Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06333704
Status:
RECRUITING
Last Update Posted:
2024-03-27
First Post:
2024-03-20
Brief Title:
Post-marketing Surveillance PMS Use-Result Surveillance With SPIKEVAX BIVALENT and SPIKEVAX X Injection
Sponsor:
ModernaTX Inc
Organization:
ModernaTX Inc
Study Overview
Official Title:
A Multi-Centre Prospective Observational Post-Marketing Surveillance to Investigate the Long-Term Safety of SPIKEVAX BIVALENT and SPIKEVAX X Injection Under Routine Clinical Care in Korea
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main objective of the surveillance is to evaluate the incidence of the adverse events AEs and other safety related information in South-Korean population
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None