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.
Status: Recruiting
Location: See all (16) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:
• Aged 18 years or above on the day of inclusion
• Participants who are healthy as determined by medical evaluation including medical history
• Not pregnant/breastfeeding; non-childbearing potential or uses effective contraception/abstinence from ≥4 weeks before the first study intervention dose to ≥8 weeks after the last dose
• Informed consent form has been signed and dated
• Able to attend all scheduled visits and to comply with all study procedures
• Covered by health insurance, if required by local regulations
Locations
United States
Arizona
AMR Clinical Phoenix, Arizona- Site Number : 8400004
RECRUITING
Tempe
California
Peninsula Research Associates- Site Number : 8400011
RECRUITING
Rolling Hills Estates
California Research Foundation- Site Number : 8400007
RECRUITING
San Diego
Florida
Alliance for Multispeciality Research - Coral Gables- Site Number : 8400003
RECRUITING
Coral Gables
Accel Research Sites Network - DeLand Clinical Research Unit- Site Number : 8400017
RECRUITING
Deland
Alliance for Multispeciality Research - Fort Myers- Site Number : 8400001
RECRUITING
Fort Myers
Indago Research & Health Center- Site Number : 8400010
RECRUITING
Miami Lakes
Georgia
Accel Research Sites - NeuroStudies- Site Number : 8400014
RECRUITING
Decatur
iResearch Atlanta- Site Number : 8400008
RECRUITING
Decatur
Illinois
AMR Chicago- Site Number : 8400005
RECRUITING
Oak Brook
Kansas
AMR Clinical Newton, Kansas- Site Number : 8400006
RECRUITING
Newton
New York
Rochester Clinical Research- Site Number : 8400012
RECRUITING
Rochester
South Carolina
Coastal Carolina Research Center - North Charleston- Site Number : 8400018
RECRUITING
North Charleston
Tennessee
Alliance for Multispecialty Research - Weisgarber Medical Park- Site Number : 8400002
RECRUITING
Knoxville
Utah
CenExel JRB - Salth Lake City- Site Number : 8400009
RECRUITING
Salt Lake City
Virginia
Charlottesville Medical Research- Site Number : 8400016
RECRUITING
Charlottesville
Contact Information
Primary
Trial Transparency email recommended (Toll free for US & Canada)
Contact-US@sanofi.com
800-633-1610
Time Frame
Start Date:2026-08-03
Estimated Completion Date:2028-02-22
Participants
Target number of participants:640
Treatments
Experimental: Group 1: Flu H5 egg pandemic low dose vaccine, with adjuvant
Participants receive 2 intramuscular injections of flu H5 egg pandemic low dose vaccine, with adjuvant
Experimental: Group 2: Flu H5 Egg Pandemic medium dose vaccine, with adjuvant
Participants receive 2 intramuscular injections of flu H5 egg pandemic medium dose vaccine, with adjuvant
Experimental: Group 3: Flu H5 Egg Pandemic high dose vaccine, with adjuvant
Participants receive 2 intramuscular injections of flu H5 egg pandemic high dose vaccine, with adjuvant
Experimental: Group 4: Flu H5 Egg Pandemic high dose vaccine, without adjuvant
Participants receive 2 intramuscular injections of flu H5 egg pandemic high dose vaccine, without adjuvant