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    Clinical Trial Results:
    A phase III, partially double-blind clinical trial to evaluate the immunogenicity and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ combined Infanrix hexa vaccine (new formulation) as compared with GSK Biologicals’ combined Infanrix hexa vaccine (current formulation) administered in healthy infants at 3, 4 and 5 months of age. The immunogenicity, safety and reactogenicity of the DTPa-HBV-IPV vaccine will also be evaluated in a third group of subjects.

    Summary
    EudraCT number
    		 2012-002427-15
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    25 Jan 2007

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 May 2016
    First version publication date
    25 Jun 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    105910
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00320463
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    20 Jun 2007
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Jan 2007
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Jan 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that the immunogenicity of the Infanrix hexa vaccine (preservative-free formulation) in terms of response to all vaccine antigens is non-inferior to that of the preservative-containing Infanrix hexa vaccine one month after a three-dose primary vaccination course
    Protection of trial subjects
    All subjects were supervised after vaccination/product administration 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.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Apr 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
    Russian Federation: 417
    Worldwide total number of subjects
    417
    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)
    417
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

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

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    The study was double-blind with respect to the 2 Infanrix Hexa Groups and single-blind with respect to the Infanrix Penta Group. Infanrix ™ Hexa vaccine (preservative-containing) was used as a control in this study.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Infanrix Hexa NEW Group
    Arm description
    		 Subjects who received the preservative-free formulation of the Infanrix hexa vaccine
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Infanrix™ Hexa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Three doses of vaccine were administered intramuscularly into the anterolateral quadrant of the right tight at 3, 4 and 5 months of age.

    Arm title
    		 Infanrix Hexa REF Group
    Arm description
    		 Subjects who received the preservative-containing formulation of the Infanrix hexa vaccine
    Arm type
    		 Experimental

    Investigational medicinal product name
    Infanrix™ Hexa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Three doses of vaccine were administered intramuscularly into the anterolateral quadrant of the right tight at 3, 4 and 5 months of age.

    Arm title
    		 Infanrix Penta Group
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Infanrix™ penta
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Three doses of vaccine were administered intramuscularly into the anterolateral quadrant of the right tight at 3, 4 and 5 months of age.

    Number of subjects in period 1
    		Infanrix Hexa NEW Group Infanrix Hexa REF Group Infanrix Penta Group
    Started
    167
    167
    83
    Completed
    163
    165
    82
    Not completed
    4
    2
    1
         Consent withdrawn by subject
    2
    1
    1
         Migrated/moved from study area
    1
    1
    -
         Unspecified
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Infanrix Hexa NEW Group
    Reporting group description
    		 Subjects who received the preservative-free formulation of the Infanrix hexa vaccine

    Reporting group title
    Infanrix Hexa REF Group
    Reporting group description
    		 Subjects who received the preservative-containing formulation of the Infanrix hexa vaccine

    Reporting group title
    Infanrix Penta Group
    Reporting group description
    		 -

    Reporting group values
    		 Infanrix Hexa NEW Group Infanrix Hexa REF Group Infanrix Penta Group Total
    Number of subjects
    		 167 167 83 417
    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)
    		 12.9 ( 1.27 ) 13 ( 1.32 ) 12.9 ( 1.28 ) -
    Gender categorical
    Units: Subjects
        Female
    		 79 69 51 199
        Male
    		 88 98 32 218

    End points

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    End points reporting groups
    Reporting group title
    Infanrix Hexa NEW Group
    Reporting group description
    		 Subjects who received the preservative-free formulation of the Infanrix hexa vaccine

    Reporting group title
    Infanrix Hexa REF Group
    Reporting group description
    		 Subjects who received the preservative-containing formulation of the Infanrix hexa vaccine

    Reporting group title
    Infanrix Penta Group
    Reporting group description
    		 -

    Primary: Number of seroprotected subjects against Hepatitis B (anti-HBS) antigen with cut off value of 10 mIU/mL

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    End point title
    		 Number of seroprotected subjects against Hepatitis B (anti-HBS) antigen with cut off value of 10 mIU/mL
    End point description
    End point type
    Primary
    End point timeframe
    At one month after (POST) Dose 3
    End point values
    		 Infanrix Hexa NEW Group Infanrix Hexa REF Group Infanrix Penta Group
    Number of subjects analysed
    116
    123
    63
    Units: Subjects
        Anti-HBs, POST (N=116,123,63)
    115
    121
    61
    Statistical analysis title
    		 Difference in seroprotection rates for anti-HBs
    Statistical analysis description
    To demonstrate that the immunogenicity of the Infanrix hexa vaccine (preservative-free formulation) in terms of response to all vaccine antigens is non-inferior to that of the preservative-containing Infanrix hexa vaccine one month after a three-dose primary vaccination course.
    Comparison groups
    Infanrix Hexa NEW Group v Infanrix Hexa REF Group
    Number of subjects included in analysis
    239
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Difference in seroprotection rate
    Point estimate
    -0.76
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -4.97
         upper limit
    		 3.24
    Notes
    [1] - The upper limit of the standardized asymptotic 95% confidence interval (CI) on the group difference [Infanrix hexa(current formulation) minus Infanrix hexa(new formulation)] for the percentage of seroprotected subjects below 10%.

    Primary: Number of seroprotected subjects against polyribosyl ribitol phosphate (anti-PRP) antigen with cut off value of 0.15 µg/mL

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    End point title
    		 Number of seroprotected subjects against polyribosyl ribitol phosphate (anti-PRP) antigen with cut off value of 0.15 µg/mL
    End point description
    End point type
    Primary
    End point timeframe
    At one month after (POST) Dose 3
    End point values
    		 Infanrix Hexa NEW Group Infanrix Hexa REF Group Infanrix Penta Group
    Number of subjects analysed
    104
    106
    54
    Units: Subjects
        Anti-PRP, POST (N=104,106,54)
    98
    102
    12
    Statistical analysis title
    		 Difference in seroprotection rates for anti-PRP
    Statistical analysis description
    To demonstrate that the immunogenicity of the Infanrix hexa vaccine (preservative-free formulation) in terms of response to all vaccine antigens is non-inferior to that of the preservative-containing Infanrix hexa vaccine one month after a three-dose primary vaccination course.
    Comparison groups
    Infanrix Hexa NEW Group v Infanrix Hexa REF Group
    Number of subjects included in analysis
    210
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    Parameter type
    		 Difference in seroprotection rate
    Point estimate
    2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.31
         upper limit
    		 8.74
    Notes
    [2] - The upper limit of the standardized asymptotic 95% confidence interval (CI) on the group difference [Infanrix hexa(current formulation) minus Infanrix hexa(new formulation)] for the percentage of seroprotected subjects below 10%.

    Primary: Number of seroprotected subjects against diphtheria (anti-D) and tetanus (anti-T) antigen with cut off value of 0.1 IU/mL.

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    End point title
    		 Number of seroprotected subjects against diphtheria (anti-D) and tetanus (anti-T) antigen with cut off value of 0.1 IU/mL.
    End point description
    End point type
    Primary
    End point timeframe
    At one month after (POST) Dose 3
    End point values
    		 Infanrix Hexa NEW Group Infanrix Hexa REF Group Infanrix Penta Group
    Number of subjects analysed
    104
    106
    54
    Units: Subjects
        Anti-D, POST (N=104,106,54)
    101
    102
    52
        Anti-T, POST (N=104,106,54)
    103
    106
    54
    Statistical analysis title
    		 Difference in seroprotection rates for Anti-D
    Statistical analysis description
    To demonstrate that the immunogenicity of the Infanrix hexa vaccine (preservative-free formulation) in terms of response to all vaccine antigens is non-inferior to that of the preservative-containing Infanrix hexa vaccine one month after a three-dose primary vaccination course.
    Comparison groups
    Infanrix Hexa NEW Group v Infanrix Hexa REF Group
    Number of subjects included in analysis
    210
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    Method
    Parameter type
    		 Difference in seroprotection rate
    Point estimate
    -0.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.8
         upper limit
    		 4.84
    Notes
    [3] - The upper limit of the standardized asymptotic 95% confidence interval (CI) on the group difference [Infanrix hexa(current formulation) minus Infanrix hexa(new formulation)] for the percentage of seroprotected subjects below 10%.
    Statistical analysis title
    		 Difference in seroprotection rates for Anti-T
    Statistical analysis description
    To demonstrate that the immunogenicity of the Infanrix hexa vaccine (preservative-free formulation) in terms of response to all vaccine antigens is non-inferior to that of the preservative-containing Infanrix hexa vaccine one month after a three-dose primary vaccination course.
    Comparison groups
    Infanrix Hexa NEW Group v Infanrix Hexa REF Group
    Number of subjects included in analysis
    210
    Analysis specification
    Pre-specified
    Analysis type
    		 [4]
    Method
    Parameter type
    		 Difference in seroprotection rate
    Point estimate
    0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.55
         upper limit
    		 5.25
    Notes
    [4] - The upper limit of the standardized asymptotic 95% confidence interval (CI) on the group difference [Infanrix hexa(current formulation) minus Infanrix hexa(new formulation)] for the percentage of seroprotected subjects below 10%.

    Primary: Number of seroprotected subjects against Poliomyelitis (anti-Polio 1, anti Polio2, Anti-Polio 3) antigen with cut off value of 8.

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    End point title
    		 Number of seroprotected subjects against Poliomyelitis (anti-Polio 1, anti Polio2, Anti-Polio 3) antigen with cut off value of 8.
    End point description
    End point type
    Primary
    End point timeframe
    At one month after (POST) Dose 3
    End point values
    		 Infanrix Hexa NEW Group Infanrix Hexa REF Group Infanrix Penta Group
    Number of subjects analysed
    71
    74
    37
    Units: Subjects
        Anti-Polio1, POST (N=60,66,31)
    60
    66
    31
        Anti-Polio2, POST (N=64,74,36)
    64
    74
    36
        Anti-Polio3, POST (N=71,72,37)
    71
    72
    37
    Statistical analysis title
    		 Seroprotection rates difference for anti-Polio 1
    Statistical analysis description
    To demonstrate that the immunogenicity of the Infanrix hexa vaccine (preservative-free formulation) in terms of response to all vaccine antigens is non-inferior to that of the preservative-containing Infanrix hexa vaccine one month after a three-dose primary vaccination course.
    Comparison groups
    Infanrix Hexa NEW Group v Infanrix Hexa REF Group
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [5]
    Method
    Parameter type
    		 Difference in seroprotection rate
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.5
         upper limit
    		 6.02
    Notes
    [5] - The upper limit of the standardized asymptotic 95% confidence interval (CI) on the group difference [Infanrix hexa(current formulation) minus Infanrix hexa(new formulation)] for the percentage of seroprotected subjects below 10%.
    Statistical analysis title
    		 Seroprotection rates difference for anti-Polio 2
    Statistical analysis description
    To demonstrate that the immunogenicity of the Infanrix hexa vaccine (preservative-free formulation) in terms of response to all vaccine antigens is non-inferior to that of the preservative-containing Infanrix hexa vaccine one month after a three-dose primary vaccination course.
    Comparison groups
    Infanrix Hexa NEW Group v Infanrix Hexa REF Group
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [6]
    Method
    Parameter type
    		 Difference in seroprotection rate
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.93
         upper limit
    		 5.66
    Notes
    [6] - The upper limit of the standardized asymptotic 95% confidence interval (CI) on the group difference [Infanrix hexa(current formulation) minus Infanrix hexa(new formulation)] for the percentage of seroprotected subjects below 10%.
    Statistical analysis title
    		 Seroprotection rates difference for anti-Polio 3
    Statistical analysis description
    To demonstrate that the immunogenicity of the Infanrix hexa vaccine (preservative-free formulation) in terms of response to all vaccine antigens is non-inferior to that of the preservative-containing Infanrix hexa vaccine one month after a three-dose primary vaccination course.
    Comparison groups
    Infanrix Hexa NEW Group v Infanrix Hexa REF Group
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [7]
    Method
    Parameter type
    		 Difference in seroprotection rate
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.07
         upper limit
    		 5.13
    Notes
    [7] - The upper limit of the standardized asymptotic 95% confidence interval (CI) on the group difference [Infanrix hexa(current formulation) minus Infanrix hexa(new formulation)] for the percentage of seroprotected subjects below 10%.

    Primary: Anti-PT, Anti-FHA, Anti-PRN antibody concentrations

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    End point title
    		 Anti-PT, Anti-FHA, Anti-PRN antibody concentrations
    End point description
    End point type
    Primary
    End point timeframe
    At one month after (POST) Dose 3
    End point values
    		 Infanrix Hexa NEW Group Infanrix Hexa REF Group Infanrix Penta Group
    Number of subjects analysed
    128
    129
    66
    Units: EL. U/mL
    geometric mean (confidence interval 95%)
        Anti-PT, POST (N=126,128,66)
    71.8 (64.1 to 80.5)
    74.7 (67.1 to 83)
    75.3 (65.6 to 86.5)
        Anti-FHA, POST (N=127,129,66)
    179.7 (158.4 to 203.8)
    215.3 (192.5 to 240.8)
    181.1 (155.8 to 210.6)
        Anti-PRN, POST (N=128,129,65)
    143 (122.2 to 167.3)
    142.5 (122.7 to 165.6)
    161.4 (130.6 to 199.6)
    Statistical analysis title
    		 GMC Ratios for anti-PT
    Statistical analysis description
    To demonstrate that the immunogenicity of the Infanrix hexa vaccine (preservative-free formulation) in terms of response to all vaccine antigens is non-inferior to that of the preservative-containing Infanrix hexa vaccine one month after a three-dose primary vaccination course.
    Comparison groups
    Infanrix Hexa NEW Group v Infanrix Hexa REF Group
    Number of subjects included in analysis
    257
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [8]
    Method
    		 ANCOVA
    Parameter type
    		 GMC ratio
    Point estimate
    1.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 1.24
    Notes
    [8] - The upper limit of the 95% CI on the geometric mean concentrations ratio [DTPa-HBVIPV/ Hib (current formulation) divided by Infanrix hexa(new formulation)] below1.5.
    Statistical analysis title
    		 GMC Ratios for anti-FHA
    Statistical analysis description
    To demonstrate that the immunogenicity of the Infanrix hexa vaccine (preservative-free formulation) in terms of response to all vaccine antigens is non-inferior to that of the preservative-containing Infanrix hexa vaccine one month after a three-dose primary vaccination course.
    Comparison groups
    Infanrix Hexa NEW Group v Infanrix Hexa REF Group
    Number of subjects included in analysis
    257
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [9]
    Method
    		 ANCOVA
    Parameter type
    		 GMC ratio
    Point estimate
    1.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.02
         upper limit
    		 1.44
    Notes
    [9] - The upper limit of the 95% CI on the geometric mean concentrations ratio [DTPa-HBVIPV/ Hib (current formulation) divided by Infanrix hexa(new formulation)] below1.5.
    Statistical analysis title
    		 GMC Ratios for anti-PRN
    Statistical analysis description
    To demonstrate that the immunogenicity of the Infanrix hexa vaccine (preservative-free formulation) in terms of response to all vaccine antigens is non-inferior to that of the preservative-containing Infanrix hexa vaccine one month after a three-dose primary vaccination course.
    Comparison groups
    Infanrix Hexa NEW Group v Infanrix Hexa REF Group
    Number of subjects included in analysis
    257
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [10]
    Method
    		 ANCOVA
    Parameter type
    		 GMC ratio
    Point estimate
    1.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.86
         upper limit
    		 1.31
    Notes
    [10] - The upper limit of the 95% CI on the geometric mean concentrations ratio [DTPa-HBVIPV/ Hib (current formulation) divided by Infanrix hexa(new formulation)] below1.5.

    Secondary: Number of subjects with vaccine response against PT (anti-PT), FHA (anti-FHA), PRN (anti-PRN) antigens

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    End point title
    		 Number of subjects with vaccine response against PT (anti-PT), FHA (anti-FHA), PRN (anti-PRN) antigens
    End point description
    Vaccine response was defined as the 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 ³ cut-off value), taking into consideration the decreasing maternal antibodies.
    End point type
    Secondary
    End point timeframe
    At one month after (POST) Dose 3
    End point values
    		 Infanrix Hexa NEW Group Infanrix Hexa REF Group Infanrix Penta Group
    Number of subjects analysed
    126
    129
    65
    Units: Subjects
        Anti-PT, POST (N=124,128,65)
    123
    125
    65
        Anti-FHA, POST (N=125,129,65)
    123
    128
    65
        Anti-PRN, POST (N=126,127,64)
    121
    124
    64
    No statistical analyses for this end point

    Secondary: Number of subjects with polyribosyl ribitol phosphate (anti-PRP) antibody concentrations ≥ 1 µg/mL

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    End point title
    		 Number of subjects with polyribosyl ribitol phosphate (anti-PRP) antibody concentrations ≥ 1 µg/mL
    End point description
    End point type
    Secondary
    End point timeframe
    At one month after (POST) Dose 3
    End point values
    		 Infanrix Hexa NEW Group Infanrix Hexa REF Group Infanrix Penta Group
    Number of subjects analysed
    104
    106
    54
    Units: Subjects
        Anti-PRP, POST (N=104,106,54)
    71
    82
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with anti Pertussis toxoid (anti-PT), anti-Filamentous haemagglutinin (anti-FHA) and anti-Pertactin (anti-PRN) antibody concentrations ≥ 5 EL.U/mL

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    End point title
    		 Number of subjects with anti Pertussis toxoid (anti-PT), anti-Filamentous haemagglutinin (anti-FHA) and anti-Pertactin (anti-PRN) antibody concentrations ≥ 5 EL.U/mL
    End point description
    End point type
    Secondary
    End point timeframe
    At one month after (POST) Dose 3
    End point values
    		 Infanrix Hexa NEW Group Infanrix Hexa REF Group Infanrix Penta Group
    Number of subjects analysed
    128
    129
    66
    Units: Subjects
        Anti-PT, POST (N=126,128,66)
    125
    128
    66
        Anti-FHA, POST (N=127,129,66)
    126
    129
    66
        Anti-PRN, POST (N=128,129,65)
    127
    129
    65
    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
    At one month after (POST) Dose 3
    End point values
    		 Infanrix Hexa NEW Group Infanrix Hexa REF Group Infanrix Penta Group
    Number of subjects analysed
    116
    123
    63
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-HBs, POST (N=116,123,63)
    327.6 (268.6 to 399.5)
    313.5 (262.4 to 374.6)
    358.6 (259.8 to 495.1)
    No statistical analyses for this end point

    Secondary: Anti-PRP antibody concentrations

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    End point title
    		 Anti-PRP antibody concentrations
    End point description
    End point type
    Secondary
    End point timeframe
    At one month after (POST) Dose 3
    End point values
    		 Infanrix Hexa NEW Group Infanrix Hexa REF Group Infanrix Penta Group
    Number of subjects analysed
    104
    106
    54
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PRP, POST (N=104,106,54)
    2.153 (1.59 to 2.915)
    3.034 (2.284 to 4.03)
    0.1 (0.085 to 0.117)
    No statistical analyses for this end point

    Secondary: Anti-D, Anti-T antibody concentrations

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    End point title
    		 Anti-D, Anti-T antibody concentrations
    End point description
    End point type
    Secondary
    End point timeframe
    At one month after (POST) Dose 3
    End point values
    		 Infanrix Hexa NEW Group Infanrix Hexa REF Group Infanrix Penta Group
    Number of subjects analysed
    104
    106
    54
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-D, POST (N=104,106,54)
    0.881 (0.732 to 1.06)
    0.951 (0.777 to 1.164)
    0.875 (0.64 to 1.197)
        Anti-T, POST (N=104,106,54)
    2.106 (1.807 to 2.454)
    2.229 (1.958 to 2.539)
    2.225 (1.869 to 2.648)
    No statistical analyses for this end point

    Secondary: Anti-Polio1, Anti-Polio2,Anti-Polio3 antibody concentrations

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    End point title
    		 Anti-Polio1, Anti-Polio2,Anti-Polio3 antibody concentrations
    End point description
    End point type
    Secondary
    End point timeframe
    At one month after (POST) Dose 3
    End point values
    		 Infanrix Hexa NEW Group Infanrix Hexa REF Group Infanrix Penta Group
    Number of subjects analysed
    71
    74
    37
    Units: Titer
    geometric mean (confidence interval 95%)
        Anti-Polio1, POST (N=60,66,31)
    500.3 (383.8 to 652.3)
    574.9 (423.9 to 779.7)
    566.2 (384.4 to 834)
        Anti-Polio2, POST (N=64,74,36)
    399.2 (297.3 to 536)
    390.4 (284.9 to 534.9)
    391.1 (269.6 to 567.3)
        Anti-Polio3, POST (N=71,72,37)
    749.3 (592.9 to 946.9)
    686.5 (525.4 to 897.1)
    737.7 (552.3 to 985.4)
    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
    During day 4 (Days 0-3) after each vaccination
    End point values
    		 Infanrix Hexa NEW Group Infanrix Hexa REF Group Infanrix Penta Group
    Number of subjects analysed
    167
    167
    83
    Units: Subjects
        Any Pain, D1 (N=167,167,83)
    15
    18
    5
        Any Redness, D1 (N=167,167,83)
    40
    43
    16
        Any Swelling, D1 (N=167,167,83)
    18
    19
    6
        Any Pain, D2 (N=166,167,83)
    15
    19
    6
        Any Redness, D2 (N=166,167,83)
    50
    43
    22
        Any Swelling, D2 (N=166,167,83)
    21
    20
    10
        Any Pain, D3 (N=164,167,82)
    10
    5
    3
        Any Redness, D3 (N=164,167,82)
    44
    48
    24
        Any Swelling, D3 (N=164,167,82)
    20
    23
    10
        Any Pain, Across (N=167,167,83)
    30
    29
    13
        Any Redness, Across (N=167167,83)
    79
    77
    36
        Any Swelling, Across (N=167,167,83)
    43
    44
    19
    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
    During day 4 (Days 0-3) after each vaccination
    End point values
    		 Infanrix Hexa NEW Group Infanrix Hexa REF Group Infanrix Penta Group
    Number of subjects analysed
    167
    167
    83
    Units: Subjects
        Any Drowsiness, D1 (N=167,167,83)
    50
    49
    12
        Any Fever (Axillary), D1 (N=167,167,83)
    28
    41
    4
        Any Irritability, D1 (N=167,167,83)
    41
    50
    15
        Any Loss of appetite, D1 (N=167,167,83)
    19
    22
    4
        Any Drowsiness, D2 (N=166,167,83)
    47
    34
    13
        Any Fever (Axilary), D2 (N=166,167,83)
    35
    30
    13
        Any Irritability, D2 (N=166,167,83)
    42
    38
    17
        Any Loss of appetite, D2 (N=166,167,83)
    20
    19
    8
        Any Drowsiness, D3 (N=164,167,82)
    22
    22
    9
        Any Fever (Axilary), D3 (N=164,167,82)
    18
    17
    4
        Any Irritability, D3 (N=164,167,82)
    25
    30
    11
        Any Loss of appetite, D3 (N=164,167,82)
    11
    12
    4
        Any Drowsiness, Across (N=167,167,83)
    67
    64
    21
        Any Fever (Axilary), Across (N=167167,83)
    62
    61
    18
        Any Irritability, Across (N=167,167,83)
    68
    74
    27
        Any Loss of appetite, Across (N=167,167,83)
    39
    41
    12
    No statistical analyses for this end point

    Secondary: Number of subjects with unsolicited adverse events

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    End point title
    		 Number of subjects with unsolicited adverse events
    End point description
    End point type
    Secondary
    End point timeframe
    During the 31 day (Days 0-30) after each vaccination
    End point values
    		 Infanrix Hexa NEW Group Infanrix Hexa REF Group Infanrix Penta Group
    Number of subjects analysed
    167
    167
    83
    Units: Subjects
        Any AEs (N=167,167,83)
    40
    33
    12
    No statistical analyses for this end point

    Secondary: Number of subjects with serious adverse events

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    End point title
    		 Number of subjects with serious adverse events
    End point description
    End point type
    Secondary
    End point timeframe
    During the entire study period
    End point values
    		 Infanrix Hexa NEW Group Infanrix Hexa REF Group Infanrix Penta Group
    Number of subjects analysed
    167
    167
    83
    Units: Subjects
        Any SAEs (N=167,167,83)
    1
    3
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited symptoms during the 4-day post-vaccination period, Unsolicited AEs during the 31-day post-vaccination period, SAEs during the entire period.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    Infanrix Hexa NEW Group
    Reporting group description
    		 -

    Reporting group title
    Infanrix Hexa REF Group
    Reporting group description
    		 -

    Reporting group title
    Infanrix Penta Group
    Reporting group description
    		 -

    Serious adverse events
    		 Infanrix Hexa NEW Group Infanrix Hexa REF Group Infanrix Penta Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 167 (0.60%)
    3 / 167 (1.80%)
    1 / 83 (1.20%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Head injury
         subjects affected / exposed
    0 / 167 (0.00%)
    1 / 167 (0.60%)
    0 / 83 (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
    Respiratory, thoracic and mediastinal disorders
    Respiratory disorder
         subjects affected / exposed
    1 / 167 (0.60%)
    0 / 167 (0.00%)
    0 / 83 (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
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 167 (0.00%)
    1 / 167 (0.60%)
    1 / 83 (1.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 167 (0.00%)
    1 / 167 (0.60%)
    0 / 83 (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
    Rhinitis
         subjects affected / exposed
    0 / 167 (0.00%)
    0 / 167 (0.00%)
    1 / 83 (1.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         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
    		 Infanrix Hexa NEW Group Infanrix Hexa REF Group Infanrix Penta Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    79 / 167 (47.31%)
    77 / 167 (46.11%)
    36 / 83 (43.37%)
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    30 / 167 (17.96%)
    29 / 167 (17.37%)
    13 / 83 (15.66%)
         occurrences all number
    30
    29
    13
    Redness
    alternative assessment type: Systematic
         subjects affected / exposed
    79 / 167 (47.31%)
    77 / 167 (46.11%)
    36 / 83 (43.37%)
         occurrences all number
    79
    77
    36
    Swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    43 / 167 (25.75%)
    44 / 167 (26.35%)
    19 / 83 (22.89%)
         occurrences all number
    43
    44
    19
    Drowsiness
    alternative assessment type: Systematic
         subjects affected / exposed
    67 / 167 (40.12%)
    64 / 167 (38.32%)
    21 / 83 (25.30%)
         occurrences all number
    67
    64
    21
    Fever(Axillary)
    alternative assessment type: Systematic
         subjects affected / exposed
    62 / 167 (37.13%)
    61 / 167 (36.53%)
    18 / 83 (21.69%)
         occurrences all number
    62
    61
    18
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed
    68 / 167 (40.72%)
    74 / 167 (44.31%)
    27 / 83 (32.53%)
         occurrences all number
    68
    74
    27
    Loss of appetite
    alternative assessment type: Systematic
         subjects affected / exposed
    39 / 167 (23.35%)
    41 / 167 (24.55%)
    12 / 83 (14.46%)
         occurrences all number
    39
    41
    12
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    13 / 167 (7.78%)
    11 / 167 (6.59%)
    8 / 83 (9.64%)
         occurrences all number
    13
    11
    8
    Rhinitis
         subjects affected / exposed
    13 / 167 (7.78%)
    5 / 167 (2.99%)
    3 / 83 (3.61%)
         occurrences all number
    13
    5
    3

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

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