A Study to Evaluate Safety and Immunogenicity of the ExPEC4V Clinical Trial Material After a Single Intramuscular Dose and a Second Dose 6 Months Later in Healthy Participants Aged 18 Years and Older
Condition: Healthy
Intervention: ExPEC4V; Placebo
Intervention description: Participants will receive ExPEC4V vaccine as an IM injection on Days 1 and 181.; Participants will receive placebo as an IM injection on Days 1 and 181.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the safety/reactogenicity of the ExPEC4V clinical
      trial material (CTM) after the first vaccination and to evaluate the immunogenicity of the
      ExPEC4V CTM, as measured by the enzyme-linked immunosorbent assay (ELISA), 14 days after the
      first vaccination (on Day 15).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who provides written informed consent and signs the informed consent form
             (ICF) indicating that he or she understands the purpose, procedures and potential
             risks and benefits of the study, and is willing to participate in the study

          -  Participant is medically stable as confirmed by documented medical history, physical
             examination and vital signs. Participant may have underlying illnesses such as
             hypertension, diabetes, or ischemic heart disease, as long as their symptoms/signs are
             medically controlled. If he/she is on medication for a condition, the medication dose
             must have been stable for at least 12 weeks preceding vaccination

          -  Participant must have a body mass index (BMI) of less than or equal to (<=)35.0
             kilogram per square meter (kg/m^2)

          -  Contraceptive (birth control) use by woman should be consistent with local regulations
             regarding the acceptable methods of contraception for participant participating in
             clinical studies

          -  All females of childbearing potential must have a negative urine beta-human chorionic
             gonadotropin (beta-hCG) at pregnancy test on Visit 1 (pre-vaccination) and Visit 4
             (prior to the second vaccination)

        Exclusion Criteria:

          -  Participant with contraindication to intramuscular (IM) injections and blood draws,
             for example, bleeding disorders

          -  Participant with known allergies, hypersensitivity, or intolerance to ExPEC4V or its
             excipients

          -  Participant with abnormal function of the immune system resulting from: a) clinical
             conditions (for example, autoimmune disease or immunodeficiency); b) chronic or
             recurrent use of systemic corticosteroids; c) administration of antineoplastic and
             immunomodulating agents or radiotherapy

          -  Participant has a history of neoplastic disease (excluding non-melanoma skin cancer or
             carcinoma in situ of the cervix that was successfully treated) within the past 1 year
             or a history of any hematological malignancy

          -  Participant with history of acute polyneuropathy (for example, Guillain-Barre
             syndrome)

          -  Participant who has a history of an underlying clinically significant acute or
             (uncontrolled) chronic medical condition or physical examination findings for which,
             in the opinion of the investigator, participation would not be in the best interest of
             the participant (for example, compromise the well-being) or that could prevent, limit,
             or confound the protocol-specified assessments