At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Systemic Allergic Reactions to SARS-CoV-2 Vaccination
In Brief
A Phase 2 clinical trial evaluating Moderna COVID-19 Vaccine, Pfizer-BioNTech COVID-19 Vaccine, and 1 other intervention for SARS-CoV Infection and 3 related conditions. Completed, enrolled 746 participants across 29 sites.
Detailed 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
Study Details
Timeline
Interventions
Intramuscular injection
Intramuscular injection
Intramuscular injection