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The New England Journal of Medicine Publishes Study Investigating the Safety and Efficacy of Baxter's Cell-Based Pandemic, Avian Flu Vaccine
Date:6/11/2008

. "This is an immunogenic vaccine without the need for an adjuvant to boost the immune response."

About CELVAPAN

CELVAPAN is manufactured in a cell culture-based system in Bohumil, Czech Republic, at one of the largest cell culture vaccine production facilities in the world. Vero cell technology uses a well-established cell line originally derived from African green monkey kidneys in 1962. A continuous cell line has been derived from these cells so that an unlimited supply of cells is available without the requirement of generating additional cells from animals.

Baxter's candidate avian flu vaccine is derived from the H5N1 strain A/Vietnam/1203/2004. Its antigen composition and structure are identical to the actual virus circulating in nature without the need to enhance an immune response by including adjuvants, additives that may cause side effects. In this Phase I/II study, CELVAPAN induced an immune response that is similar to the body's defense against a natural virus infection. Earlier this year CELVAPAN was accepted for licensure review by the Committee for Medicinal Products for Human Use within the European Medicines Agency, making it the first cell culture-based pandemic influenza vaccine to be reviewed by the regulatory authority. The U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is also conducting a trial with Baxter's CELVAPAN in the United States.

Phase I/II Clinical Trial Results

The randomized Phase I/II study enrolled 284 subjects in Austria and Singapore (ages 18-45) and met its immunogenicity and safety endpoints. The study mainly investigated the ability of the vaccine to induce substantial levels of cross-immunity against divergent H5N1 strains.

The trial tested four different antigen concentrations ranging from 3.75 micrograms to 30 micrograms; 7.5 micrograms and 15 micrograms formulations were studied with and without adjuvant (additive).
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SOURCE Baxter International Inc.
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