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

ModernaTX, Inc.13,680 enrolled

Overview

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.

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

Study Type

OBSERVATIONAL

Enrollment

13,680

Conditions

SARS-CoV-2

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

CMIC Co., Ltd

Tokyo, Japan

Outcomes

Primary Outcomes

Number of Participants With Serious Events Associated With all-Cause Hospitalizations

Time frame: Up to 1 year post vaccination

Data from ClinicalTrials.gov

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