Tdap Vaccination During Pregnancy

Project Title Tdap Vaccination During Pregnancy
Date Posted
Thursday, July 27, 2017
Project ID
cber_mpl1r_wp006_nsdp_v01
Status
Complete
Deliverables
Related Links
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.

Medical Product
tetanus, diphtheria, pertussis (Tdap) vaccine
Health Outcome
pertussis
Population / Cohort
All pregnant females 10 - 54 years of age
Time Period
January 1, 2010 - September 30, 2015
Assessment Type
Exploratory Analyses
Study Type
Modular Program
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

Data Sources
Sentinel Distributed Database (SDD)
FDA Center
CBER