Novavax, Inc. (Nasdaq: NVAX) announced today it has completed enrollment in the Phase II clinical study of its trivalent seasonal influenza (2008/2009 recommended strains) VLP vaccine candidate in healthy adults 60 years of age or older (older adults). This randomized, double-blind, active-controlled study is comparing the safety, tolerability and immunogenicity of two different doses (15 mcg and 60 mcg) of Novavax's trivalent seasonal influenza VLP vaccine to a commercially available trivalent inactivated vaccine, TIV (Fluzone®).
This study enrolled 467 older adults in a three-arm study at six different sites located within the United States. In addition to evaluating hemagglutinin inhibition (HAI) responses, anti-neuraminidase and cell-mediated immune responses are also being examined. Previous studies have shown that VLP-based flu vaccines drive strong neuraminidase inhibition (NAI) antibody titers and T-cell responses, indicating the potential for broader immunologic responses particularly in older adults.
"With the rapid completion of enrollment in this clinical trial as well as the first part of our H1N1 vaccine study in Mexico announced previously, we are on track to report results from our two most advanced clinical programs during the first quarter of next year," said Dr. Rahul Singhvi, President and Chief Executive Officer of Novavax. "If results from the seasonal flu vaccine study are positive, we will be able to advance this program into Phase III clinical testing as early as 2010."
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