Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06613984
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-23
Brief Title:
Korean Post Marketing Surveillance for Comirnaty Injection Bretovameran
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Korean Post Marketing Surveillance for Comirnaty Injection
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 doctors 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 subjects medical records and diary and record data on each subjects case report form CRF
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 doctors 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 subjects medical records and diary and record data on each subjects case report form CRF
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: