TY - JOUR
T1 - A field study of the safety and efficacy of two candidate rotavirus vaccines in a native american population
AU - Santosham, Mathuram
AU - Letson, G. William
AU - Wolff, Mark
AU - Reid, Raymond
AU - Gahagan, Sheila
AU - Adams, Roberta
AU - Callahan, Charles
AU - Sack, R. Bradley
AU - Kapikian, Albert Z.
N1 - Funding Information:
Received 27 February 1990; revised 18 September 1990. Study protocol was approved by the ethical review committees of the Indian Health Service, Johns Hopkins University School of Hygiene and Public Health, and National Institute of Allergy and Infectious Diseases and by the health boards of the three service units. The opinions expressed herein are those of the authors and do not necessarily reflect the views of the Indian Health Service. Financial support: National Institutes of Health (AI-Q2660),Thrasher Research Fund (H22.2103), and Smith Kline-RIT, Belgium. Reprints or correspondence: Dr. Mathuram Santosham, Johns Hopkins University School of Hygiene and Public Health, 615 N. Wolfe St., Rm. 5505, Baltimore, MD 21205.
Copyright:
Copyright 2016 Elsevier B.V., All rights reserved.
PY - 1991/3
Y1 - 1991/3
N2 - 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 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.
AB - 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 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.
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U2 - 10.1093/infdis/163.3.483
DO - 10.1093/infdis/163.3.483
M3 - Article
C2 - 1995721
AN - SCOPUS:0026033975
VL - 163
SP - 483
EP - 487
JO - Journal of Infectious Diseases
JF - Journal of Infectious Diseases
SN - 0022-1899
IS - 3
ER -