Effectiveness of pentavalent rotavirus vaccine in a large urban population in the United States

Pediatrics. 2010 Feb;125(2):e199-207. doi: 10.1542/peds.2009-1021. Epub 2010 Jan 18.


Objective: The goal was to assess the effectiveness of complete (3-dose) or partial (1- or 2-dose) immunization with pentavalent rotavirus vaccine (RV5) against rotavirus acute gastroenteritis (AGE) in US clinical practice.

Methods: A case-control evaluation was conducted in February through June 2008 at an emergency department in Houston, Texas. Case patients with rotavirus AGE (N = 90) were identified through testing for rotavirus in fecal specimens obtained from 205 children 15 days through 23 months of age presenting with AGE. Control groups included rotavirus-negative AGE patients (N = 115), concurrently enrolled patients with acute respiratory infection (ARI) (N = 228), and up to 10 age- and zip code-matched children sampled from the Houston-Harris County Immunization Registry (HHCIR) for each case patient >8 months of age. Immunization data were obtained from parent records, health care providers, and/or the HHCIR. Vaccine effectiveness was calculated as 1 minus odds of RV5 vaccination for case patients versus control patients, after adjustment for age at presentation and birth date.

Results: The vaccine effectiveness of a complete RV5 series was 89% (95% confidence interval [CI]: 70%-96%) and 85% (95% CI: 55%-95%) with rotavirus-negative AGE and ARI control patients, respectively. Immunization data were available for 44% of case patients (n = 40) from the HHCIR; the estimated 3-dose vaccine effectiveness with these HHCIR control patients was 82% (95% CI: 19%-96%). A complete RV5 series conferred 100% protection (95% CI: 71%-100%) against severe rotavirus disease requiring hospitalization and 96% protection (95% CI: 72%-99%) against disease requiring intravenous hydration. Vaccine effectiveness of 1 and 2 doses against hospitalization and emergency department visits was 69% (95% CI: 13%-89%) and 81% (95% CI: 13%-96%), respectively, using rotavirus-negative AGE and ARI control groups combined.

Conclusions: In this setting, a complete series of RV5 was highly effective against severe rotavirus AGE. Partial immunization also conferred substantial protection.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Age Distribution
  • Case-Control Studies
  • Emergency Service, Hospital / statistics & numerical data
  • Female
  • Gastroenteritis / epidemiology
  • Gastroenteritis / prevention & control
  • Gastroenteritis / virology*
  • Hospitalization / statistics & numerical data
  • Humans
  • Immunization Schedule
  • Infant
  • Infant, Newborn
  • Male
  • Product Surveillance, Postmarketing
  • Rotavirus Infections / epidemiology
  • Rotavirus Infections / prevention & control*
  • Rotavirus Vaccines / administration & dosage*
  • Texas / epidemiology
  • Urban Population / statistics & numerical data
  • Vaccines, Attenuated / administration & dosage


  • RotaTeq
  • Rotavirus Vaccines
  • Vaccines, Attenuated