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Safety, Efficacy, Immunogenicity Study of GSK Biologicals' HBV Viral Vector and Adjuvanted Proteins Vaccine (GSK3528869A) in Adult Patients With Chronic Hepatitis B Infection

Trial Profile

Safety, Efficacy, Immunogenicity Study of GSK Biologicals' HBV Viral Vector and Adjuvanted Proteins Vaccine (GSK3528869A) in Adult Patients With Chronic Hepatitis B Infection

Status: Discontinued
Phase of Trial: Phase I

Latest Information Update: 02 Dec 2024

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At a glance

  • Drugs ChAd155 hIi HBV (Primary) ; HBc HBs/AS01B 4; MVA HBV
  • Indications Hepatitis B
  • Focus Adverse reactions; First in man
  • Acronyms TH HBV VV-001
  • Sponsors GlaxoSmithKline; GlaxoSmithKline Biologicals; GSK

Most Recent Events

  • 28 Nov 2024 Status changed from active, no longer recruiting to discontinued following the primary phase(24 weeks post last vaccination)the predefined efficacy endpoint was not met.Noting the lack of efficacy and with the objective to prioritize patients safety GSK has decided on the early termination of the study.
  • 17 Jan 2024 Planned End Date changed from 7 Jul 2025 to 31 Oct 2025.
  • 17 Jan 2024 Planned primary completion date changed from 7 Jul 2025 to 31 Oct 2025.

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