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Active, Not Recruiting

NCT Number: NCT06613984

Korean Post Marketing Surveillance for Comirnaty Injection (Bretovameran)

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

COVID-19 Vaccination COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer

Seoul, South Korea

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bretovameran

Biological

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.

Primary outcomes

  1. Number of subjects with Solicited adverse events

    Time frame: 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.

  2. Number of subjects with Unsolicited adverse events

    Time frame: 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 outcomes

  1. Number of subjects with Adverse events (AEs)

    Time frame: 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.

  2. Number of subjects with Serious Adverse Events (SAEs)

    Time frame: 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.

  3. Number of subjects with Expected Adverse Events

    Time frame: 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.

  4. Number of subjects with Unexpected Adverse Events

    Time frame: 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.

  5. Number of subjects with Adverse Drug Reactions

    Time frame: 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.

  6. Number of subjects with Serious Adverse Drug Reactions

    Time frame: 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.

  7. Number of subjects with Expected Adverse Drug Reactions

    Time frame: 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.

  8. Number of subjects with Unexpected Adverse Drug Reactions

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Korean Post Marketing Surveillance for Comirnaty Injection

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 26, 2024
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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