Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 4 study, sponsored by Duke University.
NCT06518577 is a Phase 4 study that has completed, run by Duke University. The registered enrollment target is 605 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (17% higher). According to ClinicalTrials.gov, the official US trial registry.
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 \[28 days after acute visit if lab-confirmed positive for influenza\]).
Primary Outcome
The percent of participants with a seroprotective antibody titer (≥1:40) for each influenza vaccine antigen was determined. Cell-grown A(H1N1)pdm09 and B/Victoria were measured by hemagglutination inhibition (HAI), while A(H3N2) titers were measured by microneutralization.
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 |
What the finished NCT06518577 record still lists
NCT06518577 is an interventional study that assigns participants to a tested intervention. The registered 605 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (17% higher).
The record links to 0 conditions, and to 2 interventions - of which Flucelvax (ccIIV4) is the first listed.
NCT06518577 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06518577's enrollment target sits among peer trials
605 137th of 2000 higher than 1,864 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02342444 · 606 participants · Phase 4
Lovenox 30 mg Twice Daily (BID) Versus 40 mg Once Daily (QD)
- NCT03849443 · 604 participants · Early Phase 1
Single Versus Multi-Dose Oral and Intravenous Tranexamic Acid Patients at High Risk for Blood Transfusion After Spine Surgery
- NCT05238922 · 604 participants · Phase 1
Study of INCB123667 in Subjects With Advanced Solid Tumors
- NCT06040541 · 604 participants · Phase 1
Study of RMC-9805 in Participants With KRAS G12D-Mutant Solid Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI