High vs. Standard Dose Influenza Vaccine in Lung Allograft Recipients

This study is looking at whether a higher dose flu vaccine works better than a standard dose flu vaccine for people who have received a lung transplant. We know that lung transplant recipients are more likely to get very sick from the flu. This study will compare two doses of Fluzone High-Dose Quadrivalent Inactivated Influenza Vaccine to two doses of Fluzone Quadrivalent. Researchers want to see if the high-dose vaccine creates a stronger immune response (more antibodies) and if it is just as safe as the standard dose vaccine. You may be able to join if you are a lung transplant recipient, aged 16 or older, and had your transplant between 1 month and 3 years ago. The study aims to enroll 270 participants, but the current recruitment status is unclear.

Study design
This is a Phase 2, multi-center, double-blind, randomized controlled study comparing two different flu vaccines. It plans to enroll 270 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your antibody levels will be measured 56 days after vaccination, and reactions will be monitored for 7 days post-vaccination.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05215327

High vs. Standard Dose Influenza Vaccine in Lung Allograft Recipients

Recruiting
PHASE2Ages 16+InterventionalPrevention
Vanderbilt University Medical Center
~270 participants
Updated 2025-12-08 on ClinicalTrials.gov
What's tested:High Dose Quadrivalent Inactivated Influenza VaccineStandard Dose Quadrivalent Inactivated Influenza Vaccine

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Geometric Mean Titers of influenza vaccine antibodies.
Measured over Day 56 (post-vaccination)
+1 more outcome measured
Immunization; Infection
Transplantation Infection
Influenza
1 sites across 1 states
Tennessee1
  • Natasha Halasa, MD. MPH · PRINCIPAL_INVESTIGATOR · Vanderbilt University Medical Center

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  • Geometric Mean Titers of influenza vaccine antibodies.Day 56 (post-vaccination)

    Antibody titers will be measured by hemagglutination inhibition assay.

  • The number of participants reporting solicited injection site reactions and systemic reactions.Within 7 days post-vaccination

    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).