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NCT02209623 · ClinicalTrials.gov registry record
TDAP Safety in Pregnant Women
A clinical trial, sponsored by Vanderbilt University.
- Completed
- Registry status
- 375
- Enrollment target
NCT02209623 is a clinical trial that has completed, run by Vanderbilt University. The registered enrollment target is 375 participants.
The verdict
NCT02209623 has completed, sponsored by Vanderbilt University.
- COMPLETED
- Registry status
- 375 participants
- Enrollment target
Study Summary
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.
Interventions
- BIOLOGICAL TDAP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 375 participants |
| Start Date | 2014-05 |
| Est. Completion | 2017-12-18 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02209623
The ClinicalTrials.gov registry entry for NCT02209623 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 375 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University, which has 430 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which TDAP is the first listed.
NCT02209623 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02209623 about?
NCT02209623 is a clinical study titled "TDAP Safety in Pregnant Women". 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 rec...
What is the current status of trial NCT02209623?
This trial is currently completed. The enrollment target is 375 participants. The study started on 2014-05. Estimated completion is 2017-12-18.
What interventions are being tested in trial NCT02209623?
The interventions under investigation include: TDAP (BIOLOGICAL).
Who is sponsoring clinical trial NCT02209623?
This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.
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