Korean Post Marketing Surveillance for Comirnaty Injection (Bretovameran)

Pfizer

Status

Active, not recruiting

Conditions

COVID-19 Vaccination

Treatments

Biological: Bretovameran

Study type

Observational

Funder types

Industry

Identifiers

NCT06613984

C4591072

Details and patient eligibility

About

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

Full 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).

Enrollment

660 estimated patients

Sex

All

Ages

12+ years old

Volunteers

Accepts Healthy Volunteers

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