Post-Marketing Safety Study in Japan in Participants With High Risk of Severe Exacerbation of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) mRNA-1273 COVID-19 Vaccine

ModernaTX, Inc.8,844 enrolled

Overview

The goal of this study is to assess the adverse events in the acute phase observed after vaccination with the mRNA-1273 vaccine in persons with underlying diseases who are considered to have a high risk of severe exacerbation specified in COVID-19.

Data collected from the JDMC Claims Database between August 2020 to November 2021.

Study Type

OBSERVATIONAL

Enrollment

8,844

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 have underlying diseases. Data period for confirmation of presence/absence of underlying disease is August 2020 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

Locations (1)

CMIC Co. Ltd.,

Tokyo, Japan

Outcomes

Primary Outcomes

Number of Participants With Solicited Acute Adverse Events

Time frame: Up to 8 days post vaccination

Data from ClinicalTrials.gov

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