Trials / Completed
CompletedNCT00519389
Safety, Reactogenicity and Immunogenicity of an H5N1 VLP
A Phase I/IIa Trial to Evaluate the Safety, Reactogenicity, and Immunogenicity of an H5N1 Virus-Like Particle (VLP) Influenza Vaccine (Recombinant)
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 230 (actual)
- Sponsor
- Novavax · Industry
- Sex
- All
- Age
- 18 Years – 40 Years
- Healthy volunteers
- Accepted
Summary
This is a Phase I/IIa randomized, double-blind, placebo-controlled study to evaluate the safety, reactogenicity, and immunogenicity of 3 potencies (dosages) of H5N1 VLP vaccine or placebo in healthy adults 18 to 40 years of age.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | H5N1 VLP Vaccine | Two doses - Day 0 \& Day 28 |
| BIOLOGICAL | Placebo | Two doses - Day 0 \& Day 28 |
Timeline
- Start date
- 2007-07-01
- Primary completion
- 2008-11-01
- Completion
- 2008-11-01
- First posted
- 2007-08-22
- Last updated
- 2013-06-21
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00519389. Inclusion in this directory is not an endorsement.