The Lancet today published results from a large European study that showed GlaxoSmithKline's Rotarix, an oral rotavirus candidate vaccine to prevent rotavirus gastroenteritis, provided protection against the 5 most common rotavirus types.
While not yet approved by the U.S Food and Drug Administration, the vaccine would enable completion of the rotavirus vaccination schedule by the age of four months.
Children hit by a rotavirus experience severe, dehydrating gastroenteritis that results in 1 in 5 affected being hospitalized and most are under the age of six months.
The study, a multi-center, randomized, double-blind, placebo-controlled phase III clinical trial showed that two doses of Rotarix provided effective and sustained protection through two consecuetive seasons.
"The candidate vaccine contains a live, weakened form of natural human 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."
Currently, the CDC Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians (AAFP) advise that infants receive routine vaccination with the currently available FDA approved vaccine at two, four and six months of age.
[Source: PRNewsWire]
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