Baxter Presents Clinical Efficacy Results from Phase III Study of Seasonal Flu Vaccine
PREFLUCEL Influenza Vaccine shows 78 percent rate of prevention against matching influenza strains
DEERFIELD, Ill.--(BUSINESS WIRE)--Mar 11, 2010 - 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.
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.
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.
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.
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.
Contact: Baxter International Inc.
Andrew Lewis, 847-948-2815
Laura Jacobs, 847-948-3026
Mary Kay Ladone, 847-948-3371
Posted: March 2010