Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06189053
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-03
First Post:
2024-01-01
Brief Title:
A Study to Assess Long-term Outcomes of Myocarditis Following Administration of COVID-19 mRNA Vaccine SPIKEVAX
Sponsor:
ModernaTX Inc
Organization:
ModernaTX Inc
Study Overview
Official Title:
Long-term Outcomes of Myocarditis Following Administration of SPIKEVAX COVID-19 Vaccine mRNA
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-10
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 goal of this study is to characterize presentation clinical course and long-term outcomes of myocarditis temporally associated with administration of mRNA-1273 SPIKEVAX COVID-19 vaccine
Detailed Description:
This is an observational cohort study that combines data collected directly from healthcare providers HCP with existing retrospective real-world data as captured in clinical electronic health record EHR and administrative claims data Vaccine exposure and case identification information will be obtained retrospectively from existing real-world data to identify cases of post-vaccine myocarditis PVM and ultimately vaccine-associated myocarditis VAM for potential study inclusion Eligible participants will be identified and followed for up to 5 years until the end of the study period or loss to follow-up or death
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