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Seasonal Influenza Vaccines for Flu
Study 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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Fluzone Younger
- Group 2: Flucelvax
- Group 3: Fluzone Older
- Group 4: Fluzone High Dose
- Group 5: Fluad
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
Who is eligible to partake in this scientific research?
"This study is recruiting 50 individuals with the flu, ranging in age from 18 to 80. To be eligible they must have self-reported weight of at least 110 lbs and participation in ancillary research studies. Arm 1 and 2 are open to those between 18-50 while Arms 3, 4, and 5 accept participants aged 65-80."
Does this scientific inquiry have any precedent?
"At the moment, 16 clinical trials for Fluzone Younger are running in 17 cities and 16 countries. Initially launched by Pharmacyclics LLC back in 2016 with 42 participants, this drug has since gone on to complete Phase 2 approval as part of 166 studies conducted up until now."
Are there still opportunities for people to participate in this clinical trial?
"Correct. According to the information posted on clinicaltrials.gov, this medical study that was initially published April 1st 2021 is currently recruiting patients. Fifty participants are sought from a single site."
Does this research trial extend to individuals beyond the age of eighty-five?
"This trial is accepting participants who are aged 18 and above, up to 80 years old."
Has Fluzone Younger been approved by the Food and Drug Administration?
"Our estimation at Power is that Fluzone Younger scores a 3 on the safety scale, as Phase 4 trials have already proven its efficacy and approval."
Could you elaborate on past experiments conducted using Fluzone Younger?
"Presently, Bethesda, Maryland is home to two Phase 3 clinical trials for Fluzone Younger with a total of 16 studies being conducted. Across the United States there are 72 different sites that are involved in these investigations."
To what extent is the population being observed in this research project?
"Affirmative. The information shared on clinicaltrials.gov verifies that this trial is currently accepting new participants, with the posting date beginning on April 1st 2021 and last updated May 26th 2022. 50 people are needed at one centre for enrolment in this research program."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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