155
Participants
Start Date
September 13, 2022
Primary Completion Date
December 18, 2024
Study Completion Date
December 18, 2024
Invasive nontyphoidal Salmonella-typhoid conjugate vaccine (iNTS-TCV) low dose
3 doses of iNTS-TCV low dose vaccine administered intramuscularly at Day 1, Day 57, and Day 169 to participants in the iNTS-TCV low dose Group in Stage 1 (Europe).
Invasive nontyphoidal Salmonella-generalized modules for membrane antigens vaccine (iNTS-GMMA) low dose
3 doses of iNTS-GMMA low dose vaccine administered intramuscularly at Day 1, Day 57, and Day 169 to participants in the iNTS-GMMA and TCV low doses Group in Stage 1 (Europe).
Typhoid conjugate vaccine (TCV) low dose
3 doses of TCV low dose vaccine administered intramuscularly at Day 1, Day 57, and Day 169 to participants in the iNTS-GMMA and TCV low doses Group in Stage 1 (Europe).
Invasive nontyphoidal Salmonella-typhoid conjugate vaccine (iNTS-TCV) full dose
3 doses of iNTS-TCV full dose vaccine administered intramuscularly at Day 1, Day 57, and Day 169 to participants in the iNTS-TCV full dose\_1 Group in Stage 1 (Europe) and to participants in iNTS-TCV full dose\_2 Group in Stage 2 (Africa).
Invasive nontyphoidal Salmonella-generalized modules for membrane antigens vaccine (iNTS-GMMA) full dose
3 doses of iNTS-GMMA full dose vaccine administered intramuscularly at Day 1, Day 57, and Day 169 to participants in the iNTS-GMMA and TCV full doses\_1 Group in Stage 1 (Europe) and to participants in the iNTS-GMMA and TCV full doses\_2 Group in Stage 2 (Africa).
Typhoid conjugate vaccine (TCV) full dose
3 doses of TCV full dose vaccine administered intramuscularly at Day 1, Day 57, and Day 169 to participants in the iNTS-GMMA and TCV full doses\_1 Group in Stage 1 (Europe) and to participants in the iNTS-GMMA and TCV full doses\_2 Group in Stage 2 (Africa).
GSK's Meningococcal A, C, Y and W-135 conjugate vaccine
1 dose of GSK's Meningococcal A, C, Y and W-135 conjugate vaccine administered intramuscularly at Day 1 to participants in the Control\_Stage 2 Group in Stage 2 (Africa).
GSK's Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine
1 dose of GSK's Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine administered intramuscularly at Day 57 to participants in the Control\_Stage 2 Group in Stage 2 (Africa).
Sanofi Pasteur's Typhoid Vi polysaccharide vaccine
1 dose of Sanofi Pasteur's Typhoid Vi polysaccharide vaccine administered intramuscularly at Day 169 to participants in the Control\_Stage 2 Group in Stage 2 (Africa).
Placebo
3 doses of Placebo administered intramuscularly at Day 1, Day 57, and Day 169 to participants in the Placebo\_Step 1 and Placebo\_Step 2 in Stage 1 (Europe).
Saline
3 doses of saline solution administered intramuscularly at Day 1, Day 57, and Day 169 to participants in the iNTS-TCV low dose, Placebo\_Step 1, iNTS-TCV full dose\_1, Placebo\_Step 2 groups in Stage 1 (Europe) and to participants in iNTS-TCV full dose\_2 and Control\_Stage 2 groups in Stage 2 (Africa).
RECRUITING
GSK Investigational Site, Edegem
RECRUITING
GSK Investigational Site, Blantyre
Lead Sponsor
Biomedical Advanced Research and Development Authority
FED
Wellcome Trust
OTHER
Global Antimicrobial Resistance Innovation Fund-(GAMRIF)
UNKNOWN
Bill and Melinda Gates Foundation
OTHER
GlaxoSmithKline
INDUSTRY