Pandemic Influenza Vaccine in Organ Transplantation (PIVOT Trial)
Recruiting
Phase 3
Interventional Study
Influenza (Pandemic)
Avian Influenza
Vaccination
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 120 (estimated)
- Sponsor
- University Health Network, Toronto · Other
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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Age ≥ 18 and greater than 3 months post-transplant
* Stable graft function
* eGFR \>30mL/min/1.73m2
* Able to provide informed consent
Exclusion Criteria:
* Allergy to vaccine components;
* Previous life-threatening reaction to influenza vaccine (ie Guillain Barré Syndrome);…
Contacts