Two New Rotavirus Vaccines Effective in Clinical Trials

Promising results suggest Rotarix and Rotateq effective without excess intussusception

WEDNESDAY, Jan. 4 (HealthDay News) -- Two new rotavirus vaccines, Rotarix (an attenuated human virus vaccine) and Rotateq (a human-bovine reassortant vaccine), protect infants against severe gastroenteritis without an increase in cases of intussusception, according to two studies in the Jan. 5 issue of the New England Journal of Medicine.

In a phase 3 trial, Guillermo M. Ruiz-Palacios, M.D., of the University of Chile in Santiago, and colleagues randomized 63,225 infants to two oral doses of either attenuated G1P[8] human rotavirus vaccine (Rotarix) or placebo at about two and four months of age. The vaccine was 85% effective against severe rotavirus gastroenteritis and rotavirus-associated hospitalization, reaching 100% effectiveness against more severe rotavirus gastroenteritis. The vaccine reduced hospitalizations for diarrhea of any cause by 42%, without increasing cases of intussusception, the researchers report.

In the second study, Timo Vesikari, M.D., of the University of Tampere in Finland, and colleagues randomized 68,038 infants to three doses of a placebo or a live, pentavalent human-bovine reassortant rotavirus vaccine based on the WC3 strain (Rotateq). The vaccine was 94.5% effective at preventing hospitalizations due to G1-G4 rotavirus gastroenteritis. Intussusception rates were similar in the vaccine and placebo groups.

Despite some differences in the vaccines, both "demonstrate an impressive efficacy profile," according to an editorial. More important they have a "reassuring safety profile, particularly with respect to intussusception."

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