Influenza Vaccines and Pregnancy Outcomes (PRISM)

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

    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
    CBER
    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