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)
Phase of Trial: Phase III
Latest Information Update: 29 Mar 2018
At a glance
- Drugs Hepatitis B vaccine recombinant (Primary)
- Indications Hepatitis B
- Focus Registrational; Therapeutic Use
- Acronyms PROTECT
- Sponsors VBI Vaccines
- 19 Dec 2017 According to a VBI Vaccines media release, based on the results of this trail and other phase III trial (286793), company expects to submit marketing authorization applications to U.S., European, and Canadian regulatory authorities in 2019. Also, Dr. Nathan Segall, is a Principal Investigator of this phase 3 program.
- 18 Dec 2017 Status changed from planning to recruiting, According to a VBI Vaccines media release.
- 30 Aug 2017 According to a VBI Vaccines media release, the company expects to initiate in the second half of 2017 in the U.S., Europe and Canada.