Details
This project was a one-time assessment of the association between influenza vaccination during pregnancy and spontaneous abortion (SAB). Protocol-based assessments use study designs and analysis plans customized for the product-outcome pairs being assessed.
The Mini-Sentinel Operations Center posted this protocol for public comment from September 18, 2013 through October 2, 2013. The public comment period is now closed. A revised version was approved for implementation by FDA on December 30, 2015. A log of changes is included in the revised protocol (v3.0).
Additional Information
Contributors
Alison Tse Kawai, ScD; Grace M. Lee, MD, MPH; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA
Azadeh Shoaibi, PhD, MS, MHS; Center for Biologics Evaluation and Research, FDA, Silver Spring, MD
Sandra Feibelmann, MPH; Martin Kulldorff, PhD; Lingling Li, PhD; Hana Lipowicz, MPH; Megan Reidy, MPH; Lauren Zichittella, MS; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA
Jane Woo, MD, MPH; Center for Biologics Evaluation and Research, FDA, Silver Spring, MD
Cheryl N. McMahill-Walraven, PhD, MSW; Aetna: Aetna Informatics, Blue Bell, PA
Mano S. Selvan, PhD; Comprehensive Health Insights, Humana Inc, Louisville, KY
Chunfu Liu, PhD; HealthCore Inc., Alexandria, VA
Erin Longley, MD; Family Medicine Residency Program, Community Health Care, Tacoma, WA
Colleen Stockdale, MD, MS; Department of Obstetrics & Gynecology, University of Iowa, Iowa City, IA