At a glance
ClinicalIndex Comparison Record- ✓Subjects who had participated in the primary study
- ✓Written informed consent obtained from the subject
None specified.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Long-term Follow-Up Studies at Years 16-20, to Evaluate the Persistence of Immune Response of GSK Biologicals' Hepatitis B Vaccine in Newborns of HBeAg+ and HBsAg+ Mothers in Comparison With a Historical Control Group
In Brief
A Phase 4 clinical trial evaluating Blood sampling for Hepatitis B. Completed, enrolled 36 participants across 1 site.
Detailed Summary
This study is performed to evaluate the persistence of anti-hepatitis B surface antigen (HBs) antibodies up to 16, 17, 18, 19 and 20 years after administration of the first dose of the study vaccine, Engerix-B™. No new subjects will be recruited in this long-term follow-up study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Study Details
Timeline
Interventions
A blood sample will be taken yearly at each long-term follow-up time point (i.e. Year 16 through Year 20) after the first dose of Engerix-B™ vaccine.