GlaxoSmithKline Receives New HHS Order for H5N1 Bulk Antigen. First North American Clinical Trials with GSK's Candidate Pre-pandemic Flu Vaccine...(portance of GSK's $2 billion investment ...),Health

This Phase I/II study, which will be conducted in seven states in the United States and two provinces in Canada, is an observer-blind, randomized, active-controlled trial that will evaluate the safety and immunogenicity of two consecutive doses of H5N1 pre-pandemic vaccine. The vaccine containing H5N1 antigen alone will be evaluated against a vaccine containing H5N1 antigen in combination with the Adjuvant System, in 675 adult volunteers aged between 18 and 64 years. Results from this study will be available in early 2008.

GSK is actively pursuing research into ways to make vaccines more effective through the use of Adjuvant Systems, combinations of compounds that are designed to enhance a vaccine's ability to elicit a strong, durable and protective immune response in the human body.

GSK's candidate pre-pandemic split antigen H5N1 vaccine induced a substantial level of cross-reactive immune response against a 'drifted' strain of H5N1 virus in a clinical trial conducted in 2006. A drifted strain is one that has undergone evolution in its protective antigens relative to the vaccine; the process of 'drift' is the same phenomenon that allows new strains of seasonal flu virus to circulate and cause disease year after year. This GSK candidate vaccine was accepted for review by the Committee for Medicinal Products for Human Use (CHMP) in Europe in January 2007.

In 2005, GSK invested approximately $2 billion in expanding its vaccine manufacturing and development activities in North America, primarily through the acquisition of the Canadian company, ID Biomedical (IDB). GSK's FluLaval(R) and Fluviral(R) seasonal influenza vaccines for use in North America and Canada are currently produced in IDB's former facility in Quebec, Canada and Dresden, Germany respectively. Additionally, GSK is modernizing its facility in Marietta, PA, to develop
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SOURCE GlaxoSmithKline Copyright©2007 PR Newswire.

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