drugset / Trial / NCT01302990
Safety, Tolerability and Immunogenicity of a Plant-Made H1 VLP Influenza Vaccine in Adults
RandomizedParallel-groupQuadruple-blindPrevention
Summary
This is a Phase 1, randomized, double-blind, active- and placebo-controlled, multicenter, dose-ranging study to evaluate the safety, tolerability and Immunogenicity of a single non-adjuvanted dose of the H1 VLP Influenza vaccine in healthy adults 18-49 years of age.
Timeline
- Start
- 2011-02
- Primary completion
- 2011-07
- Completion
- 2011-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | H1 VLP | Vaccine | 5 ug | Intramuscular |
| Subject | H1 VLP | Vaccine | 13 ug | Intramuscular |
| Subject | H1 VLP | Vaccine | 28 ug | Intramuscular |
| Subject | Influenza Virus Vaccine | Vaccine | 45 ug | Intramuscular |