Hepatitis B Clinical Trial
Official title:
A Double Blind Randomised, Comparative Study of the Immunogenicity and Reactogenicity of Three Different Lots of GlaxoSmithKline Biologicals' Combined Hepatitis A - Hepatitis B Vaccine When Administered in Healthy Adults
The aim of this study is to evaluate the long-term persistence of hepatitis A and B
antibodies at Years 11, 12, 13, 14 and 15 after subjects received their first dose of a 3
dose primary vaccination schedule of combined hepatitis A/hepatitis B vaccine. The Protocol
Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
This protocol posting deals with objectives & outcome measures of the extension phase at Year
11-15.
This is a long-term follow-up study at Years 11, 12, 13, 14 and 15 after primary vaccination
with GSK Biologicals' hepatitis A/hepatitis B vaccine (three-dose schedule with 3 different
lots). To evaluate the long-term antibody persistence, volunteers will be bled at Years 11,
12, 13, 14 and 15 after the first vaccine dose of the primary vaccination course to determine
their anti-HAV and anti-HBs antibody concentrations.
No additional subjects will be recruited in the course of this extension study. If a subject
has become seronegative for anti-HAV antibodies or lost anti-HBs seroprotection
concentrations at the long-term blood sampling time point (i.e. Years 11, 12, 13, 14 or 15),
he/ she will be offered an additional vaccine dose.
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