Immunogenicity and Safety of Sci-B-Vac® to Engerix-B® in Adults

Hepatitis B Vaccines Clinical Trial

Official title:
A Phase 3 Double-Blind Randomized Controlled Trial to Compare the Immunogenicity and Safety of a Three-dose Regimen of Sci-B-Vac® to a Three-dose Regimen of Engerix-B® in Adults (PROTECT)

Status Completed

Clinical Trial Summary

Clinical Trial Description

This study is a double-blind randomized controlled trial designed to establish the non-inferiority of Sci-B-Vac® compared to Engerix-B® in adults ≥ 18 years old and the superiority of Sci-B-Vac® compared to Engerix-B® in adults ≥ 45 years old. Study subjects are randomized 1:1 to receive either a total of 3 injections of Sci-B-Vac® or 3 injections of Engerix-B® intra-muscularly (IM) on Days 0, 28, and 168. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03393754
Study type	Interventional
Source	VBI Vaccines Inc.
Contact
Status	Completed
Phase	Phase 3
Start date	December 13, 2017
Completion date	April 8, 2019

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See also
Status	Clinical Trial	Phase
Recruiting	`NCT02797782` - Study of the Long Term Efficacy of Recombinant Hepatitis B Vaccine in Nile Delta of Egypt	N/A
Completed	`NCT02898922` - Robust Antibody and Cytokine Response to Hepatitis B Vaccine Among Not-in-treatment Patients With Chronic Hepatitis C：An Open-label Control Study in China	Phase 4
Completed	`NCT03408730` - Lot-to-lot Consistency of Sci-B-Vac™ in Adults	Phase 3