A field study of the safety and efficacy of two candidate rotavirus vaccines in a Native American population

J Infect Dis. 1991 Mar;163(3):483-7. doi: 10.1093/infdis/163.3.483.

Abstract

A double-blind, randomized, placebo-controlled trial was conducted to evaluate the safety and efficacy of a rhesus rotavirus vaccine and RIT 4237, a bovine rotavirus vaccine, in a Navajo population. Infants aged 2-5 months were randomized to receive one dose of either 10(4) pfu of the rhesus rotavirus vaccine or 10(8) pfu of the RIT 4237 vaccine or placebo. Eleven (10.2%) of 108 infants in the rhesus vaccine group, 11 (10.4%) of 106 in the RIT 4237 group, and 9 (8.4%) of 107 in the placebo group experienced rotavirus diarrhea during the follow-up period of 17 months. Thus, in this population, neither vaccine was efficacious in preventing rotavirus diarrhea.

Publication types

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

MeSH terms

  • Diarrhea, Infantile / ethnology
  • Diarrhea, Infantile / microbiology
  • Diarrhea, Infantile / prevention & control*
  • Double-Blind Method
  • Female
  • Humans
  • Indians, North American
  • Infant
  • Male
  • Rotavirus Infections / complications
  • Rotavirus Infections / ethnology
  • Rotavirus Infections / prevention & control*
  • Rotavirus Vaccines*
  • Vaccines, Attenuated* / adverse effects
  • Viral Vaccines* / adverse effects

Substances

  • RIT 4237 vaccine
  • Rotavirus Vaccines
  • Vaccines, Attenuated
  • Viral Vaccines
  • rhesus rotavirus vaccine