Last updated: 11/04/2018 00:36:07

Consistency of 3 consecutive lots of a novel HBV vaccine with single-blind safety evaluation using Engerix™-B as control

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GSK study ID
208129/037
See study documents
Clinicaltrials.gov ID
NCT00697866
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: Evaluating the consistency of 3 consecutive lots of GSK Biologicals' novel adjuvanted HBV vaccine with single-blind safety evaluation using Engerix™-B as a control, administered according to a 0, 1, 2-month schedule in healthy volunteers (15-50y).
Trial description: The purpose of the present study is to evaluate the immunogenicity and safety of three consecutive production lots of the novel adjuvanted HBV vaccine. The safety of the candidate vaccine will be assessed using Engerix™-B as control.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:

Anti-HBs antibody concentrations

Timeframe: At month 3

Secondary outcomes:

Anti-HBs antibody concentrations

Timeframe: At M1, M2, M3

Anti-RF1 antibody titres in a subset of 50 subjects per group

Timeframe: At months 0 and 3

Occurrence, intensity and relationship to vaccination of solicited local and general signs and symptoms

Timeframe: During a 4-day follow-up after vaccination

Occurrence, intensity and relationship to vaccination of unsolicited symptoms

Timeframe: Within 30 days after each vaccination

Occurrence, intensity and relationship to vaccination of serious adverse events

Timeframe: During the study period

Interventions:
  • Biological/vaccine: HBV-MPL vaccine 208129
  • Biological/vaccine: Engerix™-B
    • Enrollment:
    951
    Primary completion date:
    2001-28-02
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Hepatitis B
    Product
    Hepatitis B Vaccine, Recombinant
    Collaborators
    Not applicable
    Study date(s)
    August 2000 to February 2001
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    15 - 50 years
    Accepts healthy volunteers
    Yes
    • A male or female between, and including, 15 and 50 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 where applicable
    • Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
    • Planned administration/Administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s).
    Inclusion and exclusion criteria
    Inclusion criteria:
    • A male or female between, and including, 15 and 50 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 where applicable
    • Free of obvious health problems as established by medical history and clinical examination before entering into the study.
    • If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.
    Exclusion criteria:
    • Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
    • Planned administration/Administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s).
    • Previous vaccination against hepatitis B
    • History of non-response to previous hepatitis B vaccination
    • Known exposure to hepatitis B within the previous 6 weeks
    • History of hepatitis B infection
    • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
    • A family history of congenital or hereditary immunodeficiency.
    • Suspected or confirmed multiple sclerosis in the subject (applicable to Centre 5/France only)
    • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
    • Acute disease at the time of enrolment.
    • Hepatomegaly, right upper quadrant abdominal pain or tenderness.
    • Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
    • Pregnant or lactating female

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    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
    2001-28-02
    Actual study completion date
    2001-28-02

    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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