Study to Evaluate Safety and Immunogenicity of Different Priming and Booster Regimens With Adjuvanted H5N8 and/or H5N6 Influenza Vaccine in Adults
Completed · Phase 2 · NCT05874713
Conditions: Influenza, Human, Infections, Respiratory Tract Infections, Virus Diseases, Infection Viral
At a glance
- Research payments reported, 2025
- $599,829
- U.S. investigators named
- 9
- Sites paid
- 3
- Planned or actual enrollment
- 480
About the trial
- Sponsor
- Seqirus (with Biomedical Advanced Research and Development Authority)
- Tested
- aH5N8c on Day 1 (biological), aH5N6c on Day 1 (biological), aH5N8c on Day 22 (biological), aH5N6c on Day 22 (biological), aH5N8c on Day 202 (biological)
- Dates
- Started 2023-06-07; completion 2024-09-25
- Results posted
- Not yet
This Phase 2, randomized, observer-blind clinical study is evaluating 3 different priming and booster regimens with MF59-adjuvanted H5N8 and/or H5N6 cell culture-derived influenza vaccine (aH5N8c; aH5N6c). Approximately 480 healthy adult subjects are to be randomized into 1 of 3 possible treatment groups, stratified by age group (18-64 years and ≥65 years) and by poultry worker status (yes/no). Each subject will receive a priming influenza vaccine injection on Day 1 and Day 22 and a booster vaccination on Day 202. Subjects will be followed up for approximately 6 months after the booster injection. The primary immunogenicity analysis is based on antibody responses against H5N8 and H5N6 as …
From ClinicalTrials.gov, last updated 2024-12-13. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Seqirus USA Inc reported $599,829 in research payments for this study in 2025 (87 payments).
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Randall L. Quinn, MD Family Medicine · Cullman, AL
- Naresh K. Parikh, M.D. Cardiology · Norcross, GA
- Aziz A. Pirani, MD Family Medicine · Lilburn, GA
- Katherine F. Pearce, M.D. Internal Medicine · Baton Rouge, LA
- Adam B. Brosz, M.D. Family Medicine · Grand Island, NE
- David J. Ensz, M.D. Family Medicine · South Sioux City, NE
- Charles Harper JR., MD Internal Medicine · Norfolk, NE
- Jeffrey A. Hopland, M.D. Family Medicine · Johnson City, TN
- Bryce K. Peterson, MD Family Medicine · Bountiful, UT
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Velocity Clinical Research, Inc. $312,006
- Cognitive Clinical Trials, LLC $220,887
- Cullman Clinical Trials $66,937
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.