PRESS RELEASE: Rotarix offers sustained and broad protection against all common circulating rotavirus types

New data published in The Lancet show GSK’s rotavirus vaccine Rotarix® offers sustained and broad protection against all common circulating rotavirus types

Rotavirus vaccine provides sustained and broad protection during the first two years of life1

Embargoed Until - Friday 23 November 2007, London, UK and Rixensart, Belgium, 00.01 GMT - New data from a large European clinical vaccine trial, published today in The Lancet, shows Rotarix™, GSK’s rotavirus vaccine, to be effective against the five most commonly circulating rotavirus types (G1, G2, G3, G4 and G9).These virus types are responsible for more than 98% of rotavirus gastroenteritis (RVGE) disease in Europe during the first two years of life2. In the European Region alone, rotavirus may cause annually up to 87,000 hospitalizations and close to 700,000 outpatient visits every year in children under the age of five3. Importantly, the protection afforded by the vaccine’s two-dose schedule in infants occurs before six months of age.

Results from this multi-centre, randomized, double-blind, placebo-controlled phase III trial involving nearly 4000 infants, indicate that two doses of Rotarixâ„¢ provide broad and sustained protection through two consecutive rotavirus seasons (early December through to late May in Europe). The vaccine was given concomitantly with other routine primary childhood vaccines. Vaccine efficacy during this follow-up period was 90% against severe rotavirus gastroenteritis and 96% against rotavirus hospitalizations irrespective of the rotavirus type.

Dr. Thomas Breuer, Head of Clinical R&D and Chief Medical Officer GSK Biologicals said: “The vaccine’s efficacy against the rotavirus G2 (G2P[4]) type described in The Lancet publication is scientifically very important, as it demonstrates for the first time within a single controlled study cross-protection against a non-vaccine strain (fully heterotypic protection). Efficacy against different G and P types through the G1P[8] vaccine strain is big news and validates earlier integrated analyses across multiple studies. These data provide further supporting evidence that GSK’s live-attenuated human rotavirus vaccine effectively mimics natural infection.”

Prof. Timo Vesikari, University of Tampere, Finland, and lead author of the study said: “Rotavirus is highly contagious and can cause great discomfort for infants and children with diarrhea and vomiting lasting for several days, leading to a risk of severe dehydration, which can be fatal if left untreated. These newly published data are important as they confirm that vaccination with a live-attenuated human rotavirus vaccine provides broad and sustained protection against rotavirus gastroenteritis before six months of age. This could help to reduce the peak incidence of rotavirus disease, which occurs during the first two years of a child’s life, and help prevent unnecessary illness, medical intervention and associated hospitalizations.”

In an additional exploratory analysis, protection against severe rotavirus gastroenteritis in the period between dose 1 and dose 2 was observed to be about 90 %. Such a high efficacy after the first dose is of particular importance for babies born during the peak season for rotavirus infection when early protection is desired as soon as possible.

Since rotavirus is highly infectious, the spread of the disease is difficult to control. Vaccination is recognized as the only control measure to have significant impact on disease prevention and consequently also the quality of family life and is considered the optimum first line strategy to control rotavirus infection.4,5,6 Inclusion of rotavirus vaccination in national infant vaccination schedules would reduce the burden of disease, reduce the required medical attention and ultimately reduce the burden on the healthcare system.

There was no difference in the number of serious adverse events reported for subjects administered the trial vaccine compared with those who received placebo.

About Rotarixâ„¢

Rotarixâ„¢is indicated for the active immunisation of infants from the age of 6 weeks for prevention of gastro-enteritis due to rotavirus infection. In clinical trials, efficacy was demonstrated against gastro-enteritis due to rotavirus strains G1P[8], G2P[4], G3P[8], G4P[8] and G9P[8]. The use of Rotarixâ„¢ should be based on official national recommendations. 7

Rotarixâ„¢ is a live-attenuated oral human rotavirus vaccine licensed in more than 100 countries around the world. The vaccine is designed to prevent rotavirus gastroenteritis by mimicking the protective effects of natural human rotavirus infection. Studies have shown that natural rotavirus infection provides significant protection from moderate to severe disease, regardless of rotavirus strain.

About rotavirus

Rotavirus infects virtually every child worldwide by age five and is the leading cause of severe acute gastroenteritis in infants and young children worldwide. Severe diarrhea and dehydration occurs in infants as young as three months of age with peak incidence between six months to two years.

GlaxoSmithKline Biologicals

GlaxoSmithKline Biologicals (GSK Biologicals) is one of the world’s leading vaccine manufacturers. The company is located in Rixensart (Belgium) and is the centre of all GlaxoSmithKline’s activities in the field of vaccine research, development and production. GSK Biologicals employs over 5000 people in Belgium(over 8000 worldwide), of whom more than 1500 are passionate scientists devoted to discovering innovative vaccines and developing cost-effective and convenient combination products that contribute to the health and well-being of billions of people, in every generation around the world.

In 2006, GSK Bio distributed more than 1.1 billion doses of vaccines to 169 countries in both the developed and the developing world — an average of 3 million doses a day. Of those vaccine doses, approximately 136 million were doses of combination paediatric vaccines which protect the world's children up to six diseases in one vaccine.

GlaxoSmithKline is one of the world’s leading research-based pharmaceutical and health care companies. GlaxoSmithKline is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information visit www.gsk.com.

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