Status:
COMPLETED
Immunogenicity and Reactogenicity of MPL Adjuvanted Recombinant Hepatitis B- Vaccine and Engerix™-B in Adult Non-Responders
Lead Sponsor:
GlaxoSmithKline
Conditions:
Hepatitis B
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the immunogenicity and reactogenicity of the adjuvanted recombinant hepatitis B vaccine with that of Engerix™-B when both are injected according to a three dose...
Detailed Description
At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham
Eligibility Criteria
Inclusion
- Age: older than 18 years of age.
- Documented non-responders 2 to 5 months after having received 4 doses of a hepatitis B vaccine
- Good physical condition as established by clinical examination and history taking at the time of entry.
- Female participants who are at risk to become pregnant will be on a contraceptive programme if necessary during the study period.
- Written informed consent obtained from the subjects
Exclusion
- Positive at screening for anti-HBV antibodies
- Elevated serum liver enzymes.
- History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
- Any acute disease at the moment of entry.
- Chronic alcohol consumption.
- Hepatomegaly, right upper quadrant abdominal pain or tenderness.
- 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.
- Simultaneous participation in any other clinical trial.
- Previous vaccination with an MPL containing vaccine.
- Administration of immunoglobulins 6 months before and during the whole study period
- Vaccination one month before and one month after each dose of the study vaccine
Key Trial Info
Start Date :
May 1 1997
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 1998
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT00697931
Start Date
May 1 1997
End Date
June 1 1998
Last Update
June 16 2008
Active Locations (1)
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1
GSK Clinical Trials Call Center
Leuven, Belgium