Full name
A Phase IIa Observer-blind, Randomized, Controlled, Age-de-escalation, Single Center Interventional Study to Evaluate the Safety, Reactogenicity, and Immune Response of the GVGH iNTS Vaccine Against S. Typhimurium and S. Enteritidis, in Adults, Children and Infants, Including Dose-finding in Infants, in Africa
NCT Number
NCT06213506
Geography
Non-US
Locations
Ghana
Primary Endpoints
- Anti-invasive nontyphoidal Salmonella (iNTS) serotype specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) in infants 6 weeks of age part of the dose-finding cohort. At Day 85 (28 days after the second study intervention administration)
- Percentage of adult participants 18-50 years of age with solicited administration site events. During 7 days after the first study intervention administration occurring at Day 1
- Percentage of adult participants 18-50 years of age with solicited administration site events. During 7 days after the second study intervention administration occurring at Day 57
- Percentage of adult participants 18-50 years of age with solicited systemic events. During 7 days after the first study intervention administration occurring at Day 1
- Percentage of adult participants 18-50 years of age with solicited systemic events. During 7 days after the second study intervention administration occurring at Day 57
- Percentage of adult participants 18-50 years of age with unsolicited adverse events (AEs). During 28 days after the first study intervention administration occurring at Day 1
- Percentage of adult participants 18-50 years of age with unsolicited adverse events (AEs). During 28 days after the second study intervention administration occurring at Day 57
- Percentage of adult participants 18-50 years of age with serious adverse events (SAEs). From first study intervention administration (Day 1) up to the end of study participation (Day 85)
- Percentage of adult participants 18-50 years of age with adverse events (AEs) leading to withdrawal from the study or discontinuation of study intervention. From first study intervention administration (Day 1) up to the end of study participation (Day 85)
- Percentage of adult participants 18-50 years of age with deviations from reference ranges l or baseline values for hematological, renal and hepatic panel test results. At Day 8 (7 days after the first study intervention administration)
- Percentage of adult participants 18-50 years of age with deviations from reference ranges or baseline values for hematological, renal and hepatic panel test results. At Day 64 (7 days after the second study intervention administration)
- Percentage of child participants 24-59 months of age with solicited administration site events. During 7 days after the first study intervention administration occurring at Day 1
- Percentage of child participants 24-59 months of age with solicited administration site events. During 7 days after the second study intervention administration occurring at Day 57
- Percentage of child participants 24-59 months of age with solicited systemic events. During 7 days after the first study intervention administration occurring at Day 1
- Percentage of child participants 24-59 months of age with solicited systemic events. During 7 days after the second study intervention administration occurring at Day 57
- Percentage of child participants 24-59 months of age with unsolicited AEs. During 28 days after the first study intervention administration occurring at Day 1
- Percentage of child participants 24-59 months of age with unsolicited AEs. During 28 days after the second study intervention administration occurring at Day 57
- Percentage of child participants 24-59 months of age with serious adverse events (SAEs). From first study intervention administration (Day 1) up to the end of study participation (Day 85)
- Percentage of child participants 24-59 months of age with AEs leading to withdrawal from the study or discontinuation of study intervention. From first study intervention administration (Day 1) up to the end of study participation (Day 85)
- Percentage of child participants 24-59 months of age with deviations from reference ranges or baseline values for hematological, renal and hepatic panel test results. At Day 8 (7 days after the first study intervention administration)
- Percentage of child participants 24-59 months of age with deviations from reference ranges or baseline values for hematological, renal and hepatic panel test results. At Day 64 (7 days after the second study intervention administration)
- Percentage of infant participants 9 months of age with solicited administration site events. During 7 days after the first study intervention administration occurring at Day 1
- Percentage of infant participants 9 months of age with solicited administration site events. During 7 days after the second study intervention administration occurring at Day 85
- Percentage of infant participants 9 months of age with solicited administration site events. During 7 days after the third study intervention administration occurring at Day 169
- Percentage of infant participants 9 months of age with solicited systemic events. During 7 days after the first study intervention administration occurring at Day 1
- Percentage of infant participants 9 months of age with solicited systemic events. During 7 days after the second study intervention administration occurring at Day 85
- Percentage of infant participants 9 months of age with solicited systemic events. During 7 days after the third study intervention administration occurring at Day 169
- Percentage of infant participants 9 months of age with unsolicited adverse events (AEs). During 28 days after the first study intervention administration occurring at Day 1
- Percentage of infant participants 9 months of age with unsolicited adverse events (AEs). During 28 days after the second study intervention administration occurring at Day 85
- Percentage of infant participants 9 months of age with unsolicited adverse events (AEs). During 28 days after the third study intervention administration occurring at Day 169
- Percentage of infant participants 9 months of age with serious adverse events (SAEs). From first study intervention administration (Day 1) up to the end of study participation (Day 337)
- Percentage of infant participants 9 months of age with adverse events (AEs) leading to withdrawal from the study or discontinuation of study intervention. From first study intervention administration (Day 1) up to the end of study participation (Day 337)
- Percentage of infant participants 9 months of age with deviations from reference range or baseline values for hematological, renal and hepatic panel test results. At Day 8 (7 days after the first study intervention administration)
- Percentage of infant participants 9 months of age with deviations from reference range or baseline values for hematological, renal and hepatic panel test results. At Day 92 (7 days after the second study intervention administration)
- Percentage of infant participants 9 months of age with deviations from reference range or baseline values for hematological, renal and hepatic panel test results. At Day 176 (7 days after the third study intervention administration)
- Percentage of infant participants 6 weeks of age with solicited administration site events. During 7 days after the first study intervention administration occurring at Day 1 in the Priming phase
- Percentage of infant participants 6 weeks of age with solicited administration site events. During 7 days after the second study intervention administration occurring at Day 57 in the Priming phase
- Percentage of infant participants 6 weeks of age with solicited systemic events. During 7 days after the first study intervention administration occurring at Day 1 in the Priming phase
- Percentage of infant participants 6 weeks of age with solicited systemic events. During 7 days after the second study intervention administration occurring at Day 57 in the Priming phase
- Percentage of infant participants 6 weeks of age with unsolicited adverse events (AEs). During 28 days after the first study intervention administration occurring at Day 1 in the Priming phase
- Percentage of infant participants 6 weeks of age with unsolicited adverse events (AEs). During 28 days after the second study intervention administration occurring at Day 57 in the Priming phase
- Percentage of infant participants 6 weeks of age with SAEs. From first study intervention administration (Day 1) up to 28 days after second study intervention (Day 85)
- Percentage of infant participants 6 weeks of age with adverse events (AEs) leading to MR-VAC administration withdrawal from the study or discontinuation of study intervention. From first study intervention administration (Day 1) up to 28 days after second study intervention (Day 85)
- Percentage of infant participants 6 weeks of age with deviations from reference ranges or baseline values for hematological, renal, and hepatic panel test results. At Day 8 (7 days after the first study intervention administration) in the Priming phase
- Percentage of infant participants 6 weeks of age with deviations from reference ranges or baseline values for hematological, renal, and hepatic panel test results at Day 64. At Day 64 (7 days after the second study intervention administration) in the Priming phase
External Link
https://clinicaltrials.gov/study/NCT06213506
Order
1
Disease
Version
Phase
2a