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Vaccine

Flu Vaccine Effectiveness in Aging (FluVax3 Trial)

Phase 4
Recruiting
Led By George Kuchel, MD, FRCP
Research Sponsored by The Jackson Laboratory
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Weight of 110 lbs or greater
Male or Female, 65 years and older by September 1, 2022
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, day1, day 7, day 35, day 180
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

Summary

This trial will study 66 seniors over 3 years to understand why the flu vaccine is less effective in older adults. Blood, nasal, and stool samples will be collected at 16 study visits.

Who is the study for?
This trial is for English-speaking men and women aged 65 or older, weighing at least 110 lbs, who are willing to participate in a three-year study involving 19 visits. Participants must be open to receiving annual flu vaccines and providing blood samples. They should not have severe reactions to past flu vaccines but cannot join if they've had Guillain-Barre syndrome after vaccination, recent other vaccinations, egg allergies, certain chronic diseases, or conditions affecting the immune system.
What is being tested?
The study aims to understand why older adults may have a reduced response to influenza vaccines by administering different flu shots over three years. It involves regular collection of blood samples as well as nasal swabs and stool samples at specific times during the study period.
What are the potential side effects?
Since this study isn't focused on vaccine safety or tolerability but rather on understanding immune responses in aging populations, it does not specifically address side effects; however typical flu shot side effects can include soreness at injection site, mild fever, fatigue or muscle aches.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I weigh at least 110 lbs.
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I am 65 years old or older as of September 1, 2022.
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I am willing to get the flu vaccine for the next three seasons.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, day1, day 7, day 35, day 180
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, day1, day 7, day 35, day 180 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Antibody Responses to Influenza Vaccine Year One
Change in Antibody Responses to Influenza Vaccine Year Three
Change in Antibody Responses to Influenza Vaccine Year Two
Secondary study objectives
Changes in number of cDCs, Tfh, Th10, and B lymphocytes in response to Influenza Vaccine in Year One
Changes in number of cDCs, Tfh, Th10, and B lymphocytes in response to Influenza Vaccine in Year Three
Changes in number of cDCs, Tfh, Th10, and B lymphocytes in response to Influenza Vaccine in Year Two
+9 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Healthy Older AdultsExperimental Treatment3 Interventions
Will receive FDA-approved influenza vaccine (Fluzone HD Year 1, FLUAD Year 2, Flublok Quadrivalent Year 3)

Find a Location

Who is running the clinical trial?

University of ChicagoOTHER
1,053 Previous Clinical Trials
758,999 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,319 Previous Clinical Trials
5,548,085 Total Patients Enrolled
1 Trials studying Aging
18 Patients Enrolled for Aging
The Jackson LaboratoryLead Sponsor
5 Previous Clinical Trials
2,159 Total Patients Enrolled
1 Trials studying Aging
40 Patients Enrolled for Aging

Media Library

Flu Vaccine (Year 1) (Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05518500 — Phase 4
Aging Research Study Groups: Healthy Older Adults
Aging Clinical Trial 2023: Flu Vaccine (Year 1) Highlights & Side Effects. Trial Name: NCT05518500 — Phase 4
Flu Vaccine (Year 1) (Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05518500 — Phase 4
~36 spots leftby Dec 2026
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