Clinical Trials Directory

Trials / Completed

CompletedNCT05894499

Post-Marketing Safety Study in Japan of Shock and Anaphylaxis After Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) mRNA-1273 COVID-19 Vaccine in Persons in at High Risk of Severe COVID-19

Cohort Survey on Shock and Anaphylaxis in Persons With Underlying Diseases Considered to Be at High Risk of Severe COVID-19 by Using Vaccination Information

Status
Completed
Phase
Study type
Observational
Enrollment
13,309 (actual)
Sponsor
ModernaTX, Inc. · Industry
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

Summary

The goal of this study is to confirm the onset status of hypersensitivity reactions including shock and anaphylaxis observed after vaccination with this drug in persons with underlying diseases who are considered to have a high risk of severe exacerbation of COVID-19 and explore risk factors.

Detailed description

Data collected from the JDMC Claims Database between May 2021 to November 2021.

Conditions

Timeline

Start date
2022-11-15
Primary completion
2023-05-26
Completion
2023-05-26
First posted
2023-06-08
Last updated
2024-03-15

Locations

1 site across 1 country: Japan

Source: ClinicalTrials.gov record NCT05894499. Inclusion in this directory is not an endorsement.