Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) With Pentabio® Vaccine Primed With Recombinant Hepatitis B

Study Overview
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Brief Summary
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Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) with Pentabio® vaccine Primed with Recombinant Hepatitis B

Detailed Description
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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

Official Title
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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

Conditions
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Immunogenicity, Safety

Intervention / Treatment
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* Biological: Recombinant Hepatitis B + DTP-HB-Hib
* Biological: Hep B + Pentabio (registered)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 0 Days
Maximum Age: 3 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects neonates: Randomized, double blind, 2 arms parallel groups, prospective intervention Study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HepB + Penta batch 1<br>Recombinant Hepatitis B + DTP-HB-Hib batch 1 | Biological: Recombinant Hepatitis B + DTP-HB-Hib<br>* 1 dose of 0.5 ml Recombinant Hepatitis B + 3 dose of 0.5 ml of DTP-HB-Hib<br>* Other names: Hep B + DTP-HB-Hib;|
| Active Comparator: Hep B + Pentabio (registered)<br>Recombinant Hepatitis B + Pentabio (registered) | Biological: Hep B + Pentabio (registered)<br>* 1 dose of 0.5 ml Recombinant Hepatitis B (registered) + 3 dose of 0.5 ml of Pentabio (registered)<br>* Other names: Recombinant Hepatitis B (Bio Farma) + Pentabio (Bio Farma);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 28 days after immunization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 28 days after immunization | 
| 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. | 28 days after immunization |