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Study to Evaluate Safety and Immunogenicity of a Pandemic Flu H5 mRNA Vaccine in Healthy Adults Aged 18 Years and Older
Sponsor: Sanofi Pasteur, a Sanofi Company
Summary
The purpose of this study is to evaluate a pandemic flu H5 strain messenger ribonucleic acid (mRNA) vaccine at 3 dose levels (low, medium, and high) in comparison with placebo in 276 healthy adult participants to select the adequate dose for further clinical development. The duration per participant will be approximately 13 months.
Official title: A Phase 1/2, Randomized, Modified Double-blind, Placebo-controlled, Multi-center, Dose Escalating Study to Evaluate the Safety and Immunogenicity of a Pandemic Flu H5 mRNA Vaccine in Healthy Adults Aged 18 Years and Older
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
276
Start Date
2024-12-09
Completion Date
2026-03-31
Last Updated
2026-01-21
Healthy Volunteers
Yes
Conditions
Interventions
Pandemic flu H5 mRNA vaccine
Pharmaceutical Form: Suspension for injection Route of Administration: Intramuscular (IM)
Placebo
Pharmaceutical Form: Liquid solution for injection Route of Administration: Intramuscular (IM)
Locations (14)
Velocity Clinical Research - San Diego- Site Number : 8400013
La Mesa, California, United States
Accel Research Sites Network - DeLand Clinical Research Unit- Site Number : 8400002
DeLand, Florida, United States
ARSN-Lakeland CRU- Site Number : 8400006
Lakeland, Florida, United States
Accel Research Sites - St. Petersburg- Site Number : 8400004
Largo, Florida, United States
Atlanta Clinical Research Center- Site Number : 8400007
Atlanta, Georgia, United States
Accel Research Site - NeuroStudies.net, LLC - ERN - PPDS- Site Number : 8400003
Decatur, Georgia, United States
QUEST Research Institute- Site Number : 8400014
Bingham Farms, Michigan, United States
Velocity Clinical Research - Norfolk- Site Number : 8400015
Norfolk, Nebraska, United States
Velocity Clinical Research - Omaha- Site Number : 8400012
Omaha, Nebraska, United States
Velocity Clinical Research - Springdale- Site Number : 8400010
Cincinnati, Ohio, United States
Coastal Carolina Research Center - North Charleston- Site Number : 8400001
North Charleston, South Carolina, United States
Olympus Clinical Research - Sugar Land- Site Number : 8400009
Sugar Land, Texas, United States
Velocity Clinical Research, Salt Lake City- Site Number : 8400011
West Jordan, Utah, United States
Charlottesville Medical Research- Site Number : 8400005
Charlottesville, Virginia, United States