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A Phase I/IIa, Open-label, Randomised, Controlled, Multi-country, Dose-escalation Study to Assess the Safety and Immunogenicity of AS37 in Combination With the Hepatitis B Surface Antigen (HBsAg), According to a 0-1 Month Schedule, in Healthy, HBs naïve, Adults Aged 18-45 Years

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Trial Profile

A Phase I/IIa, Open-label, Randomised, Controlled, Multi-country, Dose-escalation Study to Assess the Safety and Immunogenicity of AS37 in Combination With the Hepatitis B Surface Antigen (HBsAg), According to a 0-1 Month Schedule, in Healthy, HBs naïve, Adults Aged 18-45 Years

Status: Active, no longer recruiting
Phase of Trial: Phase I

Latest Information Update: 24 Mar 2025

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At a glance

  • Drugs Hepatitis B vaccine recombinant (Primary) ; Aluminium hydroxide
  • Indications Hepatitis B
  • Focus Adverse reactions; First in man
  • Acronyms EARLY-CLINRES-017
  • Sponsors GlaxoSmithKline; GlaxoSmithKline Biologicals; GSK

Most Recent Events

  • 02 Jul 2024 Planned End Date changed from 2 Jan 2025 to 26 Dec 2024.
  • 02 Jul 2024 Planned primary completion date changed from 6 Mar 2024 to 26 Dec 2024.
  • 02 Jul 2024 Status changed from recruiting to active, no longer recruiting.

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