Last updated: 11/07/2018 12:57:21

Comparison of adjuvanted hepatitis B vaccine to double dose of Engerix™-B in pre- /haemodialysis patients aged ≥15 years

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GSK study ID
208129/032
See study documents
Clinicaltrials.gov ID
NCT00383227
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: A phase III, clinical trial comparing the immunogenicity and safety of SmithKline Beecham Biologicals new adjuvanted hepatitis B vaccine to a double dose of Engerix™-B, in pre-haemodialysis/haemodialysis patients (>=15 years of age)
Trial description: Comparison of adjuvanted hepatitis B vaccine to double dose of Engerix™-B in pre- /haemodialysis patients aged ≥15 years
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Biological/vaccine: Hepatitis B adjuvanted vaccine
    • Enrollment:
    165
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Kong NC et al. (2008) A new adjuvant improves the immune response to hepatitis B vaccine in hemodialysis patients. Kidney International. 73(7): 856–862.
    Tong NK et al. (2005) Immunogenicity and safety of an adjuvanted hepatitis B vaccine in pre-hemodialysis and hemodialysis patients. Kidney International. 68 (5): 2298-2303.
    Verstraeten T et al. (2008) Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 26(51):6630–6638.
    Medical condition
    Hepatitis B
    Product
    Hepatitis B Vaccine, Recombinant
    Collaborators
    Not applicable
    Study date(s)
    December 1999 to November 2000
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    15+ years
    Accepts healthy volunteers
    No
    • A male or female > = 15 years of age at the time of the first vaccination.
    • Written informed consent obtained from the subject/ from the parents or guardians of the subject.
    • Use of any investigational or non-registered drug or vaccine other than the study vaccine during the study period or within 30 days preceding the first dose of study vaccine.
    • Previous vaccination against hepatitis B.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • A male or female > = 15 years of age at the time of the first vaccination.
    • Written informed consent obtained from the subject/ from the parents or guardians of the subject.
    • Seronegative for anti-HBs antibodies, anti-HBc antibodies & Hepatitis B Surface antigen (HBsAg).
    • If the subject was a female, she was of non-childbearing potential or, if of childbearing potential, she had to be abstinent or use adequate contraceptive precautions for one month prior to enrollment and up to two months after the last vaccination.
    • Pre-haemodialysis patient* or a patient on haemodialysis.
    Exclusion criteria:
    • Use of any investigational or non-registered drug or vaccine other than the study vaccine during the study period or within 30 days preceding the first dose of study vaccine.
    • Previous vaccination against hepatitis B.
    • History of hepatitis B infection.
    • Known exposure to hepatitis B virus within 6 weeks. Pregnant or lactating female
    • Clinically abnormal ALT/AST values (> 3 times normal values)

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    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
    2000-30-11

    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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