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COVID-19 VaccinationNCT06613984

Korean Post Marketing Surveillance for Comirnaty Injection (Bretovameran)

An observational study of COVID-19 Vaccination, run by Pfizer at 1 site in South Korea.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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

Who is it for?
Ages 12 years and olderHealthy volunteers can take part
Conditions the study is for
COVID-19 Vaccination
What is being tested?
Bretovameran
How many people
660 participants
Where
1 siteSouth Korea
Study dates
11 Oct 2024to 30 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Pfizer

    Seoul

Other trials in South Korea

About this study

Official title: Korean Post Marketing Surveillance for Comirnaty Injection

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

Read the 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).

Being tested
Bretovameran
Keywords
COVID-19, Bretovameran, Adverse Events, SARS-Cov-2, Safety
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BretovameranBiological

    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.

Study groups in NCT06613984
Study groupRoleWhat they receive
BretovameranKorean subjects who are eligible for administration of Comirnaty Injection (Bretovameran) according to the locally authorized label
Receives: Biological: Bretovameran

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of subjects with Solicited adverse events

    Solicited adverse events within 1 week after each dose of Comirnaty Injection (Bretovameran) and the number of subjects with such events will be collected.

    Measured: 1 week after administration of Comirnaty Injection (Bretovameran)

  2. Number of subjects with Unsolicited adverse events

    Unsolicited adverse events within 28 days after each dose of Comirnaty Injection (Bretovameran) and the number of subjects with such events will be collected.

    Measured: 28 days after administration of Comirnaty Injection (Bretovameran)

Secondary outcomes (8)

  1. Number of subjects with Adverse events (AEs)

    All adverse events within 28 days after each dose of Comirnaty Injection (Bretovameran) and the number of subjects with such events will be collected.

    Measured: 28 days after administration of Comirnaty Injection (Bretovameran)

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

    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.

    Measured: 28 days after administration of Comirnaty Injection (Bretovameran)

  3. Number of subjects with Expected Adverse Events

    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.

    Measured: 28 days after administration of Comirnaty Injection (Bretovameran)

  4. Number of subjects with Unexpected Adverse Events

    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.

    Measured: 28 days after administration of Comirnaty Injection (Bretovameran)

  5. Number of subjects with Adverse Drug Reactions

    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.

    Measured: 28 days after administration of Comirnaty Injection (Bretovameran)

  6. Number of subjects with Serious Adverse Drug Reactions

    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.

    Measured: 28 days after administration of Comirnaty Injection (Bretovameran)

  7. Number of subjects with Expected Adverse Drug Reactions

    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.

    Measured: 28 days after administration of Comirnaty Injection (Bretovameran)

  8. Number of subjects with Unexpected Adverse Drug Reactions

    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.

    Measured: 28 days after administration of Comirnaty Injection (Bretovameran)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2024
  2. Study start11 Oct 2024
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
660 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06613984
Sponsor's protocol ID
C4591072
Status last verified
Oct 2026
First submitted
23 Sep 2024
Last updated
29 Oct 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19 Vaccination, run by Pfizer at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of subjects with Solicited adverse events (time frame: 1 week after administration of Comirnaty Injection (Bretovameran)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06613984.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.

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