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

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ClinicalTrials.gov Identifier: NCT05073003
Recruitment Status : Recruiting
First Posted : October 11, 2021
Last Update Posted : November 5, 2021
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
The aim of the current clinical study is to evaluate, for the first time in humans (FTIH), the safety and immunogenicity of the altSonflex1-2-3 candidate vaccine against S. sonnei and S. flexneri serotypes 1b, 2a, and 3a. The vaccine will be first administered in adults 18 to 50 years of age in Europe. Subsequently, the vaccine will be administered to a shigellosis-endemic population in Africa, first in adults 18 to 50 years of age, then in children 24 to 59 months of age, and finally in infants 9 months of age. Infants will also receive a third vaccination. Three different doses of the vaccine [low (Dose A), medium (Dose B), and high (Dose C) amounts of antigen] will be evaluated using an age de-escalation approach (from least vulnerable adult population to most vulnerable paediatric population). The results of this study will allow the selection of the most appropriate dose for further vaccine development in infants 9 months of age, which is the main target age group for this vaccine.

Condition or disease Intervention/treatment Phase
Diarrhoea Drug: altSonflex Placebo Biological: altSonflex1-2-3 Dose C Biological: altSonflex1-2-3 Dose B Biological: altSonflex1-2-3 Dose A Biological: GSK's Meningococcal A, C, Y and W-135 conjugate vaccine Combination Product: GSK's Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine Combination Product: GSK's Poliomyelitis, diphtheria, tetanus and pertussis vaccine Combination Product: Sanofi Pasteur's Typhoid Vi polysaccharide vaccine Biological: Serum Institute of India's Measles and rubella vaccine Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 550 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Observer blind
Primary Purpose: Prevention
Official Title: A Staged Phase I/II Observer-blind, Randomised, Controlled, Multi-country Study to Evaluate the Safety, Reactogenicity, and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against S. Sonnei and S. Flexneri, Serotypes 1b, 2a, and 3a, in Adults in Europe (Stage 1) Followed by Age De-escalation From Adults to Children and Infants, and Dose-finding in Infants in Africa (Stage 2)
Actual Study Start Date : October 6, 2021
Estimated Primary Completion Date : April 12, 2024
Estimated Study Completion Date : April 20, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea Vaccines

Arm Intervention/treatment
Placebo Comparator: ST1_Adults_Placebo_GR1 Group
Adults 18 to 50 years of age in Stage 1 (Europe) randomized to receive two doses of altSonflex Placebo, one each at Day 1 and Day 85.
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).

Experimental: ST1_Adults_Dose C_GR1 Group
Adults 18 to 50 years of age in Stage 1 (Europe) randomized to receive two doses of altSonflex1-2-3 Dose C vaccine, one each at Day 1 and Day 85.
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).
Other Name: Shigella vaccine

Placebo Comparator: ST1_Adults_Placebo_GR2 Group
Adults 18 to 50 years of age in Stage 1 (Europe) randomized to receive two doses of altSonflex Placebo, one each at Day 1 and Day 169.
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).

Experimental: ST1_Adults_Dose C_GR2 Group
Adults 18 to 50 years of age in Stage 1 (Europe) randomized to receive two doses of altSonflex1-2-3 Dose C vaccine, one each at Day 1 and Day 169.
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).
Other Name: Shigella vaccine

Active Comparator: ST2_Adults_Control C Group
Adults 18 to 50 years of age in Stage 2 (Africa) randomized to receive one dose of GSK's Meningococcal A, C, Y and W-135 conjugate vaccine at Day 1 and one dose of GSK's Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine at Day 85.
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).
Other Name: MENVEO

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).
Other Name: BOOSTRIX

Experimental: ST2_Adults_Dose C Group
Adults 18 to 50 years of age in Stage 2 (Africa) randomized to receive two doses of altSonflex1-2-3 Dose C vaccine, one each at Day 1 and Day 85.
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).
Other Name: Shigella vaccine

Active Comparator: ST2_Children_Control B Group
Children 24 to 59 months of age in Stage 2 (Africa) randomized to receive one dose of GSK's Meningococcal A, C, Y and W-135 conjugate vaccine at Day 1 and one dose of Sanofi Pasteur's Typhoid Vi polysaccharide vaccine at Day 85. This group is a control group for children receiving altSonflex1-2-3 Dose B vaccine.
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).
Other Name: MENVEO

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).
Other Name: TYPHIM VI

Experimental: ST2_Children_Dose B Group
Children 24 to 59 months of age in Stage 2 (Africa) randomized to receive two doses of altSonflex1-2-3 Dose B vaccine, one each at Day 1 and Day 85.
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).
Other Name: Shigella vaccine

Active Comparator: ST2_Children_Control C Group
Children 24 to 59 months of age in Stage 2 (Africa) randomized to receive one dose of GSK's Meningococcal A, C, Y and W-135 conjugate vaccine at Day 1 and one dose of Sanofi Pasteur's Typhoid Vi polysaccharide vaccine at Day 85. This group is a control group for children receiving altSonflex1-2-3 Dose C vaccine.
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).
Other Name: MENVEO

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).
Other Name: TYPHIM VI

Experimental: ST2_Children_Dose C Group
Children 24 to 59 months of age in Stage 2 (Africa) randomized to receive two doses of altSonflex1-2-3 Dose C vaccine, one each at Day 1 and Day 85.
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).
Other Name: Shigella vaccine

Active Comparator: ST2_Infants_Control A_Safety Group
Infants 9 months of age in Stage 2 (Africa), part of the safety cohort, randomized to receive two doses of GSK's Meningococcal A, C, Y and W-135 conjugate vaccine, one each at Day 1 and Day 85, and one dose of GSK's Poliomyelitis, diphtheria, tetanus and pertussis vaccine at Day 253. These infants also receive two doses of Serum Institute of India's Measles and rubella vaccine, one each at Day 29 and Day 281, as concomitant vaccination. This group is a control group for infants receiving altSonflex1-2-3 Dose A vaccine.
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).
Other Name: MENVEO

Combination Product: GSK's Poliomyelitis, diphtheria, tetanus and pertussis vaccine
1 dose of GSK's Poliomyelitis, diphtheria, tetanus and pertussis 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).
Other Name: INFANRIX

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).
Other Name: MR-VAC

Experimental: ST2_Infants_Dose A_Safety Group
Infants 9 months of age in Stage 2 (Africa), part of the safety cohort, randomized to receive three doses of altSonflex1-2-3 Dose A, one each at Day 1, Day 85 and Day 253. These infants also receive two doses of Serum Institute of India's Measles and rubella vaccine, one each at Day 29 and Day 281, as concomitant vaccination.
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).
Other Name: Shigella vaccine

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).
Other Name: MR-VAC

Active Comparator: ST2_Infants_Control B_Safety Group
Infants 9 months of age in Stage 2 (Africa), part of the safety cohort, randomized to receive two doses of GSK's Meningococcal A, C, Y and W-135 conjugate vaccine, one each at Day 1 and Day 85, and one dose of GSK's Poliomyelitis, diphtheria, tetanus and pertussis vaccine at Day 253. These infants also receive two doses of Serum Institute of India's Measles and rubella vaccine, one each at Day 29 and Day 281, as concomitant vaccination. This group is a control group for infants receiving altSonflex1-2-3 Dose B vaccine.
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).
Other Name: MENVEO

Combination Product: GSK's Poliomyelitis, diphtheria, tetanus and pertussis vaccine
1 dose of GSK's Poliomyelitis, diphtheria, tetanus and pertussis 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).
Other Name: INFANRIX

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).
Other Name: MR-VAC

Experimental: ST2_Infants_Dose B_Safety Group
Infants 9 months of age in Stage 2 (Africa), part of the safety cohort, randomized to receive three doses of altSonflex1-2-3 Dose B vaccine, one each at Day 1, Day 85 and Day 253. These infants also receive two doses of Serum Institute of India's Measles and rubella vaccine, one each at Day 29 and Day 281, as concomitant vaccination.
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).
Other Name: Shigella vaccine

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).
Other Name: MR-VAC

Active Comparator: ST2_Infants_Control C_Safety Group
Infants 9 months of age in Stage 2 (Africa), part of the safety cohort, randomized to receive two doses of GSK's Meningococcal A, C, Y and W-135 conjugate vaccine, one each at Day 1 and Day 85, and one dose of GSK's Poliomyelitis, diphtheria, tetanus and pertussis vaccine at Day 253. These infants also receive two doses of Serum Institute of India's Measles and rubella vaccine, one each at Day 29 and Day 281, as concomitant vaccination. This group is a control group for infants receiving altSonflex1-2-3 Dose C vaccine.
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).
Other Name: MENVEO

Combination Product: GSK's Poliomyelitis, diphtheria, tetanus and pertussis vaccine
1 dose of GSK's Poliomyelitis, diphtheria, tetanus and pertussis 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).
Other Name: INFANRIX

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).
Other Name: MR-VAC

Experimental: ST2_Infants_Dose C_Safety Group
Infants 9 months of age in Stage 2 (Africa), part of the safety cohort, randomized to receive three doses of altSonflex1-2-3 Dose C vaccine, one each at Day 1, Day 85 and Day 253. These infants also receive two doses of Serum Institute of India's Measles and rubella vaccine, one each at Day 29 and Day 281, as concomitant vaccination.
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).
Other Name: Shigella vaccine

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).
Other Name: MR-VAC

Active Comparator: ST2_Infants_Control_Dose find Group
Infants 9 months of age in Stage 2 (Africa), part of the dose-finding cohort, randomized to receive two doses of GSK's Meningococcal A, C, Y and W-135 conjugate vaccine, one each at Day 1 and Day 85, and one dose of GSK's Poliomyelitis, diphtheria, tetanus and pertussis vaccine at Day 253. These infants also receive two doses of Serum Institute of India's Measles and rubella vaccine, one each at Day 1 and Day 253, as concomitant vaccination. This group is a control group for infants in dose-finding groups receiving either altSonflex1-2-3 Dose A, Dose B or Dose C vaccine.
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).
Other Name: MENVEO

Combination Product: GSK's Poliomyelitis, diphtheria, tetanus and pertussis vaccine
1 dose of GSK's Poliomyelitis, diphtheria, tetanus and pertussis 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).
Other Name: INFANRIX

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).
Other Name: MR-VAC

Experimental: ST2_Infants_Dose A_Dose find Group
Infants 9 months of age in Stage 2 (Africa), part of the dose-finding cohort, randomized to receive three doses of altSonflex1-2-3 Dose A vaccine, one each at Day 1, Day 85 and Day 253. These infants also receive two doses of Serum Institute of India's Measles and rubella vaccine, one each at Day 1 and Day 253, as concomitant vaccination.
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).
Other Name: Shigella vaccine

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).
Other Name: MR-VAC

Experimental: ST2_Infants_Dose B_Dose find Group
Infants 9 months of age in Stage 2 (Africa), part of the dose-finding cohort, randomized to receive three doses of altSonflex1-2-3 Dose B vaccine, one each at Day 1, Day 85 and Day 253. These infants also receive two doses of Serum Institute of India's Measles and rubella vaccine, one each at Day 1 and Day 253, as concomitant vaccination.
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).
Other Name: Shigella vaccine

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).
Other Name: MR-VAC

Experimental: ST2_Infants_Dose C_Dose find Group
Infants 9 months of age in Stage 2 (Africa), part of the dose-finding cohort, randomized to receive three doses of altSonflex1-2-3 Dose C vaccine, one each at Day 1, Day 85 and Day 253. These infants also receive two doses of Serum Institute of India's Measles and rubella vaccine, one each at Day 1 and Day 253, as concomitant vaccination.
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).
Other Name: Shigella vaccine

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).
Other Name: MR-VAC




Primary Outcome Measures :
  1. Anti-serotype specific Shigella lipopolysaccharide (LPS) serum immunoglobulin G (IgG) titers in infants 9 months of age in Africa [ Time Frame: At Day 281 (28 days after the third study intervention administration) ]
  2. Number of adults 18 to 50 years of age in Europe with solicited administration site events [ Time Frame: During 7 days after each study intervention administration (study interventions administered at Day 1 and Day 85/Day 169) ]
    The solicited administration site events are pain, redness, and swelling.

  3. Number of adults 18 to 50 years of age in Europe with solicited systemic events [ Time Frame: During 7 days after each study intervention administration (study interventions administered at Day 1 and Day 85/Day 169) ]
    The solicited systemic event is fever. Fever is defined as temperature equal to or above (≥) 38.0°C. The preferred location for measuring temperature is the axilla for all participants.

  4. Number of adults 18 to 50 years of age in Europe with unsolicited adverse events (AEs) [ Time Frame: During 28 days after each study intervention administration (study interventions administered at Day 1 and Day 85/Day 169) ]
    An unsolicited AE is an AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event.

  5. Number of adults 18 to 50 years of age in Europe with serious adverse events (SAEs) [ Time Frame: During the entire study participation period [Day 1 to Day 113 (for ST1_Adults_Placebo_GR1 and ST1_Adults_Dose C_GR1 groups)/Day 197 (for ST1_Adults_Placebo_GR2 and ST1_Adults_Dose C_GR2 groups) ]
    An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement.

  6. Number of adults 18 to 50 years of age in Europe with deviations from normal values of haematological, renal, and hepatic panel test results at Day 8 (7 days after the first study intervention administration) [ Time Frame: At Day 8 (7 days after the first study intervention administration) ]
    Panel tests include measures of leukocytes, erythrocytes, haemoglobin, haematocrit, platelets, eosinophils, basophils, neutrophils, monocytes, lymphocytes, creatinine, aspartate aminotransferase (AST) and alanine aminotransferase (ALT).

  7. Number of adults 18 to 50 years of age in Europe with deviations from normal values of haematological, renal, and hepatic panel test results at Day 92/Day 176 (7 days after the second study intervention administration) [ Time Frame: At Day 92 (for ST1_Adults_Placebo_GR1 and ST1_Adults_Dose C_GR1 groups)/Day 176 (for ST1_Adults_Placebo_GR2 and ST1_Adults_Dose C_GR2 groups) (7 days after the second study intervention administration) ]
    Panel tests include measures of leukocytes, erythrocytes, haemoglobin, haematocrit, platelets, eosinophils, basophils, neutrophils, monocytes, lymphocytes, creatinine, aspartate aminotransferase (AST) and alanine aminotransferase (ALT).

  8. Number of adults 18 to 50 years of age in Africa with solicited administration site events [ Time Frame: During 7 days after each study intervention administration (study interventions administered on Day 1 and Day 85) ]
    The solicited administration site events are pain, redness, and swelling.

  9. Number of adults 18 to 50 years of age in Africa with solicited systemic events [ Time Frame: During 7 days after each study intervention administration (study interventions administered at Day 1 and Day 85) ]
    The solicited systemic event is fever. Fever is defined as temperature ≥38.0°C. The preferred location for measuring temperature is the axilla for all participants.

  10. Number of adults 18 to 50 years of age in Africa with unsolicited AEs [ Time Frame: During 28 days after each study intervention administration (study interventions administered at Day 1 and Day 85) ]
    An unsolicited AE is an AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event.

  11. Number of adults 18 to 50 years of age in Africa with SAEs [ Time Frame: During the entire study participation (Day 1 to Day 113) ]
    An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement.

  12. Number of adults 18 to 50 years of age in Africa with deviations from normal values of haematological, renal, and hepatic panel test results at Day 8 (7 days after the first study intervention administration) [ Time Frame: At Day 8 (7 days after the first study intervention administration) ]
    Panel tests include measures of leukocytes, erythrocytes, haemoglobin, haematocrit, platelets, eosinophils, basophils, neutrophils, monocytes, lymphocytes, creatinine, AST and ALT.

  13. Number of adults 18 to 50 years of age in Africa with deviations from normal values of haematological, renal, and hepatic panel test results at Day 92 (7 days after the second study intervention administration) [ Time Frame: At Day 92 (7 days after the second study intervention administration) ]
    Panel tests include measures of leukocytes, erythrocytes, haemoglobin, haematocrit, platelets, eosinophils, basophils, neutrophils, monocytes, lymphocytes, creatinine, AST and ALT.

  14. Number of children 24 to 59 months of age in Africa with solicited administration site events [ Time Frame: During 7 days after each study intervention administration (study interventions administered at Day 1 and Day 85) ]
    The solicited administration site events are pain, redness, and swelling.

  15. Number of children 24 to 59 months of age in Africa with solicited systemic events [ Time Frame: During 7 days after each study intervention administration (study interventions administered at Day 1 and Day 85) ]
    The solicited systemic event is fever. Fever is defined as temperature ≥38.0°C. The preferred location for measuring temperature is the axilla for all participants.

  16. Number of children 24 to 59 months of age in Africa with unsolicited AEs [ Time Frame: During 28 days after each study intervention administration (study interventions administered on Day 1 and Day 85) ]
    An unsolicited AE is an AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event.

  17. Number of children 24 to 59 months of age in Africa with SAEs [ Time Frame: During the entire study participation period (Day 1 to Day 113) ]
    An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity or any other situation based on appropriate medical or scientific judgement.

  18. Number of children 24 to 59 months of age in Africa with deviations from normal values of haematological, renal, and hepatic panel test results at Day 8 (7 days after the first study intervention administration) [ Time Frame: At Day 8 (7 days after the first study intervention administration) ]
    Panel tests include measures of leukocytes, erythrocytes, haemoglobin, haematocrit, platelets, eosinophils, basophils, neutrophils, monocytes, lymphocytes, creatinine, AST and ALT.

  19. Number of children 24 to 59 months of age in Africa with deviations from normal values of haematological, renal, and hepatic panel test results at Day 92 (7 days after the second study intervention administration) [ Time Frame: At Day 92 (7 days after the second study intervention administration) ]
    Panel tests include measures of leukocytes, erythrocytes, haemoglobin, haematocrit, platelets, eosinophils, basophils, neutrophils, monocytes, lymphocytes, creatinine, AST and ALT.

  20. Number of infants 9 months of age in Africa with solicited administration site events [ Time Frame: During 7 days after each study intervention administration (study interventions administered at Day 1, Day 85 and Day 253) ]
    The solicited administration site events are pain, redness and swelling.

  21. Number of infants 9 months of age in Africa with solicited systemic events [ Time Frame: During 7 days after each study intervention administration (study interventions administered at Day 1, Day 85 and Day 253) ]
    The solicited systemic event is fever. Fever is defined as temperature ≥38.0°C. The preferred location for measuring temperature is the axilla for all participants.

  22. Number of infants 9 months of age in Africa with unsolicited AEs [ Time Frame: During 28 days after each study intervention administration (study intervention administered at Day 1, Day 85 and Day 253) ]
    An unsolicited AE is an AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event.

  23. Number of infants 9 months of age in Africa with SAEs [ Time Frame: During the entire study participation period (Day 1 to Day 281) ]
    An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity or any other situation based on appropriate medical or scientific judgement.

  24. Number of infants 9 months of age in Africa with deviations from normal values of haematological, renal, and hepatic panel test results at Day 8 (7 days after the first study intervention administration) [ Time Frame: At Day 8 (7 days after the first study intervention administration) ]
    Panel tests include measures of leukocytes, erythrocytes, haemoglobin, haematocrit, platelets, eosinophils, basophils, neutrophils, monocytes, lymphocytes, creatinine, AST, and ALT.

  25. Number of infants 9 months of age in Africa with deviations from normal values of haematological, renal, and hepatic panel test results at Day 92 (7 days after the second study intervention administration) [ Time Frame: At Day 92 (7 days after the second study intervention administration) ]
    Panel tests include measures of leukocytes, erythrocytes, haemoglobin, haematocrit, platelets, eosinophils, basophils, neutrophils, monocytes, lymphocytes, creatinine, AST, and ALT.

  26. Number of infants 9 months of age in Africa with deviations from normal values of haematological, renal, and hepatic panel test results at Day 260 (7 days after the third study intervention administration) [ Time Frame: At Day 260 (7 days after the third study intervention administration) ]
    Panel tests include measures of leukocytes, erythrocytes, haemoglobin, haematocrit, platelets, eosinophils, basophils, neutrophils, monocytes, lymphocytes, creatinine, AST, and ALT.


Secondary Outcome Measures :
  1. Anti-serotype specific Shigella LPS/OAg serum IgG geometric mean concentrations (GMCs) in adults 18 to 50 years of age in Europe [ Time Frame: At Day 1 and Day 85/Day 169 (before each study intervention administration), at Day 15 (14 days after the first study intervention administration) and at Day 29 and Day 113/Day197 (28 days after each study intervention administration) ]
  2. Anti-serotype specific Shigella LPS serum IgG GMTs in adults 18 to 50 years of age in Africa [ Time Frame: At Day 1 and Day 85 (before each study intervention administration) and at Day 29 and Day 113 (28 days after each study intervention administration) ]
  3. Anti-serotype specific Shigella LPS serum IgG GMTs in children 24 to 59 months of age in Africa [ Time Frame: At Day 1 and Day 85 (before each study intervention administration) and at Day 29 and Day 113 (28 days after each study intervention administration) ]
  4. Anti-serotype specific Shigella LPS serum IgG GMTs in infants 9 months of age in Africa [ Time Frame: At Day 1, Day 85 and Day 253 (before each study intervention administration) and at Day 29, Day 113 and Day 281 (28 days after each study intervention administration) ]
  5. Number of adults 18 to 50 years of age in Europe achieving an ELISA level equivalent to ≥1:800 titer against S. sonnei LPS [ Time Frame: At Day 1 and Day 85/Day 169 (before each study intervention administration), at Day 15 (14 days after the first study intervention administration) and at Day 29 and Day 113/Day 197 (28 days after each study intervention administration) ]
  6. Number of adults 18 to 50 years of age in Africa achieving an ELISA level equivalent to ≥1:800 titer against S. sonnei LPS [ Time Frame: At Day 1 and Day 85 (before each study intervention administration) and at Day 29 and Day 113 (28 days after each study intervention administration) ]
  7. Number of children 24 to 59 months of age in Africa achieving an ELISA level equivalent to ≥1:800 titer against S. sonnei LPS [ Time Frame: At Day 1 and Day 85 (before each study intervention administration) and at Day 29 and Day 113 (28 days after each study intervention administration) ]
  8. Number of infants 9 months of age in Africa achieving an ELISA level equivalent to ≥1:800 titer against S. sonnei LPS [ Time Frame: At Day 1, Day 85 and Day 253 (before each study intervention administration) and at Day 29, Day 113 and Day 281 (28 days after each study intervention administration) ]
  9. Number of adults 18 to 50 years of age in Europe achieving an ELISA level equivalent to ≥1:1600 titer against S. sonnei LPS [ Time Frame: At Day 1 and Day 85/Day 169 (before each study intervention administration), at Day 15 (14 days after the first study intervention administration) and at Day 29 and Day 113/Day 197 (28 days after each study intervention administration) ]
  10. Number of adults 18 to 50 years of age in Africa achieving an ELISA level equivalent to ≥1:1600 titer against S. sonnei LPS [ Time Frame: At Day 1 and Day 85 (before each study intervention administration) and at Day 29 and Day 113 (28 days after each study intervention administration) ]
  11. Number of children 24 to 59 months of age in Africa achieving an ELISA level equivalent to ≥1:1600 titer against S. sonnei LPS [ Time Frame: At Day 1 and Day 85 (before each study intervention administration) and at Day 29 and Day 113 (28 days after each study intervention administration) ]
  12. Number of infants 9 months of age in Africa achieving an ELISA level equivalent to ≥1:1600 titer against S. sonnei LPS [ Time Frame: At Day 1, Day 85 and Day 253 (before each study intervention administration) and at Day 29, Day 113 and Day 281 (28 days after each study intervention administration) ]
  13. Number of adults 18 to 50 years of age in Europe showing at least a 4-fold increase in anti-serotype specific Shigella LPS/OAg serum IgG concentrations [ Time Frame: At Day 15 (14 days after first study intervention administration) and at Day 29 and Day 113/197 (28 days after each study intervention administration) compared to Day 1 and Day 85/Day 169 (baseline) ]
  14. Number of adults 18 to 50 years of age in Africa showing at least a 4-fold increase in anti-serotype specific Shigella LPS serum IgG titers [ Time Frame: At Day 29 and Day 113 (28 days after each study intervention administration) compared to Day 1 and Day 85 (baseline) ]
  15. Number of children 24 to 59 months of age in Africa showing at least a 4-fold increase in anti-serotype specific Shigella LPS serum IgG titers [ Time Frame: At Day 29 and Day 113 (28 days after each study intervention administration) compared to Day 1 and Day 85 (baseline) ]
  16. Number of infants 9 months of age in Africa showing at least a 4-fold increase in anti-serotype specific Shigella LPS serum IgG titers [ Time Frame: At Day 29, Day 113 and Day 281 (28 days after each study intervention administration) compared to Day 1, Day 85 and Day 253 (baseline) ]
  17. Anti-measles IgG concentrations in infants 9 months of age in the dose-finding groups in Africa [ Time Frame: At Day 1 (before the first MR-VAC dose administration) and Day 281 (28 days after the second MR-VAC dose administration) ]
  18. Anti-rubella IgG concentrations in infants 9 months of age in the dose-finding groups in Africa [ Time Frame: At Day 1 (before the first MR-VAC dose administration) and Day 281 (28 days after the second MR-VAC dose administration) ]
  19. Number of infants 9 months of age in the dose-finding groups in Africa achieving anti-measles IgG concentrations of ≥150 mIU/mL and ≥200 mIU/mL [ Time Frame: At Day 281 (28 days after the second MR-VAC dose administration) ]
  20. Number of infants 9 months of age in the dose-finding groups in Africa achieving anti-rubella IgG concentrations of ≥4 IU/mL and ≥10 IU/mL [ Time Frame: At Day 281 (28 days after the second MR-VAC dose administration) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   9 Months to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

All participants:

  • Participants and/or participants' parent(s)/legally acceptable representative(s) LAR(s), who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).
  • Written or witnessed/thumb printed informed consent obtained from the participant/parent(s)/LAR(s) of the participant prior to performance of any study specific procedure.
  • Healthy participants as established by medical history, clinical examination, and laboratory assessment.
  • Participants satisfying all screening requirements.
  • Participants seronegative for hepatitis B, and hepatitis C.
  • Participants negative for human leukocyte antigen B27 (HLA-B27).

Adults 18 to 50 years of age:

  • A male or female between, and including, 18 and 50 years of age at the time of the first study intervention administration.
  • Female participant of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause.
  • Female participants of childbearing potential may be enrolled in the study, if the participant:
  • has practiced adequate contraception for 1 month prior to study intervention administration, and
  • has a negative pregnancy test on the day of study intervention administration, and
  • has agreed to continue adequate contraception during the entire treatment period and for 1 month after completion of the study intervention administration series.
  • Participants seronegative for human immunodeficiency virus (HIV).

Children 24 to 59 months of age:

• A male or female between, and including, 24 and 59 months of age at the time of first vaccination.

  • Normal nutritional Z score (-2 standard deviation or greater).
  • Previously completed routine childhood vaccinations to the best knowledge of the participant's parent(s)/LAR(s).
  • Born after gestation period of ≥37 weeks.
  • Participants seronegative for HIV.

Infants 9 months of age:

  • A male or female 9 months of age at the time of first vaccination.
  • Normal nutritional Z score (-2 standard deviations or greater).
  • Previously completed routine childhood vaccinations to the best knowledge of the participant's parent(s)/LAR(s).
  • Born after a gestation period of ≥37 weeks.
  • Participants negative for HIV as confirmed by deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) testing.

Exclusion Criteria:

All participants:

• Known exposure to Shigella during lifetime of the participant as confirmed during interview with the participant or documented by patient records (e.g., history of microbiologically-confirmed Shigella infection), recent travel* (within 2 years) to a country where Shigella or other enteric infections are endemic, or recent occupation* (within 3 years) involving Shigella species.

  • Exclusion due to travel or occupation is applicable only to Adults 18 to 50 years of age in Europe (Stage 1).

    • Progressive, unstable or uncontrolled clinical conditions.

    • History (known or suspected) of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccine.

    • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).

    • Hypersensitivity, including allergy, to medicinal products or medical equipment whose use is foreseen in this study.

    • Clinical conditions representing a contraindication to IM vaccination and blood draws.

    • Any behavioural or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the participant's ability to participate in the study.
    • Acute disease and/or fever (defined as temperature ≥ 38.0°C) at the time of enrolment*.
  • The participant can still be enrolled into the study at a time when the acute disease and/or fever has resolved.

    • Any clinically significant haematological and/or biochemical laboratory abnormality.

    • Confirmed positive COVID-19 test during the period starting 30 days before the first administration of study vaccines (Day -30 to Day 1).
    • Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
    • Administration of long-acting immune-modifying drugs at any time during the study period (e.g. infliximab).
    • Prior receipt of an experimental Shigella vaccine or live Shigella challenge.
    • Use of any investigational or non-registered product (drug, vaccine or medical device)* other than the study vaccine during the period starting 30 days before the first dose of study intervention (Day -30 to Day 1), or planned use during the study period.
  • Use of herbs and traditional treatments is not considered an exclusion criterion • A vaccine not foreseen* by the Study Protocol administered during the period starting at -21 days before the first dose (-28 days in the case of live vaccines) and ending after the last dose of study intervention administration.
  • Vaccines allowed by the Protocol include flu and COVID-19 vaccines in adults and EPI vaccines in children and infants.

    • Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug or invasive medical device).
    • Any study personnel or immediate dependents, family, or household member.

Adults 18 to 50 years of age:

  • Acute or chronic illness, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
  • Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first vaccine study intervention. For corticosteroids, this will mean prednisone equivalent ≥20 mg/day for adult participants. Inhaled and topical steroids are allowed.
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.
  • History of or current chronic alcohol consumption and/or drug abuse.

Adults 18 to 50 years of age and Children 24 to 59 months age:

• Administration of immunoglobulins and/or any blood products or plasma derivatives, or bone marrow transplantation, during the period starting 3 months before the first dose of study vaccine or planned administration during the study period.

Children 24 to 59 months of age and infants 9 months of age:

  • Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
  • Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first vaccine dose. For corticosteroids, this will mean prednisone ≥0.5 mg/kg/day or 20 mg/day whichever is the maximum dose for paediatric participants. Inhaled and topical steroids are allowed.
  • Child in care.

Infants 9 months of age:

• Administration of immunoglobulins and/or any blood products or plasma derivatives, or bone marrow transplantation, from birth or planned administration during the study period.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05073003


Contacts
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Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

Locations
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Belgium
GSK Investigational Site Recruiting
Gent, Belgium, 9000
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Isabel Leroux-Roels         
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT05073003    
Other Study ID Numbers: 212149
2021-000891-12 ( EudraCT Number )
First Posted: October 11, 2021    Key Record Dates
Last Update Posted: November 5, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by GlaxoSmithKline:
Shigella infection
Shigellosis
Diarrhoea
S. sonnei
S. flexneri
Low and middle income countries
Additional relevant MeSH terms:
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Diarrhea
Signs and Symptoms, Digestive
Vaccines
Immunologic Factors
Physiological Effects of Drugs