GSK Major Seasonal Influenza Vaccine Efficacy Trial To Assess Superior Protection For Those At Risk Of Influenza

Main Category: Flu / Cold / SARS
Also Included In: Respiratory / Asthma;  Clinical Trials / Drug Trials;  Immune System / Vaccines
Article Date: 07 Nov 2008 - 1:00 PST

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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.

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. The most common were injection site pain, redness, swelling and itching at the injection site, fatigue (tiredness), muscle pain, joint pain, headache, nausea and chills/shivering.

About GlaxoSmithKline (GSK)

GSK - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information, visit GlaxoSmithKline at http://www.gsk.com.

About GlaxoSmithKline Biologicals (GSK Bio)

GlaxoSmithKline Biologicals (GSK Biologicals) is a global vaccine company which has shown itself to be a leader in innovation. The company is active in the fields of vaccine research, development and production with over 30 vaccines approved for marketing and 20 more in development. Headquartered in Belgium, GSK Biologicals has 14 manufacturing sites strategically positioned around the globe. In 2007 GSK Biologicals distributed 1.1 billion doses of vaccines to 169 countries in both developed and the developing world - an average of 3 million doses a day.

GSK Biologicals employs over 9 000 people worldwide including more than 1 600 passionate scientists engaged in research aimed at discovering innovative vaccines that contribute to the health and well-being of people of all generations around the world. http://www.gsk-bio.com/english/index.html

Prepandrix™ and Pandemrix™ are trade marks of the GlaxoSmithKline group of companies.

GlaxoSmithKline