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

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).

Time frame: Baseline (Day 1, pre-vaccination), Day 15

Population: PPI analysis set included all randomized and vaccinated participants, for whom immunogenicity data were available excluding participants with major protocol deviations expected to impact the immunogenicity outcomes. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure and n (number analyzed) signifies those participants who were evaluable at specified categories.

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).

Time frame: Baseline (Day 1, pre-vaccination) and Day 15

Population: PPI analysis set included all randomized and vaccinated participants, for whom immunogenicity data were available excluding participants with major protocol deviations expected to impact the immunogenicity outcomes. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure and n (number analyzed) signifies those participants who were evaluable at specified categories.

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.

Time frame: Day 15

Population: PPI analysis set included all randomized and vaccinated participants, for whom immunogenicity data were available excluding participants with major protocol deviations expected to impact the immunogenicity outcomes. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure and n (number analyzed) signifies those participants who were evaluable at specified categories.

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.

Time frame: Day 15

Population: Per-protocol immunogenicity (PPI) analysis set included all randomized and vaccinated participants, for whom immunogenicity data were available excluding participants with major protocol deviations expected to impact the immunogenicity outcomes. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure and n (number analyzed) signifies those participants who were evaluable at specified categories.

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.

Time frame: Day 1 (post vaccination) up to Day 181

Population: FAS included all randomized participants with a vaccine administration documented.

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.

Time frame: Up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15)

Population: Full analysis set (FAS) included all randomized participants with a vaccine administration documented.

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).

Time frame: Up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15)

Population: FAS included all randomized participants with a vaccine administration documented.

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.

Time frame: Up to 29 days post vaccination on Day 1 (from Day 1 up to Day 30)

Population: FAS included all randomized participants with a vaccine administration documented.

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.

Time frame: Baseline (Day 1, pre-vaccination) and Day 15

Population: PPI analysis set included all randomized and vaccinated participants, for whom immunogenicity data were available excluding participants with major protocol deviations expected to impact the immunogenicity outcomes. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure and n (number analyzed) signifies those participants who were evaluable at specified categories.

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.

Time frame: Baseline (Day 1, pre-vaccination) and Day 15

Population: PPI analysis set included all randomized and vaccinated participants, for whom immunogenicity data were available excluding participants with major protocol deviations expected to impact the immunogenicity outcomes. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure and n (number analyzed) signifies those participants who were evaluable at specified categories.

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.

Time frame: Baseline (Day 1, pre-vaccination) and Day 30

Population: PPI analysis set included all randomized and vaccinated participants, for whom immunogenicity data were available excluding participants with major protocol deviations expected to impact the immunogenicity outcomes. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure and n (number analyzed) signifies those participants who were evaluable at specified categories.

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).

Time frame: Baseline (Day 1, pre-vaccination) and Day 30

Population: PPI analysis set included all randomized and vaccinated participants, for whom immunogenicity data were available excluding participants with major protocol deviations expected to impact the immunogenicity outcomes. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.

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.

Time frame: At Day 30

Population: PPI analysis set included all randomized and vaccinated participants, for whom immunogenicity data were available excluding participants with major protocol deviations expected to impact the immunogenicity outcomes. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure and n (number analyzed) signifies those participants who were evaluable at specified categories.

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.

Time frame: At Day 30

Population: PPI analysis set included all randomized and vaccinated participants, for whom immunogenicity data were available excluding participants with major protocol deviations expected to impact the immunogenicity outcomes. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.

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.

Time frame: Day 1 (post vaccination) up to Day 181

Population: FAS included all randomized participants with a vaccine administration documented.

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.

Time frame: Up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15)

Population: FAS included all randomized participants with a vaccine administration documented.

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).

Time frame: Up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15)

Population: FAS included all randomized participants with a vaccine administration documented.

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.

Time frame: Up to 29 days post vaccination on Day 1 (from Day 1 up to Day 30)

Population: FAS included all randomized participants with a vaccine administration documented.

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.

Time frame: Baseline (Day 1, pre-vaccination) and Day 30

Population: PPI analysis set included all randomized and vaccinated participants, for whom immunogenicity data were available excluding participants with major protocol deviations expected to impact the immunogenicity outcomes. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.

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.

Time frame: Baseline (Day 1, pre-vaccination) and Day 30

Population: PPI analysis set included all randomized and vaccinated participants, for whom immunogenicity data were available excluding participants with major protocol deviations expected to impact the immunogenicity outcomes. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure and n (number analyzed) signifies those participants who were evaluable at specified categories.

Correlation between the multiplex ECL-based immunoassay and the MOPA functional titers by serotypes on Day 15 will be analyzed.

Time frame: Day 15

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).

Time frame: 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 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).

Time frame: Baseline (Day 1, pre-vaccination) and Days 366, 731, 1096, 1461, 1826

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).

Time frame: Baseline (Day 1, pre-vaccination) and Days 30 and 181

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).

Time frame: Baseline (Day 1, pre-vaccination) and Days 366, 731, 1096, 1461, 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.

Time frame: 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.

Time frame: At 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.

Time frame: 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.

Time frame: Days 366, 731, 1096, 1461 and 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.

Time frame: From Day 182 up to end of study (Day 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.

Time frame: 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 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.

Time frame: 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 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.

Time frame: 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 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.

Time frame: Day 1 (pre-vaccination) and Days 30 and 181

Correlation between the multiplex ECL-based immunoassay and the MOPA functional titers by serotype on Day 30 will be analyzed.

Time frame: At Day 30

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).

Time frame: Baseline (Day 1, pre-vaccination), Day 181

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).

Time frame: 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).

Time frame: 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 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).

Time frame: Baseline (Day 1, pre-vaccination), Days 15 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, O15, O16, O18A, O25B, and O75 were determined in serum from collected blood samples.

Time frame: 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.

Time frame: 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.

Time frame: At Day 366

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.

Time frame: At Days 15 and 181

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.

Time frame: From Day 182 up to end of study (Day 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 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.

Time frame: 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 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.

Time frame: 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.

Time frame: 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 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.

Time frame: Baseline (Day 1, pre-vaccination) and Days 15 and 181