Senescent Immunity in Elders and Vaccine Responses (SILVER)

NCT ID: NCT04077424

Last Updated: 2022-07-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-21

Study Completion Date

2020-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Flu Vaccine

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
This is an open label trial, the study nurse and participant know which of 3 FDA approved influenza vaccines are given (Fluzone-HD, FluAd, or Flublok). However the investigator and outcomes assessor are blinded to the actual vaccine given.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Fluzone-High Dose

FDA approved high dose inactivated influenza vaccine (HD-Fluzone)

Group Type ACTIVE_COMPARATOR

Fluzone-High Dose Quadrivalent

Intervention Type BIOLOGICAL

Seasonal influenza vaccination with FDA approved vaccines for this age group.

Fluad

Adjuvanted (MF59) inactivated influenza vaccine (Fluad)

Group Type ACTIVE_COMPARATOR

Fluad

Intervention Type BIOLOGICAL

Adjuvanted (MF59) inactivated influenza vaccine

Recombinant Hemagglutinin vaccine (Flublok)

Recombinant hemagglutinin vaccine

Group Type ACTIVE_COMPARATOR

Flublock

Intervention Type BIOLOGICAL

Recombinant hemagglutinin vaccine

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fluzone-High Dose Quadrivalent

Seasonal influenza vaccination with FDA approved vaccines for this age group.

Intervention Type BIOLOGICAL

Fluad

Adjuvanted (MF59) inactivated influenza vaccine

Intervention Type BIOLOGICAL

Flublock

Recombinant hemagglutinin vaccine

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

High-dose flu vaccine standard-dose, inactivated influenza (flu) vaccine Recombinant Hemagglutinin vaccine

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

65 Years

Maximum Eligible Age

125 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Vanderbilt University Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Spyros Kalams

Associate Professor Infectious Disease

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Spyros Kalams

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

single cell

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Immunogenicity of Influenza Vaccinations
NCT06518577 COMPLETED PHASE4