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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: Completed Phase 4 study, sponsored by Duke University.
NCT03969641 is a Phase 4 study that has completed, run by Duke University. The registered enrollment target is 384 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (26% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
As measured by the number of women experiencing one of the following: * Adverse birth outcome is a composite of occurrence of at least one of the following: preterm birth, spontaneous abortion, fetal death, or neonatal death. * Preterm birth- born alive at less than 37 weeks and 0 days gestation * Spontaneous abortion (SAB)- pregnancy loss prior to 20 weeks 0 days * Fetal death- intrauterine death of fetus at or after 20 weeks 0 days * Neonatal death- infant death within first 28 days
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 |
What the finished NCT03969641 record still lists
NCT03969641 is an interventional study that assigns participants to a tested intervention. The registered 384 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (26% lower).
The record links to 0 conditions, and to 2 interventions - of which Quadrivalent Inactivated Influenza Vaccine is the first listed.
NCT03969641 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03969641's enrollment target sits among peer trials
384 222nd of 2000 higher than 1,779 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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