Evaluation of Immunogenicity and Reactogenicity of Various Formulations of Recombinant Hepatitis B Vaccine
Phase 3
Completed
- Conditions
- Hepatitis B
- Interventions
- Biological: HBsAg formulated with different concentrations of MPL and Aluminium SaltsBiological: Engerix™-B
- Registration Number
- NCT00697970
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
The purpose of the present trial is to evaluate 6 vaccine formulations of recombinant hepatitis B vaccine for their reactogenicity and immunogenicity when administered at 0-2 months with a booster at month 12
- 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
- 321
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.
- Positivity for anti hepatitis antibodies.
- 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.
- 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
- Arm && Interventions
Group Intervention Description Group C HBsAg formulated with different concentrations of MPL and Aluminium Salts - Group A HBsAg formulated with different concentrations of MPL and Aluminium Salts - Group B HBsAg formulated with different concentrations of MPL and Aluminium Salts - Group E HBsAg formulated with different concentrations of MPL and Aluminium Salts - Group D HBsAg formulated with different concentrations of MPL and Aluminium Salts - Group F Engerix™-B -
- Primary Outcome Measures
Name Time Method Anti-HBs antibody concentrations After two doses and after the booster dose
- Secondary Outcome Measures
Name Time Method Occurrence and intensity of local and general solicited symptoms 8 days after vaccination Anti-HBs antibody concentrations Screening, M1, 2, 3, 4, 6, 12, 13 Occurrence of unsolicited adverse events 30-day after vaccination Occurrence of serious adverse events During the study period and 30 days after the last vaccination
Trial Locations
- Locations (1)
GSK Clinical Trials Call Center
🇦🇹Vienna, Austria