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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
| Arizona State University | OTHER |
| University Hospitals Cleveland Medical Center | OTHER |
| University of Pittsburgh |
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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]).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flucelvax (ccIIV4) | Experimental | Participants will receive Flucelvax (ccIIV4) at Visit 1. |
|
| Flublok (RIV) or Fluzone (IIV) | Experimental | Participants will receive Flublok (RIV) or Fluzone (IIV) at Visit 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flucelvax (ccIIV4) | Biological | Participants will receive Flucelvax (ccIIV4) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Participants with a seroprotective HAI titer (≥1:40) | The number (percent) of participants with a seroprotective HAI titer (≥1:40) for each influenza vaccine antigen | Baseline, Day 29 |
| The geometric mean titer (GMT) of HAI antibody | The geometric mean titer (GMT) of HAI antibody for each influenza vaccine antigen | Baseline, Day 29 |
| Number of participants demonstrating seroconversion from baseline | The number (percent) of participants in each vaccination group demonstrating seroconversion from Baseline at Day 29 (a titer ≥1:40 at Day 29 if the baseline titer is <1:10 or a four-fold rise in titer at Day 29 if the baseline titer is >1:10) as assessed by HAI titer for each vaccine antigen | Day 29 |
| Geometric mean fold rise (GMFR) in HAI titer from baseline | The geometric mean fold rise (GMFR) in HAI titer from Baseline to Day 29 across HAI titers for each influenza vaccine antigen | Day 29 |
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Inclusion Criteria:
Exclusion Criteria:
Temporary Delay Criteria (Visit 1)
1. History of febrile illness (> 100.0°F or 37.8°C) within the past 72 hours prior to vaccine administration
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| Name | Affiliation | Role |
|---|---|---|
| Emmanuel B Walter, MD, MPH | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valleywise Health Comprehensive Health Center | Phoenix | Arizona | 85008 | United States | ||
| ASU Biodesign Institute |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 10, 2024 | Jan 23, 2025 | ICF_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 9, 2026 | Apr 29, 2026 | 8 | ||
| May 22, 2026 |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| C528512 | FluBlok |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| OTHER |
| Washington University School of Medicine | OTHER |
| VA Medical Center-Cleveland | UNKNOWN |
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| Flublok (RIV) or Fluzone (IIV) |
| Biological |
Participants will receive Flublok (RIV) or Fluzone (IIV) |
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| Tempe |
| Arizona |
| 85281 |
| United States |
| Centers for Disease Control and Prevention | Atlanta | Georgia | 30333 | United States |
| Washington University IDCRU | St Louis | Missouri | 63110 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| VA Northeast Ohio Healthcare System (VANEOHS) | Cleveland | Ohio | 44106 | United States |
| Department of Family Medicine, University of Pittsburgh School of Medicine | Pittsburgh | Pennsylvania | 15260 | United States |
| Jun 18, 2026 |
| 9 |
| Jun 30, 2026 |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |