Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT06690502
Status:
COMPLETED
Last Update Posted:
2024-11-15
First Post:
2024-11-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Post Authorization Safety Profile of Booster IndoVac COVID-19 Vaccination
Sponsor:
PT Bio Farma
Organization:
Study Overview
Official Title:
Safety Profile of Booster IndoVac COVID-19 Vaccination in Healthy Populations Aged 18 Years and Above
Status:
COMPLETED
Status Verified Date:
2024-11
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:
This study is Post Authorization Safety Study (PASS) Phase IV of Booster IndoVac COVID-19 Vaccination
Detailed Description:
This study is Post Authorization Safety Study (PASS) Phase IV, to assess any local and systemic reaction after immunization with IndoVac using retrospective cohort study trial design to assess safety profile following IndoVac booster vaccine in healthy populations aged 18 years and above.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: