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PHILADELPHIA -- GlaxoSmithKline (GSK) announced the launch of a pivotal trial with its investigational influenza vaccine, Fluarix, in partnership with the National Institute of Allergy and Infectious Diseases (NIAID), a component of the U.S. National Institutes of Health (NIH), part of the Department of Health and Human Services.
The phase III trial will start this month and will be conducted at four centers in the United States, including the University of Rochester Medical Center, the University of Maryland School of Medicine, Baltimore, Cincinnati Children's Hospital and Baylor College of Medicine.
The randomized, double-blind placebo-controlled trial will involve approximately 1,000 participants 18 to 64 years of age. The objective of the trial is to evaluate the immunogenicity and safety of Fluarix administered intramuscularly in healthy adults.
Four out of every five participants in this trial will receive Fluarix, while the fifth will receive a placebo. Those receiving placebo will be offered flu vaccine at the conclusion of the month-long study.
GSK has not filed a biologics license application (BLA) for Fluarix in the United States, however, as a result of this year's flu vaccine shortage, Fluarix is now available for use in the United States under the Investigational New Drug regulations. Results of this pivotal trial will be provided to FDA as GSK seeks licensure for Fluarix under biologics license application (BLA) in 2005.
Fluarix is a trivalent inactivated virus vaccine manufactured in a GSK facility in Germany. Each 0.5 ml dose of Fluarix contains 15 micrograms of highly purified sub-units of each of the three influenza virus strains. The vaccine contains trace levels of egg protein and should not be used by individuals with egg or chicken protein allergies.