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Open-Label Booster Vaccine for Anaphylaxis
Study Summary
This trial is studying the safety of giving a 2nd dose of COVID-19 vaccine to people who had a systemic allergic reaction to their 1st dose. People aged 16-69 who had an allergic reaction to their 1st dose of COVID-19 vaccine are eligible to participate.
- Anaphylaxis
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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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Frequently Asked Questions
Are individuals below the age of 55 allowed to partake in this medical experiment?
"Participants aged 16 to 69 are eligible for this trial. For those younger than 16, there are 227 clinical trials available; conversely, 1077 medical studies exist for patients older than 65."
Who has the capability to partake in this clinical research?
"A total of 17 individuals have been recruited into this trial, aged 16-69 years old who has previously experienced a systemic allergic reaction to either the Pfizer-BioNTech or Moderna COVID-19 vaccine. Aside from meeting these criteria, participants must also be able to provide informed consent and agree with all study procedures (such as forgoing medications if needed). Furthermore, they need an outside medical practitioner that will manage their health care beyond this particular experiment and guarantee availability throughout its duration. The time since receiving the first dose of either vaccine should not exceed 28 days in case of Moderna's nor 21 days for those vaccinated with the"
Has the Active Vaccine been granted authorization by the FDA?
"Our team at Power has assigned a safety rating of 2 to the Active Vaccine due to its Phase 2 status, indicating that while some evidence exists in regards to its safety, there is none concerning efficacy."
Is this trial a pioneering effort in its field?
"BioNTech SE's Active Vaccine is being evaluated in 27 concurrent trials, occurring in 220 cities and 27 countries. This medication was first tested on 512 volunteers at the start of 2020, and has since completed Phase 1 & 2 drug approval stage. As a result, 18333 studies have been successfully concluded by now."
How many participants are involved in this research endeavor?
"At this time, enrollment for the aforementioned clinical trial has closed. It was first listed on September 8th 2021 and last updated November 10th 2022. Thankfully, there are still 1284 investigations recruiting patients with systemic allergic reaction and 27 trials actively searching for participants to test an active vaccine."
Has recruitment for this experiment already begun?
"At this juncture, no new patients are being sought for the clinical trial. It was first posted on September 8th 2021 and was last edited November 10th 2022. For those seeking other trials, 1284 studies currently recruiting participants with systemic allergic reaction have been identified as well as 27 medical studies recruiting individuals interested in Active Vaccine therapies."
Has there been previous research into the efficacy of Active Vaccine?
"At present, 27 experiments are being implemented with Active Vaccine. 6 of these trials have progressed to Phase 3 testing and the majority take place in Roskilde or Aarhus N; 762 other medical institutions globally are running research on this vaccine."
Who else is applying?
What state do they live in?
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What portion of applicants met pre-screening criteria?
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