Status:
COMPLETED
Evaluation of Immunogenicity, Reactogenicity and Safety of HBV-MPL Vaccine vs Engerix™-B, in Haemodialysis Patients
Lead Sponsor:
GlaxoSmithKline
Conditions:
Hepatitis B
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This trial is designed to evaluate the immunogenicity, reactogenicity and safety of an MPL-adjuvanted recombinant hepatitis B vaccine in comparison with those of Engerix™-B in haemodialysis patients w...
Detailed Description
At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham
Eligibility Criteria
Inclusion
- Dialysis patients
- A medical examination including physical examination and medical history as well as serological screening established acceptability for enrollment into the study.
- Age: from 18 years onwards
- Seronegative for anti- hepatitis antibodies
Exclusion
- History of persistent hepatic, cardiac or respiratory disease
- Any acute disease at the moment of entry into the study
- Chronic alcohol consumption
- Hepatomegaly, right upper quadrant pain or tenderness
- Any treatment with coticosteroids or immunomodulating drugs
- Known hypersensitivity to any component of the vaccine
- Simultaneous participation in any other clinical trial
Key Trial Info
Start Date :
February 1 1992
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 1992
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00699231
Start Date
February 1 1992
End Date
December 1 1992
Last Update
June 17 2008
Active Locations (1)
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1
GSK Clinical Trials Call Center
Brussels, Belgium