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