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NCT06744205 · ClinicalTrials.gov registry record · Phase 1

A Study on the Safety and Immunogenicity of Hexavalent Influenza mRNA Vaccine in Adult Participants 50 Years of Age and Older

A Phase 1 study of Healthy Volunteers and Influenza, sponsored by Sanofi Pasteur, a Sanofi Company.

Active
Registry status
Phase 1
Development phase
1,162
Enrollment target
20
Study locations

NCT06744205: Active Phase 1 study of Healthy Volunteers and Influenza, sponsored by Sanofi Pasteur, a Sanofi Company.

NCT06744205 is a Phase 1 study of Healthy Volunteers and Influenza that is active but no longer recruiting, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 1,162 participants, above the 478-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (143% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06744205, a Phase 1 study of Healthy Volunteers and Influenza, is active but no longer recruiting, sponsored by Sanofi Pasteur, a Sanofi Company.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
1,162 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to evaluate the safety and immunogenicity of a single intramuscular injection of different formulations of a hexavalent influenza messenger ribonucleic acid (mRNA) vaccine composed of differing dose levels of trivalent (TIV) mRNA hemagglutinin (HA) in combination with TIV mRNA-neuraminidase (NA) compared to an active control ((Fluzone standard-dose quadrivalent influenza vaccine (QIV-SD) or Fluzone high-dose quadrivalent influenza vaccine (QIV-HD) in adults 50 years of age and older.

Primary Outcome

Unsolicited systemic AEs that occur within 30 minutes after vaccination

Conditions Studied

Healthy Volunteers Influenza

Interventions

  • BIOLOGICAL Trivalent (TIV) messenger ribonucleic acid (mRNA) hemagglutinin (HA) Vaccine 1
  • BIOLOGICAL TIV mRNA-neuraminidase (NA)
  • BIOLOGICAL TIV mRNA-HA Vaccine 2
  • BIOLOGICAL Quadrivalent Influenza Standard Dose Vaccine
  • BIOLOGICAL Quadrivalent Influenza Vaccine High Dose

Study Locations (20)

Florida

  • AMR Miami- Site Number : 8400021 - Coral Gables
  • Accel Research Sites Network - DeLand Clinical Research Unit- Site Number : 8400003 - DeLand
  • Alliance for Multispeciality Research - Fort Myers- Site Number : 8400013 - Fort Myers
  • Accel Research Sites - Maitland- Site Number : 8400007 - Maitland
  • Innovation Medical Research Center - Palmetto Bay- Site Number : 8400011 - Palmetto Bay

Alabama

  • Accel Research Sites Network - Birmingham- Site Number : 8400008 - Birmingham
  • AMR Mobile- Site Number : 8400022 - Mobile

Kansas

  • Alliance for Multispeciality Research - Newton- Site Number : 8400020 - Newton
  • Alliance for Multispeciality Research - Wichita East- Site Number : 8400014 - Wichita

Massachusetts

  • Boston Clinical Trials- Site Number : 8400009 - Boston
  • ActivMed Practices & Research- Site Number : 8400005 - Methuen

Arizona

  • Alliance for Multispeciality Research - Clinical Research Consortium- Site Number : 8400015 - Tempe

Georgia

  • Accel Research Site - NeuroStudies.net, LLC - ERN - PPDS- Site Number : 8400001 - Decatur

Illinois

  • AMR - Chicago- Site Number : 8400012 - Oak Brook

Kentucky

  • Alliance for Multispeciality Research - Lexington- Site Number : 8400018 - Lexington

Trial Details

FieldValue
Enrollment Target 1,162 participants
Start Date 2025-01-06
Est. Completion 2026-04-16
Phase Phase 1
Sanofi Pasteur, a Sanofi Company

153 total trials

What the registry record for NCT06744205 still lists

NCT06744205 is an interventional study that assigns participants to a tested intervention. Its 1,162 participants enrollment target places it among the larger protocols in the corpus, above the 478-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (143% higher).

The record links to 2 conditions, with Healthy Volunteers appearing as the primary indexed condition, and to 5 interventions - of which Trivalent (TIV) messenger ribonucleic acid (mRNA) hemagglutinin (HA) Vaccine 1 is the first listed.

NCT06744205 names 20 study sites across 13 states, led by Florida, Alabama, Kansas.

Frequently Asked Questions

What is clinical trial NCT06744205 about?

NCT06744205 is a clinical study titled "A Study on the Safety and Immunogenicity of Hexavalent Influenza mRNA Vaccine in Adult Participants 50 Years of Age and Older". The purpose of this study is to evaluate the safety and immunogenicity of a single intramuscular injection of different formulations of a hexavalent influenza messenger ribonucleic acid (mRNA) vaccine composed of differing dose levels of trivalent (TIV) mRNA hemagglutinin (HA) in combination with TI...

What is the current status of trial NCT06744205?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 1,162 participants. The study started on 2025-01-06. Estimated completion is 2026-04-16.

What conditions does trial NCT06744205 study?

This clinical trial studies the following conditions: Healthy Volunteers, Influenza.

What interventions are being tested in trial NCT06744205?

The interventions under investigation include: Trivalent (TIV) messenger ribonucleic acid (mRNA) hemagglutinin (HA) Vaccine 1 (BIOLOGICAL), TIV mRNA-neuraminidase (NA) (BIOLOGICAL), TIV mRNA-HA Vaccine 2 (BIOLOGICAL), Quadrivalent Influenza Standard Dose Vaccine (BIOLOGICAL), Quadrivalent Influenza Vaccine High Dose (BIOLOGICAL).

Who is sponsoring clinical trial NCT06744205?

This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06744205 being conducted?

This trial has 20 study locations across Alabama, Arizona, Florida, Georgia, Illinois. 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 NCT06744205's enrollment target sits among peer trials

1,162 13th of 283 higher than 271 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 NCT06744205, the US trial registry maintained by the National Library of Medicine. NCT06744205 (large enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.