Hepatitis B Clinical Trial
Official title:
Long-Term Follow-up Study at Years 16, 17, 18, 19 and 20, to Evaluate the Persistence of Immune Response of GlaxoSmithKline Biologicals' Hepatitis B Vaccine Administered With or Without HBIG in Newborns of HBeAg+ Mothers
To evaluate the persistence of anti-HBs antibodies up to 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.
No additional subjects will be recruited during this long-term follow-up study and no
vaccine will be administered.
The primary study was to evaluate the reactogenicity, immunogenicity and protective efficacy of a hepatitis B vaccine in healthy neonates of HBeAg positive mothers if administered with or without a dose of HBIg at birth. The current study describes the long term follow up of these subjects between Y16 and 20 after primary vaccination. ;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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