Last updated: 11/06/2018 23:18:47

Long term F/U studies at Y5&6 to demonstrate the equivalence of 2 vaccination schedules of combined hepatitis A & B vaccine

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GSK study ID
100386 (EXT Y5)
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Clinicaltrials.gov ID
NCT00197171
EudraCT ID
Not applicable
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: Evaluate the persistence of immune response of GSK Biologicals’ TWINRIX™ ADULT, administered according to 0,6 month schedule and 0,12 month schedule, in volunteers aged 12-15 years inclusive at the time of first vaccine dose
Trial description: To evaluate the persistence of immune response 5 years and 6 years after the first vaccine dose.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Biological/vaccine: Combined Hepatitis A and B vaccine
    • Enrollment:
    143
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Burgess MA et al. (2010) Antibody persistence six years after two doses of combined hepatitis A and B vaccine. Vaccine 28(10):2222-2226.
    Medical condition
    Hepatitis B
    Product
    SB208127
    Collaborators
    Not applicable
    Study date(s)
    September 2003 to December 2003
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    12 - 15 years
    Accepts healthy volunteers
    Yes
    • Inclusion Criteria:
    • Subjects who received GSK Biologicals' combined hepatitis A and B vaccine in the primary study (HAB-082). Subjects were aged 12 to 15 years at the time of the first vaccination.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion Criteria:
    • Subjects who received GSK Biologicals' combined hepatitis A and B vaccine in the primary study (HAB-082). Subjects were aged 12 to 15 years at the time of the first vaccination.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Melbourne, Victoria, Australia, 3001
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Paramatta, New South Wales, Australia, 2124
    Status
    Study Complete
    Contact us

    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
    2003-17-12

    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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