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Long-term efficacy of Engerix-B in newborns of HBeAg+ mothers
NCT00240526Phase 4Completed
- Sponsor
- GSK
- Start
- Oct 2003
- Primary completion
- Mar 2010
- Modality
- Split/Subunit Vaccines, Recombinant Protein Vaccines
- Countries
- 1
01
Overview
Phase 4, randomised, open-label trial of hepatitis b vaccine recombinant in hepatitis B (HBV) (4 arms), sponsored by GSK. Primary endpoints: Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) at Year 20, Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by ChemiLuminescence ImmunoAssay (CLIA) at Year 20 and 4 more. Started Oct 2003; status: completed.
02
Drugs
hepatitis b vaccine recombinant
03
Conditions
hepatitis B (HBV)
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