Safety Study Investigating if Concomitant Injections of C-Tb and 2 T.U Tuberculin Affect Induration Responses

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

456

Participants

Timeline

Start Date

October 31, 2013

Primary Completion Date

September 30, 2014

Study Completion Date

September 30, 2014

Conditions
Tuberculosis
Interventions
BIOLOGICAL

C-Tb

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

BIOLOGICAL

Tuberculin PPD RT 23 SSI

Tuberculin is administered by the Mantoux injection technique to each volunteer in the RIGHT or LEFT forearm according to a double blind randomisation scheme

BIOLOGICAL

C-Tb / Tuberculin PPD RT 23 SSI

The C-Tb and Tuberculin agents are administered by the Mantoux injection technique to each volunteer in the RIGHT and LEFT forearm according to a double blind randomisation scheme

Trial Locations (7)

6014

Primecure Medicentre, Port Elizabeth

7530

TASK, M2, Karl Bremer Hospital,, Cape Town

Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town

7626

Be Part Yoluntu Centre, Paarl

7925

UCT Lung Institute, Cape Town

0122

Synexus Stanza Bopape Clinic, Pretoria

0152

Setshaba Research Centre, Pretoria

All Listed Sponsors
lead

Statens Serum Institut

OTHER

NCT01779102 - Safety Study Investigating if Concomitant Injections of C-Tb and 2 T.U Tuberculin Affect Induration Responses | Biotech Hunter | Biotech Hunter