Last updated: 11/06/2018 23:25:34

Long-Term Immune Persistence of GlaxoSmithKline Biologicals' Inactivated Hepatitis A Vaccine, Injected According to 0, 6-month Schedule

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GSK study ID
100576 (Y11)
See study documents
Clinicaltrials.gov ID
NCT00289757
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: Double-blind, randomized study to evaluate the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine containing 1440 EL.U of antigen per mL and injected according to a 0, 6 month schedule in healthy adult subjects
Trial description: The aim of this study is to evaluate the long-term persistence of hepatitis A antibodies at 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 years after subjects received their first dose of a 2 dose vaccination schedule of hepatitis A vaccine.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration

Timeframe: At Years 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 after the first vaccine dose of the 2-dose primary vaccination

Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration

Timeframe: Before the additional dose, 14 days and 30 days after the additional dose

Number of seropositive subjects for anti-HAV antibodies.

Timeframe: From Year 11 to Year 20

Secondary outcomes:

Number of subjects reporting serious adverse events (SAE) assessed by the investigators as related to vaccination or to study procedures or lack of efficacy

Timeframe: Years 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 after the first vaccine dose of the 2-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 vaccination

Number of Subjects Reporting any, Grade 3 and Related Solicited General Symptoms

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

Number of Subjects Reporting any, Grade 3 and Related Unsolicited Adverse Events (AE)

Timeframe: During the 30-day follow-up period after additional vaccination (for subjects who received the additional vaccine dose between Year 11 and 15)

Number of Subjects Reporting serious adverse events (SAE)

Timeframe: During the follow-up period after additional vaccination up to Year 20

Interventions:
  • Biological/vaccine: Havrix™
    • Enrollment:
    78
    Primary completion date:
    2004-11-02
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Desombere I et al. (2000) Long-term persistence of cellular immunity towards hepatitis A vaccine (HAV) following HAV vaccination. J Antiviral Therapy. 5: 7.
    Van Damme P et al. (1994) Single dose inactivated hepatitis A vaccine: Rationale and clinical assessment of the safety and immunogenicity. J Med Virol. 44:435-441.
    Van Damme P et al. (1998) Long-term immunogenicity of a high potency inactivated hepatitis A vaccine. J Hepatol. 28 (suppl.1): 113.
    Van Herck K et al. (2000) Model-based estimates of long-term persistence of vaccine-induced hepatitis A antibodies. J Antiviral Therapy. 5:3-4.
    Van Herck K et al. (2001) Inactivated Hepatitis A Vaccine-Induced Antibodies: follow-up and estimates of long-term persistence. J Med Virol. 63: 1-7.
    Van Herck K et al. (2011) Antibody persistence and immune memory in healthy adults following vaccination with a two-dose inactivated hepatitis A vaccine: long-term follow-up at 15 years. J Med Virol. 83(11):1885-1891.
    Van Herck K et al. (2012) Seventeen-year antibody persistence in adults primed with two doses of an inactivated hepatitis A vaccine. Hum Vaccin Immunother. 8(3) [Epub ahead of print].
    Medical condition
    Hepatitis A
    Product
    SB208109
    Collaborators
    Not applicable
    Study date(s)
    January 2004 to February 2004
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    29 - 60 years
    Accepts healthy volunteers
    Yes
    • Inclusion Criteria:
    • Subjects who had received at least one dose of the study vaccine in the primary study
    Inclusion and exclusion criteria
    Inclusion criteria:

      Inclusion Criteria:

      • Subjects who had received at least one dose of the study vaccine in the primary study
      • Written informed consent will have been obtained from the subjects before the blood sampling visit of each year.

    Trial location(s)

    Location
    Status
    Contact us
    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

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2004-11-02
    Actual study completion date
    2004-11-02

    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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