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CDC Immunization Advisory Committee Recommends Two New Pediatric Vaccines from GlaxoSmithKline
Date:6/26/2008

roenteritis regardless of the infecting serotype(s).

Rotavirus infects virtually every child worldwide by age five and is the leading cause of severe gastroenteritis in infants and young children in the U.S. and worldwide. Severe, dehydrating gastroenteritis can occur as young as three months of age.

Clinical data published on two oral doses of ROTARIX show that protection was sustained through the first two years of life and ROTARIX was highly efficacious against rotavirus hospitalizations (96%) and severe rotavirus gastroenteritis (90%). Additionally, in a European phase III study, 90 percent efficacy against RGE of any severity was observed immediately following dose one and prior to the second dose. The protection offered by the two-dose schedule of ROTARIX, observed as early as after dose one, is particularly relevant as severe dehydrating rotavirus gastroenteritis can occur as young as three months of age.

In clinical studies, ROTARIX demonstrated significant and sustained efficacy through two rotavirus seasons against severe rotavirus gastroenteritis caused by types G1 (96%), G2 (86%), G3 (94%), G4 (95%), and G9 (85%), the most common circulating rotavirus types in the U.S.

ROTARIX is licensed in more than 100 countries around the world. More than 25 million doses of ROTARIX have been distributed worldwide. The U.S. FDA's approval of ROTARIX was based on one of the largest clinical development plans undertaken by a vaccine manufacturer and includes data from nearly 75,000 infants.

In clinical studies, common adverse events were fussiness/irritability, cough/runny nose, fever, loss of appetite, and vomiting. History of uncorrected congenital malformation of the gastrointestinal tract is a contraindication. Previous hypersensitivity to any component of ROTARIX, including latex rubber, should be reviewed prior to administration. Administration in infants suffering from acute diarrhea or vomiting should be delayed. Safety and ef
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SOURCE GlaxoSmithKline
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