Novavax, Inc. announced today that the enrollment of over 3,500 subjects in Mexico has been completed in Stage B of its pivotal 2009 H1N1 virus-like-particle (VLP) pandemic influenza vaccine study. With the 1,000 subjects already enrolled in Stage A of the trial, the enrollment in this pivotal trial is now complete with over 4,500 subjects.
In this Stage B of Novavax's pivotal study of H1N1 influenza vaccine candidate, a cohort of 3,500 healthy volunteers aged 18 to 64 years old were enrolled. 2,500 of the subjects received a 15 mcg single dose of Novavax's unadjuvanted 2009 H1N1 VLP pandemic influenza vaccine candidate while 1,000 of the subjects received placebo. The 15 mcg single dose regimen was recommended by the Data and Safety Monitoring Board (DSMB) after reviewing the results of safety and immunogenicity data from a subset of the 1,000 subjects in Stage A of this trial. These data were recently presented at a meeting sponsored by the World Health Organization in Geneva (presentation available on www.novavax.com). The purpose of the Stage B portion of the study was to evaluate safety. Favorable data from Stage B of this study will position Novavax for possible registration of the 2009 H1N1 VLP pandemic influenza vaccine candidate in Mexico.
"Novavax has now completed enrollment of the largest clinical trial in the Company's history," said Dr. Rahul Singhvi, President and Chief Executive Officer of Novavax. "This was an ambitious program from the start and we now have realized a remarkable milestone in less than five months. To conduct a clinical trial of this magnitude is a significant undertaking in any circumstance. For a Company of our size to achieve this goal under such time pressure is testament to the dedication of our employees and collaborators in Mexico. I am confident that the quality of the data from this part of the study together with the encouraging results to date from Stage A of the trial will enable Novavax to move closer to ultimate product registration."