Drug Use Investigation of COMIRNATY Intramuscular Injection

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04815031
• Other study ID #: C4591006
• Status: Completed
• Start date: March 20, 2021
• Est. completion date: January 27, 2023

Study information

• Verified date: February 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14570
• Est. completion date: January 27, 2023
• Est. primary completion date: January 27, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Biological:
• 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.

Locations

Country	Name	City	State
Japan	PfizerLocal Country Office	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of subjects with serious Adverse Events	The long-term safety of this product will be assessed.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.	11 months from the day following 28 days after the final vaccination of COMIRNATY
Primary	Proportion of subjects withe serious Adverse Events	The long-term safety of this product will be assessed.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.	11months from the day following 28days after the final vaccination of COMIRNATY
Primary	Number of subjects with severe COVID-19	The long-term safety of this procuct will be assessed.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.	11 months from the day following 28 days after the final vaccination of COMIRNATY
Primary	Proportion of subjects with severe COVID-19	The long-term safety of this produt will be assessed.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.	11 months from the day following 28 days after final vaccination of COMIRNATY

External Links

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