Study to Evaluate the Immunogenicity and Safety of GSK Biologicals' Novel Adjuvanted Hepatitis B Vaccine Administered According to a 0, 6 Month Schedule and of Engerix™-B Administered According to a 0, 1, 6 Month Schedule in Healthy Adults

GlaxoSmithKline1 site in 1 country200 target enrollmentNovember 1998

ConditionsHepatitis B

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Hepatitis B
Sponsor: GlaxoSmithKline
Enrollment: 200
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

This study is undertaken to assess the immune response and safety profile of 4 lots of the novel adjuvanted hepatitis B vaccine that were formulated following different processes, with Engerix™-B as the control vaccine

Detailed Description

This is an open, randomized study with five groups, but the four groups receiving HBV-MPL candidate vaccine are double-blinded. At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham

Registry

clinicaltrials.gov

Start Date

November 1998

End Date

July 1999

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Eligibility Criteria

Inclusion Criteria

•A male or female between 15 and 50 years of age at the time of the first vaccination.
•Free of obvious health problems as established by medical history and clinical examination before entering into the study.
•Written informed consent obtained from the subject and/or from the parents or guardians of the subject.
•If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or use adequate contraceptive precautions for one month prior to vaccination and up to two months after the last vaccination

Exclusion Criteria

•Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine.
•Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of vaccination.
•Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine and ending 30 days after.
•Previous vaccination against hepatitis B.
•History of significant and persisting hematological, hepatic, renal, cardiac or respiratory disease.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
•A family history of congenital or hereditary immunodeficiency.
•History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
•Acute disease at the time of enrollment.
•Hepatomegaly, right upper quadrant abdominal pain or tenderness.

Outcomes

Primary Outcomes

Anti-HBs antibody concentrations

Time Frame: At month 7

Secondary Outcomes

Occurrence and intensity of solicited local and general symptoms(4-day follow-up period after each vaccination)
Occurrence, intensity and relationship to vaccination of unsolicited symptoms(30-day follow-up period after each vaccination)
Anti-HBs antibody concentrations(At months 1, 2 and 6)
Occurrence, intensity and relationship to vaccination of SAEs(Throughout the entire study)