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This study evaluates the immune response and safety of a multicomponent, 2-dose Shigella vaccine in preventing shigellosis in African infants. The candidate vaccine, altSonflex1-2-3, is currently being evaluated in a Phase 2 age de-escalation (from least vulnerable adult population to most vulnerable paediatric population) clinical study in Kenya, with the aim of identifying a preferred dose, using a 3-dose vaccination schedule in infants from 9 months of age (NCT05073003). This Phase 2 clinical study will evaluate the safety and immunogenicity of an alternative 2-dose vaccination schedule.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| altSonflex1-2-3 Dose_A Group | Experimental | Participants randomized to receive altSonflex1-2-3 Dose A and MR-VAC on Day 1 and Day 169. |
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| altSonflex1-2-3 Dose_B Group | Experimental | Participants randomized to receive altSonflex1-2-3 Dose B and MR-VAC on Day 1 and Day 169. |
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| altSonflex1-2-3 Dose_C Group | Experimental | Participants randomized to receive altSonflex1-2-3 Dose C and MR-VAC on Day 1 and Day 169. |
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| Control Group | Active Comparator | Participants randomized to receive TYPHIBEV on Day 1, Infanrix hexa on Day 169 and MR-VAC on Day 1 and Day 169. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| altSonflex1-2-3 Dose A | Biological | altSonflex1-2-3 Dose A administered intramuscularly on Day 1 and Day 169 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean titers (GMTs) of anti-serotype-specific Shigella lipopolysaccharides/O-antigen (LPS/OAg) serum Immunoglobulin G (IgG) | Day 1 (before administration of Dose 1) | |
| GMTs of anti-serotype-specific Shigella LPS/OAg serum IgG | Day 169 (before administration of Dose 2) | |
| GMTs of anti-serotype-specific Shigella LPS/OAg serum IgG | Day 29 (28 days after administration of Dose 1) | |
| GMTs of anti-serotype-specific Shigella LPS/OAg serum IgG | Day 197 (28 days after administration of Dose 2) | |
| Geometric mean concentrations (GMCs) of anti-serotype-specific Shigella LPS/OAg serum IgG | Day 1 (before administration of Dose 1) | |
| GMCs of anti-serotype-specific Shigella LPS/OAg serum IgG | Day 169 (before administration of Dose 2) | |
| GMCs of anti-serotype-specific Shigella LPS/OAg serum IgG | Day 29 (28 days after administration of Dose 1) | |
| GMCs of anti-serotype-specific Shigella LPS/OAg serum IgG | Day 197 (28 days after administration of Dose 2) | |
| Number of infants with at least a 4-fold increase in anti-serotype-specific Shigella LPS/OAg serum IgG | Day 29 compared with baseline (Day 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of infants with solicited administration-site events | Solicited administration site events include pain, redness and swelling at administration site. | During 7 days after each study intervention administration (study interventions administered at Day 1 and Day 169) |
| Number of infants with solicited systemic events |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Kericho | 20200 | Kenya |
Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Anonymized IPD is shared with researchers whose proposals are approved by an 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 may be granted, when justified, for up to 6 months.
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| altSonflex1-2-3 Dose B | Biological | altSonflex1-2-3 Dose B administered intramuscularly on Day 1 and Day 169 |
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| altSonflex1-2-3 Dose C | Biological | altSonflex1-2-3 Dose C administered intramuscularly on Day 1 and Day 169 |
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| TYPHIBEV | Biological | TYPHIBEV administered intramuscularly on Day 1 |
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| Infanrix hexa | Combination Product | Infanrix hexa administered intramuscularly on Day 169 |
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| MR-VAC | Biological | MR-VAC co-administered subcutaneously on Day 1 and Day 169 |
|
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| Number of infants with at least a 4-fold increase in anti-serotype-specific Shigella LPS/OAg serum IgG | Day 197 compared with baseline (Day 1) |
| Number of infants with at least a 4-fold increase in anti-serotype-specific Shigella LPS/OAg serum IgG | Day 197 compared with pre-Dose 2 (Day 169) |
Solicited systemic events include fever. Fever is defined as temperature greater than or equal to (>=) 38.0°C and preferred location for measuring temperature is the axilla. |
| During 7 days after each study intervention administration (study interventions administered at Day 1 and Day 169) |
| Number of infants with unsolicited adverse events (AEs) | An unsolicited AE is an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. | During 28 days after each study intervention administration (study interventions administered at Day 1 and Day 169) |
| Number of infants with serious adverse events (SAEs) during the entire study period | An SAE is defined as any untoward medical occurrence that results in death, is life threatening, requires hospitalization or prolongs existing hospitalization, results in disability/incapacity or other medically significant events. | From Day 1 to Day 197 |
| Number of infants with deviations from laboratory reference values of hematological, renal, and hepatic panel test results | Panel tests include measures of white blood cells, haemoglobin, platelets, neutrophils, creatinine, alanine aminotransferase (ALT), and aspartate aminotransferase (AST). | Day 8 compared with baseline (Day 1) |
| Number of infants with deviations from laboratory reference values of hematological, renal, and hepatic panel test results compared to pre-Dose 2 values | Panel tests include measures of white blood cells, haemoglobin, platelets, neutrophils, creatinine, ALT, and AST. | Day 176 compared with pre-Dose 2 (Day 169) |
| Anti-measles IgG concentrations expressed as GMCs | At Day 1 (before the first MR-VAC vaccination) and Day 197 (28 days after the second MR-VAC vaccination) |
| Anti-rubella IgG concentrations expressed as GMCs | At Day 1 (before the first MR-VAC vaccination) and Day 197 (28 days after the second MR-VAC vaccination) |
| Number of infants with measles seroresponse >=150 mIU/mL and >=200 mIU/mL | At Day 197 (28 days after the second MR-VAC vaccination) |
| Number of infants with rubella seroresponse >=4 IU/mL and >=10 IU/mL | Day 197 (28 days after the second MR-VAC vaccination) |
| ID | Term |
|---|---|
| D003967 | Diarrhea |
| D004405 | Dysentery, Bacillary |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004756 | Enterobacteriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D004403 | Dysentery |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D022281 | Shigella Vaccines |
| C541235 | diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine |
| D013745 | Tetanus Toxoid |
| D017325 | Hepatitis B Vaccines |
| D012411 | Rubella Vaccine |
| ID | Term |
|---|---|
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D014121 | Toxoids |
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
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