Status:
COMPLETED
Comparison of Safety, Immuno- and Reactogenicity of MPL-Adjuvanted Recombinant Hepatitis B Vaccine to That of Engerix™-B
Lead Sponsor:
GlaxoSmithKline
Conditions:
Hepatitis B
Eligibility:
All Genders
18-40 years
Phase:
PHASE3
Brief Summary
The purpose of the study is to compare the safety, reactogenicity and immunogenicity of different formulations of adjuvanted recombinant hepatitis B vaccine to that of Engerix™-B when administered at ...
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.
- Positive titres for anti hepatitis B 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.
- Simultaneous administration of any other vaccine(s).
- Administration of any immunoglobulin during the study period.
- Simultaneous participation in any other clinical trial
Key Trial Info
Start Date :
January 1 1995
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 1996
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00698087
Start Date
January 1 1995
End Date
February 1 1996
Last Update
June 16 2008
Active Locations (1)
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1
GSK Clinical Trials Call Center
Vienna, Austria