A Field Study of the Safety and Efficacy of Two Candidate Rotavirus Vaccines in a Native American Population

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...

Full description

Saved in:
Bibliographic Details
Published in:The Journal of infectious diseases 1991-03, Vol.163 (3), p.483-487
Main Authors: Santosham, Mathuram, Letson, G. William, Wolff, Mark, Reid, Raymond, Gahagan, Sheila, Adams, Roberta, Callahan, Charles, Sack, R. Bradley, Kapikian, Albert Z.
Format: Article
Language:English
Subjects:
Biological and medical sciences
Children
Diarrhea
Diarrhea, Infantile - ethnology
Diarrhea, Infantile - microbiology
Diarrhea, Infantile - prevention & control
Double-Blind Method
Female
Human viral diseases
Humans
Immunization
Indians, North American
Infant
Infants
Infectious diseases
Major Articles
Male
Medical sciences
Placebos
Rotavirus
Rotavirus Infections - complications
Rotavirus Infections - ethnology
Rotavirus Infections - prevention & control
Rotavirus Vaccines
Ungulates
Vaccination
Vaccines, Attenuated - adverse effects
Viral diseases
Viral diseases of the digestive system
Viral Vaccines - adverse effects
Citations: Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary: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.
ISSN:0022-1899
1537-6613
DOI:10.1093/infdis/163.3.483