Efficacy of a pentavalent rotavirus vaccine in reducing rotavirus-associated health care utilization across three regions (11 countries)

Timo Vesikari, Robbin Itzler, David O. Matson, Mathuram Santosham, Celia D.C. Christie, Michele Coia, John R. Cook, Gary Koch, Penny Heaton

Research output: Contribution to journalReview articlepeer-review

Abstract

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 ≥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.

Original languageEnglish (US)
Pages (from-to)S29-S35
JournalInternational Journal of Infectious Diseases
Volume11
Issue numberSUPPL. 2
DOIs
StatePublished - Dec 2007

Keywords

  • Emergency department
  • Health care utilization
  • Hospitalizations
  • Human-bovine reassortant pentavalent rotavirus vaccine
  • Rotavirus
  • Vaccine

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases

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