Immunogenicity & Reactogenicity of HBV-MPL Vaccine and Engerix™-B in Healthy Adults Following 2 Different Schedules
Phase 2
Completed
- Conditions
- Hepatitis B
- Registration Number
- NCT00697229
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
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
- Detailed Description
At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 99
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Anti-hepatitis B surface antigen (HBs) antibody concentrations One month after the full primary vaccination course and one month after the booster vaccination at 70 months
- Secondary Outcome Measures
Name Time Method Incidence of unsolicited symptoms During the 30-day follow-up after vaccination Serious adverse experiences (SAE). Throughout the study period Anti-HBs antibody concentrations Months 1, 2, 3, 6, 12, 13, 42 Occurrence, intensity and relationship of solicited general symptoms 8-day follow-up after vaccination Occurrence and intensity of solicited local symptoms 8-day follow-up after vaccination
Trial Locations
- Locations (1)
GSK Clinical Trials Call Center
🇧🇪Wilrijk, Belgium
GSK Clinical Trials Call Center🇧🇪Wilrijk, Belgium