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NCT06518577 · ClinicalTrials.gov registry record · Phase 4
Immunogenicity of Influenza Vaccinations
A Phase 4 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 4
- Development phase
- 605
- Enrollment target
NCT06518577 is a Phase 4 study that has completed, run by Duke University. The registered enrollment target is 605 participants.
The verdict
NCT06518577, a Phase 4 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 605 participants
- Enrollment target
Study Summary
This study is a randomized immunogenicity study in an enrolled cohort with active surveillance for influenza-like illness (ILI). During this study, participants will be randomly assigned to receive an approved cell culture-based influenza vaccine (Flucelvax) versus a licensed comparator influenza vaccine (Flublok or Fluzone). Blood samples from participants will be collected for measurement of biomarkers of immune response at baseline (visit 1; day 1), post-vaccination (visit 2; day 29), and post-season (visit 3; day 181). Participants will be asked if they wish to also provide saliva specimens at baseline (visit 1; day 1), post-vaccination (visit 2; day 29), and post-season (visit 3; day 181). Serum and peripheral blood mononuclear cells (PBMC) and plasma samples will be isolated from whole blood and tested for biomarkers of vaccine immunogenicity, and duration of antibody responses. Participants will receive electronic surveys via email or text message weekly asking about changes in health status and new ILI symptoms; those reporting illness may be asked to provide a respiratory swab for laboratory testing for influenza and other respiratory viruses and up to 2 additional blood draws (acute \[\<10 days after symptom onset\] and convalescent \[28 days after acute visit if lab-confirmed positive for influenza\]).
Interventions
- BIOLOGICAL Flucelvax (ccIIV4)
- BIOLOGICAL Flublok (RIV) or Fluzone (IIV)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 605 participants |
| Start Date | 2024-09-09 |
| Est. Completion | 2025-06-04 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06518577
The ClinicalTrials.gov registry entry for NCT06518577 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 605 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 Flucelvax (ccIIV4) is the first listed.
NCT06518577 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06518577 about?
NCT06518577 is a clinical study titled "Immunogenicity of Influenza Vaccinations". This study is a randomized immunogenicity study in an enrolled cohort with active surveillance for influenza-like illness (ILI). During this study, participants will be randomly assigned to receive an approved cell culture-based influenza vaccine (Flucelvax) versus a licensed comparator influenza va...
What is the current status of trial NCT06518577?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 605 participants. The study started on 2024-09-09. Estimated completion is 2025-06-04.
What interventions are being tested in trial NCT06518577?
The interventions under investigation include: Flucelvax (ccIIV4) (BIOLOGICAL), Flublok (RIV) or Fluzone (IIV) (BIOLOGICAL).
Who is sponsoring clinical trial NCT06518577?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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