A Field Study of the Safety and Efficacy of Two Candidate Rotavirus Vaccines in a Native American Population
- 1 March 1991
- journal article
- clinical trial
- Published by Oxford University Press (OUP) in The Journal of Infectious Diseases
- Vol. 163 (3) , 483-487
- https://doi.org/10.1093/infdis/163.3.483
Abstract
Adouble-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 104 pfu of the rhesus rotavirus vaccine or 108 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.Keywords
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