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 information

JRCT ID: jRCT2031220748

Registered date:31/03/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Subjects with underlying disease after immunization with Spykevax monovalent Original
• Date of first enrollment: 14/01/2023
• Target sample size: 8000
• Study type: Observational

Outcome(s)

Primary Outcome

Frequency of occurrence of all serious events with hospitalization during the year from the month of inoculation.
The frequency of all serious events resulting in hospitalization during the year from the month of vaccination is shown. For reference, a similar analysis will be performed for all hospitalization-causing serious events in the year prior to the month of vaccination.

(Rationale for selecting hospitalization events as the outcome)
The self-control design eliminates the effect of confounding factors within individuals that do not vary over time, but does not eliminate the effect of time course, and the behavioral changes in society as a whole in the COVID-19 disaster may be significant in terms of outpatient visits in the year before and the year after vaccination. The effect of time course could not be ignored when outpatient events were included. On the other hand, the effect of behavior change on serious events involving hospitalization was considered to be relatively small, and therefore, we decided to include serious events involving hospitalization in the study.

• Secondary Outcome: Not applicable

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

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)

• Exclude criteria: Not applicable

Related Information

• Primary Sponsor: Uchida Akira