Second-year follow-up evaluation of live, attenuated human rotavirus vaccine 89-12 in healthy infants

J Infect Dis. 2002 Nov 15;186(10):1487-9. doi: 10.1086/344732. Epub 2002 Oct 22.

Abstract

Rotavirus vaccine development is a high priority. The association between the tetravalent rhesus-human reassortant rotavirus vaccine and intussusception has increased the need to develop new vaccines. In a small efficacy trial, the human rotavirus vaccine 89-12 recently has been shown to be safe and effective; 184 of the 215 healthy infants initially enrolled in this trial were followed for a second year. Vaccine efficacy during the second year was 59% (P=.047). For the 2 years of observation, vaccine efficacy was 76% against rotavirus gastroenteritis, 83% against severe rotavirus gastroenteritis, and 100% against rotavirus illnesses requiring medical intervention (P<.001 for each). These encouraging results have led to continued evaluation, in several countries, of a vaccine candidate derived from strain 89-12.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Double-Blind Method
  • Follow-Up Studies
  • Gastroenteritis / prevention & control*
  • Humans
  • Infant
  • Infant, Newborn
  • Reassortant Viruses / drug effects
  • Rotavirus Infections / prevention & control*
  • Rotavirus Vaccines / administration & dosage*
  • Treatment Outcome
  • Vaccines, Attenuated / administration & dosage*

Substances

  • Rotavirus Vaccines
  • Vaccines, Attenuated
  • rotavirus vaccine 89-12