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

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

540

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

May 31, 2026

Study Completion Date

May 31, 2026

Conditions
Vaccine ReactionVaccine Adverse Reaction
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)

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

RS Prof. Dr. I.G.N.G Ngoerah

UNKNOWN

lead

PT Bio Farma

INDUSTRY