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    Clinical Trial Results:
    A phase IV, partially double-blind, multicentre study to assess the immunogenicity and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ combined DTPa-HBV-IPV/Hib vaccine (new formulation) as compared with GSK Biologicals’ combined DTPa-HBV-IPV/Hib vaccine (current formulation) when administered as a booster dose to children aged 18-23 months, previously primed with the same vaccines in primary vaccination study DTPa-HBV-IPV-109 (105910). The immunogenicity and reactogenicity of a booster dose of the DTPa-HBV-IPV vaccine will be evaluated in a third group of subjects who had received this vaccine in the primary study.

    Summary
    EudraCT number
    		 2012-002428-34
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    25 Jun 2008

    Results information
    Results version number
    		 v2(current)
    This version publication date
    30 Sep 2020
    First version publication date
    29 May 2015
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Results have been amended to account for consistency with other registries.

    Trial information

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    Trial identification
    Sponsor protocol code
    110478
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00611559
    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 Biolgicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biolgicals, 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
    16 Jun 2009
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Jun 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Jun 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that the immunogenicity of the DTPa-HBV-IPV/Hib vaccine (new formulation) in terms of response to all vaccine antigens is non-inferior to that of the DTPa-HBV-IPV/Hib vaccine (current formulation), one month after the booster dose.
    Protection of trial subjects
    The vaccines were observed closely for at least 30 minutes, with appropriate medical treatment readily available in case of a rare anaphylactic reaction following the administration of vaccine.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Feb 2008
    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: 283
    Worldwide total number of subjects
    283
    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)
    283
    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
    Partially double-blind study. The study was double-blind for the two groups receiving current formulation or new formulation i.e. the investigator and parents/guardians of the subjects were unaware of the treatment administered. The study was open for the Penta Group i.e. the vaccine GSK Biologicals’ Infanrix™ penta (DTPa-HBV-IPV) administered to the subjects in this group was known to the investigator and to the parents/guardians of the subject.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Infanrix hexa preservative-free formulation Group
    Arm description
    		 Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa.
    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
    Subjects received a booster dose.

    Arm title
    		 Infanrix hexa Preservative-Containing Formulation Group
    Arm description
    		 Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa.
    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
    Subjects received a booster dose.

    Arm title
    		 Infanrix penta Preservative-Free Formulation Group
    Arm description
    		 Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Infanrix™ penta
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received a booster dose.

    Number of subjects in period 1
    		Infanrix hexa preservative-free formulation Group Infanrix hexa Preservative-Containing Formulation Group Infanrix penta Preservative-Free Formulation Group
    Started
    111
    115
    57
    Completed
    110
    114
    56
    Not completed
    1
    1
    1
         Lost to follow-up
    -
    1
    -
         Protocol deviation
    1
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Infanrix hexa preservative-free formulation Group
    Reporting group description
    		 Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa.

    Reporting group title
    Infanrix hexa Preservative-Containing Formulation Group
    Reporting group description
    		 Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa.

    Reporting group title
    Infanrix penta Preservative-Free Formulation Group
    Reporting group description
    		 Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta.

    Reporting group values
    		 Infanrix hexa preservative-free formulation Group Infanrix hexa Preservative-Containing Formulation Group Infanrix penta Preservative-Free Formulation Group Total
    Number of subjects
    		 111 115 57 283
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 21.2 ( 1.61 ) 21.3 ( 1.57 ) 21.2 ( 1.62 ) -
    Gender categorical
    Units: Subjects
        Female
    		 56 46 35 137
        Male
    		 55 69 22 146

    End points

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    End points reporting groups
    Reporting group title
    Infanrix hexa preservative-free formulation Group
    Reporting group description
    		 Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa.

    Reporting group title
    Infanrix hexa Preservative-Containing Formulation Group
    Reporting group description
    		 Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa.

    Reporting group title
    Infanrix penta Preservative-Free Formulation Group
    Reporting group description
    		 Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta.

    Primary: Number of subjects with anti-hepatitis B (HB) antibody concentrations above the cut-off one month after the booster dose.

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    End point title
    		 Number of subjects with anti-hepatitis B (HB) antibody concentrations above the cut-off one month after the booster dose.
    End point description
    Anti-HB antibodies cut-off value assessed was ≥ 10 milli-international units per milliliter (mIU/mL).
    End point type
    Primary
    End point timeframe
    One month after the booster dose.
    End point values
    		 Infanrix hexa preservative-free formulation Group Infanrix hexa Preservative-Containing Formulation Group Infanrix penta Preservative-Free Formulation Group
    Number of subjects analysed
    91
    92
    48
    Units: Subjects
        Anti-HBs (N=91; 92; 48)
    88
    92
    48
    Statistical analysis title
    		 Non-inferiority in terms of vaccine response to HB
    Comparison groups
    Infanrix hexa preservative-free formulation Group v Infanrix hexa Preservative-Containing Formulation Group
    Number of subjects included in analysis
    183
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Difference in seroprotection rate
    Point estimate
    3.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.8
         upper limit
    		 9.27
    Notes
    [1] - To assess the Non-inferiority of the Infanrix hexa preservative-free formulation Group compared to the Infanrix hexa preservative-containing formulation Group in terms of vaccine response to hepatitis B, standardized asymptotic 95% CI for the groups 'difference (Infanrix hexa preservative-containing formulation Group minus Infanrix hexa preservative-free formulation Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was below the predefined limit of 10%.

    Primary: Number of subjects with anti-polyribosyl-ribitol-phosphate (PRP) antibodies concentrations above the cut-off one month after the booster dose.

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    End point title
    		 Number of subjects with anti-polyribosyl-ribitol-phosphate (PRP) antibodies concentrations above the cut-off one month after the booster dose.
    End point description
    Anti-PRP antibodies cut-off value assessed was ≥ 0.15 microgram per milliliter (µg/mL).
    End point type
    Primary
    End point timeframe
    One month after the booster dose.
    End point values
    		 Infanrix hexa preservative-free formulation Group Infanrix hexa Preservative-Containing Formulation Group Infanrix penta Preservative-Free Formulation Group
    Number of subjects analysed
    76
    79
    42
    Units: Subjects
        Anti-PRP (N=76; 79; 42)
    74
    78
    27
    Statistical analysis title
    		 Non-inferiority - vaccine response to PRP
    Comparison groups
    Infanrix hexa preservative-free formulation Group v Infanrix hexa Preservative-Containing Formulation Group
    Number of subjects included in analysis
    155
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    Parameter type
    		 Difference in seroprotection rate
    Point estimate
    1.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.49
         upper limit
    		 8.01
    Notes
    [2] - To assess the Non-inferiority of the Infanrix hexa preservative-free formulation Group compared to the Infanrix hexa preservative-containing formulation Group in terms of vaccine response to PRP, standardized asymptotic 95% CI for the groups’difference (Infanrix hexa preservative-containing formulation Group minus Infanrix hexa preservative-free formulation Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was below the predefined limit of 10%.

    Primary: Number of subjects with anti-diphtheria and anti-tetanus antibodies concentration above the cut-off one month after the booster dose.

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    End point title
    		 Number of subjects with anti-diphtheria and anti-tetanus antibodies concentration above the cut-off one month after the booster dose.
    End point description
    Anti-diphtheria and anti-tetanus antibodies cut-off value assessed was ≥ 0.1 international units per milliliter (IU/mL).
    End point type
    Primary
    End point timeframe
    One month after the booster dose.
    End point values
    		 Infanrix hexa preservative-free formulation Group Infanrix hexa Preservative-Containing Formulation Group Infanrix penta Preservative-Free Formulation Group
    Number of subjects analysed
    77
    79
    42
    Units: Subjects
        Anti-D
    76
    76
    40
        Anti-T
    76
    78
    42
    Statistical analysis title
    		 Non-inferiority in terms of vaccine response to D
    Comparison groups
    Infanrix hexa preservative-free formulation Group v Infanrix hexa Preservative-Containing Formulation Group
    Number of subjects included in analysis
    156
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    Method
    Parameter type
    		 Difference in seroprotection rate
    Point estimate
    -2.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.48
         upper limit
    		 3.62
    Notes
    [3] - To assess the Non-inferiority of the Infanrix hexa preservative-free formulation Group compared to the Infanrix hexa preservative-containing formulation Group in terms of vaccine response to diphtheria, standardized asymptotic 95% CI for the groups’difference (Infanrix hexa preservative-containing formulation Group minus Infanrix hexa preservative-free formulation Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was below the predefined limit of 10%.
    Statistical analysis title
    		 Non-inferiority in terms of vaccine response to T
    Comparison groups
    Infanrix hexa preservative-free formulation Group v Infanrix hexa Preservative-Containing Formulation Group
    Number of subjects included in analysis
    156
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [4]
    Method
    Parameter type
    		 Difference in seroprotection rate
    Point estimate
    0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.68
         upper limit
    		 5.88
    Notes
    [4] - To assess the Non-inferiority of the Infanrix hexa preservative-free formulation Group compared to the Infanrix hexa preservative-containing formulation Group in terms of vaccine response to tetanus, standardized asymptotic 95% CI for the groups’difference (Infanrix hexa preservative-containing formulation Group minus Infanrix hexa preservative-free formulation Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was below the predefined limit of 10%.

    Primary: Number of subjects with anti-poliovirus antibodies concentration above the cut-off one month after the booster dose.

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    End point title
    		 Number of subjects with anti-poliovirus antibodies concentration above the cut-off one month after the booster dose.
    End point description
    Anti-poliovirus antibodies cut-off value assessed was ≥ 8 effective dose 50 (ED50).
    End point type
    Primary
    End point timeframe
    One month after the booster dose.
    End point values
    		 Infanrix hexa preservative-free formulation Group Infanrix hexa Preservative-Containing Formulation Group Infanrix penta Preservative-Free Formulation Group
    Number of subjects analysed
    55
    52
    31
    Units: Subjects
        Anti-polivirus 1 (N=55; 51; 31)
    55
    51
    31
        Anti-polivirus 2 (N=55; 51; 31)
    55
    51
    30
        Anti-polivirus 3 (N=55; 52; 31)
    55
    52
    29
    Statistical analysis title
    		 Non-inferiority - vaccine response to polio-1
    Comparison groups
    Infanrix hexa preservative-free formulation Group v Infanrix hexa Preservative-Containing Formulation Group
    Number of subjects included in analysis
    107
    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
    		 -7.07
         upper limit
    		 6.59
    Notes
    [5] - To assess the Non-inferiority of the Infanrix hexa preservative-free formulation Group compared to the Infanrix hexa preservative-containing formulation Group in terms of vaccine response to poliovirus type 1, standardized asymptotic 95% CI for the groups’ difference (Infanrix hexa preservative-containing formulation Group minus Infanrix hexa preservative-free formulation Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was below the predefined limit of 10%.
    Statistical analysis title
    		 Non-inferiority - vaccine response to polio-2
    Comparison groups
    Infanrix hexa preservative-free formulation Group v Infanrix hexa Preservative-Containing Formulation Group
    Number of subjects included in analysis
    107
    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
    		 -7.07
         upper limit
    		 6.59
    Notes
    [6] - To assess the Non-inferiority of the Infanrix hexa preservative-free formulation Group compared to the Infanrix hexa preservative-containing formulation Group in terms of vaccine response to poliovirus type 2, standardized asymptotic 95% CI for the groups’ difference (Infanrix hexa preservative-containing formulation Group minus Infanrix hexa preservative-free formulation Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was below the predefined limit of 10%.
    Statistical analysis title
    		 Non-inferiority - vaccine response to polio-3
    Comparison groups
    Infanrix hexa preservative-free formulation Group v Infanrix hexa Preservative-Containing Formulation Group
    Number of subjects included in analysis
    107
    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
    		 -6.94
         upper limit
    		 6.59
    Notes
    [7] - To assess the Non-inferiority of the Infanrix hexa preservative-free formulation Group compared to the Infanrix hexa preservative-containing formulation Group in terms of vaccine response to poliovirus type 3, standardized asymptotic 95% CI for the groups’ difference (Infanrix hexa preservative-containing formulation Group minus Infanrix hexa preservative-free formulation Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was below the predefined limit of 10%.

    Primary: Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration One Month After the Booster Dose

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    End point title
    		 Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration One Month After the Booster Dose
    End point description
    Concentration of anti-PT, ant-FHA and anti-PRN antibodies given as geometric mean concentration (GMC) in Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL).
    End point type
    Primary
    End point timeframe
    One month after the booster dose.
    End point values
    		 Infanrix hexa preservative-free formulation Group Infanrix hexa Preservative-Containing Formulation Group Infanrix penta Preservative-Free Formulation Group
    Number of subjects analysed
    89
    77
    41
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PT (N=84; 70; 33)
    65.5 (49.8 to 86.3)
    84.2 (61.5 to 115.4)
    43.9 (22.4 to 85.8)
        Anti-FHA (N=86; 69; 38)
    476.6 (369.7 to 614.4)
    428.3 (311.2 to 589.5)
    221.1 (120.3 to 406.6)
        Anti-PRN (N=89; 77; 41)
    418.1 (303.2 to 576.6)
    384.1 (271.3 to 544)
    251.6 (143.9 to 439.7)
    Statistical analysis title
    		 Non-inferiority in terms of vaccine response to PT
    Comparison groups
    Infanrix hexa preservative-free formulation Group v Infanrix hexa Preservative-Containing Formulation Group
    Number of subjects included in analysis
    166
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [8]
    Method
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.85
         upper limit
    		 1.94
    Notes
    [8] - To assess the Non-inferiority of the Infanrix hexa preservative-free formulation Group compared to the Infanrix hexa preservative-containing formulation Group in terms of vaccine response to pertussis toxoid. Objective of non-inferiority was met since the LL of the 95% CI was below the predefined limit of 1.5.
    Statistical analysis title
    		 Non-inferiority - vaccine response to FHA
    Comparison groups
    Infanrix hexa preservative-free formulation Group v Infanrix hexa Preservative-Containing Formulation Group
    Number of subjects included in analysis
    166
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [9]
    Method
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 1.34
    Notes
    [9] - To assess the Non-inferiority of the Infanrix hexa preservative-free formulation Group compared to the Infanrix hexa preservative-containing formulation Group in terms of vaccine response to filamentous haemagglutinin. Objective of non-inferiority was met since the LL of the 95% CI was below the predefined limit of 1.5.
    Statistical analysis title
    		 Non-inferiority - vaccine response to PRN
    Comparison groups
    Infanrix hexa preservative-free formulation Group v Infanrix hexa Preservative-Containing Formulation Group
    Number of subjects included in analysis
    166
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [10]
    Method
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.57
         upper limit
    		 1.47
    Notes
    [10] - To assess the Non-inferiority of the Infanrix hexa preservative-free formulation Group compared to the Infanrix hexa preservative-containing formulation Group in terms of vaccine response to pertactin. Objective of non-inferiority was met since the LL of the 95% CI was below the predefined limit of 1.5.

    Secondary: Number of subjects with anti-hepatitis B (HB) antibody concentrations above the cut-off before and one month after the booster dose.

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    End point title
    		 Number of subjects with anti-hepatitis B (HB) antibody concentrations above the cut-off before and one month after the booster dose.
    End point description
    Anti-HB antibodies cut-off value assessed were ≥ 10 mIU/mL and ≥ 100 mIU/mL. Number of subjects with cut-off ≥ 10 mIU/mL one month after the booster dose was already presented in the primary outcomes.
    End point type
    Secondary
    End point timeframe
    Before (Pre) and one month after (Post) the booster dose.
    End point values
    		 Infanrix hexa preservative-free formulation Group Infanrix hexa Preservative-Containing Formulation Group Infanrix penta Preservative-Free Formulation Group
    Number of subjects analysed
    93
    93
    48
    Units: Subjects
        ≥ 10 mIU/mL Pre (N=93, 93,47)
    87
    86
    44
        ≥ 100 mIU/mL Pre (N=93, 93,47)
    57
    57
    35
        ≥ 100 mIU/mL Post (N=91, 92,48)
    85
    87
    39
    No statistical analyses for this end point

    Secondary: Anti-HB antibodies concentration.

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    End point title
    		 Anti-HB antibodies concentration.
    End point description
    Concentration of anti-HB antibodies given as GMC in mIU/mL.
    End point type
    Secondary
    End point timeframe
    Before (Pre) and one month after (Post) the booster dose.
    End point values
    		 Infanrix hexa preservative-free formulation Group Infanrix hexa Preservative-Containing Formulation Group Infanrix penta Preservative-Free Formulation Group
    Number of subjects analysed
    93
    93
    48
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Pre (N=93,93,47)
    163.5 (114.3 to 233.7)
    161.2 (111.5 to 232.9)
    196.9 (124.2 to 312.2)
        Post (N=91,92,48)
    4668 (2861.4 to 7615.3)
    4962.3 (3289.7 to 7485.4)
    3867.8 (1751.4 to 8541.5)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-PRP antibodies concentrations above the cut-off before and one month after the booster dose.

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    End point title
    		 Number of subjects with anti-PRP antibodies concentrations above the cut-off before and one month after the booster dose.
    End point description
    Anti-PRP antibodies cut-off value assessed were ≥ 0.15 µg/mL and ≥ 1.0 µg/mL. Number of subjects with cut-off ≥ 0.15 µg/mL one month after the booster dose was already presented in the primary outcomes.
    End point type
    Secondary
    End point timeframe
    Before (Pre) and one month after (Post) the booster dose.
    End point values
    		 Infanrix hexa preservative-free formulation Group Infanrix hexa Preservative-Containing Formulation Group Infanrix penta Preservative-Free Formulation Group
    Number of subjects analysed
    76
    79
    42
    Units: Subjects
        ≥ 0.15 µg/mL Pre (N=75,72,42)
    55
    55
    23
        ≥ 1.0 µg/mL Pre (N=75,72,42)
    12
    14
    7
        ≥ 1.0 µg/mL Post (N=76,79,42)
    69
    74
    9
    No statistical analyses for this end point

    Secondary: Anti-PRP antibodies concentration.

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    End point title
    		 Anti-PRP antibodies concentration.
    End point description
    Concentration of anti-PRP antibodies given as GMC in µg/mL.
    End point type
    Secondary
    End point timeframe
    Before (Pre) and one month after (Post) the booster dose.
    End point values
    		 Infanrix hexa preservative-free formulation Group Infanrix hexa Preservative-Containing Formulation Group Infanrix penta Preservative-Free Formulation Group
    Number of subjects analysed
    76
    79
    42
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Pre (N=75,72,42)
    0.3 (0.2 to 0.4)
    0.4 (0.3 to 0.5)
    0.2 (0.1 to 0.4)
        Post (N=76,79,42)
    25.3 (16 to 40)
    34.7 (22.9 to 52.7)
    0.4 (0.2 to 0.7)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-diphtheria and anti-tetanus antibodies concentration above the cut-off before the booster dose.

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    End point title
    		 Number of subjects with anti-diphtheria and anti-tetanus antibodies concentration above the cut-off before the booster dose.
    End point description
    Anti-diphtheria and anti-tetanus antibodies cut-off value assessed was ≥ 0.1 IU/mL.
    End point type
    Secondary
    End point timeframe
    Before the booster dose administration (at baseline).
    End point values
    		 Infanrix hexa preservative-free formulation Group Infanrix hexa Preservative-Containing Formulation Group Infanrix penta Preservative-Free Formulation Group
    Number of subjects analysed
    75
    72
    42
    Units: Subjects
        Anti-diphtheria
    45
    47
    23
        Anti-tetanus
    69
    62
    39
    No statistical analyses for this end point

    Secondary: Anti-diphtheria and anti-tetanus antibodies concentration.

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    End point title
    		 Anti-diphtheria and anti-tetanus antibodies concentration.
    End point description
    Concentration of anti-diphtheria and anti-tetanus antibodies given as GMC in IU/mL.
    End point type
    Secondary
    End point timeframe
    Before (Pre) and one month after (Post) the booster dose.
    End point values
    		 Infanrix hexa preservative-free formulation Group Infanrix hexa Preservative-Containing Formulation Group Infanrix penta Preservative-Free Formulation Group
    Number of subjects analysed
    77
    79
    42
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-diphtheria Pre (N=75,72,42)
    0.2 (0.1 to 0.2)
    0.2 (0.1 to 0.3)
    0.1 (0.1 to 0.2)
        Anti-diphtheria Post (N=77,79,42)
    2.7 (1.9 to 3.7)
    3.4 (2.5 to 4.5)
    2.2 (1.4 to 3.5)
        Anti-tetanus Pre (N=75,72,42)
    0.5 (0.3 to 0.6)
    0.5 (0.3 to 0.7)
    0.3 (0.2 to 0.4)
        Anti-tetanus Post (N=77,79,42)
    4.9 (3.6 to 6.7)
    6.9 (5.3 to 9)
    4.5 (2.8 to 7.4)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-PT, anti-FHA and anti-PRN antibodies concentration above the cut-off before and one month after the booster dose.

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    End point title
    		 Number of subjects with anti-PT, anti-FHA and anti-PRN antibodies concentration above the cut-off before and one month after the booster dose.
    End point description
    Anti-PT, anti-FHA and anti-PRN antibodies cut-off value assessed were ≥ 5 EL.U/mL.
    End point type
    Secondary
    End point timeframe
    Before (Pre) and one month after (Post) the booster dose.
    End point values
    		 Infanrix hexa preservative-free formulation Group Infanrix hexa Preservative-Containing Formulation Group Infanrix penta Preservative-Free Formulation Group
    Number of subjects analysed
    89
    77
    42
    Units: Subjects
        Anti-PT Pre (N=83,78,42)
    45
    43
    26
        Anti-PT Post (N=84,70,33)
    79
    66
    25
        Anti-FHA Pre (N=85,77,42)
    77
    68
    39
        Anti-FHA Post (N=86,69,38)
    86
    69
    37
        Anti-PRN Pre (N=85,84,43)
    75
    67
    35
        Anti-PRN Post (N=89,77,41)
    88
    77
    40
    No statistical analyses for this end point

    Secondary: Anti-PT, anti-FHA, and anti-PRN antibodies concentration before the booster dose.

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    End point title
    		 Anti-PT, anti-FHA, and anti-PRN antibodies concentration before the booster dose.
    End point description
    Concentration of anti-PT, anti-FHA and anti-PRN antibodies given as GMC in EL.U/mL.
    End point type
    Secondary
    End point timeframe
    Before the booster dose administration (at baseline).
    End point values
    		 Infanrix hexa preservative-free formulation Group Infanrix hexa Preservative-Containing Formulation Group Infanrix penta Preservative-Free Formulation Group
    Number of subjects analysed
    85
    84
    43
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PT (N=83,78,42)
    6.6 (5.2 to 8.4)
    6.2 (5 to 7.8)
    7.1 (5.3 to 9.4)
        Anti-FHA (N=85,77,42)
    24.5 (18.4 to 32.6)
    22.1 (16.3 to 30)
    23.8 (17.3 to 32.6)
        Anti-PRN (N=85,84,43)
    17.5 (13.4 to 23)
    13.7 (10.3 to 18.1)
    15 (10.3 to 21.9)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-poliovirus antibodies concentration above the cut-off before the booster dose.

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    End point title
    		 Number of subjects with anti-poliovirus antibodies concentration above the cut-off before the booster dose.
    End point description
    Anti-poliovirus antibodies cut-off value assessed was ≥ 8 ED50.
    End point type
    Secondary
    End point timeframe
    Before the booster dose.
    End point values
    		 Infanrix hexa preservative-free formulation Group Infanrix hexa Preservative-Containing Formulation Group Infanrix penta Preservative-Free Formulation Group
    Number of subjects analysed
    49
    51
    27
    Units: Subjects
        Anti-poliovirus type 1 (N=49,50,26)
    46
    47
    24
        Anti-poliovirus type 2 (N=49,50,27)
    46
    48
    26
        Anti-poliovirus type 3 (N=49,51,27)
    47
    48
    23
    No statistical analyses for this end point

    Secondary: Anti-poliovirus antibodies titer.

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    End point title
    		 Anti-poliovirus antibodies titer.
    End point description
    Concentration of anti-poliovirus antibodies given as geometric mean titers (GMT).
    End point type
    Secondary
    End point timeframe
    Before (Pre) and one month after (Post) the booster dose.
    End point values
    		 Infanrix hexa preservative-free formulation Group Infanrix hexa Preservative-Containing Formulation Group Infanrix penta Preservative-Free Formulation Group
    Number of subjects analysed
    55
    51
    31
    Units: Titer
    geometric mean (confidence interval 95%)
        Anti-poliovirus type 1 Pre (N=49,50,26)
    106.5 (67.9 to 167)
    120.4 (76.9 to 188.4)
    85.9 (47.1 to 156.5)
        Anti-poliovirus type 1 Post (N=55,51,31)
    1237.1 (940.7 to 1626.9)
    1939.8 (1465.1 to 2568.2)
    979.5 (539.4 to 1778.8)
        Anti-poliovirus type 2 Pre (N=49,50,27)
    144.4 (96.9 to 215.2)
    102.5 (68.2 to 154.2)
    95.3 (56.3 to 161.1)
        Anti-poliovirus type 2 Post (N=55,51,31)
    1412 (1096.4 to 1818.5)
    1900.6 (1399.7 to 2580.7)
    916.3 (498.1 to 1685.5)
        Anti-poliovirus type 3 Pre (N=49,51,27)
    98.7 (68 to 143.2)
    68.9 (47 to 101.1)
    77.5 (41.9 to 143.4)
        Anti-poliovirus type 3 Post (N=49,51,27)
    1485.9 (1041.4 to 2120.3)
    1828.7 (1303.8 to 2565.1)
    605.6 (264 to 1389.1)
    No statistical analyses for this end point

    Secondary: Number of subjects reporting solicited symptoms.

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    End point title
    		 Number of subjects reporting solicited symptoms.
    End point description
    Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever, irritability, and loss of appetite.
    End point type
    Secondary
    End point timeframe
    Within the 4-day (Day 0-3) post-vaccination period.
    End point values
    		 Infanrix hexa preservative-free formulation Group Infanrix hexa Preservative-Containing Formulation Group Infanrix penta Preservative-Free Formulation Group
    Number of subjects analysed
    111
    115
    57
    Units: Subjects
        Pain
    35
    36
    14
        Redness
    54
    54
    22
        Swelling
    39
    45
    19
        Drowsiness
    21
    18
    8
        Fever
    18
    15
    6
        Irritability
    21
    21
    4
        Loss of appetite
    22
    14
    5
    No statistical analyses for this end point

    Secondary: Number of subjects reporting unsolicited adverse events (AE).

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    End point title
    		 Number of subjects reporting unsolicited adverse events (AE).
    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.
    End point type
    Secondary
    End point timeframe
    Within the 31-day (Day 0-30) post-vaccination period.
    End point values
    		 Infanrix hexa preservative-free formulation Group Infanrix hexa Preservative-Containing Formulation Group Infanrix penta Preservative-Free Formulation Group
    Number of subjects analysed
    111
    115
    57
    Units: Subjects
        Any AE(s)
    8
    9
    2
    No statistical analyses for this end point

    Secondary: Number of subjects reporting serious adverse events (SAE).

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    End point title
    		 Number of subjects reporting serious adverse events (SAE).
    End point description
    An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
    End point type
    Secondary
    End point timeframe
    Up to one month after the booster dose administration.
    End point values
    		 Infanrix hexa preservative-free formulation Group Infanrix hexa Preservative-Containing Formulation Group Infanrix penta Preservative-Free Formulation Group
    Number of subjects analysed
    111
    115
    57
    Units: Subjects
        Any SAE(s)
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited local and general symptoms: during the 4-day (Day 0-3) follow-up period after booster vaccination. Unsolicited symptoms: during the 31-day (Day 0-30) follow-up period after booster vaccination. (SAEs): following booster vaccination.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.0
    Reporting groups
    Reporting group title
    Infanrix hexa preservative-free formulation Group
    Reporting group description
    		 Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa

    Reporting group title
    Infanrix hexa preservative-containing formulation Group
    Reporting group description
    		 Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa

    Reporting group title
    Infanrix penta preservative-free formulation Group
    Reporting group description
    		 Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta

    Serious adverse events
    		 Infanrix hexa preservative-free formulation Group Infanrix hexa preservative-containing formulation Group Infanrix penta preservative-free formulation Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 111 (0.00%)
    0 / 115 (0.00%)
    0 / 57 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Infanrix hexa preservative-free formulation Group Infanrix hexa preservative-containing formulation Group Infanrix penta preservative-free formulation Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    59 / 111 (53.15%)
    62 / 115 (53.91%)
    26 / 57 (45.61%)
    General disorders and administration site conditions
    Pain
    alternative assessment type: Systematic
         subjects affected / exposed
    35 / 111 (31.53%)
    36 / 115 (31.30%)
    14 / 57 (24.56%)
         occurrences all number
    35
    36
    14
    Redness
    alternative assessment type: Systematic
         subjects affected / exposed
    54 / 111 (48.65%)
    54 / 115 (46.96%)
    22 / 57 (38.60%)
         occurrences all number
    54
    54
    22
    Swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    39 / 111 (35.14%)
    45 / 115 (39.13%)
    19 / 57 (33.33%)
         occurrences all number
    39
    45
    19
    Drowsiness
    alternative assessment type: Systematic
         subjects affected / exposed
    21 / 111 (18.92%)
    18 / 115 (15.65%)
    8 / 57 (14.04%)
         occurrences all number
    21
    18
    8
    Fever
    alternative assessment type: Systematic
         subjects affected / exposed
    18 / 111 (16.22%)
    15 / 115 (13.04%)
    6 / 57 (10.53%)
         occurrences all number
    18
    15
    6
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed
    21 / 111 (18.92%)
    21 / 115 (18.26%)
    4 / 57 (7.02%)
         occurrences all number
    21
    21
    4
    Loss of appetite
    alternative assessment type: Systematic
         subjects affected / exposed
    22 / 111 (19.82%)
    14 / 115 (12.17%)
    5 / 57 (8.77%)
         occurrences all number
    22
    14
    5

    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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