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ACTIVE NOT RECRUITING
NCT06744205
PHASE1/PHASE2

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

Sponsor: Sanofi Pasteur, a Sanofi Company

View on ClinicalTrials.gov

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.

Official title: A Phase I/II, Randomized, Modified Double-blind Study to Investigate the Safety and Immunogenicity of Different Doses of Hexavalent Influenza mRNA HA + mRNA NA Vaccine in Adult Participants 50 Years of Age and Older

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1162

Start Date

2025-01-06

Completion Date

2026-04-16

Last Updated

2025-05-30

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

Trivalent (TIV) messenger ribonucleic acid (mRNA) hemagglutinin (HA) Vaccine 1

* Pharmaceutical form: solution for injection in a vial * Route of administration: Intramuscular injection

BIOLOGICAL

TIV mRNA-neuraminidase (NA)

* Pharmaceutical form: solution for injection in a vial * Route of administration: Intramuscular injection

BIOLOGICAL

TIV mRNA-HA Vaccine 2

* Pharmaceutical form: solution for injection in a vial * Route of administration: Intramuscular injection

BIOLOGICAL

Quadrivalent Influenza Standard Dose Vaccine

* Pharmaceutical form: Liquid suspension for injection in pre-filled syringe * Route of administration: Intramuscular injection

BIOLOGICAL

Quadrivalent Influenza Vaccine High Dose

* Pharmaceutical form: Liquid suspension for injection in pre-filled syringe * Route of administration: Intramuscular injection

Locations (24)

Accel Research Sites Network - Birmingham- Site Number : 8400008

Birmingham, Alabama, United States

AMR Mobile- Site Number : 8400022

Mobile, Alabama, United States

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

Tempe, Arizona, United States

AMR Miami- Site Number : 8400021

Coral Gables, Florida, United States

Accel Research Sites Network - DeLand Clinical Research Unit- Site Number : 8400003

DeLand, Florida, United States

Alliance for Multispeciality Research - Fort Myers- Site Number : 8400013

Fort Myers, Florida, United States

Accel Research Sites - Maitland- Site Number : 8400007

Maitland, Florida, United States

Innovation Medical Research Center - Palmetto Bay- Site Number : 8400011

Palmetto Bay, Florida, United States

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

Decatur, Georgia, United States

AMR - Chicago- Site Number : 8400012

Oak Brook, Illinois, United States

Alliance for Multispeciality Research - Newton- Site Number : 8400020

Newton, Kansas, United States

Alliance for Multispeciality Research - Wichita East- Site Number : 8400014

Wichita, Kansas, United States

Alliance for Multispeciality Research - Lexington- Site Number : 8400018

Lexington, Kentucky, United States

Boston Clinical Trials- Site Number : 8400009

Boston, Massachusetts, United States

ActivMed Practices & Research- Site Number : 8400005

Methuen, Massachusetts, United States

Quest Research Institute- Site Number : 8400010

Farmington Hills, Michigan, United States

Alliance for Multispeciality Research - Kansas City- Site Number : 8400019

Kansas City, Missouri, United States

AMR Las Vegas - Site Number : 8400016

Las Vegas, Nevada, United States

Coastal Carolina Research Center - North Charleston- Site Number : 8400002

North Charleston, South Carolina, United States

Alliance for Multispeciality Research - Knoxville- Site Number : 8400017

Knoxville, Tennessee, United States

Charlottesville Medical Research- Site Number : 8400004

Charlottesville, Virginia, United States

Investigational Site Number : 0360001

Botany, New South Wales, Australia

Investigational Site Number : 0360003

Bayswater, Victoria, Australia

Investigational Site Number : 0360002

Melbourne, Victoria, Australia