title: Intussusception among infants given an oral rotavirus vaccine.
abstract: BACKGROUND
  Intussusception is a form of intestinal obstruction in which a segment of the bowel prolapses into a more distal segment. Our investigation began on May 27, 1999, after nine cases of infants who had intussusception after receiving the tetravalent rhesus-human reassortant rotavirus vaccine (RRV-TV) were reported to the Vaccine Adverse Event Reporting System.
  
  
  METHODS
  In 19 states, we assessed the potential association between RRV-TV and intussusception among infants at least 1 but less than 12 months old. Infants hospitalized between November 1, 1998, and June 30, 1999, were identified by systematic reviews of medical and radiologic records. Each infant with intussusception was matched according to age with four healthy control infants who had been born at the same hospital as the infant with intussusception. Information on vaccinations was verified by the provider.
  
  
  RESULTS
  Data were analyzed for 429 infants with intussusception and 1763 matched controls in a case-control analysis as well as for 432 infants with intussusception in a case-series analysis. Seventy-four of the 429 infants with intussusception (17.2 percent) and 226 of the 1763 controls (12.8 percent) had received RRV-TV (P=0.02). An increased risk of intussusception 3 to 14 days after the first dose of RRV-TV was found in the case-control analysis (adjusted odds ratio, 21.7; 95 percent confidence interval, 9.6 to 48.9). In the case-series analysis, the incidence-rate ratio was 29.4 (95 percent confidence interval, 16.1 to 53.6) for days 3 through 14 after a first dose. There was also an increase in the risk of intussusception after the second dose of the vaccine, but it was smaller than the increase in risk after the first dose. Assuming full implementation of a national program of vaccination with RRV-TV, we estimated that 1 case of intussusception attributable to the vaccine would occur for every 4670 to 9474 infants vaccinated.
  
  
  CONCLUSIONS
  The strong association between vaccination with RRV-TV and intussusception among otherwise healthy infants supports the existence of a causal relation. Rotavirus vaccines with an improved safety profile are urgently needed.
authors.affiliation: Epidemiology and Surveillance Division, National Immunization Program, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA. tvmurphy@cdc.gov
authors.forename: T V
authors.initials: TV
authors.lastname: Murphy
authors.forename: P M
authors.initials: PM
authors.lastname: Gargiullo
authors.forename: M S
authors.initials: MS
authors.lastname: Massoudi
authors.forename: D B
authors.initials: DB
authors.lastname: Nelson
authors.forename: A O
authors.initials: AO
authors.lastname: Jumaan
authors.forename: C A
authors.initials: CA
authors.lastname: Okoro
authors.forename: L R
authors.initials: LR
authors.lastname: Zanardi
authors.forename: S
authors.initials: S
authors.lastname: Setia
authors.forename: E
authors.initials: E
authors.lastname: Fair
authors.forename: C W
authors.initials: CW
authors.lastname: LeBaron
authors.forename: M
authors.initials: M
authors.lastname: Wharton
authors.forename: J R
authors.initials: JR
authors.lastname: Livengood
authors.forename: J R
authors.initials: JR
authors.lastname: Livingood
mesh_terms: D016022:Case-Control Studies; D005006:Ethnicity; D005260:Female; D006801:Humans; D007223:Infant; D007443:Intussusception / Q000209:etiology*; D008297:Male; D016017:Odds Ratio; D012307:Risk Factors; D022243:Rotavirus Vaccines / Q000009:adverse effects*; D012737:Sex Factors; D012959:Socioeconomic Factors; D014481:United States
chemical_list: D022243:Rotavirus Vaccines; C052014:rhesus rotavirus vaccine