Effectiveness of monovalent and pentavalent rotavirus vaccine

Pediatrics. 2013 Jul;132(1):e25-33. doi: 10.1542/peds.2012-3804. Epub 2013 Jun 17.

Abstract

Objective: Previous US evaluations have not assessed monovalent rotavirus vaccine (RV1, a G1P[8] human rotavirus strain) effectiveness, because of its later introduction (2008). Using case-control methodology, we measured the vaccine effectiveness (VE) of the 2-dose RV1 and 3-dose pentavalent vaccine (RV5) series against rotavirus disease resulting in hospital emergency department or inpatient care.

Methods: Children were eligible for enrollment if they presented to 1 of 5 hospitals (3 in Georgia, 2 in Connecticut) with diarrhea of ≤10 days' duration during January through June 2010 or 2011, and were born after RV1 introduction. Stools were collected; immunization records were obtained from providers and state electronic immunization information system (IIS). Case-subjects (children testing rotavirus antigen-positive) were compared with 2 control groups: children testing rotavirus negative and children selected from IIS.

Results: Overall, 165 rotavirus-case subjects and 428 rotavirus-negative controls were enrolled. Using the rotavirus-negative controls, RV1 VE was 91% (95% confidence interval [CI] 80 to 95) and RV5 VE was 92% (CI 75 to 97) among children aged ≥8 months. The RV1 VE against G2P[4] disease was high (94%, CI 78 to 98), as was that against G1P[8] disease (89%, CI 70 to 96). RV1 effectiveness was sustained among children aged 12 through 23 months (VE 91%; CI 75 to 96). VE point estimates using IIS controls were similar to those using rotavirus-negative controls.

Conclusions: RV1 and RV5 were both highly effective against severe rotavirus disease. RV1 conferred sustained protection during the first 2 years of life and demonstrated high effectiveness against G2P[4] (heterotypic) disease.

Keywords: diarrhea; gastroenteritis; immunization; rotavirus; rotavirus vaccine; vaccine effectiveness.

Publication types

  • Comparative Study
  • Research Support, N.I.H., Extramural
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Case-Control Studies
  • Confidence Intervals
  • Diarrhea, Infantile / epidemiology
  • Diarrhea, Infantile / immunology*
  • Diarrhea, Infantile / prevention & control*
  • Emergency Service, Hospital / statistics & numerical data
  • Female
  • Georgia
  • Hospitals, Pediatric / statistics & numerical data
  • Humans
  • Immunization, Secondary
  • Infant
  • Male
  • Patient Admission / statistics & numerical data
  • Rotavirus Infections / epidemiology
  • Rotavirus Infections / immunology*
  • Rotavirus Infections / prevention & control*
  • Rotavirus Vaccines / administration & dosage*
  • Rotavirus Vaccines / immunology*
  • Treatment Outcome
  • Utilization Review / statistics & numerical data
  • Vaccines, Attenuated / administration & dosage
  • Vaccines, Attenuated / immunology

Substances

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