NCT04188223

Safety and Immunogenicity Following Recombinant Hepatitis B (Bio Farma) Vaccine in Adults & Children

Safety and Preliminary of Immunogenicity Following Recombinant Hepatitis B (Bio Farma) Vaccine in Adults & Children (Phase I)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: PT Bio Farma · Industry
• Sex: All
• Age: 10 Years – 40 Years
• Healthy volunteers: Accepted

Summary

This trial is an experimental, randomized, double blind, prospective intervention study Approximately 100 subjects will be enrolled in this trial, divided into 2 arms, as follow: For adult (18-40 years old)

Detailed description

Each study age group/arm will be divided into two groups of treatment. One group will receive investigational product and one other group will receive active comparator. This Study is sequential age de-escalation. To be conducted in heathy adults (18-40 years old) and followed by children (10-17 years old) ). Before the study started, the subjects will be assessed for anti HBs Antibody. For subjects with anti-HBs not protective (\< 10mIU/mL) before immunization, additional 2 doses will be required with 1 month interval.

Conditions

• Hepatitis B

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant Hepatitis B (Bio Farma) Vaccine	Recombinant Hepatitis B vaccine produced by Bio Farma
BIOLOGICAL	Recombinant Hepatitis B (Bio Farma) Vaccine®	Registered Recombinant Hepatitis B vaccine produced by Bio Farma

Timeline

• Start date: 2019-12-03
• Primary completion: 2020-07-16
• Completion: 2020-07-16
• First posted: 2019-12-05
• Last updated: 2022-08-01

Locations

1 site across 1 country: Indonesia