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Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis

Authordc.contributor.authorRuiz Palacios, Guillermo M. 
Authordc.contributor.authorPérez Schael, Irene es_CL
Authordc.contributor.authorVelázquez, F. Raúl es_CL
Authordc.contributor.authorAbate, Héctor es_CL
Authordc.contributor.authorBreuer, Thomas es_CL
Authordc.contributor.authorCosta Clemens, SueAnn es_CL
Authordc.contributor.authorCheuvart, Brigitte es_CL
Authordc.contributor.authorEspinoza, Félix es_CL
Authordc.contributor.authorGillard, Paul es_CL
Authordc.contributor.authorInnis, Bruce L. es_CL
Authordc.contributor.authorCervantes, Yolanda es_CL
Authordc.contributor.authorLinhares, Alexandre C. es_CL
Authordc.contributor.authorLópez, Pío es_CL
Authordc.contributor.authorMacías Parra, Mercedes es_CL
Authordc.contributor.authorOrtega Barría, Eduardo es_CL
Authordc.contributor.authorRichardson, Vesta es_CL
Authordc.contributor.authorRivera Medina, Doris Maribel es_CL
Authordc.contributor.authorRivera, Luis es_CL
Authordc.contributor.authorSalinas, Belén es_CL
Authordc.contributor.authorPavia Ruz, Noris es_CL
Authordc.contributor.authorSalmerón, Jorge es_CL
Authordc.contributor.authorRüttimann, Ricardo es_CL
Authordc.contributor.authorTinoco, Juan Carlos es_CL
Authordc.contributor.authorRubio, Pilar es_CL
Authordc.contributor.authorNúñez, Ernesto es_CL
Authordc.contributor.authorGuerrero, Lourdes es_CL
Authordc.contributor.authorYarzábal, Juan Pablo es_CL
Authordc.contributor.authorDamaso, Silvia es_CL
Authordc.contributor.authorTornieporth, Nadia es_CL
Authordc.contributor.authorSáez Llorens, Xavier es_CL
Authordc.contributor.authorVergara, Rodrigo F. es_CL
Authordc.contributor.authorVesikari, Timo es_CL
Authordc.contributor.authorBouckenooghe, Alain es_CL
Authordc.contributor.authorClemens, Ralf es_CL
Authordc.contributor.authorDe Vos, Béatrice es_CL
Authordc.contributor.authorO'Ryan Gallardo, Miguel 
Cita de ítemdc.identifier.citationNew England Journal of Medicine Volume: 354 Issue: 1 Pages: 11-22 Published: JAN 5 2006en
General notedc.descriptionArtículo de publicación ISI
Abstractdc.description.abstractBACKGROUND: The safety and efficacy of an attenuated G1P[8] human rotavirus (HRV) vaccine were tested in a randomized, double-blind, phase 3 trial. METHODS: We 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). RESULTS: The 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). CONCLUSIONS: Two 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.en
Publisherdc.publisherMassachusetts Medical Socen
Keywordsdc.subjectIntestinal Intussusceptionen
Títulodc.titleSafety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritisen
Document typedc.typeArtículo de revistaen

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