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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
Must not have
Treatment with clinical trial medication
History of organ, bone marrow or stem cell transplant, liver cirrhosis, kidney disease requiring dialysis, HIV/AIDS, hepatitis C or active hepatitis B
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline, day 2, day 7, day 28 and day 70
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved
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.
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.
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 belowSelect...
I am either between 21-30 years old or 65 and older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently taking medication as part of a clinical trial.
Select...
I have a history of major organ transplant, liver or kidney disease, or HIV/AIDS.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at baseline, day 2, day 7, day 28 and day 70
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline, day 2, day 7, day 28 and day 70
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in production of IL-6 in monocytes to assess innate immune inflammatory response
Secondary study objectives
Change in Hemagglutination inhibition titer (HAI) in response to vaccination
Change in proteomic analyses
Change in transcriptomic analyses of gene expression
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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
1,930 Previous Clinical Trials
3,033,348 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,335 Previous Clinical Trials
5,382,708 Total Patients Enrolled
Albert Shaw, MD, PhDPrincipal InvestigatorYale University