At a glance
ClinicalIndex Comparison Record- ✓Prior enrollment in the primary study with at least one dose of Engerix-B vaccine received
- ✓Written informed consent from parent/guardian before each blood sampling visit
None specified.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Comparative Study of the Immunogenicity and Protective Efficacy of GlaxoSmithKline Biologicals' Rec-DNA Hepatitis B Vaccine With or Without Hepatitis B Immunoglobulins (HBIg) in Newborns of HBeAg+ Mothers.
In Brief
A Phase 4 clinical trial evaluating Engerix™ -B and Hepatitis B immunoglobulin (HBIg) for Hepatitis B. Completed, enrolled 79 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
3 (Groups A and C) or 4 (Groups B and D) intramuscular injections during the primary study
1 intramuscular injections at birth (primary study)