Immunogenicity and Safety of GSK Biologicals' HBV-MPL Vaccine and Engerix™-B in Healthy Adults (15-40 Yrs).

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Hepatitis B

Treatments

Biological: HBV-MPL vaccine 208129

Biological: Engerix™-B

Study type

Interventional

Funder types

Industry

Identifiers

NCT00697216

208129/027

Details and patient eligibility

About

This study evaluates the safety and immunogenicity of the candidate HBV-MPL vaccine administered to healthy adults aged from 15 to 40 years, according to a 0, 6- month vaccination schedule, with Engerix™-B as control administered at 0, 1, 6 months.

Full description

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

Enrollment

340 patients

Sex

All

Ages

15 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Age: between 15 and 40 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 aged between 18 and 40 and from the parents/tutor when the subjects are aged between 15 and 17 years.

Exclusion criteria

Positive titres at screening for anti-HBs 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 hepatitis B vaccine.
Previous vaccination with an MPL containing vaccine.
Administration of immunoglobulins in the past 6 months and during the whole study period
Simultaneous vaccination one week before and one week after each dose of the study vaccine