Last updated: 11/04/2018 00:34:27
Immunogenicity and safety of GSK Biologicals' HBV-MPL vaccine and Engerix™-B in healthy adults (15-40 yrs).
GSK study ID
208129/027
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Study comparing the immunogenicity and reactogenicity of GSK Biologicals' HBV-MPL vaccine injected according to a 0, 6 months schedule with that of Engerix™-B injected as a 0, 1, 6 months schedule in a healthy adult population (15-40 years)
Trial description: This study evaluates the safety and immunogenicity of the candidate HBV-MPL vaccine administered to healthy adults aged from 15 to 40 years, according to a 0, 6- month vaccination schedule, with Engerix™-B as control administered at 0, 1, 6 months.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Anti-HBs antibody concentrations
Timeframe: Month 7
Secondary outcomes:
Anti-HBs antibody concentrations
Timeframe: At months 1, 2, 6, 7 and 12
Occurrence, intensity and relationship to vaccination of solicited local and general symptoms
Timeframe: 4-day follow-up period after vaccination
Occurrence, intensity and relationship to vaccination of unsolicited symptoms
Timeframe: 31-day follow-up after vaccination
Occurrence and relationship to vaccination of Serious Adverse Events (SAEs)
Timeframe: During the study period
Interventions:
Biological/vaccine: HBV-MPL vaccine 208129
Biological/vaccine: Engerix™-B
Enrollment:
340
Observational study model:
Not applicable
Primary completion date:
1999-31-03
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Hepatitis B
Product
Hepatitis B Vaccine, Recombinant
Collaborators
Not applicable
Study date(s)
March 1997 to March 1999
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
15 - 40 Years
Accepts healthy volunteers
Yes
- Age: between 15 and 40 years old.
- Good physical condition as established by clinical examination and history taking at the time of entry.
- Positive titres at screening for anti-HBs antibodies.
- Elevated serum liver enzymes.
Inclusion and exclusion criteria
Inclusion criteria:
- Age: between 15 and 40 years old.
- Good physical condition as established by clinical examination and history taking at the time of entry.
- Female participants who are at risk to become pregnant will be on a contraceptive programme if necessary during the study period.
- Written informed consent obtained from the subjects aged between 18 and 40 and from the parents/tutor when the subjects are aged between 15 and 17 years.
Exclusion criteria:
- Positive titres at screening for anti-HBs antibodies.
- Elevated serum liver enzymes.
- History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
- Any acute disease at the moment of entry.
- Chronic alcohol consumption.
- Hepatomegaly, right upper quadrant abdominal pain or tenderness.
- Any chronic drug treatment, including any treatment with immunosuppressive drugs, which in the investigator's opinion, precludes inclusion into the study.
- History of allergic disease likely to be stimulated by any component of the vaccine.
- Simultaneous participation in any other clinical trial.
- Previous vaccination with a hepatitis B vaccine.
- Previous vaccination with an MPL containing vaccine.
- Administration of immunoglobulins in the past 6 months and during the whole study period
- Simultaneous vaccination one week before and one week after each dose of the study vaccine
Trial location(s)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
1999-31-03
Actual study completion date
1999-31-03
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
Additional information
Not applicable
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