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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
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
Conditions
Interventions
Trivalent (TIV) messenger ribonucleic acid (mRNA) hemagglutinin (HA) Vaccine 1
* Pharmaceutical form: solution for injection in a vial * Route of administration: Intramuscular injection
TIV mRNA-neuraminidase (NA)
* Pharmaceutical form: solution for injection in a vial * Route of administration: Intramuscular injection
TIV mRNA-HA Vaccine 2
* Pharmaceutical form: solution for injection in a vial * Route of administration: Intramuscular injection
Quadrivalent Influenza Standard Dose Vaccine
* Pharmaceutical form: Liquid suspension for injection in pre-filled syringe * Route of administration: Intramuscular injection
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