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Seasonal Influenza Vaccine High Dose Boosting in Solid Organ Transplant Recipients

NCT05663463 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2025-07-15

No results posted yet for this study

Summary

In solid organ transplant (SOT) the receipt of influenza vaccine in an influenza season is associated with decreased disease severity as demonstrated by the presence of pneumonia and ICU admissions. Different strategies have been assessed to optimize vaccine efficacy and immunogenicity of the influenza vaccine in the solid organ transplant recipient (SOTR). The primary objective of the study is to evaluate the immunogenicity of 2 doses of the high dose influenza vaccine utilizing neutralizing antibody assays. A control group receiving 1 HD influenza vaccine will be included.

Conditions

  • Solid Organ Transplant

Interventions

DRUG

Fluzone High-Dose - 2 doses

2 doses of the High-Dose (HD) influenza vaccine separated by 4-6 weeks For 2023-2024 influenza season the influenza quadrivalent HD vaccine was used. For 2024 -2025 influenza season the influenza trivalent HD vaccine will be used.

DRUG

Fluzone High-Dose - 1 dose of HD

1 dose of the High Dose (HD) influenza vaccine, followed by a placebo injection 4-6 weeks later For 2023-2024 influenza season the influenza quadrivalent HD vaccine was used. For 2024 -2025 influenza season the influenza trivalent HD vaccine will be used.

Sponsors & Collaborators

Principal Investigators

  • Lauren Fontana, MD · University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-11
Primary Completion
2025-06-16
Completion
2025-06-16

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05663463 on ClinicalTrials.gov