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.
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.
SOURCE DynPort Vaccine Company LLC (DVC)