Study to compare the immunogenicity of GlaxoSmithKline Biologicals' thiomersal-free 2-dose Engerix™-B and 3-dose preservative-free Engerix™-B vaccines administered according to a 0, 6 month and 0, 1, 6 month schedule, respectively, and to evaluate safety and reactogenicity of each vaccine in healthy adolescent volunteers (11 to 15 years).

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 384

Inclusion Criteria

A male or female between and including, 11 and 15 years of age at the time of the first vaccination.
Written informed consent obtained from the subject and subject’s parent/guardian.
Free of obvious health problems as established by medical history and clinical examination before entering the study.
If the subject is female and 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.
Subjects should be seronegative for HBs antigen, anti-HBc antibodies and anti-HBs antibodies.

Are the trial subjects under 18? yes
Number of subjects for this age range: 384
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Use of any investigational or non-registered drug or vac-cine other than the study vaccines within 30 days preced-ing the first dose of study vaccine, or planned to use during the study period.
Administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine.
Previous vaccination against hepatitis B.
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 infection.
A family history of congenital or hereditary immunodeficiency.
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 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.
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
Any chronic drug therapy to be continued during the study period.
Acute or chronic, clinically significant pulmonary, cardio-vascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
Major congenital defects or serious chronic illness.
History of chronic alcohol consumption and/or intravenous drug abuse.
Female planning to become pregnant.