Study to Evaluate the Safety and Immunogenicity of VPM1002 in Comparison With BCG in HIV-exposed/-Unexposed Newborn Infants in South Africa

PHASE2CompletedINTERVENTIONAL
Enrollment

416

Participants

Timeline

Start Date

June 30, 2015

Primary Completion Date

November 30, 2017

Study Completion Date

November 30, 2017

Conditions
Tuberculosis
Interventions
BIOLOGICAL

VPM1002

Tuberculosis vaccine

BIOLOGICAL

BCG

commercially available live vaccine BCG

BIOLOGICAL

VPM1002(Hyg+)

Tuberculosis vaccine

Trial Locations (4)

Unknown

Children's Infectious Diseases Clinical Research Unit, Tygerberg Hospital, Cape Town

Desmond Tutu TB Centre, Cape Town

South African Tuberculosis Vaccine Initiative, Cape Town

The Respiratory and Meningeal Pathogens Reserach Unit, Johannesburg

All Listed Sponsors
collaborator

Serum Life Science Europe GmbH

INDUSTRY

collaborator

Triclinium Clinical Trial Project Management

UNKNOWN

collaborator

Children's Infectious Diseases Clinical Research Unit (KID-CRU)

UNKNOWN

collaborator

Desmond Tutu TB Centre

OTHER

collaborator

The Respiratory and Meningeal Pathogens Research Unit (RMPRU)

UNKNOWN

collaborator

South African Tuberculosis Vaccine Initiative

OTHER

collaborator

University of Stellenbosch

OTHER

lead

Serum Institute of India Pvt. Ltd.

INDUSTRY

NCT02391415 - Study to Evaluate the Safety and Immunogenicity of VPM1002 in Comparison With BCG in HIV-exposed/-Unexposed Newborn Infants in South Africa | Biotech Hunter | Biotech Hunter