Long-Term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,6 Month Schedule
Long-Term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,6 Month Schedule
The aim of this study is to evaluate the long-term persistence of hepatitis A and B
 antibodies at Years 6, 7, 8, 9 and 10 after subjects received their first two doses primary
 vaccination schedule of combined hepatitis A/hepatitis B vaccine.

 This protocol posting deals with objectives & outcome measures of the extension phase at year
 6 through to 10.

 The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
 2007.
To evaluate the long-term antibody persistence, volunteers will be bled at Years 6, 7, 8, 9
 and 10 after the first vaccine dose of the primary vaccination course to determine their
 anti-HAV and anti-HBs antibody concentrations.

 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 6, 7, 8, 9 or 10), he/
 she will be offered an additional vaccine dose.
Inclusion Criteria:

 -  Subjects participating in this study should have participated in the primary study
 with combined hepatitis A/ hepatitis B vaccine.

 -  Written informed consent will be obtained from each subject and/ or parent or guardian
 of the subject before the blood sampling visit of each year.