Safety and Immunogenicity of GSK Bio's Candidate HBV-MPL Vaccines Compared to Engerix™-B, in Healthy Adolescents
Safety and Immunogenicity of GSK Bio's Candidate HBV-MPL Vaccines Compared to Engerix™-B, in Healthy Adolescents
In this study the safety and immunogenicity of 2 different formulations of the candidate
 HBV-MPL vaccine administered according to a 0, 6-month schedule were explored and compared to
 that of Engerix™-B in healthy adolescents aged 11 to 15
At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former
 name SmithKline Beecham
Inclusion Criteria:

 -  Age: between 11 and 15 years at the time of the first vaccination.

 -  Free of obvious health problems as established by medical history and clinical
 examination before entering into the study.

 -  Written informed consent obtained from the parents or guardians of the subject and
 from the subject himself/herself in all subjects 15 years of age.

 -  If the subject is female, she must be of non-childbearing potential, if of
 childbearing potential, she must be abstinent or have used an adequate contraceptive
 for one month 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) during the study period or within 30 days preceding the first dose of study
 vaccine.

 -  Administration of chronic (defined as more than 14 days) immunosuppressants or other
 immune-modifying drugs within six months of vaccination.

 -  Planned administration of a vaccine not foreseen by the study protocol during the
 period starting from one week before each dose of vaccine and ending 30 days after.

 -  Previous vaccination against hepatitis B virus.

 -  Previous vaccination with vaccine containing MPL.

 -  Any confirmed or suspected immunosuppressive or immunodeficient condition, including
 human immunodeficiency virus (HIV) infection.

 -  History of allergic disease or reactions likely to be exacerbated by any component of
 the vaccine.

 -  Acute disease at the time of enrollment.

 -  Hepatomegaly, right upper quadrant abdominal pain or tenderness.

 -  Axillary temperature of ≥ 37.5° C.

 -  Administration of immunoglobulin and / or any blood product within the six months
 preceding the first dose of study vaccine or planned administration during the study
 period.

 -  Pregnant or lactating female.

 -  History of chronic disease deemed by the investigator to be relevant.

 -  Positive for anti-HBV antibodies at screening