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

PT Bio Farma

Status and phase: Begins enrollment this month; Phase 3

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

Treatments: Biological: Recombinant Hepatitis B new Bulk vaccine; Biological: Pentabio; Biological: DTP-HB-Hib with Recombinant Hepatitis B new Bulk vaccine; Biological: Recombinant Hepatitis B vaccine (Registered BioFarma)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05482282

Penta BS22

Details and patient eligibility

About

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).

Full description

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).

Enrollment: 220 estimated patients

Sex: All

Ages: 1 to 3 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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220 participants in 2 patient groups

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

Experimental group

Description:

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

Treatment:

Biological: Recombinant Hepatitis B new Bulk vaccine

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

Hep B (Registered) + Pentabio (Registered)

Active Comparator group

Description:

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

Treatment:

Biological: Pentabio

Biological: Recombinant Hepatitis B vaccine (Registered BioFarma)