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.
This is a phase 3, experimental, randomized, observer-blind, lot to lot consistency study. A total of 540 subjects will be involved in this 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
540
3 doses of In-House Recombinant Hepatitis B (Bio Farma) vaccine
3 doses of Registered Hepatitis B vaccine recombinant (Engerix-B)
Protectivity
Number \& percentage of subjects with anti HBsAg \> 10mIU/ml
Time frame: 28 days after the primary series of Hepatitis B vaccination
Immunogenicity: Serological response
Geometric mean of anti-HBsAg, percentage of subjects with increasing antibody titer \>= 4 times and/ or percentage of subjects with transition of seronegative to seropositive
Time frame: 28 days after the primary series of Hepatitis B vaccination
Immunogenicity: comparison between IP & control
Comparison of GMT, seroprotection, percentage of subjects with increasing antibody titer \>=4 times and/ or percentage of subjects with transition of seronegative to seropositive
Time frame: 28 days after the primary series of Hepatitis B vaccination
Immunogenicity: comparison among each batch of IP
Comparison of GMT, seroprotection, percentage of subjects with increasing antibody titer \>=4 times and/ or percentage of subjects with transition of seronegative to seropositive
Time frame: 28 days after the primary series of Hepatitis B vaccination
Safety: Immediate reaction, Local and systemic events
Immediate reaction, Local and systemic events
Time frame: within the first 30 minutes, after 30 minutes to 7 days, after 7 days to 28 days after each injection
Safety: Serious adverse event
Any serious adverse event
Time frame: from inclusion until 28 days after the last injection
Safety: Comparison of 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
Safety: Comparison of adverse events between each lot number of Recombinant Hepatitis B
Adverse events occuring until 28 days after vaccination
Time frame: 28 days after each dose