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Pandemic Influenza Vaccine in Organ Transplantation (PIVOT Trial)

NCT07240558 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-12-18

No results posted yet for this study

Summary

Influenza is an important pathogen in transplant recipients. The current widespread outbreak of highly pathogenic H5N1 avian influenza (HPAI) in livestock, and the occurrence of several human cases of infection suggest that the next influenza pandemic may be soon approaching. Transplant patients will likely be uniquely predisposed to serious infection with high morbidity and mortality. There are a number of important reasons that evaluation of prevention strategies are critical in this highly vulnerable population. Currently, there is no data on the immunogenicity of H5Nx vaccines in this highly vulnerable population. The investigators plan to study the safety and immunogenicity of a two-dose regimen of the pandemic influenza H5N1 vaccine in organ transplant patients.

Conditions

  • Influenza (Pandemic)
  • Avian Influenza
  • Vaccination

Interventions

BIOLOGICAL

H5N1 vaccine (Arepanrix, GSK)

2 doses of H5N1 vaccine, 3 weeks apart, given IM (deltoid)

BIOLOGICAL

Placebo

2 doses of 0.5mls normal saline, 3 weeks apart, given IM (deltoid)

Sponsors & Collaborators

  • Laval University

    collaborator OTHER

  • University Health Network, Toronto

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-03
Primary Completion
2026-06-30
Completion
2026-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

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 NCT07240558 on ClinicalTrials.gov