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Vaccine

Flu Shot for Elderly Individuals

N/A
Recruiting
Led By Sean Leng
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adults over age 75 years
Be older than 65 years old
Must not have
On radiation or chemotherapy
Taking oral steroids (such as prednisone) or immune modulating drugs (such as methotrexate)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the end of the study, 5th year
Awards & highlights
No Placebo-Only Group

Summary

This trial is being done to study the immune system in older people and to find out if the Flu Shot is effective in them.

Who is the study for?
This trial is for adults over the age of 75, regardless of their health status. It's not suitable for those on cancer treatments, with egg or vaccine allergies, active cancers, inability to consent, acute heart/lung conditions exacerbations, or taking steroids/immune-modifying drugs.
What is being tested?
The study tests how well people over 75 respond to the flu shot and if chronic CMV infection affects this response. Participants will receive a free flu shot and undergo health assessments including blood draws before and after vaccination.
What are the potential side effects?
While the flu shot is generally safe for elderly individuals, some may experience mild side effects such as soreness at injection site, low-grade fever, muscle aches or fatigue shortly after receiving it.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently undergoing radiation or chemotherapy.
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I am currently taking oral steroids or drugs that affect my immune system.
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I currently have cancer.
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I am unable to understand or decide about getting a Flu shot on my own.
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I have worsening heart failure or lung disease.
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I do not have active inflammatory diseases like rheumatoid arthritis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the end of the study, 5th year
This trial's timeline: 3 weeks for screening, Varies for treatment, and at the end of the study, 5th year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Presence of CMV Viral DNA in Peripheral Blood Monocytes
Other study objectives
Effectiveness of High Dose TIV Immunization
Influence of Frailty and Chronic CMV Infection on Vaccine-Induced Influenza Strain-Specific Antibody Titers and T-Cell Responses

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Influenza ImmunizationExperimental Treatment1 Intervention
Influenza immunization in adults over age 75
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Influenza
2016
Completed Early Phase 1
~1940

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,328 Previous Clinical Trials
14,873,597 Total Patients Enrolled
1 Trials studying Elderly
5 Patients Enrolled for Elderly
Sean LengPrincipal InvestigatorJohns Hopkins University

Media Library

Influenza (Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT02200276 — N/A
Elderly Research Study Groups: Influenza Immunization
Elderly Clinical Trial 2023: Influenza Highlights & Side Effects. Trial Name: NCT02200276 — N/A
Influenza (Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02200276 — N/A
~23 spots leftby Mar 2025
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