Published: March 11, 2010
Baxter Presents Clinical Efficacy Results from Phase III Study of Seasonal Flu Vaccine
DEERFIELD, Ill. - (BUSINESS WIRE) - 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.
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.
* For this Phase III clinical trial, PREFLUCEL trivalent vaccine
contained a 2008/2009 seasonal influenza H1N1 strain, which differs from
the 2009 pandemic influenza H1N1 strain.
ACKNOWLEDGEMENTS:
1. This project has been funded in whole or in part with Federal
(United States Government) funds from the Office for Preparedness and
Response, Biomedical Advanced Research and Development Authority, under
contract number HHS0100200600013C.
2. Pursuant to Section 507 of P.L. 104-208 and Section 508 of P.L.
105-78; 100% of the total of this project's costs are financed with
Federal (United States Government) money.
3. The content of this publication does not necessarily reflect the
views or policies of the United States Department of Health and Human
Services, nor does mention of trade names, commercial products, or
organizations imply endorsement by the U.S. Government.
About Baxter
Baxter International Inc., through its subsidiaries, develops,
manufactures and markets products that save and sustain the lives of
people with hemophilia, immune disorders, infectious diseases, kidney
disease, trauma, and other chronic and acute medical conditions. As a
global, diversified healthcare company, Baxter applies a unique
combination of expertise in medical devices, pharmaceuticals and
biotechnology to create products that advance patient care worldwide.
About DVC
DynPort Vaccine Company LLC (DVC) manages product development programs
and provides consulting, technical and program management services to
U.S. government agencies and companies in the biotechnology and
pharmaceutical industries. DVC is part of CSC's North American Public
Sector business unit's Government Health Services Division. CSC's
expertise in providing health services to government agencies has grown
over the last five decades to offer commercial best practices integrated
to meet federal, state and local healthcare requirements. Services range
from optimizing claims processing to operating disease surveillance
systems to vaccine development and management. CSC's ideas and solutions
are improving the quality of healthcare with better information for
better decisions to save lives and money. For more information, visit www.csc.com/dvc.
About CSC
CSC is a global leader in providing technology-enabled solutions and
services through three primary lines of business. These include Business
Solutions and Services, the Managed Services Sector and the North
American Public Sector. CSC's advanced capabilities include systems
design and integration, information technology and business process
outsourcing, applications software development, Web and application
hosting, mission support and management consulting. Headquartered in
Falls Church, Va., CSC has approximately 92,000 employees and reported
revenue of $16.0 billion for the 12 months ended Jan. 1, 2010. For more
information, visit the company's Web site at www.csc.com.
Further information about this trial is posted at www.clinicaltrials.gov.
The safety and efficacy of this product has not been established. This
product is currently under clinical investigation and has not been
licensed by the FDA.
This release includes forward-looking statements concerning the
company's vaccine products, including with respect to clinical trials,
licensures, and the advantages of the vaccine products. The statements
are based on assumptions about many important factors, including the
following, which could cause actual results to differ materially from
those in the forward-looking statements: satisfaction of regulatory and
other requirements; additional clinical results demonstrating the safety
and efficacy of the products; market acceptance of vaccines developed
with Vero cell technology; continued public commitment to addressing
pandemic threats; and other risks identified in the company's most
recent filing on Form 10-K and other SEC filings, all of which are
available on the company's web site. The company does not undertake to
update its forward-looking statements.
Baxter International Inc.
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