A Study of Three Different Doses of VAC52416 (ExPEC10V) in Adults Aged 60 to 85 Years in Stable Health

Phase 1

Active, not recruiting

• Conditions: Extraintestinal Pathogenic Escherichia Coli Prevention
• Interventions: Biological: ExPEC10V; Biological: ExPEC4V; Biological: Prevnar 13; Biological: Placebo

• Registration Number: NCT03819049
• Lead Sponsor: Janssen Research & Development, LLC

Brief Summary

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.

Detailed Description

ExPEC10V (JNJ-69968054) is a 10-valent vaccine candidate in development for prevention of invasive extraintestinal pathogenic Escherichia coli (ExPEC) disease (IED) in adults 60 years of age and older. ExPEC10V consists of O-antigen polysaccharides (PSs) of the ExPEC serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B and O75 separately bioconjugate to the carrier protein, a genetically detoxified form of exotoxin A (EPA) derived from Pseudomonas aeruginosa. Since, mechanism of action of conjugate vaccines in prevention of invasive disease is not expected to be affected by antibiotic resistance mechanisms, ExPEC10V vaccine may provide protection against IED caused by drug resistant and susceptible ExPEC serotypes. The study consists of two cohorts. Cohort 1 is comprised of three periods: a screening period (28 days), an observer-blind follow-up period (181 days) with vaccination on Day 1, and an open-label long term follow up (LTFU) period (from Day 182 until 5 years \[Day 1826\] post-vaccination). Cohort 2 is also comprised of three periods: a screening period (28 days), a double-blind follow-up period (181 days) with vaccination on Day 1, and a double-blind LTFU period (from Day 182 until 1 years \[Day 366\] post-vaccination). The end of Cohort 1 is considered as the Year 5 visit (Day 1826) for the last participant. The end of Cohort 2 is considered as the Year 1 visit (Day 366) for the last participant. Key immunogenicity assessments will include the assessment of ExPEC10V and ExPEC4V serotype-specific total immunoglobulin G antibody levels elicited by the vaccine and ExPEC10V and ExPEC4V serotype-specific functional antibodies. Key safety assessments include solicited local and systemic AEs, unsolicited AEs, SAEs, physical examinations, vital sign measurements, and, for Cohort 1 only, clinical laboratory tests. The total duration of the study is up to 5 years.

Study Timeline

• Study First Submitted: 2019-01-25
• Study First Submitted QC: 2019-01-25
• Study First Posted: 2019-01-28
• Study Start: 2019-06-06
• Primary Completion: 2021-06-08
• Disposition First Submitted: 2022-06-03
• Disposition First Submitted QC: 2022-06-03
• Disposition First Posted: 2022-06-07
• Results First Submitted: 2024-05-30
• Results First Submitted QC: 2024-05-30
• Results First Posted: 2024-06-25
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-10
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 836

Inclusion Criteria

• Must have a body mass index (BMI) of greater than (>) 18.5 or less than 40 kilogram per meter square (kg/m^2)
• Before randomization, a woman must be: postmenopausal - A postmenopausal state is defined as no menses for 12 months without an alternative medical cause; or not intending to conceive by any methods
• Must be healthy or medically stable
• Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
• Willing and able to adhere to the lifestyle restrictions specified in this protocol
• Agrees not to donate blood until 12 weeks after receiving the study vaccine

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Exclusion Criteria

• Acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature greater than equal to >=38.0 degree Celsius (100.4 degree Fahrenheit) within 24 hours prior to the administration of study vaccine, or, applicable for Cohort 2 only, an ongoing or suspected symptomatic urinary tract infection (UTI); enrollment at a later date is permitted (provided the screening window of 28 days is respected)
• History of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)
• Known allergies, hypersensitivity, or intolerance to ExPEC10V or its excipients
• Applicable for Cohort 1 only: known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine products (including any of the constituents of the active control vaccines)
• Contraindication to intramuscular (IM) injections and blood draws example, bleeding disorders
• Abnormal function of the immune system
• Has had major psychiatric illness and/or drug substance or alcohol abuse in the past 12 months

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1: ExPEC10V (High dose)	ExPEC10V	Participants will be randomized to receive a single IM injection of high dose ExPEC10V on Day 1.
Cohort 1: ExPEC10V (Medium dose)	ExPEC10V	Participants will be randomized to receive a single IM injection of medium dose ExPEC10V on Day 1.
Cohort 1: ExPEC4V	ExPEC4V	Participants will be randomized to receive a single IM injection of ExPEC4V on Day 1.
Cohort 1: Prevnar 13	Prevnar 13	Participants will be randomized to receive a single IM injection of Prevnar 13 on Day 1.
Cohort 2: ExPEC10V	ExPEC10V	Participants will be randomized to receive a single IM injection of selected dose of ExPEC10V on Day 1. The ExPEC10V dose used in Cohort 2 will be based on the primary analysis (Day 30) results of Cohort 1.
Cohort 2: Placebo	Placebo	Participants will be randomized to receive a single IM injection of matching placebo on Day 1.
Cohort 1: ExPEC10V (Low Dose)	ExPEC10V	Participants will be randomized to receive a single intramuscular (IM) injection of low dose ExPEC10V on Day 1.

Primary Outcome Measures

Name	Time	Method
Cohort 1: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 14 Days After Vaccination on Day 1	Up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15)	Number of participants with solicited local AEs for 14 days after vaccination on Day 1 were reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. Solicited local AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local (injection site) AEs included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site). All solicited AEs at the injection site (local) were considered related to the study vaccine administration.
Cohort 1: Number of Participants With Unsolicited Adverse Events (AEs) up to 29 Days After Vaccination on Day 1	Up to 29 days post vaccination on Day 1 (from Day 1 up to Day 30)	Number of participants with unsolicited AEs up to 29 days after vaccination on Day 1 were reported. An AE was any untoward medical occurrence in a clinical study administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.
Cohort 1: Number of Participants With Solicited Systemic Adverse Events (AEs) Collected for 14 Days After Vaccination on Day 1	Up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15)	Number of participants with solicited systemic AEs 14 days after vaccination on Day 1 were reported. An AE was any untoward medical occurrence in a clinical study administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. Solicited systemic AEs included fatigue, headache, nausea, fever and myalgia, for which participants were specifically questioned and which were noted by participants in their participant diary for 14 days post-vaccination (day of vaccination and the subsequent 14 days).
Cohort 2: Number of Participants With Solicited Systemic Adverse Events (AEs) Collected for 14 Days After Vaccination on Day 1	Up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15)	Number of participants with solicited systemic AEs 14 days after vaccination on Day 1 were reported. An AE was any untoward medical occurrence in a clinical study administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. Solicited systemic AEs included fatigue, headache, nausea, fever and myalgia, for which participants were specifically questioned and which were noted by participants in their participant diary for 14 days post-vaccination (day of vaccination and the subsequent 14 days).
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	Baseline (Day 1, pre-vaccination) and Day 15	GMR of fold changes from baseline for serotype specific antibodies as measured by multiplex ECL based immunoassay on Day 15 were reported. GMR for each antigen serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 and EPA were determined in serum from collected blood samples by multiplex ECL based immunoassay. GMR of fold change from baseline was calculated as the ratio of GMTs on Day 15 and pre-vaccination (on Day 1).
Cohort 1: Number of Participants With Serious Adverse Events (SAEs) up to Day 181	Day 1 (post vaccination) up to Day 181	Number of participants with SAEs up to Day 181 were reported. An AE was any untoward medical occurrence in a clinical study administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.
Cohort 2: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Collected for 14 Days After Vaccination on Day 1	Up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15)	Number of participants with solicited local AEs for 14 days after vaccination on Day 1 were reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. Solicited local AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local (injection site) AEs included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site). All solicited AEs at the injection site (local) were considered related to the study vaccine administration.
Cohort 2: Number of Participants With Unsolicited Adverse Events (AEs) 29 Days After Vaccination on Day 1	Up to 29 days post vaccination on Day 1 (from Day 1 up to Day 30)	Number of participants with unsolicited AEs up to 29 days after vaccination on Day 1 were reported. An AE was any untoward medical occurrence in a clinical study administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.
Cohort 2: Number of Participants With Serious Adverse Events (SAEs) up to Day 181	Day 1 (post vaccination) up to Day 181	Number of participants with SAEs up to Day 181 were reported. An AE was any untoward medical occurrence in a clinical study administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.
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	Day 15	GMTs of serotype-specific total IgG serum antibodies as measured by multiplex ECL based immunoassay were reported. GMTs for each antigen serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 and exotoxin protein A (EPA) were determined in serum from collected blood samples.
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	Baseline (Day 1, pre-vaccination) and Day 15	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 15 was reported. The fold (\>=2-fold and \>=4-fold) increase from baseline to Day 15 for the serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 and EPA was calculated as the ratio of titer values of serum antibody on Day 15 and pre-vaccination (on day 1) that is Day 15/Day 1.
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	Day 15	GMTs of serotype-specific total IgG serum antibodies as measured by MOPA were reported. GMTs for each antigen serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B and O75 were determined in serum from collected blood samples.
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Day 15	Baseline (Day 1, pre-vaccination), Day 15	GMR of fold changes from baseline for serotype specific antibodies as measured by MOPA on Day 15 were reported. GMR for each antigen serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B and O75 were determined in serum from collected blood samples by MOPA. GMR of fold change from baseline was calculated as the ratio of GMTs on Day 15 and pre-vaccination (on Day 1).
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	Baseline (Day 1, pre-vaccination) and Day 15	Percentage of participants with a \>=2-fold and \>=4-fold increase from baseline in serotype specific serum antibody titers as measured by MOPA on Day 15 was reported. The fold (\>=2-fold and \>=4-fold) increase from baseline to Day 15 for the serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, and O75 was calculated as the ratio of titer values of serum antibody on Day 15 and pre-vaccination (on day 1) that is, Day 15/Day 1.
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Day 30	Baseline (Day 1, pre-vaccination) and Day 30	GMR of fold changes from baseline for serotype specific antibodies as measured by MOPA on Day 30 were reported. GMR for each antigen serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B and O75 were determined in serum from collected blood samples by MOPA. GMR of fold change from baseline was calculated as the ratio of GMTs on Day 30 and pre-vaccination (on Day 1). For serotype O8 functional IgG serum antibodies were not evaluated as the assay was not able to detect vaccine-induced functional antibodies against the O8 serotype.
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	At Day 30	GMTs of serotype-specific total IgG serum antibodies as measured by multiplex ECL based immunoassay were reported. GMTs for each antigen serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 and EPA were determined in serum from collected blood samples.
Cohort 2: Geometric Mean Ratio (GMR) of Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Day 30	Baseline (Day 1, pre-vaccination) and Day 30	GMR of fold changes from baseline for serotype specific antibodies as measured by multiplex ECL based immunoassay on Day 30 were reported. GMR for each antigen serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 and EPA were determined in serum from collected blood samples by multiplex ECL based immunoassay. GMR of fold change from baseline was calculated as the ratio of GMTs on Day 30 and pre-vaccination (on Day 1).
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	Baseline (Day 1, pre-vaccination) and Day 30	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 was reported. The fold (\>=2-fold and \>=4-fold) increase from baseline to Day 30 for the serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 and EPA was calculated as the ratio of titer values of serum antibody on Day 30 and pre-vaccination (on day 1) that is, Day 30/Day 1.
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	At Day 30	GMTs of serotype-specific total IgG serum antibodies as measured by MOPA were reported. GMTs for each antigen serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B, and O75 were determined in serum from collected blood samples. For serotype O8 functional IgG serum antibodies were not evaluated as the assay was not able to detect vaccine-induced functional antibodies against the O8 serotype.
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	Baseline (Day 1, pre-vaccination) and Day 30	Percentage of participants with a \>=2-fold and \>=4-fold increase from baseline in serotype specific serum antibodies titers as measured by MOPA on Day 30 was reported. The fold (\>=2-fold and \>=4-fold) increase from baseline to Day 30 for the serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B and O75 was calculated as the ratio of titer values of serum antibodies on Day 30 and pre-vaccination (on day 1) that is, Day 30/Day 1. For serotype O8 functional IgG serum antibodies were not evaluated as the assay was not able to detect vaccine-induced functional antibodies against the O8 serotype.

Secondary Outcome Measures

Name	Time	Method
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 30 and 181	Baseline (Day 1, pre-vaccination), and Days 30 and 181	GMR of fold changes from baseline for serotype specific antibodies as measured by MOPA on Days 30 and 181 were reported. GMR for each antigen serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B and O75 were determined in serum from collected blood samples by MOPA. GMR of fold change from baseline was calculated as the ratio of GMTs on Days 30 and 181 and pre-vaccination (on Day 1).
Cohort 1: Geometric Mean Ratio (GMR) of Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 30 and 181	Baseline (Day 1, pre-vaccination) and Days 30 and 181	GMR of fold changes from baseline for serotype specific antibodies measured by multiplex ECL based immunoassay on Days 30 and 181 were reported. GMR for each antigen serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 and EPA were determined in serum from collected blood samples by ECL based immunoassay. GMR of fold change from baseline was calculated as the ratio of GMTs on Days 30 and 181 and pre-vaccination (on Day 1).
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181	Days 30 and 181	GMTs of serotype-specific total IgG serum antibodies as measured by ECL based immunoassay were reported. GMTs for each antigen serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 and EPA were determined in serum from collected blood samples.
Cohort 1: Geometric Mean Titer (GMT) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex Opsonophagocytic Assay (MOPA) on Days 30 and 181	At Days 30 and 181	GMTs of serotype-specific total IgG serum antibodies as measured by MOPA were reported. GMTs for each antigen serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B and O75 were determined in serum from collected blood samples.
Cohort 1: Geometric Mean Ratio (GMR) of Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826	Baseline (Day 1, pre-vaccination) and Days 366, 731, 1096, 1461, 1826	GMR of fold changes from baseline for serotype specific antibodies as measured by multiplex ECL based immunoassay on Days 366, 731, 1096, 1461 and 1826 were reported. GMR for each antigen serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 and EPA were determined in serum from collected blood samples by ECL based immunoassay. GMR of fold change from baseline was calculated as the ratio of GMTs on Days 366, 731, 1096, 1461 and 1826 and pre-vaccination (on Day 1).
Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Antibodies Against Specified Antigens Measured by MOPA on Day 181	At Day 181	GMTs of serotype-specific total IgG serum antibodies as measured by MOPA were reported. GMTs for each antigen serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B, and O75 were determined in serum from collected blood samples.
Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Antibodies Against Specified Antigens Measured by Multiplex ECL Based Immunoassay on Day 366	At Day 366	GMTs of serotype-specific antibodies as measured by ECL based immunoassay were reported. GMTs for the serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 and EPA were determined.
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 Days 30 and 181	Day 1 (pre-vaccination) and Days 30 and 181	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 Days 30 and 181 was reported. The fold (\>=2-fold and \>=4-fold) increase from baseline to Days 30 and 181 for the serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 and EPA was calculated as the ratio of titer values of serum antibody on Day 30 and Day 181 and pre-vaccination (on Day 1) that is, Day 30/Day 1 and Day 181/Day 1.
Cohort 1: Correlation Between the Multiplex ECL-Based Immunoassay and the MOPA Functional Titers by Serotypes on Day 15	Day 15	Correlation between the multiplex ECL-based immunoassay and the MOPA functional titers by serotypes on Day 15 will be analyzed.
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 30 and 181	Baseline (Day 1, pre-vaccination) and Days 30 and 181	Percentage of participants with a \>=2-fold and \>=4-fold increase from baseline in serotype specific serum antibody titers as measured by MOPA on Days 30 and 181 was reported. The fold (\>=2-fold and \>=4-fold) increase from baseline to Days 30 and 181 for the serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, and O75 was calculated as the ratio of titer values of serum antibody on Days 30 and 181 and pre-vaccination (on day 1) that is, Day 30/Day 1 and 181/Day 1.
Cohort 1: Number of Participants With Serious Adverse Events (SAEs) Related to Study Vaccine or Study Procedure From Day 182 up to End of Study (Day 1826)	From Day 182 up to end of study (Day 1826)	An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826	Days 366, 731, 1096, 1461 and 1826	GMTs of serotype-specific total IgG serum antibodies as measured by ECL based immunoassay were reported. GMTs for each antigen serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 and EPA were determined in serum from collected blood samples.
Cohort 1: 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 Days 366, 731, 1096, 1461 and 1826	Baseline (Day 1, pre-vaccination) and Days 366, 731, 1096, 1461, 1826	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 Days 366, 731, 1096, 1461 and 1826 was reported. The fold (\>=2-fold and \>=4-fold) increase from baseline to Days 366, 731, 1096, 1461 and 1826 for the serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 and EPA was calculated as the ratio of titer values of serum antibody on Days 366, 731, 1096, 1461 and 1826 and pre-vaccination (on day 1) that is, Day 366/Day 1, 731/Day 1, 1096/Day 1, 1461/Day 1 and 1826 /Day 1.
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, 1461 and 1826	Baseline (Day 1, pre-vaccination) and Days 366, 731, 1096, 1461, 1826	Percentage of participants with a \>=2-fold and \>=4-fold increase from baseline in serotype specific serum antibody titers as measured by MOPA on Days 366, 731, 1096, 1461 and 1826 was reported. The fold (\>=2-fold and \>=4-fold) increase from baseline to Days 366, 731, 1096, 1461 and 1826 for the serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, and O75 was calculated as the ratio of titer values of serum antibody on Days 366, 731, 1096, 1461 and 1826 and pre-vaccination (on day 1) that is, Day 366/Day 1, 731/Day 1, 1096/Day 1, 1461/Day 1 and 1826/Day 1.
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Day 181	Baseline (Day 1, pre-vaccination) and Day 181	Percentage of participants with a \>=2-fold and \>=4-fold increase from baseline in serotype specific serum antibody titers as measured by MOPA on Day 181 was reported. The fold (\>=2-fold and \>=4-fold) increase from baseline to Day 181 for the serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B and O75 was calculated as the ratio of titer values of serum antibody on Day 181 and pre-vaccination (on day 1) that is, Day 181/Day 1.
Cohort 1: Geometric Mean Titer (GMT) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 366, 731, 1096, 1461 and 1826	Days 366, 731, 1096, 1461 and 1826	GMTs of serotype-specific total IgG serum antibodies as measured by MOPA were reported. GMTs for each antigen serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B and O75 were determined in serum from collected blood samples.
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 366, 731, 1096, 1461 and 1826	Baseline (Day 1, pre-vaccination) and Days 366, 731, 1096, 1461, 1826	GMR of fold changes from baseline for serotype specific antibodies as measured by MOPA on Days 366, 731, 1096, 1461 and 1826 were reported. GMR for each antigen serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B and O75 were determined in serum from collected blood samples by MOPA. GMR of fold change from baseline was calculated as the ratio of GMTs on Days 366, 731, 1096, 1461 and 1826 and pre-vaccination (on Day 1).
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Days 15 and 181	Baseline (Day 1, pre-vaccination) and Days 15 and 181	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 Days 15 and 181 were reported. The fold (\>=2-fold and \>=4-fold) increase from baseline to Days 15 and 181 for the serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 and EPA was calculated as the ratio of titer values of serum antibody on Days 15 and 181 and pre-vaccination (on day 1) that is Day 15/Day 1 and Day 181/Day 1.
Cohort 2: Correlation Between the Multiplex ECL-Based Immunoassay and the MOPA Functional Titers by Serotype on Day 30	At Day 30	Correlation between the multiplex ECL-based immunoassay and the MOPA functional titers by serotype on Day 30 will be analyzed.
Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 15 and 181	At Days 15 and 181	GMTs of serotype-specific total IgG serum antibodies as measured by ECL based immunoassay were reported. GMTs for each antigen serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 and EPA were determined in serum from collected blood samples.
Cohort 2: Geometric Mean Ratio (GMR) of Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 15 and 181	Baseline (Day 1, pre-vaccination), Days 15 and 181	GMR of fold changes from baseline for serotype specific antibodies as measured by multiplex ECL based immunoassay on Days 15 and 181 were reported. GMR for each antigen serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 and EPA were determined in serum from collected blood samples by ECL based immunoassay. GMR of fold change from baseline was calculated as the ratio of GMTs on Days 15 and 181 and pre-vaccination (on Day 1).
Cohort 2: Geometric Mean Ratio (GMR) of Serotype-specific Antibodies Measured by MOPA on Day 181	Baseline (Day 1, pre-vaccination), Day 181	GMR of fold changes from baseline for serotype specific antibodies as measured by MOPA on Day 181 were reported. GMR for each antigen serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B and O75 were determined in serum from collected blood samples by MOPA. GMR of fold change from baseline was calculated as the ratio of GMTs on Day 181 and pre-vaccination (on Day 1).
Cohort 2: Number of Participants With Serious Adverse Events (SAEs) Related to Study Vaccine or Study Procedure From Day 182 up to End of Study (Day 1826)	From Day 182 up to end of study (Day 1826)	An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.
Cohort 2: Geometric Mean Ratio (GMR) of Serotype-specific Antibodies Measured by MOPA on Day 366	Baseline (Day 1, pre-vaccination), Day 366	GMR of fold changes from baseline for serotype specific antibodies as measured by MOPA on Day 366 were reported. GMR for each antigen serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B and O75 were determined in serum from collected blood samples by MOPA. GMR of fold change from baseline was calculated as the ratio of GMTs on Day 366 and pre-vaccination (on Day 1).
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Day 366	Baseline (Day 1, pre-vaccination) and Day 366	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 366 was reported. The fold (\>=2-fold and \>=4-fold) increase from baseline to Day 366 for the serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 and EPA was calculated as the ratio of titer values of serum antibodies on Day 366 and pre-vaccination (on day 1) that is, Day 366/Day 1.
Cohort 2: Geometric Mean Ratio (GMR) of Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Day 366	Baseline (Day 1, pre-vaccination), Day 366	GMR of fold changes from baseline for serotype specific antibodies as measured by multiplex ECL based immunoassay on Day 366 were reported. GMR for each antigen serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 and EPA were determined in serum from collected blood samples by ECL based immunoassay. GMR of fold change from baseline was calculated as the ratio of GMTs on Day 366 and pre-vaccination (on Day 1).
Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Antibodies Against Specified Antigens Measured by MOPA on Day 366	At Day 366	GMTs of serotype-specific total IgG serum antibodies as measured by MOPA were reported. GMTs for each antigen serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B, and O75 were determined in serum from collected blood samples.
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Day 366	Baseline (Day 1, pre-vaccination) and Day 366	Percentage of participants with a \>=2-fold and \>=4-fold increase from baseline in serotype specific serum antibody titers as measured by MOPA on Day 366 was reported. The fold (\>=2-fold and \>=4-fold) increase from baseline to Day 366 for the serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B and O75 was calculated as the ratio of titer values of serum antibody on Day 366 and pre-vaccination (on day 1) that is, Day 366/Day 1.

Trial Locations

Locations (23)

Qps-Mra, Llc; 🇺🇸 Miami, Florida, United States

Optimal Research; 🇺🇸 Peoria, Illinois, United States

Synexus Clinical Research US Inc; 🇺🇸 Columbus, Ohio, United States

Rochester Clinical Research, Inc; 🇺🇸 Rochester, New York, United States

ATC Pharma; 🇧🇪 Luik, Belgium

Anima; 🇧🇪 Alken, Belgium

Hopital Cochin; 🇫🇷 Paris, France

CHU Nantes; 🇫🇷 Nantes, France

APHP - Hopital Bichat - Claude Bernard; 🇫🇷 Paris, France

CHU Lyon Sud; 🇫🇷 Pierre Benite, France

Chu Rennes Hopital Pontchaillou; 🇫🇷 Rennes, France

PRA Health Sciences; 🇳🇱 Groningen, Netherlands

Hosp Reina Sofia; 🇪🇸 Córdoba, Spain

Hosp. Del Mar; 🇪🇸 Barcelona, Spain

EB Flevo Research; 🇳🇱 Almere, Netherlands

Hosp. Univ. de La Princesa; 🇪🇸 Madrid, Spain

Hosp. Univ. La Paz; 🇪🇸 Madrid, Spain

Hosp. Univ. Marques de Valdecilla; 🇪🇸 Santander, Spain

Hosp. Virgen Macarena; 🇪🇸 Sevilla, Spain

Johnson County Clin-Trials; 🇺🇸 Lenexa, Kansas, United States

Clinical Pharmacology Unit; 🇧🇪 Merksem, Belgium

Coastal Carolina Research Center; 🇺🇸 North Charleston, South Carolina, United States

CHRU Tours Hopital Bretonneau; 🇫🇷 Tours, France