Baxter International Inc. (NYSE:BAX), in conjunction with DynPort
Vaccine Company LLC (DVC), a CSC Company (NYSE:CSC), today presented
Phase III study data measuring the clinical efficacy for PREFLUCEL, a
trivalent seasonal influenza candidate vaccine. PREFLUCEL is made using
Baxter’s Vero cell culture platform and does not contain an adjuvant or
preservatives. The data were presented at the International Congress on
Infectious Disease (ICID) in Miami, Florida.
“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.”
The Phase III clinical study found a 78 percent overall protection rate
against culture-confirmed influenza from influenza strains that matched
those in the vaccine and a 71 percent rate of prevention of influenza
from all circulating strains. The study was conducted during the
2008/2009 influenza season in the United States in more than 7,000
healthy clinical trial participants ages 18 to 49.
“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
Research and Development 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.”
In the double-blind, placebo-controlled trial, the highly sensitive
nasopharyngeal fluid test was used to detect the presence of influenza
infection in any of the 7,243 trial participants who presented with
clinical symptoms suggestive of influenza disease at least 21 days after
vaccination.