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: 03 Mar 2023
Price :
$35
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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
- 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.
- 10 Dec 2020 According to a Dynavax Technologies media release, based on NCT00435812,NCT01005407,NCT02117934 studies, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on the company's Marketing Authorization Application, recommending the granting of marketing authorization for HEPLISAV-B [Hepatitis B Vaccine (Recombinant), Adjuvanted] for active immunization against hepatitis B virus infection (HBV) in adults 18 years of age and older.