Study Comparing Immunogenicity, Reactogenicity and Safety of GSK Bios' HBV-MPL Vaccine With That of Engerix™-B in Adults

Study Comparing Immunogenicity, Reactogenicity and Safety of GSK Biologicals' HBV-MPL Vaccine With That of Engerix™-B When Both Are Injected According to 3 Dose Schedule (0, 1, 6 Months) in an Adult Population Aged Between 50 and 70 Years

This study is conducted to compare the immunogenicity, reactogenicity and safety of Engerix™-B and HBV-MPL vaccine against hepatitis B infection in an elderly population

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

Inclusion Criteria:

• Age: 50 to 70 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

Exclusion Criteria:

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