drugset / Trial / NCT01072799
Safety and Immunogenicity of an A (H1N1) 2009 Influenza Virus-like Particle (VLP) Vaccine
RandomizedParallel-groupQuadruple-blindPrevention
Summary
This is a Phase 2 randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and immunogenicity of three dose levels (5µg, 15µg and 45µg HA) of the novel A (H1N1) influenza VLP vaccine as compared with a placebo in healthy adults (18 to 64 years of age).
Timeline
- Start
- 2009-10
- Primary completion
- 2012-03
- Completion
- 2012-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | A/H1N1 2009 Influenza VLP Vaccine | Vaccine | 5 ug | Intramuscular |
| Subject | A/H1N1 2009 Influenza VLP Vaccine | Vaccine | 15 ug | Intramuscular |
| Subject | A/H1N1 2009 Influenza VLP Vaccine | Vaccine | 45 ug | Intramuscular |