Study to Evaluate the Safety and the Immunogenicity of a Second Generation Structurally Designed mRNA Vaccine Candidate Against Pandemic Influenza H5 HA Strain in Healthy Adult Participants Aged 18 Years and Older
Active, not recruiting · Phase 1, Phase 2 · NCT06907511
Conditions: Pandemic Influenza Immunization, Healthy Volunteers
At a glance
- Research payments reported, 2025
- $7.7M
- U.S. investigators named
- 13
- Sites paid
- 9
- Planned or actual enrollment
- 720
About the trial
- Sponsor
- Sanofi
- Tested
- Pandemic flu H5 HA mRNA SD2 vaccine (biological), Placebo (other)
- Dates
- Started 2025-04-17; completion 2026-12-01
- Results posted
- Not yet
The purpose of this phase 1/2 study is to investigate the safety and immunogenicity of different doses (high, medium and low) of a second generation structurally designed (SD2) H5 messenger ribonucleic acid (mRNA) vaccine against pandemic H5 influenza virus (pandemic flu H5 hemagglutinin (HA) mRNA SD2) in healthy younger and older adults. The study will aim to identify the appropriate dose for further clinical development of a potential pandemic response vaccine. The study also includes an extension phase for one of the 3 dose levels of the pandemic flu H5 HA mRNA SD2 vaccine to collect additional safety and the immunogenicity data for this specific dose of the vaccine. During this Extens…
From ClinicalTrials.gov, last updated 2026-01-16. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Sanofi Pasteur Inc. reported $7.7M in research payments for this study in 2025 (115 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
- Ramana K. Puppala, M.D. OB-GYN (Obstetrics & Gynecology) · Greenville, AL
- Jeffrey S. Overcash, MD Emergency Medicine · Chula Vista, CA
- James L. Andersen, M.D. Addiction Medicine · Eagle Lake, FL
- Bruce G. Rankin, D. O. Family Medicine · Deland, FL
- Shital-hiten J. Upadhyay, MD Emergency Medicine · St Petersburg, FL
- Kiran A. Saraiya, D.O. Nephrology (Kidney) · Warren, MI
- Brandon J. Essink, M.D. Family Medicine · Creighton, NE
- Charles Harper JR., MD Internal Medicine · Norfolk, NE
- Charles H. Eger, M.D Internal Medicine · Cincinnati, OH
- Kelly N. Morales, MD Family Medicine · North Charleston, SC
- Harish N. Thakkar, M.D. Internal Medicine · Sugar Land, TX
- John L. Richards, MD Family Medicine · South Jordan, UT
- James R. Clark, MD Internal Medicine · Charlottesville, VA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Velocity Clinical Research $2.0M
- Sandhill Research, Llc $1.8M
- Velocity Clinical Research,inc $1.4M
- Coastal Carolina Research Center,incorporation $583,178
- Olympus Clinical Research $580,601
- University Clinical Research Dela Llc $544,382
- Charlottesville Medical Research Center,llc $340,571
- Quest Research Institute Llc $337,106
- The Children's Mercy Hospital, MO $112,000
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.