Efficacy of a pentavalent rotavirus vaccine in reducing rotavirus-associated health care utilization across three regions (11 countries).
OBJECTIVE
To evaluate the effect of a human-bovine reassortant pentavalent rotavirus vaccine (PRV) on health care encounters in nearly 70 000 subjects randomized in three regions - Europe, the United States, and Latin America/the Caribbean - in the Rotavirus Efficacy and Safety Trial (REST).


METHODS
Healthy 6- to 12-week-old infants received 3 doses of PRV or placebo at 4- to 10-week intervals. The exact binomial method for ratios of Poisson counts was used to evaluate the effect of PRV on the rate of rotavirus-related hospitalizations and emergency department (ED) visits involving rotavirus G-types 1-4 occurring > or =14 days after the third dose of vaccine for up to 2 years.


RESULTS
In fully vaccinated infants, reductions in rotavirus-associated hospitalizations and ED visits were 94.7% (95% CI: 90.9, 96.9) in Europe, 94.9% (95% CI: 84.0, 98.9) in the United States, and 90.0% (95% CI: 29.4, 99.8) in the Latin American/Caribbean regions.


CONCLUSIONS
PRV reduced hospitalizations and ED visits within each region in REST. Results were consistent across regions and across the overall study cohort.
Vesikari
Timo
T
University of Tampere Medical School, Tampere, Finland. timo.vesikari@uta.fi
Itzler
Robbin
R
Matson
David O
DO
Santosham
Mathuram
M
Christie
Celia D C
CD
Coia
Michele
M
Cook
John R
JR
Koch
Gary
G
Heaton
Penny
P
D015331:Cohort Studies; D004632:Emergency Medical Services; D005060:Europe; D005260:Female; D005759:Gastroenteritis / Q000276:immunology / Q000517:prevention & control / Q000821:virology; D006760:Hospitalization; D006801:Humans; D007223:Infant; D007843:Latin America; D008297:Male; D016865:Reassortant Viruses / Q000276:immunology; D012401:Rotavirus / Q000276:immunology*; D012400:Rotavirus Infections / Q000276:immunology / Q000517:prevention & control* / Q000821:virology; D022243:Rotavirus Vaccines / Q000276:immunology / Q000627:therapeutic use*; D014481:United States
D022243:Rotavirus Vaccines; C058442:WC3 rotavirus vaccine