The company has received a second task order for 22.5 million doses of 15 mcg H5N1 bulk vaccine antigen from the HHS under a contract awarded in November. This is in addition to the 5 million doses of H5N1 clade 2 bulk antigen at 15 mcg HA/dose ordered in November 2006. The additional task order procures an additional 9 million doses of H5N1 clade 2 bulk vaccine produced in the 2006 manufacturing campaign and 13.5 million doses of H5N1 clade 2 bulk vaccine expected to be produced in the 2007 manufacturing campaign.
Under the terms of the contract, GSK will manufacture the bulk vaccine product at the GSK manufacturing site in Ste. Foy,
David Stout, president of pharmaceutical operations for GlaxoSmithKline said, "We applaud the U.S. government's proactive steps in protecting American citizens against this potential public health threat. We are committed to helping governments and public health officials around the world effectively respond to the global threat of a flu pandemic and we are pleased to be working with the U.S. government in its preparedness efforts."
Today also marked the start of the first pre-pandemic vaccine trials involving GSK's proprietary adjuvanted H5N1 vaccine in
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.
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.