Novavax Announces Enrollment in the Second Phase II Study of its Seasonal Influenza VLP Vaccine...( Development of the seasonal influenza...)

Development of the seasonal influenza virus-like particle (VLP) vaccine progresses with study designed to select dose for Phase III efficacy trial

ROCKVILLE, Md., May 5 /PRNewswire-FirstCall/ -- Novavax, Inc. (Nasdaq: NVAX) announced today vaccination of healthy volunteers in the second clinical trial of its virus-like particle (VLP) seasonal influenza vaccine. Building on data from the first study, this Phase II randomized, placebo controlled clinical trial has been designed to evaluate the safety and immunogenicity of a broader range of vaccine doses. The purpose of this study is to provide data to help with selecting doses for future studies in older adults and a Phase III efficacy study. Specifically, the trivalent seasonal vaccine containing VLPs against the 2008-2009 H3N2, H1N1, and B influenza strains will be studied in approximately 220 healthy adults between the ages of 18 to 49 years, who will receive a single injection of either a placebo or influenza vaccine at doses of 15 mcg or 60 mcg. As announced in December, 2008, a Phase II dose ranging clinical trial conducted by Novavax in ~300 healthy volunteers with VLPs against the 2005-2006 H3N2, H1N1, and B influenza strains showed that the trivalent VLP vaccine candidate induced robust immune responses as measured by hemagglutinin inhibition titers against both vaccine and drifted strains.

According to the Centers for Disease Control and Prevention (CDC), seasonal influenza affects 15 to 60 million people in the United States each year and is responsible for an estimated 200,000 hospitalizations and approximately 36,000 deaths. The VLP-based seasonal influenza vaccine may be another important public health weapon to fight this disease. VLPs contain 3 proteins that are important for inducing a broad immune response against influenza -- the hemagglutinin or "HA" and th
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