Special Investigation of COMIRNATY in the Population With Underlying Diseases

Study Overview
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Brief Summary
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Post-marketing study, Cohort study of COMIRNATY vaccines. To collect information on adverse events and COVID-19 observed after vaccination with COMIRNATY and to assess safety in patients with underlying disease considered to be at high risk of aggravation of COVID-19 who have received vaccination with this product under actual use conditions.

Detailed Description
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This is a multicenter cohort study to be conducted in individuals with underlying diseases considered to be at high risk of aggravation of COVID-19 who are vaccinated with this product, and the investigator will enter the information required in this study in the case report forms (CRFs) based on the information obtained through preliminary examination sheet or medical interview, etc. and records such as medical records. A health observation diary will be distributed to the subjects participating in this study and they will be requested to record information on local reactions and systemic reactions after vaccination with this product.

Official Title
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Special Investigation of COMIRNATY Intramuscular Injection (Investigation of Patients With Underlying Disease Considered to be at High Risk of Aggravation of COVID-19)

Conditions
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COVID-19

Intervention / Treatment
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* Biological: BNT162b2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -Subjects who are able to understand the content of this study and to record their symptoms in the health observation diary, and who have provided written consent to participate in this survey by themselves (or parents or legal guardians in the case of minors) Exclusion Criteria: There are no exclusion criteria for this study.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COMIRNATY<br>COVID-19 mRNA vaccine | Biological: BNT162b2<br>* COMIRNATY is administered intramuscularly after dilution as a course of 2 doses (0.3 mL each). It is recommended to administer the second dose 3 weeks after the first dose.<br>* Other names: COMIRNATY;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with Adverse reactions |  | From the date of the first vaccination with COMIRNATY (Day 1) to 28 days after the second vaccination. | 
| Number of subjects with Serious adverse reactions |  | From the date of the first vaccination with COMIRNATY (Day 1) to 28 days after the second vaccination. | 
| Proportion of subjects with Adverse reactions |  | From the date of the first vaccination with COMIRNATY (Day 1) to 28 days after the second vaccination. | 
| Proportion of subjects with Serious adverse reactions |  | From the date of the first vaccination with COMIRNATY (Day 1) to 28 days after the second vaccination. | 
| Proportion of subjects with local reaction and systemic events |  | From the date of the first vaccination with COMIRNATY (Day 1) to 28 days after the second vaccination. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19,, Post-Marketing study, COMIRNATY, Underlying Disease