Pediatrics
July 2013, VOLUME 132 / ISSUE 1
http://pediatrics.aappublications.org/current.shtml

Article
Effectiveness of Monovalent and Pentavalent Rotavirus Vaccine
Margaret M. Cortese, MD^a, Lilly Cheng Immergluck, MD, MS^b,^c, Melissa Held, MD^d, Shabnam Jain, MD, MPH^b,^e, Trisha Chan, BS^c, Alexandra P. Grizas, MPH^f, Saadia Khizer, MD, MPHP^b, Carol Barrett, MA^d, Osbourne Quaye, PhD^a, Slavica Mijatovic-Rustempasic, MSc^a, Rashi Gautam, PhD^a, Michael D. Bowen, PhD^a, Jessica Moore, MPH^a, Jacqueline E. Tate, PhD^a, Umesh D. Parashar, MBBS, MPH^a, and Marietta Vázquez, MD^f

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.