Hepatitis B Clinical Trial
Official title:
Study to Evaluate the Immunogenicity and Reactogenicity of Various Formulations of GSK Biologicals' (Previously SmithKline Beecham Biologicals') Recombinant Hepatitis B Vaccine With Different Adjuvants in Healthy Adult Volunteers
The purpose of this study is to evaluate the immunogenicity and reactogenicity of various formulations of recombinant hepatitis B vaccine with different adjuvants in healthy adult volunteers following the 0, 1, 6 months schedule
Status | Completed |
Enrollment | 60 |
Est. completion date | July 1994 |
Est. primary completion date | July 1994 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 40 Years |
Eligibility |
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. - Serological signs of HBV infection - Elevated serum liver enzymes - Any vaccination against hepatitis B in the past. - Any previous administration of MPL. - 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Belgium | GSK Clinical Trials Call Center | Gent |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Occurrence and intensity of solicited local and general symptoms | 8 days follow-up after vaccination | ||
Secondary | Anti-HBs antibody concentrations | Months 0, 1, 3, 6, 7, 8 and 12 | ||
Secondary | Occurrence, intensity of unsolicited adverse events | 30-day follow-up after vaccination | ||
Secondary | Occurrence of serious adverse events | During the study period up to 30 days after last vaccination |
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