Who is sponsoring NCT03139565?

NCT03139565 is sponsored by University Health Network, Toronto.

What condition does NCT03139565 study?

NCT03139565 studies Influenza, Immunosuppression.

What drugs are being tested in NCT03139565?

Interventions: Fluzone High-dose Influenza Vaccine, Standard 2016-2017 Flu vaccine.

What is the status of NCT03139565?

NCT03139565 is currently COMPLETED.

Last reviewed 2020-10-21 · How we verify

A Randomized Controlled Trial Comparing High-dose vs. Standard Influenza Vaccine in Adult Solid Organ Transplant Recipients

NCT03139565 Phase 3 COMPLETED

The study will test whether a high dose influenza vaccination results in improved immunogenicity in adult SOT recipients as compared to standard vaccine. This will be a single center prospective observer-blind randomized controlled trial conducted at the Toronto General Hospital Multi-Organ Transplant Unit, University Health Network, Toronto, Ontario, Canada.

Details

Lead sponsor	University Health Network, Toronto
Phase	Phase 3
Status	COMPLETED
Enrolment	172
Start date	2016-10
Completion	2020-07

Conditions

Influenza
Immunosuppression

Interventions

Fluzone High-dose Influenza Vaccine
Standard 2016-2017 Flu vaccine

Primary outcomes

Vaccine Immunogenicity (antibody titers) — 4 weeks
Comparing pre-vaccine and 4 weeks Post-Vaccine antibody titers. Positive vaccine response will be defined as: * Seroconversion rate of 4-fold or greater increase in HAI antibody titers to each of the three antigens in the vaccine, and * seroprotection rate determined by HAI tigers of 1\>=40 post immunization

Countries

Canada