Status:
COMPLETED
Evaluation of Immunogenicity and Reactogenicity of Various Formulations of Recombinant Hepatitis B Vaccine
Lead Sponsor:
GlaxoSmithKline
Conditions:
Hepatitis B
Eligibility:
All Genders
18-40 years
Phase:
PHASE3
Brief Summary
The purpose of the present trial is to evaluate 6 vaccine formulations of recombinant hepatitis B vaccine for their reactogenicity and immunogenicity when administered at 0-2 months with a booster 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.
- Positivity for anti hepatitis 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.
- 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 :
November 1 1993
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 1995
Estimated Enrollment :
321 Patients enrolled
Trial Details
Trial ID
NCT00697970
Start Date
November 1 1993
End Date
April 1 1995
Last Update
June 16 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
GSK Clinical Trials Call Center
Vienna, Austria