Full name

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)

NCT Number
NCT05073003
Geography
Non-US
Locations

Belgium (Completed), Kenya

Primary Endpoints
  • Anti-serotype specific Shigella lipopolysaccharide (LPS)/O-Antigen (OAg) serum immunoglobulin G (IgG) geometric mean concentrations (GMCs) in infants 9 months of age in Africa. At Day 281 (28 days after the third study intervention administration)
  • Number of adults 18 to 50 years of age in Europe with solicited administration site events. During 7 days after each study intervention administration (study interventions administered at Day 1 and Day 85/Day 169)
  • Number of adults 18 to 50 years of age in Europe with solicited systemic events. During 7 days after each study intervention administration (study interventions administered at Day 1 and Day 85/Day 169)
  • Number of adults 18 to 50 years of age in Europe with unsolicited adverse events (AEs). During 28 days after each study intervention administration (study interventions administered at Day 1 and Day 85/Day 169)
  • Number of adults 18 to 50 years of age in Europe with serious adverse events (SAEs). 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)
  • 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). At Day 8 (7 days after the first study intervention administration)
  • 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). 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)
  • Number of adults 18 to 50 years of age in Africa with solicited administration site events. During 7 days after each study intervention administration (study interventions administered at Day 1 and Day 85)
  • Number of adults 18 to 50 years of age in Africa with solicited systemic events. During 7 days after each study intervention administration (study interventions administered at Day 1 and Day 85)
  • Number of adults 18 to 50 years of age in Africa with unsolicited AEs. During 28 days after each study intervention administration (study interventions administered at Day 1 and Day 85)
  • Number of adults 18 to 50 years of age in Africa with SAEs. During the entire study participation (Day 1 to Day 113)
  • 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). At Day 8 (7 days after the first study intervention administration)
  • 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). At Day 92 (7 days after the second study intervention administration)
  • Number of children 24 to 59 months of age in Africa with solicited administration site events. During 7 days after each study intervention administration (study interventions administered at Day 1 and Day 85)
  • Number of children 24 to 59 months of age in Africa with solicited systemic events. During 7 days after each study intervention administration (study interventions administered at Day 1 and Day 85)
  • Number of children 24 to 59 months of age in Africa with unsolicited AEs. During 28 days after each study intervention administration (study interventions administered on Day 1 and Day 85)
  • Number of children 24 to 59 months of age in Africa with SAEs. During the entire study participation period (Day 1 to Day 113)
  • 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). At Day 8 (7 days after the first study intervention administration)
  • 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). At Day 92 (7 days after the second study intervention administration)
  • Number of infants 9 months of age in Africa with solicited administration site events. During 7 days after each study intervention administration (study interventions administered at Day 1, Day 85 and Day 253)
  • Number of infants 9 months of age in Africa with solicited systemic events. During 7 days after each study intervention administration (study interventions administered at Day 1, Day 85 and Day 253)
  • Number of infants 9 months of age in Africa with unsolicited AEs. During 28 days after each study intervention administration (study intervention administered at Day 1, Day 85 and Day 253)
  • Number of infants 9 months of age in Africa with SAEs. During the entire study participation period (Day 1 to Day 281)
  • 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). At Day 8 (7 days after the first study intervention administration)
  • 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). At Day 92 (7 days after the second study intervention administration)
  • 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). At Day 260 (7 days after the third study intervention administration)
External Link
https://clinicaltrials.gov/study/NCT05073003
Order
0
Disease
Shigella
Menu title
A Study on the Safety and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against Shigellosis in Adults, Children, and Infants
Version
IDWEEK 2024
Phase
1/2