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An Observational Study Evaluating the Long-Term Safety and Immunogenicity of HEPLISAV Compared With Engerix-B in Adults With Chronic Kidney Disease Who Have Previously Received At Least One Hepatitis B Vaccine Series

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Trial Profile

An Observational Study Evaluating the Long-Term Safety and Immunogenicity of HEPLISAV Compared With Engerix-B in Adults With Chronic Kidney Disease Who Have Previously Received At Least One Hepatitis B Vaccine Series

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 25 Apr 2023

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At a glance

  • Drugs Adjuvanted Hepatitis-B vaccine (Recombinant)-Dynavax (Primary) ; Hepatitis B vaccine recombinant
  • Indications Hepatitis B
  • Focus Pharmacodynamics; Registrational
  • Sponsors Dynavax Technologies

    • Most Recent Events

    • 19 Apr 2023 Results assessing the long-term immunogenicity and safety of HepB-CpG and HepB-Eng in eligible participants of HBV-17 who enrolled in this optional 34-month follow-up trial (HBV-19), published in the Vaccine.
    • 16 Jun 2014 Status changed from recruiting to completed as reported by ClinicalTrials.gov record.
    • 28 Mar 2012 New source identified and integrated (European Clinical Trials Database; EudraCT2010-022372-31).

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