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NOT YET RECRUITING
NCT05482295
PHASE3

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

Sponsor: PT Bio Farma

View on ClinicalTrials.gov

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.

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)

Key Details

Gender

All

Age Range

10 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

540

Start Date

2025-09

Completion Date

2026-05

Last Updated

2025-06-06

Healthy Volunteers

Yes

Interventions

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)