drugset / Trial / NCT00984945

Safety Study of a Plant-based H5 Virus-Like Particles (VLP) Vaccine in Healthy Adults

NCT00984945

Phase 1 Completed 48 enrolled Medicago
RandomizedParallel-groupTriple-blindPrevention

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®.

Timeline

Start
2009-09
Primary completion
2009-12
Completion
2010-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator H5 VLP vaccine Vaccine 5 ug Intramuscular
Comparator H5 VLP vaccine Vaccine 10 ug Intramuscular
Comparator H5 VLP vaccine Vaccine 20 ug Intramuscular