Abstract | BACKGROUND: METHODS: The exposed population included children from age 4 to 48 weeks who received RotaTeq between May 2006 and May 2008. Adverse events over the subsequent 30 days were ascertained from inpatient, outpatient, and emergency department files; cases of intussusception were validated by medical record review. An adaptation of sequential probability ratio testing was employed to compare the cumulative number of observed and expected adverse events on a weekly basis, and a "signal" was generated if the log-likelihood ratio reached a predetermined threshold. This allowed near real-time monitoring to detect selected adverse events. The expected number of cases of intussusception was determined from historical rates in the VSD population. RESULTS: There were 207,621 doses of RotaTeq administered to the study population; 42% were first doses. Five children had computerized diagnosis codes for intussusception, and 6.75 cases were expected based on historical rates (relative risk = 0.74). No elevation in risk was identified for intussusception or any other adverse event. Two of five children with suspected intussusception based on diagnosis codes met the case criteria after medical record review. CONCLUSIONS: This study illustrates the feasibility of rapid vaccine safety assessment and provides additional evidence that RotaTeq is not associated with an increased risk of intussusception.
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Authors | Edward A Belongia, Stephanie A Irving, Irene M Shui, Martin Kulldorff, Edwin Lewis, Ruihua Yin, Tracy A Lieu, Eric Weintraub, W Katherine Yih, Rong Li, James Baggs, Vaccine Safety Datalink Investigation Group |
Journal | The Pediatric infectious disease journal
(Pediatr Infect Dis J)
Vol. 29
Issue 1
Pg. 1-5
(Jan 2010)
ISSN: 1532-0987 [Electronic] United States |
PMID | 19907356
(Publication Type: Journal Article, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)
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Chemical References |
- RotaTeq
- Rotavirus Vaccines
- Vaccines, Attenuated
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Topics |
- Female
- Humans
- Infant
- Intussusception
(chemically induced, epidemiology)
- Male
- Prospective Studies
- Risk Assessment
- Rotavirus Vaccines
(adverse effects)
- Vaccines, Attenuated
(adverse effects)
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