Full name
A Phase 1, Observer-blind, Randomised, Controlled, Single-centre Study to Evaluate the Safety, Reactogenicity, and Immune Responses to an Adjuvanted and Non-adjuvanted Conjugate Vaccine Against Salmonella Typhi and Salmonella Paratyphi A in Healthy Adults 18 to 50 Years of Age in Europe
NCT Number
NCT05613205
Geography
Non-US
Locations
Belgium
Primary Endpoints
- Percentage of participants with solicited administration-site events after the first vaccination. During 7 days after the first vaccination occurring at Day 1
- Percentage of participants with solicited administration-site events after the second vaccination. During 7 days after the second vaccination occurring at Day 169
- Percentage of participants with solicited systemic events after the first vaccination. During 7 days after the first vaccination occurring at Day 1
- Percentage of participants with solicited systemic events after the second vaccination. During 7 days after the second vaccination occurring at Day 169
- Percentage of participants with unsolicited adverse events after the first vaccination. During 28 days after the first vaccination occurring at Day 1
- Percentage of participants with unsolicited adverse events after the second vaccination. During 28 days after the second vaccination occurring at Day 169
- Percentage of participants with any serious adverse event (SAE). From Day 1 to Day 197
- Percentage of participants with AEs/SAEs leading to withdrawal from the study or withholding further study intervention administration. From Day 1 to Day 197
- Percentage of participants with deviations from normal or baseline values of haematological, renal, and hepatic panel test results at Day 8. At Day 8 (7 days after the first vaccination)
- Percentage of participants with deviations from normal or baseline values of haematological, renal, and hepatic panel test results at Day 176. At Day 176 (7 days after the second vaccination)
External Link
https://clinicaltrials.gov/study/NCT05613205
Order
2
Disease
Version
Phase
1