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	Full Text PDF PDA Full Text PowerPoint Slide Set Supplementary Material Editorial by Glass, R. I. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear PubMed Citation

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 [ClinicalTrials.gov] and NCT00263666 [ClinicalTrials.gov] .)

Source Information

Address reprint requests to Dr. O'Ryan at the Institute of Biomedical Sciences, Faculty of Medicine, University of Chile, Independencia 1027, Santiago, Chile, or at moryan{at}med.uchile.cl.

Full Text of this Article

Related Letters:

Rotavirus Vaccines
Molinaro G. A., Lee D. A., Lee P.-I., Simonsen L., Taylor R. J., Kapikian A. Z., Ruiz L. P. Jr., O'Ryan M., Ruiz-Palacios G. M., Clemens R., Vesikari T., DiNubile M. J., Heaton P. M., Glass R. I., Parashar U. D.
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N Engl J Med 2006; 354:1747-1751, Apr 20, 2006. Correspondence

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