At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 402 enrolled

Drug / intervention

Sci-B-Vac-Lot B +2 morebiological

Likely dose

Sci-B-Vac-Lot B 10 μgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04531098

NCT04531098Phase 3Completed

Compare CT.gov

A Bridging Study: Comparing Two Sci-B-Vac™ Batches in Healthy Adults

VBI Vaccines Inc.·interventional·Posted Aug 28, 2020·Updated Jul 26, 2022

In Brief

A Phase 3 clinical trial evaluating Sci-B-Vac-Lot B, Sci-B-Vac-Lot A, and 1 other intervention for Hepatitis B. Completed, enrolled 402 participants across 1 site.

Detailed Summary

This was a single-blind, 3-arm, comparative, controlled, randomized, study conducted at one site in Vietnam whose primary objective was to demonstrate clinical equivalence of the two production lots of Sci-B-Vac vaccine produced at two different facilities (OLD facility (Lot A) and NEW facility (Lot B) with respect to anti-hepatitis B-Surface (HBs) response. Secondary efficacy analysis was performed to demonstrate non-inferiority of seroprotection of each lot of Sci-B-Vac vaccine when compared to Engerix-B vaccine

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHepatitis B

CountriesVietnam

Collaborators--

Timeline

Phase 3CompletedFinished

2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartMar 2006

Primary CompletionDec 2008

First PostedAug 2020

TodayJul 2026

First PostedAug 28, 2020

Enrollment StartMar 2, 2006

Primary CompletionDec 31, 2008

TodayJul 2, 2026

Enrollment to primary: 2.8 yearsPosted 5.8 years ago

Interventions

Sci-B-Vac-Lot Bbiological

Sci-B-Vac Lot B -10 μg of HBsAg, intramuscular injection of 10 μg/ml

Sci-B-Vac-Lot Abiological

Sci-B-Vac Lot A - 10 μg of HBsAg, intramuscular injection of 10 μg/ml

Engerix-Bbiological

Engerix-B (hepatitis B vaccine (recombinant)) is indicated for active immunization against hepatitis B virus infection