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

NCT03393754 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1607

Last updated 2020-07-17

Study results available
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Summary

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 ≥ 45 years old.

Conditions

  • Hepatitis B Vaccines

Interventions

BIOLOGICAL

Hepatitis B Vaccination

Prophylactic Hepatitis B Vaccination

Sponsors & Collaborators

  • VBI Vaccines Inc.

    lead INDUSTRY

Principal Investigators

  • Francisco Diaz-Mitoma, MD, PhD · VBI Vaccines

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-12-13
Primary Completion
2019-04-08
Completion
2019-04-08
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • Finland

Study Locations

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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 NCT03393754 on ClinicalTrials.gov