Trial Outcomes & Findings for Safety and Immunogenicity of Different Formulations of an MF59-Adjuvanted Influenza Vaccine in Older Adults ≥50 Years of Age (NCT NCT05501561)
NCT ID: NCT05501561
Last Updated: 2026-06-30
Results Overview
Seroconversion is defined as ≥4-fold increase in titer postvaccination in those with prevaccination titer equal to or above the lower limit of quantitation (LLOQ; 1:10), or a postvaccination titer ≥1:40 for subjects with baseline titer below the LLOQ (1:10) for HI antibodies.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
1056 participants
Primary outcome timeframe
Day 1 to Day 29
Results posted on
2026-06-30
Participant Flow
Participant milestones
| Measure |
IIV-A Investigational
Experimental: IIV-A Investigational IIV-A administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational IIV-A Investigational Quadrivalent Influenza vaccine (higher HA dose), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
aIIV-B Investigational
Experimental: aIIV-B Investigational aIIV-B administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational aIIV-B Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, standard dose MF59), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
aIIV-C Investigational
Experimental: aIIV-C Investigational aIIV-C administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational aIIV-C Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, higher dose MF59), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
Licensed IIV
Active Comparator: Licensed IIV IIV administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Licensed IIV Licensed Non-adjuvanted Quadrivalent Influenza vaccine (standard HA dose), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
264
|
265
|
264
|
263
|
|
Overall Study
COMPLETED
|
255
|
252
|
253
|
254
|
|
Overall Study
NOT COMPLETED
|
9
|
13
|
11
|
9
|
Reasons for withdrawal
| Measure |
IIV-A Investigational
Experimental: IIV-A Investigational IIV-A administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational IIV-A Investigational Quadrivalent Influenza vaccine (higher HA dose), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
aIIV-B Investigational
Experimental: aIIV-B Investigational aIIV-B administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational aIIV-B Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, standard dose MF59), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
aIIV-C Investigational
Experimental: aIIV-C Investigational aIIV-C administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational aIIV-C Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, higher dose MF59), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
Licensed IIV
Active Comparator: Licensed IIV IIV administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Licensed IIV Licensed Non-adjuvanted Quadrivalent Influenza vaccine (standard HA dose), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
|---|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
4
|
2
|
4
|
|
Overall Study
Lost to Follow-up
|
8
|
9
|
7
|
4
|
|
Overall Study
Other
|
0
|
0
|
1
|
1
|
Baseline Characteristics
Note: 6 subjects did not have body mass index data.
Baseline characteristics by cohort
| Measure |
IIV-A Investigational
n=264 Participants
Experimental: IIV-A Investigational IIV-A administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational IIV-A Investigational Quadrivalent Influenza vaccine (higher HA dose), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
aIIV-B Investigational
n=265 Participants
Experimental: aIIV-B Investigational aIIV-B administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational aIIV-B Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, standard dose MF59), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
aIIV-C Investigational
n=264 Participants
Experimental: aIIV-C Investigational aIIV-C administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational aIIV-C Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, higher dose MF59), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
Licensed IIV
n=263 Participants
Active Comparator: Licensed IIV IIV administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Licensed IIV Licensed Non-adjuvanted Quadrivalent Influenza vaccine (standard HA dose), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
Total
n=1056 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
64.5 years
STANDARD_DEVIATION 9.14 • n=264 Participants
|
64.0 years
STANDARD_DEVIATION 8.50 • n=265 Participants
|
64.1 years
STANDARD_DEVIATION 8.99 • n=264 Participants
|
63.9 years
STANDARD_DEVIATION 7.88 • n=263 Participants
|
64.1 years
STANDARD_DEVIATION 8.63 • n=1056 Participants
|
|
Age, Customized
50 to 64 years
|
139 Participants
n=264 Participants
|
138 Participants
n=265 Participants
|
137 Participants
n=264 Participants
|
136 Participants
n=263 Participants
|
550 Participants
n=1056 Participants
|
|
Age, Customized
≥65 years
|
125 Participants
n=264 Participants
|
127 Participants
n=265 Participants
|
127 Participants
n=264 Participants
|
127 Participants
n=263 Participants
|
506 Participants
n=1056 Participants
|
|
Sex: Female, Male
Female
|
154 Participants
n=264 Participants
|
154 Participants
n=265 Participants
|
155 Participants
n=264 Participants
|
149 Participants
n=263 Participants
|
612 Participants
n=1056 Participants
|
|
Sex: Female, Male
Male
|
110 Participants
n=264 Participants
|
111 Participants
n=265 Participants
|
109 Participants
n=264 Participants
|
114 Participants
n=263 Participants
|
444 Participants
n=1056 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
29 Participants
n=264 Participants
|
22 Participants
n=265 Participants
|
22 Participants
n=264 Participants
|
28 Participants
n=263 Participants
|
101 Participants
n=1056 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
235 Participants
n=264 Participants
|
243 Participants
n=265 Participants
|
238 Participants
n=264 Participants
|
234 Participants
n=263 Participants
|
950 Participants
n=1056 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=264 Participants
|
0 Participants
n=265 Participants
|
4 Participants
n=264 Participants
|
1 Participants
n=263 Participants
|
5 Participants
n=1056 Participants
|
|
Race/Ethnicity, Customized
White
|
224 Participants
n=264 Participants
|
213 Participants
n=265 Participants
|
229 Participants
n=264 Participants
|
218 Participants
n=263 Participants
|
884 Participants
n=1056 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
38 Participants
n=264 Participants
|
47 Participants
n=265 Participants
|
28 Participants
n=264 Participants
|
38 Participants
n=263 Participants
|
151 Participants
n=1056 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=264 Participants
|
2 Participants
n=265 Participants
|
4 Participants
n=264 Participants
|
3 Participants
n=263 Participants
|
10 Participants
n=1056 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=264 Participants
|
2 Participants
n=265 Participants
|
1 Participants
n=264 Participants
|
2 Participants
n=263 Participants
|
5 Participants
n=1056 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
0 Participants
n=264 Participants
|
1 Participants
n=265 Participants
|
0 Participants
n=264 Participants
|
0 Participants
n=263 Participants
|
1 Participants
n=1056 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=264 Participants
|
0 Participants
n=265 Participants
|
2 Participants
n=264 Participants
|
2 Participants
n=263 Participants
|
5 Participants
n=1056 Participants
|
|
Body mass index
|
30.35 kg/m^2
STANDARD_DEVIATION 6.552 • n=263 Participants • Note: 6 subjects did not have body mass index data.
|
30.89 kg/m^2
STANDARD_DEVIATION 7.380 • n=265 Participants • Note: 6 subjects did not have body mass index data.
|
30.69 kg/m^2
STANDARD_DEVIATION 6.818 • n=261 Participants • Note: 6 subjects did not have body mass index data.
|
31.25 kg/m^2
STANDARD_DEVIATION 6.758 • n=261 Participants • Note: 6 subjects did not have body mass index data.
|
30.80 kg/m^2
STANDARD_DEVIATION 6.883 • n=1050 Participants • Note: 6 subjects did not have body mass index data.
|
|
Vaccinated within 3 previous influenza seasons
Yes
|
190 Participants
n=264 Participants
|
188 Participants
n=265 Participants
|
194 Participants
n=264 Participants
|
188 Participants
n=263 Participants
|
760 Participants
n=1056 Participants
|
|
Vaccinated within 3 previous influenza seasons
No
|
74 Participants
n=264 Participants
|
77 Participants
n=265 Participants
|
70 Participants
n=264 Participants
|
75 Participants
n=263 Participants
|
296 Participants
n=1056 Participants
|
PRIMARY outcome
Timeframe: Day 1 and Day 29Population: Per Protocol Set, defined as all subjects in the Full Analysis Set\* who correctly received the vaccine; had no protocol deviations leading to exclusion as defined prior to unblinding/analysis; and were not excluded due to other reasons defined prior to unblinding or analysis, including subjects who withdrew informed consent prior to Day 28. \*All subjects in the All Enrolled Set who were randomized, received study vaccination and provided immunogenicity data on Day 1 and Day 29 assessment.
GMTs on Day 1 (prior to vaccination) and Day 29 as determined by HI assay against each of the 4 vaccine strains. No hypothesis testing was performed for the primary immunogenicity objectives.
Outcome measures
| Measure |
aIIV-B Investigational
n=257 Participants
Experimental: aIIV-B Investigational aIIV-B administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational aIIV-B Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, standard dose MF59), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
aIIV-C Investigational
n=259 Participants
Experimental: aIIV-C Investigational aIIV-C administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational aIIV-C Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, higher dose MF59), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
Licensed IIV
n=250 Participants
Active Comparator: Licensed IIV IIV administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Licensed IIV Licensed Non-adjuvanted Quadrivalent Influenza vaccine (standard HA dose), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
IIV-A Investigational
n=256 Participants
Experimental: IIV-A Investigational IIV-A administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational IIV-A Investigational Quadrivalent Influenza vaccine (higher HA dose), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
|---|---|---|---|---|
|
Immunogenicity Endpoint: Geometric Mean Titer (GMT): Geometric Mean of Hemagglutination Inhibition (HI) Antibodies at Day 1 and Day 29
A/H1N1 Day 1 HI GMT
|
33.09 Geometric mean titer
Interval 28.39 to 38.56
|
31.78 Geometric mean titer
Interval 27.26 to 37.04
|
39.29 Geometric mean titer
Interval 33.63 to 45.9
|
29.79 Geometric mean titer
Interval 25.54 to 34.74
|
|
Immunogenicity Endpoint: Geometric Mean Titer (GMT): Geometric Mean of Hemagglutination Inhibition (HI) Antibodies at Day 1 and Day 29
A/H1N1 Day 29 HI GMT
|
302.30 Geometric mean titer
Interval 261.92 to 348.92
|
369.57 Geometric mean titer
Interval 320.08 to 426.71
|
198.84 Geometric mean titer
Interval 171.89 to 230.02
|
286.95 Geometric mean titer
Interval 248.32 to 331.6
|
|
Immunogenicity Endpoint: Geometric Mean Titer (GMT): Geometric Mean of Hemagglutination Inhibition (HI) Antibodies at Day 1 and Day 29
A/H3N2 Day 1 HI GMT
|
35.11 Geometric mean titer
Interval 30.57 to 40.32
|
43.33 Geometric mean titer
Interval 37.72 to 49.78
|
39.80 Geometric mean titer
Interval 34.57 to 45.82
|
37.81 Geometric mean titer
Interval 32.89 to 43.46
|
|
Immunogenicity Endpoint: Geometric Mean Titer (GMT): Geometric Mean of Hemagglutination Inhibition (HI) Antibodies at Day 1 and Day 29
A/H3N2 Day 29 HI GMT
|
149.75 Geometric mean titer
Interval 132.15 to 169.69
|
171.38 Geometric mean titer
Interval 151.25 to 194.18
|
133.43 Geometric mean titer
Interval 117.54 to 151.47
|
140.71 Geometric mean titer
Interval 124.12 to 159.52
|
|
Immunogenicity Endpoint: Geometric Mean Titer (GMT): Geometric Mean of Hemagglutination Inhibition (HI) Antibodies at Day 1 and Day 29
B/Yamagata Day 1 HI GMT
|
10.49 Geometric mean titer
Interval 9.45 to 11.63
|
11.08 Geometric mean titer
Interval 9.99 to 12.29
|
11.03 Geometric mean titer
Interval 9.93 to 12.25
|
11.18 Geometric mean titer
Interval 10.07 to 12.4
|
|
Immunogenicity Endpoint: Geometric Mean Titer (GMT): Geometric Mean of Hemagglutination Inhibition (HI) Antibodies at Day 1 and Day 29
B/Yamagata Day 29 HI GMT
|
38.58 Geometric mean titer
Interval 34.61 to 43.0
|
51.61 Geometric mean titer
Interval 46.3 to 57.53
|
31.40 Geometric mean titer
Interval 28.12 to 35.06
|
35.11 Geometric mean titer
Interval 31.49 to 39.15
|
|
Immunogenicity Endpoint: Geometric Mean Titer (GMT): Geometric Mean of Hemagglutination Inhibition (HI) Antibodies at Day 1 and Day 29
B/Victoria Day 1 HI GMT
|
29.35 Geometric mean titer
Interval 25.48 to 33.79
|
32.05 Geometric mean titer
Interval 27.83 to 36.92
|
34.57 Geometric mean titer
Interval 29.94 to 39.9
|
27.39 Geometric mean titer
Interval 23.77 to 31.57
|
|
Immunogenicity Endpoint: Geometric Mean Titer (GMT): Geometric Mean of Hemagglutination Inhibition (HI) Antibodies at Day 1 and Day 29
B/Victoria Day 29 HI GMT
|
200.86 Geometric mean titer
Interval 173.7 to 232.27
|
232.61 Geometric mean titer
Interval 201.17 to 268.96
|
183.28 Geometric mean titer
Interval 158.18 to 212.37
|
210.22 Geometric mean titer
Interval 181.58 to 243.38
|
PRIMARY outcome
Timeframe: Day 1 to Day 29Population: Per Protocol Set
Geometric mean of the fold increase in serum HI titer postvaccination (Day 29) compared to prevaccination (Day 1) for each of the 4 vaccine strains.
Outcome measures
| Measure |
aIIV-B Investigational
n=257 Participants
Experimental: aIIV-B Investigational aIIV-B administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational aIIV-B Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, standard dose MF59), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
aIIV-C Investigational
n=259 Participants
Experimental: aIIV-C Investigational aIIV-C administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational aIIV-C Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, higher dose MF59), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
Licensed IIV
n=250 Participants
Active Comparator: Licensed IIV IIV administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Licensed IIV Licensed Non-adjuvanted Quadrivalent Influenza vaccine (standard HA dose), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
IIV-A Investigational
n=256 Participants
Experimental: IIV-A Investigational IIV-A administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational IIV-A Investigational Quadrivalent Influenza vaccine (higher HA dose), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
|---|---|---|---|---|
|
Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI) (HI Assay)
A/H1N1 HI GMFI (Day 29/Day 1)
|
8.57 Geometric mean fold increase
Interval 7.29 to 10.08
|
10.69 Geometric mean fold increase
Interval 9.09 to 12.57
|
5.18 Geometric mean fold increase
Interval 4.4 to 6.11
|
8.57 Geometric mean fold increase
Interval 7.28 to 10.08
|
|
Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI) (HI Assay)
A/H3N2 HI GMFI (Day 29/Day 1)
|
3.90 Geometric mean fold increase
Interval 3.39 to 4.48
|
4.06 Geometric mean fold increase
Interval 3.53 to 4.67
|
3.28 Geometric mean fold increase
Interval 2.85 to 3.78
|
3.54 Geometric mean fold increase
Interval 3.08 to 4.08
|
|
Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI) (HI Assay)
B/Yamagata HI GMFI (Day 29/Day 1)
|
3.46 Geometric mean fold increase
Interval 3.09 to 3.88
|
4.54 Geometric mean fold increase
Interval 4.05 to 5.09
|
2.77 Geometric mean fold increase
Interval 2.46 to 3.11
|
3.08 Geometric mean fold increase
Interval 2.75 to 3.45
|
|
Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI) (HI Assay)
B/Victoria HI GMFI (Day 29/Day 1)
|
6.21 Geometric mean fold increase
Interval 5.31 to 7.28
|
6.92 Geometric mean fold increase
Interval 5.91 to 8.11
|
5.27 Geometric mean fold increase
Interval 4.49 to 6.19
|
6.71 Geometric mean fold increase
Interval 5.72 to 7.86
|
PRIMARY outcome
Timeframe: Day 1 and Day 29Population: Per Protocol Set
Percentages of subjects with HI titers ≥1:40 at Day 1 and Day 29 for each of the 4 vaccine strains.
Outcome measures
| Measure |
aIIV-B Investigational
n=257 Participants
Experimental: aIIV-B Investigational aIIV-B administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational aIIV-B Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, standard dose MF59), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
aIIV-C Investigational
n=259 Participants
Experimental: aIIV-C Investigational aIIV-C administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational aIIV-C Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, higher dose MF59), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
Licensed IIV
n=250 Participants
Active Comparator: Licensed IIV IIV administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Licensed IIV Licensed Non-adjuvanted Quadrivalent Influenza vaccine (standard HA dose), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
IIV-A Investigational
n=256 Participants
Experimental: IIV-A Investigational IIV-A administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational IIV-A Investigational Quadrivalent Influenza vaccine (higher HA dose), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
|---|---|---|---|---|
|
Immunogenicity Endpoint: Percentages of Subjects With HI Titers ≥1:40 at Day 1 and Day 29
A/H1N1 HI titer ≥1:40 at Day 29
|
93.0 Percentage of participants
Interval 89.2 to 95.8
|
95.0 Percentage of participants
Interval 91.6 to 97.3
|
92.0 Percentage of participants
Interval 87.9 to 95.0
|
93.4 Percentage of participants
Interval 89.6 to 96.1
|
|
Immunogenicity Endpoint: Percentages of Subjects With HI Titers ≥1:40 at Day 1 and Day 29
A/H3N2 HI titer ≥1:40 at Day 1
|
54.9 Percentage of participants
Interval 48.6 to 61.1
|
60.6 Percentage of participants
Interval 54.4 to 66.6
|
61.6 Percentage of participants
Interval 55.3 to 67.7
|
57.0 Percentage of participants
Interval 50.7 to 63.2
|
|
Immunogenicity Endpoint: Percentages of Subjects With HI Titers ≥1:40 at Day 1 and Day 29
A/H3N2 HI titer ≥1:40 at Day 29
|
91.8 Percentage of participants
Interval 87.8 to 94.9
|
94.2 Percentage of participants
Interval 90.6 to 96.7
|
88.4 Percentage of participants
Interval 83.8 to 92.1
|
92.6 Percentage of participants
Interval 88.7 to 95.5
|
|
Immunogenicity Endpoint: Percentages of Subjects With HI Titers ≥1:40 at Day 1 and Day 29
A/H1N1 HI titer ≥1:40 at Day 1
|
55.6 Percentage of participants
Interval 49.3 to 61.8
|
54.8 Percentage of participants
Interval 48.5 to 61.0
|
62.0 Percentage of participants
Interval 55.7 to 68.0
|
53.9 Percentage of participants
Interval 47.6 to 60.1
|
|
Immunogenicity Endpoint: Percentages of Subjects With HI Titers ≥1:40 at Day 1 and Day 29
B/Yamagata HI titer ≥1:40 at Day 1
|
11.7 Percentage of participants
Interval 8.0 to 16.2
|
13.5 Percentage of participants
Interval 9.6 to 18.3
|
14.0 Percentage of participants
Interval 9.9 to 18.9
|
14.5 Percentage of participants
Interval 10.4 to 19.4
|
|
Immunogenicity Endpoint: Percentages of Subjects With HI Titers ≥1:40 at Day 1 and Day 29
B/Yamagata HI titer ≥1:40 at Day 29
|
52.9 Percentage of participants
Interval 46.6 to 59.2
|
66.4 Percentage of participants
Interval 60.3 to 72.1
|
51.2 Percentage of participants
Interval 44.8 to 57.5
|
51.6 Percentage of participants
Interval 45.3 to 57.8
|
|
Immunogenicity Endpoint: Percentages of Subjects With HI Titers ≥1:40 at Day 1 and Day 29
B/Victoria HI titer ≥1:40 at Day 1
|
51.8 Percentage of participants
Interval 45.5 to 58.0
|
52.9 Percentage of participants
Interval 46.6 to 59.1
|
56.8 Percentage of participants
Interval 50.4 to 63.0
|
48.8 Percentage of participants
Interval 42.6 to 55.1
|
|
Immunogenicity Endpoint: Percentages of Subjects With HI Titers ≥1:40 at Day 1 and Day 29
B/Victoria HI titer ≥1:40 at Day 29
|
92.2 Percentage of participants
Interval 88.2 to 95.2
|
93.8 Percentage of participants
Interval 90.2 to 96.4
|
92.4 Percentage of participants
Interval 88.4 to 95.4
|
90.6 Percentage of participants
Interval 86.4 to 93.9
|
PRIMARY outcome
Timeframe: Day 1 to Day 29Population: Per Protocol Set
Seroconversion is defined as ≥4-fold increase in titer postvaccination in those with prevaccination titer equal to or above the lower limit of quantitation (LLOQ; 1:10), or a postvaccination titer ≥1:40 for subjects with baseline titer below the LLOQ (1:10) for HI antibodies.
Outcome measures
| Measure |
aIIV-B Investigational
n=257 Participants
Experimental: aIIV-B Investigational aIIV-B administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational aIIV-B Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, standard dose MF59), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
aIIV-C Investigational
n=259 Participants
Experimental: aIIV-C Investigational aIIV-C administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational aIIV-C Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, higher dose MF59), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
Licensed IIV
n=250 Participants
Active Comparator: Licensed IIV IIV administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Licensed IIV Licensed Non-adjuvanted Quadrivalent Influenza vaccine (standard HA dose), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
IIV-A Investigational
n=256 Participants
Experimental: IIV-A Investigational IIV-A administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational IIV-A Investigational Quadrivalent Influenza vaccine (higher HA dose), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
|---|---|---|---|---|
|
Immunogenicity Endpoint: Percentage of Subjects With Seroconversion at Day 29 (HI Assay)
A/H1N1 Seroconversion at Day 29
|
63.0 Percentage of participants
Interval 56.8 to 69.0
|
68.7 Percentage of participants
Interval 62.7 to 74.3
|
45.2 Percentage of participants
Interval 38.9 to 51.6
|
63.3 Percentage of participants
Interval 57.1 to 69.2
|
|
Immunogenicity Endpoint: Percentage of Subjects With Seroconversion at Day 29 (HI Assay)
A/H3N2 Seroconversion at Day 29
|
44.7 Percentage of participants
Interval 38.6 to 51.1
|
45.9 Percentage of participants
Interval 39.8 to 52.2
|
39.2 Percentage of participants
Interval 33.1 to 45.6
|
42.6 Percentage of participants
Interval 36.4 to 48.9
|
|
Immunogenicity Endpoint: Percentage of Subjects With Seroconversion at Day 29 (HI Assay)
B/Yamagata Seroconversion at Day 29
|
36.2 Percentage of participants
Interval 30.3 to 42.4
|
44.8 Percentage of participants
Interval 38.6 to 51.1
|
25.6 Percentage of participants
Interval 20.3 to 31.5
|
28.9 Percentage of participants
Interval 23.4 to 34.9
|
|
Immunogenicity Endpoint: Percentage of Subjects With Seroconversion at Day 29 (HI Assay)
B/Victoria Seroconversion at Day 29
|
53.7 Percentage of participants
Interval 47.4 to 59.9
|
60.2 Percentage of participants
Interval 54.0 to 66.2
|
42.8 Percentage of participants
Interval 36.6 to 49.2
|
58.6 Percentage of participants
Interval 52.3 to 64.7
|
PRIMARY outcome
Timeframe: Day 29Population: Per Protocol Set Per protocol, for each of the three investigational groups, the data are analyzed together with the Licensed IIV group for the outcome measure of HI GMT ratio (Outcome Measure 5). The underlying HI GMT summary data used for this inferential calculation are reported in Outcome Measure 1.
The GMT ratio is the geometric mean of the postvaccination HI titer for the investigational vaccine over the geometric mean of the postvaccination HI titer for the licensed IIV vaccine. The Day 29 GMT ratios are calculated for the investigational vaccines with reference to the licensed vaccine, ie, the Day 29 GMT ratios are the ratio of the Day 29 GMTs in the Investigational group (IIV-A Investigational, aIIV-B Investigational, or aIIV-C Investigational) compared with the Day 29 GMTs in the Licensed IIV group (ie, Investigational group/Licensed IIV group). As the licensed vaccine is the reference for the GMT ratio, this parameter is presented as "1" for the Licensed IIV group (ie, Licensed IIV group/Licensed IIV group).
Outcome measures
| Measure |
aIIV-B Investigational
n=257 Participants
Experimental: aIIV-B Investigational aIIV-B administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational aIIV-B Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, standard dose MF59), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
aIIV-C Investigational
n=259 Participants
Experimental: aIIV-C Investigational aIIV-C administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational aIIV-C Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, higher dose MF59), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
Licensed IIV
n=250 Participants
Active Comparator: Licensed IIV IIV administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Licensed IIV Licensed Non-adjuvanted Quadrivalent Influenza vaccine (standard HA dose), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
IIV-A Investigational
n=256 Participants
Experimental: IIV-A Investigational IIV-A administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational IIV-A Investigational Quadrivalent Influenza vaccine (higher HA dose), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
|---|---|---|---|---|
|
Immunogenicity Endpoint: GMT Ratio (HI Assay)
A/H1N1 Day 29 HI GMT Ratio
|
1.52 GMT ratio
Interval 1.25 to 1.85
|
1.86 GMT ratio
Interval 1.52 to 2.27
|
1 GMT ratio
Confidence intervals do not apply for a GMT ratio based on two identical data sets
|
1.44 GMT ratio
Interval 1.18 to 1.76
|
|
Immunogenicity Endpoint: GMT Ratio (HI Assay)
A/H3N2 Day 29 HI GMT Ratio
|
1.12 GMT ratio
Interval 0.94 to 1.33
|
1.28 GMT ratio
Interval 1.08 to 1.53
|
1 GMT ratio
Confidence intervals do not apply for a GMT ratio based on two identical data sets
|
1.05 GMT ratio
Interval 0.89 to 1.25
|
|
Immunogenicity Endpoint: GMT Ratio (HI Assay)
B/Yamagata Day 29 HI GMT Ratio
|
1.23 GMT ratio
Interval 1.06 to 1.43
|
1.64 GMT ratio
Interval 1.42 to 1.91
|
1 GMT ratio
Confidence intervals do not apply for a GMT ratio based on two identical data sets
|
1.12 GMT ratio
Interval 0.96 to 1.3
|
|
Immunogenicity Endpoint: GMT Ratio (HI Assay)
B/Victoria Day 29 HI GMT Ratio
|
1.10 GMT ratio
Interval 0.9 to 1.34
|
1.27 GMT ratio
Interval 1.04 to 1.55
|
1 GMT ratio
Confidence intervals do not apply for a GMT ratio based on two identical data sets
|
1.15 GMT ratio
Interval 0.94 to 1.4
|
PRIMARY outcome
Timeframe: Day 1 through Day 7Population: Solicited Safety Set, defined as all subjects in the Exposed Set with any solicited safety data recorded by the subject in the eDiary, including solicited AEs, body temperature measurements or use of analgesics/antipyretics.
Number and percentage of subjects with solicited local or systemic AEs for 7 days following vaccination, based on the subject reported data (electronic Diary \[eDiary\]). No hypothesis testing was performed for the primary safety objectives.
Outcome measures
| Measure |
aIIV-B Investigational
n=255 Participants
Experimental: aIIV-B Investigational aIIV-B administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational aIIV-B Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, standard dose MF59), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
aIIV-C Investigational
n=249 Participants
Experimental: aIIV-C Investigational aIIV-C administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational aIIV-C Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, higher dose MF59), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
Licensed IIV
n=250 Participants
Active Comparator: Licensed IIV IIV administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Licensed IIV Licensed Non-adjuvanted Quadrivalent Influenza vaccine (standard HA dose), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
IIV-A Investigational
n=253 Participants
Experimental: IIV-A Investigational IIV-A administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational IIV-A Investigational Quadrivalent Influenza vaccine (higher HA dose), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
|---|---|---|---|---|
|
Solicited Local or Systemic AEs
Any solicited AE
|
146 Participants
|
177 Participants
|
126 Participants
|
148 Participants
|
|
Solicited Local or Systemic AEs
Any local solicited AE
|
116 Participants
|
146 Participants
|
59 Participants
|
94 Participants
|
|
Solicited Local or Systemic AEs
Any systemic solicited AE
|
93 Participants
|
124 Participants
|
107 Participants
|
117 Participants
|
|
Solicited Local or Systemic AEs
Use of antipyretic/analgesics
|
36 Participants
|
51 Participants
|
33 Participants
|
33 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 7Population: Solicited Safety Set
Number and percentage of subjects with severe solicited local or systemic AEs for 7 days following vaccination, based on the subject reported data (eDiary).
Outcome measures
| Measure |
aIIV-B Investigational
n=255 Participants
Experimental: aIIV-B Investigational aIIV-B administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational aIIV-B Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, standard dose MF59), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
aIIV-C Investigational
n=249 Participants
Experimental: aIIV-C Investigational aIIV-C administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational aIIV-C Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, higher dose MF59), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
Licensed IIV
n=250 Participants
Active Comparator: Licensed IIV IIV administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Licensed IIV Licensed Non-adjuvanted Quadrivalent Influenza vaccine (standard HA dose), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
IIV-A Investigational
n=253 Participants
Experimental: IIV-A Investigational IIV-A administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational IIV-A Investigational Quadrivalent Influenza vaccine (higher HA dose), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
|---|---|---|---|---|
|
Severe Solicited Local or Systemic AEs
Severe solicited systemic AEs
|
2 Participants
|
10 Participants
|
2 Participants
|
8 Participants
|
|
Severe Solicited Local or Systemic AEs
Severe solicited local AEs
|
2 Participants
|
5 Participants
|
1 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 29Population: Unsolicited Safety Set, defined as all subjects in the All Exposed Set for whom safety was assessed after vaccination.
Number and percentage of subjects with unsolicited AEs for 28 days following vaccination
Outcome measures
| Measure |
aIIV-B Investigational
n=263 Participants
Experimental: aIIV-B Investigational aIIV-B administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational aIIV-B Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, standard dose MF59), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
aIIV-C Investigational
n=262 Participants
Experimental: aIIV-C Investigational aIIV-C administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational aIIV-C Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, higher dose MF59), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
Licensed IIV
n=262 Participants
Active Comparator: Licensed IIV IIV administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Licensed IIV Licensed Non-adjuvanted Quadrivalent Influenza vaccine (standard HA dose), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
IIV-A Investigational
n=264 Participants
Experimental: IIV-A Investigational IIV-A administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational IIV-A Investigational Quadrivalent Influenza vaccine (higher HA dose), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
|---|---|---|---|---|
|
Unsolicited AEs
Any unsolicited AE
|
10 Participants
|
24 Participants
|
24 Participants
|
30 Participants
|
|
Unsolicited AEs
Any related unsolicited AE
|
2 Participants
|
7 Participants
|
5 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 181Population: Unsolicited Safety Set, defined as all subjects in the All Exposed Set for whom safety was assessed after vaccination.
Number and percentage of subjects with SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs
Outcome measures
| Measure |
aIIV-B Investigational
n=263 Participants
Experimental: aIIV-B Investigational aIIV-B administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational aIIV-B Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, standard dose MF59), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
aIIV-C Investigational
n=262 Participants
Experimental: aIIV-C Investigational aIIV-C administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational aIIV-C Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, higher dose MF59), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
Licensed IIV
n=262 Participants
Active Comparator: Licensed IIV IIV administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Licensed IIV Licensed Non-adjuvanted Quadrivalent Influenza vaccine (standard HA dose), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
IIV-A Investigational
n=264 Participants
Experimental: IIV-A Investigational IIV-A administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational IIV-A Investigational Quadrivalent Influenza vaccine (higher HA dose), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
|---|---|---|---|---|
|
Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESIs) and Medically-attended Adverse Events (MAAEs)
Any SAE
|
5 Participants
|
4 Participants
|
10 Participants
|
8 Participants
|
|
Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESIs) and Medically-attended Adverse Events (MAAEs)
Any related SAE
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESIs) and Medically-attended Adverse Events (MAAEs)
Any AE leading to withdrawal
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESIs) and Medically-attended Adverse Events (MAAEs)
Any AESI
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESIs) and Medically-attended Adverse Events (MAAEs)
Any non-serious MAAE
|
33 Participants
|
38 Participants
|
42 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: Day 1 and Day 29Population: Per Protocol Set
GMTs on Day 1 (prior to vaccination) and Day 29 as determined by MN assay against each of the 4 vaccine strains.
Outcome measures
| Measure |
aIIV-B Investigational
n=257 Participants
Experimental: aIIV-B Investigational aIIV-B administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational aIIV-B Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, standard dose MF59), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
aIIV-C Investigational
n=259 Participants
Experimental: aIIV-C Investigational aIIV-C administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational aIIV-C Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, higher dose MF59), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
Licensed IIV
n=250 Participants
Active Comparator: Licensed IIV IIV administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Licensed IIV Licensed Non-adjuvanted Quadrivalent Influenza vaccine (standard HA dose), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
IIV-A Investigational
n=256 Participants
Experimental: IIV-A Investigational IIV-A administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational IIV-A Investigational Quadrivalent Influenza vaccine (higher HA dose), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
|---|---|---|---|---|
|
Immunogenicity Endpoint: GMT: Geometric Mean of Microneutralization (MN) Antibodies Titer at Days 1 and 29
A/H1N1 Day 1 MN GMT
|
152.69 Geometric mean titer
Interval 137.67 to 169.36
|
172.00 Geometric mean titer
Interval 155.05 to 190.8
|
174.39 Geometric mean titer
Interval 156.96 to 193.76
|
159.95 Geometric mean titer
Interval 144.14 to 177.51
|
|
Immunogenicity Endpoint: GMT: Geometric Mean of Microneutralization (MN) Antibodies Titer at Days 1 and 29
A/H1N1 Day 29 MN GMT
|
661.34 Geometric mean titer
Interval 591.17 to 739.84
|
759.48 Geometric mean titer
Interval 679.03 to 849.47
|
475.49 Geometric mean titer
Interval 424.4 to 532.73
|
603.49 Geometric mean titer
Interval 539.24 to 675.38
|
|
Immunogenicity Endpoint: GMT: Geometric Mean of Microneutralization (MN) Antibodies Titer at Days 1 and 29
A/H3N2 Day 1 MN GMT
|
28.99 Geometric mean titer
Interval 25.04 to 33.56
|
31.31 Geometric mean titer
Interval 27.04 to 36.26
|
29.94 Geometric mean titer
Interval 25.8 to 34.75
|
28.43 Geometric mean titer
Interval 24.54 to 32.94
|
|
Immunogenicity Endpoint: GMT: Geometric Mean of Microneutralization (MN) Antibodies Titer at Days 1 and 29
A/H3N2 Day 29 MN GMT
|
134.63 Geometric mean titer
Interval 118.79 to 152.58
|
158.37 Geometric mean titer
Interval 139.71 to 179.52
|
105.67 Geometric mean titer
Interval 93.04 to 120.01
|
125.78 Geometric mean titer
Interval 110.91 to 142.65
|
|
Immunogenicity Endpoint: GMT: Geometric Mean of Microneutralization (MN) Antibodies Titer at Days 1 and 29
B/Yamagata Day 1 MN GMT
|
107.12 Geometric mean titer
Interval 96.15 to 119.34
|
106.24 Geometric mean titer
Interval 95.34 to 118.37
|
100.57 Geometric mean titer
Interval 90.11 to 112.24
|
99.60 Geometric mean titer
Interval 89.35 to 111.03
|
|
Immunogenicity Endpoint: GMT: Geometric Mean of Microneutralization (MN) Antibodies Titer at Days 1 and 29
B/Yamagata Day 29 MN GMT
|
315.46 Geometric mean titer
Interval 284.51 to 349.77
|
417.80 Geometric mean titer
Interval 376.74 to 463.33
|
274.34 Geometric mean titer
Interval 246.95 to 304.77
|
319.34 Geometric mean titer
Interval 287.79 to 354.35
|
|
Immunogenicity Endpoint: GMT: Geometric Mean of Microneutralization (MN) Antibodies Titer at Days 1 and 29
B/Victoria Day 1 MN GMT
|
202.90 Geometric mean titer
Interval 174.62 to 235.75
|
195.97 Geometric mean titer
Interval 168.62 to 227.75
|
215.80 Geometric mean titer
Interval 185.26 to 251.37
|
176.85 Geometric mean titer
Interval 152.08 to 205.65
|
|
Immunogenicity Endpoint: GMT: Geometric Mean of Microneutralization (MN) Antibodies Titer at Days 1 and 29
B/Victoria Day 29 MN GMT
|
1771.75 Geometric mean titer
Interval 1532.35 to 2048.54
|
2181.94 Geometric mean titer
Interval 1886.48 to 2523.68
|
1451.90 Geometric mean titer
Interval 1252.81 to 1682.61
|
1747.02 Geometric mean titer
Interval 1508.87 to 2022.77
|
SECONDARY outcome
Timeframe: Day 1 to Day 29Population: Per Protocol Set
Geometric mean of the fold increase in serum MN titer postvaccination (Day 29) compared to prevaccination (Day 1) for each of the 4 vaccine strains.
Outcome measures
| Measure |
aIIV-B Investigational
n=257 Participants
Experimental: aIIV-B Investigational aIIV-B administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational aIIV-B Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, standard dose MF59), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
aIIV-C Investigational
n=259 Participants
Experimental: aIIV-C Investigational aIIV-C administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational aIIV-C Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, higher dose MF59), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
Licensed IIV
n=250 Participants
Active Comparator: Licensed IIV IIV administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Licensed IIV Licensed Non-adjuvanted Quadrivalent Influenza vaccine (standard HA dose), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
IIV-A Investigational
n=256 Participants
Experimental: IIV-A Investigational IIV-A administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational IIV-A Investigational Quadrivalent Influenza vaccine (higher HA dose), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
|---|---|---|---|---|
|
Immunogenicity Endpoint: GMFI (MN Assay)
A/H1N1 MN GMFI (Day 29/Day 1)
|
4.01 Geometric mean fold increase
Interval 3.56 to 4.53
|
4.37 Geometric mean fold increase
Interval 3.87 to 4.93
|
2.72 Geometric mean fold increase
Interval 2.41 to 3.08
|
3.59 Geometric mean fold increase
Interval 3.18 to 4.05
|
|
Immunogenicity Endpoint: GMFI (MN Assay)
A/H3N2 MN GMFI (Day 29/Day 1)
|
4.48 Geometric mean fold increase
Interval 3.94 to 5.1
|
5.19 Geometric mean fold increase
Interval 4.56 to 5.91
|
3.50 Geometric mean fold increase
Interval 3.07 to 3.99
|
4.21 Geometric mean fold increase
Interval 3.7 to 4.79
|
|
Immunogenicity Endpoint: GMFI (MN Assay)
B/Yamagata MN GMFI (Day 29/Day 1)
|
2.84 Geometric mean fold increase
Interval 2.54 to 3.16
|
3.77 Geometric mean fold increase
Interval 3.38 to 4.2
|
2.52 Geometric mean fold increase
Interval 2.25 to 2.82
|
2.94 Geometric mean fold increase
Interval 2.64 to 3.29
|
|
Immunogenicity Endpoint: GMFI (MN Assay)
B/Victoria MN GMFI (Day 29/Day 1)
|
8.33 Geometric mean fold increase
Interval 7.03 to 9.87
|
10.47 Geometric mean fold increase
Interval 8.84 to 12.41
|
6.59 Geometric mean fold increase
Interval 5.54 to 7.83
|
8.91 Geometric mean fold increase
Interval 7.51 to 10.56
|
SECONDARY outcome
Timeframe: Day 1 to Day 29Population: Per Protocol Set
Seroconversion is defined as ≥4-fold increase for subjects with prevaccination MN titers ≥LLOQ (1:10) or as ≥4\*LLOQ (1:10) for subjects with prevaccination MN titer \<LLOQ.
Outcome measures
| Measure |
aIIV-B Investigational
n=257 Participants
Experimental: aIIV-B Investigational aIIV-B administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational aIIV-B Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, standard dose MF59), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
aIIV-C Investigational
n=259 Participants
Experimental: aIIV-C Investigational aIIV-C administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational aIIV-C Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, higher dose MF59), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
Licensed IIV
n=250 Participants
Active Comparator: Licensed IIV IIV administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Licensed IIV Licensed Non-adjuvanted Quadrivalent Influenza vaccine (standard HA dose), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
IIV-A Investigational
n=256 Participants
Experimental: IIV-A Investigational IIV-A administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational IIV-A Investigational Quadrivalent Influenza vaccine (higher HA dose), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
|---|---|---|---|---|
|
Immunogenicity Endpoint: Percentages of Subjects With Seroconversion at Day 29 (MN Assay)
B/Victoria Seroconversion at Day 29
|
60.3 Percentage of participants
Interval 54.0 to 66.3
|
70.7 Percentage of participants
Interval 64.7 to 76.1
|
50.0 Percentage of participants
Interval 43.6 to 56.4
|
64.8 Percentage of participants
Interval 58.7 to 70.7
|
|
Immunogenicity Endpoint: Percentages of Subjects With Seroconversion at Day 29 (MN Assay)
A/H1N1 Seroconversion at Day 29
|
40.5 Percentage of participants
Interval 34.4 to 46.7
|
44.0 Percentage of participants
Interval 37.9 to 50.3
|
24.0 Percentage of participants
Interval 18.8 to 29.8
|
37.5 Percentage of participants
Interval 31.5 to 43.7
|
|
Immunogenicity Endpoint: Percentages of Subjects With Seroconversion at Day 29 (MN Assay)
A/H3N2 Seroconversion at Day 29
|
49.4 Percentage of participants
Interval 43.1 to 55.7
|
58.7 Percentage of participants
Interval 52.4 to 64.7
|
41.2 Percentage of participants
Interval 35.0 to 47.6
|
46.9 Percentage of participants
Interval 40.6 to 53.2
|
|
Immunogenicity Endpoint: Percentages of Subjects With Seroconversion at Day 29 (MN Assay)
B/Yamagata Seroconversion at Day 29
|
26.1 Percentage of participants
Interval 20.8 to 31.9
|
42.1 Percentage of participants
Interval 36.0 to 48.4
|
22.8 Percentage of participants
Interval 17.7 to 28.5
|
28.9 Percentage of participants
Interval 23.4 to 34.9
|
SECONDARY outcome
Timeframe: Day 29Population: Per Protocol Set Per protocol, for each of the three investigational groups, the data are analyzed together with the Licensed IIV group for the outcome measure of MN GMT ratio (Outcome Measure 13). The underlying MN GMT summary data used for this inferential calculation are reported in Outcome Measure 10.
The GMT ratio is the geometric mean of the postvaccination HI titer for the investigational vaccine over the geometric mean of the postvaccination HI titer for the licensed IIV vaccine. The Day 29 GMT ratios are calculated for the investigational vaccines with reference to the licensed vaccine, ie, the Day 29 GMT ratios are the ratio of the Day 29 GMTs in the Investigational group (IIV-A Investigational, aIIV-B Investigational, or aIIV-C Investigational) compared with the Day 29 GMTs in the Licensed IIV group (ie, Investigational group/Licensed IIV group). As the licensed vaccine is the reference for the GMT ratio, this parameter is presented as "1" for the Licensed IIV group (ie, Licensed IIV group/Licensed IIV group).
Outcome measures
| Measure |
aIIV-B Investigational
n=257 Participants
Experimental: aIIV-B Investigational aIIV-B administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational aIIV-B Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, standard dose MF59), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
aIIV-C Investigational
n=259 Participants
Experimental: aIIV-C Investigational aIIV-C administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational aIIV-C Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, higher dose MF59), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
Licensed IIV
n=250 Participants
Active Comparator: Licensed IIV IIV administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Licensed IIV Licensed Non-adjuvanted Quadrivalent Influenza vaccine (standard HA dose), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
IIV-A Investigational
n=256 Participants
Experimental: IIV-A Investigational IIV-A administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational IIV-A Investigational Quadrivalent Influenza vaccine (higher HA dose), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
|---|---|---|---|---|
|
Immunogenicity Endpoint: GMT Ratio (MN Assay)
B/Yamagata Day 29 MN GMT Ratio
|
1.15 GMT ratio
Interval 1.0 to 1.33
|
1.52 GMT ratio
Interval 1.32 to 1.76
|
1 GMT ratio
Confidence intervals do not apply for a GMT ratio based on two identical data sets
|
1.16 GMT ratio
Interval 1.01 to 1.34
|
|
Immunogenicity Endpoint: GMT Ratio (MN Assay)
A/H1N1 Day 29 MN GMT Ratio
|
1.39 GMT ratio
Interval 1.19 to 1.62
|
1.60 GMT ratio
Interval 1.37 to 1.86
|
1 GMT ratio
Confidence intervals do not apply for a GMT ratio based on two identical data sets
|
1.27 GMT ratio
Interval 1.09 to 1.48
|
|
Immunogenicity Endpoint: GMT Ratio (MN Assay)
A/H3N2 Day 29 MN GMT Ratio
|
1.27 GMT ratio
Interval 1.07 to 1.51
|
1.50 GMT ratio
Interval 1.26 to 1.78
|
1 GMT ratio
Confidence intervals do not apply for a GMT ratio based on two identical data sets
|
1.19 GMT ratio
Interval 1.0 to 1.42
|
|
Immunogenicity Endpoint: GMT Ratio (MN Assay)
B/Victoria Day 29 MN GMT Ratio
|
1.22 GMT ratio
Interval 1.0 to 1.49
|
1.50 GMT ratio
Interval 1.23 to 1.84
|
1 GMT ratio
Confidence intervals do not apply for a GMT ratio based on two identical data sets
|
1.20 GMT ratio
Interval 0.98 to 1.47
|
Adverse Events
IIV-A Investigational
Serious events: 8 serious events
Other events: 161 other events
Deaths: 0 deaths
aIIV-B Investigational
Serious events: 5 serious events
Other events: 162 other events
Deaths: 0 deaths
aIIV-C Investigational
Serious events: 4 serious events
Other events: 190 other events
Deaths: 1 deaths
Licensed IIV
Serious events: 10 serious events
Other events: 141 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IIV-A Investigational
n=264 participants at risk
Experimental: IIV-A Investigational IIV-A administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational IIV-A Investigational Quadrivalent Influenza vaccine (higher HA dose), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
aIIV-B Investigational
n=263 participants at risk
Experimental: aIIV-B Investigational aIIV-B administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational aIIV-B Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, standard dose MF59), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
aIIV-C Investigational
n=262 participants at risk
Experimental: aIIV-C Investigational aIIV-C administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational aIIV-C Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, higher dose MF59), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
Licensed IIV
n=262 participants at risk
Active Comparator: Licensed IIV IIV administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Licensed IIV Licensed Non-adjuvanted Quadrivalent Influenza vaccine (standard HA dose), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
|---|---|---|---|---|
|
General disorders
Chest pain
|
0.38%
1/264 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/263 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
|
Cardiac disorders
Acute cardiac event
|
0.00%
0/264 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/263 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.38%
1/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/264 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/263 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.38%
1/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.38%
1/264 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/263 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/264 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.38%
1/263 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.38%
1/264 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/263 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.38%
1/264 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/263 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/264 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/263 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.38%
1/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/264 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/263 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.38%
1/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/264 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/263 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.38%
1/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
|
Infections and infestations
Influenza
|
0.38%
1/264 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/263 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.38%
1/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/264 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/263 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.38%
1/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
|
Infections and infestations
Cystitis
|
0.00%
0/264 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/263 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.38%
1/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/264 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.38%
1/263 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/264 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/263 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.38%
1/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/264 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/263 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.38%
1/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/264 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/263 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.38%
1/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.38%
1/264 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/263 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.38%
1/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/264 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/263 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.38%
1/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.38%
1/264 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/263 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of prostate
|
0.00%
0/264 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/263 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.38%
1/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hormone receptor positive HER2 negative breast cancer
|
0.38%
1/264 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/263 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.00%
0/264 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/263 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.38%
1/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/264 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.38%
1/263 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/264 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/263 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.38%
1/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/264 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/263 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.38%
1/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/264 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.38%
1/263 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
|
Nervous system disorders
Syncope
|
0.00%
0/264 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.38%
1/263 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.38%
1/264 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/263 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.76%
2/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/264 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/263 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.38%
1/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/264 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/263 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.38%
1/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/264 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/263 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.38%
1/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/264 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/263 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.00%
0/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
0.38%
1/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
Other adverse events
| Measure |
IIV-A Investigational
n=264 participants at risk
Experimental: IIV-A Investigational IIV-A administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational IIV-A Investigational Quadrivalent Influenza vaccine (higher HA dose), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
aIIV-B Investigational
n=263 participants at risk
Experimental: aIIV-B Investigational aIIV-B administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational aIIV-B Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, standard dose MF59), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
aIIV-C Investigational
n=262 participants at risk
Experimental: aIIV-C Investigational aIIV-C administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Investigational aIIV-C Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, higher dose MF59), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
Licensed IIV
n=262 participants at risk
Active Comparator: Licensed IIV IIV administered as a single dose intramuscularly on Day 1: Biological/Vaccine: Licensed IIV Licensed Non-adjuvanted Quadrivalent Influenza vaccine (standard HA dose), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
4.9%
13/264 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
6.1%
16/263 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
7.3%
19/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
4.2%
11/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
|
General disorders
Injection Site Pain
|
33.7%
89/264 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
42.6%
112/263 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
55.3%
145/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
21.0%
55/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
|
General disorders
Fatigue
|
33.7%
89/264 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
28.5%
75/263 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
38.9%
102/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
29.8%
78/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.6%
36/264 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
13.3%
35/263 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
19.1%
50/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
11.1%
29/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.1%
32/264 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
8.4%
22/263 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
14.5%
38/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
9.2%
24/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
|
Nervous system disorders
Headache
|
23.5%
62/264 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
18.3%
48/263 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
19.1%
50/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
19.8%
52/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
|
Skin and subcutaneous tissue disorders
Induration
|
3.4%
9/264 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
4.6%
12/263 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
8.8%
23/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
1.5%
4/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
4.5%
12/264 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
4.2%
11/263 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
6.1%
16/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
2.7%
7/262 • All-Cause Mortality, SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs are reported from Day 1 to Day 181; all unsolicited AEs are reported from Day 1 to Day 29. Solicited AEs are reported from Day 1 to Day 7.
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs). All-cause mortality and SAEs are reported for the Unsolicited Safety Set. Nonserious unsolicited AEs and solicited AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set or Unsolicited Safety Set). During the study 1 death occurred in a subject in the aIIV-C group, which was due to an acute cardiac event and assessed as unrelated to the study vaccine.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Any publication by Institution or Investigator shall not be made before the first multicenter publication of the entire study results. Seqirus must be notified of any intent to publish data collected from the study and prior approval from Seqirus must be obtained prior to submission for publication.
- Publication restrictions are in place
Restriction type: OTHER