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Four Different Study Designs To Evaluate Vaccine Safety Were Equally Validated With Contrasting Limitations, Jason M. Glanz, David L. Mcclure, Stanley Xu, Simon J. Hambidge, Martin Lee, Margarette S. Kolczak, Ken Kleinman, John P. Mullooly, Eric K. France

Public Health Department Faculty Publication Series

OBJECTIVE:

We conducted a simulation study to empirically compare four study designs [cohort, case-control, risk-interval, self-controlled case series (SCCS)] used to assess vaccine safety.

STUDY DESIGN AND METHODS:

Using Vaccine Safety Datalink data (a Centers for Disease Control and Prevention-funded project), we simulated 250 case sets of an acute illness within a cohort of vaccinated and unvaccinated children. We constructed the other three study designs from the cohort at three different incident rate ratios (IRRs, 2.00, 3.00, and 4.00), 15 levels of decreasing disease incidence, and two confounding levels (20%, 40%) for both fixed and seasonal confounding. Each of the …