Safety, Immunogenicity and Reactogenicity of Recombinant Hepatitis B Vaccine (Adjuvanted & New Formulation) and Engerix™-B
Phase 3
Completed
- Conditions
- Hepatitis B
- Interventions
- Biological: HBV-MPL 208129Biological: Engerix™-BBiological: Vaccine containing HBsAg absorbed on aluminium salts - experimental formulation
- Registration Number
- NCT00697840
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
The purpose of the present trial is to assess the safety, reactogenicity and immunogenicity of adjuvanted hepatitis B vaccine, Engerix™-B and hepatitis B vaccine new formulation when administered at 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
- 150
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
- Pregnancy or lactation.
- Positive titres for anti HBs antibody.
- Any vaccination against hepatitis B in the past.
- Any previous administration of MPL.
- Elevated serum liver enzymes.
- History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
- Axillary temperature > 37.5°C at the time of injection.
- Any acute disease at the moment of entry.
- Chronic alcohol consumption.
- Any treatment with immunosuppressive or immunostimulant therapy.
- Any chronic drug treatment, 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 administration of any other vaccine(s).
- Administration of any immunoglobulin during the study period.
- Simultaneous participation in any other clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A HBV-MPL 208129 - Group B Engerix™-B - Group C Vaccine containing HBsAg absorbed on aluminium salts - experimental formulation -
- Primary Outcome Measures
Name Time Method Anti-HBs antibody concentrations At month 7 Occurrence and intensity of solicited local and general symptoms 4-day follow-up after vaccination Occurrence of unsolicited adverse events 30-days after vaccination Incidence of serious adverse events Throughout the study period Anti-Hbs antibody concentrations Months 1, 6 and 24
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
GSK Clinical Trials Call Center
🇦🇹Vienna, Austria