Immunogenicity, Safety, Tolerability of a Plant-Made H5 VLP Influenza Vaccine

Summary

The primary objective is to assess the immunogenicity and safety and tolerability of two consecutive doses of H5 VLP Influenza vaccine given 21 days apart, at three dose levels: in part A: 20 µg, 30 µg and 45 µg combined with Alhydrogel® 1%, or 45 µg without Alhydrogel®, compared to the placebo, (100mM phosphate buffer + 150mM NaCl + 0.01% Tween 80).

Timeline

Start

2010-11

Primary completion

2011-07

Completion

2011-09

Drugs

Indications