Effectiveness of pentavalent and monovalent rotavirus vaccines in concurrent use among US children <5 years of age, 2009-2011

Clin Infect Dis. 2013 Jul;57(1):13-20. doi: 10.1093/cid/cit164. Epub 2013 Mar 13.


Background: We assessed vaccine effectiveness (VE) for RotaTeq (RV5; 3 doses) and Rotarix (RV1; 2 doses) at reducing rotavirus acute gastroenteritis (AGE) inpatient and emergency department (ED) visits in US children.

Methods: We enrolled children <5 years of age hospitalized or visiting the ED with AGE symptoms from November 2009-June 2010 and from November 2010-June 2011 at 7 medical institutions. Fecal specimens were tested for rotavirus by enzyme immunoassay and genotyped. Vaccination among laboratory-confirmed rotavirus cases was compared with rotavirus-negative AGE controls. Regression models calculated VE estimates for each vaccine, age, ethnicity, genotype, and clinical setting.

Results: RV5-specific analyses included 359 rotavirus cases and 1811 rotavirus-negative AGE controls. RV1-specific analyses included 60 rotavirus cases and 155 rotavirus-negative AGE controls. RV5 and RV1 were 84% (95% confidence interval [CI], 78%-88%) and 70% (95% CI, 39%-86%) effective, respectively, against rotavirus-associated ED visits and hospitalizations combined. By clinical setting, RV5 VE against ED and inpatient rotavirus-associated visits was 81% (95% CI, 70%-84%) and 86% (95% CI, 74%-91%), respectively. RV1 was 78% (95% CI, 46%-91%) effective against ED rotavirus disease; study power was insufficient to evaluate inpatient RV1 VE. No waning of immunity was evident during the first 4 years of life for RV5, nor during the first 2 years of life for RV1. RV5 provided genotype-specific protection against each of the predominant strains (G1P[8], G2P[4], G3P[8], G12P[8]), while RV1 VE was statistically significant for the most common genotype, G3P[8].

Conclusions: Both RV5 and RV1 significantly protected against medically attended rotavirus gastroenteritis in this real-world assessment.

Keywords: New Vaccine Surveillance Network; RotaTeq; rotavirus; vaccine.

Publication types

  • Research Support, U.S. Gov't, Non-P.H.S.
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Ambulatory Care / statistics & numerical data
  • Child, Preschool
  • Enzyme-Linked Immunosorbent Assay
  • Feces / virology
  • Female
  • Gastroenteritis / prevention & control
  • Genotype
  • Hospitalization / statistics & numerical data
  • Humans
  • Infant
  • Male
  • Rotavirus / isolation & purification
  • Rotavirus Infections / prevention & control*
  • Rotavirus Vaccines / administration & dosage*
  • Rotavirus Vaccines / immunology*
  • United States
  • Vaccines, Attenuated / administration & dosage
  • Vaccines, Attenuated / immunology


  • RIX4414 vaccine
  • RotaTeq
  • Rotavirus Vaccines
  • Vaccines, Attenuated