Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 17 Aug 2019

Price : $35 *
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Adjuvanted Hepatitis-B vaccine (Recombinant)-Dynavax (Primary) ; Hepatitis B vaccine recombinant
  • Indications Hepatitis B
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Dynavax Technologies
  • Most Recent Events

    • 17 Aug 2019 Results assessing immunogenicity and safety of 2-dose hepatitis B vaccine in type-2-diabetes mellitus patients, published in the Vaccine.
    • 28 Mar 2019 According to a Dynavax Technologies media release, the European Medicines Agency (EMA) has accepted the Company's Marketing Authorization Application (MAA) for review of HEPLISAV-B [Hepatitis B Vaccine, Recombinant (Adjuvanted)] for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older, this was based on three phase III pivotal trials (NCT00435812,NCT01005407,NCT02117934). The outcome of the MAA review by the EMA is expected next year.
    • 26 Jun 2018 Results of a post-hoc analysis (n=480) from patients aged 60 years or older presented at the 78th Annual Scientific Sessions of the American Diabetes Association
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