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Systems Investigation of Vaccine Responses in Aging and Frailty

NCT05291676 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2025-06-12

No results posted yet for this study

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

Interventions

BIOLOGICAL

Fluzone

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

BIOLOGICAL

Fluad

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

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Yale University

    lead OTHER

Principal Investigators

  • Albert Shaw, MD, PhD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-06
Primary Completion
2027-04-30
Completion
2027-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT05291676 on ClinicalTrials.gov