The objectives of this study were to analyze the immunogenicity and reactogenicity of DTP/HB/Hib (Bio Farma) combination vaccine.
This trial was randomized, double blind, prospective intervention and multi centers. Total 600 subject (6-11 weeks of ages) followed this trial, divided into 3 groups, each group consists of 200 subjects. A number of 342 subjects were recruited in Bandung, while 258 subjects were recruited in Jakarta.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
600
DPT/HB/Hib vaccine (Bio Farma)
Jatinegara Primary Health Center
Jakarta, Jakarta Special Capital Region, Indonesia
Mampang Prapatan Primary Health Center
Jakarta, Jakarta Special Capital Region, Indonesia
Tebet Primary Health Center
Jakarta, Jakarta Special Capital Region, Indonesia
Garuda Primary Health Center
Bandung, West Java, Indonesia
Protectivity of DTP/HB/Hib (Bio Farma) vaccine
Number and percentage of infants with anti diphteria titer and anti tetanus titer \>= 0.01 IU/ml, AntiHBs titer \>=10mlIU/ml, and antiHib titer \>= 0,15ug/ml 28 days after the last injection
Time frame: 4 months
Antibody response to diphtheria between groups (three different batch numbers)
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 between groups (three different batch numbers)
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 between groups (three different batch numbers)
Serological response to 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 between groups (three different batch numbers)
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
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Ibrahim Adji Primary Health Center
Bandung, West Java, Indonesia
Puter Primary Health Center
Bandung, West Java, Indonesia
Antibody response to Hib/PRP between groups (three different batch numbers)
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/HB/Hib (Bio Farma)vaccine between groups
Number and percentage of local reaction and systemic events following vaccination.
Time frame: 30 minutes, 72 hours, 28 days after immunization