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.
Eligible age
18+ yrs
Accepts
All genders
Locations
11 states
Healthy volunteers
Yes
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About this study
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).
Sponsor: Sanofi
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ Known or suspected immunodeficiency; immunosuppressive therapy in past 6 months; or long-term systemic corticosteroid (eg, prednisone for more than 2 weeks in the past 3 months)
- ✕ Known hepatitis B or hepatitis C infection (based on medical history)
- ✕ Known personal or family history of previous episodes of Guillan-Barré syndrome (GBS), neuritis (including Bell's palsy), convulsions, encephalitis, transverse myelitis, and vasculitis
- ✕ Known systemic hypersensitivity to any of the study intervention components or history of life-threatening reaction to the study interventions or products with same substances
- ✕ Self-reported thrombocytopenia contraindicating intramuscular (IM) injection based on investigator's judgment
- ✕ Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM injection based on investigator's judgment
- ✕ Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
- ✕ History of A/H5 infection prior to the study participation
Where it's recruiting
Source: ClinicalTrials.gov · NCT07779408 · last updated 2026-09-15