The purpose of this study is to assess safety, reactogenicity, and immune response of the candidate UTI vaccine compared to placebo in adults between and including 18-64 years of age (YOA), and to perform a preliminary evaluation of clinical efficacy in females between and including 18-64 YOA.
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Part 1 and 2: Number of participants reporting solicited administration site adverse events (AEs)
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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)
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: From 14 days (Day 75) up to 12 months (Day 426) post-Dose 2