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

Payne DC, Boom JA, Staat MA, Edwards KM, Szilagyi PG, Klein EJ, Selvarangan R, Azimi PH, Harrison C, Moffatt M, Johnston SH, Sahni LC, Baker CJ, Rench MA, Donauer S, McNeal M, Chappell J, Weinberg GA, Tasslimi A, Tate JE, Wikswo M, Curns AT, Sulemana I, Mijatovic-Rustempasic S, Esona MD, Bowen MD, Gentsch JR, Parashar UD
Clin Infect Dis. 2013 57 (1): 13-20

PMID: 23487388 · PMCID: PMC4618548 · DOI:10.1093/cid/cit164

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.

MeSH Terms (16)

Ambulatory Care Child, Preschool Enzyme-Linked Immunosorbent Assay Feces Female Gastroenteritis Genotype Hospitalization Humans Infant Male Rotavirus Rotavirus Infections Rotavirus Vaccines United States Vaccines, Attenuated

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