Clinical Trial

Safety and Immunogenicity of the Monovalent Influenza Vaccine A (H5N8) (Inactivated, Fragmented and Adjuvanted) in Adults and Older Adults

Recruiting Phase 1/2
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Summary
This study aims to demonstrate the safety and immunogenicity of two formulations of the monovalent influenza vaccine candidate A (H5N8) (inactivated, fragmented, and adjuvanted with IB160) from the Instituto Butantan in adults and older adults, to be developed for situations of pandemic, epidemic or outbreak of avian type A/H5 in humans, in the context of pandemic preparedness.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-02-19; most recent amendment 2026-04-01.
Status change: Not Yet Recruiting → Recruiting 2025-09-10
Trial Details
NCT Number NCT06842173
Lead Sponsor Butantan Institute
Collaborators: Butantan Foundation
Conditions Avian Influenza A Virus
Enrollment 700 participants
Start Date 2025-09-10
Primary Completion 2027-08-10 (estimated)
Study Completion 2027-10-10 (estimated)
Updated on ClinicalTrials.gov 2026-04-02