Status:
COMPLETED
Immunogenicity & Reactogenicity of Various Formulations of Recombinant Hepatitis B Vaccine With Different Adjuvants
Lead Sponsor:
GlaxoSmithKline
Conditions:
Hepatitis B
Eligibility:
All Genders
18-40 years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 1993
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 1994
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00697125
Start Date
June 1 1993
End Date
July 1 1994
Last Update
June 13 2008
Active Locations (1)
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1
GSK Clinical Trials Call Center
Ghent, Belgium