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.

Conditions

Urinary Tract Infections

Brief summary

For participants in both parts of the study (Part 1 [SLI] and Part 2 [PoP]), occurrence of: • solicited administration site and systemic AEs during the 7 days post-Dose 1 and post-Dose 2, • any unsolicited AEs during the 30 days post-Dose 1 and post Dose 2, • any immediate unsolicited AEs in the 60 minutes post-Dose 1 and post-Dose 2. • SAEs, pIMDs, MAAEs, and AEs leading to study withdrawal until Day 426 (i.e., end of follow-up)., For participants in the Part 1 of the study (SLI): • Occurrence of hematological and biochemical laboratory abnormalities, and changes from the baseline values, at 7 days after the day of Dose 1 and Dose 2 compared to pre-dose values (i.e., on Day 8 and Day 68, compared to Day 1# and Day 61, respectively)., For participants in the Part 2 of the study (PoP): • First occurrence of a urine culture confirmed UTI due to E. coli from 14 days (Day 75) up to 12 months (Day 426) post-Dose 2.

Related papers

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Interventions

DRUGsterile saline solution (0.9% w/v solution of NaCl in water).

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
For participants in both parts of the study (Part 1 [SLI] and Part 2 [PoP]), occurrence of: • solicited administration site and systemic AEs during the 7 days post-Dose 1 and post-Dose 2, • any unsolicited AEs during the 30 days post-Dose 1 and post Dose 2, • any immediate unsolicited AEs in the 60 minutes post-Dose 1 and post-Dose 2. • SAEs, pIMDs, MAAEs, and AEs leading to study withdrawal until Day 426 (i.e., end of follow-up)., For participants in the Part 1 of the study (SLI): • Occurrence of hematological and biochemical laboratory abnormalities, and changes from the baseline values, at 7 days after the day of Dose 1 and Dose 2 compared to pre-dose values (i.e., on Day 8 and Day 68, compared to Day 1# and Day 61, respectively)., For participants in the Part 2 of the study (PoP): • First occurrence of a urine culture confirmed UTI due to E. coli from 14 days (Day 75) up to 12 months (Day 426) post-Dose 2.	—

Measure

Time frame

For participants in both parts of the study (Part 1 [SLI] and Part 2 [PoP]), occurrence of: • solicited administration site and systemic AEs during the 7 days post-Dose 1 and post-Dose 2, • any unsolicited AEs during the 30 days post-Dose 1 and post Dose 2, • any immediate unsolicited AEs in the 60 minutes post-Dose 1 and post-Dose 2. • SAEs, pIMDs, MAAEs, and AEs leading to study withdrawal until Day 426 (i.e., end of follow-up)., For participants in the Part 1 of the study (SLI): • Occurrence of hematological and biochemical laboratory abnormalities, and changes from the baseline values, at 7 days after the day of Dose 1 and Dose 2 compared to pre-dose values (i.e., on Day 8 and Day 68, compared to Day 1# and Day 61, respectively)., For participants in the Part 2 of the study (PoP): • First occurrence of a urine culture confirmed UTI due to E. coli from 14 days (Day 75) up to 12 months (Day 426) post-Dose 2.

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Countries

Belgium, Spain

Outcome results

None listed