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NCT03969641 · ClinicalTrials.gov registry record · Phase 4
Safety of RIV4 Versus IIV4 in Pregnant Women
A Phase 4 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 4
- Development phase
- 384
- Enrollment target
NCT03969641 is a Phase 4 study that has completed, run by Duke University. The registered enrollment target is 384 participants.
The verdict
NCT03969641, a Phase 4 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 384 participants
- Enrollment target
Study Summary
This is a prospective, randomized clinical trial. During the study, pregnant women will be randomized (1:1) to receive RIV4 or IIV4. Vaccines will be administered by licensed providers. Prior 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 8 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 Influenza at time points that include: prior to vaccination and \~29 days post vaccination. When feasible, maternal blood at delivery and cord blood serum will be analyzed for the same antibody titers. Pregnant women will be followed through delivery with comprehensive obstetric and neonatal outcomes obtained from medical record review for 90 days of life.
Interventions
- BIOLOGICAL Quadrivalent Inactivated Influenza Vaccine
- BIOLOGICAL Quadrivalent Recombinant Influenza Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 384 participants |
| Start Date | 2019-09-05 |
| Est. Completion | 2021-09-29 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03969641
The ClinicalTrials.gov registry entry for NCT03969641 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 384 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Quadrivalent Inactivated Influenza Vaccine is the first listed.
NCT03969641 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03969641 about?
NCT03969641 is a clinical study titled "Safety of RIV4 Versus IIV4 in Pregnant Women". This is a prospective, randomized clinical trial. During the study, pregnant women will be randomized (1:1) to receive RIV4 or IIV4. Vaccines will be administered by licensed providers. Prior influenza vaccine history will be verified by medical record review when possible. Injection-site (local) ...
What is the current status of trial NCT03969641?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 384 participants. The study started on 2019-09-05. Estimated completion is 2021-09-29.
What interventions are being tested in trial NCT03969641?
The interventions under investigation include: Quadrivalent Inactivated Influenza Vaccine (BIOLOGICAL), Quadrivalent Recombinant Influenza Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT03969641?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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