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NCT05028361 · ClinicalTrials.gov registry record · Phase 4
Simultaneous mRNA COVID-19 and IIV4 Vaccination Study
A Phase 4 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 4
- Development phase
- 348
- Enrollment target
NCT05028361: Completed Phase 4 study, sponsored by Duke University.
NCT05028361 is a Phase 4 study that has completed, run by Duke University. The registered enrollment target is 348 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05028361, a Phase 4 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 348 participants
- Enrollment target
Study Summary
This study is a prospective, randomized clinical trial. During this study, participants will be randomly assigned to receive quadrivalent inactivated influenza vaccine (IIV4) and mRNA COVID-19 vaccine either simultaneously or sequentially, 7-14 days apart. Persons in the simultaneous group will receive mRNA COVID-19 and IIV4 at Visit 1 (Day 1) and a saline placebo injection at Visit 2. Persons in the sequential group will receive mRNA COVID-19 vaccine and a saline placebo at Visit 1 (Day 1) and IIV4 injection at Visit 2. For participants receiving their primary dose series, a second dose of mRNA COVID-19 vaccine will be administered either 3 to 8 weeks or 4 to 8 weeks following the first dose, depending upon the mRNA COVID-19 vaccine provided. For those receiving a booster dose of mRNA COVID-19 only a single mRNA COVID-19 will be received in this study. Solicited symptoms of reactogenicity and adverse events will be assessed on vaccination day and daily during the 7 days following each Vaccination Visit using either electronic or paper symptoms diaries, depending on study participant preference. Quality of life data will be collected using electronic or paper diaries on day of Vaccination Visit 1 and daily during the 7 days following the visit. Serious adverse events and adverse events of special interest will be collected throughout the duration of the study. Participants are followed through Day 121. Serum samples from participants will be collected for determination of SARS-CoV-2 seropositivity at baseline. Serum samples will be taken throughout the study to determine IIV4 and COVID-19 vaccine immunogenicity and for potential future studies.
Primary Outcome
Subjects will be asked to complete a memory aid to document symptoms and measure temperature daily.
Interventions
- OTHER Placebo (saline)
- BIOLOGICAL mRNA COVID-19
- BIOLOGICAL IIV4
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 348 participants |
| Start Date | 2021-10-04 |
| Est. Completion | 2023-06-15 |
| Phase | Phase 4 |
What the finished NCT05028361 record still lists
NCT05028361 is an interventional study that assigns participants to a tested intervention. The registered 348 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 (33% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo (saline) is the first listed.
NCT05028361 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05028361 about?
NCT05028361 is a clinical study titled "Simultaneous mRNA COVID-19 and IIV4 Vaccination Study". This study is a prospective, randomized clinical trial. During this study, participants will be randomly assigned to receive quadrivalent inactivated influenza vaccine (IIV4) and mRNA COVID-19 vaccine either simultaneously or sequentially, 7-14 days apart. Persons in the simultaneous group will rece...
What is the current status of trial NCT05028361?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 348 participants. The study started on 2021-10-04. Estimated completion is 2023-06-15.
What interventions are being tested in trial NCT05028361?
The interventions under investigation include: Placebo (saline) (OTHER), mRNA COVID-19 (BIOLOGICAL), IIV4 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05028361?
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 NCT05028361's enrollment target sits among peer trials
348 240th of 2000 higher than 1,760 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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