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NCT07275060
Immunogenicity and Safety of 2 Doses of Avian Influenza A (H5N1) Vaccine Administered 3 vs. 8 Weeks Apart
Phase 4 trial testing H5N1 vaccine (Arepanrix) in H5N1 Influenza in 312 participants. Participants enrolled and being followed up; not accepting new ones.
28 February 2027
Quick facts
| Lead sponsor | Canadian Immunization Research Network |
|---|---|
| Phase | Phase 4 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 312 |
| Start date | 14 October 2025 |
| Primary completion | 28 February 2027 |
| Estimated completion | 30 September 2027 |
| Sites | 4 locations across Canada |
Drugs / interventions tested
- H5N1 vaccine (Arepanrix) — full drug profile →
- Saline (as a placebo) — full drug profile →
Conditions studied
- H5N1 Influenza — all drugs for H5N1 Influenza →
- H5N1 Virus — all drugs for H5N1 Virus →
- Avian Influenza — all drugs for Avian Influenza →
- Avian Influenza A Virus — all drugs for Avian Influenza A Virus →
Sponsor
Canadian Immunization Research Network
Who can join
Adults 18 to 59, any sex, with H5N1 Influenza or H5N1 Virus. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07275060
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Canadian Immunization Research Network trials
Trials by the same sponsor.
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- NCT03031912 — African-Canadian Study of HIV-Infected Adults and a Vaccine for Ebola - ACHIV-Ebola · Phase 2 · completed
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07275060 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Canadian Immunization Research Network
- Last refreshed: 16 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07275060.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing