NOVAVAX Launches Phase II Clinical Trial of Seasonal Influenza Vaccine

Novavax, Inc.

today announced that it has begun enrollment in a Phase II clinical trial of its quadrivalent seasonal influenza virus-like particle (VLP) vaccine candidate. This randomized, observer-blind, comparator-controlled study is being conducted in multiple centers in Australia under the company's contract with the U.S. Department of Health and Human Services' Office of Biomedical Advanced Research and Development Authority (BARDA) to develop recombinant vaccines for the prevention of seasonal and pandemic influenza. The trial will evaluate the immunogenicity and safety of three dose levels of Novavax's quadrivalent seasonal recombinant VLP influenza vaccine in healthy adults between the ages of 18 and 64. Stanley C. Erck, President and Chief Executive Officer of Novavax, stated: "The start of this clinical trial is a significant milestone that reflects the progress we have made in our seasonal influenza vaccine program. We believe that most seasonal vaccines in the future will contain a second B strain and thus consist of a quadrivalent, or four-strain, composition. This trial allows us to transition from a trivalent to a quadrivalent seasonal vaccine candidate. The data will help establish the immunogenicity, safety and tolerability of our quadrivalent seasonal influenza VLP vaccine and determine the most effective and appropriate dose for later evaluation in young adults in our upcoming Phase III trial. This trial is being conducted in Australia so that we can evaluate our VLP vaccine candidate prior to the start of the influenza season in the southern hemisphere, and without waiting for the end of influenza transmission in the northern hemisphere. I commend my colleagues and our clinical investigators on their success in launching this important study."