CompletedNot Applicable

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

Japan8,844 participantsStarted 2022-11-15

Plain-language summary

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.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of Participants With Solicited Acute Adverse Events

Timeframe: Up to 8 days post vaccination

Trial details

NCT IDNCT05894525

SponsorModernaTX, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-05-26

View on ClinicalTrials.gov More SARS-CoV-2 trials