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Study to Assess Safety and Immunogenicity of an Egg-based H5N8 Influenza Vaccine at Multiple Dose Levels Adjuvanted With Matrix-M in Healthy Participants 18 Years of Age and Above.
Sponsor: Sanofi
Summary
The study aims to evaluate an egg-based H5N8 influenza vaccine up to 3 dose levels (low, medium, and high dose) given with or without adjuvant to see if the adjuvant improves vaccine effectiveness. The study will enroll healthy adults aged 18 years and over. Participants will receive 2 injections in their arm of either one of the 3 dose levels of the study vaccine (low, medium, or high dose) with the adjuvant or the unadjuvanted vaccine (high dose). Study duration per participant: approximately 14 months (including screening visit).
Official title: A Phase 1/2, Parallel, Observer-blind Study to Assess the Safety and Immunogenicity of an Egg-based H5N8 Influenza Vaccine at Multiple Dose Levels Adjuvanted With Matrix-M in Healthy Participants 18 Years of Age and Above.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
640
Start Date
2026-08-03
Completion Date
2028-02-22
Last Updated
2026-09-15
Healthy Volunteers
Yes
Conditions
Interventions
Flu H5 egg pandemic low dose vaccine, with adjuvant
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM)
Flu H5 Egg Pandemic medium dose vaccine, with adjuvant
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM)
Flu H5 Egg Pandemic high dose vaccine, with adjuvant
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM)
Flu H5 Egg Pandemic high dose vaccine, without adjuvant
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM)
Locations (16)
AMR Clinical Phoenix, Arizona- Site Number : 8400004
Tempe, Arizona, United States
Peninsula Research Associates- Site Number : 8400011
Rolling Hills Estates, California, United States
California Research Foundation- Site Number : 8400007
San Diego, California, United States
Alliance for Multispeciality Research - Coral Gables- Site Number : 8400003
Coral Gables, Florida, United States
Accel Research Sites Network - DeLand Clinical Research Unit- Site Number : 8400017
DeLand, Florida, United States
Alliance for Multispeciality Research - Fort Myers- Site Number : 8400001
Fort Myers, Florida, United States
Indago Research & Health Center- Site Number : 8400010
Miami Lakes, Florida, United States
Accel Research Sites - NeuroStudies- Site Number : 8400014
Decatur, Georgia, United States
iResearch Atlanta- Site Number : 8400008
Decatur, Georgia, United States
AMR Chicago- Site Number : 8400005
Oak Brook, Illinois, United States
AMR Clinical Newton, Kansas- Site Number : 8400006
Newton, Kansas, United States
Rochester Clinical Research- Site Number : 8400012
Rochester, New York, United States
Coastal Carolina Research Center - North Charleston- Site Number : 8400018
North Charleston, South Carolina, United States
Alliance for Multispecialty Research - Weisgarber Medical Park- Site Number : 8400002
Knoxville, Tennessee, United States
CenExel JRB - Salth Lake City- Site Number : 8400009
Salt Lake City, Utah, United States
Charlottesville Medical Research- Site Number : 8400016
Charlottesville, Virginia, United States