Initiation of H5N1 clinical trials
Today also marked the start of the first pre-pandemic vaccine trials involving GSK's proprietary adjuvanted H5N1 vaccine in North America. The vaccine used in these trials will be produced at the company's North American manufacturing facility in Quebec, Canada. These U.S. studies are supported by a contract [HHS100200700029C] from BARDA/ASPR/HHS awarded in January 2007 for the advanced development of antigen-sparing pandemic influenza vaccines towards U.S.-licensure with a commitment to U.S. production of 150 million doses of pandemic vaccine within six months of a pandemic onset.
The trials highlight the company's continuing commitment to its global pre-pandemic influenza vaccine development program. Data from earlier European studies, using a pre-pandemic vaccine produced at GSK's Dresden, Germany facility, showed that the influenza candidate vaccine may be able to induce immune responses that might protect against different strains of H5N1.
GSK's first North American pre-pandemic vaccine trial will be a Phase I/II study that evaluates its H5N1 antigen alone and in combination with one of its proprietary Adjuvant Systems, in 675 subjects. This Phase I/II study is expected to lead into a larger, multi-center, Phase III trial - one of the largest in North America - which is expected to enroll approximately 4,400 subjects later in 2007.
Ripley Ballou, Vice President of Clinical Development for Flu at
GlaxoSmithKline said: "The goal of our North American clinical development
program is to establish GSK's second manufacturing facility as a source for
H5N1 vaccine, further strengthening our efforts to support governments'
pandemic preparedness strategies. The initiation of these trials
underscores the im
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