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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: 2026-06-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

836 participants

Primary outcome timeframe

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

Results posted on

2026-06-05

Participant Flow

Participant milestones

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
35
52
17
268
136
Overall Study
NOT COMPLETED
1
2
69
1
37
12
3

Reasons for withdrawal

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
17
0
7
1
0
Overall Study
Withdrawal by Subject
0
0
50
0
29
9
1
Overall Study
Randomized but not vaccinated
0
0
0
1
0
2
1
Overall Study
Physician Decision
0
0
0
0
0
0
1
Overall Study
Other
0
0
2
0
1
0
0

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

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 ofExPEC10V 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=20 Participants
66.4 years
STANDARD_DEVIATION 5.17 • n=20 Participants
65.1 years
STANDARD_DEVIATION 5.15 • n=40 Participants
64.8 years
STANDARD_DEVIATION 4.56 • n=6 Participants
65.9 years
STANDARD_DEVIATION 5.44 • n=7 Participants
68.7 years
STANDARD_DEVIATION 6.16 • n=13 Participants
69.1 years
STANDARD_DEVIATION 7.21 • n=6 Participants
67.3 years
STANDARD_DEVIATION 6.13 • n=6 Participants
Age, Customized
18-64 years
57 Participants
n=20 Participants
48 Participants
n=20 Participants
63 Participants
n=40 Participants
32 Participants
n=6 Participants
29 Participants
n=7 Participants
90 Participants
n=13 Participants
48 Participants
n=6 Participants
367 Participants
n=6 Participants
Age, Customized
From 65 to 84 years
46 Participants
n=20 Participants
54 Participants
n=20 Participants
41 Participants
n=40 Participants
20 Participants
n=6 Participants
25 Participants
n=7 Participants
185 Participants
n=13 Participants
88 Participants
n=6 Participants
459 Participants
n=6 Participants
Age, Customized
85 years and above
1 Participants
n=20 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
0 Participants
n=6 Participants
0 Participants
n=7 Participants
3 Participants
n=13 Participants
2 Participants
n=6 Participants
6 Participants
n=6 Participants
Sex: Female, Male
Female
59 Participants
n=20 Participants
45 Participants
n=20 Participants
65 Participants
n=40 Participants
31 Participants
n=6 Participants
28 Participants
n=7 Participants
220 Participants
n=13 Participants
111 Participants
n=6 Participants
559 Participants
n=6 Participants
Sex: Female, Male
Male
45 Participants
n=20 Participants
57 Participants
n=20 Participants
39 Participants
n=40 Participants
21 Participants
n=6 Participants
26 Participants
n=7 Participants
58 Participants
n=13 Participants
27 Participants
n=6 Participants
273 Participants
n=6 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
17 Participants
n=20 Participants
15 Participants
n=20 Participants
15 Participants
n=40 Participants
4 Participants
n=6 Participants
7 Participants
n=7 Participants
38 Participants
n=13 Participants
17 Participants
n=6 Participants
113 Participants
n=6 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
85 Participants
n=20 Participants
85 Participants
n=20 Participants
86 Participants
n=40 Participants
46 Participants
n=6 Participants
47 Participants
n=7 Participants
237 Participants
n=13 Participants
117 Participants
n=6 Participants
703 Participants
n=6 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants
n=20 Participants
2 Participants
n=20 Participants
3 Participants
n=40 Participants
2 Participants
n=6 Participants
0 Participants
n=7 Participants
3 Participants
n=13 Participants
4 Participants
n=6 Participants
16 Participants
n=6 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=20 Participants
1 Participants
n=20 Participants
0 Participants
n=40 Participants
1 Participants
n=6 Participants
0 Participants
n=7 Participants
1 Participants
n=13 Participants
0 Participants
n=6 Participants
3 Participants
n=6 Participants
Race (NIH/OMB)
Asian
0 Participants
n=20 Participants
0 Participants
n=20 Participants
1 Participants
n=40 Participants
0 Participants
n=6 Participants
0 Participants
n=7 Participants
1 Participants
n=13 Participants
1 Participants
n=6 Participants
3 Participants
n=6 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants
n=20 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
0 Participants
n=6 Participants
0 Participants
n=7 Participants
0 Participants
n=13 Participants
0 Participants
n=6 Participants
1 Participants
n=6 Participants
Race (NIH/OMB)
Black or African American
10 Participants
n=20 Participants
10 Participants
n=20 Participants
13 Participants
n=40 Participants
3 Participants
n=6 Participants
4 Participants
n=7 Participants
7 Participants
n=13 Participants
4 Participants
n=6 Participants
51 Participants
n=6 Participants
Race (NIH/OMB)
White
93 Participants
n=20 Participants
91 Participants
n=20 Participants
90 Participants
n=40 Participants
48 Participants
n=6 Participants
50 Participants
n=7 Participants
261 Participants
n=13 Participants
129 Participants
n=6 Participants
762 Participants
n=6 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=20 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
0 Participants
n=6 Participants
0 Participants
n=7 Participants
2 Participants
n=13 Participants
0 Participants
n=6 Participants
2 Participants
n=6 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=20 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
0 Participants
n=6 Participants
0 Participants
n=7 Participants
6 Participants
n=13 Participants
4 Participants
n=6 Participants
10 Participants
n=6 Participants
Region of Enrollment
BELGIUM
0 Participants
n=20 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
0 Participants
n=6 Participants
0 Participants
n=7 Participants
40 Participants
n=13 Participants
24 Participants
n=6 Participants
64 Participants
n=6 Participants
Region of Enrollment
FRANCE
0 Participants
n=20 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
0 Participants
n=6 Participants
0 Participants
n=7 Participants
39 Participants
n=13 Participants
21 Participants
n=6 Participants
60 Participants
n=6 Participants
Region of Enrollment
NETHERLANDS
0 Participants
n=20 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
0 Participants
n=6 Participants
0 Participants
n=7 Participants
40 Participants
n=13 Participants
11 Participants
n=6 Participants
51 Participants
n=6 Participants
Region of Enrollment
SPAIN
0 Participants
n=20 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
0 Participants
n=6 Participants
0 Participants
n=7 Participants
30 Participants
n=13 Participants
12 Participants
n=6 Participants
42 Participants
n=6 Participants
Region of Enrollment
UNITED STATES
104 Participants
n=20 Participants
102 Participants
n=20 Participants
104 Participants
n=40 Participants
52 Participants
n=6 Participants
54 Participants
n=7 Participants
129 Participants
n=13 Participants
70 Participants
n=6 Participants
615 Participants
n=6 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

Outcome measures
Measure
Cohort 2: Placebo
n=102 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.
Cohort 2: ExPEC10V High Dose
n=104 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 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
54 Participants
46 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

Outcome measures
Measure
Cohort 2: Placebo
n=102 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.
Cohort 2: ExPEC10V High Dose
n=104 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 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
47 Participants
41 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

Outcome measures
Measure
Cohort 2: Placebo
n=102 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.
Cohort 2: ExPEC10V High Dose
n=104 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 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
21 Participants
25 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

Outcome measures
Measure
Cohort 2: Placebo
n=102 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.
Cohort 2: ExPEC10V High Dose
n=104 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 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

Outcome measures
Measure
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.
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 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
22 Participants
139 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

Outcome measures
Measure
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.
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 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
53 Participants
139 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

Outcome measures
Measure
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.
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 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
36 Participants
79 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

Outcome measures
Measure
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.
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 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
6 Participants
9 Participants
—
—
—

PRIMARY outcome

Timeframe: Day 15

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

GMTs of serotype-specific total IgG serum antibodies as measured by multiplex ECL based immunoassay were reported. GMTs for each antigen serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 and exotoxin protein A (EPA) were determined in serum from collected blood samples. Lower limit of quantification (LLOQ) values for O1A: 69149, O2: 65287, O4: 67356, O6A: 150748, O8: 72196, O15: 66910, O16: 71586, O18A: 70519, O25B: 61990, O75: 133019, and EPA: 66165. Any titer less than LLOQ is replaced by half of LLOQ (0.5\*LLOQ).

Outcome measures

Outcome measures
Measure
Cohort 2: Placebo
n=98 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.
Cohort 2: ExPEC10V High Dose
n=101 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 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 O1A
6358232.9 Titer
Interval 5664895.6 to 7136429.1
5350535.1 Titer
Interval 4644976.0 to 6163266.7
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
4787891.5 Titer
Interval 4034593.8 to 5681837.2
4873016.8 Titer
Interval 4116237.9 to 5768931.0
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
2778764.0 Titer
Interval 2281609.7 to 3384246.4
2906299.6 Titer
Interval 2339299.2 to 3610729.8
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
5150333.2 Titer
Interval 4384440.1 to 6050015.8
4349111.4 Titer
Interval 3780753.5 to 5002910.0
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
5605655.1 Titer
Interval 4917150.4 to 6390564.9
5082460.4 Titer
Interval 4435261.0 to 5824100.0
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
4635317.8 Titer
Interval 3976055.4 to 5403891.3
5151217.3 Titer
Interval 4393448.3 to 6039684.0
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
3972656.6 Titer
Interval 3378225.9 to 4671682.9
4298055.1 Titer
Interval 3664533.7 to 5041099.1
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
3585987.4 Titer
Interval 3008355.6 to 4274529.8
3532498.2 Titer
Interval 2965791.1 to 4207492.4
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
2265970.3 Titer
Interval 1766736.9 to 2906273.8
1426991.8 Titer
Interval 1113308.2 to 1829058.4
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
3107132.4 Titer
Interval 2627869.3 to 3673802.2
2932034.9 Titer
Interval 2454267.7 to 3502807.9
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
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
1496999.3 Titer
Interval 1016330.1 to 2204999.2
1170226.6 Titer
Interval 829684.5 to 1650543.4
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 LLOQ that is 66165.

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

GMR of fold changes from baseline for serotype specific antibodies as measured by multiplex ECL based immunoassay on Day 15 were reported. GMR for each antigen serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 and EPA were determined in serum from collected blood samples by multiplex ECL based immunoassay. GMR of fold change from baseline was calculated as the ratio of GMTs on Day 15 and pre-vaccination (on Day 1). Any titer less than LLOQ is replaced by value of LLOQ.

Outcome measures

Outcome measures
Measure
Cohort 2: Placebo
n=98 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.
Cohort 2: ExPEC10V High Dose
n=101 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 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 O1A
5.33 Ratio
Interval 4.429 to 6.406
4.41 Ratio
Interval 3.69 to 5.259
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
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
10.05 Ratio
Interval 8.374 to 12.056
9.54 Ratio
Interval 8.014 to 11.36
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
5.49 Ratio
Interval 4.528 to 6.656
6.28 Ratio
Interval 5.103 to 7.718
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
4.48 Ratio
Interval 3.731 to 5.389
3.55 Ratio
Interval 3.039 to 4.141
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
3.27 Ratio
Interval 2.791 to 3.826
3.34 Ratio
Interval 2.892 to 3.855
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
5.32 Ratio
Interval 4.468 to 6.339
5.94 Ratio
Interval 4.966 to 7.104
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
4.59 Ratio
Interval 3.822 to 5.502
5.04 Ratio
Interval 4.3 to 5.912
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
3.64 Ratio
Interval 3.043 to 4.344
3.79 Ratio
Interval 3.22 to 4.456
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
9.51 Ratio
Interval 7.463 to 12.126
5.80 Ratio
Interval 4.761 to 7.071
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
2.38 Ratio
Interval 2.055 to 2.756
2.33 Ratio
Interval 2.013 to 2.701
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
12.31 Ratio
Interval 9.11 to 16.62
11.31 Ratio
Interval 8.61 to 14.86
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

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

Percentage of participants with a \>=2-fold and \>=4-fold increase (FI) from baseline in serotype specific serum antibody titers as measured by multiplex ECL based immunoassay on Day 15 was reported. The fold (\>=2-fold and \>=4-fold) increase from baseline to Day 15 for the serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 and EPA was calculated as the ratio of titer values of serum antibody on Day 15 and pre-vaccination (on day 1) that is Day 15/Day 1. Any titer less than LLOQ is replaced by value of LLOQ.

Outcome measures

Outcome measures
Measure
Cohort 2: Placebo
n=98 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.
Cohort 2: ExPEC10V High Dose
n=101 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 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 O8: >= 2 Fold Increase
73.5 Percentage of participants
Interval 63.59 to 81.88
73.3 Percentage of participants
Interval 63.54 to 81.59
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 O1A: >= 2 Fold Increase
84.7 Percentage of participants
Interval 76.01 to 91.17
78.2 Percentage of participants
Interval 68.9 to 85.82
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
62. Percentage of participants
Interval 51.88 to 71.84
56.4 Percentage of participants
Interval 46.2 to 66.28
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
93.9 Percentage of participants
Interval 87.15 to 97.72
93.1 Percentage of participants
Interval 86.24 to 97.17
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
83.7 Percentage of participants
Interval 74.84 to 90.37
83.2 Percentage of participants
Interval 74.42 to 89.88
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
81.6 Percentage of participants
Interval 72.53 to 88.74
77.2 Percentage of participants
Interval 67.82 to 84.98
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
63.3 Percentage of participants
Interval 52.93 to 72.78
64.4 Percentage of participants
Interval 54.21 to 73.64
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
77.6 Percentage of participants
Interval 68.01 to 85.36
72.3 Percentage of participants
Interval 62.48 to 80.72
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
53.1 Percentage of participants
Interval 42.71 to 63.22
42.6 Percentage of participants
Interval 32.79 to 52.81
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: >= 4 Fold Increase
38.8 Percentage of participants
Interval 29.1 to 49.15
41.6 Percentage of participants
Interval 31.86 to 51.82
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 O15: >= 2 Fold Increase
82.7 Percentage of participants
Interval 73.69 to 89.56
88.1 Percentage of participants
Interval 80.17 to 93.71
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 O15: >= 4 Fold Increase
63.3 Percentage of participants
Interval 52.93 to 72.78
61.4 Percentage of participants
Interval 51.18 to 70.91
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
77.6 Percentage of participants
Interval 68.01 to 85.36
86.1 Percentage of participants
Interval 77.84 to 92.21
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
57.1 Percentage of participants
Interval 46.75 to 67.1
63.4 Percentage of participants
Interval 53.19 to 72.73
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
71.4 Percentage of participants
Interval 61.42 to 80.1
72.3 Percentage of participants
Interval 62.48 to 80.72
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
41.8 Percentage of participants
Interval 31.95 to 52.23
48.5 Percentage of participants
Interval 38.45 to 58.67
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
87.8 Percentage of participants
Interval 79.59 to 93.51
82.2 Percentage of participants
Interval 73.3 to 89.08
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
75.5 Percentage of participants
Interval 65.79 to 83.64
58.4 Percentage of participants
Interval 48.18 to 68.14
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
49.0 Percentage of participants
Interval 38.74 to 59.28
50.5 Percentage of participants
Interval 40.36 to 60.6
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
25.5 Percentage of participants
Interval 17.24 to 35.31
20.8 Percentage of participants
Interval 13.36 to 30.01
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
83.7 Percentage of participants
Interval 74.84 to 90.37
87.1 Percentage of participants
Interval 79.0 to 92.96
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
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
74.5 Percentage of participants
Interval 64.69 to 82.76
74.3 Percentage of participants
Interval 64.6 to 82.44
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

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

GMTs of serotype-specific total IgG serum antibodies as measured by MOPA were reported. GMTs for each antigen serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B and O75 were determined in serum from collected blood samples. LLOQ values were: O1A: 53, O2: 51, O4: 29, O6A: 47, O8: 196, O15: 37, O16: 54, O18A: 12, O25B: 65, and O75: 37. Any titer less than LLOQ is replaced by half of LLOQ (0.5\*LLOQ).

Outcome measures

Outcome measures
Measure
Cohort 2: Placebo
n=98 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.
Cohort 2: ExPEC10V High Dose
n=101 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 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 O1A
764.2 Titer
Interval 590.3 to 989.5
654.3 Titer
Interval 512.4 to 835.4
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
5359.8 Titer
Interval 3689.3 to 7786.7
5538.4 Titer
Interval 3884.7 to 7896.2
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
322.9 Titer
Interval 239.7 to 434.9
376.3 Titer
Interval 278.6 to 508.2
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 O6A
2256.5 Titer
Interval 1725.5 to 2951.0
1495.9 Titer
Interval 1133.1 to 1974.8
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
921.5 Titer
Interval 702.3 to 1209.1
1249.2 Titer
Interval 979.3 to 1593.5
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 O15
3018.4 Titer
Interval 2093.9 to 4351.1
3095.1 Titer
Interval 2194.3 to 4365.6
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
1172.2 Titer
Interval 822.4 to 1670.8
1532.2 Titer
Interval 1092.6 to 2148.8
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 O18A
276.2 Titer
Interval 205.0 to 372.0
274.7 Titer
Interval 202.2 to 373.2
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
489.5 Titer
Interval 373.3 to 641.9
415.5 Titer
Interval 318.4 to 542.3
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 O75
58.0 Titer
Interval 46.5 to 72.3
84.0 Titer
Interval 65.8 to 107.1
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" (Number of participants analyzed) signifies participants evaluable for this endpoint and "n" signifies those participants who were evaluable at specified categories.

GMR of fold changes from baseline for serotype specific antibodies as measured by MOPA on Day 15 were reported. GMR for each antigen serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B and O75 were determined in serum from collected blood samples by MOPA. GMR of fold change from baseline was calculated as the ratio of GMTs on Day 15 and pre-vaccination (on Day 1). Any titer less than LLOQ is replaced by value of LLOQ.

Outcome measures

Outcome measures
Measure
Cohort 2: Placebo
n=98 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.
Cohort 2: ExPEC10V High Dose
n=101 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 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
4.29 Ratio
Interval 3.372 to 5.469
2.67 Ratio
Interval 2.103 to 3.389
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
17.78 Ratio
Interval 12.567 to 25.168
14.39 Ratio
Interval 10.285 to 20.126
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
3.47 Ratio
Interval 2.723 to 4.42
3.25 Ratio
Interval 2.489 to 4.24
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
3.72 Ratio
Interval 2.74 to 5.046
2.30 Ratio
Interval 1.859 to 2.858
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
1.22 Ratio
Interval 1.107 to 1.339
1.26 Ratio
Interval 1.078 to 1.468
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
6.29 Ratio
Interval 4.285 to 9.247
4.91 Ratio
Interval 3.498 to 6.884
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
5.86 Ratio
Interval 4.051 to 8.485
6.58 Ratio
Interval 4.806 to 9.018
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
4.27 Ratio
Interval 3.192 to 5.721
4.05 Ratio
Interval 3.148 to 5.204
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
2.77 Ratio
Interval 2.155 to 3.557
2.34 Ratio
Interval 1.883 to 2.903
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
1.69 Ratio
Interval 1.44 to 1.991
1.92 Ratio
Interval 1.6 to 2.299
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" (Number of participants analyzed) signifies participants evaluable for this endpoint and "n" signifies those participants who were evaluable at specified categories.

Percentage of participants with a \>=2-fold and \>=4-fold increase from baseline in serotype specific serum antibody titers as measured by MOPA on Day 15 was reported. The fold (\>=2-fold and \>=4-fold) increase from baseline to Day 15 for the serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, and O75 was calculated as the ratio of titer values of serum antibody on Day 15 and pre-vaccination (on day 1) that is, Day 15/Day 1. Any titer less than LLOQ is replaced by value of LLOQ.

Outcome measures

Outcome measures
Measure
Cohort 2: Placebo
n=98 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.
Cohort 2: ExPEC10V High Dose
n=101 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 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 O6A: >= 2 Fold Increase
54.1 Percentage of participants
Interval 43.71 to 64.2
47.5 Percentage of participants
Interval 37.49 to 57.7
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 O18A: >= 4 Fold Increase
44.9 Percentage of participants
Interval 34.83 to 55.28
45.5 Percentage of participants
Interval 35.6 to 55.76
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
70.4 Percentage of participants
Interval 60.34 to 79.21
49.5 Percentage of participants
Interval 39.4 to 59.64
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
46.9 Percentage of participants
Interval 36.78 to 57.29
28.7 Percentage of participants
Interval 20.15 to 38.57
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
86.5 Percentage of participants
Interval 77.96 to 92.59
90.1 Percentage of participants
Interval 82.54 to 95.15
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
78.1 Percentage of participants
Interval 68.53 to 85.92
74.3 Percentage of participants
Interval 64.6 to 82.44
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
60.2 Percentage of participants
Interval 49.82 to 69.96
56.4 Percentage of participants
Interval 46.2 to 66.28
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 O4: >= 4 Fold Increase
38.8 Percentage of participants
Interval 29.1 to 49.15
33.7 Percentage of participants
Interval 24.56 to 43.75
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 O6A: >= 4 Fold Increase
41.8 Percentage of participants
Interval 31.95 to 52.23
23.8 Percentage of participants
Interval 15.86 to 33.26
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
14.3 Percentage of participants
Interval 8.04 to 22.81
19.8 Percentage of participants
Interval 12.54 to 28.91
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
3.1 Percentage of participants
Interval 0.64 to 8.69
5.9 Percentage of participants
Interval 2.21 to 12.48
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
67.0 Percentage of participants
Interval 56.73 to 76.22
61.0 Percentage of participants
Interval 50.73 to 70.6
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
53.6 Percentage of participants
Interval 43.19 to 63.8
41.0 Percentage of participants
Interval 31.26 to 51.29
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
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
70.4 Percentage of participants
Interval 60.34 to 79.21
76.2 Percentage of participants
Interval 66.74 to 84.14
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
51.0 Percentage of participants
Interval 40.72 to 61.26
55.4 Percentage of participants
Interval 45.22 to 65.34
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
66.3 Percentage of participants
Interval 56.07 to 75.56
69.3 Percentage of participants
Interval 59.34 to 78.1
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 O25B: >= 2 Fold Increase
50.0 Percentage of participants
Interval 39.73 to 60.27
47.5 Percentage of participants
Interval 37.49 to 57.7
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
33.7 Percentage of participants
Interval 24.44 to 43.93
24.8 Percentage of participants
Interval 16.7 to 34.33
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: >= 2 Fold Increase
28.6 Percentage of participants
Interval 19.9 to 38.58
36.0 Percentage of participants
Interval 26.64 to 46.21
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 O75: >= 4 Fold Increase
17.3 Percentage of participants
Interval 10.44 to 26.31
16.0 Percentage of participants
Interval 9.43 to 24.68
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

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

GMTs of serotype-specific total IgG serum antibodies as measured by multiplex ECL based immunoassay were reported. GMTs for each antigen serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 and EPA were determined in serum from collected blood samples. LLOQ values for O1A: 69149, O2: 65287, O4: 67356, O6A: 150748, O8: 72196, O15: 66910, O16: 71586, O18A: 70519, O25B: 61990, O75: 133019, and EPA: 66165. Any titer less than LLOQ is replaced by half of LLOQ (0.5\*LLOQ).

Outcome measures

Outcome measures
Measure
Cohort 2: Placebo
n=129 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.
Cohort 2: ExPEC10V High Dose
n=258 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 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
1762724.3 Titer
Interval 1505477.9 to 2063927.4
6341302.4 Titer
Interval 5889782.4 to 6827436.7
—
—
—
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 O2
749984.6 Titer
Interval 628913.9 to 894362.5
5957433.5 Titer
Interval 5487954.2 to 6467075.6
—
—
—
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
805295.5 Titer
Interval 689894.4 to 940000.1
3537556.6 Titer
Interval 3153145.2 to 3968833.1
—
—
—
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
1944280.6 Titer
Interval 1664293.0 to 2271371.1
5461039.4 Titer
Interval 4992165.2 to 5973951.2
—
—
—
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
2315932.9 Titer
Interval 2011986.2 to 2665796.4
6240213.6 Titer
Interval 5782238.7 to 6734461.7
—
—
—
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 O15
1207724.5 Titer
Interval 1028556.8 to 1418101.9
5724175.1 Titer
Interval 5301709.2 to 6180305.1
—
—
—
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 O16
1127584.4 Titer
Interval 1001022.6 to 1270147.7
5158063.5 Titer
Interval 4735530.7 to 5618297.2
—
—
—
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
1365154.9 Titer
Interval 1196273.0 to 1557878.4
4046778.4 Titer
Interval 3656809.6 to 4478334.1
—
—
—
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 O25B
375570.5 Titer
Interval 316412.1 to 445789.5
2117662.8 Titer
Interval 1843164.1 to 2433042.1
—
—
—
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 O75
1577900.4 Titer
Interval 1365705.2 to 1823065.1
3758021.3 Titer
Interval 3419541.0 to 4130005.8
—
—
—
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
75018.0 Titer
Interval to 91880.8
Lower limit of 95% CI could not be estimated as the value was below the LLOQ (66165).
780539.6 Titer
Interval 622435.7 to 978803.3
—
—
—

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

GMR of fold changes from baseline for serotype-specific antibodies as measured by multiplex ECL based immunoassay on Day 30 were reported. GMR for each antigen serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 and EPA were determined in serum from collected blood samples by multiplex ECL based immunoassay. GMR of fold change from baseline was calculated as the ratio of GMTs on Day 30 and pre-vaccination (on Day 1). Any titer less than LLOQ is replaced by value of LLOQ.

Outcome measures

Outcome measures
Measure
Cohort 2: Placebo
n=129 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.
Cohort 2: ExPEC10V High Dose
n=258 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 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 Measured by Multiplex ECL Based Immunoassay on Day 30
Serotype O1A
1.02 Ratio
Interval 0.955 to 1.095
4.40 Ratio
Interval 3.958 to 4.893
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline For Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Day 30
Serotype O2
0.98 Ratio
Interval 0.909 to 1.055
8.18 Ratio
Interval 7.255 to 9.227
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline For Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Day 30
Serotype O4
1.09 Ratio
Interval 1.014 to 1.168
5.31 Ratio
Interval 4.726 to 5.955
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline For Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Day 30
Serotype O6A
1.06 Ratio
Interval 0.993 to 1.138
3.64 Ratio
Interval 3.289 to 4.019
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline For Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Day 30
Serotype O8
1.01 Ratio
Interval 0.965 to 1.058
2.92 Ratio
Interval 2.655 to 3.221
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline For Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Day 30
Serotype O15
1.02 Ratio
Interval 0.961 to 1.077
5.00 Ratio
Interval 4.483 to 5.565
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline For Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Day 30
Serotype O16
1.06 Ratio
Interval 0.993 to 1.126
5.04 Ratio
Interval 4.571 to 5.561
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline For Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Day 30
Serotype O18
1.07 Ratio
Interval 1.017 to 1.132
3.40 Ratio
Interval 3.088 to 3.754
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline For Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Day 30
Serotype O25B
1.04 Ratio
Interval 0.963 to 1.115
5.59 Ratio
Interval 4.866 to 6.428
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline For Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Day 30
Serotype O75
1.04 Ratio
Interval 0.979 to 1.11
2.33 Ratio
Interval 2.136 to 2.531
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline For Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Day 30
Serotype EPA
1.02 Ratio
Interval 0.97 to 1.08
8.06 Ratio
Interval 6.73 to 9.64
—
—
—

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

Percentage of participants with a \>=2-fold and \>=4-fold increase from baseline in serotype specific serum antibody titers as measured by multiplex ECL based immunoassay on Day 30 was reported. The fold (\>=2-fold and \>=4-fold) increase from baseline to Day 30 for the serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 and EPA was calculated as the ratio of titer values of serum antibody on Day 30 and pre-vaccination (on day 1) that is, Day 30/Day 1. Any titer less than LLOQ is replaced by value of LLOQ.

Outcome measures

Outcome measures
Measure
Cohort 2: Placebo
n=129 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.
Cohort 2: ExPEC10V High Dose
n=258 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 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 O1A: >= 2 Fold Increase
1.6 Percentage of participants
Interval 0.19 to 5.49
78.3 Percentage of participants
Interval 72.76 to 83.17
—
—
—
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
0.8 Percentage of participants
Interval 0.02 to 4.24
54.7 Percentage of participants
Interval 48.36 to 60.84
—
—
—
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
1.6 Percentage of participants
Interval 0.19 to 5.49
89.1 Percentage of participants
Interval 84.7 to 92.67
—
—
—
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
1.6 Percentage of participants
Interval 0.19 to 5.49
77.5 Percentage of participants
Interval 71.93 to 82.46
—
—
—
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
2.3 Percentage of participants
Interval 0.48 to 6.65
81.4 Percentage of participants
Interval 76.1 to 85.95
—
—
—
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
1.6 Percentage of participants
Interval 0.19 to 5.49
58.9 Percentage of participants
Interval 52.64 to 64.98
—
—
—
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
2.3 Percentage of participants
Interval 0.48 to 6.65
73.3 Percentage of participants
Interval 67.41 to 78.56
—
—
—
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
0.8 Percentage of participants
Interval 0.02 to 4.24
44.2 Percentage of participants
Interval 38.03 to 50.48
—
—
—
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
1.6 Percentage of participants
Interval 0.19 to 5.49
64.0 Percentage of participants
Interval 57.77 to 69.82
—
—
—
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
1.6 Percentage of participants
Interval 0.19 to 5.49
38.4 Percentage of participants
Interval 32.41 to 44.61
—
—
—
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
1.6 Percentage of participants
Interval 0.19 to 5.49
84.1 Percentage of participants
Interval 79.07 to 88.35
—
—
—
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
0.8 Percentage of participants
Interval 0.02 to 4.24
58.5 Percentage of participants
Interval 52.25 to 64.6
—
—
—
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
1.6 Percentage of participants
Interval 0.19 to 5.49
86.0 Percentage of participants
Interval 81.21 to 90.03
—
—
—
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
1.6 Percentage of participants
Interval 0.19 to 5.49
62.4 Percentage of participants
Interval 56.18 to 68.33
—
—
—
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
1.6 Percentage of participants
Interval 0.19 to 5.49
69.0 Percentage of participants
Interval 62.96 to 74.58
—
—
—
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
0.8 Percentage of participants
Interval 0.02 to 4.24
43.0 Percentage of participants
Interval 36.9 to 49.31
—
—
—
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
2.3 Percentage of participants
Interval 0.48 to 6.65
78.3 Percentage of participants
Interval 72.76 to 83.17
—
—
—
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
1.6 Percentage of participants
Interval 0.19 to 5.49
56.6 Percentage of participants
Interval 50.3 to 62.72
—
—
—
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
2.3 Percentage of participants
Interval 0.48 to 6.65
51.2 Percentage of participants
Interval 44.89 to 57.41
—
—
—
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
2.3 Percentage of participants
Interval 0.48 to 6.65
23.6 Percentage of participants
Interval 18.59 to 29.31
—
—
—
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
1.6 Percentage of participants
Interval 0.19 to 5.49
77.9 Percentage of participants
Interval 72.34 to 82.82
—
—
—
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
1.6 Percentage of participants
Interval 0.19 to 5.49
65.5 Percentage of participants
Interval 59.36 to 71.29
—
—
—

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

GMTs of serotype-specific total IgG serum antibodies as measured by MOPA were reported. GMTs for each antigen serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B, and O75 were determined in serum from collected blood samples. For serotype O8 functional IgG serum antibodies were not evaluated as the assay was not able to detect vaccine-induced functional antibodies against the O8 serotype. LLOQ values were O1A: 33, O2: 42, O4: 12, O6A: 62, O15: 75, O16: 17, O18A: 44, O25B: 58, O75: 14. Any titer less than LLOQ is replaced by half of LLOQ (0.5\*LLOQ).

Outcome measures

Outcome measures
Measure
Cohort 2: Placebo
n=70 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.
Cohort 2: ExPEC10V High Dose
n=258 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 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 O1A
492.4 Titer
Interval 382.9 to 633.2
703.0 Titer
Interval 611.1 to 808.7
—
—
—
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
502.4 Titer
Interval 403.6 to 625.4
3523.2 Titer
Interval 2950.7 to 4206.7
—
—
—
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
178.7 Titer
Interval 138.7 to 230.4
803.9 Titer
Interval 683.3 to 945.7
—
—
—
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
557.0 Titer
Interval 416.8 to 744.3
1392.6 Titer
Interval 1196.9 to 1620.3
—
—
—
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
458.0 Titer
Interval 338.4 to 619.9
2773.8 Titer
Interval 2347.4 to 3277.6
—
—
—
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 O16
116.0 Titer
Interval 88.0 to 152.8
1347.0 Titer
Interval 1132.2 to 1602.5
—
—
—
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
168.2 Titer
Interval 128.8 to 219.6
516.3 Titer
Interval 446.2 to 597.3
—
—
—
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 O25B
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).
159.8 Titer
Interval 135.4 to 188.5
—
—
—
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
52.2 Titer
Interval 39.2 to 69.6
201.0 Titer
Interval 169.5 to 238.3
—
—
—

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" (number of participants analyzed) signifies participants evaluable for this outcome measure and "n" signifies those participants who were evaluable at specified categories.

GMR of fold changes from baseline for serotype specific antibodies as measured by MOPA on Day 30 were reported. GMR for each antigen serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B and O75 were determined in serum from collected blood samples by MOPA. GMR of fold change from baseline was calculated as the ratio of GMTs on Day 30 and pre-vaccination (on Day 1). For serotype O8 functional IgG serum antibodies were not evaluated as the assay was not able to detect vaccine-induced functional antibodies against the O8 serotype. Any titer less than LLOQ is replaced by value of LLOQ.

Outcome measures

Outcome measures
Measure
Cohort 2: Placebo
n=70 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.
Cohort 2: ExPEC10V High Dose
n=258 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 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
1.23 Ratio
Interval 1.036 to 1.451
1.81 Ratio
Interval 1.602 to 2.054
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Day 30
Serotype O2
1.07 Ratio
Interval 0.901 to 1.265
8.04 Ratio
Interval 6.684 to 9.681
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Day 30
Serotype O4
0.98 Ratio
Interval 0.827 to 1.162
4.26 Ratio
Interval 3.607 to 5.033
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Day 30
Serotype O6A
1.02 Ratio
Interval 0.87 to 1.192
2.57 Ratio
Interval 2.251 to 2.939
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Day 30
Serotype O15
1.05 Ratio
Interval 0.807 to 1.376
6.70 Ratio
Interval 5.641 to 7.958
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Day 30
Serotype O16
1.02 Ratio
Interval 0.841 to 1.227
9.68 Ratio
Interval 8.055 to 11.639
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Day 30
Serotype O18
0.93 Ratio
Interval 0.805 to 1.083
2.88 Ratio
Interval 2.482 to 3.332
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Day 30
Serotype O25B
0.94 Ratio
Interval 0.841 to 1.045
2.05 Ratio
Interval 1.813 to 2.308
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Day 30
Serotype O75
1.18 Ratio
Interval 0.973 to 1.438
3.21 Ratio
Interval 2.744 to 3.745
—
—
—

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

Percentage of participants with a \>=2-fold and \>=4-fold increase from baseline in serotype specific serum antibodies titers as measured by MOPA on Day 30 was reported. The fold (\>=2-fold and \>=4-fold increase from baseline to Day 30 for the serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B and O75 was calculated as the ratio of titer values of serum antibodies on Day 30 and pre-vaccination (on day 1 that is, Day 30/Day 1. For serotype O8 functional IgG serum antibodies were not evaluated as the assay was not able to detect vaccine-induced functional antibodies against the O8 serotype. Any titer less than LLOQ is replaced by value of LLOQ.

Outcome measures

Outcome measures
Measure
Cohort 2: Placebo
n=70 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.
Cohort 2: ExPEC10V High Dose
n=258 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 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
22.9 Percentage of participants
Interval 13.67 to 34.45
41.5 Percentage of participants
Interval 35.4 to 47.75
—
—
—
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
2.9 Percentage of participants
Interval 0.35 to 9.94
17.8 Percentage of participants
Interval 13.36 to 23.06
—
—
—
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
18.6 Percentage of participants
Interval 10.28 to 29.66
81.0 Percentage of participants
Interval 75.68 to 85.61
—
—
—
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
4.3 Percentage of participants
Interval 0.89 to 12.02
63.6 Percentage of participants
Interval 57.37 to 69.45
—
—
—
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 O4: >= 2 Fold Increase
14.3 Percentage of participants
Interval 7.07 to 24.71
64.7 Percentage of participants
Interval 58.56 to 70.55
—
—
—
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
4.3 Percentage of participants
Interval 0.89 to 12.02
45.7 Percentage of participants
Interval 39.54 to 52.03
—
—
—
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: >= 2 Fold Increase
17.1 Percentage of participants
Interval 9.18 to 28.03
54.3 Percentage of participants
Interval 47.97 to 60.46
—
—
—
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
1.4 Percentage of participants
Interval 0.04 to 7.7
32.9 Percentage of participants
Interval 27.24 to 39.05
—
—
—
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
22.9 Percentage of participants
Interval 13.67 to 34.45
81.4 Percentage of participants
Interval 76.1 to 85.95
—
—
—
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
8.6 Percentage of participants
Interval 3.21 to 17.73
62.8 Percentage of participants
Interval 56.58 to 68.71
—
—
—
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 O16: >= 2 Fold Increase
18.6 Percentage of participants
Interval 10.28 to 29.66
86.0 Percentage of participants
Interval 81.21 to 90.03
—
—
—
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 O16: >= 4 Fold Increase
4.3 Percentage of participants
Interval 0.89 to 12.02
70.9 Percentage of participants
Interval 64.98 to 76.4
—
—
—
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
14.3 Percentage of participants
Interval 7.07 to 24.71
55.8 Percentage of participants
Interval 49.52 to 61.97
—
—
—
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
0.0 Percentage of participants
Interval 0.0 to 5.13
34.5 Percentage of participants
Interval 28.71 to 40.64
—
—
—
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
5.7 Percentage of participants
Interval 1.58 to 13.99
41.1 Percentage of participants
Interval 35.02 to 47.36
—
—
—
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
0.0 Percentage of participants
Interval 0.0 to 5.13
21.3 Percentage of participants
Interval 16.48 to 26.83
—
—
—
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
23.5 Percentage of participants
Interval 14.09 to 35.38
58.4 Percentage of participants
Interval 52.12 to 64.55
—
—
—
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
10.3 Percentage of participants
Interval 4.24 to 20.07
36.9 Percentage of participants
Interval 30.93 to 43.11
—
—
—

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

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

Outcome measures

Outcome measures
Measure
Cohort 2: Placebo
n=98 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.
Cohort 2: ExPEC10V High Dose
n=101 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 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: Correlation Between the Multiplex ECL-Based Immunoassay and the MOPA Functional Titers by Serotypes on Day 15
Serotype O75
0.45 correlation coefficient
Interval 0.27 to 0.59
0.60 correlation coefficient
Interval 0.45 to 0.71
0.64 correlation coefficient
Interval 0.51 to 0.75
0.51 correlation coefficient
Interval 0.26 to 0.69
0.35 correlation coefficient
Interval 0.08 to 0.57
Cohort 1: Correlation Between the Multiplex ECL-Based Immunoassay and the MOPA Functional Titers by Serotypes on Day 15
Serotype O2
0.74 correlation coefficient
Interval 0.63 to 0.82
0.72 correlation coefficient
Interval 0.61 to 0.8
0.64 correlation coefficient
Interval 0.51 to 0.74
0.74 correlation coefficient
Interval 0.58 to 0.85
0.59 correlation coefficient
Interval 0.38 to 0.75
Cohort 1: Correlation Between the Multiplex ECL-Based Immunoassay and the MOPA Functional Titers by Serotypes on Day 15
Serotype O4
0.65 correlation coefficient
Interval 0.52 to 0.75
0.69 correlation coefficient
Interval 0.58 to 0.78
0.61 correlation coefficient
Interval 0.47 to 0.72
-0.12 correlation coefficient
Interval -0.39 to 0.17
0.47 correlation coefficient
Interval 0.22 to 0.66
Cohort 1: Correlation Between the Multiplex ECL-Based Immunoassay and the MOPA Functional Titers by Serotypes on Day 15
Serotype O6A
0.53 correlation coefficient
Interval 0.37 to 0.66
0.48 correlation coefficient
Interval 0.31 to 0.62
0.60 correlation coefficient
Interval 0.46 to 0.72
0.67 correlation coefficient
Interval 0.48 to 0.8
0.15 correlation coefficient
Interval -0.14 to 0.4
Cohort 1: Correlation Between the Multiplex ECL-Based Immunoassay and the MOPA Functional Titers by Serotypes on Day 15
Serotype O8
0.01 correlation coefficient
Interval -0.19 to 0.21
0.29 correlation coefficient
Interval 0.1 to 0.46
0.20 correlation coefficient
Interval 0.0 to 0.38
-0.01 correlation coefficient
Interval -0.29 to 0.28
0.15 correlation coefficient
Interval -0.13 to 0.41
Cohort 1: Correlation Between the Multiplex ECL-Based Immunoassay and the MOPA Functional Titers by Serotypes on Day 15
Serotype O15
0.58 correlation coefficient
Interval 0.43 to 0.7
0.59 correlation coefficient
Interval 0.44 to 0.7
0.60 correlation coefficient
Interval 0.46 to 0.71
0.17 correlation coefficient
Interval -0.12 to 0.43
0.41 correlation coefficient
Interval 0.15 to 0.62
Cohort 1: Correlation Between the Multiplex ECL-Based Immunoassay and the MOPA Functional Titers by Serotypes on Day 15
Serotype O16
0.67 correlation coefficient
Interval 0.54 to 0.77
0.74 correlation coefficient
Interval 0.64 to 0.82
0.69 correlation coefficient
Interval 0.58 to 0.78
0.52 correlation coefficient
Interval 0.28 to 0.7
0.48 correlation coefficient
Interval 0.24 to 0.67
Cohort 1: Correlation Between the Multiplex ECL-Based Immunoassay and the MOPA Functional Titers by Serotypes on Day 15
Serotype O18A
0.65 correlation coefficient
Interval 0.52 to 0.75
0.69 correlation coefficient
Interval 0.58 to 0.78
0.72 correlation coefficient
Interval 0.61 to 0.8
0.39 correlation coefficient
Interval 0.12 to 0.61
0.55 correlation coefficient
Interval 0.32 to 0.71
Cohort 1: Correlation Between the Multiplex ECL-Based Immunoassay and the MOPA Functional Titers by Serotypes on Day 15
Serotype O25B
0.57 correlation coefficient
Interval 0.42 to 0.69
0.55 correlation coefficient
Interval 0.4 to 0.68
0.54 correlation coefficient
Interval 0.38 to 0.66
0.46 correlation coefficient
Interval 0.21 to 0.66
-0.02 correlation coefficient
Interval -0.29 to 0.26
Cohort 1: Correlation Between the Multiplex ECL-Based Immunoassay and the MOPA Functional Titers by Serotypes on Day 15
Serotype O1A
0.51 correlation coefficient
Interval 0.35 to 0.64
0.62 correlation coefficient
Interval 0.49 to 0.73
0.63 correlation coefficient
Interval 0.49 to 0.73
0.57 correlation coefficient
Interval 0.34 to 0.73
0.51 correlation coefficient
Interval 0.27 to 0.69

SECONDARY outcome

Timeframe: Days 30 and 181

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

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

Outcome measures

Outcome measures
Measure
Cohort 2: Placebo
n=98 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.
Cohort 2: ExPEC10V High Dose
n=101 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 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 ECL Based Immunoassay on Days 30 and 181
Day 30:Serotype O1A
6188073.3 Titer
Interval 5425498.1 to 7057831.4
5112484.0 Titer
Interval 4410187.9 to 5926616.5
6383997.2 Titer
Interval 5633938.0 to 7233913.5
6070942.6 Titer
Interval 4778712.5 to 7712609.5
1794173.8 Titer
Interval 1315930.3 to 2446223.7
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 30:Serotype O2
4270069.6 Titer
Interval 3501400.5 to 5207486.0
4748963.2 Titer
Interval 4012632.8 to 5620412.3
6330528.7 Titer
Interval 5614246.1 to 7138196.7
5413245.9 Titer
Interval 4188560.3 to 6996015.3
484833.8 Titer
Interval 372182.7 to 631581.8
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 30:Serotype O4
2286562.3 Titer
Interval 1855540.8 to 2817705.3
2849977.5 Titer
Interval 2298957.5 to 3533067.3
3835055.2 Titer
Interval 3183368.8 to 4620152.0
501717.6 Titer
Interval 417216.6 to 603333.0
585948.8 Titer
Interval 448200.5 to 766032.1
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 30:Serotype O6A
4675388.4 Titer
Interval 3910364.2 to 5590082.1
3914979.5 Titer
Interval 3360214.3 to 4561335.5
5328088.3 Titer
Interval 4595271.6 to 6177768.6
4648933.4 Titer
Interval 3601807.2 to 6000482.7
1018443.7 Titer
Interval 813194.1 to 1275498.2
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 30:Serotype O8
5717188.1 Titer
Interval 4983597.2 to 6558764.4
5443708.3 Titer
Interval 4750360.8 to 6238254.6
6287045.5 Titer
Interval 5617980.2 to 7035792.2
1684506.5 Titer
Interval 1372618.1 to 2067262.5
1549931.5 Titer
Interval 1203616.5 to 1995891.3
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 30:Serotype O15
4267640.2 Titer
Interval 3590342.0 to 5072707.0
4913158.9 Titer
Interval 4214268.5 to 5727952.5
5216657.6 Titer
Interval 4496071.7 to 6052732.0
900296.6 Titer
Interval 691458.3 to 1172209.6
1106266.6 Titer
Interval 821060.3 to 1490543.2
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 30:Serotype O16
3525973.6 Titer
Interval 2932681.9 to 4239290.3
4376021.6 Titer
Interval 3720209.1 to 5147443.3
5410106.5 Titer
Interval 4684904.9 to 6247565.9
723757.2 Titer
Interval 621819.1 to 842406.6
819745.0 Titer
Interval 642584.7 to 1045748.2
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 30:Serotype O18A
3317876.1 Titer
Interval 2741547.6 to 4015360.4
3500329.1 Titer
Interval 2944423.4 to 4161189.5
4518450.7 Titer
Interval 3838422.1 to 5318955.6
1006196.4 Titer
Interval 830764.7 to 1218673.8
1121774.9 Titer
Interval 868211.3 to 1449392.5
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 30:Serotype O25B
2067379.5 Titer
Interval 1579663.8 to 2705675.7
1345602.7 Titer
Interval 1045822.6 to 1731313.4
1720048.6 Titer
Interval 1357130.9 to 2180016.1
1651715.3 Titer
Interval 1155425.4 to 2361176.7
285650.4 Titer
Interval 211348.9 to 386073.0
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 30:Serotype O75
2640901.8 Titer
Interval 2178489.5 to 3201466.9
2827912.3 Titer
Interval 2357677.6 to 3391934.5
3569256.9 Titer
Interval 3057254.3 to 4167005.2
1180934.2 Titer
Interval 941313.5 to 1481552.7
1399568.8 Titer
Interval 1063013.9 to 1842678.4
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 30:Serotype EPA
1306567.5 Titer
Interval 877517.2 to 1945396.2
1019260.3 Titer
Interval 727674.3 to 1427687.4
1344648.1 Titer
Interval 957989.8 to 1887367.1
1107480.0 Titer
Interval 641693.9 to 1911366.1
NA Titer
Interval to 77381.5
Geometric mean and lower limit of 95% CI could not be estimated as the value was one-half of the LLOQ, that is, one -half of 66165.
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 181: Serotype O1A
4537954.7 Titer
Interval 3685416.2 to 5587709.0
3583270.6 Titer
Interval 2911726.7 to 4409695.6
5046472.5 Titer
Interval 4245661.9 to 5998330.9
4468702.4 Titer
Interval 3299074.4 to 6053001.2
1523139.6 Titer
Interval 1054776.8 to 2199474.2
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 181: Serotype O2
3163734.9 Titer
Interval 2474677.1 to 4044656.4
2970482.1 Titer
Interval 2354313.7 to 3747913.3
4729234.1 Titer
Interval 3894909.1 to 5742279.2
4266510.5 Titer
Interval 3102445.5 to 5867343.2
490033.8 Titer
Interval 367540.7 to 653351.1
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 181: Serotype O4
1464137.0 Titer
Interval 1147541.0 to 1868079.0
1719377.7 Titer
Interval 1343456.0 to 2200488.7
2063300.4 Titer
Interval 1668018.7 to 2552254.6
501991.4 Titer
Interval 406178.0 to 620406.3
549904.9 Titer
Interval 410508.2 to 736636.7
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 181: Serotype O6A
3187945.6 Titer
Interval 2581356.0 to 3937077.1
2742527.1 Titer
Interval 2289293.7 to 3285491.5
3447910.8 Titer
Interval 2852867.7 to 4167066.4
3334516.2 Titer
Interval 2533469.4 to 4388842.5
958424.9 Titer
Interval 745010.8 to 1232973.1
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 181: Serotype O8
4351162.8 Titer
Interval 3653295.9 to 5182338.9
3792115.2 Titer
Interval 3159463.7 to 4551449.0
4752992.0 Titer
Interval 4056882.5 to 5568545.1
1757076.5 Titer
Interval 1418223.5 to 2176891.0
1637517.2 Titer
Interval 1193309.1 to 2247081.3
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 181: Serotype O15
3172409.9 Titer
Interval 2587224.3 to 3889954.4
3171754.0 Titer
Interval 2567192.7 to 3918686.5
3306905.3 Titer
Interval 2719748.6 to 4020821.2
919201.8 Titer
Interval 696966.2 to 1212299.8
948722.9 Titer
Interval 703688.5 to 1279081.8
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 181: Serotype O16
2527864.6 Titer
Interval 2047268.5 to 3121280.6
2952055.2 Titer
Interval 2380469.2 to 3660887.5
3713051.1 Titer
Interval 3064737.4 to 4498508.8
774950.8 Titer
Interval 638278.5 to 940888.3
720322.3 Titer
Interval 537574.2 to 965195.6
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 181: Serotype O18A
2376169.7 Titer
Interval 1917314.2 to 2944839.5
2219012.5 Titer
Interval 1830470.2 to 2690028.3
2586344.3 Titer
Interval 2158196.6 to 3099428.8
943359.0 Titer
Interval 785332.4 to 1133184.1
1025511.9 Titer
Interval 773259.0 to 1360054.9
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 181: Serotype O25B
1144537.9 Titer
Interval 849494.3 to 1542055.0
831345.5 Titer
Interval 623871.7 to 1107816.5
939742.9 Titer
Interval 725097.2 to 1217928.6
794017.4 Titer
Interval 547313.1 to 1151925.0
239952.5 Titer
Interval 185411.5 to 310537.2
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 181: Serotype O75
1882478.8 Titer
Interval 1529846.4 to 2316393.5
1984426.0 Titer
Interval 1622665.9 to 2426837.6
2398218.7 Titer
Interval 2000407.3 to 2875141.0
1034083.5 Titer
Interval 835708.8 to 1279546.9
1159722.4 Titer
Interval 858094.1 to 1567375.9
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 181: Serotype EPA
561582.3 Titer
Interval 359386.0 to 877537.3
465763.6 Titer
Interval 312682.1 to 693790.1
502960.6 Titer
Interval 354918.2 to 712754.2
584874.1 Titer
Interval 336014.2 to 1018045.1
NA Titer
Interval to 82330.5
Geometric mean and lower limit of 95% CI could not be estimated as the value was one-half of the LLOQ, that is, one -half of 66165.

SECONDARY outcome

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

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

GMR of fold changes from baseline for serotype specific antibodies measured by multiplex ECL based immunoassay on Days 30 and 181 were reported. GMR for each antigen serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 and EPA were determined in serum from collected blood samples by ECL based immunoassay. GMR of fold change from baseline was calculated as the ratio of GMTs on Days 30 and 181 and pre-vaccination (on Day 1). Any titer less than LLOQ is replaced by value of LLOQ.

Outcome measures

Outcome measures
Measure
Cohort 2: Placebo
n=98 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.
Cohort 2: ExPEC10V High Dose
n=101 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 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 Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 30:Serotype O1A
5.17 ratio
Interval 4.284 to 6.242
4.05 ratio
Interval 3.466 to 4.74
5.28 ratio
Interval 4.405 to 6.325
5.54 ratio
Interval 4.082 to 7.524
1.31 ratio
Interval 1.129 to 1.52
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 30:Serotype O2
9.20 ratio
Interval 7.551 to 11.215
9.16 ratio
Interval 7.714 to 10.884
12.00 ratio
Interval 10.318 to 13.957
11.53 ratio
Interval 8.447 to 15.729
1.05 ratio
Interval 0.979 to 1.116
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 30:Serotype O4
4.85 ratio
Interval 4.007 to 5.873
6.19 ratio
Interval 4.989 to 7.677
8.50 ratio
Interval 6.996 to 10.327
1.08 ratio
Interval 1.024 to 1.146
1.33 ratio
Interval 1.115 to 1.588
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 30:Serotype O6A
4.08 ratio
Interval 3.355 to 4.952
3.21 ratio
Interval 2.745 to 3.75
4.67 ratio
Interval 3.988 to 5.467
3.93 ratio
Interval 2.991 to 5.156
1.01 ratio
Interval 0.938 to 1.088
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 30:Serotype O8
3.28 ratio
Interval 2.81 to 3.836
3.51 ratio
Interval 3.065 to 4.013
4.01 ratio
Interval 3.437 to 4.673
1.11 ratio
Interval 1.054 to 1.174
1.16 ratio
Interval 1.04 to 1.288
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 30:Serotype O15
4.99 ratio
Interval 4.152 to 6.003
5.43 ratio
Interval 4.559 to 6.458
5.78 ratio
Interval 4.842 to 6.91
1.03 ratio
Interval 0.959 to 1.098
1.36 ratio
Interval 1.184 to 1.56
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 30:Serotype O16
3.98 ratio
Interval 3.292 to 4.805
5.05 ratio
Interval 4.318 to 5.912
6.60 ratio
Interval 5.577 to 7.802
1.08 ratio
Interval 1.016 to 1.149
1.14 ratio
Interval 1.059 to 1.23
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 30:Serotype O18A
3.35 ratio
Interval 2.777 to 4.038
3.73 ratio
Interval 3.158 to 4.395
4.83 ratio
Interval 4.067 to 5.737
1.05 ratio
Interval 0.986 to 1.116
1.13 ratio
Interval 1.004 to 1.275
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 30:Serotype O25B
8.60 ratio
Interval 6.697 to 11.044
5.48 ratio
Interval 4.481 to 6.695
7.00 ratio
Interval 5.596 to 8.766
8.70 ratio
Interval 6.293 to 12.038
1.03 ratio
Interval 0.933 to 1.141
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 30:Serotype O75
2.04 ratio
Interval 1.749 to 2.373
2.20 ratio
Interval 1.915 to 2.534
2.75 ratio
Interval 2.344 to 3.238
1.06 ratio
Interval 0.949 to 1.177
1.03 ratio
Interval 0.915 to 1.149
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 30:Serotype EPA
10.98 ratio
Interval 8.16 to 14.76
9.97 ratio
Interval 7.72 to 12.89
10.26 ratio
Interval 7.85 to 13.42
10.03 ratio
Interval 6.52 to 15.45
0.97 ratio
Interval 0.95 to 0.99
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 181: Serotype O1A
4.05 ratio
Interval 3.272 to 5.019
3.07 ratio
Interval 2.598 to 3.626
4.23 ratio
Interval 3.442 to 5.201
4.08 ratio
Interval 3.055 to 5.447
1.23 ratio
Interval 1.045 to 1.445
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 181: Serotype O2
6.67 ratio
Interval 5.312 to 8.382
6.14 ratio
Interval 5.076 to 7.438
9.38 ratio
Interval 7.788 to 11.309
9.04 ratio
Interval 6.375 to 12.817
1.07 ratio
Interval 0.99 to 1.162
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 181: Serotype O4
2.97 ratio
Interval 2.478 to 3.567
3.74 ratio
Interval 2.949 to 4.734
4.54 ratio
Interval 3.753 to 5.496
1.04 ratio
Interval 0.968 to 1.125
1.21 ratio
Interval 1.032 to 1.429
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 181: Serotype O6A
2.90 ratio
Interval 2.382 to 3.532
2.10 ratio
Interval 1.785 to 2.477
3.15 ratio
Interval 2.656 to 3.738
2.69 ratio
Interval 2.084 to 3.48
0.93 ratio
Interval 0.853 to 1.006
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 181: Serotype O8
2.52 ratio
Interval 2.135 to 2.974
2.47 ratio
Interval 2.155 to 2.841
3.14 ratio
Interval 2.673 to 3.698
1.11 ratio
Interval 0.99 to 1.242
1.17 ratio
Interval 1.022 to 1.341
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 181: Serotype O15
3.84 ratio
Interval 3.16 to 4.671
3.93 ratio
Interval 3.213 to 4.812
4.21 ratio
Interval 3.47 to 5.107
1.06 ratio
Interval 0.931 to 1.203
1.24 ratio
Interval 1.071 to 1.426
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 181: Serotype O16
2.89 ratio
Interval 2.361 to 3.53
3.30 ratio
Interval 2.752 to 3.955
4.75 ratio
Interval 3.969 to 5.685
1.06 ratio
Interval 0.946 to 1.182
1.11 ratio
Interval 1.024 to 1.195
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 181: Serotype O18A
2.48 ratio
Interval 2.061 to 2.986
2.59 ratio
Interval 2.192 to 3.049
2.96 ratio
Interval 2.481 to 3.544
0.98 ratio
Interval 0.911 to 1.062
1.10 ratio
Interval 1.005 to 1.206
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 181: Serotype O25B
5.35 ratio
Interval 4.133 to 6.918
3.61 ratio
Interval 2.92 to 4.468
3.88 ratio
Interval 3.114 to 4.841
4.67 ratio
Interval 3.387 to 6.429
0.99 ratio
Interval 0.895 to 1.104
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 181: Serotype O75
1.54 ratio
Interval 1.339 to 1.776
1.59 ratio
Interval 1.417 to 1.79
2.07 ratio
Interval 1.764 to 2.43
0.92 ratio
Interval 0.829 to 1.014
0.92 ratio
Interval 0.851 to 0.984
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 181: Serotype EPA
5.61 ratio
Interval 4.11 to 7.66
4.74 ratio
Interval 3.58 to 6.28
4.46 ratio
Interval 3.46 to 5.75
5.37 ratio
Interval 3.66 to 7.89
0.95 ratio
Interval 0.92 to 0.98

SECONDARY outcome

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

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

Percentage of participants with a \>=2-fold and \>=4-fold increase from baseline in serotype (ST)-specific serum antibody titers as measured by multiplex ECL based immunoassay on Days 30 and 181 was reported. The fold (\>=2-fold and \>=4-fold) increase from baseline to Days 30 and 181 for the serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 and EPA was calculated as the ratio of titer values of serum antibody on Day 30 and Day 181 and pre-vaccination (on Day 1 that is, Day 30/Day 1 and Day 181/Day 1). Any titer less than LLOQ is replaced by value of LLOQ.

Outcome measures

Outcome measures
Measure
Cohort 2: Placebo
n=98 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.
Cohort 2: ExPEC10V High Dose
n=101 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 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 From Baseline in Serotype-specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 30: Serotype O2: >= 4 Fold Increase
79.6 Percentage of participants
Interval 69.95 to 87.23
83.8 Percentage of participants
Interval 75.09 to 90.47
91.9 Percentage of participants
Interval 84.7 to 96.45
79.2 Percentage of participants
Interval 65.01 to 89.53
0.0 Percentage of participants
Interval 0.0 to 7.4
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase From Baseline in Serotype-specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 30: Serotype O18A: >= 2 Fold Increase
64.5 Percentage of participants
Interval 53.91 to 74.17
73.7 Percentage of participants
Interval 63.93 to 82.07
80.8 Percentage of participants
Interval 71.66 to 88.03
0.0 Percentage of participants
Interval 0.0 to 7.4
4.2 Percentage of participants
Interval 0.51 to 14.25
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase From Baseline in Serotype-specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 30: Serotype O18A: >= 4 Fold Increase
37.6 Percentage of participants
Interval 27.79 to 48.28
47.5 Percentage of participants
Interval 37.34 to 57.76
60.6 Percentage of participants
Interval 50.28 to 70.28
0.0 Percentage of participants
Interval 0.0 to 7.4
2.1 Percentage of participants
Interval 0.05 to 11.07
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase From Baseline in Serotype-specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 30: Serotype O75: >= 2 Fold Increase
43.0 Percentage of participants
Interval 32.78 to 53.69
48.5 Percentage of participants
Interval 38.32 to 58.75
59.6 Percentage of participants
Interval 49.26 to 69.34
4.2 Percentage of participants
Interval 0.51 to 14.25
2.1 Percentage of participants
Interval 0.05 to 11.07
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase From Baseline in Serotype-specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 30: Serotype EPA: >= 2 Fold Increase
80.6 Percentage of participants
Interval 71.15 to 88.11
86.9 Percentage of participants
Interval 78.59 to 92.82
85.9 Percentage of participants
Interval 77.41 to 92.05
77.1 Percentage of participants
Interval 62.69 to 87.97
0.0 Percentage of participants
Interval 0.0 to 7.4
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase From Baseline in Serotype-specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 181: Serotype O2: >= 2 Fold Increase
86.7 Percentage of participants
Interval 76.84 to 93.42
89.5 Percentage of participants
Interval 80.31 to 95.34
92.5 Percentage of participants
Interval 84.39 to 97.2
83.7 Percentage of participants
Interval 69.3 to 93.19
0.0 Percentage of participants
Interval 0.0 to 9.49
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase From Baseline in Serotype-specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 30: Serotype O1A: >= 2 Fold Increase
82.8 Percentage of participants
Interval 73.57 to 89.83
78.8 Percentage of participants
Interval 69.42 to 86.36
80.8 Percentage of participants
Interval 71.66 to 88.03
77.1 Percentage of participants
Interval 62.69 to 87.97
12.5 Percentage of participants
Interval 4.73 to 25.25
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase From Baseline in Serotype-specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 30: Serotype O1A: >= 4 Fold Increase
62.4 Percentage of participants
Interval 51.72 to 72.21
53.5 Percentage of participants
Interval 43.23 to 63.62
63.6 Percentage of participants
Interval 53.36 to 73.07
64.6 Percentage of participants
Interval 49.46 to 77.84
4.2 Percentage of participants
Interval 0.51 to 14.25
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase From Baseline in Serotype-specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 30: Serotype O2: >= 2 Fold Increase
91.4 Percentage of participants
Interval 83.75 to 96.21
93.9 Percentage of participants
Interval 87.27 to 97.74
98.0 Percentage of participants
Interval 92.89 to 99.75
89.6 Percentage of participants
Interval 77.34 to 96.53
0.0 Percentage of participants
Interval 0.0 to 7.4
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase From Baseline in Serotype-specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 30: Serotype O4: >= 2 Fold Increase
81.7 Percentage of participants
Interval 72.35 to 88.98
79.8 Percentage of participants
Interval 70.54 to 87.2
88.9 Percentage of participants
Interval 80.9 to 94.32
0.0 Percentage of participants
Interval 0.0 to 7.4
12.5 Percentage of participants
Interval 4.73 to 25.25
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase From Baseline in Serotype-specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 30: Serotype O4: >= 4 Fold Increase
59.1 Percentage of participants
Interval 48.46 to 69.23
61.6 Percentage of participants
Interval 51.3 to 71.22
75.8 Percentage of participants
Interval 66.11 to 83.81
0.0 Percentage of participants
Interval 0.0 to 7.4
4.2 Percentage of participants
Interval 0.51 to 14.25
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase From Baseline in Serotype-specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 30: Serotype O6A: >= 2 Fold Increase
74.2 Percentage of participants
Interval 64.08 to 82.71
63.6 Percentage of participants
Interval 53.36 to 73.07
80.8 Percentage of participants
Interval 71.66 to 88.03
72.9 Percentage of participants
Interval 58.15 to 84.72
0.0 Percentage of participants
Interval 0.0 to 7.4
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase From Baseline in Serotype-specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 30: Serotype O6A: >= 4 Fold Increase
48.4 Percentage of participants
Interval 37.89 to 58.99
38.4 Percentage of participants
Interval 28.78 to 48.7
61.6 Percentage of participants
Interval 51.3 to 71.22
45.8 Percentage of participants
Interval 31.37 to 60.83
0.0 Percentage of participants
Interval 0.0 to 7.4
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase From Baseline in Serotype-specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 30: Serotype O8: >= 2 Fold Increase
68.8 Percentage of participants
Interval 58.37 to 78.02
77.8 Percentage of participants
Interval 68.31 to 85.52
73.7 Percentage of participants
Interval 63.93 to 82.07
0.0 Percentage of participants
Interval 0.0 to 7.4
2.1 Percentage of participants
Interval 0.05 to 11.07
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase From Baseline in Serotype-specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 30: Serotype O8: >= 4 Fold Increase
36.6 Percentage of participants
Interval 26.81 to 47.19
41.4 Percentage of participants
Interval 31.6 to 51.76
55.6 Percentage of participants
Interval 45.22 to 65.55
0.0 Percentage of participants
Interval 0.0 to 7.4
2.1 Percentage of participants
Interval 0.05 to 11.07
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase From Baseline in Serotype-specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 30: Serotype O15: >= 2 Fold Increase
80.6 Percentage of participants
Interval 71.15 to 88.11
86.9 Percentage of participants
Interval 78.59 to 92.82
83.8 Percentage of participants
Interval 75.09 to 90.47
2.1 Percentage of participants
Interval 0.05 to 11.07
14.6 Percentage of participants
Interval 6.07 to 27.76
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase From Baseline in Serotype-specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 30: Serotype O15: >= 4 Fold Increase
63.4 Percentage of participants
Interval 52.81 to 73.19
54.5 Percentage of participants
Interval 44.23 to 64.59
64.6 Percentage of participants
Interval 54.4 to 73.99
0.0 Percentage of participants
Interval 0.0 to 7.4
6.3 Percentage of participants
Interval 1.31 to 17.2
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase From Baseline in Serotype-specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 30: Serotype O16: >= 2 Fold Increase
72.0 Percentage of participants
Interval 61.78 to 80.86
86.9 Percentage of participants
Interval 78.59 to 92.82
86.9 Percentage of participants
Interval 78.59 to 92.82
0.0 Percentage of participants
Interval 0.0 to 7.4
2.1 Percentage of participants
Interval 0.05 to 11.07
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase From Baseline in Serotype-specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 30: Serotype O16: >= 4 Fold Increase
49.5 Percentage of participants
Interval 38.93 to 60.03
60.6 Percentage of participants
Interval 50.28 to 70.28
72.7 Percentage of participants
Interval 62.85 to 81.2
0.0 Percentage of participants
Interval 0.0 to 7.4
0.0 Percentage of participants
Interval 0.0 to 7.4
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase From Baseline in Serotype-specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 30: Serotype O25B: >= 2 Fold Increase
84.9 Percentage of participants
Interval 76.03 to 91.52
81.8 Percentage of participants
Interval 72.8 to 88.85
83.8 Percentage of participants
Interval 75.09 to 90.47
87.5 Percentage of participants
Interval 74.75 to 95.27
4.2 Percentage of participants
Interval 0.51 to 14.25
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase From Baseline in Serotype-specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 30: Serotype O25B: >= 4 Fold Increase
75.3 Percentage of participants
Interval 65.24 to 83.63
60.6 Percentage of participants
Interval 50.28 to 70.28
67.7 Percentage of participants
Interval 57.53 to 76.73
75.0 Percentage of participants
Interval 60.4 to 86.36
2.1 Percentage of participants
Interval 0.05 to 11.07
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase From Baseline in Serotype-specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 30: Serotype O75: >= 4 Fold Increase
22.6 Percentage of participants
Interval 14.55 to 32.42
19.2 Percentage of participants
Interval 11.9 to 28.34
28.3 Percentage of participants
Interval 19.69 to 38.22
4.2 Percentage of participants
Interval 0.51 to 14.25
2.1 Percentage of participants
Interval 0.05 to 11.07
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase From Baseline in Serotype-specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 30: Serotype EPA: >= 4 Fold Increase
74.2 Percentage of participants
Interval 64.08 to 82.71
73.7 Percentage of participants
Interval 63.93 to 82.07
75.8 Percentage of participants
Interval 66.11 to 83.81
72.9 Percentage of participants
Interval 58.15 to 84.72
0.0 Percentage of participants
Interval 0.0 to 7.4
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase From Baseline in Serotype-specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 181: : Serotype O1A: >= 2 Fold Increase
73.3 Percentage of participants
Interval 61.86 to 82.89
64.5 Percentage of participants
Interval 52.66 to 75.12
72.5 Percentage of participants
Interval 61.38 to 81.9
67.4 Percentage of participants
Interval 51.46 to 80.92
10.8 Percentage of participants
Interval 3.03 to 25.42
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase From Baseline in Serotype-specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 181: Serotype O1A: >= 4 Fold Increase
49.3 Percentage of participants
Interval 37.58 to 61.14
35.5 Percentage of participants
Interval 24.88 to 47.34
51.3 Percentage of participants
Interval 39.81 to 62.59
51.2 Percentage of participants
Interval 35.46 to 66.69
5.4 Percentage of participants
Interval 0.66 to 18.19
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase From Baseline in Serotype-specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 181: Serotype O2: >= 4 Fold Increase
70.7 Percentage of participants
Interval 59.02 to 80.62
69.7 Percentage of participants
Interval 58.13 to 79.75
83.8 Percentage of participants
Interval 73.82 to 91.05
74.4 Percentage of participants
Interval 58.83 to 86.48
0.0 Percentage of participants
Interval 0.0 to 9.49
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase From Baseline in Serotype-specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 181: Serotype O4: >= 2 Fold Increase
65.3 Percentage of participants
Interval 53.46 to 75.96
68.4 Percentage of participants
Interval 56.75 to 78.61
81.3 Percentage of participants
Interval 70.97 to 89.11
2.3 Percentage of participants
Interval 0.06 to 12.29
5.4 Percentage of participants
Interval 0.66 to 18.19
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase From Baseline in Serotype-specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 181: Serotype O4: >= 4 Fold Increase
33.3 Percentage of participants
Interval 22.86 to 45.17
43.4 Percentage of participants
Interval 32.08 to 55.29
55.0 Percentage of participants
Interval 43.47 to 66.15
0.0 Percentage of participants
Interval 0.0 to 8.22
5.4 Percentage of participants
Interval 0.66 to 18.19
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase From Baseline in Serotype-specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 181: Serotype O6A: >= 2 Fold Increase
60.0 Percentage of participants
Interval 48.04 to 71.15
46.1 Percentage of participants
Interval 34.55 to 57.87
67.5 Percentage of participants
Interval 56.11 to 77.55
55.8 Percentage of participants
Interval 39.88 to 70.9
0.0 Percentage of participants
Interval 0.0 to 9.49
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase From Baseline in Serotype-specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 181: Serotype O6A: >= 4 Fold Increase
33.3 Percentage of participants
Interval 22.86 to 45.17
18.4 Percentage of participants
Interval 10.45 to 28.97
33.8 Percentage of participants
Interval 23.55 to 45.19
32.6 Percentage of participants
Interval 19.08 to 48.54
0.0 Percentage of participants
Interval 0.0 to 9.49
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase From Baseline in Serotype-specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 181: Serotype O8: >= 2 Fold Increase
56.0 Percentage of participants
Interval 44.06 to 67.45
60.5 Percentage of participants
Interval 48.65 to 71.56
65.0 Percentage of participants
Interval 53.52 to 75.33
9.3 Percentage of participants
Interval 2.59 to 22.14
5.4 Percentage of participants
Interval 0.66 to 18.19
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase From Baseline in Serotype-specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 181: Serotype O8: >= 4 Fold Increase
24.0 Percentage of participants
Interval 14.89 to 35.25
17.1 Percentage of participants
Interval 9.43 to 27.47
37.5 Percentage of participants
Interval 26.92 to 49.04
0.0 Percentage of participants
Interval 0.0 to 8.22
2.7 Percentage of participants
Interval 0.07 to 14.16
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase From Baseline in Serotype-specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 181: Serotype O15: >= 2 Fold Increase
76.0 Percentage of participants
Interval 64.75 to 85.11
73.7 Percentage of participants
Interval 62.32 to 83.13
81.3 Percentage of participants
Interval 70.97 to 89.11
4.7 Percentage of participants
Interval 0.57 to 15.81
8.1 Percentage of participants
Interval 1.7 to 21.91
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase From Baseline in Serotype-specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 181: Serotype O15: >= 4 Fold Increase
49.3 Percentage of participants
Interval 37.58 to 61.14
44.7 Percentage of participants
Interval 33.31 to 56.59
45.0 Percentage of participants
Interval 33.85 to 56.53
2.3 Percentage of participants
Interval 0.06 to 12.29
2.7 Percentage of participants
Interval 0.07 to 14.16
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase From Baseline in Serotype-specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 181: Serotype O16: >= 2 Fold Increase
60.0 Percentage of participants
Interval 48.04 to 71.15
72.4 Percentage of participants
Interval 60.91 to 82.01
87.5 Percentage of participants
Interval 78.21 to 93.84
4.7 Percentage of participants
Interval 0.57 to 15.81
0.0 Percentage of participants
Interval 0.0 to 9.49
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase From Baseline in Serotype-specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 181: Serotype O16: >= 4 Fold Increase
36.0 Percentage of participants
Interval 25.23 to 47.91
36.8 Percentage of participants
Interval 26.06 to 48.69
56.3 Percentage of participants
Interval 44.7 to 67.32
2.3 Percentage of participants
Interval 0.06 to 12.29
0.0 Percentage of participants
Interval 0.0 to 9.49
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase From Baseline in Serotype-specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 181: Serotype O18A: >= 2 Fold Increase
52.0 Percentage of participants
Interval 40.15 to 63.69
63.2 Percentage of participants
Interval 51.3 to 73.9
60.0 Percentage of participants
Interval 48.44 to 70.8
0.0 Percentage of participants
Interval 0.0 to 8.22
0.0 Percentage of participants
Interval 0.0 to 9.49
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase From Baseline in Serotype-specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 181: Serotype O18A: >= 4 Fold Increase
25.3 Percentage of participants
Interval 15.99 to 36.7
23.7 Percentage of participants
Interval 14.68 to 34.82
33.8 Percentage of participants
Interval 23.55 to 45.19
0.0 Percentage of participants
Interval 0.0 to 8.22
0.0 Percentage of participants
Interval 0.0 to 9.49
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase From Baseline in Serotype-specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 181: Serotype O25B: >= 2 Fold Increase
74.7 Percentage of participants
Interval 63.3 to 84.01
67.1 Percentage of participants
Interval 55.37 to 77.46
72.5 Percentage of participants
Interval 61.38 to 81.9
76.7 Percentage of participants
Interval 61.37 to 88.24
2.7 Percentage of participants
Interval 0.07 to 14.16
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase From Baseline in Serotype-specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 181: Serotype O25B: >= 4 Fold Increase
56.0 Percentage of participants
Interval 44.06 to 67.45
44.7 Percentage of participants
Interval 33.31 to 56.59
42.5 Percentage of participants
Interval 31.51 to 54.06
51.2 Percentage of participants
Interval 35.46 to 66.69
0.0 Percentage of participants
Interval 0.0 to 9.49
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase From Baseline in Serotype-specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 181: Serotype O75: >= 2 Fold Increase
26.7 Percentage of participants
Interval 17.11 to 38.14
26.3 Percentage of participants
Interval 16.87 to 37.68
45.0 Percentage of participants
Interval 33.85 to 56.53
2.3 Percentage of participants
Interval 0.06 to 12.29
0.0 Percentage of participants
Interval 0.0 to 9.49
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase From Baseline in Serotype-specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 181: Serotype O75: >= 4 Fold Increase
10.7 Percentage of participants
Interval 4.72 to 19.9
5.3 Percentage of participants
Interval 1.45 to 12.93
13.8 Percentage of participants
Interval 7.07 to 23.27
0.0 Percentage of participants
Interval 0.0 to 8.22
0.0 Percentage of participants
Interval 0.0 to 9.49
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase From Baseline in Serotype-specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 181: Serotype EPA: >= 2 Fold Increase
70.7 Percentage of participants
Interval 59.02 to 80.62
72.4 Percentage of participants
Interval 60.91 to 82.01
71.3 Percentage of participants
Interval 60.05 to 80.82
76.7 Percentage of participants
Interval 61.37 to 88.24
0.0 Percentage of participants
Interval 0.0 to 9.49
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase From Baseline in Serotype-specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Day 181: Serotype EPA: >= 4 Fold Increase
57.3 Percentage of participants
Interval 45.38 to 68.69
51.3 Percentage of participants
Interval 39.57 to 62.96
47.5 Percentage of participants
Interval 36.21 to 58.98
55.8 Percentage of participants
Interval 39.88 to 70.92
0.0 Percentage of participants
Interval 0.0 to 9.49

SECONDARY outcome

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

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

GMRs for each O-antigen (serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B and O75) were determined using a validated MOPA. For sample pairs with available validated MOPA results from both Day 1 and Day 30, or Day 1 and 181, GMR from baseline for serotype specific antibodies was calculated as the ratio of GMTs on Days 30 or 181 and pre-vaccination (on Day 1). For serotype O8 functional IgG serum antibodies were not evaluated as the assay was not able to detect vaccine-induced functional antibodies against the O8 serotype. Any titer less than LLOQ is replaced by value of LLOQ.

Outcome measures

Outcome measures
Measure
Cohort 2: Placebo
n=51 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.
Cohort 2: ExPEC10V High Dose
n=100 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 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 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 30 and 181
Day 30:Serotype O1A
0.65 Ratio
Interval 0.338 to 1.238
1.58 Ratio
Interval 1.166 to 2.153
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 30 and 181
Day 30:Serotype O2
0.67 Ratio
Interval 0.408 to 1.107
11.86 Ratio
Interval 8.298 to 16.94
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 30 and 181
Day 30:Serotype O4
1.59 Ratio
Interval 0.727 to 3.493
3.62 Ratio
Interval 2.823 to 4.642
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 30 and 181
Day 30:Serotype O6A
0.97 Ratio
Interval 0.391 to 2.394
1.72 Ratio
Interval 1.319 to 2.249
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 30 and 181
Day 30:Serotype O15
1.70 Ratio
Interval 0.565 to 5.14
6.51 Ratio
Interval 4.645 to 9.134
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 30 and 181
Day 30:Serotype O16
1.11 Ratio
Interval 0.676 to 1.825
10.50 Ratio
Interval 7.958 to 13.848
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 30 and 181
Day 30:Serotype O18A
1.04 Ratio
Interval 0.4 to 2.715
2.35 Ratio
Interval 1.758 to 3.146
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 30 and 181
Day 30:Serotype O25B
1.02 Ratio
Interval 0.972 to 1.074
2.16 Ratio
Interval 1.771 to 2.627
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 30 and 181
Day 30:Serotype O75
1.38 Ratio
Interval 0.515 to 3.689
4.02 Ratio
Interval 2.993 to 5.405
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 30 and 181
Day 181: Serotype O1A
0.99 Ratio
Interval 0.53 to 1.833
0.93 Ratio
Interval 0.732 to 1.189
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 30 and 181
Day 181: Serotype O2
0.96 Ratio
Interval 0.432 to 2.12
4.79 Ratio
Interval 3.457 to 6.649
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 30 and 181
Day 181: Serotype O4
1.13 Ratio
Interval 0.447 to 2.857
1.94 Ratio
Interval 1.575 to 2.381
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 30 and 181
Day 181: Serotype O6A
0.59 Ratio
Interval 0.268 to 1.304
1.00 Ratio
Interval 0.791 to 1.257
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 30 and 181
Day 181: Serotype O15
1.22 Ratio
Interval 0.616 to 2.415
2.75 Ratio
Interval 2.034 to 3.731
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 30 and 181
Day 181: Serotype O16
1.66 Ratio
Interval 1.086 to 2.551
4.86 Ratio
Interval 3.612 to 6.55
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 30 and 181
Day 181: Serotype O18A
1.82 Ratio
Interval 0.584 to 5.684
1.18 Ratio
Interval 0.92 to 1.508
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 30 and 181
Day 181: Serotype O25B
0.96 Ratio
Interval 0.858 to 1.07
1.37 Ratio
Interval 1.196 to 1.572
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 30 and 181
Day 181: Serotype O75
0.89 Ratio
Interval 0.406 to 1.962
1.78 Ratio
Interval 1.402 to 2.269
—
—
—

SECONDARY outcome

Timeframe: Days 30 and 181

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

GMTs of serotype-specific total IgG serum antibodies as measured by MOPA on Days 30 and 181 were reported. GMTs for each antigen serotypes O1A, O2, O4, O6A,O15, O16, O18A, O25B and O75 were determined in serum from collected blood samples. For serotype O8 functional IgG serum antibodies were not evaluated as the assay was not able to detect vaccine-induced functional antibodies against the O8 serotype. LLOQ values were O1A: 33, O2: 42, O4: 12, O6A: 62, O15: 75, O16: 17, O18A: 44, O25B: 58, O75: 14. Any titer less than LLOQ is replaced by half of LLOQ (0.5\*LLOQ).

Outcome measures

Outcome measures
Measure
Cohort 2: Placebo
n=98 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.
Cohort 2: ExPEC10V High Dose
n=101 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 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 MOPA on Days 30 and 181
Day 181: Serotype O6A
773.5 Titer
Interval 580.5 to 1030.7
616.9 Titer
Interval 469.9 to 809.8
599.4 Titer
Interval 454.6 to 790.3
623.3 Titer
Interval 383.9 to 1012.0
506.5 Titer
Interval 280.3 to 915.3
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 30 and 181
Day 30: Serotype O1A
452.6 Titer
Interval 343.0 to 597.3
485.7 Titer
Interval 383.6 to 615.0
517.3 Titer
Interval 383.9 to 697.0
815.3 Titer
Interval 545.7 to 1217.9
300.8 Titer
Interval 215.4 to 420.1
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 30 and 181
Day 30: Serotype O2
2533.1 Titer
Interval 1768.1 to 3629.1
2189.0 Titer
Interval 1618.1 to 2961.3
4431.3 Titer
Interval 3143.2 to 6247.3
3748.8 Titer
Interval 2391.6 to 5876.4
270.4 Titer
Interval 201.1 to 363.6
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 30 and 181
Day 30: Serotype O4
562.1 Titer
Interval 431.7 to 731.9
609.5 Titer
Interval 470.2 to 790.2
667.1 Titer
Interval 518.0 to 859.1
236.2 Titer
Interval 177.7 to 313.9
193.3 Titer
Interval 152.8 to 244.7
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 30 and 181
Day 30: Serotype O6A
1123.7 Titer
Interval 864.6 to 1460.4
740.5 Titer
Interval 574.6 to 954.4
994.7 Titer
Interval 763.8 to 1295.3
1067.7 Titer
Interval 718.9 to 1585.6
519.9 Titer
Interval 339.3 to 796.5
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 30 and 181
Day 30: Serotype O15
2403.7 Titer
Interval 1744.4 to 3312.2
2423.3 Titer
Interval 1767.9 to 3321.7
2658.9 Titer
Interval 1931.1 to 3660.8
477.8 Titer
Interval 341.5 to 668.4
527.5 Titer
Interval 345.5 to 805.4
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 30 and 181
Day 30: Serotype O16
1005.1 Titer
Interval 701.4 to 1440.3
987.0 Titer
Interval 727.8 to 1338.5
1465.5 Titer
Interval 1085.3 to 1978.8
107.5 Titer
Interval 74.6 to 155.0
110.4 Titer
Interval 78.1 to 156.1
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 30 and 181
Day 30: Serotype O18A
538.3 Titer
Interval 402.8 to 719.3
523.5 Titer
Interval 412.6 to 664.2
592.9 Titer
Interval 451.5 to 778.7
226.5 Titer
Interval 155.7 to 329.5
195.1 Titer
Interval 141.5 to 269.1
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 30 and 181
Day 30: Serotype O25B
168.8 Titer
Interval 122.2 to 233.1
118.2 Titer
Interval 91.1 to 153.4
134.0 Titer
Interval 103.5 to 173.4
140.2 Titer
Interval 97.0 to 202.6
63.3 Titer
Interval to 96.5
Lower limit of 95% CI could not be estimated as the value was below the LLOQ (58).
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 30 and 181
Day 30: Serotype O75
148.5 Titer
Interval 111.8 to 197.2
221.2 Titer
Interval 176.2 to 277.7
246.4 Titer
Interval 177.5 to 342.1
71.9 Titer
Interval 50.4 to 102.7
97.6 Titer
Interval 69.8 to 136.5
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 30 and 181
Day 181: Serotype O1A
249.1 Titer
Interval 194.9 to 318.4
369.0 Titer
Interval 290.7 to 468.3
291.5 Titer
Interval 215.3 to 394.7
466.6 Titer
Interval 311.9 to 698.0
254.3 Titer
Interval 162.3 to 398.4
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 30 and 181
Day 181: Serotype O2
1076.4 Titer
Interval 777.7 to 1489.8
1196.5 Titer
Interval 869.4 to 1646.7
1887.2 Titer
Interval 1313.0 to 2712.4
1687.3 Titer
Interval 1057.5 to 2692.1
246.7 Titer
Interval 173.3 to 351.3
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 30 and 181
Day 181: Serotype O4
298.9 Titer
Interval 231.5 to 385.9
340.9 Titer
Interval 259.8 to 447.3
330.5 Titer
Interval 263.7 to 414.2
190.5 Titer
Interval 140.6 to 258.2
171.5 Titer
Interval 124.8 to 235.6
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 30 and 181
Day 181: Serotype O15
1431.8 Titer
Interval 1014.1 to 2021.6
1053.1 Titer
Interval 724.1 to 1531.6
1110.1 Titer
Interval 832.6 to 1480.0
347.7 Titer
Interval 240.4 to 503.0
438.2 Titer
Interval 282.6 to 679.5
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 30 and 181
Day 181: Serotype O16
426.9 Titer
Interval 298.6 to 610.3
546.7 Titer
Interval 386.5 to 773.2
656.3 Titer
Interval 474.2 to 908.5
102.5 Titer
Interval 73.3 to 143.3
77.9 Titer
Interval 51.6 to 117.6
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 30 and 181
Day 181: Serotype O18A
341.3 Titer
Interval 255.5 to 455.9
309.4 Titer
Interval 242.6 to 394.7
291.6 Titer
Interval 221.1 to 384.5
176.9 Titer
Interval 123.3 to 253.7
203.7 Titer
Interval 142.8 to 290.6
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 30 and 181
Day 181: Serotype O25B
84.3 Titer
Interval 65.6 to 108.3
75.4 Titer
Interval 60.1 to 94.6
74.1 Titer
Interval 58.4 to 94.0
67.8 Titer
Interval to 93.0
Lower limit of 95% CI could not be estimated as the value was below the LLOQ (58).
NA Titer
Interval to 69.1
Geometric mean and lower limit of 95% CI could not be estimated as the value was below the LLOQ (58).
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 30 and 181
Day 181: Serotype O75
72.4 Titer
Interval 55.6 to 94.1
121.7 Titer
Interval 95.8 to 154.8
103.1 Titer
Interval 79.1 to 134.5
40.3 Titer
Interval 28.6 to 56.9
55.1 Titer
Interval 38.0 to 80.1

SECONDARY outcome

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

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

For sample pairs with available validated MOPA results, for each O-antigen (serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B and O75), the fold increase was calculated as the ratio of validated MOPA results on Days 30 or 181 and pre-vaccination (Day 30/Day 1 and 181/Day 1). The percentage of participants with \>=2-fold and \>=4-fold increase in serotype-specific serum antibody titers was calculated. For serotype O8 functional IgG serum antibodies were not evaluated as the assay was not able to detect vaccine-induced functional antibodies against the O8 serotype. Any titer less than LLOQ is replaced by value of LLOQ.

Outcome measures

Outcome measures
Measure
Cohort 2: Placebo
n=51 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.
Cohort 2: ExPEC10V High Dose
n=100 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 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 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 30 and 181
Day 30: Serotype O1A: >= 2 Fold Increase
11.1 Percentage of participants
Interval 0.28 to 48.25
33.7 Percentage of participants
Interval 24.31 to 44.11
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 30 and 181
Day 30: Serotype O1A: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 33.63
24.2 Percentage of participants
Interval 16.01 to 34.08
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 30 and 181
Day 30: Serotype O2: >= 2 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 33.63
80.0 Percentage of participants
Interval 70.54 to 87.51
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 30 and 181
Day 30: Serotype O2: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 33.63
73.7 Percentage of participants
Interval 63.65 to 82.19
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 30 and 181
Day 30: Serotype O4: >= 2 Fold Increase
33.3 Percentage of participants
Interval 7.49 to 70.07
63.2 Percentage of participants
Interval 52.64 to 72.83
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 30 and 181
Day 30: Serotype O4: >= 4 Fold Increase
33.3 Percentage of participants
Interval 7.49 to 70.07
43.2 Percentage of participants
Interval 33.03 to 53.72
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 30 and 181
Day 30: Serotype O6A: >= 2 Fold Increase
22.2 Percentage of participants
Interval 2.81 to 60.01
35.8 Percentage of participants
Interval 26.21 to 46.28
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 30 and 181
Day 30: Serotype O6A: >= 4 Fold Increase
11.1 Percentage of participants
Interval 0.28 to 48.25
23.2 Percentage of participants
Interval 15.12 to 32.94
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 30 and 181
Day 30: Serotype O15: >= 2 Fold Increase
33.3 Percentage of participants
Interval 7.49 to 70.07
67.4 Percentage of participants
Interval 56.98 to 76.64
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 30 and 181
Day 30: Serotype O15: >= 4 Fold Increase
22.2 Percentage of participants
Interval 2.81 to 60.01
53.7 Percentage of participants
Interval 43.15 to 63.98
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 30 and 181
Day 30: Serotype O16: >= 2 Fold Increase
22.2 Percentage of participants
Interval 2.81 to 60.01
89.4 Percentage of participants
Interval 81.3 to 94.78
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 30 and 181
Day 30: Serotype O16: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 33.63
73.4 Percentage of participants
Interval 63.29 to 81.99
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 30 and 181
Day 30: Serotype O18A: >= 2 Fold Increase
22.2 Percentage of participants
Interval 2.81 to 60.01
50.5 Percentage of participants
Interval 40.07 to 60.95
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 30 and 181
Day 30: Serotype O18A: >= 4 Fold Increase
11.1 Percentage of participants
Interval 0.28 to 48.25
33.7 Percentage of participants
Interval 24.31 to 44.11
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 30 and 181
Day 30: Serotype O25B: >= 2 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 33.63
41.5 Percentage of participants
Interval 31.41 to 52.12
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 30 and 181
Day 30: Serotype O25B: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 33.63
22.3 Percentage of participants
Interval 14.39 to 32.1
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 30 and 181
Day 30: Serotype O75: >= 2 Fold Increase
33.3 Percentage of participants
Interval 7.49 to 70.07
65.3 Percentage of participants
Interval 54.8 to 74.74
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 30 and 181
Day 30: Serotype O75: >= 4 Fold Increase
22.2 Percentage of participants
Interval 2.81 to 60.01
44.2 Percentage of participants
Interval 34.02 to 54.77
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 30 and 181
Day 181: Serotype O1A: >= 2 Fold Increase
16.7 Percentage of participants
Interval 0.42 to 64.12
15.4 Percentage of participants
Interval 8.21 to 25.33
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 30 and 181
Day 181: Serotype O1A: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 45.93
10.3 Percentage of participants
Interval 4.53 to 19.21
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 30 and 181
Day 181: Serotype O2: >= 2 Fold Increase
16.7 Percentage of participants
Interval 0.42 to 64.12
67.9 Percentage of participants
Interval 56.42 to 78.07
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 30 and 181
Day 181: Serotype O2: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 45.93
51.3 Percentage of participants
Interval 39.69 to 62.77
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 30 and 181
Day 181: Serotype O4: >= 2 Fold Increase
33.3 Percentage of participants
Interval 4.33 to 77.72
51.3 Percentage of participants
Interval 39.69 to 62.77
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 30 and 181
Day 181: Serotype O4: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 45.93
23.1 Percentage of participants
Interval 14.29 to 34.0
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 30 and 181
Day 181: Serotype O6A: >= 2 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 45.93
23.1 Percentage of participants
Interval 14.29 to 34.0
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 30 and 181
Day 181: Serotype O6A: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 45.93
10.3 Percentage of participants
Interval 4.53 to 19.21
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 30 and 181
Day 181: Serotype O15: >= 2 Fold Increase
33.3 Percentage of participants
Interval 4.33 to 77.72
56.4 Percentage of participants
Interval 44.7 to 67.61
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 30 and 181
Day 181: Serotype O15: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 45.93
33.3 Percentage of participants
Interval 23.06 to 44.92
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 30 and 181
Day 181: Serotype O16: >= 2 Fold Increase
33.3 Percentage of participants
Interval 4.33 to 77.72
75.3 Percentage of participants
Interval 64.18 to 84.44
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 30 and 181
Day 181: Serotype O16: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 45.93
51.9 Percentage of participants
Interval 40.26 to 63.48
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 30 and 181
Day 181: Serotype O18A: >= 2 Fold Increase
66.7 Percentage of participants
Interval 22.28 to 95.67
30.8 Percentage of participants
Interval 20.81 to 42.24
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 30 and 181
Day 181: Serotype O18A: >= 4 Fold Increase
33.3 Percentage of participants
Interval 4.33 to 77.72
10.3 Percentage of participants
Interval 4.53 to 19.21
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 30 and 181
Day 181: Serotype O25B: >= 2 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 45.93
22.1 Percentage of participants
Interval 13.42 to 32.98
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 30 and 181
Day 181: Serotype O25B: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 45.93
5.2 Percentage of participants
Interval 1.43 to 12.77
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 30 and 181
Day 181: Serotype O75: >= 2 Fold Increase
16.7 Percentage of participants
Interval 0.42 to 64.12
47.4 Percentage of participants
Interval 36.01 to 59.07
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 30 and 181
Day 181: Serotype O75: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 45.93
23.1 Percentage of participants
Interval 14.29 to 34.0
—
—
—

SECONDARY outcome

Timeframe: From Day 182 up to end of study (Day 1826)

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

Number of participants with SAEs related to study vaccine or study procedure was reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent understudy. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.

Outcome measures

Outcome measures
Measure
Cohort 2: Placebo
n=102 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.
Cohort 2: ExPEC10V High Dose
n=104 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 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) Related to Study Vaccine or Study Procedure From Day 182 up to End of Study (Day 1826)
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants

SECONDARY outcome

Timeframe: Days 366, 731, 1096, 1461 and 1826

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

GMTs of serotype-specific total IgG serum antibodies as measured by ECL based immunoassay were reported. GMTs for each antigen serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 and EPA were determined in serum from collected blood samples. LLOQ values for O1A: 69149, O2: 65287, O4: 67356, O6A: 150748, O8: 72196, O15: 66910, O16: 71586, O18A: 70519, O25B: 61990, O75: 133019, and EPA: 66165. Any titer less than LLOQ is replaced by half of LLOQ (0.5\*LLOQ).

Outcome measures

Outcome measures
Measure
Cohort 2: Placebo
n=39 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.
Cohort 2: ExPEC10V High Dose
n=71 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 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 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1826: Serotype O2
609740.1 titer
Interval 280074.9 to 1327441.3
3252095.8 titer
Interval 2248988.6 to 4702614.7
—
—
—
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 366: Serotype O1A
1605160.3 titer
Interval 1139469.6 to 2261174.4
3934158.7 titer
Interval 3201033.1 to 4835190.3
—
—
—
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 731: Serotype O1A
1143355.0 titer
Interval 756785.2 to 1727386.8
3045758.4 titer
Interval 2382153.2 to 3894226.5
—
—
—
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1096: Serotype O1A
1226079.9 titer
Interval 796412.6 to 1887554.1
2796702.3 titer
Interval 2156387.6 to 3627151.2
—
—
—
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1461: Serotype O1A
2051609.9 titer
Interval 1151725.0 to 3654607.7
3061251.0 titer
Interval 2233370.1 to 4196016.6
—
—
—
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1826: Serotype O1A
1415585.1 titer
Interval 729252.3 to 2747857.2
2510326.1 titer
Interval 1749766.6 to 3601472.9
—
—
—
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 366: Serotype O2
558977.9 titer
Interval 422941.4 to 738769.7
3550164.5 titer
Interval 2808076.4 to 4488363.6
—
—
—
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 731: Serotype O2
694262.8 titer
Interval 464778.4 to 1037055.1
3625183.6 titer
Interval 2836267.9 to 4633538.3
—
—
—
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1096: Serotype O2
686457.3 titer
Interval 441411.8 to 1067537.5
3629211.5 titer
Interval 2829177.2 to 4655479.5
—
—
—
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1461: Serotype O2
833384.9 titer
Interval 446849.3 to 1554283.2
3659457.8 titer
Interval 2685565.0 to 4986523.1
—
—
—
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 366: Serotype O4
555656.1 titer
Interval 427063.9 to 722968.3
1429668.5 titer
Interval 1165397.8 to 1753866.4
—
—
—
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 731: Serotype O4
475609.0 titer
Interval 338935.6 to 667394.8
1363392.1 titer
Interval 1095361.6 to 1697008.7
—
—
—
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1096: Serotype O4
548486.3 titer
Interval 379268.3 to 793204.1
1468864.1 titer
Interval 1183756.4 to 1822639.9
—
—
—
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1461: Serotype O4
698085.2 titer
Interval 433044.7 to 1125341.0
1636156.0 titer
Interval 1240514.2 to 2157981.2
—
—
—
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1826: Serotype O4
474799.1 titer
Interval 277284.3 to 813007.2
1046670.4 titer
Interval 778237.4 to 1407692.4
—
—
—
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 366: Serotype O6A
1140758.7 titer
Interval 870845.9 to 1494329.1
2720316.5 titer
Interval 2256764.3 to 3279084.9
—
—
—
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 731: Serotype O6A
656929.5 titer
Interval 476890.5 to 904938.0
1938035.7 titer
Interval 1550939.3 to 2421747.0
—
—
—
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1096: Serotype O6A
763111.9 titer
Interval 558645.1 to 1042414.4
1908743.4 titer
Interval 1507339.8 to 2417040.6
—
—
—
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1461: Serotype O6A
901423.2 titer
Interval 580706.7 to 1399267.1
1648828.8 titer
Interval 1197245.3 to 2270743.1
—
—
—
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1826: Serotype O6A
701895.9 titer
Interval 468747.4 to 1051009.2
1468233.5 titer
Interval 1065011.1 to 2024119.5
—
—
—
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 366: Serotype O8
1430653.9 titer
Interval 1072253.4 to 1908849.6
3623746.8 titer
Interval 3024857.5 to 4341209.8
—
—
—
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 731: Serotype O8
2059650.9 titer
Interval 1475833.6 to 2874417.4
4270645.7 titer
Interval 3499266.5 to 5212068.0
—
—
—
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1096: Serotype O8
1899779.1 titer
Interval 1312135.7 to 2750600.2
4008813.4 titer
Interval 3266716.4 to 4919491.9
—
—
—
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1461: Serotype O8
2118665.0 titer
Interval 1293637.1 to 3469861.5
3942469.5 titer
Interval 3029442.8 to 5130668.3
—
—
—
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1826: Serotype O8
1985249.0 titer
Interval 1280656.7 to 3077494.0
3271322.5 titer
Interval 2489462.5 to 4298739.4
—
—
—
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 366: Serotype O15
1026707.7 titer
Interval 748937.3 to 1407499.4
2758990.7 titer
Interval 2227724.4 to 3416952.9
—
—
—
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 731: Serotype O15
1282357.8 titer
Interval 894038.1 to 1839341.6
2733971.3 titer
Interval 2215513.4 to 3373754.8
—
—
—
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1096: Serotype O15
1164007.7 titer
Interval 792330.9 to 1710035.4
2605816.2 titer
Interval 2048432.4 to 3314865.4
—
—
—
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1461: Serotype O15
1318256.0 titer
Interval 878009.0 to 1979249.6
2675476.7 titer
Interval 2035772.1 to 3516196.9
—
—
—
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1826: Serotype O15
1339915.0 titer
Interval 858920.2 to 2090266.8
2452726.4 titer
Interval 1794091.2 to 3353155.4
—
—
—
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 366: Serotype O16
766620.1 titer
Interval 570562.4 to 1030047.4
2784393.1 titer
Interval 2248058.4 to 3448684.8
—
—
—
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 731: Serotype O16
432088.3 titer
Interval 280872.9 to 664714.5
2191014.4 titer
Interval 1676843.6 to 2862845.6
—
—
—
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1096: Serotype O16
408528.9 titer
Interval 257897.7 to 647139.9
1953749.9 titer
Interval 1467640.7 to 2600867.1
—
—
—
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1461: Serotype O16
588532.7 titer
Interval 315738.3 to 1097018.3
1808141.1 titer
Interval 1314903.6 to 2486398.5
—
—
—
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1826: Serotype O16
441156.2 titer
Interval 228168.2 to 852961.9
1418665.2 titer
Interval 1021423.3 to 1970398.5
—
—
—
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 366: Serotype O18A
1011099.1 titer
Interval 803648.4 to 1272100.4
2180993.4 titer
Interval 1813783.2 to 2622547.1
—
—
—
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 731: Serotype O18A
1011635.3 titer
Interval 770544.8 to 1328158.9
2120844.7 titer
Interval 1737493.1 to 2588776.9
—
—
—
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1096: Serotype O18A
1069851.1 titer
Interval 812183.5 to 1409264.4
2139682.8 titer
Interval 1721939.0 to 2658771.7
—
—
—
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1461: Serotype O18A
1155976.5 titer
Interval 798832.2 to 1672794.0
1799444.8 titer
Interval 1411938.5 to 2293302.1
—
—
—
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1826: Serotype O18A
938306.2 titer
Interval 615022.6 to 1431522.1
1634243.4 titer
Interval 1224433.2 to 2181214.6
—
—
—
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 366: Serotype O25B
278650.7 titer
Interval 211316.5 to 367440.3
744315.5 titer
Interval 587104.6 to 943623.5
—
—
—
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 731: Serotype O25B
159425.2 titer
Interval 108167.9 to 234971.5
469677.8 titer
Interval 345884.4 to 637777.3
—
—
—
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1096: Serotype O25B
180091.3 titer
Interval 120576.0 to 268982.7
457385.0 titer
Interval 342281.3 to 611196.1
—
—
—
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1461: Serotype O25B
292822.0 titer
Interval 178948.4 to 479158.8
527143.7 titer
Interval 369078.7 to 752903.0
—
—
—
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1826: Serotype O25B
173640.5 titer
Interval 98267.2 to 306826.7
376505.3 titer
Interval 247784.9 to 572093.9
—
—
—
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 366: Serotype O75
1519723.2 titer
Interval 1099805.5 to 2099970.1
1960676.9 titer
Interval 1639629.8 to 2344586.6
—
—
—
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 731: Serotype O75
1689340.2 titer
Interval 1218863.3 to 2341419.5
1991539.0 titer
Interval 1598606.6 to 2481053.0
—
—
—
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1096: Serotype O75
1732413.2 titer
Interval 1200043.3 to 2500956.0
2152383.1 titer
Interval 1720798.5 to 2692211.4
—
—
—
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1461: Serotype O75
1821419.2 titer
Interval 1047856.4 to 3166052.1
1811492.3 titer
Interval 1376465.0 to 2384008.6
—
—
—
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1826: Serotype O75
1848589.6 titer
Interval 1050960.1 to 3251582.6
1912235.2 titer
Interval 1470493.6 to 2486677.5
—
—
—
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 366: Serotype EPA
66438.6 titer
Interval to 93488.9
Lower limit of 95% CI could not be estimated as it was below LLOQ (66165).
395660.6 titer
Interval 278689.7 to 561726.1
—
—
—
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 731: Serotype EPA
74302.9 titer
Interval to 115058.4
Lower limit of 95% CI could not be estimated as it was below LLOQ (66165).
255548.1 titer
Interval 174717.6 to 373773.7
—
—
—
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1096: Serotype EPA
81384.5 titer
Interval to 128120.5
Lower limit of 95% CI could not be estimated as it was below LLOQ (66165).
284265.5 titer
Interval 191542.8 to 421873.6
—
—
—
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1461: Serotype EPA
104825.0 titer
Interval to 213630.5
Lower limit of 95% CI could not be estimated as it was below LLOQ (66165).
285201.1 titer
Interval 175060.8 to 464636.9
—
—
—
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1826: Serotype EPA
95540.4 titer
Interval to 201601.6
Lower limit of 95% CI could not be estimated as it was below LLOQ (66165).
236408.3 titer
Interval 142449.3 to 392342.4
—
—
—

SECONDARY outcome

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

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

Percentage of participants with a \>=2-fold and \>=4-fold increase from baseline in serotype specific serum antibody titers as measured by multiplex ECL based immunoassay on Days 366, 731, 1096, 1461, and 1826 was reported. The fold (\>=2-fold and \>=4-fold) increase from baseline to Days 366, 731, 1096, 1461, and 1826 for the serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 and EPA was calculated as the ratio of titer values of serum antibody on Days 366, 731, 1096, 1461 and 1826 and pre-vaccination (on day 1) that is, Day 366/Day 1, 731/Day 1, 1096/Day 1, 1461/Day 1 and 1826/Day 1. Any titer less than LLOQ is replaced by value of LLOQ.

Outcome measures

Outcome measures
Measure
Cohort 2: Placebo
n=51 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.
Cohort 2: ExPEC10V High Dose
n=100 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 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 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 366: Serotype O8: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 9.25
22.5 Percentage of participants
Interval 13.46 to 34.0
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 366: Serotype O1A: >= 2 Fold Increase
5.3 Percentage of participants
Interval 0.64 to 17.75
70.4 Percentage of participants
Interval 58.41 to 80.67
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 731: Serotype O1A: >= 2 Fold Increase
8.6 Percentage of participants
Interval 1.8 to 23.06
58.1 Percentage of participants
Interval 44.85 to 70.49
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1096: Serotype O1A: >= 2 Fold Increase
9.4 Percentage of participants
Interval 1.98 to 25.02
56.1 Percentage of participants
Interval 42.36 to 69.26
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1461: Serotype O1A: >= 2 Fold Increase
17.6 Percentage of participants
Interval 3.8 to 43.43
61.1 Percentage of participants
Interval 43.46 to 76.86
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1826: Serotype O1A: >= 2 Fold Increase
5.9 Percentage of participants
Interval 0.15 to 28.69
51.4 Percentage of participants
Interval 33.99 to 68.62
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 366: Serotype O1A: >= 4 Fold Increase
2.6 Percentage of participants
Interval 0.07 to 13.81
45.1 Percentage of participants
Interval 33.23 to 57.34
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 731: Serotype O1A: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 10.0
38.7 Percentage of participants
Interval 26.6 to 51.93
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1096: Serotype O1A: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 10.89
35.1 Percentage of participants
Interval 22.91 to 48.87
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1461: Serotype O1A: >= 4 Fold Increase
11.8 Percentage of participants
Interval 1.46 to 36.44
36.1 Percentage of participants
Interval 20.82 to 53.78
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1826: Serotype O1A: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 19.51
31.4 Percentage of participants
Interval 16.85 to 49.29
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 366: Serotype O2: >= 2 Fold Increase
5.3 Percentage of participants
Interval 0.64 to 17.75
91.5 Percentage of participants
Interval 82.51 to 96.84
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 731: Serotype O2: >= 2 Fold Increase
20.0 Percentage of participants
Interval 8.44 to 36.94
95.2 Percentage of participants
Interval 86.5 to 98.99
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1096: Serotype O2: >= 2 Fold Increase
15.6 Percentage of participants
Interval 5.28 to 32.79
98.2 Percentage of participants
Interval 90.61 to 99.96
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1461: Serotype O2: >= 2 Fold Increase
11.8 Percentage of participants
Interval 1.46 to 36.44
97.2 Percentage of participants
Interval 85.47 to 99.93
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1826: Serotype O2: >= 2 Fold Increase
17.6 Percentage of participants
Interval 3.8 to 43.43
85.7 Percentage of participants
Interval 69.74 to 95.19
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 366: Serotype O2: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 9.25
77.5 Percentage of participants
Interval 66.0 to 86.54
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 731: Serotype O2: >= 4 Fold Increase
2.9 Percentage of participants
Interval 0.07 to 14.92
75.8 Percentage of participants
Interval 63.26 to 85.78
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1096: Serotype O2: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 10.89
73.7 Percentage of participants
Interval 60.34 to 84.46
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1461: Serotype O2: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 19.51
72.2 Percentage of participants
Interval 54.81 to 85.8
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1826: Serotype O2: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 19.51
68.6 Percentage of participants
Interval 50.71 to 83.15
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 366: Serotype O4: >= 2 Fold Increase
2.6 Percentage of participants
Interval 0.07 to 13.81
70.4 Percentage of participants
Interval 58.41 to 80.67
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 731: Serotype O4: >= 2 Fold Increase
8.6 Percentage of participants
Interval 1.8 to 23.06
71.0 Percentage of participants
Interval 58.05 to 81.8
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1096: Serotype O4: >= 2 Fold Increase
15.6 Percentage of participants
Interval 5.28 to 32.79
77.2 Percentage of participants
Interval 64.16 to 87.26
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1461: Serotype O4: >= 2 Fold Increase
23.5 Percentage of participants
Interval 6.81 to 49.9
94.4 Percentage of participants
Interval 81.34 to 99.32
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1826: Serotype O4: >= 2 Fold Increase
11.8 Percentage of participants
Interval 1.46 to 36.44
65.7 Percentage of participants
Interval 47.79 to 80.87
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 366: Serotype O4: >= 4 Fold Increase
2.6 Percentage of participants
Interval 0.07 to 13.81
35.2 Percentage of participants
Interval 24.24 to 47.46
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 731: Serotype O4: >= 4 Fold Increase
2.9 Percentage of participants
Interval 0.07 to 14.92
41.9 Percentage of participants
Interval 29.51 to 55.15
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1096: Serotype O4: >= 4 Fold Increase
3.1 Percentage of participants
Interval 0.08 to 16.22
38.6 Percentage of participants
Interval 26.0 to 52.43
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1461: Serotype O4: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 19.51
50.0 Percentage of participants
Interval 32.92 to 67.08
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1826: Serotype O4: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 19.51
22.9 Percentage of participants
Interval 10.42 to 40.14
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 366: Serotype O6A: >= 2 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 9.25
56.3 Percentage of participants
Interval 44.05 to 68.09
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 731: Serotype O6A: >= 2 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 10.0
30.6 Percentage of participants
Interval 19.56 to 43.65
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1096: Serotype O6A: >= 2 Fold Increase
6.3 Percentage of participants
Interval 0.77 to 20.81
28.1 Percentage of participants
Interval 16.97 to 41.54
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1461: Serotype O6A: >= 2 Fold Increase
5.9 Percentage of participants
Interval 0.15 to 28.69
19.4 Percentage of participants
Interval 8.19 to 36.02
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1826: Serotype O6A: >= 2 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 19.51
20.0 Percentage of participants
Interval 8.44 to 36.94
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 366: Serotype O6A: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 9.25
23.9 Percentage of participants
Interval 14.61 to 35.54
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 731: Serotype O6A: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 10.0
12.9 Percentage of participants
Interval 5.74 to 23.85
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1096: Serotype O6A: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 10.89
14.0 Percentage of participants
Interval 6.26 to 25.79
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1461: Serotype O6A: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 19.51
11.1 Percentage of participants
Interval 3.11 to 26.06
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1826: Serotype O6A: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 19.51
8.6 Percentage of participants
Interval 1.8 to 23.06
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 366: Serotype O8: >= 2 Fold Increase
2.6 Percentage of participants
Interval 0.07 to 13.81
59.2 Percentage of participants
Interval 46.84 to 70.68
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 731: Serotype O8: >= 2 Fold Increase
28.6 Percentage of participants
Interval 14.64 to 46.3
66.1 Percentage of participants
Interval 52.99 to 77.67
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1096: Serotype O8: >= 2 Fold Increase
28.1 Percentage of participants
Interval 13.75 to 46.75
59.6 Percentage of participants
Interval 45.82 to 72.44
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1461: Serotype O8: >= 2 Fold Increase
29.4 Percentage of participants
Interval 10.31 to 55.96
69.4 Percentage of participants
Interval 51.89 to 83.65
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1826: Serotype O8: >= 2 Fold Increase
17.6 Percentage of participants
Interval 3.8 to 43.43
51.4 Percentage of participants
Interval 33.99 to 68.62
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 731: Serotype O8: >= 4 Fold Increase
8.6 Percentage of participants
Interval 1.8 to 23.06
38.7 Percentage of participants
Interval 26.6 to 51.93
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1096: Serotype O8: >= 4 Fold Increase
3.1 Percentage of participants
Interval 0.08 to 16.22
24.6 Percentage of participants
Interval 14.13 to 37.76
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1461: Serotype O8: >= 4 Fold Increase
17.6 Percentage of participants
Interval 3.8 to 43.43
30.6 Percentage of participants
Interval 16.35 to 48.11
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1826: Serotype O8: >= 4 Fold Increase
5.9 Percentage of participants
Interval 0.15 to 28.69
25.7 Percentage of participants
Interval 12.49 to 43.26
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 366: Serotype O15: >= 2 Fold Increase
5.3 Percentage of participants
Interval 0.64 to 17.75
67.6 Percentage of participants
Interval 55.45 to 78.24
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 731: Serotype O15: >= 2 Fold Increase
28.6 Percentage of participants
Interval 14.64 to 46.3
71.0 Percentage of participants
Interval 58.05 to 81.8
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1096: Serotype O15: >= 2 Fold Increase
21.9 Percentage of participants
Interval 9.28 to 39.97
63.2 Percentage of participants
Interval 49.34 to 75.55
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1461: Serotype O15: >= 2 Fold Increase
23.5 Percentage of participants
Interval 6.81 to 49.9
58.3 Percentage of participants
Interval 40.76 to 74.49
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1826: Serotype O15: >= 2 Fold Increase
29.4 Percentage of participants
Interval 10.31 to 55.96
54.3 Percentage of participants
Interval 36.65 to 71.17
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 366: Serotype O15: >= 4 Fold Increase
2.6 Percentage of participants
Interval 0.07 to 13.81
32.4 Percentage of participants
Interval 21.76 to 44.55
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 731: Serotype O15: >= 4 Fold Increase
8.6 Percentage of participants
Interval 1.8 to 23.06
32.3 Percentage of participants
Interval 20.94 to 45.34
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1096: Serotype O15: >= 4 Fold Increase
6.3 Percentage of participants
Interval 0.77 to 20.81
28.1 Percentage of participants
Interval 16.97 to 41.54
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1461: Serotype O15: >= 4 Fold Increase
5.9 Percentage of participants
Interval 0.15 to 28.69
27.8 Percentage of participants
Interval 14.2 to 45.19
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1826: Serotype O15: >= 4 Fold Increase
11.8 Percentage of participants
Interval 1.46 to 36.44
25.7 Percentage of participants
Interval 12.49 to 43.26
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 366: Serotype O16: >= 2 Fold Increase
2.6 Percentage of participants
Interval 0.07 to 13.81
76.1 Percentage of participants
Interval 64.46 to 85.39
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 731: Serotype O16: >= 2 Fold Increase
2.9 Percentage of participants
Interval 0.07 to 14.92
66.1 Percentage of participants
Interval 52.99 to 77.67
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1096: Serotype O16: >= 2 Fold Increase
3.1 Percentage of participants
Interval 0.08 to 16.22
54.4 Percentage of participants
Interval 40.66 to 67.64
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1461: Serotype O16: >= 2 Fold Increase
11.8 Percentage of participants
Interval 1.46 to 36.44
61.1 Percentage of participants
Interval 43.46 to 76.86
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1826: Serotype O16: >= 2 Fold Increase
5.9 Percentage of participants
Interval 0.15 to 28.69
54.3 Percentage of participants
Interval 36.65 to 71.17
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 366: Serotype O16: >= 4 Fold Increase
2.6 Percentage of participants
Interval 0.07 to 13.81
40.8 Percentage of participants
Interval 29.32 to 53.16
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 731: Serotype O16: >= 4 Fold Increase
2.9 Percentage of participants
Interval 0.07 to 14.92
32.3 Percentage of participants
Interval 20.94 to 45.34
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1096: Serotype O16: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 10.89
28.1 Percentage of participants
Interval 16.97 to 41.54
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1461: Serotype O16: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 19.51
25.0 Percentage of participants
Interval 12.12 to 42.2
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1826: Serotype O16: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 19.51
17.1 Percentage of participants
Interval 6.56 to 33.65
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 366: Serotype O18A: >= 2 Fold Increase
2.6 Percentage of participants
Interval 0.07 to 13.81
60.6 Percentage of participants
Interval 48.25 to 71.97
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 731: Serotype O18A: >= 2 Fold Increase
25.7 Percentage of participants
Interval 12.49 to 43.26
54.8 Percentage of participants
Interval 41.68 to 67.52
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1096: Serotype O18A: >= 2 Fold Increase
18.8 Percentage of participants
Interval 7.21 to 36.44
50.9 Percentage of participants
Interval 37.29 to 64.37
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1461: Serotype O18A: >= 2 Fold Increase
17.6 Percentage of participants
Interval 3.8 to 43.43
36.1 Percentage of participants
Interval 20.82 to 53.78
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1826: Serotype O18A: >= 2 Fold Increase
11.8 Percentage of participants
Interval 1.46 to 36.44
28.6 Percentage of participants
Interval 14.64 to 46.3
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 366: Serotype O18A: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 9.25
12.7 Percentage of participants
Interval 5.96 to 22.7
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 731: Serotype O18A: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 10.0
21.0 Percentage of participants
Interval 11.66 to 33.18
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1096: Serotype O18A: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 10.89
17.5 Percentage of participants
Interval 8.75 to 29.91
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1461: Serotype O18A: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 19.51
8.3 Percentage of participants
Interval 1.75 to 22.47
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1826: Serotype O18A: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 19.51
8.6 Percentage of participants
Interval 1.8 to 23.06
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 366: Serotype O25B: >= 2 Fold Increase
5.3 Percentage of participants
Interval 0.64 to 17.75
64.8 Percentage of participants
Interval 52.54 to 75.76
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 731: Serotype O25B: >= 2 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 10.0
50.0 Percentage of participants
Interval 37.02 to 62.98
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1096: Serotype O25B: >= 2 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 10.89
52.6 Percentage of participants
Interval 38.97 to 66.02
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1461: Serotype O25B: >= 2 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 19.51
52.8 Percentage of participants
Interval 35.49 to 69.59
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1826: Serotype O25B: >= 2 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 19.51
28.6 Percentage of participants
Interval 14.64 to 46.3
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 366: Serotype O25B: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 9.25
33.8 Percentage of participants
Interval 23.0 to 46.01
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 731: Serotype O25B: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 10.0
25.8 Percentage of participants
Interval 15.53 to 38.5
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1096: Serotype O25B: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 10.89
21.1 Percentage of participants
Interval 11.38 to 33.89
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1461: Serotype O25B: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 19.51
16.7 Percentage of participants
Interval 6.37 to 32.81
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1826: Serotype O25B: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 19.51
8.6 Percentage of participants
Interval 1.8 to 23.06
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 366: Serotype O75: >= 2 Fold Increase
2.6 Percentage of participants
Interval 0.07 to 13.81
33.8 Percentage of participants
Interval 23.0 to 46.01
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 731: Serotype O75: >= 2 Fold Increase
8.6 Percentage of participants
Interval 1.8 to 23.06
32.3 Percentage of participants
Interval 20.94 to 45.34
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1096: Serotype O75: >= 2 Fold Increase
15.6 Percentage of participants
Interval 5.28 to 32.79
40.4 Percentage of participants
Interval 27.56 to 54.18
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1461: Serotype O75: >= 2 Fold Increase
5.9 Percentage of participants
Interval 0.15 to 28.69
33.3 Percentage of participants
Interval 18.56 to 50.97
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1826: Serotype O75: >= 2 Fold Increase
17.6 Percentage of participants
Interval 3.8 to 43.43
31.4 Percentage of participants
Interval 16.85 to 49.29
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 366: Serotype O75: >= 4 Fold Increase
2.6 Percentage of participants
Interval 0.07 to 13.81
8.5 Percentage of participants
Interval 3.16 to 17.49
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 731: Serotype O75: >= 4 Fold Increase
2.9 Percentage of participants
Interval 0.07 to 14.92
11.3 Percentage of participants
Interval 4.66 to 21.89
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1096: Serotype O75: >= 4 Fold Increase
3.1 Percentage of participants
Interval 0.08 to 16.22
12.3 Percentage of participants
Interval 5.08 to 23.68
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1461: Serotype O75: >= 4 Fold Increase
5.9 Percentage of participants
Interval 0.15 to 28.69
16.7 Percentage of participants
Interval 6.37 to 32.81
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1826: Serotype O75: >= 4 Fold Increase
11.8 Percentage of participants
Interval 1.46 to 36.44
14.3 Percentage of participants
Interval 4.81 to 30.26
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 366: Serotype EPA: >= 2 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 9.25
60.6 Percentage of participants
Interval 48.25 to 71.97
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 731: Serotype EPA: >= 2 Fold Increase
5.7 Percentage of participants
Interval 0.7 to 19.16
45.2 Percentage of participants
Interval 32.48 to 58.32
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1096: Serotype EPA: >= 2 Fold Increase
9.4 Percentage of participants
Interval 1.98 to 25.02
42.1 Percentage of participants
Interval 29.14 to 55.92
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1461: Serotype EPA: >= 2 Fold Increase
11.8 Percentage of participants
Interval 1.46 to 36.44
47.2 Percentage of participants
Interval 30.41 to 64.51
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1826: Serotype EPA: >= 2 Fold Increase
17.6 Percentage of participants
Interval 3.8 to 43.43
40.0 Percentage of participants
Interval 23.87 to 57.89
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 366: Serotype EPA: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 9.25
38.0 Percentage of participants
Interval 26.76 to 50.33
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 731: Serotype EPA: >= 4 Fold Increase
5.7 Percentage of participants
Interval 0.7 to 19.16
29.0 Percentage of participants
Interval 18.2 to 41.95
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1096: Serotype EPA: >= 4 Fold Increase
6.3 Percentage of participants
Interval 0.77 to 20.81
28.1 Percentage of participants
Interval 16.97 to 41.54
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1461: Serotype EPA: >= 4 Fold Increase
5.9 Percentage of participants
Interval 0.15 to 28.69
27.8 Percentage of participants
Interval 14.2 to 45.19
—
—
—
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1826: Serotype EPA: >= 4 Fold Increase
11.8 Percentage of participants
Interval 1.46 to 36.44
22.9 Percentage of participants
Interval 10.42 to 40.14
—
—
—

SECONDARY outcome

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

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

GMR of fold changes from baseline for serotype specific antibodies as measured by multiplex ECL based immunoassay on Days 366, 731, 1096, 1461 and 1826 were reported. GMR for each antigen serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 and EPA were determined in serum from collected blood samples by ECL based immunoassay. GMR of fold change from baseline was calculated as the ratio of GMTs on Days 366, 731, 1096, 1461 and 1826 and pre-vaccination (on Day 1). Any titer less than LLOQ is replaced by value of LLOQ.

Outcome measures

Outcome measures
Measure
Cohort 2: Placebo
n=39 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.
Cohort 2: ExPEC10V High Dose
n=71 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 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 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1096: Serotype O1A
0.82 Ratio
Interval 0.64 to 1.047
2.52 Ratio
Interval 1.932 to 3.293
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 366: Serotype O1A
1.10 Ratio
Interval 0.969 to 1.248
3.57 Ratio
Interval 2.893 to 4.402
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 731: Serotype O1A
0.82 Ratio
Interval 0.674 to 1.009
2.74 Ratio
Interval 2.159 to 3.466
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1461: Serotype O1A
1.01 Ratio
Interval 0.678 to 1.498
2.75 Ratio
Interval 2.076 to 3.635
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1826: Serotype O1A
0.72 Ratio
Interval 0.518 to 1.009
2.23 Ratio
Interval 1.701 to 2.928
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 366: Serotype O2
1.22 Ratio
Interval 1.098 to 1.348
7.71 Ratio
Interval 6.279 to 9.457
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 731: Serotype O2
1.34 Ratio
Interval 1.103 to 1.637
7.62 Ratio
Interval 5.994 to 9.694
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1096: Serotype O2
1.31 Ratio
Interval 1.101 to 1.558
7.78 Ratio
Interval 6.202 to 9.761
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1461: Serotype O2
1.32 Ratio
Interval 1.062 to 1.651
7.13 Ratio
Interval 5.471 to 9.294
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1826: Serotype O2
1.05 Ratio
Interval 0.8 to 1.385
6.29 Ratio
Interval 4.594 to 8.616
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 366: Serotype O4
1.20 Ratio
Interval 1.053 to 1.356
3.29 Ratio
Interval 2.762 to 3.907
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 731: Serotype O4
1.06 Ratio
Interval 0.881 to 1.28
3.16 Ratio
Interval 2.63 to 3.808
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1096: Serotype O4
1.16 Ratio
Interval 0.942 to 1.439
3.35 Ratio
Interval 2.792 to 4.029
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1461: Serotype O4
1.43 Ratio
Interval 1.097 to 1.865
4.02 Ratio
Interval 3.302 to 4.89
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1826: Serotype O4
1.06 Ratio
Interval 0.767 to 1.461
2.58 Ratio
Interval 2.057 to 3.233
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 366: Serotype O6A
1.09 Ratio
Interval 0.988 to 1.205
2.54 Ratio
Interval 2.178 to 2.958
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 731: Serotype O6A
0.67 Ratio
Interval 0.547 to 0.811
1.63 Ratio
Interval 1.323 to 1.999
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1096: Serotype O6A
0.71 Ratio
Interval 0.559 to 0.896
1.64 Ratio
Interval 1.345 to 1.993
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1461: Serotype O6A
0.69 Ratio
Interval 0.548 to 0.867
1.37 Ratio
Interval 1.089 to 1.726
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1826: Serotype O6A
0.51 Ratio
Interval 0.395 to 0.655
1.27 Ratio
Interval 0.999 to 1.615
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 366: Serotype O8
1.01 Ratio
Interval 0.892 to 1.143
2.46 Ratio
Interval 2.11 to 2.868
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 731: Serotype O8
1.52 Ratio
Interval 1.221 to 1.886
2.93 Ratio
Interval 2.396 to 3.595
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1096: Serotype O8
1.29 Ratio
Interval 1.028 to 1.625
2.61 Ratio
Interval 2.12 to 3.207
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1461: Serotype O8
1.44 Ratio
Interval 0.981 to 2.106
2.99 Ratio
Interval 2.275 to 3.923
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1826: Serotype O8
1.42 Ratio
Interval 1.07 to 1.897
2.54 Ratio
Interval 1.93 to 3.33
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 366: Serotype O15
1.24 Ratio
Interval 1.082 to 1.423
3.16 Ratio
Interval 2.615 to 3.81
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 731: Serotype O15
1.52 Ratio
Interval 1.201 to 1.912
2.99 Ratio
Interval 2.477 to 3.609
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1096: Serotype O15
1.29 Ratio
Interval 0.984 to 1.681
2.90 Ratio
Interval 2.352 to 3.569
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1461: Serotype O15
1.30 Ratio
Interval 0.878 to 1.937
2.76 Ratio
Interval 2.12 to 3.586
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1826: Serotype O15
1.37 Ratio
Interval 0.903 to 2.083
2.54 Ratio
Interval 1.908 to 3.374
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 366: Serotype O16
1.08 Ratio
Interval 0.949 to 1.225
3.62 Ratio
Interval 3.025 to 4.342
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 731: Serotype O16
0.68 Ratio
Interval 0.557 to 0.836
2.79 Ratio
Interval 2.18 to 3.575
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1096: Serotype O16
0.63 Ratio
Interval 0.511 to 0.788
2.44 Ratio
Interval 1.911 to 3.125
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1461: Serotype O16
0.90 Ratio
Interval 0.656 to 1.235
2.46 Ratio
Interval 1.832 to 3.315
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1826: Serotype O16
0.73 Ratio
Interval 0.529 to 0.997
1.98 Ratio
Interval 1.454 to 2.694
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 366: Serotype O18A
1.11 Ratio
Interval 1.009 to 1.232
2.37 Ratio
Interval 2.021 to 2.778
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 731: Serotype O18A
1.16 Ratio
Interval 0.966 to 1.385
2.36 Ratio
Interval 1.939 to 2.876
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1096: Serotype O18A
1.19 Ratio
Interval 1.01 to 1.406
2.35 Ratio
Interval 1.916 to 2.872
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1461: Serotype O18A
1.03 Ratio
Interval 0.767 to 1.371
1.83 Ratio
Interval 1.495 to 2.249
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1826: Serotype O18A
0.88 Ratio
Interval 0.632 to 1.227
1.67 Ratio
Interval 1.328 to 2.099
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 366: Serotype O25B
1.16 Ratio
Interval 1.033 to 1.293
3.10 Ratio
Interval 2.573 to 3.737
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 731: Serotype O25B
0.71 Ratio
Interval 0.598 to 0.831
2.14 Ratio
Interval 1.673 to 2.733
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1096: Serotype O25B
0.74 Ratio
Interval 0.624 to 0.867
2.06 Ratio
Interval 1.638 to 2.592
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1461: Serotype O25B
0.99 Ratio
Interval 0.775 to 1.268
1.99 Ratio
Interval 1.507 to 2.64
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1826: Serotype O25B
0.65 Ratio
Interval 0.507 to 0.827
1.41 Ratio
Interval 1.094 to 1.823
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 366: Serotype O75
1.05 Ratio
Interval 0.931 to 1.182
1.71 Ratio
Interval 1.516 to 1.931
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 731: Serotype O75
1.14 Ratio
Interval 0.949 to 1.368
1.69 Ratio
Interval 1.419 to 2.01
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1096: Serotype O75
1.08 Ratio
Interval 0.845 to 1.392
1.84 Ratio
Interval 1.519 to 2.226
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1461: Serotype O75
1.04 Ratio
Interval 0.681 to 1.577
1.61 Ratio
Interval 1.253 to 2.075
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1826: Serotype O75
1.19 Ratio
Interval 0.818 to 1.731
1.67 Ratio
Interval 1.318 to 2.121
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 366: Serotype EPA
0.98 Ratio
Interval 0.946 to 1.019
3.31 Ratio
Interval 2.587 to 4.232
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 731: Serotype EPA
1.14 Ratio
Interval 0.838 to 1.546
2.25 Ratio
Interval 1.793 to 2.819
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1096: Serotype EPA
1.14 Ratio
Interval 0.844 to 1.553
2.33 Ratio
Interval 1.864 to 2.907
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1461: Serotype EPA
1.17 Ratio
Interval 0.712 to 1.939
2.11 Ratio
Interval 1.568 to 2.844
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Day 1826: Serotype EPA
1.29 Ratio
Interval 0.848 to 1.957
1.86 Ratio
Interval 1.376 to 2.513
—
—
—

SECONDARY outcome

Timeframe: Days 366, 731, 1096, 1461

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

GMTs of serotype-specific total IgG serum antibodies as measured by MOPA were reported. GMTs for each antigen serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B and O75 were determined in serum from collected blood samples. For serotype O8 functional IgG serum antibodies were not evaluated as the assay was not able to detect vaccine-induced functional antibodies against the O8 serotype. Data was planned to be analyzed for specified arms only. LLOQ values for O1A: 33, O2: 42, O4: 12, O6A: 62, O15: 75, O16: 17, O18A: 44, O25B: 58, O75: 14. Any titer less than LLOQ is replaced by half of LLOQ (0.5\*LLOQ).

Outcome measures

Outcome measures
Measure
Cohort 2: Placebo
n=51 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.
Cohort 2: ExPEC10V High Dose
n=100 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 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 1: Geometric Mean Titer (GMT) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 366: Serotype O1A
187.9 Titer
Interval 76.6 to 460.5
266.6 Titer
Interval 194.4 to 365.5
—
—
—
Cohort 1: Geometric Mean Titer (GMT) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 731: Serotype O1A
379.5 Titer
Interval 125.6 to 1146.1
198.0 Titer
Interval 146.6 to 267.5
—
—
—
Cohort 1: Geometric Mean Titer (GMT) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1096: Serotype O1A
278.9 Titer
Interval 116.4 to 667.8
229.2 Titer
Interval 162.9 to 322.4
—
—
—
Cohort 1: Geometric Mean Titer (GMT) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1461: Serotype O1A
362.3 Titer
Interval 53.0 to 2478.0
241.0 Titer
Interval 160.6 to 361.6
—
—
—
Cohort 1: Geometric Mean Titer (GMT) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 366: Serotype O2
186.1 Titer
Interval 74.2 to 466.5
1700.5 Titer
Interval 1171.9 to 2467.7
—
—
—
Cohort 1: Geometric Mean Titer (GMT) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 731: Serotype O2
261.3 Titer
Interval 132.0 to 517.2
468.2 Titer
Interval 325.6 to 673.4
—
—
—
Cohort 1: Geometric Mean Titer (GMT) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1096: Serotype O2
236.5 Titer
Interval 104.7 to 534.3
866.7 Titer
Interval 600.6 to 1250.8
—
—
—
Cohort 1: Geometric Mean Titer (GMT) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1461: Serotype O2
288.4 Titer
Interval to 2239.4
Lower limit of 95% CI could not be estimated as it was below LLOQ (42).
622.5 Titer
Interval 374.9 to 1033.5
—
—
—
Cohort 1: Geometric Mean Titer (GMT) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 366: Serotype O4
155.8 Titer
Interval 98.4 to 246.6
269.8 Titer
Interval 211.3 to 344.3
—
—
—
Cohort 1: Geometric Mean Titer (GMT) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 731: Serotype O4
229.2 Titer
Interval 92.0 to 571.1
279.7 Titer
Interval 225.2 to 347.3
—
—
—
Cohort 1: Geometric Mean Titer (GMT) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1096: Serotype O4
292.0 Titer
Interval 204.4 to 417.2
284.4 Titer
Interval 233.9 to 345.7
—
—
—
Cohort 1: Geometric Mean Titer (GMT) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1461: Serotype O4
216.3 Titer
Interval 101.2 to 462.3
242.0 Titer
Interval 180.6 to 324.2
—
—
—
Cohort 1: Geometric Mean Titer (GMT) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 366: Serotype O6A
287.6 Titer
Interval 91.7 to 902.0
620.2 Titer
Interval 471.0 to 816.6
—
—
—
Cohort 1: Geometric Mean Titer (GMT) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 731: Serotype O6A
368.0 Titer
Interval 104.3 to 1298.3
483.7 Titer
Interval 357.0 to 655.4
—
—
—
Cohort 1: Geometric Mean Titer (GMT) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1096: Serotype O6A
635.9 Titer
Interval 156.7 to 2581.5
548.5 Titer
Interval 397.1 to 757.6
—
—
—
Cohort 1: Geometric Mean Titer (GMT) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1461: Serotype O6A
921.4 Titer
Interval 200.1 to 4243.2
538.7 Titer
Interval 374.0 to 775.8
—
—
—
Cohort 1: Geometric Mean Titer (GMT) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 366: Serotype O15
434.2 Titer
Interval 160.1 to 1177.6
1062.4 Titer
Interval 770.4 to 1465.1
—
—
—
Cohort 1: Geometric Mean Titer (GMT) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 731: Serotype O15
815.5 Titer
Interval 170.5 to 3900.1
846.5 Titer
Interval 606.0 to 1182.4
—
—
—
Cohort 1: Geometric Mean Titer (GMT) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1096: Serotype O15
527.2 Titer
Interval 135.9 to 2045.2
484.3 Titer
Interval 355.7 to 659.5
—
—
—
Cohort 1: Geometric Mean Titer (GMT) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1461: Serotype O15
736.1 Titer
Interval 106.0 to 5110.6
600.8 Titer
Interval 376.3 to 959.3
—
—
—
Cohort 1: Geometric Mean Titer (GMT) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 366: Serotype O16
113.1 Titer
Interval 58.3 to 219.6
440.9 Titer
Interval 304.1 to 639.4
—
—
—
Cohort 1: Geometric Mean Titer (GMT) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 731: Serotype O16
140.7 Titer
Interval 47.6 to 416.0
375.6 Titer
Interval 263.5 to 535.6
—
—
—
Cohort 1: Geometric Mean Titer (GMT) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1096: Serotype O16
300.1 Titer
Interval 83.5 to 1078.5
265.9 Titer
Interval 181.4 to 389.7
—
—
—
Cohort 1: Geometric Mean Titer (GMT) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1461: Serotype O16
186.2 Titer
Interval 37.6 to 921.8
249.6 Titer
Interval 153.5 to 405.7
—
—
—
Cohort 1: Geometric Mean Titer (GMT) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 366: Serotype O18A
182.8 Titer
Interval 71.2 to 469.7
301.7 Titer
Interval 233.4 to 390.1
—
—
—
Cohort 1: Geometric Mean Titer (GMT) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 731: Serotype O18A
131.8 Titer
Interval to 412.7
Lower limit of 95% CI could not be estimated as it was below LLOQ (44).
213.0 Titer
Interval 167.6 to 270.7
—
—
—
Cohort 1: Geometric Mean Titer (GMT) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1096: Serotype O18A
90.2 Titer
Interval to 373.6
Lower limit of 95% CI could not be estimated as it was below LLOQ (44).
192.9 Titer
Interval 143.1 to 260.2
—
—
—
Cohort 1: Geometric Mean Titer (GMT) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1461: Serotype O18A
327.2 Titer
Interval to 2698.0
Lower limit of 95% CI could not be estimated as it was below LLOQ (44).
324.9 Titer
Interval 222.0 to 475.4
—
—
—
Cohort 1: Geometric Mean Titer (GMT) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 366: Serotype O25B
NA Titer
Geometric mean, lower and upper limit of 95% CI could not be estimated as the value was below LLOQ (58).
69.2 Titer
Interval to 90.2
Lower limit of 95% CI could not be estimated as it was below LLOQ (58).
—
—
—
Cohort 1: Geometric Mean Titer (GMT) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 731: Serotype O25B
NA Titer
Geometric mean, lower, and upper limit of 95% CI could not be estimated as the value was below LLOQ (58).
NA Titer
Interval to 70.4
Geometric mean and lower limit of 95% CI could not be estimated as the value was below LLOQ (58).
—
—
—
Cohort 1: Geometric Mean Titer (GMT) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1096: Serotype O25B
NA Titer
Geometric mean, lower, and upper limit of 95% CI could not be estimated as the value was below LLOQ (58).
NA Titer
Geometric mean, lower, and upper limit of 95% CI could not be estimated as the value was below LLOQ (58).
—
—
—
Cohort 1: Geometric Mean Titer (GMT) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1461: Serotype O25B
NA Titer
Interval to 74.0
Geometric mean and lower limit of 95% CI could not be estimated as the value was below LLOQ (58).
NA Titer
Interval to 59.9
Geometric mean and lower limit of 95% CI could not be estimated as the value was below LLOQ (58).
—
—
—
Cohort 1: Geometric Mean Titer (GMT) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 366: Serotype O75
101.5 Titer
Interval 40.9 to 251.5
80.9 Titer
Interval 62.2 to 105.2
—
—
—
Cohort 1: Geometric Mean Titer (GMT) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 731: Serotype O75
101.5 Titer
Interval 39.5 to 260.6
57.7 Titer
Interval 42.3 to 78.7
—
—
—
Cohort 1: Geometric Mean Titer (GMT) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1096: Serotype O75
100.9 Titer
Interval 33.3 to 305.4
83.0 Titer
Interval 58.7 to 117.2
—
—
—
Cohort 1: Geometric Mean Titer (GMT) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1461: Serotype O75
117.3 Titer
Interval 19.7 to 698.4
46.6 Titer
Interval 32.0 to 67.9
—
—
—

SECONDARY outcome

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

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

GMR of fold changes from baseline for serotype specific antibodies as measured by MOPA on Days 366, 731, 1096, 1461 were reported. GMR for each antigen serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B and O75 were determined in serum from collected blood samples by MOPA. GMR of fold change from baseline was calculated as the ratio of GMTs on Days 366, 731, 1096, 1461 and pre-vaccination (on Day 1). For serotype O8 functional IgG serum antibodies were not evaluated as the assay was not able to detect vaccine-induced functional antibodies against the O8 serotype. Any titer less than LLOQ is replaced by value of LLOQ.

Outcome measures

Outcome measures
Measure
Cohort 2: Placebo
n=51 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.
Cohort 2: ExPEC10V High Dose
n=100 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 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 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 366: Serotype O1A
0.62 Ratio
Interval 0.401 to 0.963
0.90 Ratio
Interval 0.738 to 1.11
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 731: Serotype O1A
0.91 Ratio
Interval 0.401 to 2.088
0.71 Ratio
Interval 0.591 to 0.865
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1096: Serotype O1A
0.69 Ratio
Interval 0.325 to 1.459
0.80 Ratio
Interval 0.665 to 0.953
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1461: Serotype O1A
0.64 Ratio
Interval 0.146 to 2.786
0.98 Ratio
Interval 0.781 to 1.225
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 366: Serotype O2
0.84 Ratio
Interval 0.437 to 1.604
5.05 Ratio
Interval 3.601 to 7.072
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 731: Serotype O2
0.93 Ratio
Interval 0.41 to 2.095
1.53 Ratio
Interval 1.131 to 2.057
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1096: Serotype O2
0.76 Ratio
Interval 0.513 to 1.14
2.63 Ratio
Interval 1.932 to 3.574
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1461: Serotype O2
0.96 Ratio
Interval 0.398 to 2.313
2.13 Ratio
Interval 1.386 to 3.274
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 366: Serotype O4
1.23 Ratio
Interval 0.367 to 4.13
1.67 Ratio
Interval 1.343 to 2.08
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 731: Serotype O4
2.04 Ratio
Interval 0.672 to 6.185
1.62 Ratio
Interval 1.313 to 1.997
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1096: Serotype O4
2.12 Ratio
Interval 0.33 to 13.573
1.62 Ratio
Interval 1.345 to 1.947
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1461: Serotype O4
1.42 Ratio
Interval 0.041 to 49.404
1.43 Ratio
Interval 1.087 to 1.88
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 366: Serotype O6A
0.59 Ratio
Interval 0.317 to 1.083
1.19 Ratio
Interval 0.954 to 1.475
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 731: Serotype O6A
0.91 Ratio
Interval 0.458 to 1.808
0.84 Ratio
Interval 0.689 to 1.018
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1096: Serotype O6A
1.47 Ratio
Interval 0.337 to 6.398
0.91 Ratio
Interval 0.711 to 1.16
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1461: Serotype O6A
2.59 Ratio
Interval 0.139 to 48.195
1.00 Ratio
Interval 0.761 to 1.319
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 366: Serotype O15
0.95 Ratio
Interval 0.594 to 1.522
2.86 Ratio
Interval 2.14 to 3.825
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 731: Serotype O15
1.81 Ratio
Interval 0.904 to 3.61
2.06 Ratio
Interval 1.549 to 2.737
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1096: Serotype O15
0.97 Ratio
Interval 0.331 to 2.85
1.23 Ratio
Interval 0.887 to 1.707
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1461: Serotype O15
0.87 Ratio
Interval 0.32 to 2.343
1.79 Ratio
Interval 1.164 to 2.753
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 366: Serotype O16
0.99 Ratio
Interval 0.495 to 1.962
3.84 Ratio
Interval 2.861 to 5.155
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 731: Serotype O16
1.13 Ratio
Interval 0.631 to 2.031
3.45 Ratio
Interval 2.618 to 4.534
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1096: Serotype O16
1.80 Ratio
Interval 0.891 to 3.618
2.39 Ratio
Interval 1.796 to 3.171
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1461: Serotype O16
1.31 Ratio
Interval 0.419 to 4.085
2.53 Ratio
Interval 1.726 to 3.719
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 366: Serotype O18A
0.93 Ratio
Interval 0.464 to 1.861
1.27 Ratio
Interval 1.008 to 1.601
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 731: Serotype O18A
0.78 Ratio
Interval 0.516 to 1.181
0.86 Ratio
Interval 0.695 to 1.064
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1096: Serotype O18A
0.57 Ratio
Interval 0.365 to 0.901
0.78 Ratio
Interval 0.647 to 0.949
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1461: Serotype O18A
1.03 Ratio
Interval 0.422 to 2.519
1.21 Ratio
Interval 0.979 to 1.491
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 366: Serotype O25B
1.08 Ratio
Interval 0.906 to 1.276
1.39 Ratio
Interval 1.188 to 1.63
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 731: Serotype O25B
1.08 Ratio
Interval 0.894 to 1.308
1.19 Ratio
Interval 0.999 to 1.428
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1096: Serotype O25B
1.00 Ratio
Interval 0.996 to 1.01
0.99 Ratio
Interval 0.918 to 1.07
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1461: Serotype O25B
1.05 Ratio
Interval 0.896 to 1.235
1.05 Ratio
Interval 0.921 to 1.185
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 366: Serotype O75
1.20 Ratio
Interval 0.496 to 2.878
1.43 Ratio
Interval 1.16 to 1.772
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 731: Serotype O75
1.17 Ratio
Interval 0.457 to 2.982
1.12 Ratio
Interval 0.886 to 1.408
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1096: Serotype O75
0.92 Ratio
Interval 0.338 to 2.479
1.57 Ratio
Interval 1.159 to 2.117
—
—
—
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1461: Serotype O75
1.11 Ratio
Interval 0.189 to 6.553
1.13 Ratio
Interval 0.875 to 1.462
—
—
—

SECONDARY outcome

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

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

The fold (\>=2-fold and \>=4-fold) increase from baseline to Days 366, 731, 1096, and 1461 for the serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B, and O75 was calculated as the ratio of titer values of serum antibody on Days 366, 731, 1096, 1461 and pre-vaccination (on day 1) that is, Day 366/Day 1, 731/Day 1, 1096/Day 1, 1461/Day 1. For serotype O8 functional IgG serum antibodies were not evaluated as the assay was not able to detect vaccine-induced functional antibodies against the O8 serotype. Any titer less than LLOQ is replaced by value of LLOQ.

Outcome measures

Outcome measures
Measure
Cohort 2: Placebo
n=39 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.
Cohort 2: ExPEC10V High Dose
n=71 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 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 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 731: Serotype O15: >= 4 Fold Increase
28.6 Percentage of participants
Interval 3.67 to 70.96
23.7 Percentage of participants
Interval 13.62 to 36.59
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1096: Serotype O15: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 45.93
20.0 Percentage of participants
Interval 10.43 to 32.97
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 366: Serotype O16: >= 2 Fold Increase
37.5 Percentage of participants
Interval 8.52 to 75.51
64.7 Percentage of participants
Interval 52.17 to 75.92
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 731: Serotype O16: >= 2 Fold Increase
14.3 Percentage of participants
Interval 0.36 to 57.87
69.0 Percentage of participants
Interval 55.46 to 80.46
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1096: Serotype O16: >= 2 Fold Increase
50.0 Percentage of participants
Interval 11.81 to 88.19
55.6 Percentage of participants
Interval 41.4 to 69.08
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1461: Serotype O16: >= 2 Fold Increase
25.0 Percentage of participants
Interval 0.63 to 80.59
54.3 Percentage of participants
Interval 36.65 to 71.17
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 366: Serotype O16: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 36.94
47.1 Percentage of participants
Interval 34.83 to 59.55
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 731: Serotype O16: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 40.96
44.8 Percentage of participants
Interval 31.74 to 58.46
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1096: Serotype O16: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 45.93
31.5 Percentage of participants
Interval 19.52 to 45.55
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1461: Serotype O16: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 60.24
34.3 Percentage of participants
Interval 19.13 to 52.21
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 366: Serotype O18A: >= 2 Fold Increase
12.5 Percentage of participants
Interval 0.32 to 52.65
26.1 Percentage of participants
Interval 16.25 to 38.06
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 731: Serotype O18A: >= 2 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 40.96
13.6 Percentage of participants
Interval 6.04 to 24.98
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1096: Serotype O18A: >= 2 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 45.93
5.5 Percentage of participants
Interval 1.14 to 15.12
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1461: Serotype O18A: >= 2 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 60.24
20.0 Percentage of participants
Interval 8.44 to 36.94
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 366: Serotype O18A: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 36.94
13.0 Percentage of participants
Interval 6.14 to 23.32
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 731: Serotype O18A: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 40.96
5.1 Percentage of participants
Interval 1.06 to 14.15
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1096: Serotype O18A: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 45.93
0.0 Percentage of participants
Interval 0.0 to 6.49
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1461: Serotype O18A: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 19.16
5.7 Percentage of participants
Interval 0.7 to 19.16
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 366: Serotype O25B: >= 2 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 36.94
16.2 Percentage of participants
Interval 8.36 to 27.1
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 731: Serotype O25B: >= 2 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 40.96
12.1 Percentage of participants
Interval 4.99 to 23.3
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1096: Serotype O25B: >= 2 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 45.93
1.9 Percentage of participants
Interval 0.05 to 9.89
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1461: Serotype O25B: >= 2 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 60.24
5.9 Percentage of participants
Interval 0.72 to 19.68
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 366: Serotype O25B: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 36.94
8.8 Percentage of participants
Interval 3.31 to 18.22
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 731: Serotype O25B: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 40.96
3.4 Percentage of participants
Interval 0.42 to 11.91
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1096: Serotype O25B: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 45.93
0.0 Percentage of participants
Interval 0.0 to 6.6
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1461: Serotype O25B: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 60.24
0.0 Percentage of participants
Interval 0.0 to 10.28
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 366: Serotype O75: >= 2 Fold Increase
25.0 Percentage of participants
Interval 3.19 to 65.09
29.0 Percentage of participants
Interval 18.69 to 41.16
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 731: Serotype O75: >= 2 Fold Increase
14.3 Percentage of participants
Interval 0.36 to 57.87
22.4 Percentage of participants
Interval 12.51 to 35.27
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1096: Serotype O75: >= 2 Fold Increase
16.7 Percentage of participants
Interval 0.42 to 64.12
38.9 Percentage of participants
Interval 25.92 to 53.12
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1461: Serotype O75: >= 2 Fold Increase
25.0 Percentage of participants
Interval 0.63 to 80.59
14.3 Percentage of participants
Interval 4.81 to 30.26
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 366: Serotype O75: >= 4 Fold Increase
12.5 Percentage of participants
Interval 0.32 to 52.65
11.6 Percentage of participants
Interval 5.14 to 21.57
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 731: Serotype O75: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 40.96
12.1 Percentage of participants
Interval 4.99 to 23.3
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1096: Serotype O75: >= 4 Fold Increase
16.7 Percentage of participants
Interval 0.42 to 64.12
20.4 Percentage of participants
Interval 10.63 to 33.53
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1461: Serotype O75: >= 4 Fold Increase
25.0 Percentage of participants
Interval 0.63 to 80.59
8.6 Percentage of participants
Interval 1.8 to 23.06
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 366: Serotype O1A: >= 2 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 36.94
8.7 Percentage of participants
Interval 3.26 to 17.97
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 731: Serotype O1A: >= 2 Fold Increase
14.3 Percentage of participants
Interval 0.36 to 57.87
6.8 Percentage of participants
Interval 1.88 to 16.46
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1096: Serotype O1A: >= 2 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 45.93
10.9 Percentage of participants
Interval 4.11 to 22.25
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1461: Serotype O1A: >= 2 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 60.24
17.1 Percentage of participants
Interval 6.56 to 33.65
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 366: Serotype O1A: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 36.94
7.2 Percentage of participants
Interval 2.39 to 16.11
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 731: Serotype O1A: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 40.96
1.7 Percentage of participants
Interval 0.04 to 9.09
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1096: Serotype O1A: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 45.93
0.0 Percentage of participants
Interval 0.0 to 6.49
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1461: Serotype O1A: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 60.24
0.0 Percentage of participants
Interval 0.0 to 10.0
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 366: Serotype O2: >= 2 Fold Increase
12.5 Percentage of participants
Interval 0.32 to 52.65
69.6 Percentage of participants
Interval 57.31 to 80.08
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 731: Serotype O2: >= 2 Fold Increase
28.6 Percentage of participants
Interval 3.67 to 70.96
31.0 Percentage of participants
Interval 19.54 to 44.54
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1096: Serotype O2: >= 2 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 45.93
52.7 Percentage of participants
Interval 38.8 to 66.35
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1461: Serotype O2: >= 2 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 60.24
51.4 Percentage of participants
Interval 33.99 to 68.62
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 366: Serotype O2: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 36.94
52.2 Percentage of participants
Interval 39.8 to 64.35
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 731: Serotype O2: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 40.96
15.5 Percentage of participants
Interval 7.35 to 27.42
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1096: Serotype O2: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 45.93
32.7 Percentage of participants
Interval 20.68 to 46.71
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1461: Serotype O2: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 60.24
31.4 Percentage of participants
Interval 16.85 to 49.29
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 366: Serotype O4: >= 2 Fold Increase
37.5 Percentage of participants
Interval 8.52 to 75.51
40.6 Percentage of participants
Interval 28.91 to 53.08
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 731: Serotype O4: >= 2 Fold Increase
71.4 Percentage of participants
Interval 29.04 to 96.33
35.6 Percentage of participants
Interval 23.55 to 49.13
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1096: Serotype O4: >= 2 Fold Increase
66.7 Percentage of participants
Interval 22.28 to 95.67
38.2 Percentage of participants
Interval 25.41 to 52.27
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1461: Serotype O4: >= 2 Fold Increase
50.0 Percentage of participants
Interval 6.76 to 93.24
28.6 Percentage of participants
Interval 14.64 to 46.3
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 366: Serotype O4: >= 4 Fold Increase
12.5 Percentage of participants
Interval 0.32 to 52.65
21.7 Percentage of participants
Interval 12.71 to 33.31
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 731: Serotype O4: >= 4 Fold Increase
28.6 Percentage of participants
Interval 3.67 to 70.96
15.3 Percentage of participants
Interval 7.22 to 26.99
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1096: Serotype O4: >= 4 Fold Increase
33.3 Percentage of participants
Interval 4.33 to 77.72
10.9 Percentage of participants
Interval 4.11 to 22.25
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1461: Serotype O4: >= 4 Fold Increase
50.0 Percentage of participants
Interval 6.76 to 93.24
8.6 Percentage of participants
Interval 1.8 to 23.06
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 366: Serotype O6A: >= 2 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 36.94
24.6 Percentage of participants
Interval 15.05 to 36.49
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 731: Serotype O6A: >= 2 Fold Increase
14.3 Percentage of participants
Interval 0.36 to 57.87
8.5 Percentage of participants
Interval 2.81 to 18.68
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1096: Serotype O6A: >= 2 Fold Increase
16.7 Percentage of participants
Interval 0.42 to 64.12
14.5 Percentage of participants
Interval 6.5 to 26.66
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1461: Serotype O6A: >= 2 Fold Increase
25.0 Percentage of participants
Interval 0.63 to 80.59
14.3 Percentage of participants
Interval 4.81 to 30.26
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 366: Serotype O6A: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 36.94
11.6 Percentage of participants
Interval 5.14 to 21.57
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 731: Serotype O6A: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 40.96
5.1 Percentage of participants
Interval 1.06 to 14.15
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1096: Serotype O6A: >= 4 Fold Increase
16.7 Percentage of participants
Interval 0.42 to 64.12
7.3 Percentage of participants
Interval 2.02 to 17.59
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1461: Serotype O6A: >= 4 Fold Increase
25.0 Percentage of participants
Interval 0.63 to 80.59
8.6 Percentage of participants
Interval 1.8 to 23.06
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 366: Serotype O15: >= 2 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 36.94
55.1 Percentage of participants
Interval 42.62 to 67.08
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 731: Serotype O15: >= 2 Fold Increase
57.1 Percentage of participants
Interval 18.41 to 90.1
50.8 Percentage of participants
Interval 37.5 to 64.11
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1096: Serotype O15: >= 2 Fold Increase
33.3 Percentage of participants
Interval 4.33 to 77.72
27.3 Percentage of participants
Interval 16.14 to 40.96
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1461: Serotype O15: >= 2 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 60.24
48.6 Percentage of participants
Interval 31.38 to 66.01
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 366: Serotype O15: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 36.94
33.3 Percentage of participants
Interval 22.44 to 45.71
—
—
—
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Day 1461: Serotype O15: >= 4 Fold Increase
0.0 Percentage of participants
Interval 0.0 to 60.24
25.7 Percentage of participants
Interval 12.49 to 43.26
—
—
—

SECONDARY outcome

Timeframe: 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" (number of participants analyzed) signifies participants evaluable for this outcome measure and "n" (number analyzed) signifies those participants who were evaluable at specified categories.

Correlation between the multiplex ECL-based immunoassay and the MOPA functional titers by serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B, and O75 on Day 30 was analyzed. Data was planned to be analyzed for specified arms only. For serotype O8 functional IgG serum antibodies were not evaluated as the assay was not able to detect vaccine-induced functional antibodies against the O8 serotype.

Outcome measures

Outcome measures
Measure
Cohort 2: Placebo
n=69 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.
Cohort 2: ExPEC10V High Dose
n=258 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 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: Correlation Between the Multiplex ECL-Based Immunoassay and the MOPA Functional Titers by Serotype on Day 30
Serotype O1A
0.20 correlation coefficient
Interval -0.04 to 0.42
0.35 correlation coefficient
Interval 0.24 to 0.46
—
—
—
Cohort 2: Correlation Between the Multiplex ECL-Based Immunoassay and the MOPA Functional Titers by Serotype on Day 30
Serotype O2
0.47 correlation coefficient
Interval 0.26 to 0.64
0.59 correlation coefficient
Interval 0.5 to 0.66
—
—
—
Cohort 2: Correlation Between the Multiplex ECL-Based Immunoassay and the MOPA Functional Titers by Serotype on Day 30
Serotype O4
0.20 correlation coefficient
Interval -0.03 to 0.42
0.61 correlation coefficient
Interval 0.53 to 0.68
—
—
—
Cohort 2: Correlation Between the Multiplex ECL-Based Immunoassay and the MOPA Functional Titers by Serotype on Day 30
Serotype O6A
0.30 correlation coefficient
Interval 0.07 to 0.5
0.55 correlation coefficient
Interval 0.45 to 0.63
—
—
—
Cohort 2: Correlation Between the Multiplex ECL-Based Immunoassay and the MOPA Functional Titers by Serotype on Day 30
Serotype O15
0.41 correlation coefficient
Interval 0.2 to 0.59
0.54 correlation coefficient
Interval 0.45 to 0.63
—
—
—
Cohort 2: Correlation Between the Multiplex ECL-Based Immunoassay and the MOPA Functional Titers by Serotype on Day 30
Serotype O16
0.41 correlation coefficient
Interval 0.19 to 0.59
0.70 correlation coefficient
Interval 0.63 to 0.76
—
—
—
Cohort 2: Correlation Between the Multiplex ECL-Based Immunoassay and the MOPA Functional Titers by Serotype on Day 30
Serotype O18A
0.19 correlation coefficient
Interval -0.05 to 0.41
0.60 correlation coefficient
Interval 0.51 to 0.67
—
—
—
Cohort 2: Correlation Between the Multiplex ECL-Based Immunoassay and the MOPA Functional Titers by Serotype on Day 30
Serotype O25B
0.40 correlation coefficient
Interval 0.19 to 0.58
0.66 correlation coefficient
Interval 0.58 to 0.72
—
—
—
Cohort 2: Correlation Between the Multiplex ECL-Based Immunoassay and the MOPA Functional Titers by Serotype on Day 30
Serotype O75
0.28 correlation coefficient
Interval 0.04 to 0.49
0.56 correlation coefficient
Interval 0.47 to 0.64
—
—
—

SECONDARY outcome

Timeframe: At Days 15 and 181

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" ( number of participants analyzed) signifies participants evaluable for this outcome measure and "n" (number analyzed) signifies those participants who were evaluable at specified categories.

GMTs of serotype-specific total IgG serum antibodies as measured by ECL based immunoassay were reported. GMTs for each antigen serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 and EPA were determined in serum from collected blood samples. Data was planned to be analyzed for specified arms only. LLOQ values for O1A: 69149, O2: 65287, O4: 67356, O6A: 150748, O8: 72196, O15: 66910, O16: 71586, O18A: 70519, O25B: 61990, O75: 133019, and EPA: 66165. Any titer less than LLOQ is replaced by half of LLOQ (0.5\*LLOQ).

Outcome measures

Outcome measures
Measure
Cohort 2: Placebo
n=131 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.
Cohort 2: ExPEC10V High Dose
n=256 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 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 Days 15 and 181
Serotype O1A: Day 15
1683620.1 titers
Interval 1434083.1 to 1976577.8
6440111.0 titers
Interval 5964513.8 to 6953631.4
—
—
—
Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
Serotype O2: Day 15
758680.9 titers
Interval 637710.3 to 902599.0
5984689.5 titers
Interval 5506341.8 to 6504592.4
—
—
—
Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
Serotype O4: Day 15
752878.3 titers
Interval 648044.1 to 874671.5
3674695.0 titers
Interval 3268908.7 to 4130853.6
—
—
—
Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
Serotype O6A: Day 15
1864516.2 titers
Interval 1602306.3 to 2169635.5
5549559.4 titers
Interval 5061238.2 to 6084995.1
—
—
—
Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
Serotype O8: Day 15
2402212.7 titers
Interval 2080311.6 to 2773923.8
6259628.9 titers
Interval 5787049.2 to 6770800.1
—
—
—
Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
Serotype O15: Day 15
1196527.5 titers
Interval 1020092.0 to 1403479.3
5820591.1 titers
Interval 5382542.2 to 6294289.8
—
—
—
Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
Serotype O16: Day 15
1094722.5 titers
Interval 967329.6 to 1238892.4
5328787.2 titers
Interval 4876101.2 to 5823499.4
—
—
—
Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
Serotype O18A: Day 15
1343124.1 titers
Interval 1178653.4 to 1530545.3
4224096.2 titers
Interval 3810089.9 to 4683088.6
—
—
—
Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
Serotype O25B: Day 15
369020.0 titers
Interval 309515.7 to 439964.0
2205580.7 titers
Interval 1907527.9 to 2550204.4
—
—
—
Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
Serotype O75: Day 15
1525428.5 titers
Interval 1313220.7 to 1771927.8
3879088.3 titers
Interval 3534225.0 to 4257602.7
—
—
—
Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
Serotype EPA: Day 15
76119.8 titers
Interval to 92444.3
NA stands for data not available for lower limit of the CI as titer value was below LLOQ (66165).
764611.5 titers
Interval 606266.0 to 964314.1
—
—
—
Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
Serotype O1A: Day 181
1363698.1 titers
Interval 1134292.4 to 1639500.3
5181579.3 titers
Interval 4717321.1 to 5691527.8
—
—
—
Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
Serotype O2: Day 181
772833.5 titers
Interval 647611.4 to 922268.6
5104290.1 titers
Interval 4630408.3 to 5626669.7
—
—
—
Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
Serotype O4: Day 181
748466.8 titers
Interval 626770.4 to 893792.2
2464185.1 titers
Interval 2180166.2 to 2785204.2
—
—
—
Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
Serotype O6A: Day 181
1377697.3 titers
Interval 1156472.5 to 1641240.8
4237338.6 titers
Interval 3839748.2 to 4676097.9
—
—
—
Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
Serotype O8: Day 181
2347175.9 titers
Interval 2014621.2 to 2734625.6
5341568.9 titers
Interval 4901755.3 to 5820845.0
—
—
—
Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
Serotype O15: Day 181
1212443.2 titers
Interval 1022590.8 to 1437543.2
4651707.1 titers
Interval 4246266.4 to 5095859.9
—
—
—
Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
Serotype O16: Day 181
974253.6 titers
Interval 851675.7 to 1114473.6
4002647.6 titers
Interval 3633889.3 to 4408826.6
—
—
—
Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
Serotype O18A: Day 181
1440992.4 titers
Interval 1251837.9 to 1658728.5
3510981.8 titers
Interval 3167417.1 to 3891812.4
—
—
—
Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
Serotype O25B: Day 181
338325.5 titers
Interval 276179.7 to 414455.2
1448059.1 titers
Interval 1242167.0 to 1688078.3
—
—
—
Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
Serotype O75: Day 181
1605445.2 titers
Interval 1367665.3 to 1884565.2
3483252.0 titers
Interval 3157048.6 to 3843160.4
—
—
—
Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
Serotype EPA: Day 181
71976.3 titers
Interval to 86879.0
NA stands for data not available for lower limit of the CI as titer value was below LLOQ (66165).
415564.1 titers
Interval 335178.0 to 515229.3
—
—
—

SECONDARY outcome

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

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" ( number of participants analyzed) signifies participants evaluable for this outcome measure and "n" (number analyzed) signifies those participants who were evaluable at specified categories.

GMR of fold changes from baseline for serotype specific antibodies as measured by multiplex ECL based immunoassay on Days 15 and 181 were reported. GMR for each antigen serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, and O75 were determined in serum from collected blood samples by ECL based immunoassay. GMR of fold change from baseline was calculated as the ratio of GMTs on Days 15 and 181 and pre-vaccination (on Day 1). Any titer less than LLOQ is replaced by value of LLOQ.

Outcome measures

Outcome measures
Measure
Cohort 2: Placebo
n=131 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.
Cohort 2: ExPEC10V High Dose
n=258 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 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 Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
Serotype O1A: Day 181
0.85 ratio
Interval 0.778 to 0.93
3.54 ratio
Interval 3.186 to 3.937
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
Serotype O1A: Day 15
0.99 ratio
Interval 0.967 to 1.023
4.40 ratio
Interval 3.932 to 4.928
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
Serotype O2: Day 15
0.99 ratio
Interval 0.933 to 1.057
7.96 ratio
Interval 7.052 to 8.987
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
Serotype O4: Day 15
1.02 ratio
Interval 0.988 to 1.063
5.45 ratio
Interval 4.825 to 6.146
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
Serotype O6A: Day 15
1.03 ratio
Interval 0.989 to 1.07
3.89 ratio
Interval 3.518 to 4.298
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
Serotype O8: Day 15
1.03 ratio
Interval 0.992 to 1.072
2.89 ratio
Interval 2.619 to 3.194
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
Serotype O15: Day 15
1.02 ratio
Interval 0.976 to 1.07
4.93 ratio
Interval 4.42 to 5.505
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
Serotype O16: Day 15
1.03 ratio
Interval 0.984 to 1.078
5.14 ratio
Interval 4.615 to 5.715
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
Serotype O18A: Day 15
1.06 ratio
Interval 1.023 to 1.093
3.63 ratio
Interval 3.266 to 4.031
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
Serotype O25B: Day 15
1.01 ratio
Interval 0.963 to 1.068
5.80 ratio
Interval 4.99 to 6.748
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
Serotype O75: Day 15
1.02 ratio
Interval 0.977 to 1.071
2.42 ratio
Interval 2.217 to 2.644
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
Serotype O2: Day 181
1.10 ratio
Interval 0.964 to 1.252
6.79 ratio
Interval 6.02 to 7.649
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
Serotype O4: Day 181
1.02 ratio
Interval 0.948 to 1.105
3.68 ratio
Interval 3.284 to 4.116
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
Serotype O6A: Day 181
0.78 ratio
Interval 0.678 to 0.894
2.88 ratio
Interval 2.569 to 3.222
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
Serotype O8: Day 181
1.06 ratio
Interval 1.0 to 1.13
2.45 ratio
Interval 2.239 to 2.681
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
Serotype O15: Day 181
1.08 ratio
Interval 1.016 to 1.15
4.08 ratio
Interval 3.692 to 4.514
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
Serotype O16: Day 181
0.92 ratio
Interval 0.859 to 0.982
3.98 ratio
Interval 3.605 to 4.385
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
Serotype O18A: Day 181
1.16 ratio
Interval 1.088 to 1.234
2.91 ratio
Interval 2.657 to 3.179
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
Serotype O25B: Day 181
0.95 ratio
Interval 0.814 to 1.102
3.73 ratio
Interval 3.237 to 4.3
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
Serotype O75: Day 181
1.11 ratio
Interval 1.029 to 1.196
2.14 ratio
Interval 1.983 to 2.307
—
—
—

SECONDARY outcome

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

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" (number of participants analyzed) signifies participants evaluable for this outcome measure and "n" (number analyzed) signifies those participants who were evaluable at specified categories.

Percentage of participants with a \>=2-fold increase from baseline in serotype specific serum antibody titers as measured by multiplex ECL based immunoassay on Days 15 and 181 were reported. The fold (\>=2-fold increase from baseline to Days 15 and 181) for the serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, and O75 was calculated as the ratio of titer values of serum antibody on Days 15 and 181 and pre-vaccination (on Day 1 that is Day 15/Day 1 and Day 181/Day 1).

Outcome measures

Outcome measures
Measure
Cohort 2: Placebo
n=131 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.
Cohort 2: ExPEC10V High Dose
n=258 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 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 Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
>=2 fold increase: Serotype O6A: Day 181
6.5 Percentage of participants
Interval 2.85 to 12.41
64.3 Percentage of participants
Interval 58.1 to 70.19
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
>=2 fold increase: Serotype O1A: Day 15
0 Percentage of participants
Interval 0.0 to 2.78
76.3 Percentage of participants
Interval 70.55 to 81.39
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
>=2 fold increase: Serotype O2: Day 15
0.8 Percentage of participants
Interval 0.02 to 4.18
88.9 Percentage of participants
Interval 84.4 to 92.52
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
>=2 fold increase: Serotype O4: Day 15
1.5 Percentage of participants
Interval 0.19 to 5.41
81.8 Percentage of participants
Interval 76.5 to 86.37
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
>=2 fold increase: Serotype O6A: Day 15
0.8 Percentage of participants
Interval 0.02 to 4.18
73.9 Percentage of participants
Interval 68.04 to 79.21
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
>=2 fold increase: Serotype O8: Day 15
1.5 Percentage of participants
Interval 0.19 to 5.41
62.1 Percentage of participants
Interval 55.77 to 68.06
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
>=2 fold increase: Serotype O15: Day 15
0.8 Percentage of participants
Interval 0.02 to 4.18
82.2 Percentage of participants
Interval 76.93 to 86.72
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
>=2 fold increase: Serotype O16: Day 15
0.8 Percentage of participants
Interval 0.02 to 4.18
86.2 Percentage of participants
Interval 81.29 to 90.17
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
>=2 fold increase: Serotype O18A: Day 15
0.8 Percentage of participants
Interval 0.02 to 4.18
69.2 Percentage of participants
Interval 63.08 to 74.8
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
>=2 fold increase: Serotype O25B: Day 15
0.8 Percentage of participants
Interval 0.02 to 4.18
77.1 Percentage of participants
Interval 71.4 to 82.11
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
>=2 fold increase: Serotype O75: Day 15
1.5 Percentage of participants
Interval 0.19 to 5.41
52.6 Percentage of participants
Interval 46.22 to 58.86
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
>=2 fold increase: Serotype O1A: Day 181
2.5 Percentage of participants
Interval 0.51 to 7.02
71.4 Percentage of participants
Interval 65.4 to 76.84
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
>=2 fold increase: Serotype O2: Day 181
12.2 Percentage of participants
Interval 6.99 to 19.32
86.7 Percentage of participants
Interval 81.94 to 90.62
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
>=2 fold increase: Serotype O4: Day 181
3.3 Percentage of participants
Interval 0.89 to 8.12
69.0 Percentage of participants
Interval 62.95 to 74.64
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
>=2 fold increase: Serotype O8: Day 181
3.3 Percentage of participants
Interval 0.89 to 8.12
55.9 Percentage of participants
Interval 49.54 to 62.04
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
>=2 fold increase: Serotype O15: Day 181
1.6 Percentage of participants
Interval 0.2 to 5.75
79.6 Percentage of participants
Interval 74.13 to 84.38
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
>=2 fold increase: Serotype O16: Day 181
0 Percentage of participants
Interval 0.0 to 2.95
78.8 Percentage of participants
Interval 73.29 to 83.67
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
>=2 fold increase: Serotype O18A: Day 181
2.4 Percentage of participants
Interval 0.51 to 6.96
62.4 Percentage of participants
Interval 56.09 to 68.32
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
>=2 fold increase: Serotype O25B: Day 181
10.6 Percentage of participants
Interval 5.75 to 17.4
65.5 Percentage of participants
Interval 59.3 to 71.31
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
>=2 fold increase: Serotype O75: Day 181
4.9 Percentage of participants
Interval 1.81 to 10.32
50.8 Percentage of participants
Interval 44.48 to 57.06
—
—
—

SECONDARY outcome

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

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" (number of participants analyzed) signifies participants evaluable for this outcome measure and "n" (number analyzed) signifies those participants who were evaluable at specified categories.

Percentage of participants with a \>=4-fold increase from baseline in serotype specific serum antibody titers as measured by multiplex ECL based immunoassay on Days 15 and 181 were reported. The fold (\>=4-fold increase from baseline to Days 15 and 181) for the serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, and O75 was calculated as the ratio of titer values of serum antibody on Days 15 and 181 and pre-vaccination (on Day 1 that is Day 15/Day 1 and Day 181/Day 1).

Outcome measures

Outcome measures
Measure
Cohort 2: Placebo
n=131 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.
Cohort 2: ExPEC10V High Dose
n=258 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 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 >= 4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
>=4 fold increase: Serotype O1A: Day 15
0 Percentage of participants
Interval 0.0 to 2.78
54.5 Percentage of participants
Interval 48.19 to 60.79
—
—
—
Cohort 2: Percentage of Participants With a >= 4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
>=4 fold increase: Serotype O2: Day 15
0.8 Percentage of participants
Interval 0.02 to 4.18
77.9 Percentage of participants
Interval 72.24 to 82.83
—
—
—
Cohort 2: Percentage of Participants With a >= 4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
>=4 fold increase: Serotype O4: Day 15
0.8 Percentage of participants
Interval 0.02 to 4.18
60.9 Percentage of participants
Interval 54.56 to 66.92
—
—
—
Cohort 2: Percentage of Participants With a >= 4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
>=4 fold increase: Serotype O6A: Day 15
0 Percentage of participants
Interval 0.0 to 2.78
49.8 Percentage of participants
Interval 43.48 to 56.13
—
—
—
Cohort 2: Percentage of Participants With a >= 4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
>=4 fold increase: Serotype O8: Day 15
1.5 Percentage of participants
Interval 0.19 to 5.41
36.4 Percentage of participants
Interval 30.43 to 42.62
—
—
—
Cohort 2: Percentage of Participants With a >= 4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
>=4 fold increase: Serotype O15: Day 15
0.8 Percentage of participants
Interval 0.02 to 4.18
58.9 Percentage of participants
Interval 52.56 to 65.02
—
—
—
Cohort 2: Percentage of Participants With a >= 4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
>=4 fold increase: Serotype O16: Day 15
0.8 Percentage of participants
Interval 0.02 to 4.18
62.5 Percentage of participants
Interval 56.17 to 68.44
—
—
—
Cohort 2: Percentage of Participants With a >= 4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
>=4 fold increase: Serotype O18A: Day 15
0 Percentage of participants
Interval 0.0 to 2.78
47.4 Percentage of participants
Interval 41.14 to 53.78
—
—
—
Cohort 2: Percentage of Participants With a >= 4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
>=4 fold increase: Serotype O25B: Day 15
0.8 Percentage of participants
Interval 0.02 to 4.18
58.1 Percentage of participants
Interval 51.76 to 64.25
—
—
—
Cohort 2: Percentage of Participants With a >= 4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
>=4 fold increase: Serotype O75: Day 15
1.5 Percentage of participants
Interval 0.19 to 5.41
24.5 Percentage of participants
Interval 19.34 to 30.28
—
—
—
Cohort 2: Percentage of Participants With a >= 4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
>=4 fold increase: Serotype O1A: Day 181
0 Percentage of participants
Interval 0.0 to 2.98
48.2 Percentage of participants
Interval 41.96 to 54.55
—
—
—
Cohort 2: Percentage of Participants With a >= 4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
>=4 fold increase: Serotype O2: Day 181
7.3 Percentage of participants
Interval 3.4 to 13.44
69.9 Percentage of participants
Interval 63.9 to 75.47
—
—
—
Cohort 2: Percentage of Participants With a >= 4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
>=4 fold increase: Serotype O4: Day 181
2.4 Percentage of participants
Interval 0.51 to 6.96
43.5 Percentage of participants
Interval 37.35 to 49.86
—
—
—
Cohort 2: Percentage of Participants With a >= 4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
>=4 fold increase: Serotype O6A: Day 181
0.8 Percentage of participants
Interval 0.02 to 4.45
39.2 Percentage of participants
Interval 33.18 to 45.5
—
—
—
Cohort 2: Percentage of Participants With a >= 4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
>=4 fold increase: Serotype O8: Day 181
0.8 Percentage of participants
Interval 0.02 to 4.45
27.3 Percentage of participants
Interval 21.98 to 33.24
—
—
—
Cohort 2: Percentage of Participants With a >= 4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
>=4 fold increase: Serotype O15: Day 181
0.8 Percentage of participants
Interval 0.02 to 4.45
52.5 Percentage of participants
Interval 46.23 to 58.81
—
—
—
Cohort 2: Percentage of Participants With a >= 4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
>=4 fold increase: Serotype O16: Day 181
0 Percentage of participants
Interval 0.0 to 2.95
49.8 Percentage of participants
Interval 43.5 to 56.11
—
—
—
Cohort 2: Percentage of Participants With a >= 4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
>=4 fold increase: Serotype O18A: Day 181
0 Percentage of participants
Interval 0.0 to 2.95
34.9 Percentage of participants
Interval 29.06 to 41.1
—
—
—
Cohort 2: Percentage of Participants With a >= 4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
>=4 fold increase: Serotype O25B: Day 181
6.5 Percentage of participants
Interval 2.85 to 12.41
44.3 Percentage of participants
Interval 38.12 to 50.64
—
—
—
Cohort 2: Percentage of Participants With a >= 4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
>=4 fold increase: Serotype O75: Day 181
3.3 Percentage of participants
Interval 0.89 to 8.12
16.0 Percentage of participants
Interval 11.74 to 21.09
—
—
—

SECONDARY outcome

Timeframe: At Day 181

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

GMTs of serotype-specific total IgG serum antibodies as measured by MOPA were reported. Serotypes: O1A, O2, O4, O6A, O15, O16, O18A, O25B, and O75 were determined in serum from collected blood samples. For serotype O8 functional IgG serum antibodies were not evaluated as the assay was not able to detect vaccine-induced functional antibodies against the O8 serotype. LLOQ values for O1A: 33, O2: 42, O4: 12, O6A: 62, O15: 75, O16: 17, O18A: 44, O25B: 58, O75: 14. Any titer less than LLOQ is replaced by half of LLOQ (0.5\*LLOQ).

Outcome measures

Outcome measures
Measure
Cohort 2: Placebo
n=123 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.
Cohort 2: ExPEC10V High Dose
n=258 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 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 IgG Serum Antibodies Against Specified Antigens Measured by MOPA on Day 181
Serotype O18A
199.7 titer
Interval 158.7 to 251.2
423.9 titer
Interval 370.3 to 485.2
—
—
—
Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Total IgG Serum Antibodies Against Specified Antigens Measured by MOPA on Day 181
Serotype O1A
334.1 titer
Interval 270.8 to 412.3
411.3 titer
Interval 355.6 to 475.7
—
—
—
Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Total IgG Serum Antibodies Against Specified Antigens Measured by MOPA on Day 181
Serotype O2
352.1 titer
Interval 284.7 to 435.5
1684.8 titer
Interval 1413.3 to 2008.5
—
—
—
Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Total IgG Serum Antibodies Against Specified Antigens Measured by MOPA on Day 181
Serotype O4
204.3 titer
Interval 173.2 to 241.0
591.2 titer
Interval 512.8 to 681.6
—
—
—
Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Total IgG Serum Antibodies Against Specified Antigens Measured by MOPA on Day 181
Serotype O6A
379.7 titer
Interval 291.9 to 494.0
747.6 titer
Interval 643.4 to 868.6
—
—
—
Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Total IgG Serum Antibodies Against Specified Antigens Measured by MOPA on Day 181
Serotype O15
469.6 titer
Interval 372.5 to 592.2
1756.2 titer
Interval 1502.7 to 2052.5
—
—
—
Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Total IgG Serum Antibodies Against Specified Antigens Measured by MOPA on Day 181
Serotype O16
144.5 titer
Interval 115.9 to 180.1
890.9 titer
Interval 758.7 to 1046.1
—
—
—
Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Total IgG Serum Antibodies Against Specified Antigens Measured by MOPA on Day 181
Serotype O25B
NA titer
Interval to 59.1
NA signifies geometric mean and lower limit of 95% CI could not be calculated as values were below LLOQ (58).
103.1 titer
Interval 88.9 to 119.6
—
—
—
Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Total IgG Serum Antibodies Against Specified Antigens Measured by MOPA on Day 181
Serotype O75
66.6 titer
Interval 52.9 to 83.8
160.4 titer
Interval 138.8 to 185.3
—
—
—

SECONDARY outcome

Timeframe: Baseline (Day 1, pre-vaccination) and Day 181

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

Percentage of participants with a \>=2-fold and \>=4-fold increase from baseline in serotype specific serum antibody titers as measured by MOPA on Day 181 was reported. The fold (\>=2-fold and \>=4-fold) increase from baseline to Day 181 for the serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B and O75 was calculated as the ratio of titer values of serum antibody on Day 181 and pre-vaccination (on Day 1) that is, Day 181/Day 1. For serotype O8 functional IgG serum antibodies were not evaluated as the assay was not able to detect vaccine-induced functional antibodies against the O8 serotype. Any titer less than LLOQ is replaced by value of LLOQ.

Outcome measures

Outcome measures
Measure
Cohort 2: Placebo
n=123 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.
Cohort 2: ExPEC10V High Dose
n=258 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 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 Antibody Titers Measured by MOPA on Day 181
Serotype O1A: >=2 fold increase
12.5 percentage of participants
Interval 5.88 to 22.41
22.1 percentage of participants
Interval 17.18 to 27.66
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Day 181
Serotype O1A: >=4 fold increase
1.4 percentage of participants
Interval 0.04 to 7.5
8.5 percentage of participants
Interval 5.42 to 12.63
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Day 181
Serotype O2: >=2 fold increase
12.5 percentage of participants
Interval 5.88 to 22.41
64.7 percentage of participants
Interval 58.56 to 70.55
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Day 181
Serotype O2: >=4 fold increase
2.8 percentage of participants
Interval 0.34 to 9.68
42.6 percentage of participants
Interval 36.52 to 48.92
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Day 181
Serotype O4: >=2 fold increase
19.4 percentage of participants
Interval 11.06 to 30.47
61.6 percentage of participants
Interval 55.39 to 67.59
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Day 181
Serotype O4: >=4 fold increase
2.8 percentage of participants
Interval 0.34 to 9.68
36.4 percentage of participants
Interval 30.55 to 42.63
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Day 181
Serotype O6A: >=2 fold increase
9.7 percentage of participants
Interval 4.0 to 19.01
31.4 percentage of participants
Interval 25.78 to 37.44
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Day 181
Serotype O6A: >=4 fold increase
1.4 percentage of participants
Interval 0.04 to 7.5
12.0 percentage of participants
Interval 8.31 to 16.62
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Day 181
Serotype O15: >=2 fold increase
23.6 percentage of participants
Interval 14.4 to 35.09
71.7 percentage of participants
Interval 65.79 to 77.12
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Day 181
Serotype O15: >=4 fold increase
5.6 percentage of participants
Interval 1.53 to 13.62
51.2 percentage of participants
Interval 44.89 to 57.41
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Day 181
Serotype O16: >=2 fold increase
25.4 percentage of participants
Interval 13.08 to 33.14
79.8 percentage of participants
Interval 74.42 to 84.57
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Day 181
Serotype O16: >=4 fold increase
0.0 percentage of participants
Interval 0.0 to 4.93
49.6 percentage of participants
Interval 43.27 to 55.95
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Day 181
Serotype O18A: >=2 fold increase
16.7 percentage of participants
Interval 8.92 to 27.3
53.5 percentage of participants
Interval 47.2 to 59.7
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Day 181
Serotype O18A: >=4 fold increase
2.8 percentage of participants
Interval 0.34 to 9.68
22.9 percentage of participants
Interval 17.89 to 28.48
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Day 181
Serotype O25B: >=2 fold increase
4.2 percentage of participants
Interval 0.87 to 11.7
26.0 percentage of participants
Interval 20.73 to 31.77
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Day 181
Serotype O25B: >=4 fold increase
1.4 percentage of participants
Interval 0.04 to 7.5
11.6 percentage of participants
Interval 7.98 to 16.18
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Day 181
Serotype O75: >=2 fold increase
29.6 percentage of participants
Interval 19.33 to 41.59
55.5 percentage of participants
Interval 49.15 to 61.66
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Day 181
Serotype O75: >=4 fold increase
5.6 percentage of participants
Interval 1.56 to 13.8
32.8 percentage of participants
Interval 27.09 to 38.93
—
—
—

SECONDARY outcome

Timeframe: Baseline (Day 1, pre-vaccination), Day 181

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

GMR of fold changes from baseline for serotype specific antibodies as measured by MOPA on Day 181 were reported. GMR for each antigen serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B and O75 were determined in serum from collected blood samples by MOPA. GMR of fold change from baseline was calculated as the ratio of GMTs on Day 181 and pre-vaccination (on Day 1). For serotype O8 functional IgG serum antibodies were not evaluated as the assay was not able to detect vaccine-induced functional antibodies against the O8 serotype. Any titer less than LLOQ is replaced by value of LLOQ.

Outcome measures

Outcome measures
Measure
Cohort 2: Placebo
n=123 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.
Cohort 2: ExPEC10V High Dose
n=258 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 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 Measured by MOPA on Day 181
Serotype O1A
0.80 ratio
Interval 0.671 to 0.954
1.07 ratio
Interval 0.948 to 1.201
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by MOPA on Day 181
Serotype O2
0.80 ratio
Interval 0.658 to 0.983
3.94 ratio
Interval 3.285 to 4.727
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by MOPA on Day 181
Serotype O4
1.15 ratio
Interval 0.988 to 1.349
3.16 ratio
Interval 2.716 to 3.686
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by MOPA on Day 181
Serotype O6A
0.80 ratio
Interval 0.68 to 0.938
1.41 ratio
Interval 1.244 to 1.5994
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by MOPA on Day 181
Serotype O15
1.13 ratio
Interval 0.885 to 1.431
4.19 ratio
Interval 3.568 to 4.919
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by MOPA on Day 181
Serotype O16
1.21 ratio
Interval 0.994 to 1.483
6.63 ratio
Interval 5.601 to 7.844
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by MOPA on Day 181
Serotype O18A
1.03 ratio
Interval 0.875 to 1.223
2.30 ratio
Interval 2.008 to 2.641
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by MOPA on Day 181
Serotype O25B
0.94 ratio
Interval 0.857 to 1.038
1.42 ratio
Interval 1.277 to 1.571
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by MOPA on Day 181
Serotype O75
1.18 ratio
Interval 0.965 to 1.442
2.56 ratio
Interval 2.246 to 2.92
—
—
—

SECONDARY outcome

Timeframe: From Day 182 up to end of study (Day 1826)

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

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 measures
Measure
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.
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 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) Related to Study Vaccine or Study Procedure From Day 182 up to End of Study (Day 1826)
0 Participants
0 Participants
—
—
—

SECONDARY outcome

Timeframe: At Day 366

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

GMTs of serotype-specific antibodies as measured by ECL based immunoassay were reported. GMTs for the serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 were determined. Any titer less than LLOQ is replaced by half of LLOQ (0.5\*LLOQ).

Outcome measures

Outcome measures
Measure
Cohort 2: Placebo
n=129 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.
Cohort 2: ExPEC10V High Dose
n=255 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 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 Antibodies Against Specified Antigens Measured by Multiplex ECL Based Immunoassay on Day 366
Serotype O18A
1538291.3 titer
Interval 1327257.2 to 1782880.0
2902883.8 titer
Interval 2610124.6 to 3228479.7
—
—
—
Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Antibodies Against Specified Antigens Measured by Multiplex ECL Based Immunoassay on Day 366
Serotype O6A
1746191.5 titer
Interval 1476781.0 to 2064750.9
3366305.0 titer
Interval 3030852.9 to 3738884.7
—
—
—
Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Antibodies Against Specified Antigens Measured by Multiplex ECL Based Immunoassay on Day 366
Serotype O8
2612423.8 titer
Interval 2233155.6 to 3056105.0
4468182.7 titer
Interval 4073515.2 to 4901088.0
—
—
—
Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Antibodies Against Specified Antigens Measured by Multiplex ECL Based Immunoassay on Day 366
Serotype O15
1379883.1 titer
Interval 1146231.7 to 1661162.7
3690523.9 titer
Interval 3327526.1 to 4093120.9
—
—
—
Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Antibodies Against Specified Antigens Measured by Multiplex ECL Based Immunoassay on Day 366
Serotype O16
909470.4 titer
Interval 771204.3 to 1072525.6
2732322.4 titer
Interval 2460092.5 to 3034676.8
—
—
—
Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Antibodies Against Specified Antigens Measured by Multiplex ECL Based Immunoassay on Day 366
Serotype O25B
344740.3 titer
Interval 281210.9 to 422621.9
1010150.2 titer
Interval 874663.8 to 1166623.5
—
—
—
Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Antibodies Against Specified Antigens Measured by Multiplex ECL Based Immunoassay on Day 366
Serotype O75
1512970.1 titer
Interval 1293159.3 to 1770144.2
2675947.8 titer
Interval 2416208.1 to 2963609.2
—
—
—
Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Antibodies Against Specified Antigens Measured by Multiplex ECL Based Immunoassay on Day 366
Serotype O1A
1425709.7 titer
Interval 1193504.1 to 1703092.6
4022674.3 titer
Interval 3621999.8 to 4467672.3
—
—
—
Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Antibodies Against Specified Antigens Measured by Multiplex ECL Based Immunoassay on Day 366
Serotype O2
945957.9 titer
Interval 770610.6 to 1161204.5
4539197.6 titer
Interval 4061044.2 to 5073649.6
—
—
—
Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Antibodies Against Specified Antigens Measured by Multiplex ECL Based Immunoassay on Day 366
Serotype O4
781470.1 titer
Interval 645829.6 to 945598.4
1877926.0 titer
Interval 1662018.9 to 2121880.9
—
—
—

SECONDARY outcome

Timeframe: Baseline (Day 1, pre-vaccination), Day 366

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

Percentage of participants with a \>=2-fold and \>=4-fold increase from baseline in serotype specific serum antibody titers as measured by multiplex ECL based immunoassay on Day 366 was reported. The fold (\>=2-fold and \>=4- fold) increase from baseline to Day 366 for the serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 was calculated as the ratio of titer values of serum antibodies on Day 366 and pre-vaccination (on day 1) that is, Day 366/ Day 1. Any titer less than LLOQ is replaced by value of LLOQ.

Outcome measures

Outcome measures
Measure
Cohort 2: Placebo
n=129 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.
Cohort 2: ExPEC10V High Dose
n=255 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 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 Antibody Titers Measured by Multiplex ECL Based Immunoassay on Day 366
Serotype O8: >=2 fold increase
10.1 percentage of participants
Interval 5.48 to 16.62
51.0 percentage of participants
Interval 44.67 to 57.27
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Day 366
Serotype O75: >=4 fold increase
0.8 percentage of participants
Interval 0.02 to 4.28
8.2 percentage of participants
Interval 5.17 to 12.31
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Day 366
Serotype O1A: >=2 fold increase
7.0 percentage of participants
Interval 3.24 to 12.83
62.4 percentage of participants
Interval 56.09 to 68.32
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Day 366
Serotype O1A: >=4 fold increase
0.0 percentage of participants
Interval 0.0 to 2.82
34.9 percentage of participants
Interval 29.06 to 41.1
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Day 366
Serotype O2: >=2 fold increase
18.6 percentage of participants
Interval 12.3 to 26.41
81.6 percentage of participants
Interval 76.26 to 86.13
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Day 366
Serotype O2: >=4 fold increase
3.9 percentage of participants
Interval 1.27 to 8.81
66.3 percentage of participants
Interval 60.11 to 72.05
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Day 366
Serotype O4: >=2 fold increase
11.6 percentage of participants
Interval 6.66 to 18.45
60.0 percentage of participants
Interval 53.7 to 66.06
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Day 366
Serotype O4: >=4 fold increase
3.1 percentage of participants
Interval 0.85 to 7.75
32.5 percentage of participants
Interval 26.84 to 38.67
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Day 366
Serotype O6: >=2 fold increase
2.3 percentage of participants
Interval 0.48 to 6.65
54.7 percentage of participants
Interval 48.38 to 60.96
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Day 366
Serotype O6: >=4 fold increase
0.8 percentage of participants
Interval 0.02 to 4.24
22.0 percentage of participants
Interval 17.11 to 27.65
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Day 366
Serotype O8: >=4 fold increase
3.1 percentage of participants
Interval 0.85 to 7.75
18.4 percentage of participants
Interval 13.87 to 23.74
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Day 366
Serotype O15: >=2 fold increase
13.2 percentage of participants
Interval 7.87 to 20.26
67.8 percentage of participants
Interval 61.73 to 73.53
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Day 366
Serotype O15: >=4 fold increase
7.0 percentage of participants
Interval 3.24 to 12.83
36.9 percentage of participants
Interval 30.93 to 43.11
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Day 366
Serotype O16: >=2 fold increase
2.3 percentage of participants
Interval 0.48 to 6.65
63.9 percentage of participants
Interval 57.7 to 69.82
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Day 366
Serotype O16: >=4 fold increase
0.8 percentage of participants
Interval 0.02 to 4.24
27.5 percentage of participants
Interval 22.07 to 33.37
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Day 366
Serotype O18A: >=2 fold increase
11.6 percentage of participants
Interval 6.66 to 18.45
55.3 percentage of participants
Interval 48.96 to 61.5
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Day 366
Serotype O18A: >=4 fold increase
0.0 percentage of participants
Interval 0.0 to 2.82
24.3 percentage of participants
Interval 19.18 to 30.06
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Day 366
Serotype O25B: >=2 fold increase
6.2 percentage of participants
Interval 2.72 to 11.85
56.9 percentage of participants
Interval 50.54 to 63.03
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Day 366
Serotype O25B: >=4 fold increase
2.3 percentage of participants
Interval 0.48 to 6.65
30.6 percentage of participants
Interval 24.99 to 36.64
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Day 366
Serotype O75: >=2 fold increase
8.6 percentage of participants
Interval 4.37 to 14.86
33.7 percentage of participants
Interval 27.95 to 39.89
—
—
—

SECONDARY outcome

Timeframe: Baseline (Day 1, pre-vaccination), Day 366

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

GMR of fold changes from baseline for serotype specific antibodies as measured by multiplex ECL based immunoassay on Day 366 were reported. GMR for each antigen serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 were determined in serum from collected blood samples by ECL based immunoassay. GMR of fold change from baseline was calculated as the ratio of GMTs on Day 366 and pre-vaccination (on Day 1). Any titer less than LLOQ is replaced by value of LLOQ.

Outcome measures

Outcome measures
Measure
Cohort 2: Placebo
n=129 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.
Cohort 2: ExPEC10V High Dose
n=255 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 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 Measured by Multiplex ECL Based Immunoassay on Day 366
Serotype O8
1.10 ratio
Interval 1.009 to 1.202
2.09 ratio
Interval 1.915 to 2.277
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Day 366
Serotype O1A
0.83 ratio
Interval 0.758 to 0.909
2.77 ratio
Interval 2.497 to 3.07
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Day 366
Serotype O2
1.21 ratio
Interval 1.087 to 1.342
6.05 ratio
Interval 5.33 to 6.878
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Day 366
Serotype O4
1.04 ratio
Interval 0.951 to 1.139
2.82 ratio
Interval 2.536 to 3.144
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Day 366
Serotype O6A
0.95 ratio
Interval 0.875 to 1.028
2.31 ratio
Interval 2.102 to 2.534
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Day 366
Serotype O15
1.18 ratio
Interval 1.064 to 1.312
3.15 ratio
Interval 2.862 to 3.468
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Day 366
Serotype O16
0.83 ratio
Interval 0.753 to 0.92
2.63 ratio
Interval 2.388 to 2.906
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Day 366
Serotype O18A
1.19 ratio
Interval 1.106 to 1.286
2.44 ratio
Interval 2.248 to 2.658
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Day 366
Serotype O25B
0.91 ratio
Interval 0.83 to 1.003
2.66 ratio
Interval 2.365 to 2.983
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Day 366
Serotype O75
1.00 ratio
Interval 0.917 to 1.088
1.68 ratio
Interval 1.563 to 1.809
—
—
—

SECONDARY outcome

Timeframe: At Day 366

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

GMTs of serotype-specific total IgG serum antibodies as measured by MOPA were reported. GMTs for each antigen serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B, and O75 were determined in serum from collected blood samples. For serotype O8 functional IgG serum antibodies were not evaluated as the assay was not able to detect vaccine-induced functional antibodies against the O8 serotype. LLOQ values for O1A: 33, O2: 42, O4: 12, O6A: 62, O15: 75, O16: 17, O18A: 44, O25B: 58, O75: 14. Any titer less than LLOQ is replaced by half of LLOQ (0.5\*LLOQ).

Outcome measures

Outcome measures
Measure
Cohort 2: Placebo
n=129 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.
Cohort 2: ExPEC10V High Dose
n=255 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 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 IgG Serum Antibodies Against Specified Antigens Measured by MOPA on Day 366
Serotype O1A
368.5 titer
Interval 302.4 to 449.1
376.0 titer
Interval 325.3 to 434.5
—
—
—
Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Total IgG Serum Antibodies Against Specified Antigens Measured by MOPA on Day 366
Serotype O2
395.5 titer
Interval 322.9 to 484.5
1167.9 titer
Interval 994.6 to 1371.5
—
—
—
Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Total IgG Serum Antibodies Against Specified Antigens Measured by MOPA on Day 366
Serotype O4
191.7 titer
Interval 163.3 to 225.0
398.1 titer
Interval 347.2 to 456.5
—
—
—
Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Total IgG Serum Antibodies Against Specified Antigens Measured by MOPA on Day 366
Serotype O6A
395.4 titer
Interval 302.6 to 516.7
592.2 titer
Interval 509.2 to 688.9
—
—
—
Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Total IgG Serum Antibodies Against Specified Antigens Measured by MOPA on Day 366
Serotype O15
478.8 titer
Interval 377.2 to 607.7
1125.8 titer
Interval 958.3 to 1322.7
—
—
—
Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Total IgG Serum Antibodies Against Specified Antigens Measured by MOPA on Day 366
Serotype O16
134.5 titer
Interval 107.8 to 167.8
557.6 titer
Interval 470.4 to 660.9
—
—
—
Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Total IgG Serum Antibodies Against Specified Antigens Measured by MOPA on Day 366
Serotype O18A
211.6 titer
Interval 171.5 to 261.1
335.1 titer
Interval 291.5 to 385.1
—
—
—
Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Total IgG Serum Antibodies Against Specified Antigens Measured by MOPA on Day 366
Serotype O25B
NA titer
NA signifies that geometric mean and 95% CI could not be calculated as the values were below LLOQ (58).
78.0 titer
Interval 67.6 to 90.0
—
—
—
Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Total IgG Serum Antibodies Against Specified Antigens Measured by MOPA on Day 366
Serotype O75
78.6 titer
Interval 62.6 to 98.7
126.5 titer
Interval 109.7 to 145.9
—
—
—

SECONDARY outcome

Timeframe: Baseline (Day 1, pre-vaccination), Day 366

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

GMR of fold changes from baseline for serotype specific antibodies as measured by MOPA on Day 366 were reported. GMR for each antigen serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B and O75 were determined in serum from collected blood samples by MOPA. GMR of fold change from baseline was calculated as the ratio of GMTs on Day 366 and pre-vaccination (on Day 1). For serotype O8 functional IgG serum antibodies were not evaluated as the assay was not able to detect vaccine-induced functional antibodies against the O8 serotype. Any titer less than LLOQ is replaced by value of LLOQ.

Outcome measures

Outcome measures
Measure
Cohort 2: Placebo
n=129 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.
Cohort 2: ExPEC10V High Dose
n=255 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 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 Measured by MOPA on Day 366
Serotype O1A
0.84 ratio
Interval 0.704 to 1.013
0.99 ratio
Interval 0.88 to 1.104
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by MOPA on Day 366
Serotype O2
0.78 ratio
Interval 0.653 to 0.931
2.70 ratio
Interval 2.292 to 3.178
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by MOPA on Day 366
Serotype O4
1.04 ratio
Interval 0.889 to 1.222
2.14 ratio
Interval 1.857 to 2.474
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by MOPA on Day 366
Serotype O6A
0.84 ratio
Interval 0.693 to 1.009
1.11 ratio
Interval 0.987 to 1.259
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by MOPA on Day 366
Serotype O15
0.98 ratio
Interval 0.736 to 1.314
2.66 ratio
Interval 2.251 to 3.137
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by MOPA on Day 366
Serotype O16
0.98 ratio
Interval 0.813 to 1.174
4.06 ratio
Interval 3.448 to 4.782
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by MOPA on Day 366
Serotype O18A
0.97 ratio
Interval 0.831 to 1.135
1.84 ratio
Interval 1.612 to 2.097
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by MOPA on Day 366
Serotype O25B
0.93 ratio
Interval 0.822 to 1.06
1.19 ratio
Interval 1.088 to 1.294
—
—
—
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by MOPA on Day 366
Serotype O75
1.40 ratio
Interval 1.137 to 1.717
2.09 ratio
Interval 1.837 to 2.369
—
—
—

SECONDARY outcome

Timeframe: Baseline (Day 1, pre-vaccination), Day 366

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

Percentage of participants with a \>=2-fold and \>=4-fold increase from baseline in serotype specific serum antibody titers as measured by MOPA on Day 366 was reported. The \>=2-fold and \>=4-fold increase from baseline to Day 366 for the serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B and O75 was calculated as the ratio of titer values of serum antibody on Day 366 and pre-vaccination (on day 1) that is, Day 366/Day 1. For serotype O8 functional IgG serum antibodies were not evaluated as the assay was not able to detect vaccine-induced functional antibodies against the O8 serotype. Any titer less than LLOQ is replaced by value of LLOQ.

Outcome measures

Outcome measures
Measure
Cohort 2: Placebo
n=129 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.
Cohort 2: ExPEC10V High Dose
n=255 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 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 Antibody Titers Measured by MOPA on Day 366
Serotype O4: >=4 fold increase
2.7 percentage of participants
Interval 0.33 to 9.55
23.0 percentage of participants
Interval 17.97 to 28.71
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Day 366
Serotype O16: >=4 fold increase
0.0 percentage of participants
Interval 0.0 to 4.93
49.6 percentage of participants
Interval 43.27 to 55.95
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Day 366
Serotype O25B: >=4 fold increase
2.7 percentage of participants
Interval 0.33 to 9.55
5.6 percentage of participants
Interval 3.07 to 9.15
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Day 366
Serotype O1A: >=2 fold increase
12.3 percentage of participants
Interval 5.8 to 22.12
22.6 percentage of participants
Interval 17.6 to 28.29
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Day 366
Serotype O1A: >=4 fold increase
2.7 percentage of participants
Interval 0.33 to 9.55
5.6 percentage of participants
Interval 3.07 to 9.15
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Day 366
Serotype O2: >=2 fold increase
11.0 percentage of participants
Interval 4.85 to 20.46
54.0 percentage of participants
Interval 47.6 to 60.24
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Day 366
Serotype O2: >=4 fold increase
1.4 percentage of participants
Interval 0.03 to 7.4
32.1 percentage of participants
Interval 26.42 to 38.29
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Day 366
Serotype O4: >=2 fold increase
11.0 percentage of participants
Interval 4.85 to 20.46
48.0 percentage of participants
Interval 41.7 to 54.37
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Day 366
Serotype O6A: >=2 fold increase
12.3 percentage of participants
Interval 5.8 to 22.12
25.1 percentage of participants
Interval 19.86 to 30.94
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Day 366
Serotype O6A: >=4 fold increase
6.8 percentage of participants
Interval 2.26 to 15.26
9.2 percentage of participants
Interval 5.9 to 13.43
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Day 366
Serotype O15: >=2 fold increase
21.9 percentage of participants
Interval 13.08 to 33.14
57.9 percentage of participants
Interval 51.58 to 64.1
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Day 366
Serotype O15: >=4 fold increase
6.8 percentage of participants
Interval 2.26 to 15.26
37.3 percentage of participants
Interval 31.31 to 43.59
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Day 366
Serotype O16: >=2 fold increase
21.9 percentage of participants
Interval 13.08 to 33.14
67.5 percentage of participants
Interval 61.3 to 73.21
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Day 366
Serotype O18A: >=2 fold increase
9.9 percentage of participants
Interval 4.06 to 19.26
38.5 percentage of participants
Interval 32.45 to 44.8
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Day 366
Serotype O18A: >=4 fold increase
2.8 percentage of participants
Interval 0.34 to 9.81
17.1 percentage of participants
Interval 12.63 to 22.29
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Day 366
Serotype O25B: >=2 fold increase
8.2 percentage of participants
Interval 3.08 to 17.04
15.9 percentage of participants
Interval 11.59 to 20.98
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Day 366
Serotype O75: >=2 fold increase
40.0 percentage of participants
Interval 28.47 to 52.41
51.6 percentage of participants
Interval 45.22 to 57.94
—
—
—
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Day 366
Serotype O75: >=4 fold increase
5.7 percentage of participants
Interval 1.58 to 13.99
24.8 percentage of participants
Interval 19.57 to 30.63
—
—
—

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

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

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
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.
Infections and infestations
Sepsis
0.00%
0/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/102 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/52 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/54 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.36%
1/278 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/138 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
Gastrointestinal disorders
Abdominal Hernia
0.00%
0/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/102 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/52 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/54 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.36%
1/278 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/138 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
General disorders
Non-Cardiac Chest Pain
0.00%
0/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/102 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/52 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/54 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.72%
2/278 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/138 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
Infections and infestations
Enterococcal Sepsis
0.00%
0/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/102 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/52 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/54 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/278 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.72%
1/138 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
Infections and infestations
Enterocolitis Infectious
0.00%
0/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/102 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/52 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/54 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.36%
1/278 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/138 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
Infections and infestations
Pyelonephritis
0.00%
0/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/102 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/52 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/54 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.36%
1/278 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/138 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
Infections and infestations
Pyelonephritis Acute
0.00%
0/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/102 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/52 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/54 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/278 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.72%
1/138 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
Infections and infestations
Urinary Tract Infection
0.00%
0/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/102 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/52 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/54 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/278 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.72%
1/138 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
Injury, poisoning and procedural complications
Lumbar Vertebral Fracture
0.00%
0/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/102 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/52 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/54 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/278 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.72%
1/138 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
0.96%
1/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.98%
1/102 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/52 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/54 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/278 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.72%
1/138 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
Musculoskeletal and connective tissue disorders
Osteoarthritis
0.96%
1/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/102 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/52 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
1.9%
1/54 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.36%
1/278 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/138 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
Nervous system disorders
Migraine
0.00%
0/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/102 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/52 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/54 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/278 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.72%
1/138 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
Renal and urinary disorders
Calculus Urinary
0.00%
0/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/102 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/52 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/54 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.36%
1/278 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/138 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
Renal and urinary disorders
Chronic Kidney Disease
0.00%
0/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/102 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/52 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/54 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/278 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.72%
1/138 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
Renal and urinary disorders
Nephrolithiasis
0.00%
0/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.98%
1/102 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/52 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/54 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.36%
1/278 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/138 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
0.00%
0/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/102 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/52 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/54 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/278 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.72%
1/138 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.

Other adverse events

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
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 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/102 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/52 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
3.7%
2/54 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/278 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/138 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
Gastrointestinal disorders
Diarrhoea
0.96%
1/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/102 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
3.8%
4/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
1.9%
1/52 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/54 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
1.1%
3/278 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
2.2%
3/138 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
Gastrointestinal disorders
Nausea (Solicited)
4.8%
5/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
8.8%
9/102 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
10.6%
11/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
1.9%
1/52 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
3.7%
2/54 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
14.4%
40/278 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
5.8%
8/138 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
General disorders
Erythema (Solicited)
10.6%
11/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
18.6%
19/102 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
18.3%
19/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
1.9%
1/52 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
9.3%
5/54 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
21.6%
60/278 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.72%
1/138 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
General disorders
Fatigue (Solicited)
20.2%
21/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
28.4%
29/102 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
23.1%
24/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
15.4%
8/52 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
24.1%
13/54 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
35.3%
98/278 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
22.5%
31/138 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
General disorders
Fever (Solicited)
1.9%
2/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/102 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
2.9%
3/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
1.9%
1/52 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/54 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
5.4%
15/278 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
2.2%
3/138 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
General disorders
Injection Site Pruritus
0.96%
1/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
4.9%
5/102 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
2.9%
3/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
3.8%
2/52 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
1.9%
1/54 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
2.5%
7/278 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/138 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
General disorders
Pain/Tenderness (Solicited)
44.2%
46/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
51.0%
52/102 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
57.7%
60/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
28.8%
15/52 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
72.2%
39/54 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
47.5%
132/278 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
14.5%
20/138 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
General disorders
Swelling (Solicited)
8.7%
9/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
14.7%
15/102 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
13.5%
14/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
3.8%
2/52 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
3.7%
2/54 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
15.8%
44/278 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
1.4%
2/138 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
Infections and infestations
Upper Respiratory Tract Infection
2.9%
3/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
3.9%
4/102 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.96%
1/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
5.8%
3/52 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
5.6%
3/54 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.36%
1/278 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/138 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
Infections and infestations
Urinary Tract Infection
0.00%
0/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/102 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.96%
1/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/52 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/54 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
2.5%
7/278 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
7.2%
10/138 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
Investigations
Blood Pressure Increased
0.00%
0/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/102 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/52 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
3.7%
2/54 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.36%
1/278 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/138 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
Musculoskeletal and connective tissue disorders
Myalgia
0.96%
1/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
2.9%
3/102 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
1.9%
2/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/52 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
0.00%
0/54 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
2.5%
7/278 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
4.3%
6/138 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
Musculoskeletal and connective tissue disorders
Myalgia (Solicited)
25.0%
26/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
35.3%
36/102 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
35.6%
37/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
19.2%
10/52 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
38.9%
21/54 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
30.2%
84/278 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
16.7%
23/138 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
Nervous system disorders
Headache (Solicited)
18.3%
19/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
24.5%
25/102 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
24.0%
25/104 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
21.2%
11/52 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
18.5%
10/54 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
26.6%
74/278 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.
24.6%
34/138 • From Day 1 (post vaccination) up to Day 1826
FAS included all randomized participants with a vaccine administration documented.

Additional Information

Trial Physician

Janssen Research & Development, LLC

Phone: 844-434-4210

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