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

NCT00984945 Phase 1 COMPLETED

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®.

Details

Lead sponsor	Medicago
Phase	Phase 1
Status	COMPLETED
Enrolment	48
Start date	2009-09
Completion	2010-07

Conditions

• Virus Diseases
• RNA Virus Infections
• Respiratory Tract Diseases
• Respiratory Tract Infections

Interventions

• H5 VLP pandemic influenza vaccine 5 µg
• H5 VLP pandemic influenza vaccine 10 µg
• H5 VLP pandemic influenza vaccine 20 µg
• Placebo

Primary outcomes

• Safety will be evaluated through reported adverse events, physical examination findings; clinical laboratory results and vital signs. — 21 days

Countries

Canada