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Lyme Disease Vaccine for Healthy Children
Study Summary
This trial is to see if a vaccine called VLA15 is safe in healthy 5-17 year olds who have not had Lyme disease or a Lyme vaccine before. Participants will receive 4 shots/year for 2 years & be monitored.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 2 trial • 572 Patients • NCT03769194Trial Design
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Who is running the clinical trial?
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- I was diagnosed with Lyme disease in the last 3 months.I am not pregnant, breastfeeding, and I am willing to use contraception as required.I have been treated for Lyme disease within the last 3 months.I was bitten by a tick in the last 4 weeks.I have been vaccinated for Lyme disease.I am not using any medication that is not allowed in this trial.I have had Lyme disease that affected my joints, heart, nervous system, or was widespread.I am willing and able to follow all study requirements.I have a condition or am receiving treatment that weakens my immune system.I haven't received blood products or immunoglobulins in the last 6 months.I haven't taken immunosuppressants or had radiotherapy in the last 6 months.I am healthy or have stable chronic conditions.I have not taken systemic corticosteroids for more than 2 weeks in the last month.
- Group 1: VLA15
- Group 2: Normal Saline (Placebo)
- 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
Is this research endeavor open to individuals over the age of thirty?
"This clinical trial is open to applicants aged 5-17, with 4 studies specifically targeting minors and 7 for those 65 or older."
Are there any potential dangers associated with the use of VLA15?
"Our team at Power has assigned VLA15 a score of 3, which indicates prior clinical data that supports both its efficacy and safety. This is based on the fact it's currently in Phase 3 of trials."
How many locales are managing this research endeavor?
"Pediatric Research of Charlottesville, LLC in Charlottesville, Virginia, Stamford Therapeutics Consortium in Stamford, Connecticut and Prime Global Research in Bronx, New york are the primary sites for this study. Additionally there are 4 other medical centres participating as well."
Are there currently opportunities to participate in this trial?
"Clinicaltrials.gov has registered that this medical trial is no longer recruiting patients, with the initial post date being December 1st 2022 and it's most recent update on December 9th 2022. However, nine other trials are actively enrolling participants at present."
Who meets the criteria for inclusion in this clinical trial?
"This clinical trial is enrolling 3000 participants aged 5 to 17 suffering from Lyme disease. To qualify, applicants must be in good health and free of chronic medical conditions or possess a condition that has been deemed stable by medical professionals. Furthermore, all patients (or their guardians) must agree to abide with the study's procedure for the entire duration of its running time."
Who else is applying?
What state do they live in?
What portion of applicants met pre-screening criteria?
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