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news.Medicago has received approval from the US Food and Drug Administration (FDA) for its Phase I H1N1 influenza VLP vaccine candidate (H1N1 vaccine) clinical trial in the US.
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The Phase I trial will be followed by a Phase IIa trial for the seasonal trivalent vaccine with the recommended H1N1, H3N2 and B influenza strains, which the company plans to initiate later in 2011.
The Phase 1, randomized, double-blind, multicenter, active- and placebo-controlled dose-ranging study will assess the safety, tolerability and immunogenicity of a single non-adjuvanted dose of the H1N1 vaccine in 100 healthy adults 18 to 49 years of age.
The subjects will be randomised to receive one of the following: an injection of the placebo, Medicago’s H1N1 vaccine or an H1N1 vaccine from a licensed trivalent vaccine.
The primary safety and immunogenicity results are expected within 3 months of the initiation of this study.
These data will facilitate the development of the Company’s seasonal influenza VLP vaccine in the United States.