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Novavax Launches Pivotal Clinical Study of Novel 2009 H1N1 VLP Flu Vaccine in Mexico
Date:10/20/2009

eful to the Mexican health authorities for their rapid clinical protocol clearance and enabling our potential solution for this escalating unmet medical need," Dr. Singhvi added.

"We are delighted to support Novavax as they move into this exciting clinical trial," said Catarina Flyborg, Enterprise Solutions Leader, GE Healthcare. "Alongside growing interest from organizations in India and Spain, this trial lends further credence to the combination of Novavax's vaccine technology with GE Healthcare's ReadyToProcess bioprocessing solutions."

Novavax and Avimex are initiating the blinded, placebo-controlled clinical trial in Mexico City to evaluate the safety, immunogenicity and efficacy of Novavax's 2009 H1N1 VLP vaccine in healthy adults. The first stage will evaluate the vaccine's safety, immunogenicity and efficacy among 1,000 subjects, including 750 VLP recipients and 250 placebo recipients. Pending favorable results from the first stage, the second stage of the study will be initiated to evaluate the safety of the vaccine in a larger cohort of 3,000 subjects (2,000 vaccine and 1,000 placebo recipients). The primary safety and immunogenicity results are expected within 3 months of the start of this study in January 2010. If the results are clinically acceptable, they will be used to seek registration of Novavax's 2009 H1N1 pandemic flu vaccine in Mexico. These data are also expected to support development of the company's pandemic and seasonal flu VLP vaccines in other countries, including the United States.

"We are pleased to be working with GE Healthcare, Avimex and the leading health officials in Mexico to launch the first and largest clinical trial to date using the 2009 H1N1 influenza VLP-based vaccine," said Thomas Johnston, Vice President of Strategy at Novavax. "This study is a continuation of our efforts to respond quickly to this current pandemic by leveraging our proprietary recombinant VLP technology and our in
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SOURCE Novavax, Inc.
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