Phase 4 N=10 Randomized Double-blind Basic Science

Senescent Immunity in Elders and Vaccine Responses (SILVER)

Flu Vaccine

Bottom Line

View on ClinicalTrials.gov: NCT04077424 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2022

Primary outcome: Primary: Hemagglutinin Antigen Inhibition Assay Titers at Baseline — 20; 160; 25; 40 antibody titers

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Fluzone-High Dose Quadrivalent (Biological); Fluad (Biological); Flublock (Biological)
Age: Older Adult · 65+ yrs
Sex: All
Sponsor: Vanderbilt University Medical Center
Primary completion: Feb 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Hemagglutinin Antigen Inhibition Assay Titers at Baseline	20; 160; 25; 40; 90; 50	—
PRIMARY Hemagglutinin Antigen Inhibition Assay Titers at Day 28	320; 120; 480; 2560; 160; 320	—

Summary

To study the effects of age on the immune system's response to flu vaccine and to study the connection between the immune system and physical and cognitive changes associated with aging.

Eligibility Criteria

Inclusion Criteria

Age 65 years and over
Independent Living (including Assisted Living)

Exclusion Criteria

Unable to understand the consent or the study.
Allergic to any vaccine components, excluding eggs.
History of Guillain-Barre.
Residing in a long -term care facility such as a nursing home.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04077424). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.