About this trial
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.
Eligibility criteria
Qualifiers
Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
Written informed consent obtained from the participant prior to performance of any study-specific procedure.
Female participants of non-childbearing potential may be enrolled in the clinical study.
has practiced adequate contraception for 1 month prior to study intervention administration, and
Disqualifiers
History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
Hypersensitivity to latex.
History of pIMD.
Trial design
Treatments tested in this trial
- Candidate UTI vaccine low dose formulation 1
- Candidate UTI vaccine low dose formulation 2
- Candidate UTI vaccine medium dose formulation 1
- Candidate UTI vaccine medium dose formulation 2
- Candidate UTI vaccine high dose formulation 1
- Candidate UTI vaccine high dose formulation 2
- Candidate UTI vaccine HTD formulation 2
- Placebo
Treatment groups
8
Treatment groupsSee each treatment group below.