drugset / Trial / NCT07275060
Immunogenicity and Safety of 2 Doses of Avian Influenza A (H5N1) Vaccine Administered 3 vs. 8 Weeks Apart
Phase 4
Active not recruiting
312 enrolled
Canadian Immunization Research Network
CHU de Quebec-Universite Laval · collabCanadian Center for Vaccinology · collabDalhousie University · collabIWK Health Centre · collabMcGill University Health Centre/Research Institute of the McGill University Health Centre · collabPublic Health Agency of Canada (PHAC) · collabVaccine Evaluation Center, Canada · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
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).
Timeline
- Start
- 2025-10-14
- Primary completion
- 2027-02-28
- Completion
- 2027-09-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Arepanrix | Vaccine | — | — |