drugset / Trial / NCT00240526
LT F-up Study 16-20 Yrs After Vaccine Dose of Hepatitis B With/Without HBIg in Newborns to HBeAg+ Mothers
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Engerix | Vaccine | — | Intramuscular |
| Subject | Hepatitis B Immunoglobulin | Protein / enzyme biologic | — | Intramuscular |