Last updated: 11/03/2018 10:11:58

Challenge dose of hepatitis B vaccine in subjects who previously received Engerix™-B vaccine

Request patient level data
GSK study ID
108988
See study documents
Clinicaltrials.gov ID
NCT00524576
See results summary
EudraCT ID
2007-000261-38
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: Administration of a challenge dose of hepatitis B vaccine in subjects who previously received Engerix™-B vaccine.
Trial description: To evaluate the response to an additional dose (challenge dose) of hepatitis B vaccine, when given to subjects who had received primary vaccination of Engerix™-B vaccine approximately 72-78 months ago.
This protocol posting deals with objectives & outcome measures of the challenge phase. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Number of participants with immunological response to challenge dose in terms of anti-hepatitis B surface antigen (anti-HBs) antibody concentration

Timeframe: 30 days post-challenge dose

Secondary outcomes:

Number of participants with anti-HBs antibody concentrations above the cut-off value

Timeframe: 30 days post-challenge dose

Concentration of anti-HBs antibodies

Timeframe: 30 days post-challenge dose

Number of participants reporting solicited local symptoms

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

Number of participants reporting solicited general symptoms

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

Number of participants reporting unsolicited adverse events (AE)

Timeframe: During the 31-day follow-up period (Day 0-30) after the challenge dose

Number of participants reporting serious adverse events (SAE)

Timeframe: During the 31-day follow-up period (Day 0-30) after the challenge dose

Interventions:
  • Biological/vaccine: Engerix™-B
    • Enrollment:
    144
    Primary completion date:
    2008-14-05
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    van Damme P. et al. (2010) Five years follow-up following two or three doses of a hepatitis B vaccine in adolescents aged 11–15 years: a randomised controlled study. BMC Infect Dis. 10:357.
    Medical condition
    Hepatitis B
    Product
    SKF103860
    Collaborators
    Not applicable
    Study date(s)
    November 2007 to May 2008
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    17 - 22 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 had received complete primary vaccination course of hepatitis B vaccine in the primary study
    • Use of any investigational/non-registered drug or vaccine other than the study vaccine within 30 days preceding the hepatitis B vaccine challenge dose or planned use during the study period.
    • Chronic administration (more than 14 days) of immunosuppressants other immune-modifying drugs within six months prior to the hepatitis B vaccine challenge dose.
    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 had received complete primary vaccination course of hepatitis B vaccine in the primary study
      • Written informed consent obtained from the subject and/or parent/guardian of the subject.
      • Healthy subjects as established by medical history and clinical examination before entering into the study.
      • If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after the hepatitis B challenge dose.
    Exclusion criteria:

      Use of any investigational/non-registered drug or vaccine other than the study vaccine within 30 days preceding the hepatitis B vaccine challenge dose or planned use during the study period.

      • Chronic administration (more than 14 days) of immunosuppressants other immune-modifying drugs within six months prior to the hepatitis B vaccine challenge dose.
      • Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before the hepatitis B vaccine challenge dose and ending 30 days after.
      • Subjects who received an additional dose of hepatitis B vaccine outside the context of the study between the primary vaccination course and the hepatitis B challenge vaccination visit.
      • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
      • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
      • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
      • Acute disease at the time of enrolment.
      • Acute or chronic, clinically significant hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
      • Administration of immunoglobulins and/or any blood products within the three months preceding the hepatitis B vaccine challenge dose or planned administration during the study period (one month).
      • Pregnant or lactating female.
      • Female planning to become pregnant or planning to discontinue contraceptive precautions.

    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
    Bruxelles, Belgium, 1200
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Westmead, New South Wales, Australia, 2145
    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
    2008-14-05
    Actual study completion date
    2008-14-05

    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

    Participate in clinical trial
    Additional information
    Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
    Click here
    Access to clinical trial data by researchers
    Visit website