03.12.10
Baxter and DynPort Vaccine Co. (DVC), achieved positive results from a Phase III study measuring the clinical efficacy for Preflucel, a trivalent seasonal flu vaccine. The vaccine is made using Baxter’s Vero cell culture platform and does not contain an adjuvant or preservatives.
The Phase III study found a 78% overall protection rate against culture-confirmed influenza from flu strains that matched those in the vaccine and a 71% rate of flu prevention from all circulating strains. The study was conducted in more than 7,000 healthy participants ages 18 to 49 during the 2008/2009 flu season in the U.S. The study also indicates that the safety profile for Preflucel is similar to licensed egg-derived seasonal influenza vaccines.
“We are pleased that these data suggest Preflucel elicits a strong immune response and may prevent influenza disease in vaccinated individuals,” said Hartmut J. Ehrlich, M.D., vice president of Global R&D for Baxter's BioScience business. “This is a landmark study assessing the efficacy of a cell culture-based, non-adjuvanted and preservative-free vaccine in the prevention of seasonal influenza.”
Under DVC and Baxter’s collaboration to develop seasonal and pandemic flu vaccines, DVC is managing the project and clinical trials and Baxter is manufacturing the vaccines. Baxter will hold the license in the U.S. if the FDA approves the vaccine.
The Phase III study found a 78% overall protection rate against culture-confirmed influenza from flu strains that matched those in the vaccine and a 71% rate of flu prevention from all circulating strains. The study was conducted in more than 7,000 healthy participants ages 18 to 49 during the 2008/2009 flu season in the U.S. The study also indicates that the safety profile for Preflucel is similar to licensed egg-derived seasonal influenza vaccines.
“We are pleased that these data suggest Preflucel elicits a strong immune response and may prevent influenza disease in vaccinated individuals,” said Hartmut J. Ehrlich, M.D., vice president of Global R&D for Baxter's BioScience business. “This is a landmark study assessing the efficacy of a cell culture-based, non-adjuvanted and preservative-free vaccine in the prevention of seasonal influenza.”
Under DVC and Baxter’s collaboration to develop seasonal and pandemic flu vaccines, DVC is managing the project and clinical trials and Baxter is manufacturing the vaccines. Baxter will hold the license in the U.S. if the FDA approves the vaccine.