Immunogenicity and Safety of GSK Biologicals' HBV-MPL Vaccine and Engerix™-B in Healthy Adults (15-40 Yrs).
Immunogenicity and Safety of GSK Biologicals' HBV-MPL Vaccine and Engerix™-B in Healthy Adults (15-40 Yrs).
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.
At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former
 name SmithKline Beecham
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