CompletedNot Applicable

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

Japan13,680 participantsStarted 2022-11-15

Plain-language 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.

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. 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 Serious Events Associated With all-Cause Hospitalizations

Timeframe: Up to 1 year post vaccination

Trial details

NCT IDNCT05894590

SponsorModernaTX, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-12-20

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