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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 4-6 years old, previously vaccinated with 4 doses of GlaxoSmithKline (GSK) Biologicals’ DTPa-HBV-IPV/Hib vaccine, in clinical trials conducted by GSK Biologicals.

    Summary
    EudraCT number
    		 2006-000553-22
    Trial protocol
    		 DE  
    Global end of trial date
    24 Apr 2007

    Results information
    Results version number
    		 v1
    This version publication date
    27 Apr 2016
    First version publication date
    10 Dec 2014
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    106745
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    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
    09 May 2007
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Apr 2007
    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 4-6 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
    02 Jun 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
    Germany: 203
    Worldwide total number of subjects
    203
    EEA total number of subjects
    203
    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)
    203
    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
    Arm title
    		 Engerix-B Kinder Group
    Arm description
    		 -
    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
    Subjects previously vaccinated with 4 doses of Infanrix hexa™ vaccine in the first 2 years of life received a dose of Engerix™-B Kinder.

    Number of subjects in period 1
    		Engerix-B Kinder Group
    Started
    203
    Completed
    201
    Not completed
    2
         Consent withdrawn by subject
    1
         Unspecified
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Engerix-B Kinder Group
    Reporting group description
    		 -

    Reporting group values
    		 Engerix-B Kinder Group Total
    Number of subjects
    		 203 203
    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: years
        geometric mean (standard deviation)
    		 4.6 ± 0.48 -
    Gender categorical
    Units: Subjects
        Female
    		 89 89
        Male
    		 114 114

    End points

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    End points reporting groups
    Reporting group title
    Engerix-B Kinder Group
    Reporting group description
    		 -

    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]
    End point description
    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
    End point values
    		 Engerix-B Kinder Group
    Number of subjects analysed
    188
    Units: Subjects
        Anti-Hbs 100mIU/mL
    173
    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
    End point description
    End point type
    Secondary
    End point timeframe
    1 month after challenge dose of Engerix™-B Kinder vaccine
    End point values
    		 Engerix-B Kinder Group
    Number of subjects analysed
    188
    Units: Subjects
        Anti-HBs 10 mIU/mL
    185
    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
    1 month after challenge dose of Engerix™-B Kinder vaccine
    End point values
    		 Engerix-B Kinder Group
    Number of subjects analysed
    188
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Anti-HBs
    7981.4 (5693.5 to 11188.7)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-HBs antibody concentrations above or equal the set cut-off values

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    End point title
    		 Number of subjects with anti-HBs antibody concentrations above or equal the set cut-off values
    End point description
    The cut-off values assessed were ≥ 10 mIU/mL and ≥ 100 mIU/mL.
    End point type
    Secondary
    End point timeframe
    Before challenge dose of Engerix™-B Kinder vaccine
    End point values
    		 Engerix-B Kinder Group
    Number of subjects analysed
    198
    Units: Subjects
        Anti-HBs 10 mIU/mL
    171
        Anti-HBs 100 mIU/mL
    106
    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
    Before challenge dose of HBV vaccine
    End point values
    		 Engerix-B Kinder Group
    Number of subjects analysed
    198
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Anti-HBs antibody concentrations
    110.8 (85.3 to 143.9)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-diphtheria (anti-D) and anti –tetanus (anti-T) antibody concentrations ≥ 0.1 IU/mL

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    End point title
    		 Number of subjects with anti-diphtheria (anti-D) and anti –tetanus (anti-T) antibody concentrations ≥ 0.1 IU/mL
    End point description
    End point type
    Secondary
    End point timeframe
    Before challenge dose of Engerix™-B Kinder vaccine
    End point values
    		 Engerix-B Kinder Group
    Number of subjects analysed
    198
    Units: Subjects
        Anti-D
    136
        Anti-T
    148
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-polyribosyl ribitol phosphate (anti-PRP) antibody concentration ≥ 0.15 µg/mL and ≥ 1 µg/mL

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    End point title
    		 Number of subjects with anti-polyribosyl ribitol phosphate (anti-PRP) antibody concentration ≥ 0.15 µg/mL and ≥ 1 µg/mL
    End point description
    End point type
    Secondary
    End point timeframe
    Before challenge dose of Engerix™-B Kinder vaccine
    End point values
    		 Engerix-B Kinder Group
    Number of subjects analysed
    198
    Units: Subjects
        Anti-PRP ≥ 0.15 µg/mL
    194
        Anti-PRP ≥ 1 µg/mL
    140
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-poliovirus types 1, 2 and 3 antibody titres ≥ 8.

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    End point title
    		 Number of subjects with anti-poliovirus types 1, 2 and 3 antibody titres ≥ 8.
    End point description
    End point type
    Secondary
    End point timeframe
    Before challenge dose of Engerix™-B Kinder vaccine
    End point values
    		 Engerix-B Kinder Group
    Number of subjects analysed
    187
    Units: Subjects
        Anti-polio 1 (N = 185)
    177
        Anti-polio 2 (N = 187)
    179
        Anti-polio 3 (N = 170)
    170
    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 concentration ≥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 concentration ≥5 EL.U/mL.
    End point description
    End point type
    Secondary
    End point timeframe
    Before challenge dose of Engerix™-B Kinder vaccine
    End point values
    		 Engerix-B Kinder Group
    Number of subjects analysed
    198
    Units: Subjects
        Anti-PT (N=197)
    50
        Anti-FHA (N=197)
    192
        Anti-PRN (N=198)
    180
    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
    The solicited local symptoms assessed were pain, redness and swelling.
    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
    End point values
    		 Engerix-B Kinder Group
    Number of subjects analysed
    202
    Units: Subjects
        Pain
    53
        Redness
    70
        Swelling
    36
    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
    The solicited general symptoms assessed were drowsiness, fever (defined as axillary temperature >37.5C), irritability and loss of appetite.
    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
    End point values
    		 Engerix-B Kinder Group
    Number of subjects analysed
    202
    Units: Subjects
        Drowsiness
    32
        Fever
    9
        Irritability
    14
        Loss of appetite
    19
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with unsolicited adverse events (AEs).
    End point description
    An unsolicited AE was any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
    End point type
    Secondary
    End point timeframe
    During the 31-day (Day 0-30) follow-up period after the challenge dose of Engerix™-B Kinder vaccine
    End point values
    		 Engerix-B Kinder Group
    Number of subjects analysed
    203
    Units: Subjects
        Subjects with any AEs
    41
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with serious adverse events (SAEs)
    End point description
    End point type
    Secondary
    End point timeframe
    During the entire study period (from Day 0 to Day 30).
    End point values
    		 Engerix-B Kinder Group
    Number of subjects analysed
    203
    Units: Subjects
        Subjects with any SAEs
    0
    No statistical analyses for this end point

    Secondary: Anti-D and anti-T antibody concentrations.

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    End point title
    		 Anti-D and anti-T antibody concentrations.
    End point description
    Concentrations were expressed as geometric mean concentrations (GMCs) in IU/mL.
    End point type
    Secondary
    End point timeframe
    Before challenge dose of Engerix™-B Kinder vaccine
    End point values
    		 Engerix-B Kinder Group
    Number of subjects analysed
    198
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-D
    0.189 (0.158 to 0.225)
        Anti-T
    0.196 (0.168 to 0.229)
    No statistical analyses for this end point

    Secondary: Anti-PRP antibody concentration.

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    End point title
    		 Anti-PRP antibody concentration.
    End point description
    Concentrations were expressed as geometric mean concentrations (GMCs) in µg/mL.
    End point type
    Secondary
    End point timeframe
    Before challenge dose of Engerix™-B Kinder vaccine
    End point values
    		 Engerix-B Kinder Group
    Number of subjects analysed
    198
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PRP
    1.813 (1.514 to 2.17)
    No statistical analyses for this end point

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

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    End point title
    		 Anti-PT, anti-FHA and anti-PRN antibody concentrations.
    End point description
    Concentrations were expressed as geometric mean concentrations (GMCs) in EL.U/mL.
    End point type
    Secondary
    End point timeframe
    Before challenge dose of Engerix™-B Kinder vaccine
    End point values
    		 Engerix-B Kinder Group
    Number of subjects analysed
    198
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PT (N=197)
    3.7 (3.3 to 4.1)
        Anti-FHA (N=197)
    49.6 (40.8 to 60.3)
        Anti-PRN (N=198)
    20.6 (17.5 to 24.3)
    No statistical analyses for this end point

    Secondary: Anti-poliovirus types 1, 2 & 3 antibody titres.

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    End point title
    		 Anti-poliovirus types 1, 2 & 3 antibody titres.
    End point description
    Titres (anti-polio) were expressed as geometric mean titres (GMTs).
    End point type
    Secondary
    End point timeframe
    Before challenge dose of Engerix™-B Kinder vaccine
    End point values
    		 Engerix-B Kinder Group
    Number of subjects analysed
    187
    Units: titres
    geometric mean (confidence interval 95%)
        Anti-polio 1 (N=185)
    87.2 (72 to 105.7)
        Anti-polio 2 (N=187)
    84.5 (70.5 to 101.3)
        Anti-polio 3 (N=174)
    158.7 (128.5 to 195.9)
    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
    9.1
    Reporting groups
    Reporting group title
    Engerix-B Kinder Group
    Reporting group description
    		 -

    Serious adverse events
    		 Engerix-B Kinder Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 202 (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
    		 Engerix-B Kinder Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    70 / 202 (34.65%)
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    53 / 202 (26.24%)
         occurrences all number
    53
    Redness
         subjects affected / exposed
    70 / 202 (34.65%)
         occurrences all number
    70
    Swelling
         subjects affected / exposed
    36 / 202 (17.82%)
         occurrences all number
    36
    Drowsiness
         subjects affected / exposed
    32 / 202 (15.84%)
         occurrences all number
    32
    Irritability
         subjects affected / exposed
    14 / 202 (6.93%)
         occurrences all number
    14
    Loss of appetite
         subjects affected / exposed
    19 / 202 (9.41%)
         occurrences all number
    19

    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
    For support, Contact us.
    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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