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COVID19 SARS Vaccinations: Systemic Allergic Reactions to SARS-CoV-2 Vaccinations
NCT04761822 · View on ClinicalTrials.gov ↗
Study Summary
Background: Allergic reactions have been reported to occur after vaccination with both the Pfizer-BioNTech COVID-19 Vaccine and Moderna COVID-19 Vaccine. Allergic reactions range from mild to severe and include life- threatening anaphylactic reactions, although no deaths have been reported with either vaccine. This study is designed with two principal aims: * To estimate the proportions of systemic allergic reactions to the Pfizer-BioNTech COVID-19 Vaccine and the Moderna COVID-19 Vaccine in a High-Allergy/Mast Cell Disorder (HA/MCD) population, and * If the risk in the HA/MCD is demonstrable, to determine whether the proportions are higher in the HA/MCD in comparison to a representative population without severe allergies or mast cell disorders
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Moderna COVID-19 Vaccine
- BIOLOGICAL Pfizer-BioNTech COVID-19 Vaccine
Study Locations (20)
New York
- Mount Sinai Hospital, Department of Medicine, Division of Clinical Immunology — New York
- Columbia University Irving Medical Center — New York
- Rochester Regional Health — Rochester
California
- University of California, Los Angeles Medical Center — Los Angeles
- Stanford Medicine, Sean N. Parker Center for Allergy & Asthma Research — Stanford
Florida
- University Health, University of Miami Health System — Miami
- University of South Florida Asthma Allergy and Immunology Clinical Research Unit — Tampa
Illinois
- Sinus and Allergy Center of Northwestern University — Chicago
- NorthShore University HealthSystem, Dermatology Clinical Trials Unit — Skokie
Massachusetts
- Massachusetts General Hospital — Boston
- Brigham and Women's Hospital — Boston
Michigan
- University of Michigan Health — Ann Arbor
- Henry Ford Hospital and Health System — Detroit
Arizona
- University of Arizona Health Sciences, College of Medicine Tucson, Department of Medicine, Division of Pulmonary, Allergy, Critical Care and Sleep Medicine — Tucson
Arkansas
- Arkansas Children's, University of Arkansas for Medical Sciences — Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 746 participants |
| Start Date | 2021-04-07 |
| Est. Completion | 2022-04-27 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04761822
The ClinicalTrials.gov registry entry for NCT04761822 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 746 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with COVID-19 appearing as the primary indexed condition, and to 3 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04761822 reports 20 study locations spanning 13 distinct geographic areas — top geographies include New York, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04761822 about?
NCT04761822 is a clinical study titled "COVID19 SARS Vaccinations: Systemic Allergic Reactions to SARS-CoV-2 Vaccinations". Background: Allergic reactions have been reported to occur after vaccination with both the Pfizer-BioNTech COVID-19 Vaccine and Moderna COVID-19 Vaccine. Allergic reactions range from mild to severe and include life- threatening anaphylactic reactions, although no deaths have been reported with eith...
What is the current status of trial NCT04761822?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 746 participants. The study started on 2021-04-07. Estimated completion is 2022-04-27.
What conditions does trial NCT04761822 study?
This clinical trial studies the following conditions: COVID-19, SARS-CoV Infection, Allergic Reaction, Mast Cell Disorder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04761822?
The interventions under investigation include: Placebo (BIOLOGICAL), Moderna COVID-19 Vaccine (BIOLOGICAL), Pfizer-BioNTech COVID-19 Vaccine (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04761822?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04761822 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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