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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: 28 Nov 2018

At a glance

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

    • 19 Nov 2018 Planned End Date changed from 1 Mar 2019 to 12 Apr 2019.
    • 19 Nov 2018 Planned primary completion date changed from 1 Oct 2018 to 12 Apr 2019.
    • 09 Nov 2018 According to a VBI Vaccines media release, The independent Data and Safety Monitoring Board (DSMB) reviewed all safety data available to-date from this trial and did not observe or report any safety signals.
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