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
- 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.