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Virus Vaccine

High vs Standard Dose Flu Vaccine for Solid Organ Transplant Recipients

Q: How does the safety profile of High Dose Quadrivalent Inactivated Influenza Vaccine compare to other similar treatments?

Currently, there are 1 Phase 3 and 16 active clinical trials in total for the High Dose Quadrivalent Inactivated <a href="https://www.withpower.com/clinical-trials/influenza">Influenza</a> <a href="https://www.withpower.com/clinical-trials/vaccine">Vaccine</a>. Trials for this vaccine are still recruiting patients at 17 different locations, including Stanford, <a href="https://www.withpower.com/clinical-trials/california">California</a>.

Q: Has a clinical trial like this been conducted before?

Since 2016, when the first trial for High Dose Quadrivalent Inactivated <a href="https://www.withpower.com/clinical-trials/influenza">Influenza</a> <a href="https://www.withpower.com/clinical-trials/vaccine">Vaccine</a> was conducted, there has been significant global interest in this medication. After the initial study involving 42 individuals in 2016, which was sponsored by Pharmacyclics LLC., further Phase 2 trials received drug approval. Today, 16 live studies are being conducted across 11 cities and 3 countries.

Q: Are researchers looking for more participants in this trial?

Yes, this information is up to date. The clinical trial was first posted on February 2nd, 2021 and the most recent edit was done on May 27th, 2022.

Q: How many people are the investigators hoping to enroll in this research project?

The listings on clinicaltrials.gov show that this is an ongoing trial which began recruitment on February 2nd, 2021. The most recent update was made on May 27th, 2022. So far, 396 patients have been enrolled from 1 site.

Q: What is the FDA's stance on High Dose Quadrivalent Inactivated Influenza Vaccine?

While there is some data supporting the safety of High Dose Quadrivalent Inactivated <a href="https://www.withpower.com/clinical-trials/influenza">Influenza</a> <a href="https://www.withpower.com/clinical-trials/vaccine">Vaccine</a>, it is still in Phase 2 of clinical trials and has not yet been proven effective. We rate its safety as a 2.

Phase 2

Recruiting

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

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

Must have

≥1 month and <12 months post-SOT

Age ≥18 years at vaccination

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 56 (post-vaccination)

Awards & highlights

Study Summary

This trial is testing whether high-dose or standard-dose influenza vaccines are more effective in organ transplant recipients 1-11 months post-transplant.

Who is the study for?

Adults aged 18+ who are 1-11 months post solid organ transplant (kidney, heart, liver) can join this trial. They must be reachable for follow-ups and not pregnant or have had lung/intestine transplants, severe vaccine allergies, low platelets, Guillain-Barre syndrome, HIV, or recent immunoglobulin therapy.Check my eligibility

What is being tested?

The study is testing if a high-dose flu vaccine gives better immunity than the standard dose in new organ transplant recipients. Participants will get either two high doses, two standard doses or one high dose of the flu shot to see which works best.See study design

What are the potential side effects?

Flu vaccines may cause soreness at injection site, mild fever, fatigue or muscle aches. Rarely they could trigger allergic reactions. The higher dose might increase these side effects but is generally considered safe.

Eligibility Criteria

Inclusion Criteria

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

Select...

I had an organ transplant between 1 and 12 months ago.

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 56 (post-vaccination)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 56 (post-vaccination)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 56 (post-vaccination) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Geometric Mean Titers of influenza vaccine antibodies.

The number of participants reporting solicited injection site reactions and systemic reactions.

Secondary outcome measures

Geometric Mean Titers Ratio of influenza vaccine antibodies (post-/pre-vaccination).

The number of participants achieving seroprotection and seroconversion for influenza virus.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Two Doses Standard Dose Quadrivalent Inactivated Influenza VaccineExperimental Treatment1 Intervention

two doses of 0.5 mL SD-IIV (15µg of each influenza antigen) 28-42 days apart

Group II: Two Doses High Dose Quadrivalent Inactivated Influenza VaccineExperimental Treatment1 Intervention

two doses of 0.7 mL HD-IIV (60µg of each influenza antigen) 28-42 days apart

Group III: One Dose High Dose Quadrivalent Inactivated Influenza VaccineExperimental Treatment1 Intervention

one dose of 0.7 mL HD-IIV (60µg of each influenza antigen) followed by placebo 28-42 days later

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Feinberg School of Medicine, Northwestern UniversityOTHER

33 Previous Clinical Trials

11,848 Total Patients Enrolled

Vanderbilt University Medical CenterLead Sponsor

857 Previous Clinical Trials

671,797 Total Patients Enrolled

Northwestern University Feinberg School of MedicineOTHER

38 Previous Clinical Trials

14,475 Total Patients Enrolled

Media Library

High Dose Quadrivalent Inactivated Influenza Vaccine (Virus Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT04613206 — Phase 2

Transplant Infection Research Study Groups: Two Doses High Dose Quadrivalent Inactivated Influenza Vaccine, Two Doses Standard Dose Quadrivalent Inactivated Influenza Vaccine, One Dose High Dose Quadrivalent Inactivated Influenza Vaccine

Transplant Infection Clinical Trial 2023: High Dose Quadrivalent Inactivated Influenza Vaccine Highlights & Side Effects. Trial Name: NCT04613206 — Phase 2

High Dose Quadrivalent Inactivated Influenza Vaccine (Virus Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04613206 — Phase 2

Frequently Asked Questions

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

How does the safety profile of High Dose Quadrivalent Inactivated Influenza Vaccine compare to other similar treatments?

"Currently, there are 1 Phase 3 and 16 active clinical trials in total for the High Dose Quadrivalent Inactivated Influenza Vaccine. Trials for this vaccine are still recruiting patients at 17 different locations, including Stanford, California."

Answered by AI

Has a clinical trial like this been conducted before?

"Since 2016, when the first trial for High Dose Quadrivalent Inactivated Influenza Vaccine was conducted, there has been significant global interest in this medication. After the initial study involving 42 individuals in 2016, which was sponsored by Pharmacyclics LLC., further Phase 2 trials received drug approval. Today, 16 live studies are being conducted across 11 cities and 3 countries."

Answered by AI

Are researchers looking for more participants in this trial?

"Yes, this information is up to date. The clinical trial was first posted on February 2nd, 2021 and the most recent edit was done on May 27th, 2022."

Answered by AI

How many people are the investigators hoping to enroll in this research project?

"The listings on clinicaltrials.gov show that this is an ongoing trial which began recruitment on February 2nd, 2021. The most recent update was made on May 27th, 2022. So far, 396 patients have been enrolled from 1 site."

Answered by AI

What is the FDA's stance on High Dose Quadrivalent Inactivated Influenza Vaccine?

"While there is some data supporting the safety of High Dose Quadrivalent Inactivated Influenza Vaccine, it is still in Phase 2 of clinical trials and has not yet been proven effective. We rate its safety as a 2."

Answered by AI