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Leading pharmaceuticals company, GlaxoSmithKline (GSK) announced today that it has initiated a worldwide clinical efficacy trial to evaluate its innovative vaccine for the prevention of seasonal influenza.
The vaccine division of the company named GlaxoSmithKline Biologicals is also the maker of influenza pre-pandemic vaccine Prepandrix™ (approved in Europe) and the pandemic vaccine Pandemrix™.
Jean Stéphenne, President and General Manager GSK Biologicals said, the company aims at developing a superior influenza vaccine that will provide those at risk of influenza with better protection. He further said the trial being conducted 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.
Talking about the new vaccine Stéphenne said, the new seasonal vaccine contains an adjuvant similar to the one pioneered for influenza pre-pandemic vaccine, Prepandrix™, and the pandemic vaccine Pandemrix™. "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", he added.
Revealing details about the clinical trial, Stéphenne informed that 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 will involve 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.
In clinical trials to date with the influenza vaccine GSK2186877A the side effects seen were mild-to-moderate, of short duration and are common to flu vaccines. Most common side-effects were injection site pain, redness, swelling and itching at the injection site, fatigue, muscle pain, joint pain, headache, nausea and chills/shivering.
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