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A Double-blind Randomized Controlled Trial to Assess the Lot-to-lot Consistency of Sci-B-Vac in Adults (CONSTANT)

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Trial Profile

A Double-blind Randomized Controlled Trial to Assess the Lot-to-lot Consistency of Sci-B-Vac in Adults (CONSTANT)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 Dec 2022

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At a glance

  • Drugs Hepatitis B vaccine recombinant (Primary)
  • Indications Hepatitis B
  • Focus Pharmacodynamics; Registrational
  • Acronyms CONSTANT
  • Sponsors VBI Vaccines

Most Recent Events

  • 08 Dec 2022 According to a VBI vaccines media release, Health Canada has approved PreHevbrio™ [3-antigen Hepatitis B Vaccine (Recombinant)] for active immunization against infection caused by all known subtypes of hepatitis B (HBV) virus in adults 18 years of age and older.The approval was based on clinical data in the new drug submission (NDS), which highlighted the positive results from PROTECT and CONSTANT studies.
  • 01 Jun 2022 According to a VBI vaccines media release, UK Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorisation for PreHevbri [Hepatitis B vaccine (recombinant, adsorbed)] for active immunisation against infection caused by all known subtypes of the hepatitis B virus (HBV) in adults.
  • 02 May 2022 According to a VBI vaccines media release, the company continues to support the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) review as part of the EC Decision Reliance Procedure (ECDRP), which was initiated upon receipt of the positive CHMP opinion.

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