Hepatitis B Clinical Trial
Official title:
Long-term Persistence of Hepatitis B Antibodies and Immune Response to a Challenge Dose of GSK Biologicals' Hepatitis B Virus Vaccine, Engerix™-B Kinder (SKF103860), in 15-16 Years Old Adolescents, Vaccinated in Infancy With Engerix™-B Kinder
The purpose of this study is to assess the long-term persistence of immunity to hepatitis B in adolescents aged 15-16 years who were vaccinated with Engerix™-B Kinder in infancy. The study will also assess the immune response to a challenge dose of Engerix™-B Kinder in these subjects.
This MDD has been updated following the Protocol Amendment 1, dated 20 June 2013.
The Protocol was amended because GSK replaced its in-house Enzyme-Linked ImmunoSorbent Assay
(ELISA) that was used to measure anti-HBs (antibodies to Hepatitis B surface antigen)
antibody concentrations with ChemiLuminescence ImmunoAssay (CLIA).
Additionally, the threshold level of prednisone was modified to reflect the dosage normally
prescribed to adolescents.
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