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
Cohort Survey on Shock and Anaphylaxis in Persons With Underlying Diseases Considered to Be at High Risk of Severe COVID-19 by Using Vaccination Information
1 other identifier
observational
13,309
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 26, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 26, 2023
CompletedFirst Submitted
Initial submission to the registry
June 5, 2023
CompletedFirst Posted
Study publicly available on registry
June 8, 2023
CompletedMarch 15, 2024
March 1, 2024
6 months
June 5, 2023
March 12, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Number of Participants With Hypersensitivity Reactions Including Shock and Anaphylaxis After Dose 1
Up to 2 days post vaccination
Number of Participants With Hypersensitivity Reactions Including Shock and Anaphylaxis After Dose 2
Up to 2 days post vaccination
Study Arms (1)
Cohort 1
Participants received 2 doses of mRNA-1273 vaccine approximately 4 weeks apart.
Eligibility Criteria
The study population was selected from participants who were registered to receive the mRNA-1273 vaccine in the Pep Up vaccination history Database whose start date of observation in the claim database was within 6 months or more before vaccination with mRNA-1273 vaccine, and those who met the definition of underlying disease based on the claim data for 6 months.
You may qualify if:
- 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.
You may not qualify if:
- Underlying diseases that were determined undetectable by the pre-screening of JMDC
- Participants who did not consent to the questionnaire.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ModernaTX, Inc.lead
Study Sites (1)
CMIC Co., Ltd.
Tokyo, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2023
First Posted
June 8, 2023
Study Start
November 15, 2022
Primary Completion
May 26, 2023
Study Completion
May 26, 2023
Last Updated
March 15, 2024
Record last verified: 2024-03