http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11332666&dopt=Abstract
Population-based study of rotavirus vaccination and
intussusception.
Kramarz P, France EK, Destefano F, Black SB, Shinefield H, Ward JI, Chang EJ,
Chen RT, Shatin D, Hill J, Lieu T, Ogren JM.
National Immunization Program, Centers for Disease Control and Prevention,
Atlanta, GA, USA.
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.
PMID: 11332666 [PubMed - indexed for MEDLINE]
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MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR GENERAL INFORMATION
PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE KNOWLEDGE OR OPINIONS
OF THE PUBLISHER, AND IS NOT TO BE CONSTRUED OR INTENDED AS PROVIDING MEDICAL OR
LEGAL ADVICE. THE DECISION WHETHER OR NOT TO VACCINATE IS AN IMPORTANT AND
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