In a new analysis data in the European subgroup of the large clinical study REST (Rotavirus Efficacy and Safety Trial), the five-type rotavirus vaccine RotaTeq® demonstrated 100% clinical efficacy against severe rotavirus disease for the first rotavirus season after vaccination. The efficacy remained high through two rotavirus seasons of follow up, preventing 98% of severe rotavirus cases. This new sub-analysis was presented last week at the 25th International Congress of Paediatrics in Athens.

Results across four Phase II/Phase III clinical trials in different regions of the world, including the complete REST study with nearly 70,000 infants enrolled worldwide, already supported the consistently high clinical efficacy of 98% to 100% of RotaTeq® in the prevention of severe rotavirus disease due to virus types directly targeted by RotaTeq®.

In this REST sub-analysis, assessing the response of more than 30 000 European infants, RotaTeq® has also proved to reduce the number of hospitalisations and emergency room visits by 95%d and to lower the number of office visits by 87%, up to two years post vaccination in Europe, due to serotypes G1 to G4.

"These data all together demonstrate that there is highly consistent and lasting protection across multiple studies of RotaTeq® and illustrates the public health benefit of this vaccine" said Timo Vesikari, Professor of Virology and Head of the Division of Paediatric Infectious Diseases at the University of Tampere, Finland. "Moreover, as rotavirus peak is between 6 and 24 months of age, it is important to vaccinate infants before 6 months of age and to ensure sufficiently long protection".

RotaTeq® is the only five-type rotavirus vaccine offering direct and broad protection against the five rotavirus types that cause more than 98% of paediatric rotavirus diseases in Europe (G1, G2, G3, G4 and G9). In the European Union (25 member states), RotaTeq® has been approved in June 2006; it is already available in 11 countries and being launched in several others.

Rotavirus is the most common cause of severe dehydrating diarrhoea in children worldwide and virtually all children will be infected with rotavirus within the first five years of life. Rotavirus disease is a leading cause of infant hospitalisation due to gastroenteritis in Europe.

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