drugset / Trial / NCT00664417
Study of Different Formulations of an Intramuscular A/H5N1 Inactivated, Split Virion Influenza Adjuvanted Vaccine
RandomizedParallel-groupSingle-blindPrevention
Summary
Following the licensure of sanofi pasteur's 90 µg rgA/Vietnam/1203/2004 pandemic influenza vaccine, efforts to develop a lower antigen dose formulation with improved immunogenicity using adjuvants were initiated. The present study is part of this endeavor. It is primarily a formulation/dose-finding study with a secondary aim at generating safety and immunogenicity data for the final formulation for the development of a pre-pandemic vaccine.
Timeline
- Start
- 2008-04
- Primary completion
- 2009-09
- Completion
- 2010-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Monovalent subvirion H5N1 influenza vaccine | Vaccine | 0.5 ml | Intramuscular |