Special Investigation of COMIRNATY in the Population With Underlying Diseases

Completed

• Conditions: COVID-19
• Interventions: Biological: BNT162b2

• Registration Number: NCT04880447
• Lead Sponsor: Pfizer

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-05-05
• Study First Submitted QC: 2021-05-05
• Study First Posted: 2021-05-10
• Study Start: 2021-05-26
• Primary Completion: 2022-04-14
• Study Completion: 2022-04-14
• Results First Submitted: 2023-01-10
• Status Verified: 2024-01
• Results First Submitted QC: 2024-01-12
• Last Update Submitted: 2024-01-12
• Results First Posted: 2024-06-21
• Last Update Posted: 2024-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1075

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)

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Exclusion Criteria

• There are no exclusion criteria for this study.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COMIRNATY	BNT162b2	COVID-19 mRNA vaccine

Primary Outcome Measures

Name	Time	Method
Proportion of Participants With Adverse Reactions	From the date of the first dose to 28 days after the second dose, up to approximately 49 days.	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.
Proportion of Participants With Serious Adverse Reactions	From the date of the first dose to 28 days after the second dose, up to approximately 49 days.	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.
Proportion of Participants With Local Reactions and Systemic Reactions (The First Vaccination)	Within 8 days after the date of the first dose.	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.
Proportion of Participants With Local Reactions and Systemic Reactions (The Second Vaccination)	Within 8 days after the date of the second dose.	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.

Trial Locations

Locations (1)

Pfizer Local County; 🇯🇵 Tokyo, Japan