clinical trial · NCT05482295
Immunogenicity and Safety Following In-House Recombinant Hepatitis B Vaccine in Indonesian Population (Phase III)
PT Bio Farma·phase3·not yet recruiting·n = 540
Vaccine ReactionVaccine Adverse ReactionIn-House Recombinant Hepatitis B (Bio Farma) vaccineRegistered Hepatitis B vaccine recombinant (Engerix-B)
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.
started
Sep 1, 2025
primary completion
May 1, 2026
completion
May 1, 2026
last updated
Jun 6, 2025
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.
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)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol