Data from one of the largest infant vaccine trials ever conducted, published today in the New England Journal of Medicine (NEJM), showed GlaxoSmithKline's (GSK) rotavirus vaccine candidate as effective against rotavirus disease (rotavirus gastroenteritis) in the first year of life. Rotavirus is the leading recognized cause of diarrhea-related illness and death among infants and young children. Every year, rotavirus is associated with an estimated 25 million clinic visits, two million hospitalizations and more than 600,000 deaths worldwide among children younger than five years of age. In the United States, the Centers for Disease Control and Prevention estimates the annual rotavirus disease burden among children younger than 5 years of age as 2.7 million illnesses, resulting in 410,000 clinic visits, up to 70,000 hospitalizations and 20 to 70 deaths. The vaccine is not approved for use in the United States, however, it has been introduced as the first vaccine available to control this highly infectious disease in several markets across the world.
Results from a double-blind, placebo-controlled trial demonstrated that two doses of the rotavirus vaccine candidate given two months apart at two and four months of age, gave 85 percent protection against severe rotavirus disease and 100 percent protection against more severe disease. This protection was proven against the most common circulating strains: G1P, G3P, G4P and the globally emerging G9P strain. A meta-analysis considering data from this trial and other efficacy studies conducted with similar methods showed 67 percent protection against G2P rotavirus disease.
The safety analysis revealed a lower incidence of serious adverse events in children receiving the rotavirus vaccine candidate compared to children receiving placebo. This finding was attributable to the lower number of gastrointestinal disease related serious adverse events in those receiving the rotavirus vaccine candPage: 1 2 3 Related biology news :1
Contact: Danielle Halstrom
Cohn & Wolfe
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