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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

n rotavirus derived from the most common human rotavirus strain with the goal of offering protection against the most commonly circulating and emerging rotavirus serotypes by mimicking the protective effects of natural human rotavirus infection," said David I. Bernstein, MD, MA, Director, Infectious Diseases; Gamble Program at Cincinnati Children's Hospital Medical Center. "These data are important because they confirm that immunization with two doses of the rotavirus candidate vaccine could provide broad protection against rotavirus gastroenteritis caused by emerging types in addition to those that are already commonly circulating."

In an additional analysis, protection against severe rotavirus gastroenteritis in the period between dose one and dose two was observed to be 90%. The protection offered by the two-dose schedule of this rotavirus vaccine observed as early as after dose one is particularly relevant as severe dehydrating rotavirus gastroenteritis can occur in infants as young as three months of age.

Since rotavirus is highly infectious, the spread of the disease may be difficult to control. Vaccination against rotavirus is recognized as the best measure to protect children against rotavirus disease and has been shown to be highly effective in preventing the disease.

The CDC Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians (AAFP) recommend that infants receive routine vaccination with the rotavirus vaccine currently licensed by the FDA at two, four, and six months of age in order to prevent rotavirus gastroenteritis.

GSK's Biologics License Application (BLA) for the candidate rotavirus vaccine is currently under review by the U.S. Food and Drug Administration (FDA). It is proposed that the vaccine would be given in two oral doses beginning at six weeks of age and completed by 24 weeks of age, with a minimum four-week interval between the
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SOURCE GlaxoSmithKline
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