GSK initiates major seasonal influenza vaccine efficacy trial

Nov 6 2008

GlaxoSmithKline (GSK) announced today that it has started a worldwide clinical efficacy trial to evaluate an innovative vaccine for the prevention of seasonal influenza.

The trial is one of the largest influenza efficacy trials ever undertaken for seasonal flu. Over 43,000 volunteers are expected to be enrolled in the phase III clinical trial.

"With this large clinical trial in seasonal influenza, we are building on the leading role GlaxoSmithKline Biologicals has already played in the development of pandemic protection. This new seasonal vaccine contains an adjuvant similar to the one pioneered for the only influenza pre-pandemic vaccine approved in Europe, Prepandrix, and the pandemic vaccine Pandemrix," said Jean Stéphenne, President and General Manager GSK Biologicals. "We are looking to develop a superior influenza vaccine that will provide those at risk of influenza with better protection."

The multicenter Phase III study is an observer-blind, randomized, efficacy study. Subjects will be randomized to receive a single dose of the new vaccine or a currently available vaccine each year of the two year trial. The study population will comprise adults aged 65 and older at the time of vaccination.

The trial involves over 43,000 volunteers and will take place in 15 countries, including Belgium, Czech Republic, Estonia, France, Germany, United Kingdom, Netherlands, Norway, Poland, Romania, Russia, Taiwan, Mexico, United States, and Canada.