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

NCT04188223 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-08-01

No results posted yet for this study

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)

Conditions

Interventions

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

Sponsors & Collaborators

  • PT Bio Farma

    lead INDUSTRY

Principal Investigators

  • Kusnandi Rusmil, Professor · Padjadjaran University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
10 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-03
Primary Completion
2020-07-16
Completion
2020-07-16

Countries

  • Indonesia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04188223 on ClinicalTrials.gov