Long-term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,1,6 Mth Schedule in Healthy Adults
Long-term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,1,6 Mth Schedule 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.
Inclusion Criteria:

 -  Subjects who had consented to participate in the long-term follow-up studies at the
 previous long-term blood sampling time points

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