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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2026-12-31

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).

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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).

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Subjects neonates: Randomized, double blind, 2 arms parallel groups, prospective intervention study

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Double (Participant, Investigator) Observer Blind : Investigational Product and Active Comparator are masking Lot number is masking

Study Groups

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Recombinant Hep B new Bulk + Penta with Recombinant HepB new Bulk

1 dose Recombinant Hepatitis B new Bulk vaccine at birth + 3 doses Pentavalent with Recombinant HepB new Bulk vaccine

Group Type EXPERIMENTAL

Recombinant Hepatitis B new Bulk vaccine

Intervention Type BIOLOGICAL

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.

DTP-HB-Hib with Recombinant Hepatitis B new Bulk vaccine

Intervention Type BIOLOGICAL

3 doses of DTP-HB-Hib with Recombinant Hepatitis B new Bulk vaccine

Hep B (Registered) + Pentabio (Registered)

1 dose Recombinant Hepatitis B vaccine (Registered) + 3 doses Pentabio with Recombinant HepB new Bulk vaccine

Group Type ACTIVE_COMPARATOR

Recombinant Hepatitis B vaccine (Registered BioFarma)

Intervention Type BIOLOGICAL

1 dose of Recombinant Hepatitis B vaccine (Registered Bio Farma)

Pentabio

Intervention Type BIOLOGICAL

3 doses of Pentabio

Interventions

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Recombinant Hepatitis B new Bulk vaccine

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.

Intervention Type BIOLOGICAL

DTP-HB-Hib with Recombinant Hepatitis B new Bulk vaccine

3 doses of DTP-HB-Hib with Recombinant Hepatitis B new Bulk vaccine

Intervention Type BIOLOGICAL

Recombinant Hepatitis B vaccine (Registered BioFarma)

1 dose of Recombinant Hepatitis B vaccine (Registered Bio Farma)

Intervention Type BIOLOGICAL

Pentabio

3 doses of Pentabio

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. Healthy, full term, newborns infants.
2. Infant born after 37-42 weeks of pregnancy.
3. Infant weighing 2500 gram or more at birth.
4. Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form.
5. Parents will commit themselves to comply with the indications of the investigator and with the schedule of the trial.

Exclusion Criteria

1. Child concomitantly enrolled or scheduled to be enrolled in another trial.
2. Child evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature 37.5 celcius degrees on Day 0).
3. Child suspected of allergy to any component of the vaccines (e.g. formaldehyde), based on anamnesis.
4. Child suspected of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection, based on anamnesis
5. Newborn suspected of congenital or acquired immunodeficiency, based on anamnesis
6. 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)).
7. Child received other vaccination with the exception of BCG and poliomyelitis.
8. Child has any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.
9. Mother with HbsAg and HIV positive (by rapid test within 30 days prior subject's birth)
10. Mother suspected of immunodeficiency disease based on anamnesis

Minimum Eligible Age

1 Day

Maximum Eligible Age

3 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes