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A Randomized, Placebo Controlled, Double-Blind Phase II Study to Evaluate Safety, Immunogencitiy and Prevention of Infection with Mycobacterium tuberculosis (Mtb) of H56:IC31 in Healthy Adolescents

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Trial Profile

A Randomized, Placebo Controlled, Double-Blind Phase II Study to Evaluate Safety, Immunogencitiy and Prevention of Infection with Mycobacterium tuberculosis (Mtb) of H56:IC31 in Healthy Adolescents

Status: Withdrawn prior to enrolment
Phase of Trial: Phase II

Latest Information Update: 05 Nov 2021

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At a glance

  • Drugs H56IC (Primary)
  • Indications Tuberculosis
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms A-043
  • Sponsors Aeras

    • Most Recent Events

    • 06 Apr 2018 Status changed from not yet recruiting to withdrawn prior to enrolment since design, sponsorship changed prior to initiation. No study procedures done
    • 21 Mar 2018 According to a Statens Serum Institut media release, Statens Serum Institut (SSI) has been granted a sum of EUR 13.8 million from the European & Developing Countries Clinical Trial Partnership (EDCTP).
    • 22 Jan 2018 Planned End Date changed from 30 Dec 2020 to 30 Jun 2021.

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