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ACTIVE NOT RECRUITING Phase 1

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

NCT06744205 · View on ClinicalTrials.gov ↗

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.

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

Sponsor

Sanofi Pasteur, a Sanofi Company

43 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06744205

The ClinicalTrials.gov registry entry for NCT06744205 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 1,162 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi Pasteur, a Sanofi Company, which has 43 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 5 interventions — of which Trivalent (TIV) messenger ribonucleic acid (mRNA) hemagglutinin (HA) Vaccine 1 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: NCT06744205 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Florida, Alabama, Kansas. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06744205?

This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 43 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial