Trial Outcomes & Findings for A Study of Three Different Doses of VAC52416 (ExPEC10V) in Adults Aged 60 to 85 Years in Stable Health (NCT NCT03819049)

NCT ID: NCT03819049

Last Updated: 2025-05-25

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 836 participants
• Primary outcome timeframe: At Day 30
• Results posted on: 2025-05-25

Participant Flow

Participant milestones

Measure	Cohort 1: Low Dose ExPEC10V Participants aged greater than or equal to (\>=) 60 to less than or equal to (\<=) 85 years in stable health with or without a history of urinary tract infection (UTI) received a single 0.5 milliliter (mL) intramuscular (IM) injection of ExPEC10V low dose (88 micrograms polysaccharide per milliliter \[mcg PS/mL\]) on Day 1.	Cohort 1: Medium Dose ExPEC10V Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC10V medium dose (120 mcg PS/mL) on Day 1.	Cohort 1: High Dose ExPEC10V Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC10V high dose (176 mcg PS/mL) on Day 1.	Cohort 1: ExPEC4V Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC4V 40 mcg PS/mL on Day 1.	Cohort 1: Prevnar 13 Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of Prevnar 13 on Day 1.	Cohort 2: ExPEC10V High Dose Participants aged \>=60 years in stable health with a history of UTI received a single 0.5 mL IM injection of ExPEC10V high dose (176 mcg PS/mL) on Day 1.	Cohort 2: Placebo Participants aged \>=60 years in stable health with a history of UTI received a single 0.5 mL IM injection of placebo (matched to ExPEC10V high dose) on Day 1.
Overall Study STARTED	104	102	104	53	54	280	139
Overall Study Vaccinated	104	102	104	52	54	278	138
Overall Study COMPLETED	103	100	0	52	0	268	136
Overall Study NOT COMPLETED	1	2	104	1	54	12	3

Reasons for withdrawal

Measure	Cohort 1: Low Dose ExPEC10V Participants aged greater than or equal to (\>=) 60 to less than or equal to (\<=) 85 years in stable health with or without a history of urinary tract infection (UTI) received a single 0.5 milliliter (mL) intramuscular (IM) injection of ExPEC10V low dose (88 micrograms polysaccharide per milliliter \[mcg PS/mL\]) on Day 1.	Cohort 1: Medium Dose ExPEC10V Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC10V medium dose (120 mcg PS/mL) on Day 1.	Cohort 1: High Dose ExPEC10V Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC10V high dose (176 mcg PS/mL) on Day 1.	Cohort 1: ExPEC4V Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC4V 40 mcg PS/mL on Day 1.	Cohort 1: Prevnar 13 Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of Prevnar 13 on Day 1.	Cohort 2: ExPEC10V High Dose Participants aged \>=60 years in stable health with a history of UTI received a single 0.5 mL IM injection of ExPEC10V high dose (176 mcg PS/mL) on Day 1.	Cohort 2: Placebo Participants aged \>=60 years in stable health with a history of UTI received a single 0.5 mL IM injection of placebo (matched to ExPEC10V high dose) on Day 1.
Overall Study Lost to Follow-up	1	2	9	0	3	1	0
Overall Study Withdrawal by Subject	0	0	18	0	10	9	1
Overall Study Ongoing	0	0	75	0	41	0	0
Overall Study Other	0	0	2	0	0	0	0
Overall Study Randomized but not vaccinated	0	0	0	1	0	2	1
Overall Study Physician Decision	0	0	0	0	0	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Cohort 1: Low Dose ExPEC10V n=104 Participants Participants aged greater than or equal to (\>=) 60 to less than or equal to (\<=) 85 years in stable health with or without a history of urinary tract infection (UTI) received a single 0.5 milliliter (mL) intramuscular (IM) injection of ExPEC10V low dose (88 micrograms polysaccharide per milliliter \[mcg PS/mL\]) on Day 1.	Cohort 1: Medium Dose ExPEC10V n=102 Participants Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC10V medium dose (120 mcg PS/mL) on Day 1.	Cohort 1: High Dose ExPEC10V n=104 Participants Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC10V high dose (176 mcg PS/mL) on Day 1.	Cohort 1: ExPEC4V n=52 Participants Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC4V 40 mcg PS/mL on Day 1.	Cohort 1: Prevnar 13 n=54 Participants Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of Prevnar 13 on Day 1.	Cohort 2: ExPEC10V High Dose n=278 Participants Participants aged \>=60 years in stable health with a history of UTI received a single 0.5 mL IM injection of ExPEC10V high dose (176 mcg PS/mL) on Day 1.	Cohort 2: Placebo n=138 Participants Participants aged \>=60 years in stable health with a history of UTI received a single 0.5 mL IM injection of placebo (matched to ExPEC10V high dose) on Day 1.	Total n=832 Participants Total of all reporting groups
Age, Continuous	66.2 years STANDARD_DEVIATION 5.77 • n=5 Participants	66.4 years STANDARD_DEVIATION 5.17 • n=7 Participants	65.1 years STANDARD_DEVIATION 5.15 • n=5 Participants	64.8 years STANDARD_DEVIATION 4.56 • n=4 Participants	65.9 years STANDARD_DEVIATION 5.44 • n=21 Participants	68.7 years STANDARD_DEVIATION 6.16 • n=10 Participants	69.1 years STANDARD_DEVIATION 7.21 • n=115 Participants	67.3 years STANDARD_DEVIATION 6.13 • n=24 Participants
Sex: Female, Male Female	59 Participants n=5 Participants	45 Participants n=7 Participants	65 Participants n=5 Participants	31 Participants n=4 Participants	28 Participants n=21 Participants	220 Participants n=10 Participants	111 Participants n=115 Participants	559 Participants n=24 Participants
Sex: Female, Male Male	45 Participants n=5 Participants	57 Participants n=7 Participants	39 Participants n=5 Participants	21 Participants n=4 Participants	26 Participants n=21 Participants	58 Participants n=10 Participants	27 Participants n=115 Participants	273 Participants n=24 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	17 Participants n=5 Participants	15 Participants n=7 Participants	15 Participants n=5 Participants	4 Participants n=4 Participants	7 Participants n=21 Participants	38 Participants n=10 Participants	17 Participants n=115 Participants	113 Participants n=24 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	85 Participants n=5 Participants	85 Participants n=7 Participants	86 Participants n=5 Participants	46 Participants n=4 Participants	47 Participants n=21 Participants	237 Participants n=10 Participants	117 Participants n=115 Participants	703 Participants n=24 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=10 Participants	4 Participants n=115 Participants	16 Participants n=24 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	0 Participants n=115 Participants	3 Participants n=24 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	1 Participants n=115 Participants	3 Participants n=24 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=24 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants	10 Participants n=7 Participants	13 Participants n=5 Participants	3 Participants n=4 Participants	4 Participants n=21 Participants	7 Participants n=10 Participants	4 Participants n=115 Participants	51 Participants n=24 Participants
Race (NIH/OMB) White	93 Participants n=5 Participants	91 Participants n=7 Participants	90 Participants n=5 Participants	48 Participants n=4 Participants	50 Participants n=21 Participants	261 Participants n=10 Participants	129 Participants n=115 Participants	762 Participants n=24 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=10 Participants	0 Participants n=115 Participants	2 Participants n=24 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	6 Participants n=10 Participants	4 Participants n=115 Participants	10 Participants n=24 Participants
Region of Enrollment BELGIUM	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	40 participants n=10 Participants	24 participants n=115 Participants	64 participants n=24 Participants
Region of Enrollment FRANCE	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	39 participants n=10 Participants	21 participants n=115 Participants	60 participants n=24 Participants
Region of Enrollment NETHERLANDS	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	40 participants n=10 Participants	11 participants n=115 Participants	51 participants n=24 Participants
Region of Enrollment SPAIN	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	30 participants n=10 Participants	12 participants n=115 Participants	42 participants n=24 Participants
Region of Enrollment UNITED STATES	104 participants n=5 Participants	102 participants n=7 Participants	104 participants n=5 Participants	52 participants n=4 Participants	54 participants n=21 Participants	129 participants n=10 Participants	70 participants n=115 Participants	615 participants n=24 Participants

PRIMARY outcome

Timeframe: 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 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.

Outcome measures

Measure	Cohort 1: Low Dose ExPEC10V n=104 Participants Participants aged greater than or equal to (\>=) 60 to less than or equal to (\<=) 85 years in stable health with or without a history of urinary tract infection (UTI) received a single 0.5 milliliter (mL) intramuscular (IM) injection of ExPEC10V low dose (88 micrograms polysaccharide per milliliter \[mcg PS/mL\]) on Day 1.	Cohort 1: Medium Dose ExPEC10V n=102 Participants Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC10V medium dose (120 mcg PS/mL) on Day 1.	Cohort 1: High Dose ExPEC10V n=104 Participants Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC10V high dose (176 mcg PS/mL) on Day 1.	Cohort 1: ExPEC4V n=52 Participants Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC4V 40 mcg PS/mL on Day 1.	Cohort 1: Prevnar 13 n=54 Participants Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of Prevnar 13 on Day 1.
Cohort 1: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 14 Days After Vaccination on Day 1	46 Participants	54 Participants	60 Participants	15 Participants	40 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Cohort 1: Low Dose ExPEC10V n=104 Participants Participants aged greater than or equal to (\>=) 60 to less than or equal to (\<=) 85 years in stable health with or without a history of urinary tract infection (UTI) received a single 0.5 milliliter (mL) intramuscular (IM) injection of ExPEC10V low dose (88 micrograms polysaccharide per milliliter \[mcg PS/mL\]) on Day 1.	Cohort 1: Medium Dose ExPEC10V n=102 Participants Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC10V medium dose (120 mcg PS/mL) on Day 1.	Cohort 1: High Dose ExPEC10V n=104 Participants Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC10V high dose (176 mcg PS/mL) on Day 1.	Cohort 1: ExPEC4V n=52 Participants Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC4V 40 mcg PS/mL on Day 1.	Cohort 1: Prevnar 13 n=54 Participants Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of Prevnar 13 on Day 1.
Cohort 1: Number of Participants With Solicited Systemic Adverse Events (AEs) Collected for 14 Days After Vaccination on Day 1	41 Participants	47 Participants	47 Participants	17 Participants	26 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Cohort 1: Low Dose ExPEC10V n=104 Participants Participants aged greater than or equal to (\>=) 60 to less than or equal to (\<=) 85 years in stable health with or without a history of urinary tract infection (UTI) received a single 0.5 milliliter (mL) intramuscular (IM) injection of ExPEC10V low dose (88 micrograms polysaccharide per milliliter \[mcg PS/mL\]) on Day 1.	Cohort 1: Medium Dose ExPEC10V n=102 Participants Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC10V medium dose (120 mcg PS/mL) on Day 1.	Cohort 1: High Dose ExPEC10V n=104 Participants Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC10V high dose (176 mcg PS/mL) on Day 1.	Cohort 1: ExPEC4V n=52 Participants Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC4V 40 mcg PS/mL on Day 1.	Cohort 1: Prevnar 13 n=54 Participants Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of Prevnar 13 on Day 1.
Cohort 1: Number of Participants With Unsolicited Adverse Events (AEs) up to 29 Days After Vaccination on Day 1	25 Participants	21 Participants	23 Participants	9 Participants	15 Participants

PRIMARY outcome

Timeframe: Day 1 (post vaccination) up to Day 181

Population: 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.

Outcome measures

Measure	Cohort 1: Low Dose ExPEC10V n=104 Participants Participants aged greater than or equal to (\>=) 60 to less than or equal to (\<=) 85 years in stable health with or without a history of urinary tract infection (UTI) received a single 0.5 milliliter (mL) intramuscular (IM) injection of ExPEC10V low dose (88 micrograms polysaccharide per milliliter \[mcg PS/mL\]) on Day 1.	Cohort 1: Medium Dose ExPEC10V n=102 Participants Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC10V medium dose (120 mcg PS/mL) on Day 1.	Cohort 1: High Dose ExPEC10V n=104 Participants Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC10V high dose (176 mcg PS/mL) on Day 1.	Cohort 1: ExPEC4V n=52 Participants Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC4V 40 mcg PS/mL on Day 1.	Cohort 1: Prevnar 13 n=54 Participants Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of Prevnar 13 on Day 1.
Cohort 1: Number of Participants With Serious Adverse Events (SAEs) up to Day 181	2 Participants	2 Participants	0 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: 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 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.

Outcome measures

Measure	Cohort 1: Low Dose ExPEC10V n=278 Participants Participants aged greater than or equal to (\>=) 60 to less than or equal to (\<=) 85 years in stable health with or without a history of urinary tract infection (UTI) received a single 0.5 milliliter (mL) intramuscular (IM) injection of ExPEC10V low dose (88 micrograms polysaccharide per milliliter \[mcg PS/mL\]) on Day 1.	Cohort 1: Medium Dose ExPEC10V n=138 Participants Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC10V medium dose (120 mcg PS/mL) on Day 1.	Cohort 1: High Dose ExPEC10V Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC10V high dose (176 mcg PS/mL) on Day 1.	Cohort 1: ExPEC4V Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC4V 40 mcg PS/mL on Day 1.	Cohort 1: Prevnar 13 Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of Prevnar 13 on Day 1.
Cohort 2: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Collected for 14 Days After Vaccination on Day 1	139 Participants	22 Participants	—	—	—

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Cohort 1: Low Dose ExPEC10V n=278 Participants Participants aged greater than or equal to (\>=) 60 to less than or equal to (\<=) 85 years in stable health with or without a history of urinary tract infection (UTI) received a single 0.5 milliliter (mL) intramuscular (IM) injection of ExPEC10V low dose (88 micrograms polysaccharide per milliliter \[mcg PS/mL\]) on Day 1.	Cohort 1: Medium Dose ExPEC10V n=138 Participants Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC10V medium dose (120 mcg PS/mL) on Day 1.	Cohort 1: High Dose ExPEC10V Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC10V high dose (176 mcg PS/mL) on Day 1.	Cohort 1: ExPEC4V Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC4V 40 mcg PS/mL on Day 1.	Cohort 1: Prevnar 13 Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of Prevnar 13 on Day 1.
Cohort 2: Number of Participants With Solicited Systemic Adverse Events (AEs) Collected for 14 Days After Vaccination on Day 1	139 Participants	53 Participants	—	—	—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Cohort 1: Low Dose ExPEC10V n=278 Participants Participants aged greater than or equal to (\>=) 60 to less than or equal to (\<=) 85 years in stable health with or without a history of urinary tract infection (UTI) received a single 0.5 milliliter (mL) intramuscular (IM) injection of ExPEC10V low dose (88 micrograms polysaccharide per milliliter \[mcg PS/mL\]) on Day 1.	Cohort 1: Medium Dose ExPEC10V n=138 Participants Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC10V medium dose (120 mcg PS/mL) on Day 1.	Cohort 1: High Dose ExPEC10V Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC10V high dose (176 mcg PS/mL) on Day 1.	Cohort 1: ExPEC4V Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC4V 40 mcg PS/mL on Day 1.	Cohort 1: Prevnar 13 Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of Prevnar 13 on Day 1.
Cohort 2: Number of Participants With Unsolicited Adverse Events (AEs) 29 Days After Vaccination on Day 1	79 Participants	36 Participants	—	—	—

PRIMARY outcome

Timeframe: Day 1 (post vaccination) up to Day 181

Population: 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.

Outcome measures

Measure	Cohort 1: Low Dose ExPEC10V n=278 Participants Participants aged greater than or equal to (\>=) 60 to less than or equal to (\<=) 85 years in stable health with or without a history of urinary tract infection (UTI) received a single 0.5 milliliter (mL) intramuscular (IM) injection of ExPEC10V low dose (88 micrograms polysaccharide per milliliter \[mcg PS/mL\]) on Day 1.	Cohort 1: Medium Dose ExPEC10V n=138 Participants Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC10V medium dose (120 mcg PS/mL) on Day 1.	Cohort 1: High Dose ExPEC10V Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC10V high dose (176 mcg PS/mL) on Day 1.	Cohort 1: ExPEC4V Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC4V 40 mcg PS/mL on Day 1.	Cohort 1: Prevnar 13 Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of Prevnar 13 on Day 1.
Cohort 2: Number of Participants With Serious Adverse Events (SAEs) up to Day 181	9 Participants	6 Participants	—	—	—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Cohort 1: Low Dose ExPEC10V n=101 Participants Participants aged greater than or equal to (\>=) 60 to less than or equal to (\<=) 85 years in stable health with or without a history of urinary tract infection (UTI) received a single 0.5 milliliter (mL) intramuscular (IM) injection of ExPEC10V low dose (88 micrograms polysaccharide per milliliter \[mcg PS/mL\]) on Day 1.	Cohort 1: Medium Dose ExPEC10V n=98 Participants Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC10V medium dose (120 mcg PS/mL) on Day 1.	Cohort 1: High Dose ExPEC10V n=100 Participants Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC10V high dose (176 mcg PS/mL) on Day 1.	Cohort 1: ExPEC4V n=48 Participants Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC4V 40 mcg PS/mL on Day 1.	Cohort 1: Prevnar 13 n=51 Participants Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of Prevnar 13 on Day 1.
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 Serotype EPA	1170226.6 Titer Interval 829684.5 to 1650543.4	1496999.3 Titer Interval 1016330.1 to 2204999.2	1542536.8 Titer Interval 1099718.5 to 2163662.7	1448761.2 Titer Interval 868026.8 to 2418023.4	NA Titer Interval to 74582.5 Geometric mean and lower limit of 95% CI could not be estimated as the value was below the lower limit of quantification (LLOQ) that is 66165.
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 Serotype O1A	5350535.1 Titer Interval 4644976.0 to 6163266.7	6358232.9 Titer Interval 5664895.6 to 7136429.1	6421446.5 Titer Interval 5730738.4 to 7195403.5	6930697.9 Titer Interval 5823442.2 to 8248484.7	1606747.3 Titer Interval 1205014.3 to 2142411.9
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 Serotype O2	4873016.8 Titer Interval 4116237.9 to 5768931.0	4787891.5 Titer Interval 4034593.8 to 5681837.2	6537864.9 Titer Interval 5861510.6 to 7292263.1	6196015.3 Titer Interval 4955643.7 to 7746845.5	447845.4 Titer Interval 343614.9 to 583692.7
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 Serotype O4	2906299.6 Titer Interval 2339299.2 to 3610729.8	2778764.0 Titer Interval 2281609.7 to 3384246.4	4140729.8 Titer Interval 3480255.9 to 4926546.7	503269.8 Titer Interval 409184.0 to 618989.3	545556.7 Titer Interval 415552.0 to 716233.0
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 Serotype O6A	4349111.4 Titer Interval 3780753.5 to 5002910.0	5150333.2 Titer Interval 4384440.1 to 6050015.8	5834052.6 Titer Interval 5130881.4 to 6633591.3	5051389.0 Titer Interval 4030377.7 to 6331051.9	984170.4 Titer Interval 805275.1 to 1202807.9
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 Serotype O8	5082460.4 Titer Interval 4435261.0 to 5824100.0	5605655.1 Titer Interval 4917150.4 to 6390564.9	6071895.4 Titer Interval 5414031.1 to 6809697.4	1738652.7 Titer Interval 1408103.9 to 2146796.9	1391481.0 Titer Interval 1093370.5 to 1770872.3
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 Serotype O15	5151217.3 Titer Interval 4393448.3 to 6039684.0	4635317.8 Titer Interval 3976055.4 to 5403891.3	5414798.2 Titer Interval 4732722.1 to 6195174.6	898897.3 Titer Interval 694569.8 to 1163333.7	1202517.7 Titer Interval 893109.0 to 1619118.0
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 Serotype O16	4298055.1 Titer Interval 3664533.7 to 5041099.1	3972656.6 Titer Interval 3378225.9 to 4671682.9	5675420.6 Titer Interval 4957603.9 to 6497170.6	759403.5 Titer Interval 619027.4 to 931612.4	732969.6 Titer Interval 586564.3 to 915917.3
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 Serotype O18A	3532498.2 Titer Interval 2965791.1 to 4207492.4	3585987.4 Titer Interval 3008355.6 to 4274529.8	4522807.6 Titer Interval 3883477.9 to 5267388.9	1015034.0 Titer Interval 840693.0 to 1225529.4	1100583.1 Titer Interval 846592.3 to 1430775.0
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 Serotype O25B	1426991.8 Titer Interval 1113308.2 to 1829058.4	2265970.3 Titer Interval 1766736.9 to 2906273.8	2044257.9 Titer Interval 1617260.1 to 2583994.0	2174362.2 Titer Interval 1533603.8 to 3082837.4	267879.1 Titer Interval 204166.3 to 351474.3
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 Serotype O75	2932034.9 Titer Interval 2454267.7 to 3502807.9	3107132.4 Titer Interval 2627869.3 to 3673802.2	3963138.0 Titer Interval 3450884.5 to 4551430.9	1336846.1 Titer Interval 1060936.4 to 1684509.5	1363797.1 Titer Interval 1041800.4 to 1785315.7

PRIMARY outcome

Timeframe: 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 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).

Outcome measures

Measure	Cohort 1: Low Dose ExPEC10V n=101 Participants Participants aged greater than or equal to (\>=) 60 to less than or equal to (\<=) 85 years in stable health with or without a history of urinary tract infection (UTI) received a single 0.5 milliliter (mL) intramuscular (IM) injection of ExPEC10V low dose (88 micrograms polysaccharide per milliliter \[mcg PS/mL\]) on Day 1.	Cohort 1: Medium Dose ExPEC10V n=98 Participants Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC10V medium dose (120 mcg PS/mL) on Day 1.	Cohort 1: High Dose ExPEC10V n=100 Participants Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC10V high dose (176 mcg PS/mL) on Day 1.	Cohort 1: ExPEC4V n=48 Participants Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC4V 40 mcg PS/mL on Day 1.	Cohort 1: Prevnar 13 n=51 Participants Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of Prevnar 13 on Day 1.
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 Serotype O2	9.54 Ratio Interval 8.014 to 11.36	10.05 Ratio Interval 8.374 to 12.056	12.31 Ratio Interval 10.564 to 14.334	12.80 Ratio Interval 9.343 to 17.53	1.01 Ratio Interval 0.953 to 1.064
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 Serotype O4	6.28 Ratio Interval 5.103 to 7.718	5.49 Ratio Interval 4.528 to 6.656	9.17 Ratio Interval 7.61 to 11.054	1.06 Ratio Interval 1.005 to 1.127	1.27 Ratio Interval 1.081 to 1.491
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 Serotype O6A	3.55 Ratio Interval 3.039 to 4.141	4.48 Ratio Interval 3.731 to 5.389	5.11 Ratio Interval 4.408 to 5.918	4.31 Ratio Interval 3.336 to 5.576	1.04 Ratio Interval 0.99 to 1.088
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 Serotype O8	3.34 Ratio Interval 2.892 to 3.855	3.27 Ratio Interval 2.791 to 3.826	3.90 Ratio Interval 3.362 to 4.534	1.07 Ratio Interval 1.033 to 1.116	1.06 Ratio Interval 0.999 to 1.128
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 Serotype O15	5.94 Ratio Interval 4.966 to 7.104	5.32 Ratio Interval 4.468 to 6.339	6.20 Ratio Interval 5.248 to 7.329	1.01 Ratio Interval 0.971 to 1.055	1.46 Ratio Interval 1.223 to 1.753
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 Serotype O16	5.04 Ratio Interval 4.3 to 5.912	4.59 Ratio Interval 3.822 to 5.502	7.02 Ratio Interval 5.904 to 8.342	1.11 Ratio Interval 0.987 to 1.254	1.08 Ratio Interval 1.01 to 1.155
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 Serotype O18A	3.79 Ratio Interval 3.22 to 4.456	3.64 Ratio Interval 3.043 to 4.344	4.84 Ratio Interval 4.132 to 5.675	1.04 Ratio Interval 0.995 to 1.087	1.13 Ratio Interval 1.027 to 1.241
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 Serotype O25B	5.80 Ratio Interval 4.761 to 7.071	9.51 Ratio Interval 7.463 to 12.126	8.24 Ratio Interval 6.529 to 10.394	11.02 Ratio Interval 7.889 to 15.388	1.02 Ratio Interval 0.932 to 1.127
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 Serotype O75	2.33 Ratio Interval 2.013 to 2.701	2.38 Ratio Interval 2.055 to 2.756	3.06 Ratio Interval 2.622 to 3.563	1.14 Ratio Interval 1.026 to 1.274	1.03 Ratio Interval 0.945 to 1.131
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 Serotype EPA	11.31 Ratio Interval 8.61 to 14.86	12.31 Ratio Interval 9.11 to 16.62	11.84 Ratio Interval 9.01 to 15.55	12.68 Ratio Interval 8.28 to 19.43	0.99 Ratio Interval 0.97 to 1.01
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 Serotype O1A	4.41 Ratio Interval 3.69 to 5.259	5.33 Ratio Interval 4.429 to 6.406	5.26 Ratio Interval 4.381 to 6.323	6.00 Ratio Interval 4.472 to 8.061	1.26 Ratio Interval 1.086 to 1.452

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Cohort 1: Low Dose ExPEC10V n=101 Participants Participants aged greater than or equal to (\>=) 60 to less than or equal to (\<=) 85 years in stable health with or without a history of urinary tract infection (UTI) received a single 0.5 milliliter (mL) intramuscular (IM) injection of ExPEC10V low dose (88 micrograms polysaccharide per milliliter \[mcg PS/mL\]) on Day 1.	Cohort 1: Medium Dose ExPEC10V n=98 Participants Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC10V medium dose (120 mcg PS/mL) on Day 1.	Cohort 1: High Dose ExPEC10V n=100 Participants Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC10V high dose (176 mcg PS/mL) on Day 1.	Cohort 1: ExPEC4V n=48 Participants Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC4V 40 mcg PS/mL on Day 1.	Cohort 1: Prevnar 13 n=51 Participants Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of Prevnar 13 on Day 1.
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 Serotype O15: >= 2 Fold Increase	88.1 Percentage of participants Interval 80.17 to 93.71	82.7 Percentage of participants Interval 73.69 to 89.56	87.0 Percentage of participants Interval 78.8 to 92.89	0.0 Percentage of participants Interval 0.0 to 7.4	21.6 Percentage of participants Interval 11.29 to 35.32
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 Serotype O1A: >= 2 Fold Increase	78.2 Percentage of participants Interval 68.9 to 85.82	84.7 Percentage of participants Interval 76.01 to 91.17	82.0 Percentage of participants Interval 73.05 to 88.97	81.3 Percentage of participants Interval 67.37 to 91.05	9.8 Percentage of participants Interval 3.26 to 21.41
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 Serotype O1A: >= 4 Fold Increase	56.4 Percentage of participants Interval 46.2 to 66.28	62. Percentage of participants Interval 51.88 to 71.84	65.0 Percentage of participants Interval 54.82 to 74.27	66.7 Percentage of participants Interval 51.59 to 79.6	5.9 Percentage of participants Interval 1.23 to 16.24
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 Serotype O2: >= 2 Fold Increase	93.1 Percentage of participants Interval 86.24 to 97.17	93.9 Percentage of participants Interval 87.15 to 97.72	99.0 Percentage of participants Interval 94.55 to 99.97	89.6 Percentage of participants Interval 77.34 to 96.53	0.0 Percentage of participants Interval 0.0 to 6.98
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 Serotype O2: >= 4 Fold Increase	83.2 Percentage of participants Interval 74.42 to 89.88	83.7 Percentage of participants Interval 74.84 to 90.37	92.0 Percentage of participants Interval 84.84 to 96.48	81.3 Percentage of participants Interval 67.37 to 91.05	0.0 Percentage of participants Interval 0.0 to 6.98
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 Serotype O4: >= 2 Fold Increase	77.2 Percentage of participants Interval 67.82 to 84.98	81.6 Percentage of participants Interval 72.53 to 88.74	91.0 Percentage of participants Interval 83.6 to 95.8	2.1 Percentage of participants Interval 0.05 to 11.07	9.8 Percentage of participants Interval 3.26 to 21.41
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 Serotype O4: >= 4 Fold Increase	64.4 Percentage of participants Interval 54.21 to 73.64	63.3 Percentage of participants Interval 52.93 to 72.78	80.0 Percentage of participants Interval 70.82 to 87.33	0.0 Percentage of participants Interval 0.0 to 7.4	3.9 Percentage of participants Interval 0.48 to 13.46
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 Serotype O6A: >= 2 Fold Increase	72.3 Percentage of participants Interval 62.48 to 80.72	77.6 Percentage of participants Interval 68.01 to 85.36	86.0 Percentage of participants Interval 77.63 to 92.13	77.1 Percentage of participants Interval 62.69 to 87.97	0.0 Percentage of participants Interval 0.0 to 6.98
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 Serotype O6A: >= 4 Fold Increase	42.6 Percentage of participants Interval 32.79 to 52.81	53.1 Percentage of participants Interval 42.71 to 63.22	66.0 Percentage of participants Interval 55.85 to 75.18	52.1 Percentage of participants Interval 37.19 to 66.71	0.0 Percentage of participants Interval 0.0 to 6.98
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 Serotype O8: >= 2 Fold Increase	73.3 Percentage of participants Interval 63.54 to 81.59	73.5 Percentage of participants Interval 63.59 to 81.88	74.0 Percentage of participants Interval 64.27 to 82.26	0.0 Percentage of participants Interval 0.0 to 7.4	3.9 Percentage of participants Interval 0.48 to 13.46
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 Serotype O8: >= 4 Fold Increase	41.6 Percentage of participants Interval 31.86 to 51.82	38.8 Percentage of participants Interval 29.1 to 49.15	51.0 Percentage of participants Interval 40.8 to 61.14	0.0 Percentage of participants Interval 0.0 to 7.4	0.0 Percentage of participants Interval 0.0 to 6.98
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 Serotype EPA: >= 4 Fold Increase	74.3 Percentage of participants Interval 64.6 to 82.44	74.5 Percentage of participants Interval 64.69 to 82.76	77.0 Percentage of participants Interval 67.51 to 84.83	72.9 Percentage of participants Interval 58.15 to 84.72	0.0 Percentage of participants Interval 0.0 to 6.98
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 Serotype O15: >= 4 Fold Increase	61.4 Percentage of participants Interval 51.18 to 70.91	63.3 Percentage of participants Interval 52.93 to 72.78	68.0 Percentage of participants Interval 57.92 to 76.98	0.0 Percentage of participants Interval 0.0 to 7.4	9.8 Percentage of participants Interval 3.26 to 21.41
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 Serotype O16: >= 2 Fold Increase	86.1 Percentage of participants Interval 77.84 to 92.21	77.6 Percentage of participants Interval 68.01 to 85.36	88.0 Percentage of participants Interval 79.98 to 93.64	2.1 Percentage of participants Interval 0.05 to 11.07	2.0 Percentage of participants Interval 0.05 to 10.45
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 Serotype O16: >= 4 Fold Increase	63.4 Percentage of participants Interval 53.19 to 72.73	57.1 Percentage of participants Interval 46.75 to 67.1	73.0 Percentage of participants Interval 63.2 to 81.39	2.1 Percentage of participants Interval 0.05 to 11.07	0.0 Percentage of participants Interval 0.0 to 6.98
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 Serotype O18A: >= 2 Fold Increase	72.3 Percentage of participants Interval 62.48 to 80.72	71.4 Percentage of participants Interval 61.42 to 80.1	84.0 Percentage of participants Interval 75.32 to 90.57	0.0 Percentage of participants Interval 0.0 to 7.4	3.9 Percentage of participants Interval 0.48 to 13.46
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 Serotype O18A: >= 4 Fold Increase	48.5 Percentage of participants Interval 38.45 to 58.67	41.8 Percentage of participants Interval 31.95 to 52.23	61.0 Percentage of participants Interval 50.73 to 70.6	0.0 Percentage of participants Interval 0.0 to 7.4	2.0 Percentage of participants Interval 0.05 to 10.45
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 Serotype O25B: >= 2 Fold Increase	82.2 Percentage of participants Interval 73.3 to 89.08	87.8 Percentage of participants Interval 79.59 to 93.51	84.8 Percentage of participants Interval 76.24 to 91.26	87.5 Percentage of participants Interval 74.75 to 95.27	3.9 Percentage of participants Interval 0.48 to 13.46
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 Serotype O25B: >= 4 Fold Increase	58.4 Percentage of participants Interval 48.18 to 68.14	75.5 Percentage of participants Interval 65.79 to 83.64	69.7 Percentage of participants Interval 59.65 to 78.53	79.2 Percentage of participants Interval 65.01 to 89.53	2.0 Percentage of participants Interval 0.05 to 10.45
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 Serotype O75: >= 2 Fold Increase	50.5 Percentage of participants Interval 40.36 to 60.6	49.0 Percentage of participants Interval 38.74 to 59.28	68.0 Percentage of participants Interval 57.92 to 76.98	6.3 Percentage of participants Interval 1.31 to 17.2	2.0 Percentage of participants Interval 0.05 to 10.45
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 Serotype O75: >= 4 Fold Increase	20.8 Percentage of participants Interval 13.36 to 30.01	25.5 Percentage of participants Interval 17.24 to 35.31	33.0 Percentage of participants Interval 23.92 to 43.12	4.2 Percentage of participants Interval 0.51 to 14.25	2.0 Percentage of participants Interval 0.05 to 10.45
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 Serotype EPA: >= 2 Fold Increase	87.1 Percentage of participants Interval 79.0 to 92.96	83.7 Percentage of participants Interval 74.84 to 90.37	85.0 Percentage of participants Interval 76.47 to 91.35	81.3 Percentage of participants Interval 67.37 to 91.05	0.0 Percentage of participants Interval 0.0 to 6.98

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Cohort 1: Low Dose ExPEC10V n=101 Participants Participants aged greater than or equal to (\>=) 60 to less than or equal to (\<=) 85 years in stable health with or without a history of urinary tract infection (UTI) received a single 0.5 milliliter (mL) intramuscular (IM) injection of ExPEC10V low dose (88 micrograms polysaccharide per milliliter \[mcg PS/mL\]) on Day 1.	Cohort 1: Medium Dose ExPEC10V n=98 Participants Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC10V medium dose (120 mcg PS/mL) on Day 1.	Cohort 1: High Dose ExPEC10V n=100 Participants Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC10V high dose (176 mcg PS/mL) on Day 1.	Cohort 1: ExPEC4V n=48 Participants Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC4V 40 mcg PS/mL on Day 1.	Cohort 1: Prevnar 13 n=51 Participants Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of Prevnar 13 on 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 Serotype O18A	274.7 Titer Interval 202.2 to 373.2	276.2 Titer Interval 205.0 to 372.0	338.2 Titer Interval 245.3 to 466.3	65.7 Titer Interval 44.6 to 96.9	62.2 Titer Interval 42.3 to 91.6
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 Serotype O25B	415.5 Titer Interval 318.4 to 542.3	489.5 Titer Interval 373.3 to 641.9	403.7 Titer Interval 312.4 to 521.6	382.7 Titer Interval 268.7 to 545.0	265.4 Titer Interval 173.1 to 406.8
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 Serotype O6A	1495.9 Titer Interval 1133.1 to 1974.8	2256.5 Titer Interval 1725.5 to 2951.0	2217.2 Titer Interval 1690.8 to 2907.6	2009.8 Titer Interval 1344.6 to 3004.0	720.7 Titer Interval 513.8 to 1010.9
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 Serotype O8	1249.2 Titer Interval 979.3 to 1593.5	921.5 Titer Interval 702.3 to 1209.1	1037.6 Titer Interval 809.7 to 1329.6	712.9 Titer Interval 527.1 to 964.3	931.3 Titer Interval 720.7 to 1203.4
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 Serotype O1A	654.3 Titer Interval 512.4 to 835.4	764.2 Titer Interval 590.3 to 989.5	1129.5 Titer Interval 842.3 to 1514.7	1377.3 Titer Interval 851.8 to 2227.0	244.6 Titer Interval 177.9 to 336.1
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 Serotype O2	5538.4 Titer Interval 3884.7 to 7896.2	5359.8 Titer Interval 3689.3 to 7786.7	12473.2 Titer Interval 9082.9 to 17129.0	9629.4 Titer Interval 5960.7 to 15555.9	363.5 Titer Interval 274.0 to 482.3
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 Serotype O4	376.3 Titer Interval 278.6 to 508.2	322.9 Titer Interval 239.7 to 434.9	505.7 Titer Interval 374.6 to 682.5	102.9 Titer Interval 74.1 to 142.8	102.5 Titer Interval 79.3 to 132.5
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 Serotype O15	3095.1 Titer Interval 2194.3 to 4365.6	3018.4 Titer Interval 2093.9 to 4351.1	3658.5 Titer Interval 2528.2 to 5294.1	650.2 Titer Interval 431.5 to 979.8	831.9 Titer Interval 542.2 to 1276.2
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 Serotype O16	1532.2 Titer Interval 1092.6 to 2148.8	1172.2 Titer Interval 822.4 to 1670.8	1853.8 Titer Interval 1353.2 to 2539.6	216.2 Titer Interval 147.0 to 317.9	176.9 Titer Interval 134.4 to 232.9
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 Serotype O75	84.0 Titer Interval 65.8 to 107.1	58.0 Titer Interval 46.5 to 72.3	91.7 Titer Interval 66.5 to 126.5	NA Titer Geometric mean, lower and upper limit of 95% CI could not be estimated as the value was below the LLOQ (37).	NA Titer Interval to 45.3 Geometric mean and lower limit of 95% CI could not be estimated as the value was below the LLOQ (37).

PRIMARY outcome

Timeframe: 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 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).

Outcome measures

Measure	Cohort 1: Low Dose ExPEC10V n=101 Participants Participants aged greater than or equal to (\>=) 60 to less than or equal to (\<=) 85 years in stable health with or without a history of urinary tract infection (UTI) received a single 0.5 milliliter (mL) intramuscular (IM) injection of ExPEC10V low dose (88 micrograms polysaccharide per milliliter \[mcg PS/mL\]) on Day 1.	Cohort 1: Medium Dose ExPEC10V n=98 Participants Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC10V medium dose (120 mcg PS/mL) on Day 1.	Cohort 1: High Dose ExPEC10V n=100 Participants Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC10V high dose (176 mcg PS/mL) on Day 1.	Cohort 1: ExPEC4V n=48 Participants Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC4V 40 mcg PS/mL on Day 1.	Cohort 1: Prevnar 13 n=51 Participants Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of Prevnar 13 on Day 1.
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Day 15 Serotype O1A	2.67 Ratio Interval 2.103 to 3.389	4.29 Ratio Interval 3.372 to 5.469	6.14 Ratio Interval 4.546 to 8.287	5.34 Ratio Interval 3.533 to 8.059	1.18 Ratio Interval 0.934 to 1.484
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Day 15 Serotype O2	14.39 Ratio Interval 10.285 to 20.126	17.78 Ratio Interval 12.567 to 25.168	30.19 Ratio Interval 22.504 to 40.49	22.96 Ratio Interval 13.31 to 39.589	1.06 Ratio Interval 0.923 to 1.228
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Day 15 Serotype O4	3.25 Ratio Interval 2.489 to 4.24	3.47 Ratio Interval 2.723 to 4.42	5.47 Ratio Interval 4.169 to 7.178	0.98 Ratio Interval 0.852 to 1.127	1.08 Ratio Interval 0.917 to 1.263
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Day 15 Serotype O6A	2.30 Ratio Interval 1.859 to 2.858	3.72 Ratio Interval 2.74 to 5.046	3.54 Ratio Interval 2.782 to 4.51	4.30 Ratio Interval 2.84 to 6.514	1.18 Ratio Interval 1.019 to 1.368
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Day 15 Serotype O8	1.26 Ratio Interval 1.078 to 1.468	1.22 Ratio Interval 1.107 to 1.339	1.15 Ratio Interval 0.995 to 1.324	0.97 Ratio Interval 0.801 to 1.17	1.07 Ratio Interval 0.891 to 1.282
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Day 15 Serotype O15	4.91 Ratio Interval 3.498 to 6.884	6.29 Ratio Interval 4.285 to 9.247	6.87 Ratio Interval 4.732 to 9.98	0.95 Ratio Interval 0.695 to 1.289	1.55 Ratio Interval 1.076 to 2.246
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Day 15 Serotype O16	6.58 Ratio Interval 4.806 to 9.018	5.86 Ratio Interval 4.051 to 8.485	10.18 Ratio Interval 7.527 to 13.755	0.94 Ratio Interval 0.795 to 1.113	0.97 Ratio Interval 0.821 to 1.157
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Day 15 Serotype O18A	4.05 Ratio Interval 3.148 to 5.204	4.27 Ratio Interval 3.192 to 5.721	6.20 Ratio Interval 4.645 to 8.279	1.03 Ratio Interval 0.869 to 1.217	1.17 Ratio Interval 0.941 to 1.458
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Day 15 Serotype O25B	2.34 Ratio Interval 1.883 to 2.903	2.77 Ratio Interval 2.155 to 3.557	2.51 Ratio Interval 2.033 to 3.096	2.48 Ratio Interval 1.83 to 3.367	1.44 Ratio Interval 1.04 to 1.997
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Day 15 Serotype O75	1.92 Ratio Interval 1.6 to 2.299	1.69 Ratio Interval 1.44 to 1.991	2.58 Ratio Interval 1.981 to 3.355	0.97 Ratio Interval 0.879 to 1.064	1.03 Ratio Interval 0.93 to 1.133

PRIMARY outcome

Timeframe: 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 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.

Outcome measures

Measure	Cohort 1: Low Dose ExPEC10V n=101 Participants Participants aged greater than or equal to (\>=) 60 to less than or equal to (\<=) 85 years in stable health with or without a history of urinary tract infection (UTI) received a single 0.5 milliliter (mL) intramuscular (IM) injection of ExPEC10V low dose (88 micrograms polysaccharide per milliliter \[mcg PS/mL\]) on Day 1.	Cohort 1: Medium Dose ExPEC10V n=98 Participants Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC10V medium dose (120 mcg PS/mL) on Day 1.	Cohort 1: High Dose ExPEC10V n=100 Participants Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC10V high dose (176 mcg PS/mL) on Day 1.	Cohort 1: ExPEC4V n=48 Participants Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC4V 40 mcg PS/mL on Day 1.	Cohort 1: Prevnar 13 n=51 Participants Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of Prevnar 13 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 Serotype O75: >= 2 Fold Increase	36.0 Percentage of participants Interval 26.64 to 46.21	28.6 Percentage of participants Interval 19.9 to 38.58	38.0 Percentage of participants Interval 28.48 to 48.25	0.0 Percentage of participants Interval 0.0 to 7.4	3.9 Percentage of participants Interval 0.48 to 13.46
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 Serotype O25B: >= 2 Fold Increase	47.5 Percentage of participants Interval 37.49 to 57.7	50.0 Percentage of participants Interval 39.73 to 60.27	50.0 Percentage of participants Interval 39.83 to 60.17	50.0 Percentage of participants Interval 35.23 to 64.77	15.7 Percentage of participants Interval 7.02 to 28.59
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 Serotype O25B: >= 4 Fold Increase	24.8 Percentage of participants Interval 16.7 to 34.33	33.7 Percentage of participants Interval 24.44 to 43.93	31.0 Percentage of participants Interval 22.13 to 41.03	35.4 Percentage of participants Interval 22.16 to 50.54	5.9 Percentage of participants Interval 1.23 to 16.24
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 Serotype O75: >= 4 Fold Increase	16.0 Percentage of participants Interval 9.43 to 24.68	17.3 Percentage of participants Interval 10.44 to 26.31	25.0 Percentage of participants Interval 16.88 to 34.66	0.0 Percentage of participants Interval 0.0 to 7.4	0.0 Percentage of participants Interval 0.0 to 6.98
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 Serotype O4: >= 4 Fold Increase	33.7 Percentage of participants Interval 24.56 to 43.75	38.8 Percentage of participants Interval 29.1 to 49.15	56.0 Percentage of participants Interval 45.72 to 65.92	2.1 Percentage of participants Interval 0.05 to 11.07	3.9 Percentage of participants Interval 0.48 to 13.46
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 Serotype O16: >= 2 Fold Increase	76.2 Percentage of participants Interval 66.74 to 84.14	70.4 Percentage of participants Interval 60.34 to 79.21	85.0 Percentage of participants Interval 76.47 to 91.35	8.3 Percentage of participants Interval 2.32 to 19.9	9.8 Percentage of participants Interval 3.26 to 21.41
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 Serotype O16: >= 4 Fold Increase	55.4 Percentage of participants Interval 45.22 to 65.34	51.0 Percentage of participants Interval 40.72 to 61.26	76.0 Percentage of participants Interval 66.43 to 83.98	2.1 Percentage of participants Interval 0.05 to 11.07	3.9 Percentage of participants Interval 0.48 to 13.46
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 Serotype O18A: >= 2 Fold Increase	69.3 Percentage of participants Interval 59.34 to 78.1	66.3 Percentage of participants Interval 56.07 to 75.56	77.0 Percentage of participants Interval 67.51 to 84.83	6.3 Percentage of participants Interval 1.31 to 17.2	7.8 Percentage of participants Interval 2.18 to 18.88
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 Serotype O18A: >= 4 Fold Increase	45.5 Percentage of participants Interval 35.6 to 55.76	44.9 Percentage of participants Interval 34.83 to 55.28	58.0 Percentage of participants Interval 47.71 to 67.8	4.2 Percentage of participants Interval 0.51 to 14.25	5.9 Percentage of participants Interval 1.23 to 16.24
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 Serotype O1A: >= 2 Fold Increase	49.5 Percentage of participants Interval 39.4 to 59.64	70.4 Percentage of participants Interval 60.34 to 79.21	72.0 Percentage of participants Interval 62.13 to 80.52	75.0 Percentage of participants Interval 60.4 to 86.36	13.7 Percentage of participants Interval 5.7 to 26.26
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 Serotype O1A: >= 4 Fold Increase	28.7 Percentage of participants Interval 20.15 to 38.57	46.9 Percentage of participants Interval 36.78 to 57.29	53.0 Percentage of participants Interval 42.76 to 63.06	52.1 Percentage of participants Interval 37.19 to 66.71	3.9 Percentage of participants Interval 0.48 to 13.46
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 Serotype O2: >= 2 Fold Increase	90.1 Percentage of participants Interval 82.54 to 95.15	86.5 Percentage of participants Interval 77.96 to 92.59	98.0 Percentage of participants Interval 92.89 to 99.75	87.5 Percentage of participants Interval 74.75 to 95.27	11.8 Percentage of participants Interval 4.44 to 23.87
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 Serotype O2: >= 4 Fold Increase	74.3 Percentage of participants Interval 64.6 to 82.44	78.1 Percentage of participants Interval 68.53 to 85.92	88.9 Percentage of participants Interval 80.99 to 94.32	77.1 Percentage of participants Interval 62.69 to 87.97	0.0 Percentage of participants Interval 0.0 to 6.98
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 Serotype O4: >= 2 Fold Increase	56.4 Percentage of participants Interval 46.2 to 66.28	60.2 Percentage of participants Interval 49.82 to 69.96	73.0 Percentage of participants Interval 63.2 to 81.39	4.2 Percentage of participants Interval 0.51 to 14.25	11.8 Percentage of participants Interval 4.44 to 23.87
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 Serotype O6A: >= 2 Fold Increase	47.5 Percentage of participants Interval 37.49 to 57.7	54.1 Percentage of participants Interval 43.71 to 64.2	63.0 Percentage of participants Interval 52.76 to 72.44	66.7 Percentage of participants Interval 51.59 to 79.6	9.8 Percentage of participants Interval 3.26 to 21.41
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 Serotype O6A: >= 4 Fold Increase	23.8 Percentage of participants Interval 15.86 to 33.26	41.8 Percentage of participants Interval 31.95 to 52.23	40.0 Percentage of participants Interval 30.33 to 50.28	39.6 Percentage of participants Interval 25.77 to 54.73	2.0 Percentage of participants Interval 0.05 to 10.45
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 Serotype O8: >= 2 Fold Increase	19.8 Percentage of participants Interval 12.54 to 28.91	14.3 Percentage of participants Interval 8.04 to 22.81	10.0 Percentage of participants Interval 4.9 to 17.62	6.3 Percentage of participants Interval 1.31 to 17.2	11.8 Percentage of participants Interval 4.44 to 23.87
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 Serotype O8: >= 4 Fold Increase	5.9 Percentage of participants Interval 2.21 to 12.48	3.1 Percentage of participants Interval 0.64 to 8.69	4.0 Percentage of participants Interval 1.1 to 9.9	2.1 Percentage of participants Interval 0.05 to 11.07	3.9 Percentage of participants Interval 0.48 to 13.46
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 Serotype O15: >= 2 Fold Increase	61.0 Percentage of participants Interval 50.73 to 70.6	67.0 Percentage of participants Interval 56.73 to 76.22	70.0 Percentage of participants Interval 60.02 to 78.76	12.5 Percentage of participants Interval 4.73 to 25.25	28.0 Percentage of participants Interval 16.23 to 42.49
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 Serotype O15: >= 4 Fold Increase	41.0 Percentage of participants Interval 31.26 to 51.29	53.6 Percentage of participants Interval 43.19 to 63.8	57.0 Percentage of participants Interval 46.71 to 66.86	8.3 Percentage of participants Interval 2.32 to 19.9	14.0 Percentage of participants Interval 5.82 to 26.74

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Cohort 1: Low Dose ExPEC10V n=258 Participants Participants aged greater than or equal to (\>=) 60 to less than or equal to (\<=) 85 years in stable health with or without a history of urinary tract infection (UTI) received a single 0.5 milliliter (mL) intramuscular (IM) injection of ExPEC10V low dose (88 micrograms polysaccharide per milliliter \[mcg PS/mL\]) on Day 1.	Cohort 1: Medium Dose ExPEC10V n=129 Participants Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC10V medium dose (120 mcg PS/mL) on Day 1.	Cohort 1: High Dose ExPEC10V Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC10V high dose (176 mcg PS/mL) on Day 1.	Cohort 1: ExPEC4V Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC4V 40 mcg PS/mL on Day 1.	Cohort 1: Prevnar 13 Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of Prevnar 13 on Day 1.
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 Serotype O1A	6341302.4 Titer Interval 5889782.4 to 6827436.7	1762724.3 Titer Interval 1505477.9 to 2063927.4	—	—	—
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 Serotype O2	5957433.5 Titer Interval 5487954.2 to 6467075.6	749984.6 Titer Interval 628913.9 to 894362.5	—	—	—
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 Serotype O4	3537556.6 Titer Interval 3153145.2 to 3968833.1	805295.5 Titer Interval 689894.4 to 940000.1	—	—	—
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 Serotype O6A	5461039.4 Titer Interval 4992165.2 to 5973951.2	1944280.6 Titer Interval 1664293.0 to 2271371.1	—	—	—
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 Serotype O8	6240213.6 Titer Interval 5782238.7 to 6734461.7	2315932.9 Titer Interval 2011986.2 to 2665796.4	—	—	—
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 Serotype O15	5724175.1 Titer Interval 5301709.2 to 6180305.1	1207724.5 Titer Interval 1028556.8 to 1418101.9	—	—	—
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 Serotype O16	5158063.5 Titer Interval 4735530.7 to 5618297.2	1127584.4 Titer Interval 1001022.6 to 1270147.7	—	—	—
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 Serotype O18	4046778.4 Titer Interval 3656809.6 to 4478334.1	1365154.9 Titer Interval 1196273.0 to 1557878.4	—	—	—
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 Serotype O25B	2117662.8 Titer Interval 1843164.1 to 2433042.1	375570.5 Titer Interval 316412.1 to 445789.5	—	—	—
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 Serotype O75	3758021.3 Titer Interval 3419541.0 to 4130005.8	1577900.4 Titer Interval 1365705.2 to 1823065.1	—	—	—
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 Serotype EPA	780539.6 Titer Interval 622435.7 to 978803.3	75018.0 Titer Interval to 91880.8 Lower limit of 95% CI could not be estimated as the value was below the LLOQ (66165).	—	—	—

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Measure	Cohort 1: Low Dose ExPEC10V n=258 Participants Participants aged greater than or equal to (\>=) 60 to less than or equal to (\<=) 85 years in stable health with or without a history of urinary tract infection (UTI) received a single 0.5 milliliter (mL) intramuscular (IM) injection of ExPEC10V low dose (88 micrograms polysaccharide per milliliter \[mcg PS/mL\]) on Day 1.	Cohort 1: Medium Dose ExPEC10V n=129 Participants Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC10V medium dose (120 mcg PS/mL) on Day 1.	Cohort 1: High Dose ExPEC10V Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC10V high dose (176 mcg PS/mL) on Day 1.	Cohort 1: ExPEC4V Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC4V 40 mcg PS/mL on Day 1.	Cohort 1: Prevnar 13 Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of Prevnar 13 on Day 1.
Cohort 2: Geometric Mean Ratio (GMR) of Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Day 30 Serotype O1A	4.40 Ratio Interval 3.958 to 4.893	1.02 Ratio Interval 0.955 to 1.095	—	—	—
Cohort 2: Geometric Mean Ratio (GMR) of Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Day 30 Serotype O2	8.18 Ratio Interval 7.255 to 9.227	0.98 Ratio Interval 0.909 to 1.055	—	—	—
Cohort 2: Geometric Mean Ratio (GMR) of Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Day 30 Serotype O4	5.31 Ratio Interval 4.726 to 5.955	1.09 Ratio Interval 1.014 to 1.168	—	—	—
Cohort 2: Geometric Mean Ratio (GMR) of Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Day 30 Serotype O6A	3.64 Ratio Interval 3.289 to 4.019	1.06 Ratio Interval 0.993 to 1.138	—	—	—
Cohort 2: Geometric Mean Ratio (GMR) of Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Day 30 Serotype O8	2.92 Ratio Interval 2.655 to 3.221	1.01 Ratio Interval 0.965 to 1.058	—	—	—
Cohort 2: Geometric Mean Ratio (GMR) of Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Day 30 Serotype O15	5.00 Ratio Interval 4.483 to 5.565	1.02 Ratio Interval 0.961 to 1.077	—	—	—
Cohort 2: Geometric Mean Ratio (GMR) of Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Day 30 Serotype O16	5.04 Ratio Interval 4.571 to 5.561	1.06 Ratio Interval 0.993 to 1.126	—	—	—
Cohort 2: Geometric Mean Ratio (GMR) of Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Day 30 Serotype O18	3.40 Ratio Interval 3.088 to 3.754	1.07 Ratio Interval 1.017 to 1.132	—	—	—
Cohort 2: Geometric Mean Ratio (GMR) of Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Day 30 Serotype O25B	5.59 Ratio Interval 4.866 to 6.428	1.04 Ratio Interval 0.963 to 1.115	—	—	—
Cohort 2: Geometric Mean Ratio (GMR) of Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Day 30 Serotype O75	2.33 Ratio Interval 2.136 to 2.531	1.04 Ratio Interval 0.979 to 1.11	—	—	—
Cohort 2: Geometric Mean Ratio (GMR) of Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Day 30 Serotype EPA	8.06 Ratio Interval 6.73 to 9.64	1.02 Ratio Interval 0.97 to 1.08	—	—	—

PRIMARY outcome

Timeframe: 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 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.

Outcome measures

Measure	Cohort 1: Low Dose ExPEC10V n=258 Participants Participants aged greater than or equal to (\>=) 60 to less than or equal to (\<=) 85 years in stable health with or without a history of urinary tract infection (UTI) received a single 0.5 milliliter (mL) intramuscular (IM) injection of ExPEC10V low dose (88 micrograms polysaccharide per milliliter \[mcg PS/mL\]) on Day 1.	Cohort 1: Medium Dose ExPEC10V n=129 Participants Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC10V medium dose (120 mcg PS/mL) on Day 1.	Cohort 1: High Dose ExPEC10V Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC10V high dose (176 mcg PS/mL) on Day 1.	Cohort 1: ExPEC4V Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC4V 40 mcg PS/mL on Day 1.	Cohort 1: Prevnar 13 Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of Prevnar 13 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 Serotype O4: >= 4 Fold Increase	58.9 Percentage of participants Interval 52.64 to 64.98	1.6 Percentage of participants Interval 0.19 to 5.49	—	—	—
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 Serotype O6A: >= 2 Fold Increase	73.3 Percentage of participants Interval 67.41 to 78.56	2.3 Percentage of participants Interval 0.48 to 6.65	—	—	—
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 Serotype O1A: >= 2 Fold Increase	78.3 Percentage of participants Interval 72.76 to 83.17	1.6 Percentage of participants Interval 0.19 to 5.49	—	—	—
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 Serotype O1A: >= 4 Fold Increase	54.7 Percentage of participants Interval 48.36 to 60.84	0.8 Percentage of participants Interval 0.02 to 4.24	—	—	—
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 Serotype O2: >= 2 Fold Increase	89.1 Percentage of participants Interval 84.7 to 92.67	1.6 Percentage of participants Interval 0.19 to 5.49	—	—	—
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 Serotype O2: >= 4 Fold Increase	77.5 Percentage of participants Interval 71.93 to 82.46	1.6 Percentage of participants Interval 0.19 to 5.49	—	—	—
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 Serotype O4: >= 2 Fold Increase	81.4 Percentage of participants Interval 76.1 to 85.95	2.3 Percentage of participants Interval 0.48 to 6.65	—	—	—
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 Serotype O6A: >= 4 Fold Increase	44.2 Percentage of participants Interval 38.03 to 50.48	0.8 Percentage of participants Interval 0.02 to 4.24	—	—	—
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 Serotype O8: >= 2 Fold Increase	64. Percentage of participants Interval 57.77 to 69.82	1.6 Percentage of participants Interval 0.19 to 5.49	—	—	—
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 Serotype O8: >= 4 Fold Increase	38.4 Percentage of participants Interval 32.41 to 44.61	1.6 Percentage of participants Interval 0.19 to 5.49	—	—	—
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 Serotype O16: >= 2 Fold Increase	86.0 Percentage of participants Interval 81.21 to 90.03	1.6 Percentage of participants Interval 0.19 to 5.49	—	—	—
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 Serotype O15: >= 2 Fold Increase	84.1 Percentage of participants Interval 79.07 to 88.35	1.6 Percentage of participants Interval 0.19 to 5.49	—	—	—
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 Serotype O15: >= 4 Fold Increase	58.5 Percentage of participants Interval 52.25 to 64.6	0.8 Percentage of participants Interval 0.02 to 4.24	—	—	—
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 Serotype O16: >= 4 Fold Increase	62.4 Percentage of participants Interval 56.18 to 68.33	1.6 Percentage of participants Interval 0.19 to 5.49	—	—	—
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 Serotype O18: >= 2 Fold Increase	69.0 Percentage of participants Interval 62.96 to 74.58	1.6 Percentage of participants Interval 0.19 to 5.49	—	—	—
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 Serotype O18: >= 4 Fold Increase	43.0 Percentage of participants Interval 36.9 to 49.31	0.8 Percentage of participants Interval 0.02 to 4.24	—	—	—
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 Serotype O25B: >= 2 Fold Increase	78.3 Percentage of participants Interval 72.76 to 83.17	2.3 Percentage of participants Interval 0.48 to 6.65	—	—	—
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 Serotype O25B: >= 4 Fold Increase	56.6 Percentage of participants Interval 50.3 to 62.72	1.6 Percentage of participants Interval 0.19 to 5.49	—	—	—
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 Serotype O75: >= 2 Fold Increase	51.2 Percentage of participants Interval 44.89 to 57.41	2.3 Percentage of participants Interval 0.48 to 6.65	—	—	—
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 Serotype O75: >= 4 Fold Increase	23.6 Percentage of participants Interval 18.59 to 29.31	2.3 Percentage of participants Interval 0.48 to 6.65	—	—	—
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 Serotype EPA: >= 2 Fold Increase	77.9 Percentage of participants Interval 72.34 to 82.82	1.6 Percentage of participants Interval 0.19 to 5.49	—	—	—
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 Serotype EPA: >= 4 Fold Increase	65.5 Percentage of participants Interval 59.36 to 71.29	1.6 Percentage of participants Interval 0.19 to 5.49	—	—	—

PRIMARY outcome

Timeframe: 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 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.

Outcome measures

Measure	Cohort 1: Low Dose ExPEC10V n=258 Participants Participants aged greater than or equal to (\>=) 60 to less than or equal to (\<=) 85 years in stable health with or without a history of urinary tract infection (UTI) received a single 0.5 milliliter (mL) intramuscular (IM) injection of ExPEC10V low dose (88 micrograms polysaccharide per milliliter \[mcg PS/mL\]) on Day 1.	Cohort 1: Medium Dose ExPEC10V n=70 Participants Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC10V medium dose (120 mcg PS/mL) on Day 1.	Cohort 1: High Dose ExPEC10V Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC10V high dose (176 mcg PS/mL) on Day 1.	Cohort 1: ExPEC4V Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC4V 40 mcg PS/mL on Day 1.	Cohort 1: Prevnar 13 Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of Prevnar 13 on 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 Serotype O25B	159.8 Titer Interval 135.4 to 188.5	NA Titer Interval to 69.6 Geometric mean and lower limit of 95% CI could not be estimated as the value was below the LLOQ (58).	—	—	—
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 Serotype O2	3523.2 Titer Interval 2950.7 to 4206.7	502.4 Titer Interval 403.6 to 625.4	—	—	—
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 Serotype O4	803.9 Titer Interval 683.3 to 945.7	178.7 Titer Interval 138.7 to 230.4	—	—	—
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 Serotype O6A	1392.6 Titer Interval 1196.9 to 1620.3	557.0 Titer Interval 416.8 to 744.3	—	—	—
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 Serotype O15	2773.8 Titer Interval 2347.4 to 3277.6	458.0 Titer Interval 338.4 to 619.9	—	—	—
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 Serotype O16	1347.0 Titer Interval 1132.2 to 1602.5	116.0 Titer Interval 88.0 to 152.8	—	—	—
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 Serotype O18	516.3 Titer Interval 446.2 to 597.3	168.2 Titer Interval 128.8 to 219.6	—	—	—
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 Serotype O75	201.0 Titer Interval 169.5 to 238.3	52.2 Titer Interval 39.2 to 69.6	—	—	—
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 Serotype O1A	703.0 Titer Interval 611.1 to 808.7	492.4 Titer Interval 382.9 to 633.2	—	—	—

PRIMARY outcome

Timeframe: 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 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.

Outcome measures

Measure	Cohort 1: Low Dose ExPEC10V n=258 Participants Participants aged greater than or equal to (\>=) 60 to less than or equal to (\<=) 85 years in stable health with or without a history of urinary tract infection (UTI) received a single 0.5 milliliter (mL) intramuscular (IM) injection of ExPEC10V low dose (88 micrograms polysaccharide per milliliter \[mcg PS/mL\]) on Day 1.	Cohort 1: Medium Dose ExPEC10V n=70 Participants Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC10V medium dose (120 mcg PS/mL) on Day 1.	Cohort 1: High Dose ExPEC10V Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC10V high dose (176 mcg PS/mL) on Day 1.	Cohort 1: ExPEC4V Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC4V 40 mcg PS/mL on Day 1.	Cohort 1: Prevnar 13 Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of Prevnar 13 on Day 1.
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Day 30 Serotype O1A	1.81 Ratio Interval 1.602 to 2.054	1.23 Ratio Interval 1.036 to 1.451	—	—	—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Day 30 Serotype O2	8.04 Ratio Interval 6.684 to 9.681	1.07 Ratio Interval 0.901 to 1.265	—	—	—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Day 30 Serotype O4	4.26 Ratio Interval 3.607 to 5.033	0.98 Ratio Interval 0.827 to 1.162	—	—	—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Day 30 Serotype O6A	2.57 Ratio Interval 2.251 to 2.939	1.02 Ratio Interval 0.87 to 1.192	—	—	—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Day 30 Serotype O18	2.88 Ratio Interval 2.482 to 3.332	0.93 Ratio Interval 0.805 to 1.083	—	—	—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Day 30 Serotype O25B	2.05 Ratio Interval 1.813 to 2.308	0.94 Ratio Interval 0.841 to 1.045	—	—	—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Day 30 Serotype O75	3.21 Ratio Interval 2.744 to 3.745	1.18 Ratio Interval 0.973 to 1.438	—	—	—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Day 30 Serotype O15	6.70 Ratio Interval 5.641 to 7.958	1.05 Ratio Interval 0.807 to 1.376	—	—	—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Day 30 Serotype O16	9.68 Ratio Interval 8.055 to 11.639	1.02 Ratio Interval 0.841 to 1.227	—	—	—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Cohort 1: Low Dose ExPEC10V n=258 Participants Participants aged greater than or equal to (\>=) 60 to less than or equal to (\<=) 85 years in stable health with or without a history of urinary tract infection (UTI) received a single 0.5 milliliter (mL) intramuscular (IM) injection of ExPEC10V low dose (88 micrograms polysaccharide per milliliter \[mcg PS/mL\]) on Day 1.	Cohort 1: Medium Dose ExPEC10V n=70 Participants Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC10V medium dose (120 mcg PS/mL) on Day 1.	Cohort 1: High Dose ExPEC10V Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC10V high dose (176 mcg PS/mL) on Day 1.	Cohort 1: ExPEC4V Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC4V 40 mcg PS/mL on Day 1.	Cohort 1: Prevnar 13 Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of Prevnar 13 on Day 1.
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 Serotype O1A: >= 2 Fold Increase	41.5 Percentage of participants Interval 35.4 to 47.75	22.9 Percentage of participants Interval 13.67 to 34.45	—	—	—
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 Serotype O1A: >= 4 Fold Increase	17.8 Percentage of participants Interval 13.36 to 23.06	2.9 Percentage of participants Interval 0.35 to 9.94	—	—	—
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 Serotype O6A: >= 2 Fold Increase	54.3 Percentage of participants Interval 47.97 to 60.46	17.1 Percentage of participants Interval 9.18 to 28.03	—	—	—
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 Serotype O6A: >= 4 Fold Increase	32.9 Percentage of participants Interval 27.24 to 39.05	1.4 Percentage of participants Interval 0.04 to 7.7	—	—	—
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 Serotype O15: >= 4 Fold Increase	62.8 Percentage of participants Interval 56.58 to 68.71	8.6 Percentage of participants Interval 3.21 to 17.73	—	—	—
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 Serotype O16: >= 2 Fold Increase	86.0 Percentage of participants Interval 81.21 to 90.03	18.6 Percentage of participants Interval 10.28 to 29.66	—	—	—
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 Serotype O16: >= 4 Fold Increase	70.9 Percentage of participants Interval 64.98 to 76.4	4.3 Percentage of participants Interval 0.89 to 12.02	—	—	—
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 Serotype O18: >= 2 Fold Increase	55.8 Percentage of participants Interval 49.52 to 61.97	14.3 Percentage of participants Interval 7.07 to 24.71	—	—	—
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 Serotype O18: >= 4 Fold Increase	34.5 Percentage of participants Interval 28.71 to 40.64	0.0 Percentage of participants Interval 0.0 to 5.13	—	—	—
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 Serotype O25B: >= 4 Fold Increase	21.3 Percentage of participants Interval 16.48 to 26.83	0.0 Percentage of participants Interval 0.0 to 5.13	—	—	—
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 Serotype O75: >= 2 Fold Increase	58.4 Percentage of participants Interval 52.12 to 64.55	23.5 Percentage of participants Interval 14.09 to 35.38	—	—	—
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 Serotype O75: >= 4 Fold Increase	36.9 Percentage of participants Interval 30.93 to 43.11	10.3 Percentage of participants Interval 4.24 to 20.07	—	—	—
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 Serotype O2: >= 2 Fold Increase	81.0 Percentage of participants Interval 75.68 to 85.61	18.6 Percentage of participants Interval 10.28 to 29.66	—	—	—
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 Serotype O2: >= 4 Fold Increase	63.6 Percentage of participants Interval 57.37 to 69.45	4.3 Percentage of participants Interval 0.89 to 12.02	—	—	—
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 Serotype O4: >= 2 Fold Increase	64.7 Percentage of participants Interval 58.56 to 70.55	14.3 Percentage of participants Interval 7.07 to 24.71	—	—	—
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 Serotype O4: >= 4 Fold Increase	45.7 Percentage of participants Interval 39.54 to 52.03	4.3 Percentage of participants Interval 0.89 to 12.02	—	—	—
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 Serotype O15: >= 2 Fold Increase	81.4 Percentage of participants Interval 76.1 to 85.95	22.9 Percentage of participants Interval 13.67 to 34.45	—	—	—
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 Serotype O25B: >= 2 Fold Increase	41.1 Percentage of participants Interval 35.02 to 47.36	5.7 Percentage of participants Interval 1.58 to 13.99	—	—	—

SECONDARY outcome

Timeframe: Day 15

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At Day 30

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome data not reported

Adverse Events

Cohort 1: Low Dose ExPEC10V

Serious events: 2 serious events

Other events: 60 other events

Deaths: 0 deaths

Cohort 1: Medium Dose ExPEC10V

Serious events: 2 serious events

Other events: 61 other events

Deaths: 0 deaths

Cohort 1: High Dose ExPEC10V

Serious events: 0 serious events

Other events: 71 other events

Deaths: 0 deaths

Cohort 1: ExPEC4V

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Cohort 1: Prevnar 13

Serious events: 1 serious events

Other events: 41 other events

Deaths: 0 deaths

Cohort 2: ExPEC10V High Dose

Serious events: 9 serious events

Other events: 180 other events

Deaths: 0 deaths

Cohort 2: Placebo

Serious events: 6 serious events

Other events: 64 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cohort 1: Low Dose ExPEC10V n=104 participants at risk Participants aged greater than or equal to (\>=) 60 to less than or equal to (\<=) 85 years in stable health with or without a history of urinary tract infection (UTI) received a single 0.5 milliliter (mL) intramuscular (IM) injection of ExPEC10V low dose (88 micrograms polysaccharide per milliliter \[mcg PS/mL\]) on Day 1.	Cohort 1: Medium Dose ExPEC10V n=102 participants at risk Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC10V medium dose (120 mcg PS/mL) on Day 1.	Cohort 1: High Dose ExPEC10V n=104 participants at risk Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC10V high dose (176 mcg PS/mL) on Day 1.	Cohort 1: ExPEC4V n=52 participants at risk Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC4V 40 mcg PS/mL on Day 1.	Cohort 1: Prevnar 13 n=54 participants at risk Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of Prevnar 13 on Day 1.	Cohort 2: ExPEC10V High Dose n=278 participants at risk Participants aged \>=60 years in stable health with a history of UTI received a single 0.5 mL IM injection of ExPEC10V high dose (176 mcg PS/mL) on Day 1.	Cohort 2: Placebo n=138 participants at risk Participants aged \>=60 years in stable health with a history of UTI received a single 0.5 mL IM injection of placebo (matched to ExPEC10V high dose) on Day 1.
Gastrointestinal disorders Abdominal Hernia	0.00% 0/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/102 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/52 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/54 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.36% 1/278 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/138 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.
General disorders Non-Cardiac Chest Pain	0.00% 0/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/102 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/52 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/54 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.72% 2/278 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/138 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.
Infections and infestations Enterococcal Sepsis	0.00% 0/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/102 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/52 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/54 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/278 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.72% 1/138 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.
Infections and infestations Enterocolitis Infectious	0.00% 0/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/102 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/52 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/54 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.36% 1/278 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/138 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.
Infections and infestations Pyelonephritis	0.00% 0/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/102 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/52 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/54 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.36% 1/278 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/138 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.
Infections and infestations Pyelonephritis Acute	0.00% 0/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/102 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/52 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/54 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/278 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.72% 1/138 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.
Infections and infestations Sepsis	0.00% 0/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/102 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/52 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/54 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.36% 1/278 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/138 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.
Infections and infestations Urinary Tract Infection	0.00% 0/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/102 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/52 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/54 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/278 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.72% 1/138 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.
Injury, poisoning and procedural complications Lumbar Vertebral Fracture	0.00% 0/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/102 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/52 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/54 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/278 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.72% 1/138 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.
Musculoskeletal and connective tissue disorders Intervertebral Disc Protrusion	0.96% 1/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.98% 1/102 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/52 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/54 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/278 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.72% 1/138 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.96% 1/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/102 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/52 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	1.9% 1/54 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.36% 1/278 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/138 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.
Nervous system disorders Migraine	0.00% 0/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/102 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/52 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/54 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/278 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.72% 1/138 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.
Renal and urinary disorders Calculus Urinary	0.00% 0/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/102 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/52 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/54 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.36% 1/278 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/138 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.
Renal and urinary disorders Chronic Kidney Disease	0.00% 0/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/102 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/52 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/54 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/278 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.72% 1/138 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.
Renal and urinary disorders Nephrolithiasis	0.00% 0/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.98% 1/102 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/52 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/54 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.36% 1/278 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/138 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.00% 0/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/102 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/52 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/54 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/278 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.72% 1/138 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.

Other adverse events

Measure	Cohort 1: Low Dose ExPEC10V n=104 participants at risk Participants aged greater than or equal to (\>=) 60 to less than or equal to (\<=) 85 years in stable health with or without a history of urinary tract infection (UTI) received a single 0.5 milliliter (mL) intramuscular (IM) injection of ExPEC10V low dose (88 micrograms polysaccharide per milliliter \[mcg PS/mL\]) on Day 1.	Cohort 1: Medium Dose ExPEC10V n=102 participants at risk Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC10V medium dose (120 mcg PS/mL) on Day 1.	Cohort 1: High Dose ExPEC10V n=104 participants at risk Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC10V high dose (176 mcg PS/mL) on Day 1.	Cohort 1: ExPEC4V n=52 participants at risk Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of ExPEC4V 40 mcg PS/mL on Day 1.	Cohort 1: Prevnar 13 n=54 participants at risk Participants aged \>=60 to \<= 85 years in stable health with or without a history of UTI received a single 0.5 mL IM injection of Prevnar 13 on Day 1.	Cohort 2: ExPEC10V High Dose n=278 participants at risk Participants aged \>=60 years in stable health with a history of UTI received a single 0.5 mL IM injection of ExPEC10V high dose (176 mcg PS/mL) on Day 1.	Cohort 2: Placebo n=138 participants at risk Participants aged \>=60 years in stable health with a history of UTI received a single 0.5 mL IM injection of placebo (matched to ExPEC10V high dose) on Day 1.
Ear and labyrinth disorders Tinnitus	0.00% 0/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/102 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/52 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	3.7% 2/54 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/278 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/138 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.
Gastrointestinal disorders Diarrhoea	0.96% 1/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/102 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	3.8% 4/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	1.9% 1/52 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/54 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	1.1% 3/278 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	2.2% 3/138 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.
Gastrointestinal disorders Nausea	4.8% 5/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	8.8% 9/102 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	10.6% 11/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	1.9% 1/52 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	3.7% 2/54 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	14.4% 40/278 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	5.8% 8/138 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.
General disorders Erythema	10.6% 11/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	18.6% 19/102 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	18.3% 19/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	1.9% 1/52 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	9.3% 5/54 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	21.6% 60/278 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.72% 1/138 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.
General disorders Fatigue	20.2% 21/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	28.4% 29/102 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	23.1% 24/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	15.4% 8/52 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	24.1% 13/54 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	35.3% 98/278 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	22.5% 31/138 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.
General disorders Fever	1.9% 2/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/102 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	2.9% 3/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	1.9% 1/52 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/54 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	5.4% 15/278 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	2.2% 3/138 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.
General disorders Injection Site Pruritus	0.96% 1/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	4.9% 5/102 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	2.9% 3/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	3.8% 2/52 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	1.9% 1/54 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	2.5% 7/278 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/138 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.
General disorders Pain/Tenderness	44.2% 46/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	51.0% 52/102 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	57.7% 60/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	28.8% 15/52 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	72.2% 39/54 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	47.5% 132/278 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	14.5% 20/138 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.
General disorders Swelling	8.7% 9/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	14.7% 15/102 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	13.5% 14/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	3.8% 2/52 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	3.7% 2/54 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	15.8% 44/278 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	1.4% 2/138 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.
Infections and infestations Upper Respiratory Tract Infection	2.9% 3/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	3.9% 4/102 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.96% 1/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	5.8% 3/52 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	5.6% 3/54 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.36% 1/278 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/138 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.
Infections and infestations Urinary Tract Infection	0.00% 0/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/102 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.96% 1/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/52 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/54 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	2.5% 7/278 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	7.2% 10/138 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.
Investigations Blood Pressure Increased	0.00% 0/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/102 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/52 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	3.7% 2/54 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.36% 1/278 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	0.00% 0/138 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.
Musculoskeletal and connective tissue disorders Myalgia	25.0% 26/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	35.3% 36/102 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	35.6% 37/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	19.2% 10/52 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	38.9% 21/54 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	30.2% 84/278 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	16.7% 23/138 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.
Nervous system disorders Headache	18.3% 19/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	24.5% 25/102 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	24.0% 25/104 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	21.2% 11/52 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	18.5% 10/54 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	26.6% 74/278 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.	24.6% 34/138 • SAEs and All-Cause Mortality: Day 1 (post vaccination) up to Day 181; unsolicited AEs (not SAEs): Day 1 (post vaccination) up to 30 days; Solicited (local and systemic) AEs: up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15) FAS included all participants with a study vaccine administration documented. Cohort 1 AEs were coded using MedDRA version 23.0 and Cohort 2 AEs were coded using MedDRA version 24.1.

Additional Information

Trial Physician

Janssen Research & Development, LLC

Phone: 844-434-4210

Email: ClinicalTrialDisclosure@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
• Publication restrictions are in place

Restriction type: OTHER