MISSISSAUGA, ON, Aug. 3 /CNW/ - GlaxoSmithKline, one of the world's
leading research-based pharmaceutical and health-care companies, today
announced the start of the first North American pre-pandemic vaccine trials in
the company's global pre-pandemic influenza program.
The trials, involving GSK's proprietary adjuvanted H5N1 vaccine produced
at its North American manufacturing facility, are the first GSK pre-pandemic
vaccine trials to commence in North America. The vaccine used in these trials
will be produced at the company's North American manufacturing facility in
Quebec, Canada. The trials highlight the company's continuing commitment to
its global pre-pandemic influenza vaccine development program.
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 importance of GSK's $2 billion investment in 2005 to create a new
influenza vaccine infrastructure in North America."
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.
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. Additionally, GSK is modernizing its facility in Marietta, PA, to
develop and manufacture cell-culture based seasonal and pandemic influenza
vaccines. These cell culture vaccine candidates and GSK's pre-pandemic vaccine
are investigational products and have not been approved for use in North
GlaxoSmithKline - one of the world's leading research-based
pharmaceutical and health-care companies - is committed to improving the
quality of human life by enabling people to do more, feel better and live
longer. In Canada, GlaxoSmithKline is among the top 15 investors in research
and development, contributing more than $176 million in 2006 alone. GSK is an
Imagine Caring Company, and is consistently recognized as one of the 50 Best
Employers in Canada. For company information, please visit www.gsk.ca.
About GSK Biologicals
GSK Biologicals, based in Rixensart, Belgium, is the vaccine division of
GlaxoSmithKline. As one of the world's leading vaccine manufacturers, GSK
Biologicals employs more than 1,500 scientists devoted to discovering new
vaccines and developing more cost-effective and convenient combination
products to prevent infections that cause serious medical problems.
(R) Fluviral and FluLaval are registered trademarks, used under license
by GlaxoSmithKline Inc.
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For further information: Media contact: GlaxoSmithKline, (905) 819-3363