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
Completed
- Conditions
- SARS-CoV-2
- Registration Number
- NCT05894590
- Lead Sponsor
- ModernaTX, Inc.
- Brief 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.
- Detailed Description
Data collected from the JMDC Claims database from May 2020 to October 2022.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13680
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Participants With Serious Events Associated With all-Cause Hospitalizations Up to 1 year post vaccination
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CMIC Co., Ltd
🇯🇵Tokyo, Japan