Systems Investigation of Vaccine Responses in Aging and Frailty

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT05291676
Phase
PHASE2
Status
Recruiting
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Conditions

  • Influenza

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Fluzone — BIOLOGICAL
    Fluzone High-Dose 0.7 ml intramuscular injection, standard as recommended by manufacturer
  • Fluad — BIOLOGICAL
    Fluad Quadrivalent, MF59 adjuvanted 0.5 ml intramuscular injection, standard as recommended by manufacturer

Study Details

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).

Key Dates

Start date
Nov 6, 2023
Status verified
Jun 2025
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
96 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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

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

Locations (1)

FacilityCityStateZIPSite coordinators
Yale School of MedicineNew HavenConnecticut06520
Irene Matos, RN
[email protected]
203-737-4739

Find similar trials in New Haven, CT

By research site
Yale School of Medicine· New Haven, CT

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