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High-Dose vs Standard-Dose Influenza Vaccine in Solid Organ Transplant Recipients
NCT01808456Phase 4
Key facts
- Status
- Completed
- Start
- Oct 2013
- Primary completion
- Dec 2016
- Countries
- 1
- Sponsor
- Inova Health System
- Modality
- Vaccines & Immunotherapeutics
- Conditions
- influenza
01
Overview
Phase 4, randomised, single-blind trial of influenza virus vaccine, split virion in influenza (2 arms), sponsored by Inova Health System. Primary endpoints: Number of Patients With Local Site Reactions at 12 weeks and Measurement of Strain-specific Hemagglutination Inhibition (HI) Antibody Titers at 12 weeks. Started Oct 2013; status: completed.
02
Design
2 arms- Study design
- RandomizedSingle-blind
High Dose Flu Vaccine
Fluzone High-Dose IM injection
Flu Vaccine
Fluzone Standard Dose IM injection
03
Who it enrols
Adult solid organ transplant recipients (kidney, heart, lung) at least 30 days post-transplant without acute rejection, infection, or bleeding diathesis.
04
Endpoints
Primary
Number of Patients With Local Site Reactions
Measurement of Strain-specific Hemagglutination Inhibition (HI) Antibody Titers
Secondary
All Cause ED Visits/Unscheduled Clinic Visits
Number and Percentage of Subjects in Each Group Achieving Seroconversion for Each Strain
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