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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.

StatusNot Yet Recruiting
PhasePhase 1/2
SponsorSanofi
Started2026-08-10
View on ClinicalTrials.gov ↗
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).
Trial Details
NCT Number NCT07779408
Lead Sponsor Sanofi
Conditions Healthy Volunteers, Influenza
Enrollment 640 participants
Start Date 2026-08-10
Primary Completion 2028-02-22 (estimated)
Study Completion 2028-02-22 (estimated)
Updated on ClinicalTrials.gov 2026-08-21