Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis
- PMID: 16394298
- DOI: 10.1056/NEJMoa052434
Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis
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.)
Copyright 2006 Massachusetts Medical Society.
Comment in
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The promise of new rotavirus vaccines.N Engl J Med. 2006 Jan 5;354(1):75-7. doi: 10.1056/NEJMe058285. N Engl J Med. 2006. PMID: 16394305 No abstract available.
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Rotavirus vaccines.N Engl J Med. 2006 Apr 20;354(16):1747-51; author reply 1747-51. doi: 10.1056/NEJMc060253. N Engl J Med. 2006. PMID: 16625014 No abstract available.
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Rotavirus vaccines.N Engl J Med. 2006 Apr 20;354(16):1747-51; author reply 1747-51. N Engl J Med. 2006. PMID: 16625742 No abstract available.
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Studies on human rotavirus (HRV) vaccination.J Pediatr Gastroenterol Nutr. 2007 Jan;44(1):157-9. doi: 10.1097/01.mpg.0000252192.99331.4a. J Pediatr Gastroenterol Nutr. 2007. PMID: 17204972 No abstract available.
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New rotavirus vaccine is effective and appears to have no increased risk of intussception.J Pediatr. 2006 Jul;149(1):143. doi: 10.1016/j.jpeds.2006.04.032. J Pediatr. 2006. PMID: 17243309 No abstract available.
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