At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 100 enrolled
Drug / intervention
Sci-B-Vac® +1 morebiological
Likely dose
Sci-B-Vac® 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.
A Comparative Randomized Double-Blind Study of Safety and Immunogenicity of Recombinant Hepatitis B Vaccine Sci-B-Vac® in Adult Study Subjects
In Brief
A Phase 3 clinical trial evaluating Sci-B-Vac® and Engerix-B® for Hepatitis B. Completed, enrolled 100 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B
CountriesRussia
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartApr 2014
Primary CompletionApr 2015
First PostedDec 2019
TodayJul 2026
First PostedDec 24, 2019
Enrollment StartApr 18, 2014
Primary CompletionApr 20, 2015
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 6.5 years ago
Interventions
Sci-B-Vac®biological
Sci-B-Vac® vaccine-10 μg of HBsAg, intramuscular injection of 10 μg/ml
Engerix-B®biological
Engerix-B® vaccine-20 μg of HBsAg, intramuscular injection of 20 μg/ml