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Novavax Completes Enrollment of Its Second Phase II Seasonal Influenza VLP Vaccine Clinical Trial
Date:5/15/2009

Completion of enrollment keeps Company on track to report primary study results in third quarter of this year

ROCKVILLE, Md., May 15 /PRNewswire-FirstCall/ -- Novavax, Inc. (Nasdaq: NVAX) announced today that enrollment has been completed in the second Phase II clinical trial of its trivalent virus-like particle (VLP) seasonal influenza vaccine. This Phase IIa randomized, placebo-controlled study is evaluating a VLP vaccine against the H3N2, H1N1, and B influenza strains that circulated in the 2008-2009 influenza season. This clinical trial represents another step in the development of Novavax's VLP seasonal influenza vaccine, allowing further evaluation of safety and immunogenicity of a broad range of vaccine doses against a new set of influenza strains. As announced in December of 2008, the first Phase II study evaluated a trivalent VLP vaccine against the seasonal influenza strains that circulated in the 2005-2006 influenza season.

Specifically, this new study is evaluating the safety and immunogenicity of the 2008-2009 influenza vaccine in approximately 220 healthy adults between the ages of 18 and 49 years. Subjects have received a single injection of either a placebo or the VLP vaccine at doses of 15 mcg or 60 mcg per strain. The results of this study will be used to help select a dose for further evaluation in a clinical trial involving adults 65 years of age and older later this year and in a subsequent Phase III efficacy study.

"Enrollment of this second Phase II clinical trial represents another important developmental milestone for our VLP seasonal influenza vaccine program," said Dr. Rahul Singhvi, President and CEO of Novavax. "This study provides the opportunity to evaluate the safety and immunogenicity of our VLP vaccine against a new set of influenza strains, further strengthening our growing
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SOURCE Novavax, Inc.
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