Clinical trial NCT04815031: Drug Use Investigation of COMIRNATY Intramuscular Injection
Official title: General Investigation of COMIRNATY Intramuscular Injection (Follow-up Study for Subjects [Healthcare Professionals] Who Are Vaccinated at an Early Post-Approval Stage)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: COVID-19
Post-Marketing study, COMIRNATY,Vaccine
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-03-24
Enrollment: 14570
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All subjects who have been vaccinated with this product and have consented to participate in this study during participation in the Investigation of Health Status of Recipients Vaccinated First at contract sites.

Brief summary: 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.

Detailed 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.

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.

Primary outcomes:
measure: Proportion of Participants With Serious Adverse Events
timeFrame: From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination was 11 months, If booster vaccination was conducted, up to the day before booster vaccination.
measure: Proportion of Participants With Severe COVID-19
timeFrame: From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination was 11 months, If booster vaccination was conducted, up to the day before booster vaccination.
measure: Proportion of Participants With Serious Adverse Reactions
timeFrame: From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination was 11 months, If booster vaccination was conducted, up to the day before booster vaccination.
measure: Number of Participants With Serious Adverse Events After Booster Vaccination
timeFrame: From the day of booster vaccination up to 11 months from the day following 28 days after the final vaccination of COMIRNATY. (out of scope of the safety evaluation)
measure: Number of Participants With Severe COVID-19 After Booster Vaccination
timeFrame: From the day of booster vaccination up to 11 months from the day following 28 days after the final vaccination of COMIRNATY. (out of scope of the safety evaluation)
measure: Number of Participants With Serious Adverse Reactions After Booster Vaccination
timeFrame: From the day of booster vaccination up to 11 months from the day following 28 days after the final vaccination of COMIRNATY. (out of scope of the safety evaluation)
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: PfizerLocal Country Office
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: