Hepatitis B Clinical Trial
Official title:
Long-Term F-U Study at Yrs 16-20, to Evaluate the Persistence of Immune Response of GSK Biologicals' Hepatitis B Vaccine in Newborns of HBeAg+ and HBsAg+ Mothers
The purpose of this study is to evaluate the persistence of anti-hepatitis B surface antigen (anti-HBs) antibodies 16, 17, 18, 19 and 20 years after administration of the first dose of the study vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
The primary study was designed to evaluate the immunogenicity and protective efficacy of
hepatitis B vaccine in newborns of HBeAg+ and HBsAg+ mothers in comparison with a historical
control group.
The present study is carried out to evaluate the anti-HBs persistence 16-20 years after the
first vaccine dose and to further investigate the prevalence and incidence of other
hepatitis B markers and the clinical significance of these at all time points from Year
16-20.
No additional subjects will be recruited during this long-term follow-up study and no
vaccine will be administered.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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