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RecruitingAccepts healthy volunteersPhase 2

Systems Investigation of Vaccine Responses in Aging and Frailty

Yale University · with National Institute of Allergy and Infectious Diseases (NIAID) · NCT05291676

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 21+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 2
Target enrollment
96
US sites recruiting
1
Study start
November 6, 2023
Record last updated
June 12, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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).

Being studied: Fluzone; Fluad

Conditions: Influenza

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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 Criteria

  • 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.

Recruiting US locations

  • Yale School of Medicine

    New Haven, CT 06520

    Site contact: Irene Matos, RN · 203-737-4739 · irene.matos@yale.edu

Study contacts (from the official record)

  • Irene Matos, RN · (203) 737-4739 · irene.matos@yale.edu
All vaccine studies in Connecticut →
Systems Investigation of Vaccine Responses in Aging and Frailty (NCT05291676) | Bored Studies