drugset / Trial / NCT06702449
A Study on the Safety and Immune Response of a Urinary Tract Infection (UTI) Vaccine in Adults 18-64 Years of Age and Clinical Efficacy in Females 18-64 Years of Age
RandomizedSequentialTriple-blindPrevention
Summary
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.
Timeline
- Start
- 2024-11-19
- Primary completion
- 2027-05-31
- Completion
- 2027-05-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Candidate UTI vaccine HTD formulation 2 | Vaccine | — | Intramuscular |
| Subject | Candidate UTI vaccine high dose formulation 1 | Vaccine | — | Intramuscular |
| Subject | Candidate UTI vaccine high dose formulation 2 | Vaccine | — | Intramuscular |
| Subject | Candidate UTI vaccine low dose formulation 1 | Vaccine | — | Intramuscular |
| Subject | Candidate UTI vaccine low dose formulation 2 | Vaccine | — | Intramuscular |
| Subject | Candidate UTI vaccine medium dose formulation 1 | Vaccine | — | Intramuscular |
| Subject | Candidate UTI vaccine medium dose formulation 2 | Vaccine | — | Intramuscular |