Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02209623 · ClinicalTrials.gov registry record
TDAP Safety in Pregnant Women
A clinical trial, sponsored by Vanderbilt University.
- Completed
- Registry status
- 375
- Enrollment target
NCT02209623: Completed study, sponsored by Vanderbilt University.
NCT02209623 is a clinical trial that has completed, run by Vanderbilt University. The registered enrollment target is 375 participants. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Rates of injection-site and systemic reactions after Tdap in pregnant women versus non-pregnant women will be compared.
Interventions
- BIOLOGICAL TDAP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 375 participants |
| Start Date | 2014-05 |
| Est. Completion | 2017-12-18 |
What the finished NCT02209623 record still lists
NCT02209623 is an observational study that tracks outcomes without assigning an intervention. The registered 375 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which TDAP is the first listed.
NCT02209623 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03686124 · 375 participants · Phase 1
ACTengine® IMA203/IMA203CD8 as Monotherapy or in Combination With Nivolumab in Recurrent and/or Refractory Solid Tumors
- NCT04059172 · 375 participants · Early Phase 1
Efficacy of Combined Ibuprofen and Acetaminophen Therapy Versus Ibuprofen Alone Versus Placebo Alone for Pain Management
- NCT04134923 · 375 participants
Imaging Biomarkers in Preclinical and Symptomatic AD
- NCT04569747 · 375 participants · Phase 2
A Single Arm Phase II Study of ADjuvant Endocrine Therapy, Pertuzumab, and Trastuzumab for Patients With Anatomic Stage I Hormone Receptor-positive, HER2-positive Breast Cancer
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia