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

Long Term Follow-up Study at Years 2, 3, 4 and 5 Where 2 dosing schedules of the Combined Hepatitis A and B Vaccine were Compared

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GSK study ID
208127/132 (EXT Y2)
See study documents
Clinicaltrials.gov ID
NCT00197184
See results summary
EudraCT ID
2015-001515-12
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: Evaluate the Persistence of Immune Response of GSK Biologicals' Twinrix™ Vaccine, Administered According to a 0,6 month Schedule and a 0,1,6 month Schedule, in Healthy Children Aged Between 1-11 years at the Time of First Vaccine Dose
Trial description: To evaluate the persistence of anti-hepatitis A virus (HAV) and anti-hepatitis B surface antigen (HBs) antibodies up to 2, 3, 4 and 5 years after administration of the first dose of the study vaccine.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Anti-hepatitis A (HAV) antibody concentrations

Timeframe: Year 2 (Month 24), Year 3 (Month 36), Year 4 (Month 48) and Year 5 (Month 60)

Anti-hepatitis B (HBs) antibody concentrations

Timeframe: Year 2 (Month 24), Year 3 (Month 36), Year 4 (Month 48) and Year 5 (Month 60)

Anti-HAV antibody concentrations in subjects receiving the additional vaccine dose.

Timeframe: Before and one month after additional vaccination

Anti-HBs antibody concentrations in subjects receiving the additional vaccine dose.

Timeframe: Before and One month after additional vaccination

Secondary outcomes:

Number of subjects reporting Serious Adverse Events (SAEs) determined by the investigator to have a causal relationship to primary vaccination or due to lack of vaccine efficacy.

Timeframe: From last study visit of the primary study up to Year 5 long term follow-up

Number of subjects receiving an additional vaccine dose and reporting solicited local symptoms

Timeframe: during the 4-day follow-up period after additional vaccination

Number of subjects receiving an additional vaccine dose and reporting solicited general symptoms.

Timeframe: During the 4-day follow-up period after additional vaccination

Number of subjects receiving an additional vaccine dose and reporting unsolicited adverse events (AEs).

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

Number of subjects receiving an additional vaccine dose and reporting any Serious Adverse Events

Timeframe: At least one month after additional vaccination

Interventions:
  • Biological/vaccine: Twinrix™ Adult
  • Biological/vaccine: Twinrix™ Junior
    • Enrollment:
    276
    Primary completion date:
    2004-10-03
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Marshall H et al. (2010) Long-term (5-year) antibody persistence following two- and three-dose regimens of a combined hepatitis A and B vaccine in children aged 1–11 years. Vaccine. 28:4411–4415
    Medical condition
    Hepatitis B
    Product
    SB208127
    Collaborators
    Not applicable
    Study date(s)
    November 2003 to March 2004
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    3 - 13 years
    Accepts healthy volunteers
    Yes
    • Inclusion Criteria:
    • Participation in primary study
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion Criteria:
    • Participation in primary study
    • Written informed consent obtained before each long term follow up visit.

    Trial location(s)

    Location
    Status
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    Location
    GSK Investigational Site
    Valencia, Spain, 46024
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Blanes (Girona), Spain, 17300
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bruxelles, Belgium, 1200
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Cerdanyola del Vallés / Barcelona, Spain, 08290
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Barcelona, Spain, 08042
    Status
    Study Complete
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    Location
    GSK Investigational Site
    North Adelaide, South Australia, Australia, 5006
    Status
    Study Complete
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    Study documents

    Clinical study report
    Available language(s): English
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    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
    2004-10-03
    Actual study completion date
    2004-10-03

    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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