Clinical Trial

Immunogenicity and Safety Following In-House Recombinant Hepatitis B Vaccine in Indonesian Population (Phase III)

Not Yet Recruiting Phase 3
View on ClinicalTrials.gov →
Record status
This record was last updated June 6, 2025 (before its estimated May 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2022-07-29; most recent amendment 2025-06-03.
Trial Details
NCT Number NCT05482295
Lead Sponsor PT Bio Farma
Collaborators: RSUP Prof. Dr. I.G.N.G. Ngoerahal
Conditions Vaccine Reaction, Vaccine Adverse Reaction
Enrollment 540 participants
Start Date 2025-09
Primary Completion 2026-05 (estimated)
Study Completion 2026-05 (estimated)
Updated on ClinicalTrials.gov 2025-06-06