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Influenza Vaccine for Flu
Study Summary
This trial looked at the immune response of a vaccine in different age groups and its safety.
- Flu Shot
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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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- You or a family member have had Guillain-Barre Syndrome (GBS) in the past.You have a history of delays in development, neurological disorders, or seizure disorders that are considered significant by the study doctor.You have a bleeding disorder or have taken blood-thinning medication in the last 3 weeks, which may prevent you from receiving a vaccination via a muscle injection.You have had a severe reaction to any of the vaccine components or to a vaccine with similar ingredients.
- Group 1: Group 9 to 17 years old
- Group 2: Group 18 to 49 years old
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Are we still enrolling people in this research project?
"As of today, this clinical trial is still recruiting potential candidates. The listing for this study was first posted on October 25th, 2022 and updated November 2nd, 2022."
Could I possibly qualify to take part in this medical research?
"This clinical trial is looking for 1334 participants between the ages of 9 and 49 who have influenza immunization. In addition to meeting this age criteria, patients must also: Aged 9 to 49 years on the day of inclusion, A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies: 1) Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be pre-menarche, post-menopausal for at least 1 year, or surgically sterile OR 2) Is of childbearing potential and agrees to use an effective"
Are people of all ages being accepted for this trial, or are there age restrictions?
"The target population for this clinical trial are those patients who have not yet reached their 50th birthday, and have already celebrated their 9th year of life."
At how many total sites is this research being conducted?
"There are a total of 5 sites where this trial is recruiting patients. To name a few, these locations include Charleston, Barnwell and Salt Lake City. If you are considering participating in this clinical trial, please choose the nearest location to minimize travel time and inconvenience."
How many test subjects are currently enrolled in this experiment?
"In order to run this study, 1334 participants that meet the criteria will be needed. The sponsor, Sanofi Pasteur, a subsidiary of the French company Sanofi, plans to recruit patients from different sites including Coastal Pediatric Research Charleston-Site Number:8400005 in Charleston, South carolina and Rainbow Pediatrics-Site Number:8400014 in Barnwell, Utah."
Is it medically advisable for people aged 9 to 17 years old to be in Group?
"There is prior clinical data supporting Group 9 to 17 years old's safety, so it received a score of 3."
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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