Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis

Ruiz Palacios GM

Por favor, use este identificador para citar o enlazar este ítem: http://repositorio.pediatria.gob.mx:8180/handle/20.500.12103/2785

Título :	Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis
Creador:	Ruiz Palacios GM
Nivel de acceso:	Open access
Palabras clave :	Gastroenteritis - prevención y control Infecciones por Rotavirus - prevención y control Vacunas contra Rotavirus - Administración y dosificación Vacunas contra Rotavirus - Efectos adversos Vacunas Atenuadas - Administración y dosificación Vacunas Atenuadas - efectos adversos Gastroenteritis - prevention & control Rotavirus Infections - prevention & control Rotavirus Vaccines - administration & dosage Rotavirus Vaccines - adverse effects Vaccines, Attenuated - administration & dosage Vaccines, Attenuated - adverse effects
Descripción :	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.
Colaborador(es) u otros Autores:	Pérez-Schael I Velázquez Fr Abate H Breuer T Clemens Sc Cheuvart B Espinoza F Gillard P Innis Bl Cervantes Y Linhares Ac López P Macías-Parra M Ortega-Barría E Richardson V Rivera-Medina Dm Rivera L Salinas B Pavía-Ruz N Salmerón J Rüttimann R Tinoco Jc Rubio P Nuñez E Guerrero Ml Yarzábal Jp Damaso S Tornieporth N Sáez-Llorens X Vergara Rf Vesikari T Bouckenooghe A Clemens R De Vos B O'ryan M Human Rotavirus Vaccine Study Group
Fecha de publicación :	2006
Tipo de publicación:	Artículo
Formato:	PDF
Fuente:	N Engl J Med. 354(1):11-22
URI :	http://repositorio.pediatria.gob.mx:8180/handle/20.500.12103/2785
Idioma:	eng
Aparece en las colecciones:	Artículos

Ficheros en este ítem:

No hay ficheros asociados a este ítem.