Post-Licensure Observational Study of the Safety of GARDASIL™ in Males
Observational
Observational Model: Cohort, Time Perspective: Retrospective
Incidence of health outcomes resulting in emergency room visits or hospitalizations in 60-day risk periods after each dose of GARDASIL™ compared to post-vaccination self-comparison periods
Within 60 days after each dose
Yes
United States: Food and Drug Administration
V501-070
NCT01567813
June 2011
June 2017
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