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Immunogenicity and Safety of 2 Doses of Avian Influenza A (H5N1) Vaccine Administered 3 vs. 8 Weeks Apart

StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 4 of 4 sites
    v2
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Given the recent circulation of avian influenza A(H5N1) clade 2.3.4.4b strains in birds and mammals in North America, Canada procured a supply of Arepanrix™ H5N1 for potential use in persons at high risk of highly pathogenic avian influenza exposure. This vaccine received regulatory approval in 2013, to be given in two doses at least 3 weeks apart. There is limited data on the effect of various intervals between the two doses on immunogenicity and tolerability. In this study two intervals between doses will be compared (3 vs. 8 weeks apart).
Trial Details
NCT Number NCT07275060
Lead Sponsor Canadian Immunization Research Network
Collaborators: Dalhousie University, IWK Health Centre, Public Health Agency of Canada (PHAC), Canadian Center for Vaccinology, CHU de Quebec-Universite Laval, Vaccine Evaluation Center, Canada, McGill University Health Centre/Research Institute of the McGill University Health Centre
Conditions
(from sponsor)		 H5N1 Influenza, H5N1 Virus, Avian Influenza, Avian Influenza A Virus
Related terms Influenza in Birds
Enrollment 312 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov