Evaluation of Efficacy and Safety of VPM1002 in Comparison to BCG in Prevention of Tb Infection in Infants

PHASE3CompletedINTERVENTIONAL
Enrollment

6,940

Participants

Timeline

Start Date

November 9, 2020

Primary Completion Date

October 30, 2024

Study Completion Date

October 30, 2024

Conditions
Mycobacterium Tuberculosis Infection
Interventions
BIOLOGICAL

VPM1002

"The active ingredient of the recombinant BCG vaccine, VPM1002 is Mycobacterium bovis A dose of 0.05 ml will be administered intradermally.~Manufactured by the Serum Institute of India Pvt. Ltd., India~Diluent: 1 ml of Water for injection/vial"

BIOLOGICAL

BCG SII

"Commercially available BCG vaccine from Serum Institute of India Pvt. Ltd. A dose of 0.05 ml will be administered intradermally.~Manufactured by the Serum Institute of India Pvt. Ltd., India~Diluent: 1 ml of Sodium Chloride for injection/vial Injection"

Trial Locations (12)

144

Kenya Medical Research Institute - Center for Respiratory Disease Research, Siaya

2013

Respiratory and Meningeal Pathogens Research Unit, Soweto

2093

Empilweni Services and Research Unit (ESRU), Johannesburg

2410

The national institute for Medical Research (NIMR) - Mbeya Medical Research Center (MMRC), Mbeya

6850

South African Tuberculosis Vaccine Initiative, Worcester

7062

Makerere University/CISMAC, Kampala

7505

Family Center for Research with Ubuntu, Cape Town

61665

Ifakara Health Institute, Dar es Salaam

Unknown

Centre de Recherches Médicales de Lambaréné, Lambaréné

Medical Research Council / Uganda Virus Research Institute and London School of Hygiene and Tropical Medicines (MRC/UVRI and LSHTM) Uganda Research Unit, Entebbe

47855-00100

Kenya Medical Research Institute / Center for Respiratory Disease Research, Nairobi

0204

Mecru Clinical Research Unit, Medunsa

All Listed Sponsors
collaborator

Serum Life Science Europe GmbH

INDUSTRY

lead

Serum Institute of India Pvt. Ltd.

INDUSTRY

NCT04351685 - Evaluation of Efficacy and Safety of VPM1002 in Comparison to BCG in Prevention of Tb Infection in Infants | Biotech Hunter | Biotech Hunter