Korea Comirnaty Post-marketing Surveillance

Active, not recruiting

• Conditions: COVID-19; Vaccines; SARS-CoV-2; Safety; Adverse Effects
• Interventions: Biological: Riltozinameran 12 Years of age and older; Biological: Famtozinameran 12 Years of age and older; Biological: Raxtozinameran 12 years of age and older; Biological: Tozinameran 12 Years of age and older; Biological: Raxtozinameran 6 months to 4 years of age; Biological: Tozinameran 5 to 11 Years of age; Biological: Famtozinameran 5 to 11 Years of age; Biological: Tozinameran 6 months to 4 years of age

• Registration Number: NCT05032976
• Lead Sponsor: Pfizer

Brief Summary

This study will collect information on the safety of BNT162b2 products for subjects who have been administered in a routine clinical practice from 05Mar2021 to 04Mar2027 in Korea, and will be conducted in accordance with the New Drug Re-Examination Guideline of the Ministry of Food and Drug Safety (MFDS).

Detailed Description

This is an open-label, non-comparative, non-interventional, prospective, and multi-center study conducted in Korean health care centers by accredited physicians (investigator). The study population is Korean subjects who are scheduled for COVID-19 vaccination. BNT162b2 products will be administered according to the "Dosage and Administration" of the approved labeling. There is no visit or activity mandated by this study. The investigator will collect data from the subject's medical records and patient (subject) report outcome (PRO), and record the information on each subject's case report form (CRF).

Pfizer Pharmaceuticals Korea will conclude a post-marketing surveillance agreement with an investigator site before performing the study. Investigators at the institution that sign the agreement should prepare the CRFs from all the subjects who this vaccine was administered to after the start date of the study.

Each investigator will sequentially enroll all subjects to whom BNT162b2 products is prescribed for the first time according to the local product document and who agree to participate in this study by signing the data privacy statement used in place of the informed consent form until the total requested cases per center are collected for this study.

An electronic diary will be used in this study to collect adverse events that occur after injection. Follow-up exams will be carried out from after the first injection to before the second injection, and from after the second injection to 28 days after the second injection. Those who received booster doses will be followed up for the 28 days from the date of the booster dose. For the follow-up adverse event CRF, either an application using the mobile phones of subjects or entry on a paper questionnaire may be selected. The CRF will be filled out every day after the first and second injections. If an application is used, it is automatically sent as an eCRF. If a paper questionnaire is used, the questionnaire filled out after the first injection is collected at the time of the visit for the second injection, and the questionnaires filled out after the second injection and booster dose are collected 28 days after the second injection and 28 days after the booster dose respectively by mail.

To promote the collection of adverse events after injection, a reminder may be given by phone about entering the information and the collection of the CRF to subjects who gave consent beforehand. If it is difficult to record CRF due to the subject, the occurrence of adverse events can be confirmed by phone.

Safety is the primary interest of this study, which will be assessed based on adverse events (AEs) that occur during 28 days from the date of the first, second and booster doses of BNT162b2.

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: 2021-08-27
• Study First Submitted QC: 2021-08-27
• Study First Posted: 2021-09-02
• Study Start: 2022-03-18
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-31
• Last Update Posted: 2024-11-01
• Primary Completion: 2027-03-04
• Study Completion: 2027-03-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 18000

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Tozinameran (BNT162b2)	Tozinameran 6 months to 4 years of age	Subjects aged 6 months and older who are scheduled for Tozinameran vaccination
Raxtozinameran (BNT162b2 OMI XBB.1.5)	Raxtozinameran 6 months to 4 years of age	Subject aged 6 months to 4 years and 12 years and older who are scheduled for Raxtozinameran vaccination
Tozinameran (BNT162b2)	Tozinameran 5 to 11 Years of age	Subjects aged 6 months and older who are scheduled for Tozinameran vaccination
Riltozinameran (BNT162b2 OMI BA.1)	Riltozinameran 12 Years of age and older	Subject aged 12 years and older who are scheduled for Riltozinameran vaccination
Famtozinameran (BNT162b2 OMI BA.4-5)	Famtozinameran 12 Years of age and older	Subject aged 5 years and older who are scheduled for Famtozinameran vaccination
Raxtozinameran (BNT162b2 OMI XBB.1.5)	Raxtozinameran 12 years of age and older	Subject aged 6 months to 4 years and 12 years and older who are scheduled for Raxtozinameran vaccination
Famtozinameran (BNT162b2 OMI BA.4-5)	Famtozinameran 5 to 11 Years of age	Subject aged 5 years and older who are scheduled for Famtozinameran vaccination
Tozinameran (BNT162b2)	Tozinameran 12 Years of age and older	Subjects aged 6 months and older who are scheduled for Tozinameran vaccination

Primary Outcome Measures

Name	Time	Method
Number of subjects with Solicited adverse events	1 week after administration of BNT162b2 products	Solicited adverse events within 1 week (Day 1-7) after each dose of BNT162b2 products, and a number of subjects with such events will be collected.
Number of subjects with Unsolicited adverse events	28 days after administration of BNT162b2 products	Unsolicited adverse events within 28 days by its last dose, and a number of subjects with such events will be collected

Secondary Outcome Measures

Name	Time	Method
Number of subjects with Expected Adverse Events	28 days after administration of BNT162b2 products	All expected adverse events within 28 days by its last dose, and a number of subjects with such events will be collected
Number of subjects with Serious Adverse Drug Reactions	28 days after administration of BNT162b2 products	All serious adverse drug reactions within 28 days by its last dose, and a number of subjects with such events will be collected
Number of subjects with Serious Adverse Events	28 days after administration of BNT162b2 products	All Serious adverse events within 28 days by its last dose, and a number of subjects with such events will be collected
Number of subjects with Adverse Events (AEs)	28 days after administration of BNT162b2 products	All adverse events within 28 days by its last dose, and a number of subjects with such events will be collected
Number of subjects with Unexpected Adverse Drug Reactions	28 days after administration of BNT162b2 products	All unexpected adverse drug reactions within 28 days by its last dose, and a number of subjects with such events will be collected
Number of subjects with Expected Adverse Drug Reactions	28 days after administration of BNT162b2 products	All expected adverse drug reactions within 28 days by its last dose, and a number of subjects with such events will be collected
Number of subjects with Adverse Drug Reactions	28 days after administration of BNT162b2 products	All adverse Drug Reactions within 28 days by its last dose, and a number of subjects with such events will be collected

Trial Locations

Locations (1)

Pfizer Inc; 🇰🇷 Seoul, Korea, Republic of