A Study on the Safety and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against Shigellosis in Adults, Children, and Infants

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

552

Participants

Timeline

Start Date

October 6, 2021

Primary Completion Date

July 4, 2025

Study Completion Date

July 4, 2025

Conditions
Diarrhoea
Interventions
DRUG

altSonflex Placebo

2 doses of altSonflex Placebo, administered intramuscularly, in the non-dominant arm, either at Day 1 and Day 85 or at Day 1 and Day 169 (depending on the vaccination schedule) to adults in the ST1\_Adults\_Placebo\_GR1 and ST1\_Adults\_Placebo\_GR2 groups in Stage 1 (Europe).

BIOLOGICAL

altSonflex1-2-3 Dose C

2 doses of altSonflex1-2-3 Dose C administered intramuscularly, in the non-dominant arm, at Day 1 and Day 85 to adults in the ST1\_Adults\_Dose C\_GR1 and ST2\_Adults\_Dose C groups in Stage 1 and 2 (Europe and Africa) and children in the ST2\_Children\_Dose C group in Stage 2 (Africa), and at Day 1 and Day 169 to adults in the ST1\_Adults\_Dose C\_GR2 group in Stage 1 (Europe); 3 doses of altSonflex1-2-3 Dose C administered intramuscularly, in the non-dominant arm, at Day 1, Day 85 and Day 253 to infants in the ST2\_Infants\_Dose C\_Safety and ST2\_Infants\_Dose C\_Dose find groups in Stage 2 (Africa).

BIOLOGICAL

altSonflex1-2-3 Dose B

2 doses of altSonflex1-2-3 Dose B administered intramuscularly, in the non-dominant arm, at Day 1 and Day 85 to children in the ST2\_Children\_Dose B group in Stage 2 (Africa); 3 doses of altSonflex1-2-3 Dose B administered intramuscularly, in the non-dominant arm, at Day 1, Day 85 and Day 253 to infants in the ST2\_Infants\_Dose B\_Safety and ST2\_Infants\_Dose B\_Dose find groups in Stage 2 (Africa).

BIOLOGICAL

altSonflex1-2-3 Dose A

3 doses of altSonflex1-2-3 Dose A administered intramuscularly, in the non-dominant arm, at Day 1, Day 85 and Day 253 to infants in the ST2\_Infants\_Dose A\_Safety and ST2\_Infants\_Dose A\_Dose find groups in Stage 2 (Africa).

BIOLOGICAL

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, in the non-dominant arm, at Day 1 to adults in the ST2\_Adults\_Control C group and children in the ST2\_Children\_Control B and ST2\_Children\_Control C groups in Stage 2 (Africa); 2 doses of GSK's Meningococcal A, C, Y and W-135 conjugate vaccine administered intramuscularly, in the non-dominant arm, at Day 1 and Day 85 to infants in the ST2\_Infants\_Control A\_Safety, ST2\_Infants\_Control B\_Safety, ST2\_Infants\_Control C\_Safety and ST2\_Infants\_Control\_Dose find groups in Stage 2 (Africa).

COMBINATION_PRODUCT

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, in the non-dominant arm, at Day 85 to adults in the ST2\_Adults\_Control C group in Stage 2 (Africa).

COMBINATION_PRODUCT

GSK's Diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis (inactivated), and Haemophilus influenzae type b vaccine

1 dose of GSK's Diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis (inactivated), and Haemophilus influenzae type b vaccine administered intramuscularly, in the non-dominant arm, at Day 253 to infants in the ST2\_Infants\_Control A\_Safety, ST2\_Infants\_Control B\_Safety, ST2\_Infants\_Control C\_Safety and ST2\_Infants\_Control\_Dose find groups in Stage 2 (Africa).

COMBINATION_PRODUCT

Sanofi Pasteur's Typhoid Vi polysaccharide vaccine

1 dose of Sanofi Pasteur's Typhoid Vi polysaccharide vaccine administered intramuscularly, in the non-dominant arm, at Day 85 to children in the ST2\_Children\_Control B and ST2\_Children\_Control C groups in Stage 2 (Africa).

BIOLOGICAL

Serum Institute of India's Measles and rubella vaccine

2 doses of Serum Institute of India's Measles and rubella vaccine administered subcutaneously, in the non-dominant arm, at Day 29 and Day 281 to infants in the safety groups, and at Day 1 and Day 253 to infants in the dose-finding groups, in Stage 2 (Africa).

Trial Locations (2)

9000

GSK Investigational Site, Ghent

20200

GSK Investigational Site, Kericho

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT05073003 - A Study on the Safety and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against Shigellosis in Adults, Children, and Infants | Biotech Hunter | Biotech Hunter