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: 09 Nov 2017

At a glance

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

    • 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.
    • 04 Sep 2016 The U.S. FDA has decided not 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 other trial (see profile 2237965), to support the proposed indication for adults 18 years and over, as per
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top