Effectiveness of Pentavalent and Monovalent Rotavirus Vaccines in Concurrent Use Among US Children <5 Years of Age, 2009–2011

• Published in: Clinical infectious diseases Vol. 57; no. 1; pp. 13 - 20
• Main Authors: Payne, Daniel C., Boom, Julie A., Staat, Mary Allen, Edwards, Kathryn M., Szilagyi, Peter G., Klein, Eileen J., Selvarangan, Rangaraj, Azimi, Parvin H., Harrison, Christopher, Moffatt, Mary, Johnston, Samantha H., Sahni, Leila C., Baker, Carol J., Rench, Marcia A., Donauer, Stephanie, McNeal, Monica, Chappell, James, Weinberg, Geoffrey A., Tasslimi, Azadeh, Tate, Jacqueline E., Wikswo, Mary, Curns, Aaron T., Sulemana, Iddrisu, Mijatovic-Rustempasic, Slavica, Esona, Mathew D., Bowen, Michael D., Gentsch, Jon R., Parashar, Umesh D.
• Format: Journal Article
• Language: English
• Published: United States Oxford University Press 01-07-2013
• Subjects: Ambulatory Care - statistics & numerical data; ARTICLES AND COMMENTARIES; Child, Preschool; Children; Childrens health; Enzyme-Linked Immunosorbent Assay; Feces; Feces - virology; Female; Gastroenteritis; Gastroenteritis - prevention & control; Gastrointestinal diseases; Genotype; Genotype & phenotype; Genotypes; Hospitalization; Hospitalization - statistics & numerical data; Humans; Immunization; Infant; Male; Pediatrics; Rotavirus; Rotavirus - isolation & purification; Rotavirus Infections - prevention & control; Rotavirus vaccines; Rotavirus Vaccines - administration & dosage; Rotavirus Vaccines - immunology; Surveillance; United States; Vaccination; Vaccines; Vaccines, Attenuated - administration & dosage; Vaccines, Attenuated - immunology; Viruses; United States; United States > US; New Vaccine Surveillance Network; vaccine; rotavirus; RotaTeq
• ISSN: 1058-4838; 1537-6591
• 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.