NCT05482295

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

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 540 (estimated)
• Sponsor: PT Bio Farma · Industry
• Sex: All
• Age: 10 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Vaccine Reaction
• Vaccine Adverse Reaction

Interventions

Type	Name	Description
BIOLOGICAL	In-House Recombinant Hepatitis B (Bio Farma) vaccine	3 doses of In-House Recombinant Hepatitis B (Bio Farma) vaccine
BIOLOGICAL	Registered Hepatitis B vaccine recombinant (Engerix-B)	3 doses of Registered Hepatitis B vaccine recombinant (Engerix-B)

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2022-08-01
• Last updated: 2025-06-06