drugset / Trial / NCT04761822

COVID19 SARS Vaccinations: Systemic Allergic Reactions to SARS-CoV-2 Vaccinations

NCT04761822

RandomizedParallel-groupTriple-blindTreatment

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

Timeline

Start
2021-04-07
Primary completion
2022-04-20
Completion
2022-04-27

Drugs

EvaluationDrugModalityDoseRoute
Subject BNT162b2 Messenger RNA (mRNA) 0.3 ml Intramuscular
Subject Elasomeran Messenger RNA (mRNA) 0.5 ml Intramuscular