The main objective of this study was to evaluate the protectivity and safety of DTP/HB/Hib (Bio Farma) vaccine compared to DTP/HB and Hib vaccine given simultaneously.
This trial was randomized, single blind, prospective intervention study. Total 220 subject (6-11 weeks of ages) followed this trial, divided into 2 groups, each group consists of 110 subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
220
Dosage equal to 0.5 mL administered intramuscularly
Dosage equal to 0.5 mL administered intramuscularly
Garuda Primary Health Center
Bandung, West Java, Indonesia
Ibrahim Adji Primary Health Care Center
Bandung, West Java, Indonesia
Puter Primary Health Center
Bandung, West Java, Indonesia
Protectivity of DTP/HB/Hib (Bio Farma) vaccine
Percentage of infants with anti diphteria titer and anti tetanus titer \>= 0.01 IU/ml, AntiHbs titer \>=10mlIU/ml, and antiPRP-TT titer \>= 0,15ug/ml 28 days after the last injection (third) in DPT/HB/Hib liquid vaccine group
Time frame: 4 months
Antibody response to diphteria toxoid in both group
Serological response to diphteria toxoid: GMT, percentage of infants with titer \>=0.01 IU/ml and \>=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: 4 months
Antibody response to Tetanus Toxoid in both group
Serological response to tetanus toxoid: GMT, percentage of infants with titer \>=0.01 IU/ml and \>=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: 4 months
Antibody response to Pertussis component in both group
Serological response to the pertussis component (agglutinins): GMT,percentage of infants with titre \>=40, \>=80,\>=160 and \>=320 (1/dil.), percentage of infants with increasing antibody titer \>=4 times.
Time frame: 4 months
Antibody response to Hepatitis B in both group
Serological response to Hepatitis B: Geometric mean of anti-HBs, percentage of infants with titer \>=10mlIU/ml, percentage of infants with increasing antibody titer \>=4 times and/ or percentage of infants with transition of seronegative to seropositive.
Time frame: 4 months
Antibody response to PRP-T in both group
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Serological response to Hib/PRP: GMT, percentage of infants with titre \>=1ug/ml and \>=0.15ug/ml, percentage of infants with increasing antibody titer \>=4 times and/or percentage of infants with transition of seronegative to seropositive
Time frame: 4 months
Incidence rate of adverse event of DTP/Hepatitis B/Hib vaccine (Bio Farma)
Local and systemic reaction
Time frame: 30 minutes, 72 hours, 28 days after immunization