Post-marketing database survey [Spykevax intramuscular injection (monovalent: strain of original) ] Non-acute safety cohort study of persons with underlying diseases considered to be at high risk of severe COVID-19 infection utilizing vaccination informatio
- Conditions
- Subjects with underlying disease after immunization with Spykevax monovalent Original
- Registration Number
- JPRN-jRCT2031220748
- Lead Sponsor
- chida Akira
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 8000
Target number of patients: 8,000; those who have been registered for vaccination with PeP Up and have the underlying diseases listed below.
(Definition of persons with underlying diseases)
Based on the definitions of underlying diseases that are positioned at the top of the order of immunization based on the current medical knowledge, etc., reviewed at the 43rd Meeting of the Subcommittee on Immunization and Vaccine of the Health Sciences Council (held on December 25, 2020), the following diseases that are considered extractable from the JMDC database will be defined as diseases for this survey. The following diseases are considered to be extractable from the JMDC database. 1.
1. chronic respiratory disease
2. chronic heart disease (including hypertension)
Chronic kidney disease
4. chronic liver disease (e.g., cirrhosis)
5. diabetes mellitus being treated with insulin or oral medication or diabetes mellitus with other concomitant illnesses
6. blood diseases (except iron deficiency anemia) 7. diseases of the blood (but excluding iron deficiency anemia) and diseases that impair the function of the immune system (including malignant tumors under treatment)
7. treatment for immune system deterioration, such as steroids
8. chromosomal abnormalities
9. severe mental or physical disability (a combination of severe physical disability and severe intellectual disability)
10. sleep apnea syndrome
11. obesity (BMI over 30)
Not applicable
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method