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Virus Vaccine

Influenza Vaccines for Older Adults

Phase 2
Recruiting
Led By Albert Shaw, MD, PhD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 21-30 or 65 and older
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline, day 2, day 7, day 28 and day 70
Awards & highlights

Study Summary

This trial will compare how well two different influenza vaccines work in adults over age 65.

Who is the study for?
This trial is for adults aged either 21-30 or over 65 who plan to stay in New Haven, CT for the next month or so. They must understand and agree to participate. It's not for pregnant individuals, those on recent antibiotics due to acute infections, people who've donated a lot of blood recently, have missed many appointments, had bad reactions to flu shots before, are on trial meds, have an infection currently, cancer treatments recently or severe chronic diseases.Check my eligibility
What is being tested?
The study is looking at how two different flu vaccines (Fluad and Fluzone High-Dose) approved for older adults affect the body's immune response. Researchers will examine changes in immune cells and substances they produce after vaccination.See study design
What are the potential side effects?
Common side effects from Fluad and Fluzone may include pain at the injection site, muscle aches, fatigue and headache. Severe allergic reactions are rare but can occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am either between 21-30 years old or 65 and older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline, day 2, day 7, day 28 and day 70
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, day 2, day 7, day 28 and day 70 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in production of IL-6 in monocytes to assess innate immune inflammatory response
Secondary outcome measures
Change in Hemagglutination inhibition titer (HAI) in response to vaccination
Change in proteomic analyses
Change in transcriptomic analyses of gene expression
+2 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: ≥65 years standard dose FluadExperimental Treatment1 Intervention
Participants age ≥65 years will receive standard dose Fluad
Group II: ≥65 years high dose FluzoneExperimental Treatment1 Intervention
Participants age ≥65 years will receive high dose Fluzone
Group III: 21-30 standard dose FluadActive Control1 Intervention
Participants age 21-30 years will receive the standard dose Fluad
Group IV: 21-30 high dose FluzoneActive Control1 Intervention
Participants age 21-30 years will receive the high dose Fluzone
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Influenza A virus A/Switzerland/9715293/2013 NIB-88 (H3N2) antigen (formaldehyde inactivated)
FDA approved
Influenza A virus A/California/7/2009 X-179A (H1N1) antigen (formaldehyde inactivated)
FDA approved

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,852 Previous Clinical Trials
2,738,345 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,270 Previous Clinical Trials
5,485,141 Total Patients Enrolled
Albert Shaw, MD, PhDPrincipal InvestigatorYale University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent does Fluad pose a risk to individuals?

"The safety of Fluad has been evaluated as a score of 2, since it is still within the Phase 2 stage and there is evidence claiming its safety but not yet its efficacy."

Answered by AI

Are there openings for enrollment in this experiment?

"The information posted on clinicaltrials.gov confirms that this trial is no longer recruiting participants. The study was first announced on August 1, 2022 and its last update came through on March 15th of the same year. Nevertheless, there are 208 other medical studies still seeking volunteers at the moment."

Answered by AI

Who else is applying?

What site did they apply to?
Yale School of Medicine
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I'm interested in the study.and compensation.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Systems Investigation of Vaccine Responses in Aging and Frailty
2023. "Systems Investigation of Vaccine Responses in Aging and Frailty". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05291676.
All > Vaccine > Influenza
~64 spots leftby Apr 2027
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