Adapting Group Sequential Methods to Observational Postlicensure Vaccine Safety Surveillance

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Adapting Group Sequential Methods to Observational Postlicensure Vaccine Safety Surveillance: Results of a Pentavalent Combination DTaP-IPV-Hib Vaccine Safety …

JC Nelson, O Yu, CP Dominguez-Islas, AJ Cook… – American Journal of …, 2013

Abstract To address gaps in traditional postlicensure vaccine safety surveillance and to
promote rapid signal identification, new prospective monitoring systems using large health-
care database cohorts have been developed. We newly adapted clinical trial group …