drugset / Trial / NCT00240526

LT F-up Study 16-20 Yrs After Vaccine Dose of Hepatitis B With/Without HBIg in Newborns to HBeAg+ Mothers

NCT00240526

Phase 4 Completed 79 enrolled GlaxoSmithKline
Non-randomizedParallel-groupOpen-labelPrevention

Summary

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.

Timeline

Start
2003-10
Primary completion
2010-03
Completion
2010-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Engerix Vaccine Intramuscular
Subject Hepatitis B Immunoglobulin Protein / enzyme biologic Intramuscular