CompletedNot Applicable

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

Japan13,309 participantsStarted 2022-11-15

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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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.

What they're measuring

Number of Participants With Hypersensitivity Reactions Including Shock and Anaphylaxis After Either Dose 1 and Dose 2

Timeframe: Up to 2 days post vaccination after either the first or second vaccination

Trial details

NCT IDNCT05894499

SponsorModernaTX, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-05-26

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