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NCT01711645 · ClinicalTrials.gov registry record · Phase 4
Tdap Vaccine in Post-Partum Women
A Phase 4 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 4
- Development phase
- 55
- Enrollment target
NCT01711645: Completed Phase 4 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01711645 is a Phase 4 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 55 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01711645, a Phase 4 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 55 participants
- Enrollment target
Study Summary
Monitoring immune response and longevity in serum and milk after Tdap administration to postpartum women. The clinical trial will involve women (aged 18 - 45 years) who have just delivered full-term infants (greater than or equal to 37 completed weeks of gestation) at Vanderbilt University Medical Center. The enrollment period will be fifteen months. The duration is over two years of observation.
Primary Outcome
Blood was collected from participants at baseline prior to vaccination and at 2 weeks after vaccination for assessment of IgG by ELISA against the pertussis toxin (PT), filamentous hemaggluttinin (FHA), pertactin (PRN) and fimbrae (FIM) antigens. Antibody concentrations were reported as ELISA units per milliliter (EU/mL). The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% confidence interval (CI).
Interventions
- BIOLOGICAL Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed onto aluminum phosphate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2012-10-26 |
| Est. Completion | 2015-08-28 |
| Phase | Phase 4 |
What the finished NCT01711645 record still lists
NCT01711645 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 1 intervention - of which Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed onto aluminum phosphate is the first listed.
NCT01711645 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01711645 about?
NCT01711645 is a clinical study titled "Tdap Vaccine in Post-Partum Women". Monitoring immune response and longevity in serum and milk after Tdap administration to postpartum women. The clinical trial will involve women (aged 18 - 45 years) who have just delivered full-term infants (greater than or equal to 37 completed weeks of gestation) at Vanderbilt University Medical C...
What is the current status of trial NCT01711645?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 55 participants. The study started on 2012-10-26. Estimated completion is 2015-08-28.
What interventions are being tested in trial NCT01711645?
The interventions under investigation include: Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed onto aluminum phosphate (BIOLOGICAL).
Who is sponsoring clinical trial NCT01711645?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01711645's enrollment target sits among peer trials
55 1218th of 2000 higher than 778 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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