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

Inclusion Criteria:

• Participants, who, in the opinion of the investigator, can and will comply with therequirements of the protocol.

• Written informed consent obtained from the participant prior to performance of anystudy-specific procedure.

• Female participants of non-childbearing potential may be enrolled in the clinicalstudy.

• Female participants of childbearing potential may be enrolled in the clinical study,if the participant:

• has practiced adequate contraception for 1 month prior to study interventionadministration, and

• has a negative pregnancy test on the day of study intervention administration,and

• has agreed to continue adequate contraception during the entire treatmentperiod and for at least 1 month after completion of the study interventionadministration series.

• Blood sample for simultaneous follicle stimulating hormone (FSH) and estradiollevels may be collected.

Additional inclusion criterion only for participants in Part 1 of the study (SLI):

• Female and male between and including 18 through 64 YOA at the time of ICFsignature.

• Healthy participants, according to medical history, laboratory assessment andclinical examination at Screening Visit.

Additional inclusion criterion only for participants in Part 2 of the study (PoP):

• Females between and including 18 through 64 YOA at the time of ICF signature.

• Participants with documented history of at least 1 episode of urine cultureconfirmed E. coli uncomplicated UTI in the last 12 months prior to study vaccineadministration.

Exclusion Criteria:

Medical conditions:

• History of any reaction or hypersensitivity likely to be exacerbated by anycomponent of the study intervention(s).

• Any confirmed or suspected immunosuppressive or immunodeficient condition, based onmedical history and physical examination.

• Hypersensitivity to latex.

• History of pIMD.

• Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renalfunctional abnormality, as determined by physical examination or laboratoryscreening tests.

• History of endocrinologic, hematologic, metabolic, urologic, dermatologic, orgastrointestinal conditions that, in the opinion of the investigator, places theparticipant at unacceptable risk or would make adhering to study procedures for theduration of the study difficult.

• Recurrent history or uncontrolled neurological disorders or any neuroinflammatory (including, but not limited to demyelinating disorders, encephalitis or myelitis ofany origin), congenital neurological conditions, encephalopathies, or seizures.

• Any behavioral or cognitive impairment or psychiatric disease that, in the opinionof the investigator, may interfere with the participant's ability to participate inthe study.

• Condition that in the judgment of the investigator would make intramuscularinjection unsafe.

• Any other clinical condition that, in the opinion of the investigator, might poseadditional risk to the participant due to participation in the study.

Additional exclusionary medical conditions only for participants in Part 1 of the study (SLI):

• Any clinically significant hematologic and/or biochemical laboratory abnormality at Screening Visit.

Additional exclusionary medical conditions only for participants in Part 2 of the study (PoP):

• The participant has UTI that is known or suspected to be due to fungal, parasitic,or viral pathogens; or known or suspected to be due to Pseudomonas aeruginosa or anyEnterobacter species.

• The participant has symptoms known or suspected to be caused by another diseaseprocess, such as asymptomatic bacteriuria, overactive bladder, chronic incontinence,or chronic interstitial cystitis, that may interfere with the clinical efficacyassessments.

• The participant has an anatomical or physiological anomaly that predisposes theparticipant to UTIs or may be a source of persistent bacterial colonization,including calculi, obstruction or stricture of the urinary tract, primary renaldisease or neurogenic bladder, or the participant has a history of anatomical orfunctional abnormalities of the urinary tract.

• The participant has an indwelling catheter, nephrostomy, ureteral stent, or otherforeign material in the urinary tract.

• The participant who, in the opinion of the investigator, has an otherwisecomplicated UTI or has an active upper UTI.

• Use of any investigational or non-registered product (drug, vaccine or invasivemedical device) other than the study intervention(s) during the period beginning 30days before the first dose of study intervention(s) (Day -29 to Day 1), or theirplanned use during the study period.

• Planned administration and/or administration of a vaccine not foreseen by the studyprotocol in the period starting 15 days before the first dose and ending 15 daysafter the last dose of study intervention(s) administration.

• Administration of immunoglobulins and/or any blood products or plasma derivativesduring the period starting 90 days before the study intervention or plannedadministration during the study period.

• Chronic administration of immune-modifying drugs (defined as more than 14consecutive days in total) and/or planned use of long-acting immune modifyingtreatments at any time up to the end of the study.

• Up to 3 months prior to the study intervention administration:

• For corticosteroids, this will mean prednisone equivalent >=20 mg/day for adultparticipants. Inhaled and topical steroids are allowed.

• Up to 3 months prior to study intervention administration: long-actingimmune-modifying drugs including among others immunotherapy (e.g.,TNF-inhibitors), monoclonal antibodies, antitumoral medication.

• Concurrently participating in another clinical study, at any time during the studyperiod, in which the participant has been or will be exposed to an investigationalor a non-investigational intervention (drug, vaccine or invasive medical device).

• Pregnant or lactating female participant.

• Female participant planning to become pregnant or planning to discontinuecontraceptive precautions before 1 month after completion of the study interventionadministration series.

• History of chronic alcohol consumption and/or drug abuse, based on investigatorjudgment.

• Persons under guardianship or trusteeship.

• Persons deprived of liberty.

• Any study personnel or their immediate dependents, family, or household members.