• Guillermo M Ruiz-Palacios, Irene Pérez-Schael, F Raúl Velázquez, Hector Abate, Thomas Breuer, SueAnn Costa Clemens, Brigitte Cheuvart, Felix Espinoza, Paul Gillard, Bruce L Innis, Yolanda Cervantes, Alexandre C Linhares, Pío López, Mercedes Macías-Parra, Eduardo Ortega-Barría, Vesta Richardson, Doris Maribel Rivera-Medina, Luis Rivera, Belén Salinas, Noris Pavía-Ruz, Jorge Salmerón, Ricardo Rüttimann, Juan Carlos Tinoco, Pilar Rubio, Ernesto Nuñez, M Lourdes Guerrero, Juan Pablo Yarzábal, Silvia Damaso, Nadia Tornieporth, Xavier Sáez-Llorens, Rodrigo F Vergara, Timo Vesikari, Alain Bouckenooghe, Ralf Clemens, Béatrice De Vos, Miguel O'Ryan, and Human Rotavirus Vaccine Study Group.
• Instituto Nacional de Ciencas Medicas y Nutricion, México Distrito Federal, Mexico.
• N. Engl. J. Med. 2006 Jan 5; 354 (1): 11-22.

BackgroundThe safety and efficacy of an attenuated G1P[8] human rotavirus (HRV) vaccine were tested in a randomized, double-blind, phase 3 trial.MethodsWe studied 63,225 healthy infants from 11 Latin American countries and Finland who received two oral doses of either the HRV vaccine (31,673 infants) or placebo (31,552 infants) at approximately two months and four months of age. Severe gastroenteritis episodes were identified by active surveillance. The severity of disease was graded with the use of the 20-point Vesikari scale. Vaccine efficacy was evaluated in a subgroup of 20,169 infants (10,159 vaccinees and 10,010 placebo recipients).ResultsThe efficacy of the vaccine against severe rotavirus gastroenteritis and against rotavirus-associated hospitalization was 85 percent (P<0.001 for the comparison with placebo) and reached 100 percent against more severe rotavirus gastroenteritis. Hospitalization for diarrhea of any cause was reduced by 42 percent (95 percent confidence interval, 29 to 53 percent; P<0.001). During the 31-day window after each dose, six vaccine recipients and seven placebo recipients had definite intussusception (difference in risk, -0.32 per 10,000 infants; 95 percent confidence interval, -2.91 to 2.18; P=0.78).ConclusionsTwo oral doses of the live attenuated G1P[8] HRV vaccine were highly efficacious in protecting infants against severe rotavirus gastroenteritis, significantly reduced the rate of severe gastroenteritis from any cause, and were not associated with an increased risk of intussusception. (ClinicalTrials.gov numbers, NCT00139347 and NCT00263666.)Copyright 2006 Massachusetts Medical Society.

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