Comparison of Diagnostic Performance of C-Tb to QuantiFERON®-TB, in Combination With a Safety Assessment of C-Tb vs Tuberculin PPD RT23 SSI

PHASE3CompletedINTERVENTIONAL
Enrollment

979

Participants

Timeline

Start Date

July 31, 2012

Primary Completion Date

October 31, 2014

Study Completion Date

October 31, 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 (13)

15706

Complejo Hospitalario Universitario de Santiago, Santiago de Compostela

27004

Hospital Universitario Lucus Augusti, Lugo

36071

Complexo Hospitalario de Pontevedra, Pontevedra

48903

Hospital Universitario de Cruces, Barakaldo

08001

CAP Drassanes, Unitat de Prevenció i Control de Tuberculosi, Barcelona

08003

Hospital del Mar, Barcelona

08023

Public Health Agency of Barcelona, Barcelona

08025

Hospital de la Santa Creu i Sant Pau, Barcelona

08035

Hospital Vall d'Hebron, Barcelona

08036

Hospital Clínic i Provincial de Barcelona, Barcelona

08221

Hospital Mutua de Terrassa, Barcelona

08950

Hospital San Joan De Deu, Barcelona

+34 981 950 036

Complexo Hospitalario Universitario de Vigo, Vigo

All Listed Sponsors
lead

Statens Serum Institut

OTHER

NCT01631266 - Comparison of Diagnostic Performance of C-Tb to QuantiFERON®-TB, in Combination With a Safety Assessment of C-Tb vs Tuberculin PPD RT23 SSI | Biotech Hunter | Biotech Hunter