Effectiveness of Monovalent and Pentavalent Rotavirus Vaccine

Abstract

WHAT'S KNOWN ON THIS SUBJECT: Monovalent rotavirus vaccine was introduced for infants in the United States in 2008. Previous US evaluations have not specifically assessed the performance of this vaccine under routine use. WHAT THIS STUDY ADDS:Using the same methodology and covering the same time period, high effectiveness (∼90%) was demonstrated for the monovalent and the pentavalent rotavirus vaccine series against rotavirus disease resulting in emergency department/inpatient care, in children up to 2 years of age. 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 antigenpositive) 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 rotavirusnegative 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. Pediatrics 2013;132:e25-e33 AUTHORS: