Post-marketing database survey [Spykevax intramuscular injection (monovalent: strain of origin) ] Acute safety cohort study of subjects with underlying diseases considered to be at high risk of severe COVID-19 infection utilizing vaccination information

JRCT ID: jRCT2031220749

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: 3000
• Study type: Observational

Outcome(s)

Primary Outcome

Acute specific adverse events occurring within 8 days* after each vaccination: The following events based on the acute specific adverse event questionnaire survey:.
Fever (37.5 degree or higher), redness, swelling, pain, vomiting, diarrhea, headache, malaise, chills, myalgia, arthralgia
The day of vaccination is defined as "1 day".

(Outcome definition: Basis for setting the data tracking period)
The data follow-up period for acute phase specific adverse events was set with reference to a cohort study conducted in the early period of administration of the new corona vaccine under the fiscal 2020 Health and Labor Administration Research Grant (Research on Emerging and Re-emerging Infections and Immunization Policy Promotion Project).

Secondary Outcome

Subpopulation analysis will be performed for the following items
Gender, age, and underlying disease*1
The data period for underlying diseases will be 6 months from August 2020 to January 2021*2.
*1: Underlying diseases included in the definition of "persons with underlying diseases
*2: In order to select candidates for the acute phase specific adverse event questionnaire survey, the presence or absence of underlying disease was confirmed from the data of the relevant period.

(Basis for setting the period for checking the presence or absence of underlying disease)
Since the maximum duration of drug prescriptions is 90 days, it is considered that even those who visit the hospital infrequently may have a hospital visit every 3 months due to an underlying disease. We thought that by setting a data period of 6 months for information on past visits, drug use, and procedures for the relevant inoculated persons, it would be possible to reliably capture the presence or absence of data regardless of the timing of visits to the hospital.

Key inclusion & exclusion criteria

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

Include criteria

Target number of patients: 3,000; persons who have responded to the Acute-Specific Adverse Events Questionnaire among 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 are 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