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

Phase 3

Not yet recruiting

• Conditions: Diphtheria Vaccine Adverse Reaction; Hepatitis B Vaccine Adverse Reaction; Tetanus Vaccine Adverse Reaction; Pertussis Vaccine Adverse Reaction; Haemophilus Influenzae Type B Vaccine Adverse Reaction
• Interventions: Biological: Recombinant Hepatitis B new Bulk vaccine; Biological: Recombinant Hepatitis B vaccine (Registered BioFarma); Biological: DTP-HB-Hib with Recombinant Hepatitis B new Bulk vaccine; Biological: Pentabio

• Registration Number: NCT05482282
• Lead Sponsor: PT Bio Farma

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2022-07-29
• Study First Submitted QC: 2022-07-29
• Study First Posted: 2022-08-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-05
• Last Update Posted: 2024-04-08
• Study Start: 2025-01
• Primary Completion: 2025-04
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 220

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Recombinant Hep B new Bulk + Penta with Recombinant HepB new Bulk	DTP-HB-Hib with Recombinant Hepatitis B new Bulk vaccine	1 dose Recombinant Hepatitis B new Bulk vaccine at birth + 3 doses Pentavalent with Recombinant HepB new Bulk vaccine
Recombinant Hep B new Bulk + Penta with Recombinant HepB new Bulk	Recombinant Hepatitis B new Bulk vaccine	1 dose Recombinant Hepatitis B new Bulk vaccine at birth + 3 doses Pentavalent with Recombinant HepB new Bulk vaccine
Hep B (Registered) + Pentabio (Registered)	Recombinant Hepatitis B vaccine (Registered BioFarma)	1 dose Recombinant Hepatitis B vaccine (Registered) + 3 doses Pentabio with Recombinant HepB new Bulk vaccine
Hep B (Registered) + Pentabio (Registered)	Pentabio	1 dose Recombinant Hepatitis B vaccine (Registered) + 3 doses Pentabio with Recombinant HepB new Bulk vaccine

Primary Outcome Measures

Name	Time	Method
To evaluate protectivity of DTP-HB-Hib Vaccine (Bio Farma) using new Hepatitis B bulk (Bio Farma)	28 days	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.

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Garuda Primary Health Centre; 🇮🇩 Bandung, West Java, Indonesia

Ibrahim Adjie Primary Health Centre; 🇮🇩 Bandung, West Java, Indonesia

Puter Primary Health Centre; 🇮🇩 Bandung, West Java, Indonesia