Evaluation of Immunogenicity, Reactogenicity and Safety of HBV-MPL Vaccine vs Engerix™-B, in Haemodialysis Patients

Study to Evaluate the Immunogenicity, Reactogenicity and Safety of GSK Biologicals' (Previously SmithKline Beecham Biologicals') MPL-Adjuvanted Recombinant Hepatitis B Vaccine Versus Engerix™-B, in Haemodialysis Patients

This trial is designed to evaluate the immunogenicity, reactogenicity and safety of an MPL-adjuvanted recombinant hepatitis B vaccine in comparison with those of Engerix™-B in haemodialysis patients with or without previous vaccination against hepatitis B

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

Inclusion Criteria:

• Dialysis patients
• A medical examination including physical examination and medical history as well as serological screening established acceptability for enrollment into the study.
• Age: from 18 years onwards
• Seronegative for anti- hepatitis antibodies

Exclusion Criteria:

• History of persistent hepatic, cardiac or respiratory disease
• Any acute disease at the moment of entry into the study
• Chronic alcohol consumption
• Hepatomegaly, right upper quadrant pain or tenderness
• Any treatment with coticosteroids or immunomodulating drugs
• Known hypersensitivity to any component of the vaccine
• Simultaneous participation in any other clinical trial