High vs.Standard Dose Influenza Vaccine in Pediatric Solid Organ Transplant (SOT) Recipients

PHASE2RecruitingINTERVENTIONAL
Enrollment

312

Participants

Timeline

Start Date

September 26, 2024

Primary Completion Date

July 1, 2027

Study Completion Date

September 1, 2027

Conditions
Immunization; InfectionTransplantation InfectionInfluenza
Interventions
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.

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."

Trial Locations (8)

15224

RECRUITING

UPMC Children's Hospital of Pittsburgh, Pittsburgh

30322

RECRUITING

Children's Healthcare of Atlanta, Atlanta

37232

RECRUITING

Monroe Carell Jr. Children's Hospital at Vanderbilt, Nashville

45229

RECRUITING

Cincinnati Children's Hospital Medical Center, Cincinnati

60614

RECRUITING

Ann Robert H. Lurie Children's Hospital of Chicago, Chicago

64108

RECRUITING

Children's Mercy Hospital, Kansas City

77030

RECRUITING

Texas Children's Hospital, Houston

94305

RECRUITING

Stanford University, Stanford

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH