The phase III trial will start this month and will be conducted at four centers in the
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
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.