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Comparing Flu Vaccines in Older Adults

This study is comparing two flu vaccines, Fluzone High-Dose and Fluad Quadrivalent, which are both approved for adults aged 65 and over. Researchers want to understand how these vaccines affect the immune system in older adults, especially those in nursing homes, and also in younger adults. They will measure changes in a specific immune marker called IL-6 in blood cells (monocytes) at different times after vaccination to see how well the vaccines work. You might be able to join if you are 21-40 or 65 and older, can give informed consent, and plan to be in the New Haven, CT area for 4-6 weeks. The current recruitment status is unclear.

Study design
This is a randomized, open-label study comparing two flu vaccines in about 96 participants. It includes both younger adults (21-30) and older adults (65 and older) living in nursing homes.
What's involved
Participants will receive one of the two flu vaccines. Blood samples will be taken at the start of the study and again on Day 2, 7, and 28 after vaccination.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 28 days after vaccination to measure immune responses.

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NCT05291676

Systems Investigation of Vaccine Responses in Aging and Frailty

Recruiting
PHASE2Ages 21+InterventionalPrevention
Yale University
~96 participants
Updated 2025-06-12 on ClinicalTrials.gov
What's tested:FluzoneFluad

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in production of IL-6 in monocytes to assess innate immune inflammatory response
Measured over Baseline and at Day 2, 7, and 28 post-vaccine

Conditions

Influenza

Explore related trials

Influenza

Where it's being run

1 sites across 1 states
Connecticut1

Study leadership

  • Albert Shaw, MD, PhD · PRINCIPAL_INVESTIGATOR · Yale University

Who to contact

Irene Matos, RN
[email protected]
(203) 737-4739
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age 21-40 or 65 and older
Ability to understand and give informed consent (surrogate consent may apply to nursing home subjects who are decisionally impaired, with verbal assent to be obtained from subject)
Plan to be in the New Haven, CT area for the next 4-6 weeks

Exclusion

Current use of medication, such as antibiotics in past two weeks. To clarify, patients taking antibiotics for the reason of a current acute infection will not be eligible. Those potential participants receiving antibiotics for prophylaxis purposes will be eligible to participate. The intention is not to create a separate group to drawn conclusions, but not to exclude these participants who are not acutely ill.
Evidence of acute infection, identified by self- report of fever or symptoms in past two weeks
Treatment for cancer in past three months.
Previous adverse reaction to influenza vaccine requiring medical attention, such as allergic response (rash, anaphylaxis) or Guillain-Barré syndrome.
Pregnant/possibly pregnant.
History of organ, bone marrow or stem cell transplant, liver cirrhosis, kidney disease requiring dialysis, HIV/AIDS, hepatitis C or active hepatitis B
Blood donation of 1 pint or more in past 2 months
Treatment with clinical trial medication
Presence of any other condition (e.g., geographical or social), actual or projected, that the investigator feels would restrict or limit the patient's participation for the duration of the study. This provision includes participants who have 50% or more missed appointments in the last three months.

What this trial measures

  • Change in production of IL-6 in monocytes to assess innate immune inflammatory responseBaseline and at Day 2, 7, and 28 post-vaccine

    Measurement of IL-6 production in monocytes via flow cytometry