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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: Active Phase 1 study of Healthy Volunteers and Pandemic Influenza Immunization, sponsored by Sanofi.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Number of participants with immediate AEs

Conditions Studied

Healthy Volunteers Pandemic Influenza Immunization

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

FieldValue
Enrollment Target 720 participants
Start Date 2025-04-17
Est. Completion 2026-12-01
Phase Phase 1
Sanofi

713 total trials

What the registry record for NCT06907511 still lists

NCT06907511 is an interventional study that assigns participants to a tested intervention. The registered 720 participants enrollment target is mid-sized for trials with a published cap, above the 479-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (50% higher).

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 lists 13 locations in 10 states (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.

Where NCT06907511's enrollment target sits among peer trials

720 22nd of 283 higher than 262 of 283 other Healthy Volunteers trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Healthy Volunteers trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT06907511, the US trial registry maintained by the National Library of Medicine. NCT06907511 (mid enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.