Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2025-12-27 @ 10:08 PM
Study NCT ID:
NCT06147895
Status:
COMPLETED
Last Update Posted:
2024-03-25
First Post:
2023-11-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Prophylactic Hepatitis B Vaccine
Sponsor:
CHA Vaccine Institute Co., Ltd.
Organization:
Study Overview
Official Title:
A Randomized, Open-labelled, Parallel, Phase 1 Clinical Study to Evaluate the Safety, Reactogenicity and Immunogenicity of the Hepatitis B Vaccine CVI-HBV-002 in Adults
Status:
COMPLETED
Status Verified Date:
2023-11
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:
CVI-HBV-002
Brief Summary:
The purpose of this study is to evaluate the safety and immunogenicity of the investigational medicinal product, CVI-HBV-002.
Detailed Description:
A Randomized, Open-labelled, Parallel, Phase 1 clinical study to evaluate the safety, reactogenicity and immunogenicity of the hepatitis B vaccine CVI-HBV-002 in adults
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?: