Influenza Vaccines and Pregnancy Outcomes (PRISM)

Basic Details
Date Posted
Friday, January 26, 2018
Medical Product
influenza vaccine
Health Outcome(s)
spontaneous abortion (SAB)

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 Details
FDA Center
Time Period
2004 - 2012
Study Type
Protocol/Surveillance Plan
Assessment Type
Safety Analyses
HOI Study Type
Validations Supported by Traditional Medical Chart Review
Population / Cohort
All females 10 -55 years of age
Data Sources
Mini-Sentinel Distributed Database (MSDD)
Workgroup Leader(s)

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

Workgroup Members

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