Last updated: 11/07/2018 01:35:39

Persistence of the immune response to hepatitis B in 7-9 years old children previously vaccinated with DTPa-HBV-IPV/Hib

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GSK study ID
106744
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Clinicaltrials.gov ID
NCT00356564
EudraCT ID
2006-000549-20
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Multicentre study to assess persistence of antibodies against hepatitis B and immune response to a hepatitis B challenge dose in healthy children 7 to 9 years old previously vaccinated with 4 doses of GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine
Trial description: Persistence of seroprotective antibody concentrations & immunological memory shown by the ability to mount a response to a challenge dose of HBV vaccine
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Biological/vaccine: hepatitis B vaccine
    • Enrollment:
    350
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Zinke M et al. (2009) Immune memory to hepatitis B virus in 4-9-year old children vaccinated in infancy with four doses of hexavalent DTPa-HBV-IPV/Hib vaccine. Hum Vaccin. 5(9): 592-598.
    Zinke M et al. (2010) Immunological persistence in 4-6 and 7-9 year olds previously vaccinated in infancy with hexavalent DTPa-HBV-IPV/Hib. Hum Vaccin. 6(2):189-193.
    Medical condition
    Hepatitis B
    Product
    SB217744
    Collaborators
    Not applicable
    Study date(s)
    July 2006 to December 2006
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    7 - 9 years
    Accepts healthy volunteers
    Yes
    • Inclusion Criteria:
    • A male or female aged 7 to 9 years at the time of study entry .
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion Criteria:
    • A male or female aged 7 to 9 years at the time of study entry .
    • Subjects who have received a total of 4 doses of DTPa-HBV-IPV/Hib vaccine or a total of 4 doses of HBV vaccine in previous vaccination studies.
    • Evidence of previous hepatitis B booster vaccination or disease since administration of the fourth dose of DTPa-HBV-IPV/Hib or HBV vaccine.

    Trial location(s)

    Location
    Status
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    Location
    GSK Investigational Site
    Ettenheim, Baden-Wuerttemberg, Germany, 77955
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Lobenstein, Thueringen, Germany, 07356
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Mainz, Rheinland-Pfalz, Germany, 55131
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Willich, Nordrhein-Westfalen, Germany, 47877
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Altenholz, Schleswig-Holstein, Germany, 24161
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Hamburg, Hamburg, Germany, 22415
    Status
    Study Complete
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    Showing 1 - 6 of 42 Results

    Study documents

    Clinical study report
    Available language(s): English
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    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2006-14-12

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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