Full name
A Seamless Phase 1/2, Observer-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Safety and Immunogenicity of a UTI Vaccine When Administered to Adults 18 Through 64 Years of Age and Clinical Efficacy When Administered to Females 18 Through 64 Years of Age
NCT Number
NCT06702449
Geography
US
Non-US
Locations
South Africa, United States
Primary Endpoints
- Part 1 and 2: Number of participants reporting solicited administration site adverse events (AEs). During the 7 days follow-up period post-Dose 1 (study intervention administered at Day 1)
- Part 1 and 2: Number of participants reporting solicited administration site AEs. During the 7 days follow-up period post-Dose 2 (study intervention administered at Day 61)
- Part 1 and 2: Number of participants reporting solicited systemic AEs. During the 7 days follow-up period post-Dose 1 (study intervention administered at Day 1)
- Part 1 and 2: Number of participants reporting solicited systemic AEs. During the 7 days follow-up period post-Dose 2 (study intervention administered at Day 61)
- Part 1 and 2: Number of participants reporting unsolicited AEs. During the 30 days follow-up period post-Dose 1 (study intervention administered at Day 1)
- Part 1 and 2: Number of participants reporting unsolicited AEs. During the 30 days follow-up period post-Dose 2 (study intervention administered at Day 61)
- Part 1 and 2: Number of participants reporting any immediate unsolicited AEs. During the 60 minutes follow-up period post-Dose 1 (study intervention administered at Day 1)
- Part 1 and 2: Number of participants reporting any immediate unsolicited AEs. During the 60 minutes follow-up period post-Dose 2 (study intervention administered at Day 61)
- Part 1 and 2: Number of participants reporting serious adverse events (SAEs). From Day 1 (Dose 1 administration) until Day 426 (end of follow-up)
- Part 1 and 2: Number of participants reporting potential immune-mediated diseases (pIMDs) leading to study withdrawal. From Day 1 (Dose 1 administration) until Day 426 (end of follow-up)
- Part 1 and 2: Number of participants reporting medically-attended adverse events (MAAEs) leading to study withdrawal. From Day 1 (Dose 1 administration) until Day 426 (end of follow-up)
- Part 1 and 2: Number of participants reporting AEs leading to study withdrawal. From Day 1 (Dose 1 administration) until Day 426 (end of follow-up)
- Part 1: Number of participants with hematology or biochemistry abnormalities or changes in baseline value. At 7 days post-Dose 1 (Day 8) compared with baseline (pre-Dose 1, Day 1)
- Part 1: Number of participants with hematology or biochemistry abnormalities or changes in baseline value. At 7 days post-Dose 2 (Day 68) compared with Day 61 (pre-Dose 2)
- Part 2: Incidence rate (IR) of the first occurrence of a urine culture confirmed UTI due to E. coli in the investigational group compared to the IR in placebo group. From 14 days (Day 75) up to 12 months (Day 426) post-Dose 2
Order
0
Disease
Version
Phase
1/2
Status
Recruiting