Trials / Completed
CompletedNCT00984945
Safety Study of a Plant-based H5 Virus-Like Particles (VLP) Vaccine in Healthy Adults
Phase 1 Single Centre, Double-blind, Randomized, Placebo-controlled, Dose-escalation Study of Plant-based H5 VLP (Virus-like Particles), (H5N1) Pandemic Influenza Vaccine Adjuvanted With Aluminium Hydroxide and Administered to Healthy Adults 18-60 Years of Age
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- Sponsor
- Medicago · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
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®.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | H5 VLP pandemic influenza vaccine 5 µg | 0.5 mL, IM, 2 injections 21 days apart |
| BIOLOGICAL | H5 VLP pandemic influenza vaccine 10 µg | 0.5 mL, IM, 2 injections 21 days apart |
| BIOLOGICAL | H5 VLP pandemic influenza vaccine 20 µg | 0.5 mL, IM, two injections 21 days apart |
| BIOLOGICAL | Placebo | 0.5 mL, IM, two injections 21 days apart |
Timeline
- Start date
- 2009-09-01
- Primary completion
- 2009-12-01
- Completion
- 2010-07-01
- First posted
- 2009-09-25
- Last updated
- 2010-11-04
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT00984945. Inclusion in this directory is not an endorsement.