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.

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).

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.

FAS included all randomized participants with a vaccine administration documented.

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.

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.

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).

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.

FAS included all randomized participants with a vaccine administration documented.

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.

FAS included all randomized participants with a vaccine administration documented.

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. Lower limit of quantification (LLOQ) values for O1A: 69149, O2: 65287, O4: 67356, O6A: 150748, O8: 72196, O15: 66910, O16: 71586, O18A: 70519, O25B: 61990, O75: 133019, and EPA: 66165. Any titer less than LLOQ is replaced by half of LLOQ (0.5*LLOQ).

Per-protocol immunogenicity (PPI) analysis set: 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"(Number of participants analyzed)signifies participants evaluable for this endpoint and "n" 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). Any titer less than LLOQ is replaced by value of LLOQ.

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" (Number of participants analyzed) signifies participants evaluable for this endpoint and "n" signifies those participants who were evaluable at specified categories.

Percentage of participants with a >=2-fold and >=4-fold increase (FI) 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. Any titer less than LLOQ is replaced by value of LLOQ.

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" (Number of participants analyzed) signifies participants evaluable for this endpoint and "n" 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. LLOQ values were: O1A: 53, O2: 51, O4: 29, O6A: 47, O8: 196, O15: 37, O16: 54, O18A: 12, O25B: 65, and O75: 37. Any titer less than LLOQ is replaced by half of LLOQ (0.5*LLOQ).

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" (Number of participants analyzed) signifies participants evaluable for this endpoint and "n" 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 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). Any titer less than LLOQ is replaced by value of LLOQ.

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" (Number of participants analyzed) signifies participants evaluable for this endpoint and "n" 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 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. Any titer less than LLOQ is replaced by value of LLOQ.

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" (Number of participants analyzed) signifies participants evaluable for this endpoint and "n" 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. LLOQ values for O1A: 69149, O2: 65287, O4: 67356, O6A: 150748, O8: 72196, O15: 66910, O16: 71586, O18A: 70519, O25B: 61990, O75: 133019, and EPA: 66165. Any titer less than LLOQ is replaced by half of LLOQ (0.5*LLOQ).

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" (number of participants analyzed) signifies participants evaluable for this endpoint.

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). Any titer less than LLOQ is replaced by value of LLOQ.

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" (number of participants analyzed) signifies participants evaluable for this endpoint.

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. Any titer less than LLOQ is replaced by value of LLOQ.

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" (number of participants analyzed) signifies participants evaluable for this endpoint.

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. LLOQ values were O1A: 33, O2: 42, O4: 12, O6A: 62, O15: 75, O16: 17, O18A: 44, O25B: 58, O75: 14. Any titer less than LLOQ is replaced by half of LLOQ (0.5*LLOQ).

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" (number of participants analyzed) signifies participants evaluable for this endpoint and "n" 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. Any titer less than LLOQ is replaced by value of LLOQ.

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" (number of participants analyzed) signifies participants evaluable for this outcome measure and "n" 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 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. Any titer less than LLOQ is replaced by value of LLOQ.

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" (Number of participants analyzed) signifies participants evaluable for this endpoint and "n" signifies those participants who were evaluable at specified categories.

Correlation between the multiplex ECL-based immunoassay and the MOPA functional titers by serotypes (O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B and O75) on Day 15 were analyzed. Any titer less than LLOQ is replaced by half of LLOQ (0.5*LLOQ).

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 endpoint. Here, "N" (Number of participants analyzed) signifies participants evaluable for this outcome measure and "n" signifies those participants who were evaluable at specified categories.

GMTs of serotype-specific total IgG serum antibodies as measured by multiplex ECL based immunoassay on Days 30 and 181 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. LLOQ values for O1A: 69149, O2: 65287, O4: 67356, O6A: 150748, O8: 72196, O15: 66910, O16: 71586, O18A: 70519, O25B: 61990, O75: 133019, and EPA: 66165. Any titer less than LLOQ is replaced by half of LLOQ (0.5*LLOQ).

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" (Number of participants analyzed) signifies participants evaluable for this endpoint and "n" signifies those participants who were evaluable at specified categories.

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). Any titer less than LLOQ is replaced by value of LLOQ.

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" (Number of participants analyzed) signifies participants evaluable for this endpoint and "n" signifies those participants who were evaluable at specified categories.

Percentage of participants with a >=2-fold and >=4-fold increase from baseline in serotype (ST)-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). Any titer less than LLOQ is replaced by value of LLOQ.

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" (Number of participants analyzed) signifies participants evaluable for this endpoint and "n" signifies those participants who were evaluable at specified categories.

GMRs for each O-antigen (serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B and O75) were determined using a validated MOPA. For sample pairs with available validated MOPA results from both Day 1 and Day 30, or Day 1 and 181, GMR from baseline for serotype specific antibodies was calculated as the ratio of GMTs on Days 30 or 181 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. Any titer less than LLOQ is replaced by value of LLOQ.

PPI analysis set used. "N" = number of participants evaluable for the endpoint. High dose ExPEC10V and Prevnar 13: validated MOPA at all timepoints. Low and medium ExPEC10V and ExPEC4V: Day 1 tested with qualified MOPA; Days 30 and 181 with validated MOPA. GMRs require data from the same assay at both timepoints. Because validated MOPA data are missing at Day 1 for low and medium ExPEC10V and ExPEC4V, GMRs could not be calculated.

GMTs of serotype-specific total IgG serum antibodies as measured by MOPA on Days 30 and 181 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. LLOQ values were O1A: 33, O2: 42, O4: 12, O6A: 62, O15: 75, O16: 17, O18A: 44, O25B: 58, O75: 14. Any titer less than LLOQ is replaced by half of LLOQ (0.5*LLOQ).

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" (number of participants analyzed) signifies participants evaluable for this outcome measure. High dose ExPEC10V and Prevnar 13: validated MOPA at all timepoints. Low and medium ExPEC10V and ExPEC4V: Day 1 tested with qualified MOPA; Days 30 and 181 with validated MOPA.

For sample pairs with available validated MOPA results, for each O-antigen (serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B and O75), the fold increase was calculated as the ratio of validated MOPA results on Days 30 or 181 and pre-vaccination (Day 30/Day 1 and 181/Day 1). The percentage of participants with >=2-fold and >=4-fold increase in serotype-specific serum antibody titers was calculated. 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. Any titer less than LLOQ is replaced by value of LLOQ.

PPI analysis set used. "N" = number of participants evaluable for the endpoint. High dose ExPEC10V and Prevnar 13: validated MOPA at all timepoints. Low and medium ExPEC10V and ExPEC4V: Day 1 tested with qualified MOPA; Days 30 and 181 with validated MOPA. Percentage of participants with a >= 2-fold and >=4-fold require data from the same assay at both timepoints. Because validated MOPA data are missing at Day 1 for low and medium ExPEC10V and ExPEC4V, fold change could not be calculated.

Number of participants with SAEs related to study vaccine or study procedure was reported. 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 understudy. 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.

The FAS included all randomized participants with a vaccine administration documented.

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. LLOQ values for O1A: 69149, O2: 65287, O4: 67356, O6A: 150748, O8: 72196, O15: 66910, O16: 71586, O18A: 70519, O25B: 61990, O75: 133019, and EPA: 66165. Any titer less than LLOQ is replaced by half of LLOQ (0.5*LLOQ).

PPI analysis set used. "N" (number of participants analyzed): participants evaluable for this endpoint and "n" (number analyzed): participants evaluable at specified categories. Data for this endpoint was planned to be collected and analyzed only on the ExPEC10V dose selected for further clinical development based on Day 30 primary analysis. Since high-dose ExPEC10V was selected and Prevnar 13 was continued as comparator, only data from these groups is available.

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. Any titer less than LLOQ is replaced by value of LLOQ.

PPI analysis set used. Here, "N" (number of participants analyzed) signifies participants evaluable for this outcome measure. Data for this endpoint was planned to be collected and analyzed only on the ExPEC10V dose selected for further clinical development based on Day 30 primary analysis. Since high-dose ExPEC10V was selected and Prevnar 13 was continued as comparator, only data from these groups is available.

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). Any titer less than LLOQ is replaced by value of LLOQ.

PPI analysis set used. Here, "N" (number of participants analyzed) signifies participants evaluable for this endpoint. Data for this endpoint was planned to be collected and analyzed only on the ExPEC10V dose selected for further clinical development based on Day 30 primary analysis. Since high-dose ExPEC10V was selected and Prevnar 13 was continued as comparator, only data from these groups is available.

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. Data was planned to be analyzed for specified arms only. LLOQ values for O1A: 33, O2: 42, O4: 12, O6A: 62, O15: 75, O16: 17, O18A: 44, O25B: 58, O75: 14. Any titer less than LLOQ is replaced by half of LLOQ (0.5*LLOQ).

PPI analysis set used. Here, "N" (number of participants analyzed) signifies participants evaluable for this endpoint. Data for this endpoint was planned to be collected and analyzed only on the ExPEC10V dose selected for further clinical development based on Day 30 primary analysis. Since high-dose ExPEC10V was selected and Prevnar 13 was continued as comparator, only data from these groups is available.

GMR of fold changes from baseline for serotype specific antibodies as measured by MOPA on Days 366, 731, 1096, 1461 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 Days 366, 731, 1096, 1461 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. Any titer less than LLOQ is replaced by value of LLOQ.

PPI analysis set used. Here, "N" (number of participants analyzed) signifies participants evaluable for this endpoint. Data for this endpoint was planned to be collected and analyzed only on the ExPEC10V dose selected for further clinical development based on Day 30 primary analysis. Since high-dose ExPEC10V was selected and Prevnar 13 was continued as comparator, only data from these groups is available.

The fold (>=2-fold and >=4-fold) increase from baseline to Days 366, 731, 1096, and 1461 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 Days 366, 731, 1096, 1461 and pre-vaccination (on day 1) that is, Day 366/Day 1, 731/Day 1, 1096/Day 1, 1461/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. Any titer less than LLOQ is replaced by value of LLOQ.

PPI analysis set used. "N" (number of participants analyzed): participants evaluable for this endpoint and "n" (number analyzed): participants evaluable at specified categories. Data for this endpoint was planned to be collected and analyzed only on the ExPEC10V dose selected for further clinical development based on Day 30 primary analysis. Since high-dose ExPEC10V was selected and Prevnar 13 was continued as comparator, only data from these groups is available.

Correlation between the multiplex ECL-based immunoassay and the MOPA functional titers by serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B, and O75 on Day 30 was analyzed. Data was planned to be analyzed for specified arms only. 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.

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" (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 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. Data was planned to be analyzed for specified arms only. LLOQ values for O1A: 69149, O2: 65287, O4: 67356, O6A: 150748, O8: 72196, O15: 66910, O16: 71586, O18A: 70519, O25B: 61990, O75: 133019, and EPA: 66165. Any titer less than LLOQ is replaced by half of LLOQ (0.5*LLOQ).

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" ( 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 Days 15 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 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). Any titer less than LLOQ is replaced by value of LLOQ.

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" ( 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 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 increase from baseline to Days 15 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 15 and 181 and pre-vaccination (on Day 1 that is Day 15/Day 1 and Day 181/Day 1).

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" (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 >=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 (>=4-fold increase from baseline to Days 15 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 15 and 181 and pre-vaccination (on Day 1 that is Day 15/Day 1 and Day 181/Day 1).

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" (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. 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. LLOQ values for O1A: 33, O2: 42, O4: 12, O6A: 62, O15: 75, O16: 17, O18A: 44, O25B: 58, O75: 14. Any titer less than LLOQ is replaced by half of LLOQ (0.5*LLOQ).

PPI analysis set included all randomized and vaccinated participants, for whom immunogenicity data were available excluding those samples with major protocol deviations expected to impact the immunogenicity outcomes. Participants in this analysis set had to have at least a baseline antibody titer measurement. Here, "N" (Number of participants analyzed) signifies participants evaluable for this endpoint.

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. 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. Any titer less than LLOQ is replaced by value of LLOQ.

The PPI analysis set included all randomized and vaccinated participants, for whom immunogenicity data were available excluding those samples with major protocol deviations expected to impact the immunogenicity outcomes. Participants in this analysis set had to have at least a baseline antibody titer measurement. Here, "N" (Number of participants analyzed) signifies participants evaluable for this endpoint.

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). 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. Any titer less than LLOQ is replaced by value of LLOQ.

The PPI analysis set included all randomized and vaccinated participants, for whom immunogenicity data were available excluding those samples with major protocol deviations expected to impact the immunogenicity outcomes. Participants in this analysis set had to have at least a baseline antibody titer measurement. Here, "N" (number of participants analyzed) signifies participants evaluable for this outcome measure.

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.

The FAS included all randomized participants with a vaccine administration documented.

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 were determined. Any titer less than LLOQ is replaced by half of LLOQ (0.5*LLOQ).

The PPI analysis set included all randomized and vaccinated participants, for whom immunogenicity data were available excluding those samples with major protocol deviations expected to impact the immunogenicity outcomes. Participants in this analysis set had to have at least a baseline antibody titer measurement. 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 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 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. Any titer less than LLOQ is replaced by value of LLOQ.

The PPI analysis set included all randomized and vaccinated participants, for whom immunogenicity data were available excluding those samples with major protocol deviations expected to impact the immunogenicity outcomes. Participants in this analysis set had to have at least a baseline antibody titer measurement. Here, "N" (Number of participants analyzed) signifies participants evaluable for this endpoint.

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 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). Any titer less than LLOQ is replaced by value of LLOQ.

The PPI analysis set included all randomized and vaccinated participants, for whom immunogenicity data were available excluding those samples with major protocol deviations expected to impact the immunogenicity outcomes. Participants in this analysis set had to have at least a baseline antibody titer measurement. Here, "N" (Number of participants analyzed) signifies participants evaluable for this endpoint.

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. LLOQ values for O1A: 33, O2: 42, O4: 12, O6A: 62, O15: 75, O16: 17, O18A: 44, O25B: 58, O75: 14. Any titer less than LLOQ is replaced by half of LLOQ (0.5*LLOQ).

The PPI analysis set included all randomized and vaccinated participants, for whom immunogenicity data were available excluding those samples with major protocol deviations expected to impact the immunogenicity outcomes. Participants in this analysis set had to have at least a baseline antibody titer measurement. Here, "N" (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.

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). 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. Any titer less than LLOQ is replaced by value of LLOQ.

The PPI analysis set included all randomized and vaccinated participants, for whom immunogenicity data were available excluding those samples with major protocol deviations expected to impact the immunogenicity outcomes. Participants in this analysis set had to have at least a baseline antibody titer measurement. Here, "N" (Number of participants analyzed) signifies participants evaluable for this endpoint.

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 >=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. 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. Any titer less than LLOQ is replaced by value of LLOQ.

The PPI analysis set included all randomized and vaccinated participants, for whom immunogenicity data were available excluding those samples with major protocol deviations expected to impact the immunogenicity outcomes. Participants in this analysis set had to have at least a baseline antibody titer measurement. Here, "N" (Number of participants analyzed) signifies participants evaluable for this endpoint.