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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.

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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.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 15 Jan 2024

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At a glance

Most Recent Events

  • 08 Jan 2024 According to a Dynavax Technologies media release, A supplemental Biologic License Application (sBLA) for HEPLISAV-B vaccination of adults on hemodialysis is currently under priority review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) action date planned for May 13, 2024.
  • 28 Feb 2023 According to a Dynavax Technologies media release, company announced that the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) has granted Marketing Authorization in Great Britain for HEPLISAV B in adults 18 years of age and older. The approval was based on the results of three phase 3 studies and the approval was issued to Dynavax's affiliate Dynavax GmbH via the European Commission Decision Reliance Procedure (ECDRP).
  • 19 Feb 2021 According to a Dynavax Technologies media release, European Commission (EC) has granted Marketing Authorization for HEPLISAV B (Hepatitis B Vaccine (Recombinant), Adjuvanted) for the active immunization against hepatitis B virus infection (HBV) caused by all known subtypes of hepatitis B virus in adults 18 years of age and older. The approval and CHMP recommendation were based results of three Phase 3 clinical trials

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