Safety and Efficacy of an Attenuated Vaccine against Severe Rotavirus Gastroenteritis

• Published in: The New England journal of medicine Vol. 354; no. 1; pp. 11 - 22
• Main Authors: Ruiz-Palacios, Guillermo M, Pérez-Schael, Irene, Velázquez, F. Raúl, Abate, Hector, Breuer, Thomas, Clemens, Ralf, Clemens, SueAnn Costa, Cheuvart, Brigitte, Espinoza, Felix, Gillard, Paul, Innis, Bruce L, Cervantes, Yolanda, Linhares, Alexandre C, López, Pío, Macías-Parra, Mercedes, Ortega-Barría, Eduardo, Richardson, Vesta, Rivera-Medina, Doris Maribel, Rivera, Luis, Salinas, Belén, Pavía-Ruz, Noris, Salmerón, Jorge, Rüttimann, Ricardo, Tinoco, Juan Carlos, Rubio, Pilar, Nuñez, Ernesto, Guerrero, M. Lourdes, Yarzábal, Juan Pablo, Damaso, Silvia, Tornieporth, Nadia, Sáez-Llorens, Xavier, Vergara, Rodrigo F, Vesikari, Timo, Bouckenooghe, Alain, De Vos, Béatrice, O'Ryan, Miguel
• Format: Journal Article
• Language: English
• Published: Boston, MA Massachusetts Medical Society 05.01.2006
• Subjects: Administration, Oral; Babies; Biological and medical sciences; Diarrhea, Infantile - epidemiology; Diarrhea, Infantile - prevention & control; Diarrhea, Infantile - virology; Double-Blind Method; Female; Gastroenteritis - epidemiology; Gastroenteritis - prevention & control; Gastroenteritis - virology; General aspects; Health risk assessment; Hospitalization; Humans; Incidence; Infant; Intussusception - etiology; Male; Medical disorders; Medical sciences; Medical treatment; Risk; Rotavirus; Rotavirus Infections - complications; Rotavirus Infections - mortality; Rotavirus Infections - prevention & control; Rotavirus Vaccines - administration & dosage; Rotavirus Vaccines - adverse effects; Survival Analysis; Vaccines; Vaccines, Attenuated - administration & dosage; Vaccines, Attenuated - adverse effects; Virus; Medicine; Rotavirus; Toxicity; Gastroenteritis; Digestive diseases; Intestinal disease; Safety; Severe; Attenuated strain; Reoviridae; Gastric disease
• ISSN: 0028-4793; 1533-4406
• DOI: 10.1056/NEJMoa052434

In this double-blind trial, two oral doses of a live attenuated G1P[8] rotavirus vaccine were highly efficacious in protecting infants against severe diarrheal disease. During the active surveillance of 63,225 infants, the risk of intussusception was no greater after vaccination than it was with placebo (six cases vs. seven cases). In this double-blind trial, two oral doses of a live attenuated G1P[8] rotavirus vaccine were highly efficacious in protecting infants against severe diarrheal disease. Rotavirus is the leading recognized cause of diarrhea-related illness and death among infants and young children. 1 – 5 Every year, rotavirus is associated with 25 million clinic visits, 2 million hospitalizations, and more than 600,000 deaths worldwide among children younger than five years of age. 6 , 7 Development of a safe and effective rotavirus vaccine is therefore a high priority, particularly but not exclusively in developing countries, where the burden of disease is highest. 8 , 9 Since the withdrawal from the market of the tetravalent rhesus–human reassortant vaccine (RotaShield, Wyeth Laboratories) because of an association with intussusception, 10 , 11 ruling out such a risk . . .