MedTrace Logo

A Bridging Study: Comparing Two Lots of Sci-B-Vac™ and Engerix-B in Healthy Adults

NCT04531098 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 402

Last updated 2022-07-26

Study results available
· View outcomes & findings →

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

Conditions

Interventions

BIOLOGICAL

Sci-B-Vac-Lot B

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

BIOLOGICAL

Sci-B-Vac-Lot A

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

BIOLOGICAL

Engerix-B

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

Sponsors & Collaborators

  • VBI Vaccines Inc.

    lead INDUSTRY

Principal Investigators

  • Do G Canh, MD · National Institute of Hygiene and Epidemiology (NIHE), Hanoi, Vietnam

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-03-02
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • Vietnam

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 NCT04531098 on ClinicalTrials.gov