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)

Trial Profile

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)

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 22 Oct 2018

At a glance

  • Drugs Hepatitis B vaccine recombinant (Primary)
  • Indications Hepatitis B
  • Focus Pharmacodynamics; Registrational
  • Acronyms PROTECT
  • Sponsors VBI Vaccines
  • Most Recent Events

    • 16 Oct 2018 According to a VBI Vaccines media release, last subject has received the last vaccination. Top-line data from this study are expected mid-2019.
    • 19 Apr 2018 According to a VBI Vaccines media release, company has completed enrollment with the last patient receiving the first dose.More than 1,600 adults have now been enrolled in the study at 27 sites across the U.S., Europe, and Canada.
    • 19 Apr 2018 According to a VBI Vaccines media release, Topline data from the PROTECT study are expected mid-year 2019.
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