A phase II, randomized, observer-blinded, single centre trial evaluating the immunogenicity and safety of 2 doses of an adjuvated TB subunit vaccine (Ag85B-ESAT-6 + IC31) using 2 different vaccination schedules in healthy adolescents

Trial Profile

A phase II, randomized, observer-blinded, single centre trial evaluating the immunogenicity and safety of 2 doses of an adjuvated TB subunit vaccine (Ag85B-ESAT-6 + IC31) using 2 different vaccination schedules in healthy adolescents

Completed
Phase of Trial: Phase II

Latest Information Update: 13 Sep 2016

At a glance

  • Drugs H1IC (Primary)
  • Indications Tuberculosis
  • Focus Adverse reactions; Pharmacodynamics
  • Acronyms THYB-04
  • Sponsors Statens Serum Institut
  • Most Recent Events

    • 31 Mar 2014 Planned initiation date changed to 27 Aug 2012 according to Pan African Clinical Trials Registry record.
    • 31 Mar 2014 Status changed from recruiting to completed according to Pan African Clinical Trials Registry record.
    • 31 Mar 2014 New source identified and integrated (Pan-African Clinical Trials Registry).
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