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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the end of the study-5th year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am over 75 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at the end of the study-5th year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the end of the study-5th year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Presence of CMV Viral DNA in Peripheral Blood Monocytes
Secondary outcome measures
Immune Responses to High Dose TIV Immunization
Other outcome measures
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
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
N/A
~1300
Find a Location
Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,263 Previous Clinical Trials
14,822,140 Total Patients Enrolled
1 Trials studying Immunizations
225 Patients Enrolled for Immunizations
Sean LengPrincipal InvestigatorJohns Hopkins University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently undergoing radiation or chemotherapy.I am currently taking oral steroids or drugs that affect my immune system.You are allergic to eggs or vaccines.I currently have cancer.I am unable to understand or decide about getting a Flu shot on my own.I have worsening heart failure or lung disease.I am over 75 years old.I do not have active inflammatory diseases like rheumatoid arthritis.
Research Study Groups:
This trial has the following groups:- Group 1: Influenza Immunization
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are enrolled in this research endeavor?
"Affirmative. According to the clinicaltrials.gov records, 525 participants are needed at one medical site for this trial - which was initially posted on March 1st 2014 and recently revised on March 14th 2022."
Answered by AI
Is enrollment for this experiment open at present?
"Clinicaltrials.gov affirms the active recruitment of patients for this medical study, which was initially posted on March 1st 2014 and recently updated on March 14th 2022."
Answered by AI
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