High vs.Standard Dose Influenza Vaccine in Pediatric SOT Recipients (PSOT)
Immunization; Infection, Transplantation Infection, Influenza
About this trial
This is an interventional prevention trial for Immunization; Infection focused on measuring Influenza, Vaccination, Immunization, High Dose, Fluzone, Standard Dose, Influenza, Human, Communicable Diseases, Pediatric transplantation
Eligibility Criteria
Inclusion Criteria: Male or female, 3-17 years of age at time of enrollment Pediatric kidney, heart, and/or liver transplant recipient ≥1 month and <24 months post-transplant at the time of study immunization Note: Inclusion of recipients of multiple organs is permitted but is limited to recipients of any combination of organs including kidney, heart and/or liver Note: Participants undergoing re-transplantation are permitted Anticipated to be available for duration of the study Available Exclusion Criteria: Inability (i.e. not able to understanding and provide consent) or unwillingness of a participant/parent/legal guardian to give written informed consent or comply with study protocol History of severe hypersensitivity to influenza vaccination or anaphylaxis to eggs/egg protein History of severe latex hypersensitivity History of Guillain-Barre syndrome History of lung or intestine transplant Receipt of rituximab or other B-cell depleting antibody (including proteasome inhibitors) therapy in the past 56 days. Receipt of T cell depleting/impacting antibody therapy < 28 days prior to enrollment. New diagnosis of rejection < 28 days prior to enrollment. HIV positive patients (testing within 24 months of enrollment) Receipt of current season's influenza vaccine post-transplant prior to enrollment in the study Currently pregnant or lactating (females of childbearing age may be enrolled based on self-report, urine pregnancy test must be performed prior to each influenza vaccine) Proven influenza disease after September 1st and before first study vaccine (patient can still receive the second influenza vaccination despite proven influenza disease once enrolled) CMV hyperimmune globulin (CMVIG) / Intravenous Immunoglobulin (IVIG) / Subcutaneous Immunoglobulin (SCIG) receipt within 28 days prior to enrollment or planned administration within 84-126 days of the calendar date of first vaccination Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
Sites / Locations
- Vanderbilt University Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Two Doses Standard Dose Quadrivalent Inactivated Influenza Vaccine
Two Doses High Dose Quadrivalent Inactivated Influenza Vaccine
two doses of SD-QIV (0.5 mL; 15µg of each influenza antigen) 28-42 days apart
two doses of HD-QIV (0.7 mL; 60µg of each influenza antigen) 28-42 days apart