Korean Post Marketing Surveillance for Comirnaty Injection (Bretovameran)

Korean Post Marketing Surveillance for Comirnaty Injection

This study is to identify any problems and questions with respect to the safety of Comirnaty Injection (Bretovameran) during the post-marketing period.

Study Overview

• Status: Active, not recruiting
• Conditions: COVID-19 Vaccination
• Intervention / Treatment: Biological: Bretovameran

Detailed Description

All assessments are performed as part of normal clinical practice or standard practice guidelines for the subject population and healthcare provider specialty in the countries where this non-interventional study is being conducted.

This study is conducted under normal clinical practice in accordance with regulatory requirements. Therefore, the inclusion and exclusion criteria for study subjects are related to indications and contraindications outlined in the local product document. This study will not provide or make recommendations on any vaccine use. The vaccines are all given as part of the standard of care. All enrolled subjects have to meet the general prescription criteria for Comirnaty Injection (Bretovameran) according to the local product document and have to be enrolled at the doctor's discretion.

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. Comirnaty Injection (Bretovameran) will be administered according to the "Dosage and Administration" of the authorized label. There is no visit or activity mandated by this study. The investigator will collect data from the subject's medical records and diary and record data on each subject's case report form (CRF).

• Study Type: Observational
• Enrollment (Estimated): 660

Contacts and Locations

Study Locations

• South Korea
  • Seoul, South Korea
    • Pfizer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study population is Korean subjects who are eligible for "indications" specified in the approved label.

[INDICATIONS] Active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 12 years of age and older.

Description

Inclusion Criteria:

• Korean subjects who are eligible for administration of Comirnaty Injection according to the locally authorized label
• Subjects with evidence of a personally signed and dated informed consent/assent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study

Exclusion Criteria:

• Subjects who involved in the contraindications of use indicated in the locally authorized label
• Subjects with a history of hypersensitivity to any ingredients of this product or this product
• Any subjects (or a legally acceptable representative) who does not agree that Pfizer and companies working with Pfizer use his/her information

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Bretovameran; Korean subjects who are eligible for administration of Comirnaty Injection (Bretovameran) according to the locally authorized label	Biological: Bretovameran; Comirnaty Injection (Bretovameran) is administered intramuscularly as a single dose of 0.3 mL for individuals 12 years of age and older regardless of prior COVID-19 vaccination status.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects with Solicited adverse events	Solicited adverse events within 1 week after each dose of Comirnaty Injection (Bretovameran) and the number of subjects with such events will be collected.	1 week after administration of Comirnaty Injection (Bretovameran)
Number of subjects with Unsolicited adverse events	Unsolicited adverse events within 28 days after each dose of Comirnaty Injection (Bretovameran) and the number of subjects with such events will be collected.	28 days after administration of Comirnaty Injection (Bretovameran)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects with Adverse events (AEs)	All adverse events within 28 days after each dose of Comirnaty Injection (Bretovameran) and the number of subjects with such events will be collected.	28 days after administration of Comirnaty Injection (Bretovameran)
Number of subjects with Serious Adverse Events (SAEs)	All Serious adverse events within 28 days after each dose of Comirnaty Injection (Bretovameran) and the number of subjects with such events will be collected.	28 days after administration of Comirnaty Injection (Bretovameran)
Number of subjects with Expected Adverse Events	All expected adverse events within 28 days after each dose of Comirnaty Injection (Bretovameran) and the number of subjects with such events will be collected.	28 days after administration of Comirnaty Injection (Bretovameran)
Number of subjects with Unexpected Adverse Events	All Unexpected Adverse Events within 28 days after each dose of Comirnaty Injection (Bretovameran) and the number of subjects with such events will be collected.	28 days after administration of Comirnaty Injection (Bretovameran)
Number of subjects with Adverse Drug Reactions	All Adverse Drug Reactions within 28 days after each dose of Comirnaty Injection (Bretovameran) and the number of subjects with such events will be collected.	28 days after administration of Comirnaty Injection (Bretovameran)
Number of subjects with Serious Adverse Drug Reactions	All Serious Adverse Drug Reactions within 28 days after each dose of Comirnaty Injection (Bretovameran) and the number of subjects with such events will be collected.	28 days after administration of Comirnaty Injection (Bretovameran)
Number of subjects with Expected Adverse Drug Reactions	All Expected Adverse Drug Reactions within 28 days after each dose of Comirnaty Injection (Bretovameran) and the number of subjects with such events will be collected.	28 days after administration of Comirnaty Injection (Bretovameran)
Number of subjects with Unexpected Adverse Drug Reactions	All Unexpected Adverse Drug Reactions within 28 days after each dose of Comirnaty Injection (Bretovameran) and the number of subjects with such events will be collected.	28 days after administration of Comirnaty Injection (Bretovameran)

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: September 23, 2024
• First Submitted That Met QC Criteria: September 23, 2024
• First Posted (Actual): September 26, 2024

Study Record Updates

• Last Update Posted (Estimated): January 14, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Safety; COVID-19; Adverse Events; SARS-Cov-2; Bretovameran
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19
• Other Study ID Numbers: C4591072

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No