Hepatitis B Clinical Trial
Official title:
An Open Multicentre, Multicountry Study to Evaluate Long-term Antibody Persistence and Immune Memory Between Years 11 and 15 After the Primary Study HAB-084 in Which Healthy Adolescents Were Vaccinated With Twinrix™ Adult Following a Two-dose Schedule or Twinrix™ Junior Following a Three-dose Schedule.
This study will evaluate the immune response against Hepatitis-A (HAV) and Hepatitis B
surface (HBs) antigen in healthy subjects aged 12 to 15 years (at the time of primary
vaccination), who received vaccination course with GSK Biologicals' Twinrix Adult and Twinrix
Junior vaccine, approximately 10 years ago in the primary study. The subjects will be invited
for blood sampling at 11, 12, 13, 14 and 15 years after primary vaccination to evaluate the
persistence of immune response. For subjects detected with decreased immunity, the presence
of immune memory against hepatitis A & B antigens will be investigated by the administration
of a challenge dose of the appropriate vaccine 6 to 12 months after the Year 15 follow-up
time-point.
No new subjects will be recruited during this booster phase of the study.
n/a
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