Medicago Inc MDCGF

human trials - patience

[Indicator]

Further study details as provided by Medicago:

Primary Outcome Measures:

• Safety will be evaluated through reported adverse events, physical examination findings; clinical laboratory results and vital signs. [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

• The secondary objective is to evaluate the immunogenicity of two consecutive doses of plant-based H5 VLP vaccine combined with Alhydrogel®, at three dose levels: 5µg, 10µg and 20µg, compared to the placebo, combined with Alhydrogel®. [ Time Frame: 21days after each vaccination and 6-month after boost injection ] [ Designated as safety issue: No ]

Estimated Enrollment:	48
Study Start Date:	September 2009
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)