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Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis.
N Engl J Med. 2006 Jan 05; 354(1):11-22.NEJM

Abstract

BACKGROUND

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. (ClinicalTrials.gov numbers, NCT00139347 and NCT00263666.)

Authors+Show Affiliations

Instituto Nacional de Ciencas Medicas y Nutricion, México Distrito Federal, Mexico.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16394298

Citation

Ruiz-Palacios, Guillermo M., et al. "Safety and Efficacy of an Attenuated Vaccine Against Severe Rotavirus Gastroenteritis." The New England Journal of Medicine, vol. 354, no. 1, 2006, pp. 11-22.
Ruiz-Palacios GM, Pérez-Schael I, Velázquez FR, et al. Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis. N Engl J Med. 2006;354(1):11-22.
Ruiz-Palacios, G. M., Pérez-Schael, I., Velázquez, F. R., Abate, H., Breuer, T., Clemens, S. C., Cheuvart, B., Espinoza, F., Gillard, P., Innis, B. L., Cervantes, Y., Linhares, A. C., López, P., Macías-Parra, M., Ortega-Barría, E., Richardson, V., Rivera-Medina, D. M., Rivera, L., Salinas, B., ... O'Ryan, M. (2006). Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis. The New England Journal of Medicine, 354(1), 11-22.
Ruiz-Palacios GM, et al. Safety and Efficacy of an Attenuated Vaccine Against Severe Rotavirus Gastroenteritis. N Engl J Med. 2006 Jan 5;354(1):11-22. PubMed PMID: 16394298.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis. AU - Ruiz-Palacios,Guillermo M, AU - Pérez-Schael,Irene, AU - Velázquez,F Raúl, AU - Abate,Hector, AU - Breuer,Thomas, AU - Clemens,SueAnn Costa, AU - Cheuvart,Brigitte, AU - Espinoza,Felix, AU - Gillard,Paul, AU - Innis,Bruce L, AU - Cervantes,Yolanda, AU - Linhares,Alexandre C, AU - López,Pío, AU - Macías-Parra,Mercedes, AU - Ortega-Barría,Eduardo, AU - Richardson,Vesta, AU - Rivera-Medina,Doris Maribel, AU - Rivera,Luis, AU - Salinas,Belén, AU - Pavía-Ruz,Noris, AU - Salmerón,Jorge, AU - Rüttimann,Ricardo, AU - Tinoco,Juan Carlos, AU - Rubio,Pilar, AU - Nuñez,Ernesto, AU - Guerrero,M Lourdes, AU - Yarzábal,Juan Pablo, AU - Damaso,Silvia, AU - Tornieporth,Nadia, AU - Sáez-Llorens,Xavier, AU - Vergara,Rodrigo F, AU - Vesikari,Timo, AU - Bouckenooghe,Alain, AU - Clemens,Ralf, AU - De Vos,Béatrice, AU - O'Ryan,Miguel, AU - ,, PY - 2006/1/6/pubmed PY - 2006/1/13/medline PY - 2006/1/6/entrez SP - 11 EP - 22 JF - The New England journal of medicine JO - N. Engl. J. Med. VL - 354 IS - 1 N2 - BACKGROUND: 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. (ClinicalTrials.gov numbers, NCT00139347 and NCT00263666.) SN - 1533-4406 UR - https://www.unboundmedicine.com/medline/citation/16394298/Safety_and_efficacy_of_an_attenuated_vaccine_against_severe_rotavirus_gastroenteritis_ L2 - http://www.nejm.org/doi/full/10.1056/NEJMoa052434?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -