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

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Dec 2025 to Aug 10, 2027
    • Study completion date: Jul 2026 to Oct 10, 2027
    • Start date: Sep 1, 2025 to Sep 10, 2025
    v4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 1, 2025 to Sep 1, 2025
    • Site details revised at 5 of 5 sites
    v3
  3. Start date: Apr 23, 2025 to Aug 1, 2025
    • Site details revised at 1 of 5 sites
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06842173
Lead Sponsor Butantan Institute
Collaborators: Butantan Foundation
Conditions
(from sponsor)		 Avian Influenza A Virus
Related terms Influenza in Birds
Enrollment 700 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov