Mini-Sentinel: Pilot Of Self-Controlled Tree-Temporal Scan Analysis For Gardasil Vaccine

Methods project to develop test unconditional and conditional variants of the self-controlled tree-temporal scan statistic, both with and without day-of-week adjustment using Gardasil human papillomavirus quadrivalent vaccine (types 6, 11, 16, 18) as the test vaccine.
 
The Mini-Sentinel Operations Center posted this final draft protocol for public comment from February 9, 2015 through February 23, 2015.  A revised version was approved for implementation by FDA on March 30, 2015. A log of changes is included in the revised protocol (v2.0).