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PICO
Question: Among US infants who receive a rotavirus vaccine, what is the risk of intussusception?
Question type: Occurrence
Study design: Case control
Investigators from 2 independent groups conducted postmarketing surveillance studies to determine the risk of intussusception among US infants after vaccination with the rotavirus vaccines, RotaTeq (RV5) and Rotarix (RV1). One study was initiated by the FDA as part of the Post-Licensure Rapid Immunization Safety Monitoring (PRISM) program, which utilized clinic data from 3 large insurance groups (FDA study). The other study was initiated by the CDC as part of the Vaccine Safety …
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