Comparing immune responses to two influenza vaccines in older adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study compares the immune response signatures of two influenza vaccines approved for adults aged 65 and over: the high-dose Fluzone and the standard-dose Fluad. It aims to evaluate the innate and adaptive immune responses, as well as transcriptomic and proteomic signatures, in nursing home residents, who are particularly vulnerable to influenza. The study is randomized and open-label, including participants aged 21-30 as a control group. Participants will be monitored for influenza-like illness to assess the effectiveness of the vaccines.

Why it matters

Who can join: the full rules

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.

Where it's running

• Yale School of Medicine
  New Haven, Connecticut, United States Recruiting

Study contacts

• Principal investigator: Albert Shaw, MD, PhD — Yale University
• Study coordinator: Irene Matos, RN
• Email: irene.matos@yale.edu
• Phone: (203) 737-4739

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• High-dose vs standard-dose flu vaccine in adults with blood cancers on B-cell-depleting therapy

  This study tests whether a high-dose flu shot evokes a stronger immune response than a standard-dose shot in adults with hematologic cancers who recently had B-cell-depleting therapy.

  Recruiting Phase 2 Asan Medical Center · Seoul · NCT07926217

• Abbott ID NOW at the point of care for flu-like illness in long-term care facilities

  This trial tests whether the Abbott ID NOW rapid test at the point of care in long-term care facilities can help identify influenza sooner for residents 65 and older with fever and respiratory symptoms.

  Recruiting China Medical University Hospital · Taichung · NCT07846423

• Egg-based H5N8 influenza vaccine at multiple doses with or without adjuvant in healthy adults

  This trial tests whether an egg-based H5N8 flu vaccine, given at low to high doses with or without an adjuvant, is safe and can provoke a stronger immune response in healthy adults 18 and older.

  Recruiting at 16 sites Phase 1/2 Sanofi · Tempe, Arizona and 15 other locations · NCT07779408

• Safety and PK of Ingavirin Forte vs Ingavirin in healthy adults under fasting and fed conditions

  This early-phase study tests whether Ingavirin Forte (90 mg + 20 mg) is safe and how it behaves in the body compared with Ingavirin (90 mg) in healthy adults aged 18–45, under different meal conditions.

  Recruiting Phase 1 Valenta Pharm JSC · Saint Petersburg · NCT07645534

• Light-based immune boost to help prevent viral upper respiratory infections

  A daily handheld light therapy device is tested to see if it can lower how often adults at a military medical facility get colds, flu, or other upper respiratory infections.

  Recruiting Mike O'Callaghan Military Hospital · Nellis Air Force Base, Nevada · NCT07610967

• Virological Monitoring of Seasonal Respiratory Infections in France

  This project tests how often common respiratory viruses show up in patients seen by primary care doctors in metropolitan France during the fall and winter.

  Recruiting Institut National de la Santé Et de la Recherche Médicale, France · Paris · NCT07599449

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.