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NOVAVAX Announces Positive Results for the Second Phase II Clinical Trial of its Trivalent Seasonal Influenza Virus-like Particle (VLP) Vaccine Candidate
Date:9/1/2009

ROCKVILLE, Md., Sept. 1 /PRNewswire-FirstCall/ -- Novavax, Inc. (Nasdaq: NVAX) announced today favorable results from a Phase II human clinical trial of its trivalent seasonal influenza virus-like particle (VLP) vaccine candidate. The vaccine was well tolerated and induced robust immune responses against all three influenza strains in the vaccine. These results continue to support the planned study in elderly adults scheduled for the fourth quarter this year and pave the way for Novavax to advance its seasonal influenza VLP vaccine into Phase III studies next year.

This Phase IIa study, which began in May of this year, was a randomized, blinded, placebo-controlled study to examine the safety and immunogenicity of different doses of Novavax's seasonal influenza VLP vaccine candidate. The vaccine contained three VLPs (H3N2, H1N1, and B) that were matched to the strains recommended for influenza vaccines for the past flu season (2008-2009). The study enrolled 221 human subjects 18 to 49 years of age who received either placebo or VLP vaccine at doses of 15 mcg and 60 mcg per strain. Twenty additional subjects received a licensed, egg-based influenza vaccine (Fluzone(R), sanofi pasteur, USA).

Novavax's influenza VLP vaccine candidate was well tolerated. No vaccine-related serious adverse events were reported in the study and the rate of non-serious adverse events was comparable in the vaccine and placebo groups.

The VLP vaccine also induced strong hemagglutination inhibition (HAI) antibody responses against the influenza H1N1, H3N2, and B strains. The HAI responses met the seroconversion criteria for licensure as outlined in the FDA guidance document for influenza vaccine development. Seroconversion rates (i.e., percentage of subjects with a
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SOURCE Novavax, Inc.
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