A Trial in Subjects Suspected to Have Tuberculosis, Comparing the Diagnostic Performance of C-Tb to QuantiFERON®, in Combination With a Safety Assessment of C-Tb Versus Tuberculin PPD RT23 SSI

PHASE3CompletedINTERVENTIONAL
Enrollment

1,190

Participants

Timeline

Start Date

September 30, 2012

Primary Completion Date

September 30, 2014

Study Completion Date

September 30, 2014

Conditions
Tuberculosis
Interventions
BIOLOGICAL

C-Tb

The C-Tb agent is administered by the Mantoux injection technique to each volunteer in the RIGHT or LEFT forearm according to a double blind randomisation scheme

BIOLOGICAL

2 T.U. Tuberculin PPD RT 23 SSI

The 2 T.U. Tuberculin PPD RT 23 SSI agent is administered by the Mantoux injection technique to each volunteer in the RIGHT or LEFT forearm according to a double blind randomisation scheme

Trial Locations (9)

1501

Worthwhile Clinical Trials, Lakeview Hospital, Benoni

6014

Primecure Medicentre, Mercantile Hospital, Port Elizabeth

7530

M2 Karl Bremer Hospital, Bellville, Cape Town

Tiervlei Trial Centre, Karl Bremer Hospital, Bellville, Cape Town

7626

Be Part Yoluntu Centre, Paarl

7925

UCT Lung Institute, Groote Schuur Hospital, Cape Town

0002

Synnyside Medi-Clinic, Pretoria

0122

Synexus Stanza Bopape Clinic, Pretoria

0152

Setshaba Research Centre, Pretoria

All Listed Sponsors
lead

Statens Serum Institut

OTHER

NCT01642888 - A Trial in Subjects Suspected to Have Tuberculosis, Comparing the Diagnostic Performance of C-Tb to QuantiFERON®, in Combination With a Safety Assessment of C-Tb Versus Tuberculin PPD RT23 SSI | Biotech Hunter | Biotech Hunter