The purpose of this study is to assess the safety, reactogenicity, and immunogenicity of 3 different doses of ExPEC10V and to select the optimal dose for further clinical development (Cohort 1). Cohort 2 is aimed to expand the dataset supporting the short- and long-term safety and immunogenicity of the optimal dose of ExPEC10V, selected from the primary analysis results of Cohort 1. Cohort 2 will include participants in stable health with a history of urinary tract infection (UTI) in the past 5 years and will be included in the study to support the plan for late stage development of ExPEC vaccine.
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Cohort 1: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 14 Days After Vaccination on Day 1
Timeframe: Up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15)
Cohort 1: Number of Participants With Solicited Systemic Adverse Events (AEs) Collected for 14 Days After Vaccination on Day 1
Timeframe: Up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15)
Cohort 1: Number of Participants With Unsolicited Adverse Events (AEs) up to 29 Days After Vaccination on Day 1
Timeframe: Up to 29 days post vaccination on Day 1 (from Day 1 up to Day 30)
Cohort 1: Number of Participants With Serious Adverse Events (SAEs) up to Day 181
Timeframe: Day 1 (post vaccination) up to Day 181
Cohort 2: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Collected for 14 Days After Vaccination on Day 1
Timeframe: Up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15)
Cohort 2: Number of Participants With Solicited Systemic Adverse Events (AEs) Collected for 14 Days After Vaccination on Day 1
Timeframe: Up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15)
Cohort 2: Number of Participants With Unsolicited Adverse Events (AEs) 29 Days After Vaccination on Day 1
Timeframe: Up to 29 days post vaccination on Day 1 (from Day 1 up to Day 30)
Cohort 2: Number of Participants With Serious Adverse Events (SAEs) up to Day 181
Timeframe: Day 1 (post vaccination) up to Day 181
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex Electrochemiluminescent (ECL) Based Immunoassay on Day 15
Timeframe: Day 15
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by Multiplex ECL Based Immunoassay on Day 15
Timeframe: Baseline (Day 1, pre-vaccination) and Day 15
Cohort 1: Percentage of Participants With a Greater Than or Equal to (>=) 2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Day 15
Timeframe: Baseline (Day 1, pre-vaccination) and Day 15
Cohort 1: Geometric Mean Titers (GMT) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex Opsonophagocytic Assay (MOPA) on Day 15
Timeframe: Day 15
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Day 15
Timeframe: Baseline (Day 1, pre-vaccination), Day 15
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Day 15
Timeframe: Baseline (Day 1, pre-vaccination) and Day 15
Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Day 30
Timeframe: At Day 30
Cohort 2: Geometric Mean Ratio (GMR) of Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Day 30
Timeframe: Baseline (Day 1, pre-vaccination) and Day 30
Cohort 2: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Day 30
Timeframe: Baseline (Day 1, pre-vaccination) and Day 30
Cohort 2: Geometric Mean Titer (GMT) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex Opsonophagocytic Assay (MOPA) on Day 30
Timeframe: At Day 30
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Day 30
Timeframe: Baseline (Day 1, pre-vaccination) and Day 30
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibodies Titers Measured by MOPA on Day 30
Timeframe: Baseline (Day 1, pre-vaccination) and Day 30