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
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
- 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).