High vs. Standard Dose Flu Vaccine for Pediatric Transplant Patients
This study is looking at how well two different flu vaccines work in children who have received a solid organ transplant (kidney, heart, and/or liver). We know that children who have had transplants don't always respond well to the usual flu shot. This study compares a standard dose vaccine, Fluzone® Quadrivalent, with a high-dose vaccine, Fluzone High-Dose, to see if the high-dose version creates a stronger immune response. Researchers will also check how safe each vaccine is by looking at any side effects in the first 7 days after each shot. The study aims to enroll about 312 children aged 3 to 17 years who are 1 to 23 months post-transplant. The current status of this study is unclear.
- Study design
- This is a Phase 2, multi-center study where about 312 participants will be randomly assigned to receive either two doses of Fluzone® Quadrivalent or two doses of Fluzone High-Dose. It is a double-blind study, meaning neither you nor your doctor will know which vaccine you receive.
- What's involved
- Participants will receive two doses of a study vaccine. Researchers will measure your immune response at 4 weeks after the second vaccine and check for side effects in the first 7 days after each vaccine.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your immune response will be measured 4 weeks after the second study vaccine. Safety will be monitored for 7 days following each vaccine.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
High vs.Standard Dose Influenza Vaccine in Pediatric Solid Organ Transplant (SOT) Recipients
At a glance
Conditions
Where it's being run
8 sites across 8 statesWho to contact
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Do you actually qualify for this trial?
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Inclusion
What this trial measures
- Immunogenicity: Hemagglutination Inhibition (HAI) titers4 weeks following the 2nd study vaccine
Antibody titers will be measured by hemagglutination inhibition assay.
- Safety: solicited local and systemic post-administration reactionsin the first 7 days following each study vaccine
Post-vaccination local adverse events (pain, tenderness, swelling/induration, erythema/redness, swelling/induration size, and erythema/redness size) and systemic adverse events (Fatigue/malaise, headache, nausea, body ache/myalgia (not at the injection site), general activity level, vomiting, and fever).