Actively Recruiting

Phase 2
Age: 21Years +
All Genders
Healthy Volunteers
NCT05291676

Systems Investigation of Vaccine Responses in Aging and Frailty

Led by Yale University · Updated on 2025-06-12

96

Participants Needed

1

Research Sites

177 weeks

Total Duration

On this page

Sponsors

Y

Yale University

Lead Sponsor

N

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This study will compare the immune response signatures (including immunologic, transcriptomic and metabolomic) of the two influenza vaccines approved for use in adults age 65 and over (Fluad and Fluzone High-Dose).

CONDITIONS

Official Title

Systems Investigation of Vaccine Responses in Aging and Frailty

Who Can Participate

Age: 21Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 21 to 40 years or 65 years and older
  • Ability to understand and provide informed consent; surrogate consent allowed for nursing home residents who are decisionally impaired with verbal assent
  • Plan to remain in the New Haven, CT area for the next 4 to 6 weeks
Not Eligible

You will not qualify if you...

  • Use of antibiotics for an acute infection within the past two weeks
  • Evidence of acute infection or fever in the past two weeks
  • Cancer treatment within the past three months
  • Previous serious adverse reaction to influenza vaccine requiring medical attention, including allergic reactions or Guillain-Barré syndrome
  • Pregnant or 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 one pint or more in the past two months
  • Treatment with clinical trial medication
  • Any condition or circumstance that may limit participation, including missing 50% or more appointments in the last three months

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Yale School of Medicine

New Haven, Connecticut, United States, 06520

Actively Recruiting

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Research Team

I

Irene Matos, RN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

4

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