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

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

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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
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2008-14-05
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
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Location
GSK Investigational Site
Wilrijk, Belgium, 2610
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
Westmead, New South Wales, Australia, 2145
Status
Study Complete
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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
Completed
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

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