Status:
COMPLETED
Study Comparing Immunogenicity, Reactogenicity and Safety of GSK Bios' HBV-MPL Vaccine With That of Engerix™-B in Adults
Lead Sponsor:
GlaxoSmithKline
Conditions:
Hepatitis B
Eligibility:
All Genders
50-70 years
Phase:
PHASE3
Brief Summary
This study is conducted to compare the immunogenicity, reactogenicity and safety of Engerix™-B and HBV-MPL vaccine against hepatitis B infection in an elderly population
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: 50 to 70 years old.
- 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 a recombinant hepatitis B vaccine.
- Previous vaccination with an MPL containing vaccine.
- Administration of immunoglobulins in the past 6 months and during the whole study period
- Vaccination one week before and one week after each dose of the study vaccine
Key Trial Info
Start Date :
June 1 1997
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
380 Patients enrolled
Trial Details
Trial ID
NCT00696891
Start Date
June 1 1997
Last Update
June 13 2008
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
GSK Clinical Trials Call Center
Wilrijk, Belgium
2
GSK Clinical Trials Call Center
Toronto, Canada
3
GSK Clinical Trials Call Center
Gothenburg, Sweden