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
Completed
- Conditions
- SARS-CoV-2
- Registration Number
- NCT05894499
- Lead Sponsor
- ModernaTX, Inc.
- Brief 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.
- Detailed Description
Data collected from the JDMC Claims Database between May 2021 to November 2021.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13309
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Participants With Hypersensitivity Reactions Including Shock and Anaphylaxis After Either Dose 1 and Dose 2 Up to 2 days post vaccination after either the first or second vaccination
- Secondary Outcome Measures
Name Time Method Number of Participants With Hypersensitivity Reactions Including Shock and Anaphylaxis After Dose 2 Up to 2 days post vaccination Number of Participants With Hypersensitivity Reactions Including Shock and Anaphylaxis After Dose 1 Up to 2 days post vaccination
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of hypersensitivity reactions to mRNA-1273 vaccine in high-risk SARS-CoV-2 populations?
How does the safety profile of mRNA-1273 compare to standard-of-care vaccines for SARS-CoV-2 in immunocompromised individuals?
Which biomarkers are associated with increased risk of shock or anaphylaxis after mRNA-1273 vaccination in Japan?
What adverse event management strategies are effective for mRNA vaccine-induced anaphylaxis in high-risk patients?
Are there specific SARS-CoV-2 subtypes or variants that correlate with heightened hypersensitivity risks in mRNA-1273 recipients?
Trial Locations
- Locations (1)
CMIC Co., Ltd.
🇯🇵Tokyo, Japan
CMIC Co., Ltd.🇯🇵Tokyo, Japan