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
Completed
- Conditions
- SARS-CoV-2
- Registration Number
- NCT05894525
- Lead Sponsor
- ModernaTX, Inc.
- Brief 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.
- Detailed Description
Data collected from the JDMC Claims Database between August 2020 to November 2021.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8844
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Participants With Solicited Acute Adverse Events Up to 8 days post vaccination
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CMIC Co. Ltd.,
🇯🇵Tokyo, Japan