Safety and efficacy of high-dose rhesus-human reassortant rotavirus vaccines--report of the National Multicenter Trial. United States Rotavirus Vaccine Efficacy Group.
Pediatrics
; 97(1): 7-13, 1996 Jan.
Article
in En
| MEDLINE
| ID: mdl-8545227
ABSTRACT
OBJECTIVE:
Rotavirus is a leading cause of morbidity and mortality from dehydrating gastroenteritis in infants and young children worldwide. Virtually every child is infected by age 4 years, justifying universal childhood immunization when a safe and effective vaccine is available. We report the results of a multicenter, placebo-controlled field trial in the United States of monovalent serotype 1 and tetravalent (TV) rhesus-human reassortant rotavirus vaccines (RRVs).DESIGN:
In this randomized, double-blind trial, 1278 healthy infants ages 5 to 25 weeks received three oral doses of RRV serotype 1, RRV-TV, or a placebo at approximately 2, 4, and 6 months of age. Vaccines contained 4 x 10(5) plaque-forming units of virus. Gastroenteritis episodes were monitored, and severity was graded throughout one rotavirus season. Two stool specimens per episode were tested for rotavirus.RESULTS:
The incidence of reactions did not differ among treatment groups during the 5-day, postvaccination safety surveillance period for any of the three doses. Both vaccines significantly reduced the incidence of rotavirus gastroenteritis. Vaccination was most protective against serious rotavirus illness; RRV-TV prevented 49% of rotavirus episodes, 80% of very severe episodes, and 100% of dehydrating rotavirus illness. Reduction of rotavirus disease by RRV-TV resulted in significantly fewer total episodes of gastroenteritis of all causes and an 82% reduction in all cases of dehydrating diarrhea.CONCLUSION:
RRV-TV is highly protective against very severe, dehydrating rotavirus gastroenteritis.
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Collection:
01-internacional
Database:
MEDLINE
Main subject:
Viral Vaccines
/
Rotavirus
/
Rotavirus Vaccines
/
Gastroenteritis
Type of study:
Clinical_trials
Limits:
Humans
/
Infant
Language:
En
Journal:
Pediatrics
Year:
1996
Document type:
Article
Affiliation country: