Population-based study of rotavirus vaccination and intussusception
Authors
Kramarz, PoitrFrance, Eric K.
Destefano, Frank
Black, Steven B.
Shinefield, Henry
Ward, Joel I.
Chang, Emily J.
Chen, Robert T.
Shatin, Deborah
Hill, Jerrold
Lieu, Tracy
Ogren, John M.
Gurwitz, Jerry H.
Andrade, Susan E.
Cernieux, Jackie
UMass Chan Affiliations
Meyers Primary Care InstituteDocument Type
Journal ArticlePublication Date
2001-04-03Keywords
HumansInfant
Intussusception
Poisson Distribution
Proportional Hazards Models
Retrospective Studies
Risk
Rotavirus Vaccines
Vaccination
Health Services Research
Primary Care
Metadata
Show full item recordAbstract
BACKGROUND: During the first year that the rhesus rotavirus tetravalent vaccine (RRV-TV) was licensed, the Vaccine Adverse Event Reporting System received several reports of intussusception after vaccination. To evaluate the risk of intussusception, we conducted a retrospective cohort study in ten managed care organizations. METHODS: Cases of intussusception were identified by searching electronic databases for diagnoses of intussusception (ICD-9 Code 560.0) in infants 1 to 11 months of age and confirmed by medical chart review. Vaccination and enrollment data were obtained from administrative databases. Incidence rate ratios (RR) of intussusception were computed by dividing incidence rates in prespecified risk intervals after vaccination by the background rate of intussusception and adjusted for age by Poisson regression. Cox proportional hazard regression was used to evaluate risk by vaccine dose. RESULTS: Of 463,277 children 56,253 had been vaccinated with a total of 91 371 doses of RRV-TV. The incidence rate of intussusception was 25/100,000 person years among unexposed infants and 340/100,000 person years 3 to 7 days postvaccination. In the interval 3 to 7 days after vaccination, the age-adjusted RR was 16.0 (95% confidence interval, 5.5 to 46.7) for all doses combined and 30.4 (95% confidence interval, 8.8 to 104.9) after the first dose. RRs for the 8- to 14- and 15- to 21-day risk intervals were >1.0, but the confidence intervals substantially overlapped 1.0. The attributable risk was one case of intussusception per 11 073 children vaccinated. CONCLUSIONS: RRV-TV is associated with an increased risk of intussusception. The risk is greatest 3 to 7 days after the first vaccination dose.Source
Pediatr Infect Dis J. 2001 Apr;20(4):410-6.Permanent Link to this Item
http://hdl.handle.net/20.500.14038/36905PubMed ID
11332666Notes
Jerry H. Gurwitz, M.D., Susan E. Andrade, Sc.D., and Jackie Cernieux, M.P.H., of Meyers Primary Care Institute, Fallon Healthcare System, Worcester, MA, are listed as additional co-authors at the end of the paper.