Recruiting at 1 site Phase 2 Influenza

Influenza study: Fluzone vs Fluad

Official title Systems Investigation of Vaccine Responses in Aging and Frailty

ClinicalTrials.gov ID: NCT05291676

What this study is testing

What is Fluzone High-Dose?

An investigational high‑dose influenza vaccine being studied for its immune response in adults 65 and older. is designed to deliver four times the hemagglutinin dose of a standard influenza vaccine to enhance antibody production.

Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
The study aims to compare the immune response signatures of Fluad and Fluzone High‑Dose vaccines in older adults.
Who it's for
Adults aged 65 years and older.
What's involved
Participants will receive one of the two influenza vaccines and have blood samples taken to analyze immune, gene, and metabolic responses.
  • Phase 2: a mid-size study of how well it works
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 21 and older. Healthy volunteers may be eligible.

You may be able to join if

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

You likely can't join if

  • Current use of medication, such as antibiotics in past two weeks. To clarify, patients taking antibiotics for the reason of a current acute infection...
  • 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
See the full eligibility criteria
Who can join
  • Age 21-40 or 65 and older
  • Ability to understand and give informed consent (surrogate consent may apply to nursing home people 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
What rules you out
  • 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.
  • 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.

The study team makes the final eligibility decision.

Where it is enrolling

  • New Haven, Connecticut, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 21 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.

Where is this trial taking place?

This study is enrolling now at New Haven, Connecticut, United States. Enter your location above to see the nearest enrolling site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.