Last updated: 11/04/2018 00:32:52
Immunogenicity & reactogenicity of HBV-MPL vaccine and Engerix™-B in healthy adults following 2 different schedules
GSK study ID
208129/004
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Study to evaluate the immunogenicity and reactogenicity of GSK Biologicals' MPL-adjuvanted recombinant hepatitis B vaccine in comparison with those of Engerix™-B in healthy adult volunteers following 2 different schedules
Trial description: The purpose of this study is to evaluate the safety, immunogenicity and reactogenicity of MPL-adjuvanted recombinant hepatitis B vaccine in comparison with those of Engerix™-B in healthy adult volunteers following two different schedules: 0, 2 months and 0, 6 months
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Anti-hepatitis B surface antigen (HBs) antibody concentrations
Timeframe: One month after the full primary vaccination course and one month after the booster vaccination at 70 months
Secondary outcomes:
Anti-HBs antibody concentrations
Timeframe: Months 1, 2, 3, 6, 12, 13, 42
Serious adverse experiences (SAE).
Timeframe: Throughout the study period
Occurrence and intensity of solicited local symptoms
Timeframe: 8-day follow-up after vaccination
Occurrence, intensity and relationship of solicited general symptoms
Timeframe: 8-day follow-up after vaccination
Incidence of unsolicited symptoms
Timeframe: During the 30-day follow-up after vaccination
Interventions:
Enrollment:
99
Primary completion date:
1996-31-05
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Hepatitis B
Product
Hepatitis B Vaccine, Recombinant
Collaborators
Not applicable
Study date(s)
September 1992 to December 1998
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 40 Years
Accepts healthy volunteers
Yes
- Between 18 and 40 years old.
- Written informed consent will have been obtained from the subjects.
- Positive titres for anti hepatitis B antibodies.
- Any vaccination against hepatitis B in the past.
Inclusion and exclusion criteria
Inclusion criteria:
- Between 18 and 40 years old.
- Written informed consent will have been obtained from the subjects.
- Good physical condition as established by physical examination and history taking at the time of entry.
- Female participants will avoid becoming pregnant during the study period and they will have been on a contraceptive program for at least 2 months before entry.
Exclusion criteria:
- Positive titres for anti hepatitis B antibodies.
- Any vaccination against hepatitis B in the past.
- Elevated serum liver enzymes.
- History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
- Axillary temperature > 37°C at the time of injection.
- Any acute disease at the moment of entry.
- Chronic alcohol consumption.
- 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.
- Administration of any other vaccine(s) or any immunoglobulin during the study period.
- Simultaneous participation in any other clinical trial.
Trial location(s)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Study complete
Actual primary completion date
1996-31-05
Actual study completion date
1998-31-12
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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