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Protectivity and Safety Following Recombinant Hepatitis B Vaccine

NCT03919578 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 536

Last updated 2022-09-19

No results posted yet for this study

Summary

Protectivity and Safety Following Recombinant Hepatitis B Vaccine with different source of Hepatitis B bulk compared to Hepatitis B (Bio Farma) vaccine in Indonesian Population

Conditions

  • Immunogenicity

Interventions

BIOLOGICAL

Recombinant Hepatitis B vaccine

Recombinant Hepatitis B vaccine is an inactivated HbsAg produced in yeast cells (Hansenula polymorpha) using recombinant DNA technology. It is a whitish liquid produced by culture genetically engineered yeast cell which carry the relevant gene of the HbsAg. The inactivated HbsAg (bulk) is imported from Serum Institute of India and then formulated and filled at Bio Farma.

BIOLOGICAL

Recombinant Hepatitis B (Bio Farma)

Recombinant Hepatitis B vaccine is an inactivated HbsAg produced in yeast cells (Hansenula polymorpha) using recombinant DNA technology. It is a whitish liquid produced by culture genetically engineered yeast cell which carry the relevant gene of the HbsAg. The inactivated HbsAg (bulk) is imported from The Janssen Vaccine Corp and then formulated and filled at Bio Farma.

Sponsors & Collaborators

  • PT Bio Farma

    lead INDUSTRY

Principal Investigators

  • Yetty M Nency, MD · Universitas Diponegoro

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-09-11
Primary Completion
2020-01-30
Completion
2020-02-28

Countries

  • Indonesia

Study Locations

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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 NCT03919578 on ClinicalTrials.gov