A Phase III Safety and Efficacy Study to Compare Immune Responses Following Injection With Either Two Doses of HEPLISAV or Three Doses of Engerix-B

Trial Profile

A Phase III Safety and Efficacy Study to Compare Immune Responses Following Injection With Either Two Doses of HEPLISAV or Three Doses of Engerix-B

Completed
Phase of Trial: Phase III

Latest Information Update: 05 Apr 2018

At a glance

  • Drugs V 270 (Primary) ; Hepatitis B vaccine recombinant
  • Indications Hepatitis B
  • Focus Registrational; Therapeutic Use
  • Acronyms PHAST
  • Sponsors Dynavax Technologies
  • Most Recent Events

    • 05 Apr 2018 Results assessing safety of hepatitis B vaccine by using data from three phase III studies including this study published in the Vaccine.
    • 09 Nov 2017 According to a Dynavax Technologies media release, the U.S. Food and Drug Administration (FDA) has approved HEPLISAV-B for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.
    • 04 Sep 2016 According to Dynava Technologies media release, the U.S. FDA Center for Biologics Evaluation and Research has cancelled the scheduled November 16, 2016, Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to review the BLA for HEPLISAV-B.
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