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

NCT07275060 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 312

Last updated 2026-01-16

No results posted yet for this study

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 Arepanrixâ„¢ 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).

Conditions

  • H5N1 Influenza
  • H5N1 Virus
  • Avian Influenza
  • Avian Influenza A Virus

Interventions

BIOLOGICAL

H5N1 vaccine (Arepanrix)

The H5N1 (Arepanrix) vaccine will be administered according to the Product Monograph.

OTHER

Saline (as a placebo)

Normal saline will be administered as a placebo according to the Product Monograph.

Sponsors & Collaborators

  • Dalhousie University

    collaborator OTHER

  • IWK Health Centre

    collaborator OTHER

  • Public Health Agency of Canada (PHAC)

    collaborator OTHER_GOV

  • Canadian Center for Vaccinology

    collaborator OTHER

  • CHU de Quebec-Universite Laval

    collaborator OTHER

  • Vaccine Evaluation Center, Canada

    collaborator OTHER

  • McGill University Health Centre/Research Institute of the McGill University Health Centre

    collaborator OTHER

  • Canadian Immunization Research Network

    lead NETWORK

Principal Investigators

  • Joanne M Langley · CIRN, Canadian Center for Vaccinology, Dalhousie University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-14
Primary Completion
2027-02-28
Completion
2027-09-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07275060 on ClinicalTrials.gov