Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) With Pentabio® Vaccine Primed With Recombinant Hepatitis B
- Conditions
- SafetyImmunogenicity
- Interventions
- Biological: Recombinant Hepatitis B + DTP-HB-HibBiological: Hep B + Pentabio (registered)
- Registration Number
- NCT04071379
- Lead Sponsor
- PT Bio Farma
- Brief Summary
Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) with Pentabio® vaccine Primed with Recombinant Hepatitis B
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 220
- Healthy, full term, newborns infants.
- Infant born after 37-42 weeks of pregnancy.
- Infant weighing 2500 gram or more at birth.
- Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form.
- Parents will commit themselves to comply with the indications of the investigator and with the schedule of the trial.
- Child concomitantly enrolled or scheduled to be enrolled in another trial.
- Mother with HBsAg positive.
- Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature >37.5C on Day 0).
- Suspected of allergy to any component of the vaccines (e.g. formaldehyde).
- Suspected of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
- Newborn suspected of congenital or acquired immunodeficiency (including HIV infection).
- Received or plans to receive any treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long term corticotherapy (> 2 weeks)).
- Received other vaccination 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 objectives.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HepB + Penta batch 1 Recombinant Hepatitis B + DTP-HB-Hib Recombinant Hepatitis B + DTP-HB-Hib batch 1 Hep B + Pentabio (registered) Hep B + Pentabio (registered) Recombinant Hepatitis B + Pentabio (registered)
- Primary Outcome Measures
Name Time Method To evaluate protectivity of DTP-HB-Hib Vaccine (Bio Farma) with new Hepatitis B bulk 28 days after immunization 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.
- Secondary Outcome Measures
Name Time Method Geometric mean of anti-HbsAg 28 days after immunization 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
Serological response to Hib/PRP 28 days after immunization 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
Describes antibody response to diphtheria toxoid, tetanus toxoid in both group with the evaluation criteria 28 days after immunization 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
Serological response to the pertussis component (agglutinins) 28 days after immunization 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
Seroconversion 28 days after immunization 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.
Trial Locations
- Locations (3)
Ibrahim Adjie Primary Health Centre
🇮🇩Bandung, West Java, Indonesia
Garuda Primary Health Centre
🇮🇩Bandung, West Java, Indonesia
Puter Primary Health Care
🇮🇩Bandung, West Java, Indonesia