TDAP Safety in Pregnant Women
Completed
Conditions studied: Pertussis
In brief
The purpose of this observational study is to evaluate the safety of Tetanus Toxoid Reduced Diphtheria, Toxoid, and Acelluar Pertussis Vaccine (Tdap) in pregnant women at ≥ 20 weeks 0 days gestation receiving Tdap as part of standard practice. Prior Tdap/Td/TT history will be verified by medical record review when possible. There will be an emphasis on enrolling women who have received Tdap before the current pregnancy, to the greatest extent possible. Non-pregnant women who are receiving their initial Tdap will also be recruited. Injection-site (local) and systemic reaction data will be assessed on the vaccination day and during the 7 days following vaccination using either identical web-based or paper diaries, depending on the preference of the study participant. Pregnant women will be followed until delivery with comprehensive obstetric and neonatal outcomes obtained from review of the electronic medical record.
Key facts
- Study ID
- NCT02209623
- Run by
- Vanderbilt University
- People needed
- 375
- Starts
- 2014-05-01
- Expected to finish
- 2017-12-18
- Last updated by the study team
- 2017-12-20
Who can join
Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.
Where it is running
- Duke University Dept of ObGyn, Division of Maternal-Fetal Medicine — Durham, North Carolina, United States
- Vanderbilt Medical Center, Vaccine Research Program — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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