsiness dose 3 (N=233,117)
    8
    1
        Fever ≥38°C dose 3 (N=233,117)
    96
    31
        Fever >39°C dose 3 (N=233,117)
    8
    2
        Fever >40°C dose 3 (N=233,117)
    2
    0
        Any Irritablity dose 3 (N=233,117)
    109
    46
        Grade 3 Irritability dose 3 (N=233,117)
    20
    4
        Any Loss Appet. dose 3 (N=233,117)
    49
    20
        Grade 3 Loss Appet. dose 3 (N=233,117)
    3
    2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    For other AEs day 0-3 (solicited) and day 0-30 unsolicited. For SAEs month 0 to Month 3.
    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
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.1
    Reporting groups
    Reporting group title
    Synflorix and Tritanrix-HepB/Hib Group
    Reporting group description
    		 Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2).

    Reporting group title
    Hiberix group and Tritanrix-HepB Group
    Reporting group description
    		 Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)

    Serious adverse events
    		 Synflorix and Tritanrix-HepB/Hib Group Hiberix group and Tritanrix-HepB Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 240 (2.08%)
    1 / 120 (0.83%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 240 (1.25%)
    0 / 120 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypochromic anaemia
         subjects affected / exposed
    1 / 240 (0.42%)
    0 / 120 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 240 (0.42%)
    0 / 120 (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
    Pneumonia aspiration
         subjects affected / exposed
    1 / 240 (0.42%)
    0 / 120 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Infections and infestations
    Bronchopneumonia
         subjects affected / exposed
    2 / 240 (0.83%)
    1 / 120 (0.83%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chikungunya virus infection
         subjects affected / exposed
    1 / 240 (0.42%)
    0 / 120 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 240 (0.42%)
    0 / 120 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 240 (0.42%)
    0 / 120 (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
    		 Synflorix and Tritanrix-HepB/Hib Group Hiberix group and Tritanrix-HepB Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    209 / 240 (87.08%)
    105 / 120 (87.50%)
    General disorders and administration site conditions
    Pain
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    209 / 238 (87.82%)
    105 / 119 (88.24%)
         occurrences all number
    209
    105
    Redness
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    128 / 238 (53.78%)
    76 / 119 (63.87%)
         occurrences all number
    128
    76
    Swelling
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    166 / 238 (69.75%)
    83 / 119 (69.75%)
         occurrences all number
    166
    83
    Drowsiness
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    73 / 238 (30.67%)
    34 / 119 (28.57%)
         occurrences all number
    73
    34
    Fever
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    182 / 238 (76.47%)
    85 / 119 (71.43%)
         occurrences all number
    182
    85
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    178 / 238 (74.79%)
    88 / 119 (73.95%)
         occurrences all number
    178
    88
    Loss of appetite
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    96 / 238 (40.34%)
    49 / 119 (41.18%)
         occurrences all number
    96
    49
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    13 / 240 (5.42%)
    4 / 120 (3.33%)
         occurrences all number
    13
    4
    Infections and infestations
    Rhinitis
         subjects affected / exposed
    13 / 240 (5.42%)
    6 / 120 (5.00%)
         occurrences all number
    13
    6
    Pyrexia
         subjects affected / exposed
    12 / 240 (5.00%)
    3 / 120 (2.50%)
         occurrences all number
    12
    3
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis of the solicited symptom included only subjects with documented data.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis of the solicited symptom included only subjects with documented data.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis of the solicited symptom included only subjects with documented data.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis of the solicited symptom included only subjects with documented data.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis of the solicited symptom included only subjects with documented data.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis of the solicited symptom included only subjects with documented data.
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis of the solicited symptom included only subjects with documented data.

    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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