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Novavax Announces Top Line Results of Phase IIa Clinical Trial for Its Seasonal Influenza VLP (Trivalent) Vaccine Candidate
Date:12/11/2008

Favorable immunogenicity results for seasonal vaccine program follows positive results from its pandemic influenza vaccine Phase IIa trial in July 2008; plans to initiate a study of the seasonal vaccine in the elderly in 2009

ROCKVILLE, Md., Dec. 11 /PRNewswire-FirstCall/ -- Novavax, Inc. (Nasdaq: NVAX) announced today favorable results from a Phase IIa human clinical trial of its seasonal influenza VLP (trivalent) vaccine candidate. The vaccine, which does not include an adjuvant, induced robust hemagglutination inhibition (HAI) responses, which have been shown to correlate with protection against seasonal influenza disease.

The Phase IIa randomized, placebo-controlled clinical trial evaluated the safety and immunogenicity of different doses of Novavax's seasonal influenza VLP vaccine. Specifically, the vaccine was studied in approximately 300 healthy adults between the ages of 18 to 49 years, who received a single injection of either a placebo or an influenza vaccine at doses of 5 mcg, 15 mcg or 30 mcg per strain.

The adverse events that were reported from the trial are similar in type to those reported for other approved influenza vaccines. Adverse events such as fever, chills, joint pain, muscle aches, headaches, and fatigue were reported at a higher frequency among vaccine as compared with placebo recipients. No serious adverse events have been reported to date. Subjects in the study continue to be monitored for safety through 6 months after vaccination.

The vaccine was immunogenic, inducing HAI responses against the vaccine strains and drifted strains. For subjects in the 15 mcg or 30 mcg vaccination groups, seroprotection rates (i.e., percentage of subjects with HAI titers greater than or equal to 40) for the vaccine strains ranged from 95 to 97% for H3N2, 83 to
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SOURCE Novavax, Inc.
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