drugset / Trial / NCT07779408

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 ↗

Phase 1/2 Recruiting 640 enrolled Sanofi
RandomizedParallel-groupDouble-blindPrevention

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).

Timeline

Start
2026-08-03
Primary completion
2028-02-22
Completion
2028-02-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Matrix-M1 Adjuvant Other / unclassified — Intramuscular
Subject egg-based H5N8 influenza vaccine Vaccine — Intramuscular

Indications