Post-marketing database survey [Spykevax intramuscular injection (monovalent: strain of original) ] Cohort study on shock and anaphylaxis in subjects with underlying diseases considered to be at high risk of severe COVID-19 infection by utilizing vaccination information

JRCT ID: jRCT2031220747

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

Definition of hypersensitivity reactions including shock and anaphylaxis
(1) A diagnosis of a disease (ICD-10 code) corresponding to hypersensitivity reactions including shock and anaphylaxis is made within 2 or 8 days after vaccination with Clozapine.
(ii) A drug (drug code (ATC classification)) is prescribed as a treatment within 2 or 8 days after Clozapine inoculation, and a diagnosis of a disease (ICD-10 code) corresponding to hypersensitivity reactions including shock and anaphylaxis is made on the same day.

*The day of vaccination is defined as "1 day".

Primary analysis
Hypersensitivity reactions including shock and anaphylaxis occurring within 2 days after either the first or second vaccination

Secondary Outcome

Secondary analysis:.
Hypersensitivity reactions including shock and anaphylaxis that occurred within 2 days after the first vaccination
Hypersensitivity reactions including shock and anaphylaxis occurring within 2 days after the second vaccination

Sensitivity analysis
Hypersensitivity reactions, including shock and anaphylaxis, occurring within 8 days after either the first or second vaccination

(Outcome definition: Basis for setting the data follow-up period)
Anaphylaxis generally occurs within minutes to hours after exposure to the allergen1) . Most of the anaphylaxis-like reactions that occurred in clinical studies of this product also occurred within a few hours after inoculation. However, it is possible that anaphylaxis-like reactions may occur "the next day" (or "two days" by the above definition) after the inoculation, depending on the circumstances, such as inoculation during the evening hours. Considering the above, hypersensitivity reactions including shock and anaphylaxis within 2 days after vaccination were set as the data follow-up period for the main analysis. In addition, based on the concept of sensitivity analysis, we also defined an extended data follow-up period as a secondary analysis.
A table of correspondence between hypersensitivity reactions including shock and anaphylaxis and disease codes is shown in Appendix 2 (attached as an Appendix), and a table of correspondence between drugs and drug codes (ATC classification) is shown in Appendix 3.

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