Last updated: 11/03/2018 11:52:33

Evaluation of immune memory to Twinrix or comparator by challenge dose administration 4 years after primary vaccination

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GSK study ID
111572
Clinicaltrials.gov ID
NCT00684671
See results summary
EudraCT ID
2008-000526-39
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: Challenge dose administration of Twinrix™ or comparator 4 years after primary vaccination.
Trial description: Only subjects who participated in the primary study will be invited to participate in the extension phase and the challenge dose phase of this study.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Number of subjects with anamnestic response to the challenge dose for anti-hepatitis A (anti-HAV) antibodies

Timeframe: One month after the challenge dose.

Number of subjects with anamnestic response to the challenge dose for anti-hepatitis B surface antigen (anti-HBs) antibodies

Timeframe: One month after the challenge dose.

Secondary outcomes:

Anti-hepatitis A (anti-HAV) and anti-hepatitis B surface antigen (anti-HBs) antibody concentrations

Timeframe: Prior to administration of challenge dose

Anti-hepatitis A (Anti-HAV) and Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations

Timeframe: Two weeks and one month after the challenge dose

Number of subjects reporting solicited symptoms

Timeframe: During the 4-day follow-up period after the challenge dose.

Number of subjects reporting unsolicited symptoms

Timeframe: During the 31-day follow-up period after the challenge dose.

Number of subjects with serious adverse events (SAEs) since the last study visit of the HAB-160 (NCT00603252) long-term follow-up study considered by the investigator to have a causal relationship to primary vaccination

Timeframe: Since the last study visit of the primary study long-term follow-up study up to challenge dose administration (1 year)

Number of subjects reporting serious adverse events (SAEs)

Timeframe: During one month following the administration of the challenge dose

Interventions:
  • Biological/vaccine: Twinrix
  • Biological/vaccine: Engerix-B
  • Biological/vaccine: Havrix
  • Biological/vaccine: HBVAXPRO
  • Biological/vaccine: Vaqta
    • Enrollment:
    506
    Primary completion date:
    2008-03-11
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Hepatitis A
    Product
    SB208127
    Collaborators
    Not applicable
    Study date(s)
    May 2008 to November 2008
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    41+ years
    Accepts healthy volunteers
    Yes
    • Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
    • A male or female who completed the primary vaccination phase of the HAB-160 study (NCT 00603252).
    • The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:
    • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the challenge dose, or planned use during the study period.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
    • A male or female who completed the primary vaccination phase of the HAB-160 study (NCT 00603252).
    • Written informed consent obtained from the subject.
    • 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 the vaccination.
    Exclusion criteria:
    • The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:
    • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the challenge dose, or planned use during the study period.
    • History of any hepatitis A or hepatitis B vaccination or infection since the primary vaccination study.
    • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
    • Acute disease at the time of enrolment.
    • Pregnant or lactating female.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Wilrijk, Belgium, 2610
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Hradec Kralove, Czech Republic, 500 01
    Status
    Study Complete
    Contact us

    Study documents

    No study documents available.

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2008-03-11
    Actual study completion date
    2008-03-11

    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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