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Clinical trial

General Investigation of COMIRNATY Intramuscular Injection (Follow-up Study for Subjects [Healthcare Professionals] Who Are Vaccinated at an Early Post-Approval Stage)

ID
Name
C4591006
Description
Post-marketing study, Chotor study of COMIRNATY vaccenees followed for 11months. Serious adverse events and COVID-19 observed during the follow-up period will be collected, and the long-term safety of this product will be assessed.
Trial arms
Trial start
2021-03-20
Estimated PCD
2023-01-27
Trial end
2023-01-27
Status
Completed
Treatment
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. Individuals 16 years of age and older.
Arms:
COMIRNATY
Other names:
COMIRNATY
Size
14570
Primary endpoint
The number of subjects with serious Adverse Events
11 months from the day following 28 days after the final vaccination of COMIRNATY
Proportion of subjects withe serious Adverse Events
11months from the day following 28days after the final vaccination of COMIRNATY
Number of subjects with severe COVID-19
11 months from the day following 28 days after the final vaccination of COMIRNATY
Proportion of subjects with severe COVID-19
11 months from the day following 28 days after final vaccination of COMIRNATY
Eligibility criteria
Inclusion Criteria: * Subjects who have participated in the Investigation of Health Status of Recipients Vaccinated First and have provided written consent to continue participation in this study. Exclusion Criteria: * No exclusion criteria.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 14570, 'type': 'ACTUAL'}}
Updated at
2023-02-23

1 organization

1 product

1 indication

Organization
Pfizer
Product
BNT162b2
Indication
COVID-19