Recruiting
Phase 2

Vaccine Responses

Sponsor:

Yale University

Code:

NCT05291676

Conditions

Influenza

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Interventions

Fluzone

Fluad

Study Details

Brief summary:

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

Influenza

Study ID

NCT05291676

Start date

Nov 6, 2023

Status verified date

Jun, 2025

Completion date

Apr, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

96 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: 21-30 standard dose Fluad

Participants age 21-30 years will receive the standard dose Fluad

active comparator: 21-30 high dose Fluzone

Participants age 21-30 years will receive the high dose Fluzone

experimental: ≥65 years standard dose Fluad

Participants age ≥65 years will receive standard dose Fluad

experimental: ≥65 years high dose Fluzone

Participants age ≥65 years will receive high dose Fluzone

Interventions

Fluzone

Fluzone High-Dose 0.7 ml intramuscular injection, standard as recommended by manufacturer

Fluad

Fluad Quadrivalent, MF59 adjuvanted 0.5 ml intramuscular injection, standard as recommended by manufacturer

Primary outcome measure

  • Change in production of IL-6 in monocytes to assess innate immune inflammatory response [ Time Frame: Baseline and at Day 2, 7, and 28 post-vaccine ]

Central Contacts and Locations

Central contacts

Irene Matos, RN

(203) 737-4739irene.matos@yale.edu

Locations

Yale School of Medicine

Recruiting

New Haven, Connecticut, United States, 06520

Contacts

Irene Matos, RN

203-737-4739irene.matos@yale.edu

More Information

Sponsor

Yale University

Last update posted

Jun 12, 2025

Last verified

Jun, 2025

Keywords

  • vaccine
  • influenza vaccine
  • older adults
  • vaccine response
  • toll-like receptors
  • immune response

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-03. This information was provided to ClinicalTrials.gov by Yale University on 2025-06-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.