Immunogenicity and Safety of DTP-HB-Hib Using New Hepatitis B Bulk (Bio Farma)

Study Overview
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Brief Summary
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This bridging study is a randomized, double-blind, two arms parallel group, prospective intervention study. The primary objective of this study is to evaluate protectivity of DTP-HB-Hib Vaccine (Bio Farma) using new Hepatitis B bulk (Bio Farma).

Detailed Description
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This bridging study is a randomized, double blind, two arms parallel groups, prospective intervention study. Total 220 infants, 0-3 days old will be involved in this study. The subject will be divided into 2 groups, 110 subjects are the investigational group and 110 subjects are the active comparator group. The objective of this study is to evaluate protectivity of DTP-HB-Hib Vaccine (Bio Farma) using new Hepatitis B bulk (Bio Farma) and to asses the safety of DTP-HB-Hib Vaccine (Bio Farma) and Recombinant Hepatitis B Vaccine using new Hepatitis B bulk (Bio Farma).

Official Title
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Comparison of Immunogenicity and Safety of DTP-HB-Hib Using New Hepatitis B Bulk (Bio Farma) With Pentabio® Vaccine Primed With Recombinant Hepatitis B at Birth Dose Using New Hepatitis B Bulk (Bio Farma), in Indonesian Infants

Conditions
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Diphtheria Vaccine Adverse Reaction, Tetanus Vaccine Adverse Reaction, Pertussis Vaccine Adverse Reaction, Haemophilus Influenzae Type B Vaccine Adverse Reaction, Hepatitis B Vaccine Adverse Reaction

Intervention / Treatment
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* Biological: Recombinant Hepatitis B new Bulk vaccine
* Biological: DTP-HB-Hib with Recombinant Hepatitis B new Bulk vaccine
* Biological: Recombinant Hepatitis B vaccine (Registered BioFarma)
* Biological: Pentabio


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. Child evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature 37.5 celcius degrees on Day 0). Child suspected of allergy to any component of the vaccines (e.g. formaldehyde), based on anamnesis. Child suspected of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection, based on anamnesis Newborn suspected of congenital or acquired immunodeficiency, based on anamnesis Child received or plans to receive any treatment likely to alter the immune response intravenous (immunoglobulins, blood-derived products or long term corticotherapy (> 2 weeks)). Child received other vaccination with the exception of BCG and poliomyelitis. Child has any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives. Mother with HbsAg and HIV positive (by rapid test within 30 days prior subject's birth) Mother suspected of immunodeficiency disease based on anamnesis

Ages Eligible for Study
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Minimum Age: 1 Day
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: Recombinant Hep B new Bulk + Penta with Recombinant HepB new Bulk<br>1 dose Recombinant Hepatitis B new Bulk vaccine at birth + 3 doses Pentavalent with Recombinant HepB new Bulk vaccine | Biological: Recombinant Hepatitis B new Bulk vaccine<br>* 1 dose of Recombinant Hepatitis B vaccine using new Hepatitis B bulk (Bio Farma) 1 dose of 0.5 ml Recombinant Hepatitis B new Bulk vaccine dose of DTP-HB-Hib using new Hepatitis B Bulk vaccine injected intramuscularly into the left external antero-lateral thigh region.<br>Biological: DTP-HB-Hib with Recombinant Hepatitis B new Bulk vaccine<br>* 3 doses of DTP-HB-Hib with Recombinant Hepatitis B new Bulk vaccine<br>|
| Active Comparator: Hep B (Registered) + Pentabio (Registered)<br>1 dose Recombinant Hepatitis B vaccine (Registered) + 3 doses Pentabio with Recombinant HepB new Bulk vaccine | Biological: Recombinant Hepatitis B vaccine (Registered BioFarma)<br>* 1 dose of Recombinant Hepatitis B vaccine (Registered Bio Farma)<br>Biological: Pentabio<br>* 3 doses of Pentabio<br>|

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) using new Hepatitis B bulk (Bio Farma) | Percentage of infants with anti-diphtheria titer and anti-tetanus titer more than 0.01 IU/ml, anti HbsAg titer more than 10 mIU/ml, and anti PRP-TT titer more than 0.15 microgram/ml 28 days after the last injection of DTP-HB-Hib using new Hepatitis B bulk (Bio Farma) vaccine group. | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To asses the local and systemic reactions within 30 minutes | Local reaction and systemic events occurring within 30 minutes after immunization. | 30 minutes | 
| To asses the local and systemic reactions within 30 minutes to 7 days after immunization | Local reaction and systemic events occurring after 30 minutes to 7 days after immunization. | 7 days | 
| To asses the local and systemic reactions within 7 days to 28 days after immunization | Local reaction and systemic events occurring after 7 days to 28 days following the vaccination. | 28 days | 
| To asses the serious adverse event | Any serious adverse event occuring from inclusion until 28 days after the last dose | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DTP-HB-Hib Vaccine, Hepatitis B Vaccine