Ignite Creation Date:
2025-12-24 @ 1:41 PM
Ignite Modification Date:
2026-01-01 @ 11:31 AM
Study NCT ID:
NCT05482295
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-06
First Post:
2022-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunogenicity and Safety Following In-House Recombinant Hepatitis B Vaccine in Indonesian Population (Phase III)
Sponsor:
PT Bio Farma
Organization:
Study Overview
Official Title:
Immunogenicity and Safety Following In-House Recombinant Hepatitis B (Bio Farma) Vaccine Compared to Registered Hepatitis B Vaccine in Indonesian Population (Phase III)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-06
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 is a phase 3, experimental, randomized, observer-blind, lot to lot consistency study. The primary objective of this study is to assess the protectivity of In-House Recombinant Hepatitis B vaccine 28 days after 3 doses immunization.
Detailed Description:
This is a phase 3, experimental, randomized, observer-blind, lot to lot consistency study. A total of 540 subjects will be involved in this study.
The primary objective of this study is to assess the protectivity of In-House Recombinant Hepatitis B vaccine 28 days after 3 doses immunization.
The primary objective of this study is to assess the protectivity of In-House Recombinant Hepatitis B vaccine 28 days after 3 doses immunization.
Study Oversight
Has Oversight DMC:
True
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?: