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

Hepatitis B Vaccine Adverse Reaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05482282
• Other study ID #: Penta BS22
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: January 2025
• Est. completion date: July 2025

Study information

• Verified date: April 2024
• Source: PT Bio Farma
• Contact: Rini Mulia Sari, MD
• Phone: +622033755
• Email: rini.mulia[@]biofarma.co.id
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 220
• Est. completion date: July 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day to 3 Days

Eligibility

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

Related Conditions & MeSH terms

• Diphtheria
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B Vaccine Adverse Reaction

Intervention

Biological:
• 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.
• DTP-HB-Hib with Recombinant Hepatitis B new Bulk vaccine
3 doses of DTP-HB-Hib with Recombinant Hepatitis B new Bulk vaccine
• Recombinant Hepatitis B vaccine (Registered BioFarma)
1 dose of Recombinant Hepatitis B vaccine (Registered Bio Farma)
• Pentabio
3 doses of Pentabio

Locations

Country	Name	City	State
Indonesia	Garuda Primary Health Centre	Bandung	West Java
Indonesia	Ibrahim Adjie Primary Health Centre	Bandung	West Java
Indonesia	Puter Primary Health Centre	Bandung	West Java

Sponsors (2)

Lead Sponsor	Collaborator
PT Bio Farma	Hasan Sadikin General Hospital

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To asses the local and systemic reactions within 30 minutes	Local reaction and systemic events occurring within 30 minutes after immunization.	30 minutes
Secondary	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
Secondary	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
Secondary	To asses the serious adverse event	Any serious adverse event occuring from inclusion until 28 days after the last dose	28 days