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

COMBINATION_PRODUCT

Candidate UTI vaccine low dose formulation 1

Candidate UTI vaccine low dose formulation 1 administered intramuscularly according to a 0, 2 months administration schedule.

COMBINATION_PRODUCT

Candidate UTI vaccine low dose formulation 2

Candidate UTI vaccine low dose formulation 2 administered intramuscularly according to a 0, 2 months administration schedule.

COMBINATION_PRODUCT

Candidate UTI vaccine medium dose formulation 1

Candidate UTI vaccine medium dose formulation 1 administered intramuscularly according to a 0, 2 months administration schedule.

COMBINATION_PRODUCT

Candidate UTI vaccine medium dose formulation 2

Candidate UTI vaccine medium dose formulation 2 administered intramuscularly according to a 0, 2 months administration schedule.

COMBINATION_PRODUCT

Candidate UTI vaccine high dose formulation 1

Candidate UTI vaccine high dose formulation 1 administered intramuscularly according to a 0, 2 months administration schedule.

COMBINATION_PRODUCT

Candidate UTI vaccine high dose formulation 2

Candidate UTI vaccine high dose formulation 2 administered intramuscularly according to a 0, 2 months administration schedule.

COMBINATION_PRODUCT

Candidate UTI vaccine HTD formulation 2

Candidate UTI vaccine HTD formulation 2 administered intramuscularly according to a 0, 2 months administration schedule.

COMBINATION_PRODUCT

Placebo

Placebo administered intramuscularly according to a 0, 2 months administration schedule.

Part 1 and 2: Number of participants reporting solicited administration site adverse events (AEs)

Time frame: During the 7 days follow-up period post-Dose 1 (study intervention administered at Day 1)

Solicited administration site events include pain, redness and swelling at administration site.

Part 1 and 2: Number of participants reporting solicited administration site AEs

Time frame: During the 7 days follow-up period post-Dose 2 (study intervention administered at Day 61)

Solicited administration site events include pain, redness and swelling at administration site.

Part 1 and 2: Number of participants reporting solicited systemic AEs

Time frame: During the 7 days follow-up period post-Dose 1 (study intervention administered at Day 1)

Solicited systemic events include fever, headache, myalgia (muscle pain), arthralgia (joint pain), and fatigue (tiredness). Fever is defined as temperature greater than or equal to (\>=) 38.0°C and preferred location for measuring temperature is the axilla.

Part 1 and 2: Number of participants reporting solicited systemic AEs

Time frame: During the 7 days follow-up period post-Dose 2 (study intervention administered at Day 61)

Solicited systemic events include fever, headache, myalgia (muscle pain), arthralgia (joint pain), and fatigue (tiredness). Fever is defined as temperature \>=38.0°C and preferred location for measuring temperature is the axilla.

Part 1 and 2: Number of participants reporting unsolicited AEs

Time frame: During the 30 days follow-up period post-Dose 1 (study intervention administered at Day 1)

An unsolicited AE is an AE that is either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events.

Part 1 and 2: Number of participants reporting unsolicited AEs

Time frame: During the 30 days follow-up period post-Dose 2 (study intervention administered at Day 61)

An unsolicited AE is an AE that is either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events.

Part 1 and 2: Number of participants reporting any immediate unsolicited AEs

Time frame: During the 60 minutes follow-up period post-Dose 1 (study intervention administered at Day 1)

An unsolicited AE is an AE that is either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events.

Part 1 and 2: Number of participants reporting any immediate unsolicited AEs

Time frame: During the 60 minutes follow-up period post-Dose 2 (study intervention administered at Day 61)

An unsolicited AE is an AE that is either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events.

Part 1 and 2: Number of participants reporting serious adverse events (SAEs)

Time frame: From Day 1 (Dose 1 administration) until Day 426 (end of follow-up)

An SAE is defined as any untoward medical occurrence that results in death, is life threatening, requires hospitalization or prolongs existing hospitalization, results in disability/incapacity or other medically significant events.

Part 1 and 2: Number of participants reporting potential immune-mediated diseases (pIMDs) leading to study withdrawal

Time frame: From Day 1 (Dose 1 administration) until Day 426 (end of follow-up)

pIMDs are a subset of Adverse Events of Special Interest (AESIs) that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.

Part 1 and 2: Number of participants reporting medically-attended adverse events (MAAEs) leading to study withdrawal

Time frame: From Day 1 (Dose 1 administration) until Day 426 (end of follow-up)

An MAAE is defined as an unsolicited AE, such as a symptom or illness, which required hospitalization, or emergency room visit, or visit to/by a health care provider.

Part 1 and 2: Number of participants reporting AEs leading to study withdrawal

Time frame: From Day 1 (Dose 1 administration) until Day 426 (end of follow-up)

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.

Part 1: Number of participants with hematology or biochemistry abnormalities or changes in baseline value

Time frame: 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

Time frame: 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

Time frame: From 14 days (Day 75) up to 12 months (Day 426) post-Dose 2

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.