NCT06613984

Korean Post Marketing Surveillance for Comirnaty Injection (Bretovameran)

Korean Post Marketing Surveillance for Comirnaty Injection

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 660 (estimated)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Accepted

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).

Conditions

• COVID-19 Vaccination

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-10-11
• Primary completion: 2026-12-30
• Completion: 2026-12-30
• First posted: 2024-09-26
• Last updated: 2026-01-14

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated drug study