Trial Outcomes & Findings for A Study of 9-valent Extraintestinal Pathogenic Escherichia Coli Vaccine (ExPEC9V) and High-dose Quadrivalent Influenza Vaccine, With and Without Co-administration, in Adults Aged 65 Years or Older (NCT NCT06134804)
NCT ID: NCT06134804
Last Updated: 2026-04-03
Results Overview
HI antibody titers against H1N1, H3N2, B/Victoria, and B/Yamagata Influenza vaccine strains 29 days after the administration of HD quadrivalent seasonal influenza vaccine as measured by HI assay were reported.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
959 participants
Primary outcome timeframe
29 days after the administration of HD quadrivalent seasonal influenza vaccine on Day 1 (Day 30)
Results posted on
2026-04-03
Participant Flow
Participant milestones
| Measure |
CoAd
Participants received a single blinded intramuscular injection of 176 micrograms (mcg) polysaccharide per milliliter (PS/mL) ExPEC9V vaccine in one arm and an unblinded High-dose (HD) quadrivalent seasonal influenza vaccine (240 mcg of haemagglutinin) in the contralateral arm on Day 1, followed by a blinded placebo matching the ExPEC9V vaccine on Day 30 in Coadministration (CoAd) group.
|
Control
Participants received a single blinded intramuscular injection of placebo matching the ExPEC9V vaccine in one arm and an unblinded HD quadrivalent seasonal influenza vaccine (240 mcg of haemagglutinin) in the contralateral arm on Day 1, followed by blinded single intramuscular injection of 176 mcg PS/mL ExPEC9V vaccine on Day 30.
|
|---|---|---|
|
Overall Study
STARTED
|
477
|
482
|
|
Overall Study
Treated
|
476
|
481
|
|
Overall Study
COMPLETED
|
455
|
460
|
|
Overall Study
NOT COMPLETED
|
22
|
22
|
Reasons for withdrawal
| Measure |
CoAd
Participants received a single blinded intramuscular injection of 176 micrograms (mcg) polysaccharide per milliliter (PS/mL) ExPEC9V vaccine in one arm and an unblinded High-dose (HD) quadrivalent seasonal influenza vaccine (240 mcg of haemagglutinin) in the contralateral arm on Day 1, followed by a blinded placebo matching the ExPEC9V vaccine on Day 30 in Coadministration (CoAd) group.
|
Control
Participants received a single blinded intramuscular injection of placebo matching the ExPEC9V vaccine in one arm and an unblinded HD quadrivalent seasonal influenza vaccine (240 mcg of haemagglutinin) in the contralateral arm on Day 1, followed by blinded single intramuscular injection of 176 mcg PS/mL ExPEC9V vaccine on Day 30.
|
|---|---|---|
|
Overall Study
Initiated Prohibited Medication
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
5
|
2
|
|
Overall Study
Withdrawal of Consent
|
9
|
12
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Protocol Deviation
|
3
|
1
|
|
Overall Study
Death
|
0
|
2
|
|
Overall Study
Randomized not Treated
|
1
|
1
|
|
Overall Study
Other
|
1
|
1
|
Baseline Characteristics
A Study of 9-valent Extraintestinal Pathogenic Escherichia Coli Vaccine (ExPEC9V) and High-dose Quadrivalent Influenza Vaccine, With and Without Co-administration, in Adults Aged 65 Years or Older
Baseline characteristics by cohort
| Measure |
CoAd
n=476 Participants
Participants received a single blinded intramuscular injection of 176 micrograms (mcg) polysaccharide per milliliter (PS/mL) ExPEC9V vaccine in one arm and an unblinded High-Dose (HD) quadrivalent seasonal influenza vaccine (240 mcg of haemagglutinin) in the contralateral arm on Day 1, followed by a blinded placebo matching the ExPEC9V vaccine on Day 30 in Coadministration (CoAd) group.
|
Control
n=481 Participants
Participants received a single blinded intramuscular injection of placebo matching the ExPEC9V vaccine in one arm and an unblinded HD quadrivalent seasonal influenza vaccine (240 mcg of haemagglutinin) in the contralateral arm on Day 1, followed by blinded single intramuscular injection of 176 mcg PS/mL ExPEC9V vaccine on Day 30.
|
Total
n=957 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.5 years
STANDARD_DEVIATION 5.08 • n=5 Participants
|
71.8 years
STANDARD_DEVIATION 4.89 • n=5 Participants
|
71.6 years
STANDARD_DEVIATION 4.99 • n=10 Participants
|
|
Sex: Female, Male
Female
|
265 Participants
n=5 Participants
|
264 Participants
n=5 Participants
|
529 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
211 Participants
n=5 Participants
|
217 Participants
n=5 Participants
|
428 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
34 Participants
n=5 Participants
|
27 Participants
n=5 Participants
|
61 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
441 Participants
n=5 Participants
|
451 Participants
n=5 Participants
|
892 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=5 Participants
|
9 Participants
n=5 Participants
|
22 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
22 Participants
n=5 Participants
|
36 Participants
n=5 Participants
|
58 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
438 Participants
n=5 Participants
|
430 Participants
n=5 Participants
|
868 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 29 days after the administration of HD quadrivalent seasonal influenza vaccine on Day 1 (Day 30)Population: Per protocol influenza immunogenicity (PPII) analysis set included all randomized participants who received first study vaccination (ExPEC9V in combination with HD quadrivalent seasonal influenza vaccine for CoAd group and HD quadrivalent seasonal influenza vaccine alone for the Control group) for whom immunogenicity data were available for at least 1 of the influenza strains in vaccine. N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure (OM).
HI antibody titers against H1N1, H3N2, B/Victoria, and B/Yamagata Influenza vaccine strains 29 days after the administration of HD quadrivalent seasonal influenza vaccine as measured by HI assay were reported.
Outcome measures
| Measure |
CoAd
n=448 Participants
Participants received a single blinded intramuscular injection of 176 micrograms (mcg) polysaccharide per milliliter (PS/mL) ExPEC9V vaccine in one arm and an unblinded High-dose (HD) quadrivalent seasonal influenza vaccine (240 mcg of haemagglutinin) in the contralateral arm on Day 1, followed by a blinded placebo matching the ExPEC9V vaccine on Day 30 in Coadministration (CoAd) group.
|
Control
n=453 Participants
Participants received a single blinded intramuscular injection of placebo matching the ExPEC9V vaccine in one arm and an unblinded HD quadrivalent seasonal influenza vaccine (240 mcg of haemagglutinin) in the contralateral arm on Day 1, followed by blinded single intramuscular injection of 176 mcg PS/mL ExPEC9V vaccine on Day 30.
|
|---|---|---|
|
Hemagglutination Inhibition (HI) Antibody Titers Against H1N1, H3N2, B/Victoria, and B/Yamagata Influenza Vaccine Strains 29 Days After the Administration of High-Dose (HD) Quadrivalent Seasonal Influenza Vaccine
H1N1
|
368.94 Titer
Interval 321.31 to 423.62
|
362.43 Titer
Interval 316.39 to 415.16
|
|
Hemagglutination Inhibition (HI) Antibody Titers Against H1N1, H3N2, B/Victoria, and B/Yamagata Influenza Vaccine Strains 29 Days After the Administration of High-Dose (HD) Quadrivalent Seasonal Influenza Vaccine
H3N2
|
328.38 Titer
Interval 280.72 to 384.13
|
335.91 Titer
Interval 287.93 to 391.89
|
|
Hemagglutination Inhibition (HI) Antibody Titers Against H1N1, H3N2, B/Victoria, and B/Yamagata Influenza Vaccine Strains 29 Days After the Administration of High-Dose (HD) Quadrivalent Seasonal Influenza Vaccine
B/Victoria
|
727.27 Titer
Interval 647.29 to 817.12
|
703.30 Titer
Interval 627.21 to 788.62
|
|
Hemagglutination Inhibition (HI) Antibody Titers Against H1N1, H3N2, B/Victoria, and B/Yamagata Influenza Vaccine Strains 29 Days After the Administration of High-Dose (HD) Quadrivalent Seasonal Influenza Vaccine
B/Yamagata
|
638.64 Titer
Interval 572.77 to 712.07
|
572.60 Titer
Interval 514.5 to 637.26
|
PRIMARY outcome
Timeframe: CoAd Group: 29 days after the administration of ExPEC9V on Day 1 (Day 30); Control Group: 29 days after the administration of ExPEC9V on Day 30 (Day 59)Population: Per protocol ExPEC immunogenicity (PPEI) analysis set included all randomized participants who received ExPEC9V in combination with a HD quadrivalent seasonal influenza vaccine for the CoAd group and ExPEC9V alone for the control group and for whom O-antigen immunogenicity data were available for at least one E. coli serotype.
Antibody titers to vaccine O-serotype antigens (O1A, O2, O4, O6A, O15, O16, O18A, O25B, and O75) as determined by ECL based Immunoassay 29 days after administration of ExPEC9V on Day 1 in CoAd group and on Day 30 in Control group were reported.
Outcome measures
| Measure |
CoAd
n=448 Participants
Participants received a single blinded intramuscular injection of 176 micrograms (mcg) polysaccharide per milliliter (PS/mL) ExPEC9V vaccine in one arm and an unblinded High-dose (HD) quadrivalent seasonal influenza vaccine (240 mcg of haemagglutinin) in the contralateral arm on Day 1, followed by a blinded placebo matching the ExPEC9V vaccine on Day 30 in Coadministration (CoAd) group.
|
Control
n=442 Participants
Participants received a single blinded intramuscular injection of placebo matching the ExPEC9V vaccine in one arm and an unblinded HD quadrivalent seasonal influenza vaccine (240 mcg of haemagglutinin) in the contralateral arm on Day 1, followed by blinded single intramuscular injection of 176 mcg PS/mL ExPEC9V vaccine on Day 30.
|
|---|---|---|
|
Antibody Titers to Vaccine O-serotype Antigens as Determined by Multiplex Electrochemiluminescent (ECL)-Based Immunoassay 29 Days After Administration of ExPEC9V
O1A serotype
|
5346351.53 Titer
Interval 4590112.96 to 6227183.28
|
7269565.30 Titer
Interval 6248177.53 to 8457919.04
|
|
Antibody Titers to Vaccine O-serotype Antigens as Determined by Multiplex Electrochemiluminescent (ECL)-Based Immunoassay 29 Days After Administration of ExPEC9V
O2 serotype
|
2452599.76 Titer
Interval 2080377.11 to 2891420.77
|
3865399.96 Titer
Interval 3282667.19 to 4551578.33
|
|
Antibody Titers to Vaccine O-serotype Antigens as Determined by Multiplex Electrochemiluminescent (ECL)-Based Immunoassay 29 Days After Administration of ExPEC9V
O4 serotype
|
5584467.27 Titer
Interval 4877747.63 to 6393581.02
|
7110481.05 Titer
Interval 6216723.83 to 8132730.69
|
|
Antibody Titers to Vaccine O-serotype Antigens as Determined by Multiplex Electrochemiluminescent (ECL)-Based Immunoassay 29 Days After Administration of ExPEC9V
O6A serotype
|
7337171.91 Titer
Interval 6439792.25 to 8359600.66
|
10104308.16 Titer
Interval 8876863.29 to 11501477.51
|
|
Antibody Titers to Vaccine O-serotype Antigens as Determined by Multiplex Electrochemiluminescent (ECL)-Based Immunoassay 29 Days After Administration of ExPEC9V
O15 serotype
|
3702737.22 Titer
Interval 3222088.49 to 4255085.77
|
4799596.43 Titer
Interval 4180767.8 to 5510022.79
|
|
Antibody Titers to Vaccine O-serotype Antigens as Determined by Multiplex Electrochemiluminescent (ECL)-Based Immunoassay 29 Days After Administration of ExPEC9V
O16 serotype
|
5874788.10 Titer
Interval 5082969.87 to 6789954.72
|
7715064.34 Titer
Interval 6682202.59 to 8907574.55
|
|
Antibody Titers to Vaccine O-serotype Antigens as Determined by Multiplex Electrochemiluminescent (ECL)-Based Immunoassay 29 Days After Administration of ExPEC9V
O18A serotype
|
22297849.38 Titer
Interval 19548964.41 to 25433269.85
|
28863213.00 Titer
Interval 25329039.85 to 32890511.03
|
|
Antibody Titers to Vaccine O-serotype Antigens as Determined by Multiplex Electrochemiluminescent (ECL)-Based Immunoassay 29 Days After Administration of ExPEC9V
O25B serotype
|
12264386.02 Titer
Interval 10440594.11 to 14406762.95
|
18321682.05 Titer
Interval 15615304.68 to 21497117.08
|
|
Antibody Titers to Vaccine O-serotype Antigens as Determined by Multiplex Electrochemiluminescent (ECL)-Based Immunoassay 29 Days After Administration of ExPEC9V
O75 serotype
|
10831355.27 Titer
Interval 9499949.54 to 12349355.79
|
12424865.47 Titer
Interval 10907925.98 to 14152762.16
|
SECONDARY outcome
Timeframe: 29 days after the administration of HD quadrivalent seasonal influenza vaccine on Day 1 (Day 30)Population: PPII analysis set included all randomized participants who received first study vaccination (ExPEC9V in combination with HD quadrivalent seasonal influenza vaccine for CoAd group and HD quadrivalent seasonal influenza vaccine alone for Control group) and for whom immunogenicity data were available for at least 1 of the influenza strains in vaccine. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.
Seroconversion was defined for each of the 4 influenza vaccine strains as 1) HI titer greater than or equal to (\>=) 1:40 in participants with a pre-vaccination HI titer of less than (\<) 1:10, or 2) a \>=4-fold HI titer increase in participants with a pre-vaccination HI titer of \>=1:10.
Outcome measures
| Measure |
CoAd
n=448 Participants
Participants received a single blinded intramuscular injection of 176 micrograms (mcg) polysaccharide per milliliter (PS/mL) ExPEC9V vaccine in one arm and an unblinded High-dose (HD) quadrivalent seasonal influenza vaccine (240 mcg of haemagglutinin) in the contralateral arm on Day 1, followed by a blinded placebo matching the ExPEC9V vaccine on Day 30 in Coadministration (CoAd) group.
|
Control
n=453 Participants
Participants received a single blinded intramuscular injection of placebo matching the ExPEC9V vaccine in one arm and an unblinded HD quadrivalent seasonal influenza vaccine (240 mcg of haemagglutinin) in the contralateral arm on Day 1, followed by blinded single intramuscular injection of 176 mcg PS/mL ExPEC9V vaccine on Day 30.
|
|---|---|---|
|
Percentage of Participants With Seroconversion Against H1N1, H3N2, B/Victoria, and B/Yamagata Influenza Vaccine Strains 29 Days After the Administration of HD Quadrivalent Seasonal Influenza Vaccine
H1N1
|
76.1 Percentage of participants
Interval 72.0 to 79.9
|
74.4 Percentage of participants
Interval 70.2 to 78.3
|
|
Percentage of Participants With Seroconversion Against H1N1, H3N2, B/Victoria, and B/Yamagata Influenza Vaccine Strains 29 Days After the Administration of HD Quadrivalent Seasonal Influenza Vaccine
H3N2
|
79.9 Percentage of participants
Interval 76.0 to 83.4
|
73.1 Percentage of participants
Interval 68.8 to 77.0
|
|
Percentage of Participants With Seroconversion Against H1N1, H3N2, B/Victoria, and B/Yamagata Influenza Vaccine Strains 29 Days After the Administration of HD Quadrivalent Seasonal Influenza Vaccine
B/Victoria
|
71.7 Percentage of participants
Interval 67.3 to 75.7
|
65.6 Percentage of participants
Interval 61.1 to 69.8
|
|
Percentage of Participants With Seroconversion Against H1N1, H3N2, B/Victoria, and B/Yamagata Influenza Vaccine Strains 29 Days After the Administration of HD Quadrivalent Seasonal Influenza Vaccine
B/Yamagata
|
56.9 Percentage of participants
Interval 52.3 to 61.5
|
52.3 Percentage of participants
Interval 47.7 to 56.9
|
SECONDARY outcome
Timeframe: 29 days after the administration of HD quadrivalent seasonal influenza vaccine on Day 1 (Day 30)Population: PPII analysis set included all randomized participants who received first study vaccination (ExPEC9V in combination with HD quadrivalent seasonal influenza vaccine for CoAd group and HD quadrivalent seasonal influenza vaccine alone for Control group) and for whom immunogenicity data were available for at least 1 of the influenza strains in vaccine. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.
Seroprotection was defined for each of the 4 influenza vaccine strains as HI titer \>=1:40 at 29 days after the administration of a HD quadrivalent seasonal influenza vaccine.
Outcome measures
| Measure |
CoAd
n=448 Participants
Participants received a single blinded intramuscular injection of 176 micrograms (mcg) polysaccharide per milliliter (PS/mL) ExPEC9V vaccine in one arm and an unblinded High-dose (HD) quadrivalent seasonal influenza vaccine (240 mcg of haemagglutinin) in the contralateral arm on Day 1, followed by a blinded placebo matching the ExPEC9V vaccine on Day 30 in Coadministration (CoAd) group.
|
Control
n=453 Participants
Participants received a single blinded intramuscular injection of placebo matching the ExPEC9V vaccine in one arm and an unblinded HD quadrivalent seasonal influenza vaccine (240 mcg of haemagglutinin) in the contralateral arm on Day 1, followed by blinded single intramuscular injection of 176 mcg PS/mL ExPEC9V vaccine on Day 30.
|
|---|---|---|
|
Percentage of Participants With Seroprotection Against H1N1, H3N2, B/Victoria, and B/Yamagata Influenza Vaccine Strains 29 Days After the Administration of HD Quadrivalent Seasonal Influenza Vaccine
B/Yamagata
|
98.7 Percentage of participants
Interval 97.2 to 99.5
|
99.6 Percentage of participants
Interval 98.5 to 99.9
|
|
Percentage of Participants With Seroprotection Against H1N1, H3N2, B/Victoria, and B/Yamagata Influenza Vaccine Strains 29 Days After the Administration of HD Quadrivalent Seasonal Influenza Vaccine
H1N1
|
93.1 Percentage of participants
Interval 90.4 to 95.2
|
93.4 Percentage of participants
Interval 90.8 to 95.4
|
|
Percentage of Participants With Seroprotection Against H1N1, H3N2, B/Victoria, and B/Yamagata Influenza Vaccine Strains 29 Days After the Administration of HD Quadrivalent Seasonal Influenza Vaccine
H3N2
|
88.6 Percentage of participants
Interval 85.4 to 91.3
|
89.6 Percentage of participants
Interval 86.6 to 92.2
|
|
Percentage of Participants With Seroprotection Against H1N1, H3N2, B/Victoria, and B/Yamagata Influenza Vaccine Strains 29 Days After the Administration of HD Quadrivalent Seasonal Influenza Vaccine
B/Victoria
|
98.0 Percentage of participants
Interval 96.3 to 99.0
|
99.6 Percentage of participants
Interval 98.5 to 99.9
|
SECONDARY outcome
Timeframe: Up to 14 days post-vaccination 1 on Day 1 (Day 1 up to Day 15) and up to 14 days post-vaccination 2 on Day 30 (Day 30 up to Day 44)Population: FAS included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo). Here, n (number analyzed) signifies participants evaluated at specified timepoints.
An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccination. Solicited local AEs were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site) events for which participants were to be 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). Solicited local AEs were injection site pain or tenderness, erythema and swelling at the study vaccine injection site.
Outcome measures
| Measure |
CoAd
n=476 Participants
Participants received a single blinded intramuscular injection of 176 micrograms (mcg) polysaccharide per milliliter (PS/mL) ExPEC9V vaccine in one arm and an unblinded High-dose (HD) quadrivalent seasonal influenza vaccine (240 mcg of haemagglutinin) in the contralateral arm on Day 1, followed by a blinded placebo matching the ExPEC9V vaccine on Day 30 in Coadministration (CoAd) group.
|
Control
n=481 Participants
Participants received a single blinded intramuscular injection of placebo matching the ExPEC9V vaccine in one arm and an unblinded HD quadrivalent seasonal influenza vaccine (240 mcg of haemagglutinin) in the contralateral arm on Day 1, followed by blinded single intramuscular injection of 176 mcg PS/mL ExPEC9V vaccine on Day 30.
|
|---|---|---|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 14 Days After Each Vaccination
Post-vaccination 1
|
64.9 Percentage of participants
|
54.3 Percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 14 Days After Each Vaccination
Post-vaccination 2
|
11.9 Percentage of participants
|
35.2 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 14 days post-vaccination 1 on Day 1 (Day 1 up to Day 15) and up to 14 days post-vaccination 2 on Day 30 (Day 30 up to Day 44)Population: FAS included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo). Here, n (number analyzed) signifies participants evaluated at specified timepoints.
An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccination. Solicited systemic AEs were used to assess the reactogenicity of the study vaccine and were pre-defined systemic events for which participants were to be 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). Solicited systemic AEs included fever (body temperature \>=100.4 degree Fahrenheit), fatigue, headache, nausea, myalgia, and fever.
Outcome measures
| Measure |
CoAd
n=476 Participants
Participants received a single blinded intramuscular injection of 176 micrograms (mcg) polysaccharide per milliliter (PS/mL) ExPEC9V vaccine in one arm and an unblinded High-dose (HD) quadrivalent seasonal influenza vaccine (240 mcg of haemagglutinin) in the contralateral arm on Day 1, followed by a blinded placebo matching the ExPEC9V vaccine on Day 30 in Coadministration (CoAd) group.
|
Control
n=481 Participants
Participants received a single blinded intramuscular injection of placebo matching the ExPEC9V vaccine in one arm and an unblinded HD quadrivalent seasonal influenza vaccine (240 mcg of haemagglutinin) in the contralateral arm on Day 1, followed by blinded single intramuscular injection of 176 mcg PS/mL ExPEC9V vaccine on Day 30.
|
|---|---|---|
|
Percentage of Participants With Solicited Systemic AEs for 14 Days After Each Vaccination
Post-vaccination 1
|
53.8 Percentage of participants
|
44.9 Percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs for 14 Days After Each Vaccination
Post-vaccination 2
|
26.0 Percentage of participants
|
36.9 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 29 days post-vaccination 1 on Day 1 (Day 1 up to Day 30) and up to 29 days post-vaccination 2 on Day 30 (Day 30 up to Day 59)Population: FAS included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo). Here, n (number analyzed) signifies participants evaluated at specified timepoints.
Percentage of participants with unsolicited AEs for 29 days after each vaccination was reported. An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccination. Unsolicited AEs were all AEs for which the participant was not specifically questioned in the participant diary.
Outcome measures
| Measure |
CoAd
n=476 Participants
Participants received a single blinded intramuscular injection of 176 micrograms (mcg) polysaccharide per milliliter (PS/mL) ExPEC9V vaccine in one arm and an unblinded High-dose (HD) quadrivalent seasonal influenza vaccine (240 mcg of haemagglutinin) in the contralateral arm on Day 1, followed by a blinded placebo matching the ExPEC9V vaccine on Day 30 in Coadministration (CoAd) group.
|
Control
n=481 Participants
Participants received a single blinded intramuscular injection of placebo matching the ExPEC9V vaccine in one arm and an unblinded HD quadrivalent seasonal influenza vaccine (240 mcg of haemagglutinin) in the contralateral arm on Day 1, followed by blinded single intramuscular injection of 176 mcg PS/mL ExPEC9V vaccine on Day 30.
|
|---|---|---|
|
Percentage of Participants With Unsolicited AEs for 29 Days After Each Vaccination
Post-vaccination 1
|
15.3 Percentage of participants
|
17.7 Percentage of participants
|
|
Percentage of Participants With Unsolicited AEs for 29 Days After Each Vaccination
Post-vaccination 2
|
13.4 Percentage of participants
|
15.0 Percentage of participants
|
SECONDARY outcome
Timeframe: From vaccination 1 on Day 1 up to 6 months after vaccination 2 on Day 30 (up to Day 210)Population: FAS included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
MAAEs were defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccination.
Outcome measures
| Measure |
CoAd
n=476 Participants
Participants received a single blinded intramuscular injection of 176 micrograms (mcg) polysaccharide per milliliter (PS/mL) ExPEC9V vaccine in one arm and an unblinded High-dose (HD) quadrivalent seasonal influenza vaccine (240 mcg of haemagglutinin) in the contralateral arm on Day 1, followed by a blinded placebo matching the ExPEC9V vaccine on Day 30 in Coadministration (CoAd) group.
|
Control
n=481 Participants
Participants received a single blinded intramuscular injection of placebo matching the ExPEC9V vaccine in one arm and an unblinded HD quadrivalent seasonal influenza vaccine (240 mcg of haemagglutinin) in the contralateral arm on Day 1, followed by blinded single intramuscular injection of 176 mcg PS/mL ExPEC9V vaccine on Day 30.
|
|---|---|---|
|
Percentage of Participants With Medically-attended Adverse Events (MAAEs) From Vaccination 1 Until 6 Months After Vaccination 2
|
17.2 Percentage of participants
|
17.7 Percentage of participants
|
SECONDARY outcome
Timeframe: From vaccination 1 on Day 1 up to 6 months after vaccination 2 on Day 30 (up to Day 210)Population: FAS included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
Percentage of participants with SAEs from vaccination 1 to until 6 months after vaccination 2 was 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 was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.
Outcome measures
| Measure |
CoAd
n=476 Participants
Participants received a single blinded intramuscular injection of 176 micrograms (mcg) polysaccharide per milliliter (PS/mL) ExPEC9V vaccine in one arm and an unblinded High-dose (HD) quadrivalent seasonal influenza vaccine (240 mcg of haemagglutinin) in the contralateral arm on Day 1, followed by a blinded placebo matching the ExPEC9V vaccine on Day 30 in Coadministration (CoAd) group.
|
Control
n=481 Participants
Participants received a single blinded intramuscular injection of placebo matching the ExPEC9V vaccine in one arm and an unblinded HD quadrivalent seasonal influenza vaccine (240 mcg of haemagglutinin) in the contralateral arm on Day 1, followed by blinded single intramuscular injection of 176 mcg PS/mL ExPEC9V vaccine on Day 30.
|
|---|---|---|
|
Percentage of Participants With Serious Adverse Events (SAEs) From Vaccination 1 Until 6 Months After Vaccination 2
|
2.7 Percentage of participants
|
2.3 Percentage of participants
|
SECONDARY outcome
Timeframe: CoAd Group: Day 1 (Day of ExPEC9V vaccination), Day 30 (29 days after ExPEC9V vaccination), Day 59 (58 days after ExPEC9V vaccination); Control Group: Day 30 (Day of ExPEC9V vaccination), Day 59 (29 days after ExPEC9V vaccination)Population: PPEI analysis set: who received ExPEC9V with HD quadrivalent seasonal influenza vaccine (CoAd) and ExPEC9V alone (control), with O-antigen immunogenicity data available for atleast one E. coli serotype. N (Overall number of participants analyzed): participants evaluable for this OM, n (number analyzed): participants analyzed at specified timepoints. n=0: data was not planned to be collected and analyzed for Control group at Day 1 as participants did not receive ExPEC9V vaccine on Day 1.
Antibody titers to vaccine O-serotype antigens (O1A, O2, O4, O6A, O15, O16, O18A, O25B, and O75) and EPA as determined by multiplex ECL-based immunoassay were reported.
Outcome measures
| Measure |
CoAd
n=466 Participants
Participants received a single blinded intramuscular injection of 176 micrograms (mcg) polysaccharide per milliliter (PS/mL) ExPEC9V vaccine in one arm and an unblinded High-dose (HD) quadrivalent seasonal influenza vaccine (240 mcg of haemagglutinin) in the contralateral arm on Day 1, followed by a blinded placebo matching the ExPEC9V vaccine on Day 30 in Coadministration (CoAd) group.
|
Control
n=464 Participants
Participants received a single blinded intramuscular injection of placebo matching the ExPEC9V vaccine in one arm and an unblinded HD quadrivalent seasonal influenza vaccine (240 mcg of haemagglutinin) in the contralateral arm on Day 1, followed by blinded single intramuscular injection of 176 mcg PS/mL ExPEC9V vaccine on Day 30.
|
|---|---|---|
|
Geometric Mean Titers of O-serotype Antigens and EPA as Determined by Multiplex ECL-based Immunoassay
Study Day 1: Serotype: O6A
|
1901934.2 Titer
Interval 1732938.4 to 2087410.5
|
—
|
|
Geometric Mean Titers of O-serotype Antigens and EPA as Determined by Multiplex ECL-based Immunoassay
Study Day 30: Serotype: O6A
|
7156596.9 Titer
Interval 6427055.1 to 7968949.7
|
1791162.7 Titer
Interval 1633927.6 to 1963528.8
|
|
Geometric Mean Titers of O-serotype Antigens and EPA as Determined by Multiplex ECL-based Immunoassay
Study Day 1: Serotype: O1A
|
739070.3 Titer
Interval 669135.0 to 816315.0
|
—
|
|
Geometric Mean Titers of O-serotype Antigens and EPA as Determined by Multiplex ECL-based Immunoassay
Study Day 30: Serotype: O1A
|
5317596.0 Titer
Interval 4646244.8 to 6085953.1
|
670938.4 Titer
Interval 608664.5 to 739583.8
|
|
Geometric Mean Titers of O-serotype Antigens and EPA as Determined by Multiplex ECL-based Immunoassay
Study Day 59: Serotype: O1A
|
5075672.7 Titer
Interval 4449521.2 to 5789938.3
|
7240450.4 Titer
Interval 6377170.4 to 8220592.9
|
|
Geometric Mean Titers of O-serotype Antigens and EPA as Determined by Multiplex ECL-based Immunoassay
Study Day 1: Serotype: O2
|
154948.9 Titer
Interval 138739.5 to 173052.1
|
—
|
|
Geometric Mean Titers of O-serotype Antigens and EPA as Determined by Multiplex ECL-based Immunoassay
Study Day 30: Serotype: O2
|
2329847.8 Titer
Interval 2019334.8 to 2688108.5
|
164346.0 Titer
Interval 146920.4 to 183838.3
|
|
Geometric Mean Titers of O-serotype Antigens and EPA as Determined by Multiplex ECL-based Immunoassay
Study Day 59: Serotype: O2
|
2217716.1 Titer
Interval 1924806.1 to 2555200.0
|
3686001.2 Titer
Interval 3202636.3 to 4242319.2
|
|
Geometric Mean Titers of O-serotype Antigens and EPA as Determined by Multiplex ECL-based Immunoassay
Study Day 1: Serotype: O4
|
1564005.0 Titer
Interval 1425279.8 to 1716232.6
|
—
|
|
Geometric Mean Titers of O-serotype Antigens and EPA as Determined by Multiplex ECL-based Immunoassay
Study Day 30: Serotype O4
|
5099824.4 Titer
Interval 4537696.2 to 5731588.9
|
1346800.0 Titer
Interval 1239440.7 to 1463458.7
|
|
Geometric Mean Titers of O-serotype Antigens and EPA as Determined by Multiplex ECL-based Immunoassay
Study Day 59: Serotype: O4
|
5004607.3 Titer
Interval 4462459.9 to 5612620.5
|
6521007.1 Titer
Interval 5808494.1 to 7320922.1
|
|
Geometric Mean Titers of O-serotype Antigens and EPA as Determined by Multiplex ECL-based Immunoassay
Study Day 59: Serotype: O6A
|
6886171.6 Titer
Interval 6192370.5 to 7657707.0
|
9878642.6 Titer
Interval 8786488.6 to 11106550.5
|
|
Geometric Mean Titers of O-serotype Antigens and EPA as Determined by Multiplex ECL-based Immunoassay
Study Day 1: Serotype: O15
|
741905.9 Titer
Interval 679551.3 to 809982.1
|
—
|
|
Geometric Mean Titers of O-serotype Antigens and EPA as Determined by Multiplex ECL-based Immunoassay
Study Day 30: Serotype: O15
|
3411803.8 Titer
Interval 3028416.3 to 3843726.8
|
699571.2 Titer
Interval 642187.1 to 762083.0
|
|
Geometric Mean Titers of O-serotype Antigens and EPA as Determined by Multiplex ECL-based Immunoassay
Study Day 59: Serotype: O15
|
3118988.3 Titer
Interval 2776994.8 to 3503099.2
|
4440509.8 Titer
Interval 3939850.4 to 5004790.8
|
|
Geometric Mean Titers of O-serotype Antigens and EPA as Determined by Multiplex ECL-based Immunoassay
Study Day 1: Serotype O16
|
1010837.1 Titer
Interval 926671.6 to 1102646.9
|
—
|
|
Geometric Mean Titers of O-serotype Antigens and EPA as Determined by Multiplex ECL-based Immunoassay
Study Day 30: Serotype: O16
|
5893902.4 Titer
Interval 5218770.4 to 6656373.5
|
901580.8 Titer
Interval 824373.8 to 986018.6
|
|
Geometric Mean Titers of O-serotype Antigens and EPA as Determined by Multiplex ECL-based Immunoassay
Study Day 59: Serotype: O16
|
5713728.3 Titer
Interval 5062282.9 to 6449005.6
|
7743888.3 Titer
Interval 6823177.2 to 8788839.0
|
|
Geometric Mean Titers of O-serotype Antigens and EPA as Determined by Multiplex ECL-based Immunoassay
Study Day 1: Serotype: O18A
|
4082083.1 Titer
Interval 3777876.0 to 4410786.0
|
—
|
|
Geometric Mean Titers of O-serotype Antigens and EPA as Determined by Multiplex ECL-based Immunoassay
Study Day 30: Serotype: O18A
|
22020363.1 Titer
Interval 19671755.8 to 24649370.1
|
3746407.0 Titer
Interval 3461334.1 to 4054958.3
|
|
Geometric Mean Titers of O-serotype Antigens and EPA as Determined by Multiplex ECL-based Immunoassay
Study Day 59: Serotype: O18A
|
20585891.2 Titer
Interval 18468648.5 to 22945854.2
|
28537804.5 Titer
Interval 25492351.3 to 31947083.9
|
|
Geometric Mean Titers of O-serotype Antigens and EPA as Determined by Multiplex ECL-based Immunoassay
Study Day 1: Serotype: O25B
|
1698792.6 Titer
Interval 1537019.5 to 1877592.6
|
—
|
|
Geometric Mean Titers of O-serotype Antigens and EPA as Determined by Multiplex ECL-based Immunoassay
Study Day 30: Serotype: O25B
|
11509271.3 Titer
Interval 10075621.4 to 13146913.9
|
1748932.5 Titer
Interval 1575803.2 to 1941083.2
|
|
Geometric Mean Titers of O-serotype Antigens and EPA as Determined by Multiplex ECL-based Immunoassay
Study Day 59: Serotype: O25B
|
10336834.3 Titer
Interval 9059429.3 to 11794357.0
|
17258900.2 Titer
Interval 14951682.1 to 19922148.9
|
|
Geometric Mean Titers of O-serotype Antigens and EPA as Determined by Multiplex ECL-based Immunoassay
Study Day 1: Serotype: O75
|
3418906.1 Titer
Interval 3135488.7 to 3727941.6
|
—
|
|
Geometric Mean Titers of O-serotype Antigens and EPA as Determined by Multiplex ECL-based Immunoassay
Study Day 30: Serotype: O75
|
10802399.4 Titer
Interval 9624671.7 to 12124240.3
|
3215214.2 Titer
Interval 2939502.0 to 3516787.0
|
|
Geometric Mean Titers of O-serotype Antigens and EPA as Determined by Multiplex ECL-based Immunoassay
Study Day 59: Serotype: O75
|
10254160.6 Titer
Interval 9186950.8 to 11445343.8
|
12407457.8 Titer
Interval 11112490.8 to 13853330.5
|
|
Geometric Mean Titers of O-serotype Antigens and EPA as Determined by Multiplex ECL-based Immunoassay
Study Day 1: Antigen EPA
|
28443.3 Titer
Interval 24417.0 to 33133.4
|
—
|
|
Geometric Mean Titers of O-serotype Antigens and EPA as Determined by Multiplex ECL-based Immunoassay
Study Day 30: Antigen EPA
|
453328.0 Titer
Interval 367274.7 to 559543.7
|
29136.4 Titer
Interval 24905.8 to 34085.6
|
|
Geometric Mean Titers of O-serotype Antigens and EPA as Determined by Multiplex ECL-based Immunoassay
Study Day 59: Antigen EPA
|
375153.2 Titer
Interval 307300.5 to 457988.0
|
519757.9 Titer
Interval 426230.4 to 633808.2
|
SECONDARY outcome
Timeframe: 29 days after the administration of ExPEC9V vaccine on Day 1 (Day 30)Population: PPEI analysis set included all randomized participants who received ExPEC9V in combination with a HD quadrivalent seasonal influenza vaccine for the CoAd group and ExPEC9V alone for the control group and for whom O-antigen immunogenicity data were available for at least one E. coli serotype. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure and n (number analyzed) signifies participants evaluated for specified categories.
Opsonophagocytic antibody titers to vaccine O-serotype antigens O1A, O2, O4, O6A, O15, O16, O18A, O25B, and O75 as determined by MOPA were reported.
Outcome measures
| Measure |
CoAd
n=448 Participants
Participants received a single blinded intramuscular injection of 176 micrograms (mcg) polysaccharide per milliliter (PS/mL) ExPEC9V vaccine in one arm and an unblinded High-dose (HD) quadrivalent seasonal influenza vaccine (240 mcg of haemagglutinin) in the contralateral arm on Day 1, followed by a blinded placebo matching the ExPEC9V vaccine on Day 30 in Coadministration (CoAd) group.
|
Control
Participants received a single blinded intramuscular injection of placebo matching the ExPEC9V vaccine in one arm and an unblinded HD quadrivalent seasonal influenza vaccine (240 mcg of haemagglutinin) in the contralateral arm on Day 1, followed by blinded single intramuscular injection of 176 mcg PS/mL ExPEC9V vaccine on Day 30.
|
|---|---|---|
|
CoAd Group: Opsonophagocytic Geometric Mean Titers of O-serotype Antigens as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)
Serotype: O1A
|
1630.0 Titer
Interval 1403.7 to 1892.7
|
—
|
|
CoAd Group: Opsonophagocytic Geometric Mean Titers of O-serotype Antigens as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)
Serotype: O2
|
2245.4 Titer
Interval 1928.8 to 2614.0
|
—
|
|
CoAd Group: Opsonophagocytic Geometric Mean Titers of O-serotype Antigens as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)
Serotype O4
|
394.8 Titer
Interval 352.6 to 442.0
|
—
|
|
CoAd Group: Opsonophagocytic Geometric Mean Titers of O-serotype Antigens as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)
Serotype: O6A
|
1078.1 Titer
Interval 949.7 to 1223.8
|
—
|
|
CoAd Group: Opsonophagocytic Geometric Mean Titers of O-serotype Antigens as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)
Serotype: O15
|
1262.7 Titer
Interval 1103.6 to 1444.8
|
—
|
|
CoAd Group: Opsonophagocytic Geometric Mean Titers of O-serotype Antigens as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)
Serotype: O16
|
1079.1 Titer
Interval 924.3 to 1259.7
|
—
|
|
CoAd Group: Opsonophagocytic Geometric Mean Titers of O-serotype Antigens as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)
Serotype: O18A
|
619.0 Titer
Interval 545.7 to 702.0
|
—
|
|
CoAd Group: Opsonophagocytic Geometric Mean Titers of O-serotype Antigens as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)
Serotype: O25B
|
129.3 Titer
Interval 114.4 to 146.0
|
—
|
|
CoAd Group: Opsonophagocytic Geometric Mean Titers of O-serotype Antigens as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)
Serotype: O75
|
92.3 Titer
Interval 79.8 to 106.9
|
—
|
SECONDARY outcome
Timeframe: 29 days after the administration of ExPEC9V vaccine on Day 30 (Day 59)Population: PPEI analysis set included all randomized participants who received ExPEC9V in combination with a HD quadrivalent seasonal influenza vaccine for the CoAd group and ExPEC9V alone for the control group and for whom O-antigen immunogenicity data were available for at least one E. coli serotype. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure and n (number analyzed) signifies participants evaluated for specified categories.
Opsonophagocytic antibody titers to vaccine O-serotype antigens (O1A, O2, O4, O6A, O15, O16, O18A, O25B, and O75) as determined by MOPA were reported.
Outcome measures
| Measure |
CoAd
n=442 Participants
Participants received a single blinded intramuscular injection of 176 micrograms (mcg) polysaccharide per milliliter (PS/mL) ExPEC9V vaccine in one arm and an unblinded High-dose (HD) quadrivalent seasonal influenza vaccine (240 mcg of haemagglutinin) in the contralateral arm on Day 1, followed by a blinded placebo matching the ExPEC9V vaccine on Day 30 in Coadministration (CoAd) group.
|
Control
Participants received a single blinded intramuscular injection of placebo matching the ExPEC9V vaccine in one arm and an unblinded HD quadrivalent seasonal influenza vaccine (240 mcg of haemagglutinin) in the contralateral arm on Day 1, followed by blinded single intramuscular injection of 176 mcg PS/mL ExPEC9V vaccine on Day 30.
|
|---|---|---|
|
Control Group: Opsonophagocytic Geometric Mean Titers of O-serotype Antigens as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)
Serotype: O16
|
1744.7 Titer
Interval 1481.8 to 2054.2
|
—
|
|
Control Group: Opsonophagocytic Geometric Mean Titers of O-serotype Antigens as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)
Serotype: O18A
|
1033.5 Titer
Interval 892.9 to 1196.3
|
—
|
|
Control Group: Opsonophagocytic Geometric Mean Titers of O-serotype Antigens as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)
Serotype: O25B
|
177.2 Titer
Interval 153.4 to 204.8
|
—
|
|
Control Group: Opsonophagocytic Geometric Mean Titers of O-serotype Antigens as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)
Serotype: O75
|
160.0 Titer
Interval 136.7 to 187.3
|
—
|
|
Control Group: Opsonophagocytic Geometric Mean Titers of O-serotype Antigens as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)
Serotype: O1A
|
2149.3 Titer
Interval 1857.2 to 2487.3
|
—
|
|
Control Group: Opsonophagocytic Geometric Mean Titers of O-serotype Antigens as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)
Serotype: O2
|
3459.4 Titer
Interval 2931.0 to 4083.1
|
—
|
|
Control Group: Opsonophagocytic Geometric Mean Titers of O-serotype Antigens as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)
Serotype: O4
|
482.9 Titer
Interval 423.9 to 550.1
|
—
|
|
Control Group: Opsonophagocytic Geometric Mean Titers of O-serotype Antigens as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)
Serotype: O6A
|
1223.2 Titer
Interval 1061.4 to 1409.6
|
—
|
|
Control Group: Opsonophagocytic Geometric Mean Titers of O-serotype Antigens as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)
Serotype: O15
|
1712.4 Titer
Interval 1478.3 to 1983.5
|
—
|
SECONDARY outcome
Timeframe: 29 days after the administration of ExPEC9V on Day 1 (Day 30)Population: Analysis population included participants with and without history of UTI at enrollment. Here, N (Overall number of participants analyzed) signifies participants evaluable for this OM and n (number analyzed) signifies participants evaluated for specified categories.
Antibody titers to vaccine O-serotype antigens (O1A, O2, O4, O6A, O15, O16, O18A, O25B, and O75) in participants with and without history of UTI at enrollment as determined by multiplex ECL-based immunoassay were reported.
Outcome measures
| Measure |
CoAd
n=448 Participants
Participants received a single blinded intramuscular injection of 176 micrograms (mcg) polysaccharide per milliliter (PS/mL) ExPEC9V vaccine in one arm and an unblinded High-dose (HD) quadrivalent seasonal influenza vaccine (240 mcg of haemagglutinin) in the contralateral arm on Day 1, followed by a blinded placebo matching the ExPEC9V vaccine on Day 30 in Coadministration (CoAd) group.
|
Control
Participants received a single blinded intramuscular injection of placebo matching the ExPEC9V vaccine in one arm and an unblinded HD quadrivalent seasonal influenza vaccine (240 mcg of haemagglutinin) in the contralateral arm on Day 1, followed by blinded single intramuscular injection of 176 mcg PS/mL ExPEC9V vaccine on Day 30.
|
|---|---|---|
|
CoAd Group: Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of Urinary Tract Infection (UTI) at Enrollment as Determined by Multiplex ECL-based Immunoassay
UTI at baseline: Serotype O1A
|
6160478.9 Titer
Interval 4774254.0 to 7949200.1
|
—
|
|
CoAd Group: Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of Urinary Tract Infection (UTI) at Enrollment as Determined by Multiplex ECL-based Immunoassay
No UTI at baseline: Serotype O1A
|
5071887.4 Titer
Interval 4327266.3 to 5944640.4
|
—
|
|
CoAd Group: Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of Urinary Tract Infection (UTI) at Enrollment as Determined by Multiplex ECL-based Immunoassay
UTI at baseline: Serotype O2
|
2997612.3 Titer
Interval 2188289.3 to 4106257.6
|
—
|
|
CoAd Group: Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of Urinary Tract Infection (UTI) at Enrollment as Determined by Multiplex ECL-based Immunoassay
No UTI at baseline: Serotype O2
|
2148504.9 Titer
Interval 1831461.7 to 2520431.2
|
—
|
|
CoAd Group: Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of Urinary Tract Infection (UTI) at Enrollment as Determined by Multiplex ECL-based Immunoassay
UTI at baseline: Serotype O4
|
6432286.8 Titer
Interval 5039834.4 to 8209458.8
|
—
|
|
CoAd Group: Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of Urinary Tract Infection (UTI) at Enrollment as Determined by Multiplex ECL-based Immunoassay
No UTI at baseline: Serotype O4
|
4733052.6 Titer
Interval 4145078.6 to 5404430.0
|
—
|
|
CoAd Group: Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of Urinary Tract Infection (UTI) at Enrollment as Determined by Multiplex ECL-based Immunoassay
UTI at baseline: Serotype O6A
|
8346692.5 Titer
Interval 6553684.5 to 10630245.5
|
—
|
|
CoAd Group: Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of Urinary Tract Infection (UTI) at Enrollment as Determined by Multiplex ECL-based Immunoassay
No UTI at baseline: Serotype O6A
|
6811230.2 Titer
Interval 6045896.6 to 7673445.4
|
—
|
|
CoAd Group: Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of Urinary Tract Infection (UTI) at Enrollment as Determined by Multiplex ECL-based Immunoassay
UTI at baseline: Serotype O15
|
3960546.9 Titer
Interval 3079674.6 to 5093373.0
|
—
|
|
CoAd Group: Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of Urinary Tract Infection (UTI) at Enrollment as Determined by Multiplex ECL-based Immunoassay
No UTI at baseline: Serotype O15
|
3252055.4 Titer
Interval 2839890.8 to 3724039.1
|
—
|
|
CoAd Group: Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of Urinary Tract Infection (UTI) at Enrollment as Determined by Multiplex ECL-based Immunoassay
UTI at baseline: Serotype O16
|
7395994.7 Titer
Interval 5815386.0 to 9406209.2
|
—
|
|
CoAd Group: Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of Urinary Tract Infection (UTI) at Enrollment as Determined by Multiplex ECL-based Immunoassay
No UTI at baseline: Serotype O16
|
5479005.5 Titer
Interval 4759609.9 to 6307134.7
|
—
|
|
CoAd Group: Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of Urinary Tract Infection (UTI) at Enrollment as Determined by Multiplex ECL-based Immunoassay
UTI at baseline: Serotype O18A
|
24137685.4 Titer
Interval 19023324.3 to 30627026.5
|
—
|
|
CoAd Group: Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of Urinary Tract Infection (UTI) at Enrollment as Determined by Multiplex ECL-based Immunoassay
No UTI at baseline: Serotype O18A
|
21379844.8 Titer
Interval 18803127.4 to 24309667.0
|
—
|
|
CoAd Group: Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of Urinary Tract Infection (UTI) at Enrollment as Determined by Multiplex ECL-based Immunoassay
UTI at baseline: Serotype O25B
|
16547661.1 Titer
Interval 12619680.5 to 21698258.2
|
—
|
|
CoAd Group: Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of Urinary Tract Infection (UTI) at Enrollment as Determined by Multiplex ECL-based Immunoassay
No UTI at baseline: Serotype O25B
|
10241074.7 Titer
Interval 8802458.2 to 11914809.4
|
—
|
|
CoAd Group: Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of Urinary Tract Infection (UTI) at Enrollment as Determined by Multiplex ECL-based Immunoassay
UTI at baseline: Serotype O75
|
12800664.6 Titer
Interval 9939927.9 to 16484728.5
|
—
|
|
CoAd Group: Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of Urinary Tract Infection (UTI) at Enrollment as Determined by Multiplex ECL-based Immunoassay
No UTI at baseline: Serotype O75
|
10228671.4 Titer
Interval 8988055.3 to 11640529.1
|
—
|
SECONDARY outcome
Timeframe: 29 days after the administration of ExPEC9V on Day 30 (Day 59)Population: Analysis population included participants with and without history of UTI at enrollment. Here, N (Overall number of participants analyzed) signifies participants evaluable for this OM and n (number analyzed) signifies participants evaluated for specified categories.
Antibody titers to vaccine O-serotype antigens (O1A, O2, O4, O6A, O15, O16, O18A, O25B, and O75) in participants with and without history of UTI at enrollment as determined by multiplex ECL-based immunoassay were reported.
Outcome measures
| Measure |
CoAd
n=442 Participants
Participants received a single blinded intramuscular injection of 176 micrograms (mcg) polysaccharide per milliliter (PS/mL) ExPEC9V vaccine in one arm and an unblinded High-dose (HD) quadrivalent seasonal influenza vaccine (240 mcg of haemagglutinin) in the contralateral arm on Day 1, followed by a blinded placebo matching the ExPEC9V vaccine on Day 30 in Coadministration (CoAd) group.
|
Control
Participants received a single blinded intramuscular injection of placebo matching the ExPEC9V vaccine in one arm and an unblinded HD quadrivalent seasonal influenza vaccine (240 mcg of haemagglutinin) in the contralateral arm on Day 1, followed by blinded single intramuscular injection of 176 mcg PS/mL ExPEC9V vaccine on Day 30.
|
|---|---|---|
|
Control Group: Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex ECL-based Immunoassay
UTI at baseline: Serotype O1A
|
8651535.9 Titer
Interval 6830776.3 to 10957623.4
|
—
|
|
Control Group: Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex ECL-based Immunoassay
No UTI at baseline: Serotype O1A
|
6805961.9 Titer
Interval 5856748.1 to 7909016.4
|
—
|
|
Control Group: Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex ECL-based Immunoassay
UTI at baseline: Serotype O2
|
4943585.5 Titer
Interval 3847110.9 to 6352569.0
|
—
|
|
Control Group: Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex ECL-based Immunoassay
No UTI at baseline: Serotype O2
|
3328481.3 Titer
Interval 2815169.6 to 3935389.1
|
—
|
|
Control Group: Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex ECL-based Immunoassay
UTI at baseline: Serotype O4
|
6839103.3 Titer
Interval 5512300.2 to 8485266.0
|
—
|
|
Control Group: Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex ECL-based Immunoassay
No UTI at baseline: Serotype O4
|
6413949.7 Titer
Interval 5590982.3 to 7358054.2
|
—
|
|
Control Group: Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex ECL-based Immunoassay
UTI at baseline: Serotype O6A
|
12562209.1 Titer
Interval 9936839.7 to 15881215.9
|
—
|
|
Control Group: Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex ECL-based Immunoassay
No UTI at baseline: Serotype O6A
|
9087046.9 Titer
Interval 7941272.3 to 10398135.1
|
—
|
|
Control Group: Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex ECL-based Immunoassay
UTI at baseline: Serotype O15
|
5243066.0 Titer
Interval 4122485.6 to 6668244.4
|
—
|
|
Control Group: Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex ECL-based Immunoassay
No UTI at baseline: Serotype O15
|
4191364.6 Titer
Interval 3650913.9 to 4811819.1
|
—
|
|
Control Group: Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex ECL-based Immunoassay
UTI at baseline: Serotype O16
|
7315224.0 Titer
Interval 5814557.3 to 9203194.7
|
—
|
|
Control Group: Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex ECL-based Immunoassay
No UTI at baseline: Serotype O16
|
7898684.5 Titer
Interval 6789138.0 to 9189563.8
|
—
|
|
Control Group: Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex ECL-based Immunoassay
UTI at baseline: Serotype O18A
|
31863829.0 Titer
Interval 25896033.0 to 39206916.3
|
—
|
|
Control Group: Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex ECL-based Immunoassay
No UTI at baseline: Serotype O18A
|
27465040.3 Titer
Interval 24014129.8 to 31411858.3
|
—
|
|
Control Group: Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex ECL-based Immunoassay
UTI at baseline: Serotype O25B
|
18356720.0 Titer
Interval 14010182.8 to 24051732.6
|
—
|
|
Control Group: Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex ECL-based Immunoassay
No UTI at baseline: Serotype O25B
|
16892921.0 Titer
Interval 14254902.0 to 20019133.1
|
—
|
|
Control Group: Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex ECL-based Immunoassay
UTI at baseline: Serotype O75
|
14476793.4 Titer
Interval 11780693.2 to 17789916.6
|
—
|
|
Control Group: Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex ECL-based Immunoassay
No UTI at baseline: Serotype O75
|
11759797.5 Titer
Interval 10323754.0 to 13395596.0
|
—
|
SECONDARY outcome
Timeframe: 29 days after the administration of ExPEC9V on Day 1 (Day 30)Population: Analysis population included participants with and without history of UTI at enrollment. Here, N (Overall number of participants analyzed) signifies participants evaluable for this OM and n (number analyzed) signifies participants evaluated for specified categories.
Opsonophagocytic antibody titers to vaccine O-serotype antigens (O1A, O2, O4, O6A, O15, O16, O18A, O25B, and O75) in participants with and without history of UTI at enrollment as determined by MOPA were reported.
Outcome measures
| Measure |
CoAd
n=448 Participants
Participants received a single blinded intramuscular injection of 176 micrograms (mcg) polysaccharide per milliliter (PS/mL) ExPEC9V vaccine in one arm and an unblinded High-dose (HD) quadrivalent seasonal influenza vaccine (240 mcg of haemagglutinin) in the contralateral arm on Day 1, followed by a blinded placebo matching the ExPEC9V vaccine on Day 30 in Coadministration (CoAd) group.
|
Control
Participants received a single blinded intramuscular injection of placebo matching the ExPEC9V vaccine in one arm and an unblinded HD quadrivalent seasonal influenza vaccine (240 mcg of haemagglutinin) in the contralateral arm on Day 1, followed by blinded single intramuscular injection of 176 mcg PS/mL ExPEC9V vaccine on Day 30.
|
|---|---|---|
|
CoAd Group: Opsonophagocytic Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)
UTI at baseline: Serotype O1A
|
1960.7 Titer
Interval 1476.2 to 2604.4
|
—
|
|
CoAd Group: Opsonophagocytic Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)
No UTI at baseline: Serotype O1A
|
1535.9 Titer
Interval 1288.8 to 1830.5
|
—
|
|
CoAd Group: Opsonophagocytic Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)
UTI at baseline: Serotype O2
|
2609.3 Titer
Interval 1890.7 to 3600.8
|
—
|
|
CoAd Group: Opsonophagocytic Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)
No UTI at baseline: Serotype O2
|
2139.6 Titer
Interval 1800.2 to 2543.0
|
—
|
|
CoAd Group: Opsonophagocytic Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)
UTI at baseline: Serotype O4
|
455.3 Titer
Interval 352.5 to 588.0
|
—
|
|
CoAd Group: Opsonophagocytic Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)
No UTI at baseline: Serotype O4
|
377.1 Titer
Interval 332.8 to 427.3
|
—
|
|
CoAd Group: Opsonophagocytic Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)
UTI at baseline: Serotype O6A
|
1279.6 Titer
Interval 947.0 to 1729.2
|
—
|
|
CoAd Group: Opsonophagocytic Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)
No UTI at baseline: Serotype O6A
|
1020.3 Titer
Interval 889.4 to 1170.4
|
—
|
|
CoAd Group: Opsonophagocytic Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)
UTI at baseline: Serotype O15
|
1492.2 Titer
Interval 1130.9 to 1969.0
|
—
|
|
CoAd Group: Opsonophagocytic Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)
No UTI at baseline: Serotype O15
|
1196.2 Titer
Interval 1025.0 to 1395.9
|
—
|
|
CoAd Group: Opsonophagocytic Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)
UTI at baseline: Serotype O16
|
1585.8 Titer
Interval 1180.3 to 2130.7
|
—
|
|
CoAd Group: Opsonophagocytic Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)
No UTI at baseline: Serotype O16
|
951.7 Titer
Interval 794.9 to 1139.5
|
—
|
|
CoAd Group: Opsonophagocytic Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)
UTI at baseline: Serotype O18A
|
619.3 Titer
Interval 481.5 to 796.6
|
—
|
|
CoAd Group: Opsonophagocytic Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)
No UTI at baseline: Serotype O18A
|
618.9 Titer
Interval 534.7 to 716.3
|
—
|
|
CoAd Group: Opsonophagocytic Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)
UTI at baseline: Serotype O25B
|
175.1 Titer
Interval 133.0 to 230.6
|
—
|
|
CoAd Group: Opsonophagocytic Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)
No UTI at baseline: Serotype O25B
|
117.3 Titer
Interval 102.6 to 134.1
|
—
|
|
CoAd Group: Opsonophagocytic Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)
UTI at baseline: Serotype O75
|
104.1 Titer
Interval 77.7 to 139.5
|
—
|
|
CoAd Group: Opsonophagocytic Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)
No UTI at baseline: Serotype O75
|
88.9 Titer
Interval 75.1 to 105.3
|
—
|
SECONDARY outcome
Timeframe: 29 days after the administration of ExPEC9V on Day 30 (Day 59)Population: Analysis population included participants with and without history of UTI at enrollment. Here, N (Overall number of participants analyzed) signifies participants evaluable for this OM and n (number analyzed) signifies participants evaluated for specified categories.
Opsonophagocytic antibody titers to vaccine O-serotype antigens (O1A, O2, O4, O6A, O15, O16, O18A, O25B, and O75) in participants with and without history of UTI at enrollment as determined by MOPA were reported.
Outcome measures
| Measure |
CoAd
n=442 Participants
Participants received a single blinded intramuscular injection of 176 micrograms (mcg) polysaccharide per milliliter (PS/mL) ExPEC9V vaccine in one arm and an unblinded High-dose (HD) quadrivalent seasonal influenza vaccine (240 mcg of haemagglutinin) in the contralateral arm on Day 1, followed by a blinded placebo matching the ExPEC9V vaccine on Day 30 in Coadministration (CoAd) group.
|
Control
Participants received a single blinded intramuscular injection of placebo matching the ExPEC9V vaccine in one arm and an unblinded HD quadrivalent seasonal influenza vaccine (240 mcg of haemagglutinin) in the contralateral arm on Day 1, followed by blinded single intramuscular injection of 176 mcg PS/mL ExPEC9V vaccine on Day 30.
|
|---|---|---|
|
Control Group: Opsonophagocytic Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)
UTI at baseline: Serotype O6A
|
1584.5 Titer
Interval 1190.0 to 2109.8
|
—
|
|
Control Group: Opsonophagocytic Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)
No UTI at baseline: Serotype O6A
|
1117.9 Titer
Interval 949.8 to 1315.8
|
—
|
|
Control Group: Opsonophagocytic Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)
UTI at baseline: Serotype O75
|
179.9 Titer
Interval 134.1 to 241.5
|
—
|
|
Control Group: Opsonophagocytic Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)
UTI at baseline: Serotype O1A
|
2286.3 Titer
Interval 1709.8 to 3057.3
|
—
|
|
Control Group: Opsonophagocytic Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)
No UTI at baseline: Serotype O1A
|
2103.6 Titer
Interval 1775.1 to 2492.9
|
—
|
|
Control Group: Opsonophagocytic Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)
UTI at baseline: Serotype O2
|
3910.8 Titer
Interval 2842.1 to 5381.4
|
—
|
|
Control Group: Opsonophagocytic Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)
No UTI at baseline: Serotype O2
|
3314.6 Titer
Interval 2728.4 to 4026.9
|
—
|
|
Control Group: Opsonophagocytic Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)
UTI at baseline: Serotype O4
|
450.4 Titer
Interval 352.6 to 575.3
|
—
|
|
Control Group: Opsonophagocytic Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)
No UTI at baseline: Serotype O4
|
494.7 Titer
Interval 424.0 to 577.2
|
—
|
|
Control Group: Opsonophagocytic Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)
UTI at baseline: Serotype O15
|
2019.4 Titer
Interval 1490.7 to 2735.5
|
—
|
|
Control Group: Opsonophagocytic Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)
No UTI at baseline: Serotype O15
|
1614.3 Titer
Interval 1364.6 to 1909.7
|
—
|
|
Control Group: Opsonophagocytic Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)
UTI at baseline: Serotype O16
|
1562.4 Titer
Interval 1150.8 to 2121.1
|
—
|
|
Control Group: Opsonophagocytic Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)
No UTI at baseline: Serotype O16
|
1813.1 Titer
Interval 1494.1 to 2200.2
|
—
|
|
Control Group: Opsonophagocytic Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)
UTI at baseline: Serotype O18A
|
1282.5 Titer
Interval 977.7 to 1682.3
|
—
|
|
Control Group: Opsonophagocytic Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)
No UTI at baseline: Serotype O18A
|
955.3 Titer
Interval 803.2 to 1136.3
|
—
|
|
Control Group: Opsonophagocytic Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)
UTI at baseline: Serotype O25B
|
187.1 Titer
Interval 137.9 to 253.8
|
—
|
|
Control Group: Opsonophagocytic Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)
No UTI at baseline: Serotype O25B
|
173.9 Titer
Interval 147.6 to 205.0
|
—
|
|
Control Group: Opsonophagocytic Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)
No UTI at baseline: Serotype O75
|
153.9 Titer
Interval 127.7 to 185.5
|
—
|
Adverse Events
CoAd: Post-dose 1
Serious events: 0 serious events
Other events: 362 other events
Deaths: 0 deaths
CoAd: Post-dose 2
Serious events: 13 serious events
Other events: 148 other events
Deaths: 0 deaths
Control: Post-dose 1
Serious events: 3 serious events
Other events: 326 other events
Deaths: 0 deaths
Control: Post-dose 2
Serious events: 8 serious events
Other events: 225 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
CoAd: Post-dose 1
n=476 participants at risk
Participants received a single blinded intramuscular injection of 176 micrograms (mcg) polysaccharide per milliliter (PS/mL) ExPEC9V vaccine in one arm and an unblinded HD quadrivalent seasonal influenza vaccine (240 mcg of haemagglutinin) in the contralateral arm on Day 1.
|
CoAd: Post-dose 2
n=461 participants at risk
Participants received a single blinded intramuscular injection of placebo matching the ExPEC9V vaccine on Day 30.
|
Control: Post-dose 1
n=481 participants at risk
Participants received a single blinded intramuscular injection of placebo matching the ExPEC9V vaccine in one arm and an unblinded HD quadrivalent seasonal influenza vaccine (240 mcg of haemagglutinin) in the contralateral arm on Day 1.
|
Control: Post-dose 2
n=466 participants at risk
Participants received a single blinded intramuscular injection of 176 mcg PS/mL ExPEC9V vaccine on Day 30.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/476 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/461 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/481 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.21%
1/466 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/476 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/461 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/481 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.21%
1/466 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
|
Cardiac disorders
Angina Unstable
|
0.00%
0/476 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.22%
1/461 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/481 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/466 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/476 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.22%
1/461 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/481 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/466 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/476 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.22%
1/461 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/481 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/466 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
|
Endocrine disorders
Goitre
|
0.00%
0/476 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.22%
1/461 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/481 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/466 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/476 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/461 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/481 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.21%
1/466 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/476 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/461 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/481 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.21%
1/466 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/476 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.22%
1/461 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/481 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/466 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/476 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.22%
1/461 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/481 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/466 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/476 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/461 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.21%
1/481 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.21%
1/466 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
|
General disorders
Death
|
0.00%
0/476 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/461 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/481 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.21%
1/466 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.00%
0/476 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.22%
1/461 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/481 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/466 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
|
Infections and infestations
COVID-19 Pneumonia
|
0.00%
0/476 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.22%
1/461 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/481 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/466 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
|
Infections and infestations
Escherichia Sepsis
|
0.00%
0/476 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.22%
1/461 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/481 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/466 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/476 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.22%
1/461 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/481 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/466 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/476 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/461 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/481 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.21%
1/466 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
|
Injury, poisoning and procedural complications
Pelvic Fracture
|
0.00%
0/476 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.22%
1/461 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/481 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/466 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/476 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.22%
1/461 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/481 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/466 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Gastric Neoplasm
|
0.00%
0/476 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/461 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.21%
1/481 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/466 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Carcinoma
|
0.00%
0/476 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.22%
1/461 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/481 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/466 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.00%
0/476 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.22%
1/461 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/481 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/466 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
|
Nervous system disorders
Ischaemic Stroke
|
0.00%
0/476 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/461 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/481 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.21%
1/466 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
|
Nervous system disorders
Presyncope
|
0.00%
0/476 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/461 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/481 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.21%
1/466 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/476 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.22%
1/461 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.21%
1/481 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/466 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/476 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.22%
1/461 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/481 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/466 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/476 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/461 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/481 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.21%
1/466 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/476 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.43%
2/461 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/481 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/466 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/476 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/461 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.21%
1/481 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/466 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/476 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/461 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/481 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.21%
1/466 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
|
Skin and subcutaneous tissue disorders
Excessive Skin
|
0.00%
0/476 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/461 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/481 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.21%
1/466 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
Other adverse events
| Measure |
CoAd: Post-dose 1
n=476 participants at risk
Participants received a single blinded intramuscular injection of 176 micrograms (mcg) polysaccharide per milliliter (PS/mL) ExPEC9V vaccine in one arm and an unblinded HD quadrivalent seasonal influenza vaccine (240 mcg of haemagglutinin) in the contralateral arm on Day 1.
|
CoAd: Post-dose 2
n=461 participants at risk
Participants received a single blinded intramuscular injection of placebo matching the ExPEC9V vaccine on Day 30.
|
Control: Post-dose 1
n=481 participants at risk
Participants received a single blinded intramuscular injection of placebo matching the ExPEC9V vaccine in one arm and an unblinded HD quadrivalent seasonal influenza vaccine (240 mcg of haemagglutinin) in the contralateral arm on Day 1.
|
Control: Post-dose 2
n=466 participants at risk
Participants received a single blinded intramuscular injection of 176 mcg PS/mL ExPEC9V vaccine on Day 30.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
1.1%
5/476 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.22%
1/461 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.42%
2/481 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.00%
0/466 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
|
Gastrointestinal disorders
Nausea (Solicited)
|
13.9%
66/476 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
6.5%
30/461 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
7.9%
38/481 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
7.5%
35/466 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
|
General disorders
Fatigue (Solicited)
|
38.7%
184/476 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
16.7%
77/461 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
28.1%
135/481 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
23.8%
111/466 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
|
General disorders
Pyrexia (Solicited)
|
4.2%
20/476 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
1.1%
5/461 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
2.3%
11/481 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
3.9%
18/466 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
|
General disorders
Vaccination Site Erythema (Solicited)
|
15.5%
74/476 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
1.1%
5/461 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
6.7%
32/481 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
12.4%
58/466 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
|
General disorders
Vaccination Site Pain (Solicited)
|
63.9%
304/476 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
11.5%
53/461 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
52.4%
252/481 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
34.3%
160/466 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
|
General disorders
Vaccination Site Swelling (Solicited)
|
13.7%
65/476 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.43%
2/461 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
7.1%
34/481 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
10.1%
47/466 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
|
Infections and infestations
COVID-19
|
1.3%
6/476 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.87%
4/461 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
1.9%
9/481 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.21%
1/466 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
|
Infections and infestations
Nasopharyngitis
|
1.5%
7/476 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
2.2%
10/461 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.62%
3/481 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
1.5%
7/466 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
1.3%
6/476 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
1.1%
5/461 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
1.2%
6/481 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
1.9%
9/466 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
|
Infections and infestations
Urinary Tract Infection
|
1.1%
5/476 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.65%
3/461 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.83%
4/481 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
0.86%
4/466 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
|
Musculoskeletal and connective tissue disorders
Myalgia (Solicited)
|
32.4%
154/476 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
12.1%
56/461 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
27.2%
131/481 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
22.5%
105/466 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
|
Nervous system disorders
Headache (Solicited)
|
29.2%
139/476 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
13.0%
60/461 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
24.7%
119/481 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
20.4%
95/466 • All-Cause Mortality: CoAd/control group post dose-1:Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; SAEs: CoAd/control group post dose-1: Day 1 to Day 30, CoAd/control group post dose-2:Day 30 to Day 210; Unsolicited AEs (other AEs): Up to 29 days post-dose 1 (Day 1 to Day 30), Up to 29 days post-dose 2 (Day 30 to Day 59); Solicited local and systemic AEs: Up to 14 days post-dose 1 (Day 1 to Day 15), Up to 14 days post-dose 2 (Day 30 to Day 44)
Full analysis set included all participants who received at least one study vaccination, regardless of the occurrence of protocol deviations and vaccine type (HD quadrivalent seasonal influenza vaccine, ExPEC9V, or placebo).
|
Additional Information
Executive Medical Director
Janssen Research & Development, LLC
Phone: 844-434-4210
Email: [email protected]
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 to allow for filing of a patent application.
- Publication restrictions are in place
Restriction type: OTHER