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

Status Not yet recruiting

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).

Clinical Trial 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). ;

Related Conditions & MeSH terms

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

• NCT number: NCT05482282
• Study type: Interventional
• Source: PT Bio Farma
• Contact: Rini Mulia Sari, MD
• Phone: +622033755
• Email: rini.mulia@biofarma.co.id
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: January 2025
• Completion date: July 2025