The study also assessed the immunogenicity of PREFLUCEL by determining the rates of seroprotection and seroconversion, as well as geometric mean titer increases, in vaccinated study participants. Immunogenicity results met all of the requirements for each of these criteria set forth by the European Medicines Agency ™s Committee for Medicinal Products for Human Use (CHMP). For licensure of new influenza vaccines, CHMP mandates that at least one of these criteria are met for each of the three strains (H1N1, H3N2, B) included in the vaccine. The findings were also consistent with immunogenicity data from Baxter ™s previous studies of PREFLUCEL in adults and the elderly.

The Phase III study also indicates that PREFLUCEL ™s safety profile is similar to that of licensed egg-derived seasonal influenza vaccines. The most common side effects observed in the study were injection site reactions, myalgia, fatigue, headache and malaise.

Baxter and DVC plan to complete the PREFLUCEL Phase III clinical trial program in adults and elderly individuals in early 2010. Work on this vaccine is being completed as part of a U.S. Department of Health and Human Services (HHS) Office of Public Health and Emergency Preparedness contract awarded to DVC in May 2006. DVC is working in collaboration with Baxter to develop seasonal and pandemic influenza vaccines. Under this contract, DVC is managing the project and clinical trials. Baxter is manufacturing the vaccines and will serve as the FDA license-holder should the product be licensed in the United States.