Status:
COMPLETED
Immunogenicity & Reactogenicity of HBV-MPL Vaccine and Engerix™-B in Healthy Adults Following 2 Different Schedules
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 safety, immunogenicity and reactogenicity of MPL-adjuvanted recombinant hepatitis B vaccine in comparison with those of Engerix™-B in healthy adult volunte...
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
- 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.
Key Trial Info
Start Date :
September 1 1992
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 1998
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT00697229
Start Date
September 1 1992
End Date
December 1 1998
Last Update
June 13 2008
Active Locations (1)
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1
GSK Clinical Trials Call Center
Wilrijk, Belgium