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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.

NCT07779408

This study is recruiting at 16 US sites in 11 states, according to its ClinicalTrials.gov record last updated .

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).

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

  • Healthy Volunteers
  • Influenza

Eligibility basics and study details

Study type
Interventional
Phase
Phase 1/2
Ages
18 years and older
Sex
All
Healthy volunteers
Accepted
Sponsor
Sanofi
Last updated on ClinicalTrials.gov
September 15, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

Arizona · 1

  • AMR Clinical Phoenix, Arizona- Site Number : 8400004 · Tempe, AZ

California · 2

  • Peninsula Research Associates- Site Number : 8400011 · Rolling Hills Estates, CA
  • California Research Foundation- Site Number : 8400007 · San Diego, CA

Florida · 4

  • Alliance for Multispeciality Research - Coral Gables- Site Number : 8400003 · Coral Gables, FL
  • Accel Research Sites Network - DeLand Clinical Research Unit- Site Number : 8400017 · DeLand, FL
  • Alliance for Multispeciality Research - Fort Myers- Site Number : 8400001 · Fort Myers, FL
  • Indago Research & Health Center- Site Number : 8400010 · Miami Lakes, FL

Georgia · 2

  • Accel Research Sites - NeuroStudies- Site Number : 8400014 · Decatur, GA
  • iResearch Atlanta- Site Number : 8400008 · Decatur, GA

Illinois · 1

  • AMR Chicago- Site Number : 8400005 · Oak Brook, IL

Kansas · 1

  • AMR Clinical Newton, Kansas- Site Number : 8400006 · Newton, KS

New York · 1

  • Rochester Clinical Research- Site Number : 8400012 · Rochester, NY

South Carolina · 1

  • Coastal Carolina Research Center - North Charleston- Site Number : 8400018 · North Charleston, SC

Tennessee · 1

  • Alliance for Multispecialty Research - Weisgarber Medical Park- Site Number : 8400002 · Knoxville, TN

Utah · 1

  • CenExel JRB - Salth Lake City- Site Number : 8400009 · Salt Lake City, UT

Virginia · 1

  • Charlottesville Medical Research- Site Number : 8400016 · Charlottesville, VA

Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.