An Observer-Blinded, Randomized, Parallel-Group, Multi-Center Study Comparing the Safety and Immunogenicity of HEPLISAV to Licensed Vaccine (Engerix-B) Among Healthy Subjects 40 to 70 Years of Age.

Trial Profile

An Observer-Blinded, Randomized, Parallel-Group, Multi-Center Study Comparing the Safety and Immunogenicity of HEPLISAV to Licensed Vaccine (Engerix-B) Among Healthy Subjects 40 to 70 Years of Age.

Completed
Phase of Trial: Phase III

Latest Information Update: 06 Mar 2017

At a glance

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

    • 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 a
    • 04 Sep 2016 Company has been suggested to submit the overall immunogenicity as a supplemental BLA following approval, as per a Dynavax media release.
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