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A phase I/IIa randomized, observer-blind, placebo-controlled, multicenter study to evaluate the safety and immunogenicity of the GSK Biologicals' herpes zoster vaccine, gE/AS01B in comparison to placebo when administered as 3 doses to adult HIV-infected subjects.

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Trial Profile

A phase I/IIa randomized, observer-blind, placebo-controlled, multicenter study to evaluate the safety and immunogenicity of the GSK Biologicals' herpes zoster vaccine, gE/AS01B in comparison to placebo when administered as 3 doses to adult HIV-infected subjects.

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 05 Jul 2022

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At a glance

  • Drugs GSK 137173A (Primary) ; AS01B
  • Indications Herpes zoster; Varicella zoster virus infections
  • Focus Adverse reactions; Pharmacodynamics; Registrational
  • Acronyms ZOSTER-015
  • Sponsors GlaxoSmithKline; GSK

    • Most Recent Events

    • 28 Jun 2022 According to a GlaxoSmithKline media release, based on data from six clinical trials (NCT01610414, NCT01798056, NCT01767467, NCT00920218, NCT01165203), the company has submitted regulatory application to the Japanese MHLW for Shingrix for the prevention of shingles in adults aged 18 years and older who are at increased risk. This includes individuals with immunodeficiency or immunosuppression caused by known disease or therapy.
    • 12 May 2019 This trial has been completed in UK as per European Clinical Trials Database record.
    • 01 May 2013 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
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