Status:
COMPLETED
Comparison of Immuno, Reacto and Safety of Recombinant Hepatitis B Vaccine With or Without MPL in Healthy Older Adults
Lead Sponsor:
GlaxoSmithKline
Conditions:
Hepatitis B
Eligibility:
All Genders
50-70 years
Phase:
PHASE3
Brief Summary
In the present study the immunogenicity, reactogenicity and safety of recombinant hepatitis B vaccines with and without MPL will be evaluated in older healthy subjects
Detailed Description
At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham
Eligibility Criteria
Inclusion
- Healthy male or female subjects between 50 and 70 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
Exclusion
- Positive titres for anti hepatitis antibodies
- Any vaccination against hepatitis B in the past.
- Any previous administration of MPL
- Elevated serum liver enzymes at two subsequent determinations 14 days apart.
- 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 :
January 1 1994
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 1995
Estimated Enrollment :
362 Patients enrolled
Trial Details
Trial ID
NCT00697242
Start Date
January 1 1994
End Date
November 1 1995
Last Update
June 13 2008
Active Locations (4)
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1
GSK Clinical Trials Call Center
Vienna, Austria
2
GSK Clinical Trials Call Center
Ghent, Belgium
3
GSK Clinical Trials Call Center
Hvidovre, Denmark
4
GSK Clinical Trials Call Center
Reykjavik, Iceland