Last updated: 11/06/2018 23:24:20

Long-Term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,1,6 Month Schedule

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GSK study ID
100556 (Y11)
See study documents
Clinicaltrials.gov ID
NCT00289718
See results summary
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: Long-Term Persistence Follow-up Study to Evaluate the Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers
Trial description: The aim of this study is to evaluate the long-term persistence of hepatitis A and B antibodies at Years 11, 12, 13, 14 and 15 years after subjects received their first dose of a 3 dose vaccination schedule of combined hepatitis A/hepatitis B vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
This protocol posting deals with objectives & outcome measures of the extension phase at year 11 to 15.
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:

Anti-hepatitis A Virus (Anti-HAV) antibody concentration

Timeframe: At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination

Number of subjects reporting any and grade 3 solicited local symptoms.

Timeframe: During the 4-day (Day 0-3) follow-up period after additional HBV vaccination

Number of subjects seropositive for anti-HAV antibodies

Timeframe: At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination

Anti-hepatitis B surface antigen (Anti-HBs) antibody concentration

Timeframe: At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination

Number of subjects seropositive for anti-HB antibodies

Timeframe: At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination

Number of subjects seroprotected for anti-HBs antibodies.

Timeframe: At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination

Number of Subjects Reporting Serious Adverse Events (SAE)

Timeframe: During the follow-up period after additional vaccination (minimum 30 days)

Anti-Hepatitis B surface antigen (Anti-HBs) antibody concentration

Timeframe: Before the additional dose and 1 month after the additional dose

Number of subjects reporting any solicited general symptoms.

Timeframe: During the 4-day (Day 0-3) follow-up period after additional HBV vaccination

Number of Subjects Reporting Unsolicited Adverse Events (AE)

Timeframe: During the 30-day follow-up period after additional vaccination

Number of subjects reporting serious adverse events (SAEs)

Timeframe: At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination

Secondary outcomes:
Not applicable
Interventions:
  • Biological/vaccine: Twinrix™ adult
    • Enrollment:
    51
    Primary completion date:
    2005-02-03
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Van Damme P et al. (2000) Long-Term persistence of antibodies induced by vaccination and safety Follow-Up, with the first combined vaccine against hepatitis A and B in children and adults. J Med Virol. 65 (1):6-13.
    Van Damme P et al. (2012) Antibody persistence and immune memory in adults, 15 years after a three-dose schedule of a combined hepatitis A and B vaccine. J Med Virol. 84(1):11-17.
    Van Herck et al. (2007) Ten-year antibody persistence induced by hepatitis A and B vaccine (Twinrix) in adults. Travel Medicine and Infectious Disease. 5(3):171-175.
    Medical condition
    Hepatitis B
    Product
    SB208127
    Collaborators
    Not applicable
    Study date(s)
    November 2004 to March 2005
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    Yes
    • Inclusion Criteria:
    • Subjects participating in this study should have received three-dose primary vaccination with combined hepatitis A/hepatitis B vaccine in the primary study.
    Inclusion and exclusion criteria
    Inclusion criteria:

      Inclusion Criteria:

      • Subjects participating in this study should have received three-dose primary vaccination with combined hepatitis A/hepatitis B vaccine in the primary study.
      • Written informed consent will be obtained from each subject before the blood sampling visit of each year

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Gent, Belgium, 9000
    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

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2005-02-03
    Actual study completion date
    2005-02-03

    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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