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Virus Vaccine
Seasonal Influenza Vaccines for Flu
Phase 4
Recruiting
Led By James J Kobie, PhD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18-50 years old for Arm 1 and Arm 2
Weight of at least 110 lbs as determined by self-reporting
Must not have
Lymphoproliferative Disorder
Inability to give informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months after vaccination
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial will look at how well different types of flu vaccines work in people of different ages, and whether previous vaccinations affect immunity.
Who is the study for?
This trial is for healthy adults aged 18-50 and 65-80 who can consent to participate. They must weigh at least 110 lbs and not have a history of severe illnesses, recent heart attacks, strokes, or certain chronic diseases like dementia or lupus. Pregnant women, those with egg allergies, bleeding disorders, drug abuse issues (excluding marijuana), or immunodeficiencies are excluded.
What is being tested?
The study tests how different FDA-approved flu vaccines—Flucelvax, Fluzone High-Dose, Fluzone, Fluad—affect antibody responses in younger and older adults. It also looks at the impact of past vaccinations on these responses.
What are the potential side effects?
Common side effects from flu vaccines may include soreness at the injection site, headache, feverish feelings or fever itself; muscle aches; fatigue; allergic reactions are rare but can be serious.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 50 years old.
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I weigh at least 110 lbs.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a disorder where my lymphocytes are increasing abnormally.
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I am unable to understand and give consent for treatment.
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I have a condition like Lupus, RA, or Crohn's Disease.
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I have kidney failure.
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I have been diagnosed with cancer.
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I have no psychiatric conditions that would stop me from following study rules.
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I have a diagnosed bleeding disorder that needs special care.
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I have high blood pressure and elevated BUN levels.
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I have had Guillain-Barre Syndrome in the past.
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I have had a stroke.
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I have had hepatitis in the past.
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My illness is moderate to severe right now.
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I have been diagnosed with congestive heart failure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months after vaccination
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months after vaccination
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Hemagglutinin antibody
Neuraminidase antibody
Secondary study objectives
Hemagglutinin
Neuraminidase Memory B cell ELISPOT Response
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
5Treatment groups
Active Control
Group I: Fluzone YoungerActive Control1 Intervention
10 adults 18-50 years old, will receive a single dose of the Fluzone influenza vaccine each year for two sequential years
Group II: FlucelvaxActive Control1 Intervention
10 adults 18-50 years old, will receive a single dose of the Flucelvax influenza vaccine each year for two sequential years
Group III: Fluzone OlderActive Control1 Intervention
10 adults 65-80 years old, will receive a single dose of the Fluzone influenza vaccine
Group IV: Fluzone High DoseActive Control1 Intervention
10 adults 65-80 years old, will receive a single dose of the Fluzone High-Dose influenza vaccine
Group V: FluadActive Control1 Intervention
10 adults 65-80 years old, will receive a single dose of the Fluad influenza vaccine
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,655 Previous Clinical Trials
2,444,108 Total Patients Enrolled
James J Kobie, PhDPrincipal InvestigatorUniversity of Alabama at Birmingham
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had a moderate to severe illness after getting the flu shot within the last 6 weeks.I have a disorder where my lymphocytes are increasing abnormally.You have a weakened immune system.You have had an allergic reaction to eggs in the past.I am between 65 and 80 years old.I had a procedure to reopen my blood vessels less than 6 months ago.I am between 18 and 50 years old.I am unable to understand and give consent for treatment.You have received a flu shot from a different source this season.I have a condition like Lupus, RA, or Crohn's Disease.I have kidney failure.I weigh at least 110 lbs.You drink more than 17 drinks per week.You have a history of using drugs, except for marijuana.I have been diagnosed with cancer.I have no psychiatric conditions that would stop me from following study rules.I have a diagnosed bleeding disorder that needs special care.I haven't had a respiratory infection in the last 4 weeks.I have high blood pressure and elevated BUN levels.I have not had a heart attack in the last 6 months.You have dementia.I have had Guillain-Barre Syndrome in the past.I have had a stroke.I have had hepatitis in the past.I haven't had vaccines in the last 4 weeks and don't plan to get any in the next 4 weeks.You have had an allergic reaction to gelatin in the past.You have HIV.My illness is moderate to severe right now.I have had a bad reaction to the flu shot or have been advised not to get it.I have been diagnosed with congestive heart failure.
Research Study Groups:
This trial has the following groups:- Group 1: Fluzone Younger
- Group 2: Flucelvax
- Group 3: Fluzone Older
- Group 4: Fluzone High Dose
- Group 5: Fluad
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.