Clinical trial NCT06613984: Korean Post Marketing Surveillance for Comirnaty Injection (Bretovameran)
Official title: Korean Post Marketing Surveillance for Comirnaty Injection
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: COVID-19 Vaccination
Keywords: COVID-19
Bretovameran
Adverse Events
SARS-Cov-2
Safety
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2024-09-26
Enrollment: 660
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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).

Eligibility criteria: 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

Primary outcomes:
measure: Number of subjects with Solicited adverse events
timeFrame: 1 week after administration of Comirnaty Injection (Bretovameran)
measure: Number of subjects with Unsolicited adverse events
timeFrame: 28 days after administration of Comirnaty Injection (Bretovameran)
Secondary outcomes:
measure: Number of subjects with Adverse events (AEs)
timeFrame: 28 days after administration of Comirnaty Injection (Bretovameran)
measure: Number of subjects with Serious Adverse Events (SAEs)
timeFrame: 28 days after administration of Comirnaty Injection (Bretovameran)
measure: Number of subjects with Expected Adverse Events
timeFrame: 28 days after administration of Comirnaty Injection (Bretovameran)
measure: Number of subjects with Unexpected Adverse Events
timeFrame: 28 days after administration of Comirnaty Injection (Bretovameran)
measure: Number of subjects with Adverse Drug Reactions
timeFrame: 28 days after administration of Comirnaty Injection (Bretovameran)
measure: Number of subjects with Serious Adverse Drug Reactions
timeFrame: 28 days after administration of Comirnaty Injection (Bretovameran)
measure: Number of subjects with Expected Adverse Drug Reactions
timeFrame: 28 days after administration of Comirnaty Injection (Bretovameran)
measure: Number of subjects with Unexpected Adverse Drug Reactions
timeFrame: 28 days after administration of Comirnaty Injection (Bretovameran)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Pfizer Korea
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: