Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2026-01-04 @ 1:23 PM
Study NCT ID:
NCT03188692
Status:
COMPLETED
Last Update Posted:
2025-01-03
First Post:
2017-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of BK1310 Intramuscular Injection in Healthy Infants
Sponsor:
Tanabe Pharma Corporation
Organization:
Study Overview
Official Title:
Phase 3 Study of BK1310 Intramuscular Injection in Healthy Infants
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:
The purpose of this study is to evaluate the safety and efficacy of an intramuscular injection of BK1310 in healthy infants.
Detailed Description:
None
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?: