Korean Post Marketing Surveillance for Comirnaty Injection (Bretovameran)

N/AActive Not RecruitingNCT06613984

Pfizer660 enrolled

Overview

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

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

660

Conditions

COVID-19 Vaccination

Interventions

BretovameranBIOLOGICAL

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.

Eligibility

Sex: ALLMin age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Pfizer

Seoul, South Korea

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 28 days after administration of Comirnaty Injection (Bretovameran)

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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