High vs. Standard Dose Influenza Vaccine in Adult SOT Recipients

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

396

Participants

Timeline

Start Date

January 11, 2021

Primary Completion Date

January 1, 2026

Study Completion Date

April 30, 2026

Conditions
Immunization; InfectionTransplantation InfectionInfluenzaSolid Organ Transplant
Interventions
BIOLOGICAL

High Dose Quadrivalent Inactivated Influenza Vaccine

"Fluzone High-Dose (Influenza Vaccine) for intramuscular injection is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton® X-100), producing a split virus. The split virus is further purified and then suspended in sodium phosphatebuffered isotonic sodium chloride solution. The Fluzone High-Dose process uses an additional concentration factor after the ultrafiltration step in order to obtain a higher hemagglutinin (HA) antigen concentration."

BIOLOGICAL

Standard Dose Quadrivalent Inactivated Influenza Vaccine

Fluzone ® Quadrivalent is a vaccine indicated for active immunization for the prevention of influenza disease caused by two influenza A subtype viruses and two type B viruses contained in the vaccine.

Trial Locations (1)

37232

Vanderbilt Univeristy Medical Center, Nashville

All Listed Sponsors
collaborator

Northwestern University Feinberg School of Medicine

OTHER

collaborator

University of Alabama at Birmingham

OTHER

collaborator

University of Washington

OTHER

lead

Vanderbilt University Medical Center

OTHER