Study to Check the Efficacy and Safety of Recombinant BCG Vaccine in Prevention of TB Recurrence

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

2,000

Participants

Timeline

Start Date

December 15, 2017

Primary Completion Date

December 29, 2023

Study Completion Date

December 29, 2023

Conditions
Prevention of TB Recurrence
Interventions
BIOLOGICAL

VPM1002 (Recombinant BCG Vaccine)

"VPM1002 is a formulated, lyophilized cake of live recombinant Mycobacterium bovis rBCGÄureC::Hly+; VPM1002.~VPM1002 is the active pharmaceutical ingredient. It is a genetically modified BCG vaccine derived from the Mycobacterium bovis BCG subtype Prague characterized as rBCGÄureC::Hly+. Single dose of VPM1002 is administered intradermally."

OTHER

Placebo

Single dose of Placebo is administered intradermally.

Trial Locations (10)

1212

International Centre for Diarrhoeal Disease Research, Dhaka

141008

Christian Medical College and Hospital, Ludhiana, Ludhiana

180001

Government Medical College, Jammu, Jammu

411001

B.J. Govt. Medical College and Sassoon General Hospitals, Pune

442102

Mahatma Gandhi Institute of Medical Sciences, Sevagram, Sevāgrām

500004

Mahavir Hospital & Research Centre, Hyderabad, Hyderabad

600013

MV Hopsital for Diabetes Pvt Ltd, Chennai, Chennai

600116

Sri Ramachandra Hospital Chennai, Chennai

605006

Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, Puducherry

632004

Christian Medical College and Hospital, Vellore, Vellore

All Listed Sponsors
lead

Serum Institute of India Pvt. Ltd.

INDUSTRY

NCT03152903 - Study to Check the Efficacy and Safety of Recombinant BCG Vaccine in Prevention of TB Recurrence | Biotech Hunter | Biotech Hunter