Last updated: 11/03/2018 09:07:25

Evaluate immune response approximately 5 to 6 years after receiving different formulations of GSK Bio hep B vaccine

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GSK study ID
106640
See study documents
Clinicaltrials.gov ID
NCT00329576
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 anti-HBs antibody persistence, in subjects who received GSK Biologicals’ preservative-free or thiomersal-free Engerix™-B or Engerix™-B containing thiomersal, approximately 5 to 6 yrs earlier
Trial description: To evaluate the persistence of antibodies against hepatitis B, approximately 5 to 6 years after the first dose of the hepatitis B in the primary vaccination study.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Biological/vaccine: Hepatitis B vaccine
    • Enrollment:
    632
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Hepatitis B
    Product
    SKF103860
    Collaborators
    Not applicable
    Study date(s)
    May 2006 to August 2006
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 50 years
    Accepts healthy volunteers
    Yes
    • Inclusion Criteria:
    • Subjects should have participated in the primary study and should have received the first primary dose of vaccination more than five years ago and less than six years ago before blood sampling in this long-term follow-up study.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion Criteria:
    • Subjects should have participated in the primary study and should have received the first primary dose of vaccination more than five years ago and less than six years ago before blood sampling in this long-term follow-up study.
    • Written informed consent obtained from the subject for the long-term follow-up.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Muenchen, Bayern, Germany, 80799
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Basel, Switzerland, 4002
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Wilrijk, Belgium, 2610
    Status
    Study Complete
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    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
    2006-18-08

    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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