Drug Use Investigation of COMIRNATY Intramuscular Injection
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About
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.
Full description
The healthcare professionals who are vaccinated with this product early after the marketing approval of this product (participants in the Investigation of Health Status of Recipients Vaccinated First conducted by the Science Research Group of the Ministry of Health, Labour and Welfare) will be followed for 11 months from the day following 28 days after the final vaccination of the initial immunization with this product (end date of observation period in Investigation of Health Status of Recipients Vaccinated First) to 12 months after the final vaccination of the initial immunization with this product, information on serious adverse events and COVID-19 observed during the follow-up period will be collected.
If booster vaccination isn't conducted, the long-term safety after the initial immunization of this product during the follow-up period will be assessed.
If booster vaccination is conducted, the long-term safety after the initial immunization of this product up to the day before booster vaccination will be confirmed, and information on serious adverse events and COVID-19 will be continuously obtained after booster vaccination.
Enrollment
Sex
Ages
Volunteers
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.
Trial design
14,570 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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