The initial landmark trials of Rotateq and Rotarix—rotavirus vaccines approved for widespread use in 2006 and 2008, respectively—revealed impressive efficacy and safety profiles from a large cohort of various countries, as well as a reduction in rates of hospitalizations, and emergency room and office visits.However, none of these studies were conducted in the United States. Accordingly, this study’s primary aim is to assess the effectiveness of the recently licensed rotavirus vaccines in preventing hospitalization, and emergency room and office visits, in young children specifically in a US clinical setting. This study will provide a generalizable model and better understanding of the vaccines’ effectiveness in the current setting of the US health care system.
Goals & Objectives
- Assess the effectiveness of rotavirus vaccine in preventing hospitalization, and emergency room and office visits due to laboratory-confirmed rotavirus illness in children under 6 years of age
- Assess the effectiveness of rotavirus vaccine by severity of illness, number of doses given, and type of vaccine given; among different risk groups; and against vaccine and non-vaccine serotypes
- Evaluate the relationship between rotavirus viremia and severity of illness
- Assess the effectiveness of rotavirus vaccine in preventing rotavirus gastroenteritis in older unvaccinated household contacts
- Evaluate the etiology of diarrheal illness requiring outpatient or inpatient care in the post-vaccine era
- Active surveillance for laboratory-confirmed cases of rotavirus among pediatric inpatients at Yale-New Haven Hospital (YNHH) and Connecticut Children’s Medical Center (CCMC)
- Active surveillance for pediatric outpatients and inpatients with symptoms of acute gastroenteritis at YNHH and CCMC
- Laboratory analysis of specimens for rotavirus presence and serotype
- Caregiver questionnaire to assess the etiology of gastroenteritis and symptomatology
- Composite medical record review for complete and detailed immunization history
- Outpatient and inpatient medical record review for gastroenteritis visit history
- Case-control study of the effectiveness of Rotarix and Rotateq rotavirus vaccines
Margaret M. Cortese, Julie LeBlanc, Karen E. White, Robert C. Jerris, Patricia Stinchfield, Kenan L. Preston, James Meek, Lynda Odofin, Saadia Khizer, Claudia A Miller, Vicki Buttery, Slavica Mijatovic-Rustempasic, Jamie Lewis, Umesh D. Parashar and Lilly Cheng Immergluck. Leveraging State Immunization Information Systems to Measure the Effectiveness of Rotavirus Vaccine . Pediatrics. 2011 Nov 14. [Epub ahead of print]
Desai SN, Esposito DB, Shapiro ED, Dennehy PH, Vázquez M. Effectiveness of rotavirus vaccine in preventing hospitalization due to rotavirus gastroenteritis in young children in Connecticut, USA. Vaccine. 2010 Nov 3;28(47):7501-6.
Desai SN, Vázquez M. Update on Rotavirus Trends and the Importance of Surveillance. The Pediatric Infectious Disease Journal. 2010 Dec;29(12):1130-2.