Special Investigation of COMIRNATY in the Population With Underlying Diseases

COVID-19 Clinical Trial

Official title:

Special Investigation of COMIRNATY Intramuscular Injection (Investigation of Patients With Underlying Disease Considered to be at High Risk of Aggravation of COVID-19)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04880447
• Other study ID #: C4591019
• Status: Completed
• Start date: May 26, 2021
• Est. completion date: April 14, 2022

Study information

• Verified date: January 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1075
• Est. completion date: April 14, 2022
• Est. primary completion date: April 14, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

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.

Locations

Country	Name	City	State
Japan	Pfizer Local County	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Participants With Adverse Reactions	An adverse reaction was any untoward medical occurrence attributed to COMIRNATY in a participant who was vaccinated with COMIRNATY. Relatedness to COMIRNATY was assessed by the physician. The proportion of adverse reactions was presented for the overall observation period, the observation period from the date of the first dose of Comirnaty up to 28 days after the second dose, and the observation period from the date of Dose 1 up to 28 days after Dose 2.	From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
Primary	Proportion of Participants With Serious Adverse Reactions	A serious adverse reaction was any untoward medical occurrence attributed to COMIRNATY resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; or congenital anomaly. Relatedness to COMIRNATY was assessed by the physician. The proportion of serious adverse reactions was presented for the overall observation period, the observation period from the first to the second vaccination, and the observation period from the date of Dose 1 up to 28 days after Dose 2.	From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
Primary	Proportion of Participants With Local Reactions and Systemic Reactions (The First Vaccination)	Local and systemic reactions were treated as specific adverse events of interest in this study, and were reported using the health observation diary filled out by the participants. Severity was rated and recorded as grade 1, 2, or 3 according to the FDA Guidance for industry: toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials. Health observation diary for the first vaccination was collected from 1035 participants of the 1038 safety analysis set participants.	Within 8 days after the date of the first dose.
Primary	Proportion of Participants With Local Reactions and Systemic Reactions (The Second Vaccination)	Local and systemic reactions were treated as specific adverse events of interest in this study, and were reported using the health observation diary filled out by the participants. Severity was rated and recorded as grade 1, 2, or 3 according to the FDA Guidance for industry: toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials. Health observation diary for the second vaccination was collected from 1026 participants of the 1032 participants who received the second vaccination with Comirnaty.	Within 8 days after the date of the second dose.

External Links

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