Protectivity and Safety Following Recombinant Hepatitis B Vaccine

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

536

Participants

Timeline

Start Date

September 11, 2019

Primary Completion Date

January 30, 2020

Study Completion Date

February 28, 2020

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.

Trial Locations (1)

Unknown

RSND, Semarang

Sponsors

Lead Sponsor

All Listed Sponsors
lead

PT Bio Farma

INDUSTRY