At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,607 enrolled
Drug / intervention
Hepatitis B Vaccinationbiological
Likely dose
Not stated in 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 Phase 3 Double-Blind Randomized Controlled Trial to Compare the Immunogenicity and Safety of a Three-dose Regimen of Sci-B-Vac® to a Three-dose Regimen of Engerix-B® in Adults (PROTECT)
In Brief
A Phase 3 clinical trial evaluating Hepatitis B Vaccination for Hepatitis B Vaccines. Completed, enrolled 1,607 participants across 28 sites in 4 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B Vaccines
CountriesBelgium, Canada, Finland, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
Enrollment StartDec 2017
First PostedJan 2018
Primary CompletionApr 2019
TodayJul 2026
First PostedJan 8, 2018
Enrollment StartDec 13, 2017
Primary CompletionApr 8, 2019
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 8.5 years ago
Interventions
Hepatitis B Vaccinationbiological
Prophylactic Hepatitis B Vaccination