Consistency of 3 Consecutive Lots of a Novel HBV Vaccine With Single-blind Safety Evaluation Using Engerix™-B as Control

Double-blind for the identity of the consistency lots, single-blind for the control group/study vaccine identity.

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

Inclusion criteria

• A male or female between, and including, 15 and 50 years of age at the time of the first vaccination.
• Written informed consent obtained from the subject/ from the parents or guardians of the subject where applicable
• Free of obvious health problems as established by medical history and clinical examination before entering into the study.
• If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.

Exclusion criteria

• Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Planned administration/Administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s).
• Previous vaccination against hepatitis B
• History of non-response to previous hepatitis B vaccination
• Known exposure to hepatitis B within the previous 6 weeks
• History of hepatitis B infection
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
• A family history of congenital or hereditary immunodeficiency.
• Suspected or confirmed multiple sclerosis in the subject (applicable to Centre 5/France only)
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• Acute disease at the time of enrolment.
• Hepatomegaly, right upper quadrant abdominal pain or tenderness.
• Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
• Pregnant or lactating female