Protectivity and Safety of DTP/HB/Hib (Bio Farma) Vaccines in Infants, Batch Consistency, Multi Center Trial
- Conditions
- Healthy
- Interventions
- Biological: DTP/HB/Hib Vaccine
- Registration Number
- NCT01986335
- Lead Sponsor
- PT Bio Farma
- Brief Summary
The objectives of this study were to analyze the immunogenicity and reactogenicity of DTP/HB/Hib (Bio Farma) combination vaccine.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 600
- Infant 6-11 week of age
- Infant born after 37-42 week of pregnancy
- Infant weighting more than 2.5 kg at birth
- Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form
- Parents commit themselves to comply with the indication of the investigator and with the schedule of the trial
- Mother at least graduate from elementary school
- Received Hepatitis B vaccine (Bio Farma) at birth
- Child concomitantly enroll or schedule to be enroll in another trial
- Evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature >=37.5 Celsius on Day 0)
- Known history of allergy to any component of the vaccine component (e.g.formaldehyde)
- History of uncontrolled coagulopathy or blood disorder contraindicating intramuscular injection
- Known history of congenital or acquired immunodeficiency (including HIV infection)
- Child who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulin, blood derived product or long term corticotherapy (>2 weeks)
- Other vaccination within the 1 month prior to inclusion with the exception of BCG and poliomyelitis
- Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objective
- Infant with a known history of diphteria, tetanus, pertussis, Hib, Hepatitis B infection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DTP/HB/Hib vaccine (Batch: B) DTP/HB/Hib Vaccine Purified diphteria toxoid Purified tetanus toxoid Inactivated Bordetella pertussis HbsAg PRP-TT Aluminum phosphate Natrium Chloride Thimerosal DTP/HB/Hib Vaccine (Batch: A) DTP/HB/Hib Vaccine Purified diphteria toxoid Purified tetanus toxoid Inactivated Bordetella pertussis HbsAg PRP-TT Aluminum phosphate Natrium Chloride Thimerosal DTP/HB/Hib vaccine (Batch: C) DTP/HB/Hib Vaccine Purified diphteria toxoid Purified tetanus toxoid Inactivated Bordetella pertussis HbsAg PRP-TT Aluminum phosphate Natrium Chloride Thimerosal
- Primary Outcome Measures
Name Time Method Protectivity of DTP/HB/Hib (Bio Farma) vaccine 4 months 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
- Secondary Outcome Measures
Name Time Method Antibody response to Tetanus between groups (three different batch numbers) 4 months 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
Antibody response to Pertussis component between groups (three different batch numbers) 4 months 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.
Antibody response to Hepatitis B between groups (three different batch numbers) 4 months 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.
Antibody response to Hib/PRP between groups (three different batch numbers) 4 months 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
Incidence rate of adverse event of DTP/HB/Hib (Bio Farma)vaccine between groups 30 minutes, 72 hours, 28 days after immunization Number and percentage of local reaction and systemic events following vaccination.
Antibody response to diphtheria between groups (three different batch numbers) 4 months 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
Trial Locations
- Locations (6)
Puter Primary Health Center
🇮🇩Bandung, West Java, Indonesia
Garuda Primary Health Center
🇮🇩Bandung, West Java, Indonesia
Jatinegara Primary Health Center
🇮🇩Jakarta, Indonesia
Mampang Prapatan Primary Health Center
🇮🇩Jakarta, Indonesia
Ibrahim Adji Primary Health Center
🇮🇩Bandung, West Java, Indonesia
Tebet Primary Health Center
🇮🇩Jakarta, Indonesia