drugset / Trial / NCT01044095
Study of Seasonal Influenza Vaccine Against H5N1 Avian Influenza Virus
RandomizedParallel-groupOpen-labelBasic science
Summary
This will be a randomized, open-label, pilot feasibility study of four 2-dose vaccine regimens in healthy volunteers using two commercially available seasonal influenza vaccines to compare immune responses and in vitro cross-reactivity against H5N1. Vaccine doses will be spaced by approximately 8 weeks to allow for optimal prime boost conditions. Humoral, cellular and secretory immune responses will be measured 2 and 4 weeks after each vaccine dose and compared with baseline values.
Timeline
- Start
- 2009-11
- Primary completion
- 2010-07
- Completion
- 2012-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | FluMist | Vaccine | 0.2 ml | Intranasal |
| Subject | Influenza Virus Vaccine | Vaccine | 0.5 ml | Intramuscular |