Special Investigation of COMIRNATY in the Population With Underlying Diseases

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1075 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-26

Study Completion Date

2022-04-14

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.

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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.

Conditions

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COVID-19

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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COMIRNATY

COVID-19 mRNA vaccine

BNT162b2

Intervention Type BIOLOGICAL

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.

Interventions

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BNT162b2

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.

Intervention Type BIOLOGICAL

Other Intervention Names

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COMIRNATY

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)

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes