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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 is a Phase 4 study that has completed, run by Duke University. The registered enrollment target is 348 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05028361
The ClinicalTrials.gov registry entry for NCT05028361 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 348 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 3 interventions - of which Placebo (saline) is the first listed.
NCT05028361 reports 0 study locations.
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.
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