Last updated: 11/06/2018 23:25:14

Long-Term Immune Persistence of GlaxoSmithKline Biologicals' Inactivated Hepatitis A Vaccine Injected According to a 0, 12-month Schedule

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GSK study ID
100571 (M138)
See study documents
Clinicaltrials.gov ID
NCT00291876
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 two different lots of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine containing 1440 EL.U of antigen per mL and injected according to a 0, 12 month schedule in healthy adult volunteers
Trial description: The aim of this study is to evaluate the persistence of hepatitis A antibodies at 138, 150, 162, 174,186, 198, 210, 222, 234 and 246 months after subjects received their first dose of a 2 dose vaccination schedule of hepatitis A vaccine.
This protocol posting deals with objectives & outcome measures of the extension phase at year 11 to 20.
No additional subjects will be recruited during this long-term follow-up.
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 Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246

Number of seropositive subjects against hepatitis A virus

Timeframe: At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246

Secondary outcomes:

Anti-hepatitis A virus (anti-HAV) antibody concentration

Timeframe: Before additional vaccination, 14 days after additional vaccination and 30 days after additional vaccination

Number of subjects reporting solicited local symptoms

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

Number of subjects reporting solicited general symptoms

Timeframe: During the 4-day (Days 0-3) follow-up period after additional 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 (SAE) assessed by the investigator as related to primary study vaccination, procedures or lack of vaccine efficacy

Timeframe: At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246

Number of subjects reporting Serious Adverse Events (SAE) after additional vaccination

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

Number of subjects reporting pregnancies after additional vaccination

Timeframe: At Months 186 and 198

Interventions:
  • Biological/vaccine: Havrix™
    • Enrollment:
    135
    Primary completion date:
    2004-15-03
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    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 March 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
    2004-15-03
    Actual study completion date
    2004-15-03

    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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