RecruitingPhase 1Phase 2NCT07779408

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.

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.


Sponsor

Sanofi

Enrollment

640 participants

Start Date

Aug 3, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Flu H5 Egg Pandemic high dose vaccine, with adjuvant, a biological treatment called Flu H5 Egg Pandemic high dose vaccine, without adjuvant, and others for people with healthy volunteers and influenza. The study is currently recruiting participants at 16 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALFlu H5 egg pandemic low dose vaccine, with adjuvant

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM)

BIOLOGICALFlu H5 Egg Pandemic medium dose vaccine, with adjuvant

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM)

BIOLOGICALFlu H5 Egg Pandemic high dose vaccine, with adjuvant

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM)

BIOLOGICALFlu 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

View Full Details on ClinicalTrials.gov

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NCT07779408


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