Study to Evaluate the Immunogenicity and Reactogenicity of Various Formulations of GSK Biologicals' (Previously SmithKline Beecham Biologicals') Recombinant Hepatitis B Vaccine With Different Adjuvants in Healthy Adult Volunteers

GlaxoSmithKline1 site in 1 country60 target enrollmentJune 1993

ConditionsHepatitis B

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Hepatitis B
Sponsor: GlaxoSmithKline
Enrollment: 60
Locations: 1
Primary Endpoint: Occurrence and intensity of solicited local and general symptoms
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the immunogenicity and reactogenicity of various formulations of recombinant hepatitis B vaccine with different adjuvants in healthy adult volunteers following the 0, 1, 6 months schedule

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

June 1993

End Date

July 1994

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.
•Serological signs of HBV infection
•Elevated serum liver enzymes
•Any vaccination against hepatitis B in the past.
•Any previous administration of MPL.
•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.

Outcomes

Primary Outcomes

Occurrence and intensity of solicited local and general symptoms

Time Frame: 8 days follow-up after vaccination

Secondary Outcomes

Anti-HBs antibody concentrations(Months 0, 1, 3, 6, 7, 8 and 12)
Occurrence, intensity of unsolicited adverse events(30-day follow-up after vaccination)
Occurrence of serious adverse events(During the study period up to 30 days after last vaccination)