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drugset / Trial / NCT05482295

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

NCT05482295 ↗

Phase 3 Not yet recruiting 540 enrolled PT Bio Farma RS Prof. Dr. I.G.N.G Ngoerah · collab
RandomizedParallel-groupDouble-blindPrevention

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.

Timeline

Start
2025-09
Primary completion
2026-05
Completion
2026-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Engerix-B Vaccine — —
Subject In-House Recombinant Hepatitis B (Bio Farma) Vaccine — —

Indications

vaccinia