Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) with Pentabio® vaccine Primed with Recombinant Hepatitis B
Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) with Pentabio® vaccine Primed with Recombinant Hepatitis B at Birth dose (using different source of Hepatitis B), in Indonesian Infants
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
220
1 dose of 0.5 ml Recombinant Hepatitis B + 3 dose of 0.5 ml of DTP-HB-Hib
1 dose of 0.5 ml Recombinant Hepatitis B (registered) + 3 dose of 0.5 ml of Pentabio (registered)
Garuda Primary Health Centre
Bandung, West Java, Indonesia
Ibrahim Adjie Primary Health Centre
Bandung, West Java, Indonesia
Puter Primary Health Care
Bandung, West Java, Indonesia
To evaluate protectivity of DTP-HB-Hib Vaccine (Bio Farma) with new Hepatitis B bulk
Percentage of infants with anti-diphtheria titer and anti-tetanus titer \> 0.01 IU/ml, anti HbsAg titer \> 10 mIU/ml, and anti PRP-T titer \> 0.15 ug/ml 28 days after the last injection of DTP/HB/Hib with different source of Hepatitis B bulk vaccine group.
Time frame: 28 days after immunization
Describes antibody response to diphtheria toxoid, tetanus toxoid in both group with the evaluation criteria
Serological response to diphtheria toxoid, tetanus toxoid: GMT, percentage of infants with titer \> 0.01 IU/ml, \> 0.1 IU/ml percentage of infants with increasing antibody titer \> 4 times and/or percentage of infants with transition of seronegative to seropositive
Time frame: 28 days after immunization
Serological response to the pertussis component (agglutinins)
Serological response to the pertussis component (agglutinins): GMT, percentage of infants with titer \> 40, \> 80, \> 160 and \> 320 (1/dil.), percentage of infants with increasing antibody titer \> 4 times
Time frame: 28 days after immunization
Geometric mean of anti-HbsAg
Geometric mean of anti-HbsAg, percentage of infants with titer \> 10mIU/ml, percentage of infants with increasing antibody titer \> 4 times and/ or percentage of infants with transition of seronegative to seropositive
Time frame: 28 days after immunization
Serological response to Hib/PRP
Serological response to Hib/PRP: GMT, percentage of infants with titer \>1 ug /ml ; \> 0.15 ug /ml percentage of infants with increasing antibody titer \> 4 times and/or percentage of infants with transition of seronegative to seropositive
Time frame: 28 days after immunization
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Seroconversion
Comparison of GMT, seroprotection, percentage of subjects with increasing antibody titer \> 4 times and/ or percentage of subjects with transition of seronegative to seropositive following primary series of investigational product compare to control.
Time frame: 28 days after immunization