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    Clinical Trial Results:
    An open, phase IV, multicentre study to assess the long-term persistence of antibodies against hepatitis B and the immune response to a hepatitis B vaccine challenge in healthy children 7 to 9 years old, previously vaccinated with 4 doses of GlaxoSmithKline (GSK) Biologicals’ DTPa-HBV-IPV/Hib vaccine or 4 doses of GSK Biologicals’ HBV vaccine, in clinical trials conducted by GSK Biologicals.

    Summary
    EudraCT number
    		 2006-000549-20
    Trial protocol
    		 DE  
    Global end of trial date
    19 May 2008

    Results information
    Results version number
    		 v2(current)
    This version publication date
    31 Jul 2016
    First version publication date
    04 Dec 2014
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Data (typos) were corrected.

    Trial information

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    Trial identification
    Sponsor protocol code
    106744
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00356564
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    30 Apr 2007
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 May 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the anti-HBs antibody response to a challenge dose of HBV vaccine in subjects aged 7 to 9 years, previously primed and boosted with 4 doses of Infanrix hexa in the first two years of life.
    Protection of trial subjects
    As with all injectable vaccines, appropriate medical treatment was always readily available in case of anaphylactic reactions following the administration of the vaccine. For this reason, the vaccine remained under medical supervision for 30 minutes after vaccination.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Jul 2006
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 224
    Worldwide total number of subjects
    224
    EEA total number of subjects
    224
    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)
    0
    Children (2-11 years)
    224
    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
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Infanrix hexa Group
    Arm description
    		 Subjects previously vaccinated with 4 doses of Infanrix hexa™ vaccine in the first 2 years of life.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Engerix™-B Kinder
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose, intramuscular use

    Arm title
    		 Engerix-B Kinder Group
    Arm description
    		 Subjects previously vaccinated with 4 doses of Engerix™-B Kinder vaccine co-administered with Infanrix hexa™ vaccine in the first 2 years of life.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Engerix™-B Kinder
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose, intramuscular use

    Arm title
    		 No vaccination Group
    Arm description
    		 Subjects in this group were enrolled even though they had no previous vaccination history.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 All subjects Group
    Arm description
    		 Pooled group including subjects from the other three groups.
    Arm type
    		 Merged group

    Investigational medicinal product name
    Engerix™-B Kinder
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose, intramuscular use

    Number of subjects in period 1
    		Infanrix hexa Group Engerix-B Kinder Group No vaccination Group All subjects Group
    Started
    200
    11
    13
    224
    Completed
    200
    11
    13
    224

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Infanrix hexa Group
    Reporting group description
    		 Subjects previously vaccinated with 4 doses of Infanrix hexa™ vaccine in the first 2 years of life.

    Reporting group title
    Engerix-B Kinder Group
    Reporting group description
    		 Subjects previously vaccinated with 4 doses of Engerix™-B Kinder vaccine co-administered with Infanrix hexa™ vaccine in the first 2 years of life.

    Reporting group title
    No vaccination Group
    Reporting group description
    		 Subjects in this group were enrolled even though they had no previous vaccination history.

    Reporting group title
    All subjects Group
    Reporting group description
    		 Pooled group including subjects from the other three groups.

    Reporting group values
    		 Infanrix hexa Group Engerix-B Kinder Group No vaccination Group All subjects Group Total
    Number of subjects
    		 200 11 13 224
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        geometric mean (standard deviation)
    		 8 ( 0.17 ) 8 ( 0 ) 7.9 ( 0.28 ) 8 ( 0.32 ) -
    Gender categorical
    Units: Subjects
        Female
    		 85 6 6 97 97
        Male
    		 115 5 7 127 127

    End points

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    End points reporting groups
    Reporting group title
    Infanrix hexa Group
    Reporting group description
    		 Subjects previously vaccinated with 4 doses of Infanrix hexa™ vaccine in the first 2 years of life.

    Reporting group title
    Engerix-B Kinder Group
    Reporting group description
    		 Subjects previously vaccinated with 4 doses of Engerix™-B Kinder vaccine co-administered with Infanrix hexa™ vaccine in the first 2 years of life.

    Reporting group title
    No vaccination Group
    Reporting group description
    		 Subjects in this group were enrolled even though they had no previous vaccination history.

    Reporting group title
    All subjects Group
    Reporting group description
    		 Pooled group including subjects from the other three groups.

    Primary: Number of subjects with anti-HBs antibody concentrations ≥ 100 mIU/mL.

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    End point title
    		 Number of subjects with anti-HBs antibody concentrations ≥ 100 mIU/mL. [1] [2]
    End point description
    The data for the Infanrix hexa Group are the primary efficacy results.
    End point type
    Primary
    End point timeframe
    1 month after challenge dose of Engerix™-B Kinder vaccine
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Analysis assessed only in subjects who received HBs containing vaccines.
    End point values
    		 Infanrix hexa Group Engerix-B Kinder Group
    Number of subjects analysed
    187
    9
    Units: Subjects
        Anti-Hbs 100mIU/mL
    175
    9
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-HBs antibody concentrations ≥ 10 mIU/mL.

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    End point title
    		 Number of subjects with anti-HBs antibody concentrations ≥ 10 mIU/mL. [3]
    End point description
    1 month after challenge dose of Engerix-B Kinder vaccine
    End point type
    Secondary
    End point timeframe
    1 month after challenge dose of Engerix™-B Kinder vaccine
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Analysis assessed only in subjects who received HBs containing vaccines.
    End point values
    		 Infanrix hexa Group Engerix-B Kinder Group
    Number of subjects analysed
    187
    9
    Units: Subjects
        Anti-HBs 10 mIU/mL
    184
    9
    No statistical analyses for this end point

    Secondary: Anti-HBs antibody concentrations.

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    End point title
    		 Anti-HBs antibody concentrations. [4]
    End point description
    Concentrations were expressed as geometric mean concentrations (GMCs) for the cut-off value of ≥ 100 mIU/mL (milli-international units per milliliter).
    End point type
    Secondary
    End point timeframe
    1 month after challenge dose of Engerix™-B Kinder vaccine
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Analysis assessed only in subjects who received HBs containing vaccines.
    End point values
    		 Infanrix hexa Group Engerix-B Kinder Group
    Number of subjects analysed
    187
    9
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Anti-HBs
    4093.9 (2930.9 to 5718.3)
    7698.5 (1314.4 to 45089.6)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-HBs antibody concentrations between set cut-off values.

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    End point title
    		 Number of subjects with anti-HBs antibody concentrations between set cut-off values. [5]
    End point description
    The cut-off values assessed for this outcome were ≥ 10 mIU/mL, ≥ 100 mIU/mL and 10 mIU/mL - 100 mIU/mL.
    End point type
    Secondary
    End point timeframe
    Before challenge dose of Engerix™-B Kinder vaccine
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Analysis assessed only in subjects who received HBs containing vaccines.
    End point values
    		 Infanrix hexa Group Engerix-B Kinder Group
    Number of subjects analysed
    193
    11
    Units: Subjects
        Anti-HBs 10 mIU/mL
    149
    10
        Anti-HBs 10 mIU/mL - 100 mIU/mL
    83
    8
        Anti-HBs 100 mIU/mL
    66
    2
    No statistical analyses for this end point

    Secondary: Anti-HBs antibody concentrations.

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    End point title
    		 Anti-HBs antibody concentrations. [6]
    End point description
    Concentrations were expressed as GMCs for the 10 mIU/mL - 100 mIU/mL cut-off.
    End point type
    Secondary
    End point timeframe
    Before challenge dose of Engerix™-B Kinder vaccine.
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Analysis assessed only in subjects who received HBs containing vaccines.
    End point values
    		 Infanrix hexa Group Engerix-B Kinder Group
    Number of subjects analysed
    193
    11
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Anti-HBs antibody concentrations
    42.1 (33.4 to 53)
    34.4 (13.8 to 86)
    No statistical analyses for this end point

    Secondary: Number of seroprotected subjects for anti-diphtheria (anti-D) and anti –tetanus (anti-T).

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    End point title
    		 Number of seroprotected subjects for anti-diphtheria (anti-D) and anti –tetanus (anti-T). [7]
    End point description
    A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL.
    End point type
    Secondary
    End point timeframe
    Before challenge dose of Engerix™-B Kinder vaccine
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Analysis assessed only in subjects who received HBs containing vaccines.
    End point values
    		 Infanrix hexa Group Engerix-B Kinder Group
    Number of subjects analysed
    193
    11
    Units: Subjects
        Anti-D
    161
    10
        Anti-T
    175
    11
    No statistical analyses for this end point

    Secondary: Number of seroprotected subjects for anti-polyribosyl ribitol phosphate (anti-PRP)

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    End point title
    		 Number of seroprotected subjects for anti-polyribosyl ribitol phosphate (anti-PRP) [8]
    End point description
    A seroprotected subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL) and ≥ 1 µg/mL.
    End point type
    Secondary
    End point timeframe
    Before challenge dose of Engerix™-B Kinder vaccine
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Analysis assessed only in subjects who received HBs containing vaccines.
    End point values
    		 Infanrix hexa Group Engerix-B Kinder Group
    Number of subjects analysed
    193
    11
    Units: Subjects
        Anti-PRP ≥ 0.15 µg/mL
    192
    11
        Anti-PRP ≥ 1 µg/mL
    121
    8
    No statistical analyses for this end point

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

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    End point title
    		 Number of seroprotected subjects for anti-poliovirus types 1, 2 and 3. [9]
    End point description
    A seroprotected subject was defined as a subject with anti-polio types 1, 2 and 3 antibody concentrations ≥ 8.
    End point type
    Secondary
    End point timeframe
    Before challenge dose of Engerix™-B Kinder vaccine
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Analysis assessed only in subjects who received HBs containing vaccines.
    End point values
    		 Infanrix hexa Group Engerix-B Kinder Group
    Number of subjects analysed
    181
    11
    Units: Subjects
        Anti-polio 1 (N=176, 10)
    165
    8
        Anti-polio 2 (N=181,11)
    169
    10
        Anti-polio 3 (N=177,11)
    173
    11
    No statistical analyses for this end point

    Secondary: Number of seropositive subjects for anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN).

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    End point title
    		 Number of seropositive subjects for anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN). [10]
    End point description
    A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL
    End point type
    Secondary
    End point timeframe
    Before challenge dose of Engerix™-B Kinder vaccine
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Analysis assessed only in subjects who received HBs containing vaccines.
    End point values
    		 Infanrix hexa Group Engerix-B Kinder Group
    Number of subjects analysed
    193
    11
    Units: Subjects
        Anti-PT (N=191,11)
    73
    5
        Anti-FHA (N=192, 11)
    189
    11
        Anti-PRN (N=193,11)
    173
    10
    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 [11]
    End point description
    End point type
    Secondary
    End point timeframe
    During the 4-day (Day 0-3) follow-up period after the challenge dose of Engerix™-B Kinder vaccine
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Assessment done for All subjects Group.
    End point values
    		 All subjects Group
    Number of subjects analysed
    224
    Units: Subjects
        Pain
    52
        Redness
    71
        Swelling
    28
    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 [12]
    End point description
    End point type
    Secondary
    End point timeframe
    During the 4-day (Day 0-3) follow-up period after the challenge dose of Engerix™-B Kinder vaccine
    Notes
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Assessment done for All subjects Group.
    End point values
    		 All subjects Group
    Number of subjects analysed
    224
    Units: Subjects
        Fatigue
    23
        Fever
    7
        Gastrointestinal
    14
        Headache
    25
    No statistical analyses for this end point

    Secondary: Number of subjects with unsolicited symptoms

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    End point title
    		 Number of subjects with unsolicited symptoms [13]
    End point description
    End point type
    Secondary
    End point timeframe
    During the 31-day (Day 0-30) follow-up period after the challenge dose of Engerix™-B Kinder vaccine
    Notes
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Assessment done for All subjects Group.
    End point values
    		 All subjects Group
    Number of subjects analysed
    224
    Units: Subjects
        Subjects with any AEs
    34
    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) [14]
    End point description
    End point type
    Secondary
    End point timeframe
    during the entire study period
    Notes
    [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Assessment done for All subjects Group.
    End point values
    		 All subjects Group
    Number of subjects analysed
    224
    Units: Subjects
        Subjects with any SAEs
    0
    No statistical analyses for this end point

    Secondary: Number of seroprotected subjects for anti-diphteria

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    End point title
    		 Number of seroprotected subjects for anti-diphteria [15]
    End point description
    End point type
    Secondary
    End point timeframe
    Before challenge dose
    Notes
    [15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Analysis assessed only in subjects who received HBs containing vaccines.
    End point values
    		 Infanrix hexa Group Engerix-B Kinder Group
    Number of subjects analysed
    193
    11
    Units: Subjects
        Seroprotected subjects
    185
    11
    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 [16]
    End point description
    End point type
    Secondary
    End point timeframe
    Before the challenge dose of Engerix™-B Kinder vaccine
    Notes
    [16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Analysis assessed only in subjects who received HBs containing vaccines.
    End point values
    		 Infanrix hexa Group Engerix-B Kinder Group
    Number of subjects analysed
    193
    11
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-D (N=193, 11)
    0.452 (0.369 to 0.554)
    0.447 (0.214 to 0.934)
        Anti-T (N=193,11)
    1.465 (1.16 to 1.851)
    1.777 (0.615 to 5.137)
    No statistical analyses for this end point

    Secondary: Anti-PT, anti-FHA, anti-PRN antibody concentrations

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    End point title
    		 Anti-PT, anti-FHA, anti-PRN antibody concentrations [17]
    End point description
    End point type
    Secondary
    End point timeframe
    Before the challenge dose of Engerix™-B Kinder vaccine
    Notes
    [17] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Analysis assessed only in subjects who received HBs containing vaccines.
    End point values
    		 Infanrix hexa Group Engerix-B Kinder Group
    Number of subjects analysed
    193
    11
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PT (N=191,11)
    5.4 (4.6 to 6.4)
    5.6 (2.8 to 11)
        Anti-FHA (N=192,11)
    63.7 (53.8 to 75.4)
    39 (18.1 to 84.3)
        Anti-PRN (N=193,11)
    25.5 (20.7 to 31.3)
    25.3 (10.1 to 63.3)
    No statistical analyses for this end point

    Secondary: Anti-Polio types 1, 2 and 3 antibody titers

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    End point title
    		 Anti-Polio types 1, 2 and 3 antibody titers [18]
    End point description
    End point type
    Secondary
    End point timeframe
    Before the challenge dose of Engerix™-B Kinder vaccine
    Notes
    [18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Analysis assessed only in subjects who received HBs containing vaccines.
    End point values
    		 Infanrix hexa Group Engerix-B Kinder Group
    Number of subjects analysed
    181
    11
    Units: Titer
    geometric mean (confidence interval 95%)
        Anti-polio 1 (N=176,10)
    73.8 (59.1 to 92.1)
    59.7 (15.4 to 232.1)
        Anti-polio 2 (N=181,11)
    68.6 (55.1 to 85.4)
    30 (13.5 to 66.2)
        Anti-polio 3 (N=177,11)
    136.9 (108.5 to 172.7)
    124.1 (40 to 385.1)
    No statistical analyses for this end point

    Secondary: Anti-PRP antibody concentrations

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    End point title
    		 Anti-PRP antibody concentrations [19]
    End point description
    End point type
    Secondary
    End point timeframe
    Before the challenge dose of the Engerix™-B Kinder vaccine
    Notes
    [19] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Analysis assessed only in subjects who received HBs containing vaccines.
    End point values
    		 Infanrix hexa Group Engerix-B Kinder Group
    Number of subjects analysed
    193
    11
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PRP
    1.584 (1.33 to 1.886)
    2.225 (1.229 to 4.03)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited symptoms: 4 - day follow-up period after vaccination (Day 0 - Day 3); Unsolicited AEs: 31 - day follow-up period after vaccination (Day 0 - Day 30); SAEs: during the entire study period.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    9.0
    Reporting groups
    Reporting group title
    All Subjects Group
    Reporting group description
    		 -

    Serious adverse events
    		 All Subjects Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 224 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 All Subjects Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    71 / 224 (31.70%)
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    52 / 224 (23.21%)
         occurrences all number
    52
    Redness
         subjects affected / exposed
    71 / 224 (31.70%)
         occurrences all number
    71
    Swelling
         subjects affected / exposed
    28 / 224 (12.50%)
         occurrences all number
    28
    Fatigue
         subjects affected / exposed
    23 / 224 (10.27%)
         occurrences all number
    23
    Gastrointestinal
         subjects affected / exposed
    14 / 224 (6.25%)
         occurrences all number
    14
    Headache
         subjects affected / exposed
    25 / 224 (11.16%)
         occurrences all number
    25

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    31 May 2006
    This amendment was prepared to take advantage of higher enrolment capacity than envisaged earlier and increase the sample size of the DTPa-HBV-IPV/Hib group. The number of subjects to be enrolled in that group is increased from 100 to at least 200, which results in increased power of the study to define the percentage of children showing boostability of the HBV response.

    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
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