← Back to Search

Vaccine

High-Dose Flu Vaccine for Solid Organ Transplant Recipients

N/A

Recruiting

Led By Hareesh Singam, MD

Research Sponsored by University of Minnesota

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

>=18 years old who underwent a solid organ transplant (Liver, lung, heart, kidney, pancreas) > 1 year prior to enrollment

At least 1-year post-transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial will evaluate how best to optimize influenza vaccine efficacy & immunogenicity in solid organ transplant recipients, to reduce severity of disease.

Who is the study for?

This trial is for adults over 18 who had a solid organ transplant (like liver, lung, heart, kidney, pancreas) more than a year ago. They must be able to consent and participate in all study activities. People can't join if they've recently received certain immune therapies or high-dose steroids, are pregnant, or have had severe allergies to flu vaccines.Check my eligibility

What is being tested?

The trial is testing the effectiveness of giving two doses of Fluzone High-Dose Quadrivalent influenza vaccine compared to just one dose in people who have received solid organ transplants. The goal is to see which strategy better stimulates the body's defenses against the flu.See study design

What are the potential side effects?

Possible side effects from the Fluzone High-Dose vaccine may include pain at injection site, muscle aches, headache, fatigue and fever. Severe allergic reactions are rare but can occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am over 18 and had an organ transplant more than a year ago.

Select...

I had my transplant surgery over a year ago.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Neutralizing antibody levels- Immunogenicity

Secondary outcome measures

clinical - death rates

clinical outcome- ICU admissions

clinical outcome- hospitalization rates

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: booster groupExperimental Treatment1 Intervention

Participants who have undergone a solid organ transplant will receive two doses of an inactivated high dose influenza vaccine

Group II: Control groupActive Control1 Intervention

Participants who have undergone a solid organ transplant will receive one dose of inactivated high dose influenza vaccine followed by a placebo injection

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor

1,381 Previous Clinical Trials

1,588,875 Total Patients Enrolled

Hareesh Singam, MDPrincipal InvestigatorUniversity of Minnesota

Lauren Fontana, MDPrincipal InvestigatorUniversity of Minnesota

Media Library

Fluzone High-Dose Quadrivalent (Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05663463 — N/A

Solid Organ Transplant Research Study Groups: booster group, Control group

Solid Organ Transplant Clinical Trial 2023: Fluzone High-Dose Quadrivalent Highlights & Side Effects. Trial Name: NCT05663463 — N/A

Fluzone High-Dose Quadrivalent (Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05663463 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacancies in this experiment for participants?

"According to clinicaltrials.gov, the study posted on January 1st 2023 is no longer recruiting patients and has not been updated since December of 2022. Fortunately, there are 11 other trials currently accepting participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Seasonal Influenza Vaccine High Dose Boosting in Solid Organ Transplant Recipients

2023. "Seasonal Influenza Vaccine High Dose Boosting in Solid Organ Transplant Recipients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05663463.

All > Influenza