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NCT06020118 · ClinicalTrials.gov registry record · Phase 4
Comparative Immunogenicity of Concomitant vs Sequential mRNA COVID-19 and Influenza Vaccinations
A Phase 4 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 4
- Development phase
- 455
- Enrollment target
NCT06020118: Completed Phase 4 study, sponsored by Duke University.
NCT06020118 is a Phase 4 study that has completed, run by Duke University. The registered enrollment target is 455 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (12% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06020118, a Phase 4 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 455 participants
- Enrollment target
Study Summary
This is a prospective, randomized randomized immunologic study of response to influenza and SARS-CoV-2 vaccination across four of the US Influenza Vaccine Effectiveness (Flu VE) Network study sites.
Primary Outcome
Number of participants with a seroconversion HAI Titer ≥1:40 at Day 29 if Day 1 titer is \<1:10 or a four-fold rise at Day 29 if Day 1 titer is ≥1:10 for each ccIIV4 antigen in the 2023-2024 influenza season.
Interventions
- BIOLOGICAL Simultaneous Vaccination (Influenza Vaccine and mRNA COVID booster)
- BIOLOGICAL Sequential Vaccination (Influenza vaccine then mRNA COVID booster)
- BIOLOGICAL Sequential Vaccination (mRNA COVID booster then Influenza vaccine)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 455 participants |
| Start Date | 2023-09-25 |
| Est. Completion | 2024-05-17 |
| Phase | Phase 4 |
What the finished NCT06020118 record still lists
NCT06020118 is an interventional study that assigns participants to a tested intervention. The registered 455 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 (12% lower).
The record links to 0 conditions, and to 3 interventions - of which Simultaneous Vaccination (Influenza Vaccine and mRNA COVID booster) is the first listed.
NCT06020118 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06020118 about?
NCT06020118 is a clinical study titled "Comparative Immunogenicity of Concomitant vs Sequential mRNA COVID-19 and Influenza Vaccinations". This is a prospective, randomized randomized immunologic study of response to influenza and SARS-CoV-2 vaccination across four of the US Influenza Vaccine Effectiveness (Flu VE) Network study sites.
What is the current status of trial NCT06020118?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 455 participants. The study started on 2023-09-25. Estimated completion is 2024-05-17.
What interventions are being tested in trial NCT06020118?
The interventions under investigation include: Simultaneous Vaccination (Influenza Vaccine and mRNA COVID booster) (BIOLOGICAL), Sequential Vaccination (Influenza vaccine then mRNA COVID booster) (BIOLOGICAL), Sequential Vaccination (mRNA COVID booster then Influenza vaccine) (BIOLOGICAL).
Who is sponsoring clinical trial NCT06020118?
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 NCT06020118's enrollment target sits among peer trials
455 187th of 2000 higher than 1,814 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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