Safety and Immunogenicity of 3 Lots of GSK Biologicals' HBV-MPL Vaccine and Engerix™-B in Healthy Volunteers ≥ 15y

Launched by GLAXOSMITHKLINE · Jun 11, 2008

Keywords

ClinConnect Summary

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

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • A male or female aged ≥ 15 years at the time of the first vaccination. In Centre 103 (Germany) and Centre 1 (Netherlands), only subjects ≥ 18 years will be enrolled.
• • Free of obvious health problems as established by medical history and clinical examination before entering into the study.
• • Written informed consent obtained from the subject and/or from the parent or guardian of the subject.
• • If the subject was a female, she was of non-childbearing potential, if of childbearing potential, she was abstinent or used adequate contraceptive precautions for one month prior to enrollment and up to two months after the last vaccination
• 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.
• • Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine and ending 30 days after.
• • Previous vaccination against hepatitis B.
• • History of non-response to previous hepatitis B vaccination.
• • Known exposure to hepatitis B within the past 6 weeks.
• • History of hepatitis B infection.
• • Confirmed 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 vaccine.
• • Acute disease at the time of enrollment.
• • 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/ administration during the study period.
• • Pregnant or lactating female