A Phase 3, Observer-Blinded, Randomized, Active-Controlled (Engerix-B), Multicenter Trial of the Safety and Immunogenicity of HEPLISAV in Adults 18 to 70 Years of Age

Trial Profile

A Phase 3, Observer-Blinded, Randomized, Active-Controlled (Engerix-B), Multicenter Trial of the Safety and Immunogenicity of HEPLISAV in Adults 18 to 70 Years of Age

Completed
Phase of Trial: Phase III

Latest Information Update: 02 Sep 2017

At a glance

  • Drugs V 270 (Primary) ; Hepatitis B vaccine recombinant
  • Indications Hepatitis B
  • Focus Adverse reactions; Pharmacodynamics; Registrational
  • Sponsors Dynavax Technologies
  • Most Recent Events

    • 03 Apr 2017 According to a Dynavax Technologies media release, the U.S. Food and Drug Administration (FDA) has informed the company that the Vaccines and Related Biological Products Advisory Committee (VRBPAC) will review HEPLISAV-B™ at its meeting scheduled for July 28, 2017. The scheduled VRBPAC meeting is close to the HEPLISAV-B Prescription Drug User Fee Act date of August 10, 2017 solely as a function of meeting logistics. The PDUFA date remains unchanged.
    • 26 Oct 2016 Sub-group results published in the Dynavax Media Release.
    • 04 Sep 2016 The U.S.FDA has decided not to review immunogenicity data related to sub-populations with results in individuals with diabetes because these data were not a direct response to the FDA's February 22, 2013 Complete Response Letter and therefore fell outside of the review time allocated to a Class 2 resubmission and confirmed to company that it will review the overall immunogenicity data from this trial, to support the proposed indication for adults 18 years and over, as per a Dynavax media release
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