Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06907511 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Healthy Volunteers and Pandemic Influenza Immunization, sponsored by Sanofi.
- Active
- Registry status
- Phase 1
- Development phase
- 720
- Enrollment target
- 13
- Study locations
NCT06907511 is a Phase 1 study of Healthy Volunteers and Pandemic Influenza Immunization that is active but no longer recruiting, run by Sanofi. The registered enrollment target is 720 participants, above the 479-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (50% higher). The trial reports 13 study locations across 10 states.
The verdict
NCT06907511, a Phase 1 study of Healthy Volunteers and Pandemic Influenza Immunization, is active but no longer recruiting, sponsored by Sanofi.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 720 participants
- Enrollment target
- 13
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 1. The registered enrollment target is 720 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 479-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (50% higher). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
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.
NCT06907511 reports 13 study locations spanning 10 distinct geographic areas - top geographies include Florida, Nebraska, California.
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.
What interventions are being tested in trial NCT06907511?
The interventions under investigation include: Placebo (OTHER), Pandemic flu H5 HA mRNA SD2 vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT06907511?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Healthy Volunteers
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
A Research Study to Evaluate the Safety of NNC4004-0002 When Given to Participants With Asymptomatic Hyperuricemia
RECRUITING · Phase 1
-
A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of ABBV-243 in Healthy Adults.
RECRUITING · Phase 1
-
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of ABBV-277 in Healthy Adult Participants
RECRUITING · Phase 1
-
A Study to Evaluate the Effect of Single Oral Dose of Balinatunfib on Cardiac Repolarization in Healthy Adult Participants.
RECRUITING · Phase 1
-
Classroom Break, Cognition, and Fitness in Elementary School Children
RECRUITING · Phase 1
-
A Study to Assess the Relative Bioavailability of BMS-986435 and Food Effect on the BMS-986435 in Healthy Adult Participants
RECRUITING · Phase 1
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.