Study to Compare the Safety, Immunogenicity and Reactogenicity of Different Formulations of GSK Biologicals' (Previously SmithKline Beecham Biologicals') MPL-Adjuvanted Recombinant Hepatitis B Vaccine to That of Engerix™-B

GlaxoSmithKline1 site in 1 country60 target enrollmentJanuary 1995

ConditionsHepatitis B

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Hepatitis B
Sponsor: GlaxoSmithKline
Enrollment: 60
Locations: 1
Primary Endpoint: Anti-HBs antibody concentrations
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to compare the safety, reactogenicity and immunogenicity of different formulations of adjuvanted recombinant hepatitis B vaccine to that of Engerix™-B when administered at 0, 2 months with a booster at month 12 if necessary

Detailed Description

At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham

Registry

clinicaltrials.gov

Start Date

January 1995

End Date

February 1996

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•Pregnancy or lactation.
•Positive titres for anti hepatitis B 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.