NCT06613984

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
660

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Oct 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
Oct 2024Dec 2026

First Submitted

Initial submission to the registry

September 23, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 26, 2024

Completed
15 days until next milestone

Study Start

First participant enrolled

October 11, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

2.2 years

First QC Date

September 23, 2024

Last Update Submit

January 12, 2026

Conditions

COVID-19 Vaccination

Keywords

COVID-19BretovameranAdverse EventsSARS-Cov-2Safety

Outcome Measures

Primary Outcomes (2)

  • 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.

    1 week after administration of Comirnaty Injection (Bretovameran)

  • 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.

    28 days after administration of Comirnaty Injection (Bretovameran)

Secondary Outcomes (8)

  • Number of subjects with Adverse events (AEs)

    28 days after administration of Comirnaty Injection (Bretovameran)

  • Number of subjects with Serious Adverse Events (SAEs)

    28 days after administration of Comirnaty Injection (Bretovameran)

  • Number of subjects with Expected Adverse Events

    28 days after administration of Comirnaty Injection (Bretovameran)

  • Number of subjects with Unexpected Adverse Events

    28 days after administration of Comirnaty Injection (Bretovameran)

  • Number of subjects with Adverse Drug Reactions

    28 days after administration of Comirnaty Injection (Bretovameran)

  • +3 more secondary outcomes

Study Arms (1)

Bretovameran

Korean subjects who are eligible for administration of Comirnaty Injection (Bretovameran) according to the locally authorized label

Biological: Bretovameran

Interventions

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.

Bretovameran

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer

Seoul, South Korea

Location

Related Links

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2024

First Posted

September 26, 2024

Study Start

October 11, 2024

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

January 14, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

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.

Locations

KR(1)