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
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. Experimental, randomized, double blind, four arm parallel group study, lot to lot consistency study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
536
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.
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.
RSND
Semarang, Central Java, Indonesia
Percentage of subjects with increasing antibody titer >= 4 times
Percentage of subjects with increasing antibody titer \>= 4 times: in all subjects; comparison between investigational product and control and between each lot number of Recombinant Hepatitis B
Time frame: 28 days after the last dose immunization
Geometric Mean Titer (GMT)
GMT in all subjects; comparison of GMT between investigational products and control and comparison of GMT between each lot number of Recombinant Hepatitis B
Time frame: 28 days after the last dose immunization
Percentage of subjects with transition of seronegative to seropositive
Percentage of subjects with transition of seronegative to seropositive: in all subjects; Subjets which get investigational products and control and each lot number of Recombinant Hepatitis B
Time frame: 28 days after the last dose immunization
Percentage of subjects with at least one immediate reaction
Immediate reaction (local reaction or systemic event)
Time frame: 30 minutes after each vaccination
Percentage of subjects with at least one of these adverse events
At least one of these adverse events, expected or not
Time frame: within 72 hours, between 72 hours to 28 days after vaccination
Serious adverse event after vaccination
Serious adverse event occurring from inclusion until 28 days after vaccination.
Time frame: 28 days after the last dose immunization
Comparison adverse events between Investigational Products (Hepatitis B) and Control
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Adverse events occuring until 28 days after vaccination
Time frame: 28 days after each dose
Comparison of adverse events between each lot number of Recombinant Hepatitis B vaccine
Adverse events occuring until 28 days after vaccination
Time frame: 28 days after each dose