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Effectiveness of Pentavalent Rotavirus Vaccine in a Large Urban Population in the United States

2010; American Academy of Pediatrics; Volume: 125; Issue: 2 Linguagem: Inglês

10.1542/peds.2009-1021

1098-4275

Julie A. Boom, Jacqueline E. Tate, Leila C. Sahni, Marcia A. Rench, Jennifer J. Hull, Jon R. Gentsch, Manish M. Patel, Carol J. Baker, Umesh D. Parashar,

Viral Infections and Immunology Research

OBJECTIVE: The goal was to assess the effectiveness of complete (3-dose) or partial (1- or 2-dose) immunization with pentavalent rotavirus vaccine (RV5) against rotavirus acute gastroenteritis (AGE) in US clinical practice. METHODS: A case-control evaluation was conducted in February through June 2008 at an emergency department in Houston, Texas. Case patients with rotavirus AGE (N = 90) were identified through testing for rotavirus in fecal specimens obtained from 205 children 15 days through 23 months of age presenting with AGE. Control groups included rotavirus-negative AGE patients (N = 115), concurrently enrolled patients with acute respiratory infection (ARI) (N = 228), and up to 10 age- and zip code-matched children sampled from the Houston-Harris County Immunization Registry (HHCIR) for each case patient >8 months of age. Immunization data were obtained from parent records, health care providers, and/or the HHCIR. Vaccine effectiveness was calculated as 1 minus odds of RV5 vaccination for case patients versus control patients, after adjustment for age at presentation and birth date. RESULTS: The vaccine effectiveness of a complete RV5 series was 89% (95% confidence interval [CI]: 70%–96%) and 85% (95% CI: 55%–95%) with rotavirus-negative AGE and ARI control patients, respectively. Immunization data were available for 44% of case patients (n = 40) from the HHCIR; the estimated 3-dose vaccine effectiveness with these HHCIR control patients was 82% (95% CI: 19%–96%). A complete RV5 series conferred 100% protection (95% CI: 71%–100%) against severe rotavirus disease requiring hospitalization and 96% protection (95% CI: 72%–99%) against disease requiring intravenous hydration. Vaccine effectiveness of 1 and 2 doses against hospitalization and emergency department visits was 69% (95% CI: 13%–89%) and 81% (95% CI: 13%–96%), respectively, using rotavirus-negative AGE and ARI control groups combined. CONCLUSIONS: In this setting, a complete series of RV5 was highly effective against severe rotavirus AGE. Partial immunization also conferred substantial protection.