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NCT02783170 · ClinicalTrials.gov registry record · Phase 4
Safety and Immunogenicity of Simultaneous Tdap and IIV in Pregnant Women
A Phase 4 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 4
- Development phase
- 81
- Enrollment target
NCT02783170: Completed Phase 4 study, sponsored by Duke University.
NCT02783170 is a Phase 4 study that has completed, run by Duke University. The registered enrollment target is 81 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02783170, a Phase 4 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 81 participants
- Enrollment target
Study Summary
This is a pilot, prospective, randomized, open-label clinical trial. During the study, pregnant women will be randomized (1:1) to receive co-administration of a single intramuscular (IM) 0.5 mL dose of US-licensed inactivated influenza vaccine (IIV) and a single intramuscular (IM) 0.5 mL dose of US-licensed Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap) or sequential administration of the vaccines (IIV followed by Tdap \~ 21 days later). Vaccines will be administered by licensed study personnel. Prior Tdap/Td/TT and influenza vaccine history will be verified by medical record review when possible. Injection-site (local) and systemic reaction data will be assessed on vaccination day and during the 7 days following vaccination using either identical web-based or paper diaries, depending on study participant preference. Maternal serum samples will be collected for antibody titers relevant to the Tdap and Influenza at time points that include: prior to vaccination(s), \~21 days post vaccination(s), and at delivery. Additionally, cord blood serum will be analyzed for the same antibody titers. Pregnant women will be followed with comprehensive obstetric and neonatal outcomes obtained from medical record review.
Primary Outcome
Percentage of injection-site reactions will be compared in simultaneous and sequential groups as determined by self-assessment via memory aid
Interventions
- BIOLOGICAL Tetanus, Diphtheria, and Pertussis Vaccine
- BIOLOGICAL 2016-2017 Quadrivalent Inactivated Influenza Vaccine
- BIOLOGICAL 2017-2018 Quadrivalent Inactivated Influenza Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2016-09 |
| Est. Completion | 2018-05-10 |
| Phase | Phase 4 |
What the finished NCT02783170 record still lists
NCT02783170 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 3 interventions - of which Tetanus, Diphtheria, and Pertussis Vaccine is the first listed.
NCT02783170 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02783170 about?
NCT02783170 is a clinical study titled "Safety and Immunogenicity of Simultaneous Tdap and IIV in Pregnant Women". This is a pilot, prospective, randomized, open-label clinical trial. During the study, pregnant women will be randomized (1:1) to receive co-administration of a single intramuscular (IM) 0.5 mL dose of US-licensed inactivated influenza vaccine (IIV) and a single intramuscular (IM) 0.5 mL dose of US-...
What is the current status of trial NCT02783170?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 81 participants. The study started on 2016-09. Estimated completion is 2018-05-10.
What interventions are being tested in trial NCT02783170?
The interventions under investigation include: Tetanus, Diphtheria, and Pertussis Vaccine (BIOLOGICAL), 2016-2017 Quadrivalent Inactivated Influenza Vaccine (BIOLOGICAL), 2017-2018 Quadrivalent Inactivated Influenza Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT02783170?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02783170's enrollment target sits among peer trials
81 940th of 2000 higher than 1,055 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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