A Study to Compare the Immune Response and Safety Elicited by Henogen's Adjuvanted Hepatitis B Vaccine Compared to GSK Biologicals Adjuvanted Hepatitis B Vaccine in Pre-Dialysis and Dialysis Patients Who Have Not Been Exposed to Hepatitis B.

A Multicentric, Randomised Study Comparing the Immunogenicity and Safety of Henogen's Adjuvanted Hepatitis B Vaccine Given at 0, 1, 6 Months to That of GSK Biologicals' Adjuvanted Hepatitis B Vaccine Given at 0, 1, 2, 6 Moths in Pre-Dialysis, and Dialysis Patients Who Are Hepatitis B Naive.

The pre-dialysis, peritoneal dialysis and haemodialysis patients would benefit from an improved hepatitis B vaccine, which will elicit stronger and faster cellular and humoral immune responses after the primary vaccination course.

Study participants will receive either Henogen's adjuvanted hepatitis B vaccine or GSK Biologicals' adjuvanted hepatitis B vaccine. The study involves a total of 7 visits and blood samples will taken at each of these visits.

Inclusion Criteria:

• A male or female subject 15 years of age or older at the time of the study entry.
• Written informed consent obtained from the subject/ from the parent or guardian of the subject.
• Seronegative for anti-HBs antibodies, anti-HBc antibodies and for HBsAg at screening.
• Pre-dialysis patients, peritoneal dialysis patients or haemodialysis patients.
• Non-childbearing potential female

Exclusion Criteria:

• Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Use of any registered vaccine within 7 days before the first dose of study vaccine.
• Previous vaccination against hepatitis B (whether or not the subject responded to the vaccine).
• History of hepatitis B infection.
• Known exposure to hepatitis B virus within 6 months.
• Use of immunoglobulins within six months preceding the first study vaccination.
• Immunosuppression caused by the administration of parenteral steroids or chemotherapy (oral steroids are allowed).
• Any confirmed or suspected 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 vaccines.
• Acute disease at the time of enrolment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. oral/ axillary temperature < 37.5°C (or 37 °C in Czech Republic).
• Oral/axillary temperature superior or equal to 37.5°C (or 37 °C in Czech Republic).
• Pregnant or lactating female