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Immunogenicity and Safety Following In-House Recombinant Hepatitis B Vaccine in Indonesian Population (Phase III)
Sponsor: PT Bio Farma
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
Conditions
Interventions
In-House Recombinant Hepatitis B (Bio Farma) vaccine
3 doses of In-House Recombinant Hepatitis B (Bio Farma) vaccine
Registered Hepatitis B vaccine recombinant (Engerix-B)
3 doses of Registered Hepatitis B vaccine recombinant (Engerix-B)