Long-Term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,1,6 Month Schedule
Long-Term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,1,6 Month Schedule
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 years after subjects received their first dose of a
 3 dose 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 to 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, 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 during the course of this long-term 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.
Inclusion Criteria:

 -  Subjects participating in this study should have received three-dose primary
 vaccination with combined hepatitis A/hepatitis B vaccine in the primary study.

 -  Written informed consent will be obtained from each subject before the blood sampling
 visit of each year