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Safety and Immunogenicity of Recombinant Hepatitis B Vaccine Sci-B-Vac® Compared to Engerix-B®

NCT04209400 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-07-25

Study results available
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Summary

This study was a comparative, randomized, double-blind clinical study of the efficacy and safety of Sci-B-Vac® (10 μg dose) and the Engerix-B® (20 μg dose) vaccines in two parallel groups of hepatitis B-naive healthy adult subjects in Russia.

Conditions

Interventions

BIOLOGICAL

Sci-B-Vac®

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

BIOLOGICAL

Engerix-B®

Engerix-B® vaccine-20 μg of HBsAg, intramuscular injection of 20 μg/ml

Sponsors & Collaborators

  • VBI Vaccines Inc.

    lead INDUSTRY

Principal Investigators

  • Elena Esaulenko · Saint Petersburg State Paediatric Medical University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-04-18
Primary Completion
2015-04-20
Completion
2015-04-20

Countries

  • Russia

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 NCT04209400 on ClinicalTrials.gov