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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
NCT06907511 · View on ClinicalTrials.gov ↗
Study Summary
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 Extension Phase, an additional 480 participants will be randomized according to a 1:1 ratio and stratified by age (≥ 18 to \< 65 years and ≥ 65 years) to receive either the low dose of the pandemic flu H5 HA mRNA DS2 vaccine (Group 1) or placebo (Group 4). This extension will enhance the safety database and improve precision of the immunogenicity results for the selected dose while preserving the original study design integrity. The study duration per participant will be approximately 13 months. There will be two injections of placebo or pandemic flu H5 mRNA vaccine 21 days apart at high, medium and low doses. Study visits/contact include: 7 study visits and 1 telephone call. Vaccination visits (including blood samples) will occur at Day 01 and Day 22. Short-term follow-up visits (including blood samples) will occur 8 and 21 days after each injection. Participants will be also followed up (including blood samples) at 3 and 6 months after 2nd injection, and at 12 months after 2nd injection for safety.
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL Pandemic flu H5 HA mRNA SD2 vaccine
Study Locations (13)
Florida
- Accel Research Sites Network - DeLand Clinical Research Unit- Site Number : 8400002 — DeLand
- Accel Research Sites - Lakeland Clinical Research Unit- Site Number : 8400006 — Lakeland
- Accel Research Sites - St. Petersburg - Largo- Site Number : 8400004 — Largo
Nebraska
- Velocity Clinical Research - Norfolk- Site Number : 8400015 — Norfolk
- Velocity Clinical Research - Omaha- Site Number : 8400012 — Omaha
California
- Velocity Clinical Research - San Diego- Site Number : 8400013 — La Mesa
Georgia
- Accel Research Site - NeuroStudies.net, LLC - ERN - PPDS- Site Number : 8400003 — Decatur
Michigan
- QUEST Research Institute- Site Number : 8400014 — Bingham Farms
Ohio
- Velocity Clinical Research - Springdale- Site Number : 8400010 — Cincinnati
South Carolina
- Coastal Carolina Research Center- Site Number : 8400001 — North Charleston
Texas
- Olympus Clinical Research - Sugar Land- Site Number : 8400009 — Sugar Land
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 720 participants |
| Start Date | 2025-04-17 |
| Est. Completion | 2026-12-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06907511
The ClinicalTrials.gov registry entry for NCT06907511 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 720 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 275 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06907511 reports 13 study locations spanning 10 distinct geographic areas — top geographies include Florida, Nebraska, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06907511 about?
NCT06907511 is a clinical study titled "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". 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 S...
What is the current status of trial NCT06907511?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 720 participants. The study started on 2025-04-17. Estimated completion is 2026-12-01.
What conditions does trial NCT06907511 study?
This clinical trial studies the following conditions: Healthy Volunteers, Pandemic Influenza Immunization. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06907511?
The interventions under investigation include: Placebo (OTHER), Pandemic flu H5 HA mRNA SD2 vaccine (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06907511?
This trial is sponsored by Sanofi, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06907511 being conducted?
This trial has 13 study locations across California, Florida, Georgia, Michigan, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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