Special Investigation of COMIRNATY in the Population With Underlying Diseases
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
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.
Trial design
1,075 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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