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

NCT05482295 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 540

Last updated 2025-06-06

No results posted yet for this study

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.

Conditions

  • Vaccine Reaction
  • Vaccine 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 & Collaborators

  • RS Prof. Dr. I.G.N.G Ngoerah

    collaborator UNKNOWN

  • PT Bio Farma

    lead INDUSTRY

Principal Investigators

  • Trisna Windiani, MD · RSUP Prof. dr. I.G.N.G. Ngoerah

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2026-05-31
Completion
2026-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05482295 on ClinicalTrials.gov