ROCKVILLE, Md., Feb. 18, 2011 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX) a clinical-stage biopharmaceutical company, today presented the final safety and immunogenicity results from its 2009 H1N1 virus-like particle (VLP) pandemic influenza vaccine clinical trial in Mexico at the invitation-only 7th World Health Organization Meeting (WHO) on Evaluation of Pandemic Influenza Vaccines in Clinical Trials. The meeting was held at the WHO headquarters in Geneva, Switzerland where Dr. Gregory Glenn, Chief Medical Officer of Novavax, presented the findings at a session entitled: "Pandemic and Potentially Pandemic Vaccines Developed Using New Technologies." Dr. Glenn's presentation was entitled: "Phase II randomized, double-blind, placebo-controlled trial of a novel (H1N1) influenza VLP vaccine" and is available at www.novavax.com under the Investors/Events tab.
In this randomized, double-blind, placebo-controlled Phase II trial, Novavax's H1N1 VLP vaccine was administered in a single-dose regimen to over 3,000 subjects. The study found that the vaccine exceeded the immunogenicity criteria for seasonal influenza vaccine licensure at all dose levels including the 5mcg dose. Additionally, a single administration of the VLP vaccine induced high levels of hemaglutinin inhibition (HAI) titers in subjects without pre-existing detectable immunity to this pandemic influenza strain. Together, the data indicate that the H1N1 VLP vaccine was well-tolerated and immunogenic.
Dr. Glenn commented: "This trial was an important milestone for our influenza vaccine program and demonstrated the potential of our recombinant vaccine technology. The data indicate that our VLP vaccine was well-tolerated and generated robust immunogenicity at all dose levels, including the 5mcg dose. The single-dose seroprotection data in patients who had no pre-existing immunity (seronegatives) achieved protective titers in up