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    Clinical Trial Results:
    A phase II, observer-blind, randomized study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ combined DSSITGDPa-HBV-IPV/Hib vaccine containing diphtheria toxoid from the Statens Serum Institute (SSI) of Denmark and tetanus toxoid from GSK Biologicals’ Kft [GD], compared to the currently licensed GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix hexa) when administered to healthy infants at 2, 3 and 4 months of age.

    Summary
    EudraCT number
    		 2006-000554-46
    Trial protocol
    		 FI  
    Global end of trial date
    31 May 2007

    Results information
    Results version number
    		 v1
    This version publication date
    02 May 2016
    First version publication date
    03 Jun 2015
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    106786
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00376779
    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 Advisor Call Center, GlaxoSmithKline Biologicals, 004 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Advisor Call Center, GlaxoSmithKline Biologicals, 004 2089904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    07 Aug 2007
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 May 2007
    Global end of trial reached?
    Yes
    Global end of trial date
    31 May 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that the immunogenicity of the DSSITGDPa-HBV-IPV/Hib vaccine (preservative-free formulation) in terms of antibody response to all vaccine antigens is non-inferior to that of the DTPa-HBV-IPV/Hib vaccine, one month after a three-dose primary vaccination course.
    Protection of trial subjects
    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.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Oct 2006
    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
    Finland: 455
    Worldwide total number of subjects
    455
    EEA total number of subjects
    455
    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)
    455
    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 (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Preservative-Free Fromulation Group
    Arm description
    		 Subjects received the preservative-free (PF) formulation of DSSITGDPa-HBV-IPV/Hib.
    Arm type
    		 Experimental

    Investigational medicinal product name
    DSSITGDPa-HBV-IPV/Hib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The vaccine was administered intramuscularly into the anterolateral quadrant of the right thigh according to a 3-dose vaccination schedule at 2, 3 and 4 months of age.

    Arm title
    		 Preservative-Containing Formulation Group
    Arm description
    		 Subjects received the preservative-containing (PC) formulation of DSSITGDPa-HBV-IPV/Hib.
    Arm type
    		 Experimental

    Investigational medicinal product name
    DSSITGDPa-HBV-IPV/Hib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The vaccine was administered intramuscularly into the anterolateral quadrant of the right thigh according to a 3-dose vaccination schedule at 2, 3 and 4 months of age.

    Arm title
    		 Infanrix-hexa Group
    Arm description
    		 Subjects received the licensed formulation of DTPa-HBV-IPV/Hib.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Infanrix hexa
    Investigational medicinal product code
    Other name
    DTPa-HBV-IPV/Hib
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The vaccine was administered intramuscularly into the anterolateral quadrant of the right thigh according to a 3-dose vaccination schedule at 2, 3 and 4 months of age.

    Number of subjects in period 1
    		Preservative-Free Fromulation Group Preservative-Containing Formulation Group Infanrix-hexa Group
    Started
    153
    150
    152
    Completed
    151
    148
    152
    Not completed
    2
    2
    0
         Consent withdrawn by subject
    -
    1
    -
         Adverse event, non-fatal
    1
    1
    -
         Migrated/moved from study area
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Preservative-Free Fromulation Group
    Reporting group description
    		 Subjects received the preservative-free (PF) formulation of DSSITGDPa-HBV-IPV/Hib.

    Reporting group title
    Preservative-Containing Formulation Group
    Reporting group description
    		 Subjects received the preservative-containing (PC) formulation of DSSITGDPa-HBV-IPV/Hib.

    Reporting group title
    Infanrix-hexa Group
    Reporting group description
    		 Subjects received the licensed formulation of DTPa-HBV-IPV/Hib.

    Reporting group values
    		 Preservative-Free Fromulation Group Preservative-Containing Formulation Group Infanrix-hexa Group Total
    Number of subjects
    		 153 150 152 455
    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)
    		 9.9 ( 1.51 ) 10 ( 1.45 ) 10.1 ( 1.35 ) -
    Gender categorical
    Units: Subjects
        Female
    		 68 75 64 207
        Male
    		 85 75 88 248

    End points

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    End points reporting groups
    Reporting group title
    Preservative-Free Fromulation Group
    Reporting group description
    		 Subjects received the preservative-free (PF) formulation of DSSITGDPa-HBV-IPV/Hib.

    Reporting group title
    Preservative-Containing Formulation Group
    Reporting group description
    		 Subjects received the preservative-containing (PC) formulation of DSSITGDPa-HBV-IPV/Hib.

    Reporting group title
    Infanrix-hexa Group
    Reporting group description
    		 Subjects received the licensed formulation of DTPa-HBV-IPV/Hib.

    Primary: Number of subjects with anti-diphtheria (Anti-D) [by Vero-cell neutralization assay] antibody concentrations equal to or above (≥) 0.016 international units per milliliter (IU/mL)

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    End point title
    		 Number of subjects with anti-diphtheria (Anti-D) [by Vero-cell neutralization assay] antibody concentrations equal to or above (≥) 0.016 international units per milliliter (IU/mL) [1]
    End point description
    End point type
    Primary
    End point timeframe
    One month after the third dose of vaccine (POST)
    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 scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Preservative-Free Fromulation Group Preservative-Containing Formulation Group Infanrix-hexa Group
    Number of subjects analysed
    138
    134
    145
    Units: Subjects
        Anti-diphtheria, POST
    135
    133
    145
    No statistical analyses for this end point

    Primary: Number of subjects with anti-tetanus toxoids (Anti-TT) antibody concentrations ≥ 0.1 IU/mL

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    End point title
    		 Number of subjects with anti-tetanus toxoids (Anti-TT) antibody concentrations ≥ 0.1 IU/mL [2]
    End point description
    End point type
    Primary
    End point timeframe
    One month after the third dose of vaccine (POST)
    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 scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Preservative-Free Fromulation Group Preservative-Containing Formulation Group Infanrix-hexa Group
    Number of subjects analysed
    138
    134
    146
    Units: Subjects
        Anti-tetanus, POST
    138
    134
    146
    No statistical analyses for this end point

    Primary: Number of subjects with anti-hepatitis B surface antigen (anti-HBs) antibody concentrations ≥ 10.0 mili-international units per illilitre (mIU/mL)

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    End point title
    		 Number of subjects with anti-hepatitis B surface antigen (anti-HBs) antibody concentrations ≥ 10.0 mili-international units per illilitre (mIU/mL) [3]
    End point description
    End point type
    Primary
    End point timeframe
    One month after the third dose of vaccine (POST)
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Preservative-Free Fromulation Group Preservative-Containing Formulation Group Infanrix-hexa Group
    Number of subjects analysed
    135
    131
    143
    Units: Subjects
        Anti-HBs, POST
    125
    125
    141
    No statistical analyses for this end point

    Primary: Number of subjects with anti-polio type 1, 2 and 3 antibody titers ≥ 8

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    End point title
    		 Number of subjects with anti-polio type 1, 2 and 3 antibody titers ≥ 8 [4]
    End point description
    End point type
    Primary
    End point timeframe
    One month after the third dose of vaccine (POST)
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Preservative-Free Fromulation Group Preservative-Containing Formulation Group Infanrix-hexa Group
    Number of subjects analysed
    131
    123
    130
    Units: Subjects
        Anti-Polio 1, POST [N=128;123;121]
    119
    114
    117
        Anti-Polio 2, POST [N=121;119;130]
    90
    95
    99
        Anti-Polio 3, POST [N=131;122;128]
    126
    116
    125
    No statistical analyses for this end point

    Primary: Number of subjects with anti-polyribosylribitol phosphate (Anti-PRP) concentrations equal to or above cut-off value of 0.15 µg/mL

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    End point title
    		 Number of subjects with anti-polyribosylribitol phosphate (Anti-PRP) concentrations equal to or above cut-off value of 0.15 µg/mL [5]
    End point description
    End point type
    Primary
    End point timeframe
    One month after the third dose of vaccine (POST)
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Preservative-Free Fromulation Group Preservative-Containing Formulation Group Infanrix-hexa Group
    Number of subjects analysed
    138
    134
    145
    Units: Subjects
        Anti-PRP, POST
    132
    129
    138
    No statistical analyses for this end point

    Primary: Anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) antibody concentrations

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    End point title
    		 Anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) antibody concentrations [6]
    End point description
    End point type
    Primary
    End point timeframe
    One month after the third dose of vaccine (POST)
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Preservative-Free Fromulation Group Preservative-Containing Formulation Group Infanrix-hexa Group
    Number of subjects analysed
    138
    134
    146
    Units: EL.U/ml
    geometric mean (confidence interval 95%)
        Anti-PT, POST [N=138;134;146]
    59.2 (54.2 to 64.5)
    49.6 (44.9 to 54.8)
    67.4 (61.9 to 73.3)
        Anti-FHA, POST [N=138;134;146]
    135 (120.7 to 151.1)
    137.5 (122.8 to 154)
    200.3 (181.1 to 221.5)
        Anti-PRN, POST [N=138;134;146]
    68.6 (59.8 to 78.6)
    75.3 (64.6 to 87.7)
    119.9 (105.5 to 136.2)
    No statistical analyses for this end point

    Primary: Anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) antibody concentrations

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    End point title
    		 Anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) antibody concentrations [7]
    End point description
    End point type
    Primary
    End point timeframe
    Before the first dose of the vaccine (PRE)
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Preservative-Free Fromulation Group Preservative-Containing Formulation Group Infanrix-hexa Group
    Number of subjects analysed
    140
    139
    145
    Units: EL.U/ml
    geometric mean (confidence interval 95%)
        Anti-PT, PRE [N=140;139;145]
    3.4 (3 to 3.8)
    3.7 (3.3 to 4.2)
    3.4 (3.1 to 3.8)
        Anti-FHA, PRE [N=138;139;143]
    11.2 (9.3 to 13.4)
    8.8 (7.3 to 10.6)
    10 (8.5 to 11.8)
        Anti-PRN, PRE [N=140;139;145]
    5.8 (4.9 to 7)
    5.8 (4.9 to 7)
    4.9 (4.2 to 5.7)
    No statistical analyses for this end point

    Secondary: Number of subjects with vaccine response to anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN)

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    End point title
    		 Number of subjects with vaccine response to anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN)
    End point description
    Vaccine response defined as appearance of antibodies in subjects who were initially seronegative (i.e. with concentrations < cut-off value) or at least maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e. with concentrations ≥ cut-off value), taking into consideration the decreasing maternal antibodies.
    End point type
    Secondary
    End point timeframe
    One month after the third dose of vaccine (POST)
    End point values
    		 Preservative-Free Fromulation Group Preservative-Containing Formulation Group Infanrix-hexa Group
    Number of subjects analysed
    134
    131
    142
    Units: Subjects
        Anti-PT, POST [N=134;131;142]
    132
    127
    141
        Anti-FHA, POST [N=133;131;140]
    126
    124
    139
        Anti-PRN, POST [N=134;131;142]
    120
    121
    137
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-diphtheria (Anti-DT) antibody concentrations ≥ 0.1 IU/mL

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    End point title
    		 Number of subjects with anti-diphtheria (Anti-DT) antibody concentrations ≥ 0.1 IU/mL
    End point description
    End point type
    Secondary
    End point timeframe
    One month after the third dose of vaccine (POST)
    End point values
    		 Preservative-Free Fromulation Group Preservative-Containing Formulation Group Infanrix-hexa Group
    Number of subjects analysed
    138
    134
    146
    Units: Subjects
        Anti-diphtheria, POST
    136
    134
    146
    No statistical analyses for this end point

    Secondary: Anti-diphtheria (Anti-DT) and anti-tetanus toxoids (Anti-TT) antibody concentrations

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    End point title
    		 Anti-diphtheria (Anti-DT) and anti-tetanus toxoids (Anti-TT) antibody concentrations
    End point description
    End point type
    Secondary
    End point timeframe
    Before the first dose (PRE) and one month after the third dose of the vaccine (POST)
    End point values
    		 Preservative-Free Fromulation Group Preservative-Containing Formulation Group Infanrix-hexa Group
    Number of subjects analysed
    140
    139
    146
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-diphtheria, PRE [N=140;139;145]
    0.174 (0.144 to 0.21)
    0.227 (0.184 to 0.282)
    0.183 (0.148 to 0.226)
        Anti-diphtheria, POST [N=138;134;146]
    0.51 (0.441 to 0.59)
    0.513 (0.445 to 0.592)
    0.75 (0.658 to 0.854)
        Anti-tetanus, PRE [N=140;139;145]
    0.654 (0.562 to 0.76)
    0.71 (0.606 to 0.833)
    0.708 (0.627 to 0.8)
        Anti-tetanus, POST [N=138;134;146]
    1.423 (1.28 to 1.582)
    1.438 (1.296 to 1.596)
    1.758 (1.591 to 1.941)
    No statistical analyses for this end point

    Secondary: Anti-HBs antibody concentrations

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    End point title
    		 Anti-HBs antibody concentrations
    End point description
    End point type
    Secondary
    End point timeframe
    One month after the third dose of vaccine (POST)
    End point values
    		 Preservative-Free Fromulation Group Preservative-Containing Formulation Group Infanrix-hexa Group
    Number of subjects analysed
    135
    131
    143
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Anti-HBs, POST
    166.1 (131.6 to 209.5)
    173.4 (140.3 to 214.3)
    299 (254.1 to 351.8)
    No statistical analyses for this end point

    Secondary: Anti-polio type 1, 2 and 3 antibody titers

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    End point title
    		 Anti-polio type 1, 2 and 3 antibody titers
    End point description
    End point type
    Secondary
    End point timeframe
    One month after the third dose of vaccine (POST)
    End point values
    		 Preservative-Free Fromulation Group Preservative-Containing Formulation Group Infanrix-hexa Group
    Number of subjects analysed
    131
    123
    130
    Units: Titers
    geometric mean (confidence interval 95%)
        Anti-Polio 1, POST [N=128;123;121]
    36.8 (29.8 to 45.4)
    41.8 (33.5 to 52.1)
    74.6 (57.5 to 96.7)
        Anti-Polio 2, POST [N=121;119;130]
    21.5 (16.4 to 28.1)
    16.9 (13.5 to 21.1)
    22.4 (17.6 to 28.5)
        Anti-Polio 3, POST [N=131;122;128]
    51.4 (41.4 to 63.9)
    67 (52.1 to 86.1)
    113.9 (85.6 to 151.5)
    No statistical analyses for this end point

    Secondary: Anti-PRP concentrations

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    End point title
    		 Anti-PRP concentrations
    End point description
    End point type
    Secondary
    End point timeframe
    One month after the third dose of vaccine (POST)
    End point values
    		 Preservative-Free Fromulation Group Preservative-Containing Formulation Group Infanrix-hexa Group
    Number of subjects analysed
    138
    134
    145
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PRP, POST [N=138;134;145]
    1.174 (0.961 to 1.435)
    1.098 (0.894 to 1.349)
    1.661 (1.326 to 2.081)
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited local symptoms

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    End point title
    		 Number of subjects with solicited local symptoms
    End point description
    End point type
    Secondary
    End point timeframe
    Within 8 days (Day 0-Day 7) after each vaccine dose
    End point values
    		 Preservative-Free Fromulation Group Preservative-Containing Formulation Group Infanrix-hexa Group
    Number of subjects analysed
    153
    150
    152
    Units: Subjects
        Any Pain Dose 1 [N=153;150;152]
    55
    38
    48
        Any Redness Dose 1 [N=153;150;152]
    41
    33
    37
        Any Swelling Dose 1 [N=153;150;152]
    36
    28
    32
        Any Pain Dose 2 [N=152;149;152]
    34
    27
    35
        Any Redness Dose 2 [N=152;149;152]
    46
    66
    73
        Any Swelling Dose 2 [N=152;149;152]
    33
    36
    46
        Any Pain Dose 3 [N=151;148;152]
    17
    16
    24
        Any Redness Dose 3 [N=151;148;152]
    49
    53
    67
        Any Swelling Dose 3 [N=151;148;152]
    32
    31
    44
        Any Pain Across doses [N=153;150;152]
    73
    52
    65
        Any Redness Across doses [N=153;150;152]
    81
    89
    97
        Any Swelling Across doses [N=153;150;152]
    62
    65
    75
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited general symptoms

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    End point title
    		 Number of subjects with solicited general symptoms
    End point description
    End point type
    Secondary
    End point timeframe
    Within 8 days (Day 0-Day 7) after each vaccine dose
    End point values
    		 Preservative-Free Fromulation Group Preservative-Containing Formulation Group Infanrix-hexa Group
    Number of subjects analysed
    153
    150
    152
    Units: Subjects
        Any Drowsiness Dose 1 [N=153;150;152]
    88
    82
    85
        Any Fever Dose 1 [N=153;150;152]
    29
    30
    24
        Any Irritability Dose 1 [N=153;150;152]
    114
    102
    112
        Any Loss of appetite Dose 1 [N=153;150;152]
    45
    32
    32
        Any Drowsiness Dose 2 [N=152;149;152]
    55
    55
    63
        Any Fever Dose 2 [N=152;149;152]
    29
    17
    34
        Any Irritability Dose 2 [N=152;149;152]
    87
    85
    99
        Any Loss of appetite Dose 2 [N=152;149;152]
    28
    32
    19
        Any Drowsiness Dose 3 [N=151;148;152]
    47
    44
    47
        Any Fever Dose 3 [N=151;148;152]
    24
    17
    36
        Any Irritability Dose 3 [N=151;148;152]
    74
    68
    82
        Any Loss of appetite Dose 3 [N=151;148;152]
    28
    25
    20
        Any Drowsiness Across doses [N=153;150;152]
    111
    105
    103
        Any Fever Across doses [N=153;150;152]
    58
    51
    67
        Any Irritability Across doses [N=153;150;152]
    140
    128
    135
        Any Loss of appetite Across doses [N=153;150;152]
    66
    58
    51
    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
    End point type
    Secondary
    End point timeframe
    Within 31 days (Day 0-Day 30)
    End point values
    		 Preservative-Free Fromulation Group Preservative-Containing Formulation Group Infanrix-hexa Group
    Number of subjects analysed
    153
    150
    152
    Units: Subjects
        AEs
    111
    110
    117
    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
    End point type
    Secondary
    End point timeframe
    During the entire study period
    End point values
    		 Preservative-Free Fromulation Group Preservative-Containing Formulation Group Infanrix-hexa Group
    Number of subjects analysed
    153
    150
    152
    Units: Subjects
        SAEs
    2
    5
    5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    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
    10.0
    Reporting groups
    Reporting group title
    Preservative-Free Fromulation Group
    Reporting group description
    		 -

    Reporting group title
    Preservative-Containing Formulation Group
    Reporting group description
    		 -

    Reporting group title
    Infanrix-hexa Group
    Reporting group description
    		 -

    Serious adverse events
    		 Preservative-Free Fromulation Group Preservative-Containing Formulation Group Infanrix-hexa Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 153 (1.31%)
    5 / 150 (3.33%)
    5 / 152 (3.29%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Overdose
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 150 (0.67%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 150 (0.67%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Haematemesis
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 150 (0.67%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    0 / 153 (0.00%)
    0 / 150 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Listless
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 150 (0.67%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Laryngitis
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 150 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anal abscess
         subjects affected / exposed
    0 / 153 (0.00%)
    0 / 150 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 150 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 153 (0.00%)
    0 / 150 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 153 (0.00%)
    0 / 150 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 150 (0.67%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 150 (0.67%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 150 (0.67%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Preservative-Free Fromulation Group Preservative-Containing Formulation Group Infanrix-hexa Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    111 / 153 (72.55%)
    110 / 150 (73.33%)
    117 / 152 (76.97%)
    General disorders and administration site conditions
    Injection site induration
         subjects affected / exposed
    10 / 153 (6.54%)
    18 / 150 (12.00%)
    19 / 152 (12.50%)
         occurrences all number
    10
    18
    19
    Pyrexia
         subjects affected / exposed
    15 / 153 (9.80%)
    18 / 150 (12.00%)
    11 / 152 (7.24%)
         occurrences all number
    15
    18
    11
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    15 / 153 (9.80%)
    16 / 150 (10.67%)
    9 / 152 (5.92%)
         occurrences all number
    15
    16
    9
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    12 / 153 (7.84%)
    6 / 150 (4.00%)
    21 / 152 (13.82%)
         occurrences all number
    12
    6
    21
    Constipation
         subjects affected / exposed
    5 / 153 (3.27%)
    11 / 150 (7.33%)
    4 / 152 (2.63%)
         occurrences all number
    5
    11
    4
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    8 / 153 (5.23%)
    13 / 150 (8.67%)
    9 / 152 (5.92%)
         occurrences all number
    8
    13
    9
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    5 / 153 (3.27%)
    9 / 150 (6.00%)
    10 / 152 (6.58%)
         occurrences all number
    5
    9
    10
    Infections and infestations
    Rhinitis
         subjects affected / exposed
    28 / 153 (18.30%)
    23 / 150 (15.33%)
    22 / 152 (14.47%)
         occurrences all number
    28
    23
    22
    Upper respiratory tract infection
         subjects affected / exposed
    35 / 153 (22.88%)
    16 / 150 (10.67%)
    22 / 152 (14.47%)
         occurrences all number
    35
    16
    22
    Otitis media
         subjects affected / exposed
    6 / 153 (3.92%)
    12 / 150 (8.00%)
    13 / 152 (8.55%)
         occurrences all number
    6
    12
    13

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Nov 2006
    Amendment 2 GSK Biologicals is currently validating new providers of the diphtheria toxoid (Statens Serum Institute [SSI], Denmark) and of the tetanus toxoid (GSK Biologicals Korlatolt Felelossegu Tarsasag [Kft] in Gödöllö [GD], Hungary) for inclusion in DTPa based vaccines. The purpose of this study is to demonstrate that the immunogenicity of the hexavalent DSSITGDPa-HBV-IPV/Hib vaccine containing diphtheria toxoid provided by the Statens Serum Institute of Denmark (DSSI) and tetanus toxoid provided by GSK Biologicals Kft in Gödöllö (TGD) is non-inferior to the immunogenicity of the currently licensed formulation of the vaccine. The vaccine will be administered as a primary vaccination course to healthy infants at 2, 3 and 4 months of age and its safety and reactogenicity will also be assessed. Two formulations of the DSSITGDPa-HBV-IPV/Hib vaccine will be evaluated: one in which the vaccine will be manufactured according to the new preservative-free process and the other in which the vaccine will be manufactured with preservative as the currently licensed formulation.

    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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