This bridging study is a randomized, double-blind, two arms parallel group, prospective intervention study. The primary objective of this study is to evaluate protectivity of DTP-HB-Hib Vaccine (Bio Farma) using new Hepatitis B bulk (Bio Farma).
This bridging study is a randomized, double blind, two arms parallel groups, prospective intervention study. Total 220 infants, 0-3 days old will be involved in this study. The subject will be divided into 2 groups, 110 subjects are the investigational group and 110 subjects are the active comparator group. The objective of this study is to evaluate protectivity of DTP-HB-Hib Vaccine (Bio Farma) using new Hepatitis B bulk (Bio Farma) and to asses the safety of DTP-HB-Hib Vaccine (Bio Farma) and Recombinant Hepatitis B Vaccine using new Hepatitis B bulk (Bio Farma).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
1 dose of Recombinant Hepatitis B vaccine using new Hepatitis B bulk (Bio Farma) 1 dose of 0.5 ml Recombinant Hepatitis B new Bulk vaccine dose of DTP-HB-Hib using new Hepatitis B Bulk vaccine injected intramuscularly into the left external antero-lateral thigh region.
3 doses of DTP-HB-Hib with Recombinant Hepatitis B new Bulk vaccine
1 dose of Recombinant Hepatitis B vaccine (Registered Bio Farma)
Garuda Primary Health Centre
Bandung, West Java, Indonesia
Ibrahim Adjie Primary Health Centre
Bandung, West Java, Indonesia
Puter Primary Health Centre
Bandung, West Java, Indonesia
To evaluate protectivity of DTP-HB-Hib Vaccine (Bio Farma) using new Hepatitis B bulk (Bio Farma)
Percentage of infants with anti-diphtheria titer and anti-tetanus titer more than 0.01 IU/ml, anti HbsAg titer more than 10 mIU/ml, and anti PRP-TT titer more than 0.15 microgram/ml 28 days after the last injection of DTP-HB-Hib using new Hepatitis B bulk (Bio Farma) vaccine group.
Time frame: 28 days
To asses the local and systemic reactions within 30 minutes
Local reaction and systemic events occurring within 30 minutes after immunization.
Time frame: 30 minutes
To asses the local and systemic reactions within 30 minutes to 7 days after immunization
Local reaction and systemic events occurring after 30 minutes to 7 days after immunization.
Time frame: 7 days
To asses the local and systemic reactions within 7 days to 28 days after immunization
Local reaction and systemic events occurring after 7 days to 28 days following the vaccination.
Time frame: 28 days
To asses the serious adverse event
Any serious adverse event occuring from inclusion until 28 days after the last dose
Time frame: 28 days
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3 doses of Pentabio