drugset / Trial / NCT00462215
Phase 3 Immunogenicity and Safety Study of an Inactivated H5N1 Influenza Vaccine (Whole Virion, Vero Cell Derived)
RandomizedParallel-groupOpen-labelPrevention
Summary
The objectives of this study are to assess the immune response as well as the safety and tolerability of an H5N1 influenza vaccine in an adult and elderly population. Further, the study will assess the need for a booster vaccination and whether a 6-month booster or a 12-month booster is more appropriate. An independent data safety monitoring board will review and evaluate the safety data obtained in this study on an ongoing basis.
Timeline
- Start
- 2007-04
- Primary completion
- 2007-06
- Completion
- 2010-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Whole virion, Vero cell-derived influenza vaccine containing H5N1 HA antigen | Vaccine | 3.75 mg | — |
| Subject | Whole virion, Vero cell-derived influenza vaccine containing H5N1 HA antigen | Vaccine | 7.5 mg | — |