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NCT05894590 Clinical Trial

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

SARS-CoV-2 Clinical Trial

Official title:
Cohort Survey on Non-Acute Safety in Persons With Underlying Diseases Who Are Considered to Be at High Risk of Severe COVID-19 by Using Vaccination Information

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05894590
Other study ID # mRNA-1273-P917
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 15, 2022
Est. completion date December 20, 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 assess serious adverse events associated with hospitalizations in the non-acute phase after vaccination with the mRNA-1273 vaccine in persons with underlying diseases who are considered to have a high risk of severe exacerbation of COVID-19.

Description:

Data collected from the JMDC Claims database from May 2020 to October 2022.

Recruitment information / eligibility
Status Completed
Enrollment 13680
Est. completion date December 20, 2023
Est. primary completion date December 20, 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. 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 Serious Events Associated With all-Cause Hospitalizations Up to 1 year post vaccination
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