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New Data Published in The Lancet Show GSK's ROTARIX(R) Offers Protection Against the Most Common Circulating Rotavirus Types
Date:11/23/2007

Protection Sustained During the First Two Years of Life

PHILADELPHIA, Nov. 23 /PRNewswire-FirstCall/ -- New data from a large European clinical trial published today in The Lancet show ROTARIX(R), GlaxoSmithKline's (NYSE: GSK) oral rotavirus candidate vaccine to prevent rotavirus gastroenteritis, provides protection against the five most commonly circulating rotavirus types around the world and in the United States (U.S.). The GSK candidate vaccine, if approved by the U.S. Food and Drug Administration (FDA), would enable completion of the rotavirus vaccination series by four months of age. Severe, dehydrating gastroenteritis occurs most commonly among children aged three to 35 months. Of children in the U.S. hospitalized with rotavirus, approximately one in five are younger than six months old.

Results from this multi-center, randomized, double-blind, placebo- controlled phase III clinical trial involving almost 4,000 European infants (candidate rotavirus vaccine n=2,572; placebo n=1,302) demonstrated that two doses of ROTARIX provided highly effective and sustained protection through two consecutive rotavirus seasons (approximately two years of age). The data show that, through two rotavirus seasons, the vaccine was highly efficacious against rotavirus hospitalizations (96%), severe rotavirus gastroenteritis (90%) and against rotavirus gastroenteritis of any severity (79%). Specifically, significant protection was demonstrated against severe rotavirus gastroenteritis caused by types G1 (96%), G2 (86%), G3 (94%), G4 (95%), and G9 (85%), the most commonly circulating rotavirus types around the world and in the United States.

"The candidate vaccine contains a live, weakened form of natural huma
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SOURCE GlaxoSmithKline
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