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
Sentinel Modular Program Report: Tdap Vaccination During Pregnancy
Related Links
ICPE 2017 Poster: Trends of Tetanus, Diphtheria, and Acellular Pertussis (Tdap) Vaccination During Pregnancy in the Sentinel System
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
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