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Shingrix Vaccine for Shingles
Study Summary
This trial will test if a new shingles vaccine is effective in reducing the risk of shingles and its complications.
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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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- You are allergic to lidocaine, silver nitrate, or mupirocin.You have received the Shingrix, Zostavax, or chickenpox vaccines in the past.You have a history of developing big scars or keloids.You have received an organ transplant or a stem cell transplant in the past.You have a history of bleeding problems or take medications that increase the risk of bleeding, like high doses of aspirin, heparin, or coumadin (except for low-dose aspirin under 100 mg per day).You have had frequent cases of skin infections like cellulitis or boils, requiring antibiotics three or more times in the past two years.You have had a severe allergic reaction in the past to any ingredient in the vaccine that could be life-threatening.You have a serious autoimmune disease like rheumatoid arthritis or multiple sclerosis that requires strong medication to control.
- Group 1: Cohort 2: 70 years of age or older
- Group 2: Cohort 1: 30-40 year of age
- 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.
- 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
Is there still capacity for participants in this scientific experiment?
"The clinicaltrials.gov database has indicated that, as of January 13th 2022, this particular investigation is not currently recruiting patients. Nevertheless, there are 49 other studies actively enrolling participants across various medical sites at present."
How many participants are engaged in this experiment?
"This study is no longer enrolling new members. After first appearing on March 1st 2022, the trial's most recent update occurred on January 13th 2022. However, there are currently 34 studies investigating congenital varicella syndrome and 15 trials actively recruiting participants for this particular treatment option."
Are there any prior records of this therapeutic approach being examined in a medical experiment?
"At this time, 15 clinical trials are in progress to research the efficacy of this therapy with 4 studies at phase 3. Madison, Wisconsin is hosting most of these tests but 206 other sites have joined in on the study."
Has this research been previously conducted?
"Since 2014, this particular treatment has been under investigation. The initial clinical trial occurred that year and was sponsored by Bristol-Myers Squibb with 130 participants. This led to Phase 2 drug approval before another 15 trials were conducted in 91 cities located within 23 countries."
Has this therapeutic intervention obtained approval from the federal regulatory body?
"This treatment has gone through numerous rounds of testing and evaluation, so our team awarded it a rating of 3 for safety. This signifies that the medication is approved by regulatory authorities."
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