COVID-19 Vaccination
Conditions
Keywords
COVID-19, Bretovameran, Adverse Events, SARS-Cov-2, Safety
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).
Interventions
BIOLOGICALBretovameran
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.
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with Solicited adverse events | 1 week after administration of Comirnaty Injection (Bretovameran) | Solicited adverse events within 1 week after each dose of Comirnaty Injection (Bretovameran) and the number of subjects with such events will be collected. |
| Number of subjects with Unsolicited adverse events | 28 days after administration of Comirnaty Injection (Bretovameran) | Unsolicited adverse events within 28 days after each dose of Comirnaty Injection (Bretovameran) and the number of subjects with such events will be collected. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with Expected Adverse Events | 28 days after administration of Comirnaty Injection (Bretovameran) | 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. |
| Number of subjects with Unexpected Adverse Events | 28 days after administration of Comirnaty Injection (Bretovameran) | 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. |
| Number of subjects with Adverse Drug Reactions | 28 days after administration of Comirnaty Injection (Bretovameran) | 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. |
| Number of subjects with Adverse events (AEs) | 28 days after administration of Comirnaty Injection (Bretovameran) | All adverse events within 28 days after each dose of Comirnaty Injection (Bretovameran) and the number of subjects with such events will be collected. |
| Number of subjects with Expected Adverse Drug Reactions | 28 days after administration of Comirnaty Injection (Bretovameran) | 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. |
| Number of subjects with Unexpected Adverse Drug Reactions | 28 days after administration of Comirnaty Injection (Bretovameran) | 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. |
| Number of subjects with Serious Adverse Drug Reactions | 28 days after administration of Comirnaty Injection (Bretovameran) | 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. |
| Number of subjects with Serious Adverse Events (SAEs) | 28 days after administration of Comirnaty Injection (Bretovameran) | 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. |
Countries
South Korea
Outcome results
None listed