Tdap Vaccination During Pregnancy

    Basic Details
    Date Posted
    Thursday, July 27, 2017
    Status
    Complete
    Medical Product
    tetanus, diphtheria, pertussis (Tdap) vaccine
    Health Outcome(s)
    pertussis
    Description

    CBER has requested execution of the pregnancy tool to determine the number of pregnant women/episodes with a Tdap vaccination. This a feasibility assessment to determine if Sentinel data can provide enough sample size/power to be used to resolve regulatory concerns, such as the investigation of the impact of Tdap vaccination of pregnant women on the rates of pertussis in children in a full PBA.

    Additional Details
    FDA Center
    CBER
    Time Period
    January 1, 2010 - September 30, 2015
    Study Type
    Modular Program
    Assessment Type
    Exploratory Analyses
    Population / Cohort
    All pregnant females 10 - 54 years of age
    Data Sources
    Sentinel Distributed Database (SDD)
    Workgroup Leader(s)

    Alison Kawai, ScD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

    Workgroup Members

    Genna Panucci, MPH; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA