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A Deep Longitudinal Analysis of Next Generation Influenza Vaccines in Older Adults

NCT05518500 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2026-05-01

No results posted yet for this study

Summary

This is a prospective, single-arm study designed to understand the mechanisms that lead to a loss of response to influenza vaccine in older adults. The investigators will recruit and longitudinally follow a cohort of 75 older adults (65 years and older) who will receive three different influenza vaccines over three annual influenza seasons. Blood samples will be collected from the participants at sixteen study visits over three years. Nasal swab and stool samples will also be collected from participants at seven time-points across the study period. After completion of study visits other than the End of Study visit around vaccination in Year 3, participants will be offered the opportunity to be vaccinated with a different FDA approved influenza vaccine and participate in study visits for Year 4. The study is not designed to assess safety or tolerability of the influenza vaccines administered as part of this study.

Conditions

  • Aging
  • Influenza Vaccine
  • Dendritic Cell
  • Vaccine Response

Interventions

BIOLOGICAL

Flu Vaccine (Year 3)

Participants will receive Flublok Quadrivalent in the 2024-2025 flu season.

BIOLOGICAL

Flu Vaccine (Year 4)

Participants will receive Fluzone® High-Dose Trivalent in the 2025-2026 flu season.

BIOLOGICAL

Flu Vaccine (Year 2)

Participants will receive FLUAD® Quadrivalent in the 2023-2024 flu season.

BIOLOGICAL

Flu Vaccine (Year 1)

Participants will receive Fluzone® Quadrivalent High-Dose in the 2022-2023 flu season.

Sponsors & Collaborators

  • UConn Health

    collaborator OTHER

  • Icahn School of Medicine at Mount Sinai

    collaborator OTHER

  • Weill Medical College of Cornell University

    collaborator OTHER

  • University of Chicago

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • The Jackson Laboratory

    lead OTHER

Principal Investigators

  • George Kuchel, MD, FRCP · UConn Center on Aging

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-31
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05518500 on ClinicalTrials.gov