drugset / Trial / NCT00984945
Safety Study of a Plant-based H5 Virus-Like Particles (VLP) Vaccine in Healthy Adults
RandomizedParallel-groupTriple-blindPrevention
Summary
The primary objective is to assess the safety and tolerability of two consecutive doses of plant-based H5 VLP, (H5N1) pandemic influenza vaccine combined with Alhydrogel®, given 21 days apart, at three dose levels: 5µg, 10µg and 20µg., compared to the placebo, and combined with Alhydrogel®.
Timeline
- Start
- 2009-09
- Primary completion
- 2009-12
- Completion
- 2010-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | H5 VLP vaccine | Vaccine | 5 ug | Intramuscular |
| Comparator | H5 VLP vaccine | Vaccine | 10 ug | Intramuscular |
| Comparator | H5 VLP vaccine | Vaccine | 20 ug | Intramuscular |