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NCT05894499 Clinical Trial

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

SARS-CoV-2 Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05894499
Other study ID # mRNA-1273-P915
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 15, 2022
Est. completion date May 26, 2023

Study information
Verified date March 2024
Source ModernaTX, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 13309
Est. completion date May 26, 2023
Est. primary completion date May 26, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Participants registered to receive the mRNA-1273 vaccine in the Pep Up vaccination history Database - Participants who have a history of vaccination with the mRNA-1273 vaccine in the Pep-Up vaccination history Database and the observation start date is at least 6 months prior to vaccination with the mRNA-1273 vaccine and have underlying diseases. Data period for confirmation of presence/absence of underlying disease is May 2021 to November 2021. Exclusion Criteria: - Underlying diseases that were determined undetectable by the pre-screening of JMDC - Participants who did not consent to the questionnaire.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Japan CMIC Co., Ltd. Tokyo

Sponsors (1)
Lead Sponsor Collaborator
ModernaTX, Inc.

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants With Hypersensitivity Reactions Including Shock and Anaphylaxis After Either Dose 1 and Dose 2 Up to 2 days post vaccination after either the first or second vaccination
Secondary Number of Participants With Hypersensitivity Reactions Including Shock and Anaphylaxis After Dose 1 Up to 2 days post vaccination
Secondary Number of Participants With Hypersensitivity Reactions Including Shock and Anaphylaxis After Dose 2 Up to 2 days post vaccination
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