Trial Outcomes & Findings for Safety and Immunogenicity of Different Formulations of an MF59-Adjuvanted Influenza Vaccine in Older Adults (NCT NCT04782323)
NCT ID: NCT04782323
Last Updated: 2024-10-10
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
839 participants
Primary outcome timeframe
[28 days post-vaccination]
Results posted on
2024-10-10
Participant Flow
Participant milestones
| Measure |
Group H Licensed QII Active Comparator
Licensed QII Active Comparator: Biological/Vaccine: Licensed QII Active Comparator Licensed Quadrivalent Influenza vaccine, 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.
|
Group A aQII-1 Investigational
aQII-1: Biological/Vaccine: Investigational aQII-1 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group E aQII-9 Investigational
aQII-9 Investigational: Biological/Vaccine: Investigational aQII-9 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group C aQII-6 Investigational
aQII-6 Investigational: Biological/Vaccine: Investigational aQII-6 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group F aQII-10 Investigational
aQII-10 Investigational: Biological/Vaccine: Investigational aQII-10 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group B aQII-3 Investigational
aQII-3 Investigational: Biological/Vaccine: Investigational aQII-3 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group D aQII-7 Investigational
aQII-7 Investigational: Biological/Vaccine: Investigational aQII-7 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group G aQII-11 Investigational
aQII-11 Investigational: Biological/Vaccine: Investigational aQII-11 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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
|
98
|
107
|
107
|
103
|
106
|
108
|
101
|
109
|
|
Overall Study
COMPLETED
|
96
|
106
|
105
|
103
|
105
|
105
|
99
|
106
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
2
|
0
|
1
|
3
|
2
|
3
|
Reasons for withdrawal
| Measure |
Group H Licensed QII Active Comparator
Licensed QII Active Comparator: Biological/Vaccine: Licensed QII Active Comparator Licensed Quadrivalent Influenza vaccine, 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.
|
Group A aQII-1 Investigational
aQII-1: Biological/Vaccine: Investigational aQII-1 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group E aQII-9 Investigational
aQII-9 Investigational: Biological/Vaccine: Investigational aQII-9 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group C aQII-6 Investigational
aQII-6 Investigational: Biological/Vaccine: Investigational aQII-6 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group F aQII-10 Investigational
aQII-10 Investigational: Biological/Vaccine: Investigational aQII-10 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group B aQII-3 Investigational
aQII-3 Investigational: Biological/Vaccine: Investigational aQII-3 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group D aQII-7 Investigational
aQII-7 Investigational: Biological/Vaccine: Investigational aQII-7 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group G aQII-11 Investigational
aQII-11 Investigational: Biological/Vaccine: Investigational aQII-11 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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
|
1
|
0
|
0
|
0
|
1
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
0
|
0
|
1
|
1
|
2
|
|
Overall Study
randomization in error
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Safety and Immunogenicity of Different Formulations of an MF59-Adjuvanted Influenza Vaccine in Older Adults
Baseline characteristics by cohort
| Measure |
Group H Licensed QII Active Comparator
n=98 Participants
Licensed QII Active Comparator: Biological/Vaccine: Licensed QII Active Comparator Licensed Quadrivalent Influenza vaccine, 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.
|
Group A aQII-1 Investigational
n=107 Participants
aQII-1: Biological/Vaccine: Investigational aQII-1 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group E aQII-9 Investigational
n=107 Participants
aQII-9 Investigational: Biological/Vaccine: Investigational aQII-9 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group C aQII-6 Investigational
n=103 Participants
aQII-6 Investigational: Biological/Vaccine: Investigational aQII-6 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group F aQII-10 Investigational
n=106 Participants
aQII-10 Investigational: Biological/Vaccine: Investigational aQII-10 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group B aQII-3 Investigational
n=108 Participants
aQII-3 Investigational: Biological/Vaccine: Investigational aQII-3 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group D aQII-7 Investigational
n=101 Participants
aQII-7 Investigational: Biological/Vaccine: Investigational aQII-7 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group G aQII-11 Investigational
n=109 Participants
aQII-11 Investigational: Biological/Vaccine: Investigational aQII-11 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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=839 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
52 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
58 Participants
n=21 Participants
|
58 Participants
n=8 Participants
|
54 Participants
n=8 Participants
|
60 Participants
n=24 Participants
|
442 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
46 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
50 Participants
n=8 Participants
|
47 Participants
n=8 Participants
|
49 Participants
n=24 Participants
|
397 Participants
n=42 Participants
|
|
Age, Continuous
|
63.4 years
STANDARD_DEVIATION 7.68 • n=5 Participants
|
63.6 years
STANDARD_DEVIATION 8.91 • n=7 Participants
|
63.6 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
63.3 years
STANDARD_DEVIATION 8.48 • n=4 Participants
|
62.8 years
STANDARD_DEVIATION 8.22 • n=21 Participants
|
63.5 years
STANDARD_DEVIATION 8.82 • n=8 Participants
|
64.4 years
STANDARD_DEVIATION 9.12 • n=8 Participants
|
63.1 years
STANDARD_DEVIATION 8.5 • n=24 Participants
|
63.5 years
STANDARD_DEVIATION 8.47 • n=42 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
57 Participants
n=21 Participants
|
49 Participants
n=8 Participants
|
53 Participants
n=8 Participants
|
59 Participants
n=24 Participants
|
475 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
59 Participants
n=8 Participants
|
48 Participants
n=8 Participants
|
50 Participants
n=24 Participants
|
364 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
white
|
56 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
61 Participants
n=21 Participants
|
58 Participants
n=8 Participants
|
58 Participants
n=8 Participants
|
63 Participants
n=24 Participants
|
469 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
black or african american
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
13 Participants
n=8 Participants
|
17 Participants
n=24 Participants
|
111 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
asian
|
21 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
18 Participants
n=8 Participants
|
16 Participants
n=8 Participants
|
18 Participants
n=24 Participants
|
147 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
native hawaiian or other pacific islander
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
15 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
other
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
10 Participants
n=24 Participants
|
97 Participants
n=42 Participants
|
|
Region of Enrollment
New Zealand
|
29 participants
n=5 Participants
|
32 participants
n=7 Participants
|
32 participants
n=5 Participants
|
30 participants
n=4 Participants
|
30 participants
n=21 Participants
|
33 participants
n=8 Participants
|
29 participants
n=8 Participants
|
31 participants
n=24 Participants
|
246 participants
n=42 Participants
|
|
Region of Enrollment
Philippines
|
15 participants
n=5 Participants
|
11 participants
n=7 Participants
|
16 participants
n=5 Participants
|
17 participants
n=4 Participants
|
12 participants
n=21 Participants
|
13 participants
n=8 Participants
|
12 participants
n=8 Participants
|
13 participants
n=24 Participants
|
109 participants
n=42 Participants
|
|
Region of Enrollment
South Africa
|
18 participants
n=5 Participants
|
27 participants
n=7 Participants
|
21 participants
n=5 Participants
|
20 participants
n=4 Participants
|
26 participants
n=21 Participants
|
24 participants
n=8 Participants
|
20 participants
n=8 Participants
|
25 participants
n=24 Participants
|
181 participants
n=42 Participants
|
|
Region of Enrollment
Australia
|
36 participants
n=5 Participants
|
37 participants
n=7 Participants
|
38 participants
n=5 Participants
|
36 participants
n=4 Participants
|
38 participants
n=21 Participants
|
38 participants
n=8 Participants
|
40 participants
n=8 Participants
|
40 participants
n=24 Participants
|
303 participants
n=42 Participants
|
|
vaccinated within 3 previous influenza season
Yes
|
60 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
62 Participants
n=21 Participants
|
65 Participants
n=8 Participants
|
61 Participants
n=8 Participants
|
63 Participants
n=24 Participants
|
506 Participants
n=42 Participants
|
|
vaccinated within 3 previous influenza season
No
|
38 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
43 Participants
n=8 Participants
|
40 Participants
n=8 Participants
|
46 Participants
n=24 Participants
|
333 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: [28 days post-vaccination]Population: Per Protocol Set (PPS) Immunogenicity: All subjects in the FAS Immunogenicity who * Correctly received the vaccine (ie, received the vaccine to which the subject was randomized within the defined window). * Had no CSR-reportable PD leading to exclusion (ie, impacting the results) as defined prior to unblinding. * Had immunogenicity assessments within the window of -7/+21 days around the Day 29 visit, and Day 1 sample taken. * Were not excluded due to other reason defined prior to unblinding.
Outcome measures
| Measure |
Group H Licensed QII Active Comparator
n=95 Participants
Licensed QII Active Comparator: Biological/Vaccine: Licensed QII Active Comparator Licensed Quadrivalent Influenza vaccine, 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.
|
Group A aQII-1 Investigational
n=105 Participants
aQII-1: Biological/Vaccine: Investigational aQII-1 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group E aQII-9 Investigational
n=106 Participants
aQII-9 Investigational: Biological/Vaccine: Investigational aQII-9 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group C aQII-6 Investigational
n=99 Participants
aQII-6 Investigational: Biological/Vaccine: Investigational aQII-6 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group F aQII-10 Investigational
n=102 Participants
aQII-10 Investigational: Biological/Vaccine: Investigational aQII-10 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group B aQII-3 Investigational
n=104 Participants
aQII-3 Investigational: Biological/Vaccine: Investigational aQII-3 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group D aQII-7 Investigational
n=95 Participants
aQII-7 Investigational: Biological/Vaccine: Investigational aQII-7 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group G aQII-11 Investigational
n=104 Participants
aQII-11 Investigational: Biological/Vaccine: Investigational aQII-11 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay
A/H1N1 Day 1 HI GMT
|
42.31 titer
Interval 34.3 to 52.2
|
40.39 titer
Interval 33.1 to 49.3
|
48.29 titer
Interval 39.6 to 58.9
|
49.31 titer
Interval 40.1 to 60.6
|
46.19 titer
Interval 37.7 to 56.6
|
47.50 titer
Interval 38.9 to 58.1
|
46.92 titer
Interval 38.0 to 57.9
|
37.24 titer
Interval 30.5 to 45.5
|
|
Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay
A/H1N1 Day 29 HI GMT
|
228.11 titer
Interval 181.2 to 287.1
|
175.95 titer
Interval 141.3 to 219.1
|
200.22 titer
Interval 161.1 to 248.8
|
225.66 titer
Interval 180.0 to 282.8
|
223.37 titer
Interval 179.0 to 278.8
|
243.16 titer
Interval 195.2 to 302.9
|
270.55 titer
Interval 215.0 to 340.5
|
220.29 titer
Interval 176.8 to 274.5
|
|
Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay
B/Yamagata Day 1 HI GMT
|
15.02 titer
Interval 12.5 to 18.0
|
16.7 titer
Interval 14.1 to 19.8
|
20.83 titer
Interval 17.6 to 24.7
|
18.35 titer
Interval 15.4 to 21.9
|
15.51 titer
Interval 13.0 to 18.5
|
16.41 titer
Interval 13.8 to 19.5
|
17.13 titer
Interval 14.3 to 20.5
|
16.00 titer
Interval 13.5 to 19.0
|
|
Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay
B/Yamagata Day 29 HI GMT
|
47.73 titer
Interval 40.0 to 56.9
|
47.46 titer
Interval 40.2 to 56.1
|
59.74 titer
Interval 50.6 to 70.5
|
62.34 titer
Interval 52.5 to 74.1
|
61.36 titer
Interval 51.8 to 72.7
|
63.21 titer
Interval 53.5 to 74.7
|
68.14 titer
Interval 57.2 to 81.2
|
69.13 titer
Interval 58.5 to 81.7
|
|
Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay
B/Victoria Day 1 HI GMT
|
58.85 titer
Interval 48.0 to 72.1
|
74.31 titer
Interval 61.2 to 90.1
|
65.27 titer
Interval 53.9 to 79.1
|
68.00 titer
Interval 55.7 to 83.0
|
62.26 titer
Interval 51.2 to 75.7
|
63.72 titer
Interval 52.5 to 77.4
|
79.15 titer
Interval 64.6 to 97.0
|
64.13 titer
Interval 52.8 to 77.8
|
|
Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay
B/Victoria Day 29 HI GMT
|
145.12 titer
Interval 124.5 to 169.1
|
146.85 titer
Interval 126.9 to 169.9
|
138.29 titer
Interval 119.7 to 159.8
|
141.84 titer
Interval 122.1 to 164.8
|
178.15 titer
Interval 153.7 to 206.4
|
160.54 titer
Interval 138.7 to 185.8
|
181.93 titer
Interval 156.1 to 212.0
|
186.06 titer
Interval 160.8 to 215.3
|
|
Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay
A/H3N2 Day 1 MN GMT
|
35.31 titer
Interval 29.2 to 42.7
|
31.61 titer
Interval 26.4 to 37.8
|
32.05 titer
Interval 26.8 to 38.3
|
32.48 titer
Interval 27.0 to 39.1
|
36.83 titer
Interval 30.7 to 44.2
|
32.71 titer
Interval 27.3 to 39.2
|
30.80 titer
Interval 25.5 to 37.2
|
27.15 titer
Interval 22.7 to 32.5
|
|
Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay
A/H3N2 Day 29 MN GMT
|
146.59 titer
Interval 124.0 to 173.3
|
142.04 titer
Interval 121.2 to 166.5
|
178.87 titer
Interval 152.8 to 209.4
|
185.07 titer
Interval 157.1 to 218.0
|
193.02 titer
Interval 164.3 to 226.8
|
189.17 titer
Interval 161.3 to 221.9
|
197.27 titer
Interval 166.9 to 233.1
|
157.90 titer
Interval 134.6 to 185.3
|
PRIMARY outcome
Timeframe: 28 days post-vaccinationPopulation: The analysis population is PPS Immunogenicity.
Outcome measures
| Measure |
Group H Licensed QII Active Comparator
n=105 Participants
Licensed QII Active Comparator: Biological/Vaccine: Licensed QII Active Comparator Licensed Quadrivalent Influenza vaccine, 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.
|
Group A aQII-1 Investigational
n=106 Participants
aQII-1: Biological/Vaccine: Investigational aQII-1 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group E aQII-9 Investigational
n=99 Participants
aQII-9 Investigational: Biological/Vaccine: Investigational aQII-9 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group C aQII-6 Investigational
n=102 Participants
aQII-6 Investigational: Biological/Vaccine: Investigational aQII-6 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group F aQII-10 Investigational
n=104 Participants
aQII-10 Investigational: Biological/Vaccine: Investigational aQII-10 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group B aQII-3 Investigational
n=95 Participants
aQII-3 Investigational: Biological/Vaccine: Investigational aQII-3 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group D aQII-7 Investigational
n=104 Participants
aQII-7 Investigational: Biological/Vaccine: Investigational aQII-7 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group G aQII-11 Investigational
aQII-11 Investigational: Biological/Vaccine: Investigational aQII-11 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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 Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and for A/H3N2 Strain Using MN Assay
B/Victoria HI GMR (aQII/QII)
|
1.01 Ratio
Interval 0.82 to 1.25
|
0.95 Ratio
Interval 0.77 to 1.18
|
0.98 Ratio
Interval 0.79 to 1.21
|
1.23 Ratio
Interval 0.99 to 1.52
|
1.11 Ratio
Interval 0.9 to 1.37
|
1.25 Ratio
Interval 1.01 to 1.56
|
1.28 Ratio
Interval 1.04 to 1.58
|
—
|
|
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and for A/H3N2 Strain Using MN Assay
A/H1N1 HI GMR (aQII/QII)
|
0.77 Ratio
Interval 0.56 to 1.06
|
0.88 Ratio
Interval 0.64 to 1.2
|
0.99 Ratio
Interval 0.72 to 1.36
|
0.98 Ratio
Interval 0.71 to 1.35
|
1.07 Ratio
Interval 0.78 to 1.46
|
1.19 Ratio
Interval 0.86 to 1.64
|
0.97 Ratio
Interval 0.7 to 1.33
|
—
|
|
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and for A/H3N2 Strain Using MN Assay
B/Yamagata HI GMR (aQII/QII)
|
0.99 Ratio
Interval 0.78 to 1.27
|
1.25 Ratio
Interval 0.98 to 1.59
|
1.31 Ratio
Interval 1.02 to 1.67
|
1.29 Ratio
Interval 1.01 to 1.64
|
1.32 Ratio
Interval 1.04 to 1.69
|
1.43 Ratio
Interval 1.12 to 1.83
|
1.45 Ratio
Interval 1.14 to 1.84
|
—
|
|
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and for A/H3N2 Strain Using MN Assay
A/H3N2 MN GMR (aQII/QII)
|
0.97 Ratio
Interval 0.77 to 1.22
|
1.22 Ratio
Interval 0.97 to 1.53
|
1.26 Ratio
Interval 1.0 to 1.59
|
1.32 Ratio
Interval 1.04 to 1.66
|
1.29 Ratio
Interval 1.03 to 1.62
|
1.35 Ratio
Interval 1.06 to 1.7
|
1.08 Ratio
Interval 0.86 to 1.36
|
—
|
PRIMARY outcome
Timeframe: 28 days post-vaccinationPopulation: The analysis population is PPS Immunogenicity.
Seroconversion is defined as ≥4-fold increase in titer postvaccination in those with pre-vaccination titer above or equal to the Lower Limit of Quantitation (LLOQ) (≥1:10), or a post-vaccination titer ≥1:40 for subjects with baseline titer below the LLOQ (1:10) for HI titers
Outcome measures
| Measure |
Group H Licensed QII Active Comparator
n=95 Participants
Licensed QII Active Comparator: Biological/Vaccine: Licensed QII Active Comparator Licensed Quadrivalent Influenza vaccine, 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.
|
Group A aQII-1 Investigational
n=105 Participants
aQII-1: Biological/Vaccine: Investigational aQII-1 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group E aQII-9 Investigational
n=106 Participants
aQII-9 Investigational: Biological/Vaccine: Investigational aQII-9 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group C aQII-6 Investigational
n=99 Participants
aQII-6 Investigational: Biological/Vaccine: Investigational aQII-6 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group F aQII-10 Investigational
n=102 Participants
aQII-10 Investigational: Biological/Vaccine: Investigational aQII-10 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group B aQII-3 Investigational
n=104 Participants
aQII-3 Investigational: Biological/Vaccine: Investigational aQII-3 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group D aQII-7 Investigational
n=95 Participants
aQII-7 Investigational: Biological/Vaccine: Investigational aQII-7 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group G aQII-11 Investigational
n=104 Participants
aQII-11 Investigational: Biological/Vaccine: Investigational aQII-11 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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 Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and A/H3N2 Strain Using MN Assay
A/H1N1 HI seroconversion Day 29
|
55.8 percentage of subjects
Interval 45.2 to 66.0
|
53.3 percentage of subjects
Interval 43.3 to 63.1
|
51.9 percentage of subjects
Interval 42.0 to 61.7
|
54.5 percentage of subjects
Interval 44.2 to 64.6
|
57.8 percentage of subjects
Interval 47.7 to 67.6
|
58.7 percentage of subjects
Interval 48.6 to 68.2
|
60.0 percentage of subjects
Interval 49.4 to 69.9
|
57.7 percentage of subjects
Interval 47.6 to 67.3
|
|
Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and A/H3N2 Strain Using MN Assay
B/Yamagata HI seroconversion Day 29
|
35.8 percentage of subjects
Interval 26.2 to 46.3
|
35.2 percentage of subjects
Interval 26.2 to 45.2
|
42.5 percentage of subjects
Interval 32.9 to 52.4
|
46.5 percentage of subjects
Interval 36.4 to 56.8
|
41.2 percentage of subjects
Interval 31.5 to 51.4
|
46.2 percentage of subjects
Interval 36.3 to 56.2
|
48.4 percentage of subjects
Interval 38.0 to 58.9
|
51.0 percentage of subjects
Interval 41.0 to 60.9
|
|
Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and A/H3N2 Strain Using MN Assay
B/Victoria HI seroconversion Day 29
|
32.6 percentage of subjects
Interval 23.4 to 43.0
|
25.7 percentage of subjects
Interval 17.7 to 35.2
|
22.6 percentage of subjects
Interval 15.1 to 31.8
|
26.3 percentage of subjects
Interval 17.9 to 36.1
|
35.3 percentage of subjects
Interval 26.1 to 45.4
|
38.5 percentage of subjects
Interval 29.1 to 48.5
|
34.7 percentage of subjects
Interval 25.3 to 45.2
|
34.6 percentage of subjects
Interval 25.6 to 44.6
|
|
Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and A/H3N2 Strain Using MN Assay
A/H3N2 MN seroconversion Day 29
|
53.7 percentage of subjects
Interval 43.2 to 64.0
|
54.3 percentage of subjects
Interval 44.3 to 64.0
|
67.0 percentage of subjects
Interval 57.2 to 75.8
|
62.6 percentage of subjects
Interval 52.3 to 72.1
|
59.8 percentage of subjects
Interval 49.6 to 69.4
|
62.5 percentage of subjects
Interval 52.5 to 71.8
|
71.6 percentage of subjects
Interval 61.4 to 80.4
|
65.4 percentage of subjects
Interval 55.4 to 74.4
|
PRIMARY outcome
Timeframe: 28 days post-vaccinationPopulation: The analysis population is PPS Immunogenicity.
Outcome measures
| Measure |
Group H Licensed QII Active Comparator
n=95 Participants
Licensed QII Active Comparator: Biological/Vaccine: Licensed QII Active Comparator Licensed Quadrivalent Influenza vaccine, 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.
|
Group A aQII-1 Investigational
n=105 Participants
aQII-1: Biological/Vaccine: Investigational aQII-1 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group E aQII-9 Investigational
n=106 Participants
aQII-9 Investigational: Biological/Vaccine: Investigational aQII-9 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group C aQII-6 Investigational
n=99 Participants
aQII-6 Investigational: Biological/Vaccine: Investigational aQII-6 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group F aQII-10 Investigational
n=102 Participants
aQII-10 Investigational: Biological/Vaccine: Investigational aQII-10 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group B aQII-3 Investigational
n=104 Participants
aQII-3 Investigational: Biological/Vaccine: Investigational aQII-3 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group D aQII-7 Investigational
n=95 Participants
aQII-7 Investigational: Biological/Vaccine: Investigational aQII-7 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group G aQII-11 Investigational
n=104 Participants
aQII-11 Investigational: Biological/Vaccine: Investigational aQII-11 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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 HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay)
A/H1N1 Day 1
|
66.3 percentage of subjects
Interval 55.9 to 75.7
|
60.0 percentage of subjects
Interval 50.0 to 69.4
|
67.9 percentage of subjects
Interval 58.2 to 76.7
|
71.7 percentage of subjects
Interval 61.8 to 80.3
|
68.6 percentage of subjects
Interval 58.7 to 77.5
|
66.3 percentage of subjects
Interval 56.4 to 75.3
|
66.3 percentage of subjects
Interval 55.9 to 75.7
|
51.0 percentage of subjects
Interval 41.0 to 60.9
|
|
Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay)
A/H1N1 Day 29
|
95.8 percentage of subjects
Interval 89.6 to 98.8
|
94.3 percentage of subjects
Interval 88.0 to 97.9
|
96.2 percentage of subjects
Interval 90.6 to 99.0
|
93.9 percentage of subjects
Interval 87.3 to 97.7
|
92.2 percentage of subjects
Interval 85.1 to 96.6
|
95.2 percentage of subjects
Interval 89.1 to 98.4
|
98.9 percentage of subjects
Interval 94.3 to 100.0
|
90.4 percentage of subjects
Interval 83.0 to 95.3
|
|
Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay)
B/Yamagata day 1
|
22.1 percentage of subjects
Interval 14.2 to 31.8
|
29.5 percentage of subjects
Interval 21.0 to 39.2
|
34.9 percentage of subjects
Interval 25.9 to 44.8
|
28.3 percentage of subjects
Interval 19.7 to 38.2
|
22.5 percentage of subjects
Interval 14.9 to 31.9
|
25.0 percentage of subjects
Interval 17.0 to 34.4
|
27.4 percentage of subjects
Interval 18.7 to 37.5
|
26.9 percentage of subjects
Interval 18.7 to 36.5
|
|
Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay)
B/Yamagata day 29
|
74.7 percentage of subjects
Interval 64.8 to 83.1
|
68.6 percentage of subjects
Interval 58.8 to 77.3
|
78.3 percentage of subjects
Interval 69.2 to 85.7
|
84.8 percentage of subjects
Interval 76.2 to 91.3
|
77.5 percentage of subjects
Interval 68.1 to 85.1
|
75.0 percentage of subjects
Interval 65.6 to 83.0
|
80.0 percentage of subjects
Interval 70.5 to 87.5
|
79.8 percentage of subjects
Interval 70.8 to 87.0
|
|
Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay)
B/Victoria Day 1
|
72.6 percentage of subjects
Interval 62.5 to 81.3
|
78.1 percentage of subjects
Interval 69.0 to 85.6
|
81.1 percentage of subjects
Interval 72.4 to 88.1
|
79.8 percentage of subjects
Interval 70.5 to 87.2
|
71.6 percentage of subjects
Interval 61.8 to 80.1
|
76.0 percentage of subjects
Interval 66.6 to 83.8
|
78.9 percentage of subjects
Interval 69.4 to 86.6
|
74.0 percentage of subjects
Interval 64.5 to 82.1
|
|
Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay)
B/Victoria Day 29
|
94.7 percentage of subjects
Interval 88.1 to 98.3
|
92.4 percentage of subjects
Interval 85.5 to 96.7
|
95.3 percentage of subjects
Interval 89.3 to 98.5
|
94.9 percentage of subjects
Interval 88.6 to 98.3
|
97.1 percentage of subjects
Interval 91.6 to 99.4
|
97.1 percentage of subjects
Interval 91.8 to 99.4
|
94.7 percentage of subjects
Interval 88.1 to 98.3
|
98.1 percentage of subjects
Interval 93.2 to 99.8
|
PRIMARY outcome
Timeframe: 7 days post-vaccinationPopulation: Solicited Safety Set, defined as all subjects in the Exposed Set with any solicited AE data.
Percentage of subjects with at least one solicited AE Day 1 through Day 7 after study vaccination
Outcome measures
| Measure |
Group H Licensed QII Active Comparator
n=96 Participants
Licensed QII Active Comparator: Biological/Vaccine: Licensed QII Active Comparator Licensed Quadrivalent Influenza vaccine, 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.
|
Group A aQII-1 Investigational
n=107 Participants
aQII-1: Biological/Vaccine: Investigational aQII-1 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group E aQII-9 Investigational
n=107 Participants
aQII-9 Investigational: Biological/Vaccine: Investigational aQII-9 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group C aQII-6 Investigational
n=103 Participants
aQII-6 Investigational: Biological/Vaccine: Investigational aQII-6 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group F aQII-10 Investigational
n=105 Participants
aQII-10 Investigational: Biological/Vaccine: Investigational aQII-10 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group B aQII-3 Investigational
n=105 Participants
aQII-3 Investigational: Biological/Vaccine: Investigational aQII-3 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group D aQII-7 Investigational
n=101 Participants
aQII-7 Investigational: Biological/Vaccine: Investigational aQII-7 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group G aQII-11 Investigational
n=108 Participants
aQII-11 Investigational: Biological/Vaccine: Investigational aQII-11 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
|---|---|---|---|---|---|---|---|---|
|
Safety Endpoint: Percentage of Subjects With Solicited Local or Systemic Reactions
solicited AEs
|
44 Participants
|
69 Participants
|
71 Participants
|
76 Participants
|
85 Participants
|
73 Participants
|
60 Participants
|
82 Participants
|
|
Safety Endpoint: Percentage of Subjects With Solicited Local or Systemic Reactions
Solicited local AEs
|
29 Participants
|
55 Participants
|
63 Participants
|
68 Participants
|
72 Participants
|
57 Participants
|
55 Participants
|
73 Participants
|
|
Safety Endpoint: Percentage of Subjects With Solicited Local or Systemic Reactions
Solicited systemic AEs
|
34 Participants
|
48 Participants
|
49 Participants
|
59 Participants
|
66 Participants
|
52 Participants
|
46 Participants
|
64 Participants
|
PRIMARY outcome
Timeframe: 28 days post-vaccinationPopulation: Unsolicited Safety Set, defined as all subjects in the Exposed Set with any unsolicited AE data
The percentage of subjects with at least one unsolicited AE from Day 1 to Day 29. Related AEs = considered at least possibly related to study vaccination by the investigator
Outcome measures
| Measure |
Group H Licensed QII Active Comparator
n=97 Participants
Licensed QII Active Comparator: Biological/Vaccine: Licensed QII Active Comparator Licensed Quadrivalent Influenza vaccine, 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.
|
Group A aQII-1 Investigational
n=107 Participants
aQII-1: Biological/Vaccine: Investigational aQII-1 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group E aQII-9 Investigational
n=108 Participants
aQII-9 Investigational: Biological/Vaccine: Investigational aQII-9 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group C aQII-6 Investigational
n=103 Participants
aQII-6 Investigational: Biological/Vaccine: Investigational aQII-6 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group F aQII-10 Investigational
n=106 Participants
aQII-10 Investigational: Biological/Vaccine: Investigational aQII-10 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group B aQII-3 Investigational
n=107 Participants
aQII-3 Investigational: Biological/Vaccine: Investigational aQII-3 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group D aQII-7 Investigational
n=101 Participants
aQII-7 Investigational: Biological/Vaccine: Investigational aQII-7 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group G aQII-11 Investigational
n=109 Participants
aQII-11 Investigational: Biological/Vaccine: Investigational aQII-11 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
|---|---|---|---|---|---|---|---|---|
|
Safety Endpoint: The Percentage of Subjects With Any Unsolicited Adverse Events
Any Unsolicited AE
|
29 Participants
|
27 Participants
|
26 Participants
|
30 Participants
|
32 Participants
|
26 Participants
|
30 Participants
|
30 Participants
|
|
Safety Endpoint: The Percentage of Subjects With Any Unsolicited Adverse Events
Any Related Unsolicited AE
|
9 Participants
|
7 Participants
|
11 Participants
|
14 Participants
|
15 Participants
|
9 Participants
|
6 Participants
|
16 Participants
|
PRIMARY outcome
Timeframe: 28 days post-vaccinationPopulation: Unsolicited Safety Set, defined as all subjects in the Exposed Set with any unsolicited AE data
Outcome measures
| Measure |
Group H Licensed QII Active Comparator
n=97 Participants
Licensed QII Active Comparator: Biological/Vaccine: Licensed QII Active Comparator Licensed Quadrivalent Influenza vaccine, 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.
|
Group A aQII-1 Investigational
n=107 Participants
aQII-1: Biological/Vaccine: Investigational aQII-1 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group E aQII-9 Investigational
n=108 Participants
aQII-9 Investigational: Biological/Vaccine: Investigational aQII-9 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group C aQII-6 Investigational
n=103 Participants
aQII-6 Investigational: Biological/Vaccine: Investigational aQII-6 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group F aQII-10 Investigational
n=106 Participants
aQII-10 Investigational: Biological/Vaccine: Investigational aQII-10 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group B aQII-3 Investigational
n=107 Participants
aQII-3 Investigational: Biological/Vaccine: Investigational aQII-3 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group D aQII-7 Investigational
n=101 Participants
aQII-7 Investigational: Biological/Vaccine: Investigational aQII-7 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group G aQII-11 Investigational
n=109 Participants
aQII-11 Investigational: Biological/Vaccine: Investigational aQII-11 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
|---|---|---|---|---|---|---|---|---|
|
Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs)
Any Serious Unsolicited AE
|
4 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs)
Any Unsolicited AE of Special Interest
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs)
Any Medically Attended AE
|
13 Participants
|
5 Participants
|
5 Participants
|
8 Participants
|
4 Participants
|
9 Participants
|
9 Participants
|
7 Participants
|
|
Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs)
Any Unsolicited AE Leading to Withdrawal from the Study
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs)
Any deaths
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 180 days post-vaccinationPopulation: Unsolicited Safety Set, defined as all subjects in the Exposed Set with any unsolicited AE data
Outcome measures
| Measure |
Group H Licensed QII Active Comparator
n=97 Participants
Licensed QII Active Comparator: Biological/Vaccine: Licensed QII Active Comparator Licensed Quadrivalent Influenza vaccine, 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.
|
Group A aQII-1 Investigational
n=107 Participants
aQII-1: Biological/Vaccine: Investigational aQII-1 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group E aQII-9 Investigational
n=108 Participants
aQII-9 Investigational: Biological/Vaccine: Investigational aQII-9 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group C aQII-6 Investigational
n=103 Participants
aQII-6 Investigational: Biological/Vaccine: Investigational aQII-6 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group F aQII-10 Investigational
n=106 Participants
aQII-10 Investigational: Biological/Vaccine: Investigational aQII-10 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group B aQII-3 Investigational
n=107 Participants
aQII-3 Investigational: Biological/Vaccine: Investigational aQII-3 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group D aQII-7 Investigational
n=101 Participants
aQII-7 Investigational: Biological/Vaccine: Investigational aQII-7 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group G aQII-11 Investigational
n=109 Participants
aQII-11 Investigational: Biological/Vaccine: Investigational aQII-11 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
|---|---|---|---|---|---|---|---|---|
|
Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period
Any Serious Unsolicited AE
|
8 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
5 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period
Any Related Serious Unsolicited AE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period
Any Unsolicited AE of Special Interest
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period
Any Medically Attended AE
|
20 Participants
|
15 Participants
|
13 Participants
|
18 Participants
|
14 Participants
|
21 Participants
|
20 Participants
|
16 Participants
|
|
Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period
Any Unsolicited AE Leading to Withdrawal from the Study
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period
Deaths
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 28 days post-vaccinationPopulation: The analysis population is PPS Immunogenicity.
Outcome measures
| Measure |
Group H Licensed QII Active Comparator
n=95 Participants
Licensed QII Active Comparator: Biological/Vaccine: Licensed QII Active Comparator Licensed Quadrivalent Influenza vaccine, 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.
|
Group A aQII-1 Investigational
n=105 Participants
aQII-1: Biological/Vaccine: Investigational aQII-1 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group E aQII-9 Investigational
n=106 Participants
aQII-9 Investigational: Biological/Vaccine: Investigational aQII-9 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group C aQII-6 Investigational
n=99 Participants
aQII-6 Investigational: Biological/Vaccine: Investigational aQII-6 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group F aQII-10 Investigational
n=102 Participants
aQII-10 Investigational: Biological/Vaccine: Investigational aQII-10 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group B aQII-3 Investigational
n=104 Participants
aQII-3 Investigational: Biological/Vaccine: Investigational aQII-3 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group D aQII-7 Investigational
n=95 Participants
aQII-7 Investigational: Biological/Vaccine: Investigational aQII-7 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group G aQII-11 Investigational
n=104 Participants
aQII-11 Investigational: Biological/Vaccine: Investigational aQII-11 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay
A/H1N1 Day 1
|
44.55 titer
Interval 34.6 to 57.4
|
29.77 titer
Interval 23.4 to 37.9
|
31.77 titer
Interval 25.0 to 40.3
|
39.02 titer
Interval 30.4 to 50.0
|
32.29 titer
Interval 25.3 to 41.2
|
32.99 titer
Interval 25.9 to 42.0
|
30.44 titer
Interval 23.6 to 39.2
|
32.49 titer
Interval 25.5 to 41.4
|
|
Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay
A/H1N1 Day 29
|
476.69 titer
Interval 351.4 to 646.6
|
495.34 titer
Interval 370.7 to 661.8
|
430.24 titer
Interval 322.8 to 573.4
|
596.45 titer
Interval 442.5 to 804.0
|
660.96 titer
Interval 493.1 to 886.0
|
634.42 titer
Interval 474.5 to 848.3
|
730.30 titer
Interval 538.8 to 989.8
|
465.89 titer
Interval 348.5 to 622.8
|
|
Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay
B/Yamagata Day 1
|
14.80 titer
Interval 12.8 to 17.2
|
15.53 titer
Interval 13.5 to 17.9
|
18.04 titer
Interval 15.7 to 20.8
|
18.01 titer
Interval 15.6 to 20.8
|
16.05 titer
Interval 13.9 to 18.5
|
15.84 titer
Interval 13.7 to 18.3
|
14.92 titer
Interval 12.9 to 17.3
|
14.63 titer
Interval 12.7 to 16.9
|
|
Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay
B/Yamagata Day 29
|
43.60 titer
Interval 37.6 to 50.5
|
43.1 titer
Interval 37.5 to 49.6
|
56.7 titer
Interval 49.4 to 65.1
|
54.23 titer
Interval 46.9 to 62.6
|
58.79 titer
Interval 51.0 to 67.7
|
51.38 titer
Interval 44.6 to 59.1
|
54.7 titer
Interval 47.2 to 63.4
|
52.65 titer
Interval 45.8 to 60.6
|
|
Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay
B/Victoria Day 1
|
35.10 titer
Interval 28.1 to 43.9
|
43.96 titer
Interval 35.5 to 54.4
|
38.15 titer
Interval 30.9 to 47.1
|
41.08 titer
Interval 33.0 to 51.1
|
39.86 titer
Interval 32.2 to 49.4
|
44.56 titer
Interval 36.0 to 55.1
|
38.07 titer
Interval 30.5 to 47.6
|
34.77 titer
Interval 28.1 to 43.0
|
|
Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay
B/Victoria Day 29
|
112.86 titer
Interval 93.4 to 136.3
|
117.97 titer
Interval 98.5 to 141.2
|
157.54 titer
Interval 131.8 to 188.3
|
168.62 titer
Interval 140.1 to 203.0
|
173.89 titer
Interval 144.9 to 208.6
|
152.41 titer
Interval 127.2 to 182.6
|
161.86 titer
Interval 134.0 to 195.5
|
146.56 titer
Interval 122.4 to 175.5
|
SECONDARY outcome
Timeframe: 28 days post-vaccinationPopulation: The analysis population is PPS Immunogenicity.
Outcome measures
| Measure |
Group H Licensed QII Active Comparator
n=105 Participants
Licensed QII Active Comparator: Biological/Vaccine: Licensed QII Active Comparator Licensed Quadrivalent Influenza vaccine, 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.
|
Group A aQII-1 Investigational
n=106 Participants
aQII-1: Biological/Vaccine: Investigational aQII-1 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group E aQII-9 Investigational
n=99 Participants
aQII-9 Investigational: Biological/Vaccine: Investigational aQII-9 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group C aQII-6 Investigational
n=102 Participants
aQII-6 Investigational: Biological/Vaccine: Investigational aQII-6 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group F aQII-10 Investigational
n=104 Participants
aQII-10 Investigational: Biological/Vaccine: Investigational aQII-10 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group B aQII-3 Investigational
n=95 Participants
aQII-3 Investigational: Biological/Vaccine: Investigational aQII-3 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group D aQII-7 Investigational
n=104 Participants
aQII-7 Investigational: Biological/Vaccine: Investigational aQII-7 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group G aQII-11 Investigational
aQII-11 Investigational: Biological/Vaccine: Investigational aQII-11 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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 Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization Assay
A/H1N1 GMR (aQII/QII)
|
1.04 Ratio
Interval 0.68 to 1.58
|
0.90 Ratio
Interval 0.59 to 1.37
|
1.25 Ratio
Interval 0.82 to 1.91
|
1.39 Ratio
Interval 0.91 to 2.11
|
1.33 Ratio
Interval 0.87 to 2.03
|
1.53 Ratio
Interval 1.0 to 2.35
|
0.98 Ratio
Interval 0.64 to 1.49
|
—
|
|
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization Assay
B/Yamagata GMR (aQII/QII)
|
0.99 Ratio
Interval 0.81 to 1.21
|
1.30 Ratio
Interval 1.06 to 1.59
|
1.24 Ratio
Interval 1.01 to 1.53
|
1.35 Ratio
Interval 1.1 to 1.65
|
1.18 Ratio
Interval 0.96 to 1.44
|
1.25 Ratio
Interval 1.02 to 1.54
|
1.21 Ratio
Interval 0.99 to 1.48
|
—
|
|
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization Assay
B/Victoria GMR (aQII/QII)
|
1.05 Ratio
Interval 0.81 to 1.36
|
1.40 Ratio
Interval 1.08 to 1.81
|
1.49 Ratio
Interval 1.15 to 1.94
|
1.54 Ratio
Interval 1.19 to 2.0
|
1.35 Ratio
Interval 1.04 to 1.75
|
1.43 Ratio
Interval 1.1 to 1.87
|
1.30 Ratio
Interval 1.0 to 1.68
|
—
|
SECONDARY outcome
Timeframe: 28 days post-vaccinationPopulation: The analysis population is PPS Immunogenicity.
Seroconversion is defined as ≥4-fold increase in titer postvaccination in those with pre-vaccination titer above or equal to the Lower Limit of Quantitation (LLOQ) (≥1:10), or a post-vaccination titer ≥1:40 for subjects with baseline titer below the LLOQ (1:10) for HI titers
Outcome measures
| Measure |
Group H Licensed QII Active Comparator
n=95 Participants
Licensed QII Active Comparator: Biological/Vaccine: Licensed QII Active Comparator Licensed Quadrivalent Influenza vaccine, 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.
|
Group A aQII-1 Investigational
n=105 Participants
aQII-1: Biological/Vaccine: Investigational aQII-1 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group E aQII-9 Investigational
n=106 Participants
aQII-9 Investigational: Biological/Vaccine: Investigational aQII-9 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group C aQII-6 Investigational
n=99 Participants
aQII-6 Investigational: Biological/Vaccine: Investigational aQII-6 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group F aQII-10 Investigational
n=102 Participants
aQII-10 Investigational: Biological/Vaccine: Investigational aQII-10 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group B aQII-3 Investigational
n=104 Participants
aQII-3 Investigational: Biological/Vaccine: Investigational aQII-3 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group D aQII-7 Investigational
n=95 Participants
aQII-7 Investigational: Biological/Vaccine: Investigational aQII-7 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group G aQII-11 Investigational
n=104 Participants
aQII-11 Investigational: Biological/Vaccine: Investigational aQII-11 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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 Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by MN Assay
A/H1N1 Day 29
|
73.7 percentage of subjects
Interval 63.6 to 82.2
|
82.9 percentage of subjects
Interval 74.3 to 89.5
|
82.1 percentage of subjects
Interval 73.4 to 88.8
|
79.8 percentage of subjects
Interval 70.5 to 87.2
|
87.3 percentage of subjects
Interval 79.2 to 93.0
|
83.7 percentage of subjects
Interval 75.1 to 90.2
|
87.4 percentage of subjects
Interval 79.0 to 93.3
|
87.5 percentage of subjects
Interval 79.6 to 93.2
|
|
Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by MN Assay
B/Yamagata Day 29
|
31.6 percentage of subjects
Interval 22.4 to 41.9
|
27.6 percentage of subjects
Interval 19.3 to 37.2
|
39.6 percentage of subjects
Interval 30.3 to 49.6
|
38.4 percentage of subjects
Interval 28.8 to 48.7
|
45.1 percentage of subjects
Interval 35.2 to 55.3
|
37.5 percentage of subjects
Interval 28.2 to 47.5
|
40.0 percentage of subjects
Interval 30.1 to 50.6
|
42.3 percentage of subjects
Interval 32.7 to 52.4
|
|
Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by MN Assay
B/Victoria Day 29
|
37.9 percentage of subjects
Interval 28.1 to 48.4
|
35.2 percentage of subjects
Interval 26.2 to 45.2
|
48.1 percentage of subjects
Interval 38.3 to 58.0
|
44.4 percentage of subjects
Interval 34.5 to 54.8
|
50.0 percentage of subjects
Interval 39.9 to 60.1
|
42.3 percentage of subjects
Interval 32.7 to 52.4
|
45.3 percentage of subjects
Interval 35.0 to 55.8
|
42.3 percentage of subjects
Interval 32.7 to 52.4
|
SECONDARY outcome
Timeframe: 180 days post-vaccinationPopulation: The analysis population is PPS Immunogenicity.
Outcome measures
| Measure |
Group H Licensed QII Active Comparator
n=94 Participants
Licensed QII Active Comparator: Biological/Vaccine: Licensed QII Active Comparator Licensed Quadrivalent Influenza vaccine, 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.
|
Group A aQII-1 Investigational
n=106 Participants
aQII-1: Biological/Vaccine: Investigational aQII-1 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group E aQII-9 Investigational
n=105 Participants
aQII-9 Investigational: Biological/Vaccine: Investigational aQII-9 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group C aQII-6 Investigational
n=99 Participants
aQII-6 Investigational: Biological/Vaccine: Investigational aQII-6 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group F aQII-10 Investigational
n=102 Participants
aQII-10 Investigational: Biological/Vaccine: Investigational aQII-10 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group B aQII-3 Investigational
n=97 Participants
aQII-3 Investigational: Biological/Vaccine: Investigational aQII-3 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group D aQII-7 Investigational
n=94 Participants
aQII-7 Investigational: Biological/Vaccine: Investigational aQII-7 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group G aQII-11 Investigational
n=102 Participants
aQII-11 Investigational: Biological/Vaccine: Investigational aQII-11 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay
A/H1N1 Day 181
|
110.69 titer
Interval 89.3 to 137.2
|
95.07 titer
Interval 77.7 to 116.3
|
78.87 titer
Interval 64.4 to 96.5
|
86.67 titer
Interval 70.3 to 106.8
|
92.45 titer
Interval 75.3 to 113.5
|
78.23 titer
Interval 63.4 to 96.6
|
85.50 titer
Interval 69.0 to 105.9
|
86.67 titer
Interval 70.6 to 106.5
|
|
Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay
B/Yamagata Day 181
|
25.05 titer
Interval 21.3 to 29.5
|
26.58 titer
Interval 22.8 to 31.0
|
26.71 titer
Interval 22.9 to 31.2
|
24.89 titer
Interval 21.2 to 29.2
|
25.52 titer
Interval 21.8 to 29.8
|
24.73 titer
Interval 21.1 to 29.0
|
27.00 titer
Interval 22.9 to 31.8
|
27.33 titer
Interval 23.4 to 32.0
|
|
Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay
B/Victoria Day 181
|
55.42 titer
Interval 44.5 to 69.1
|
53.30 titer
Interval 43.3 to 65.6
|
59.26 titer
Interval 48.2 to 72.9
|
56.00 titer
Interval 45.2 to 69.4
|
56.97 titer
Interval 46.1 to 70.4
|
55.86 titer
Interval 45.0 to 69.3
|
68.07 titer
Interval 54.6 to 84.8
|
57.94 titer
Interval 46.9 to 71.5
|
SECONDARY outcome
Timeframe: 180 days post-vaccinationPopulation: The analysis population is PPS Immunogenicity.
Outcome measures
| Measure |
Group H Licensed QII Active Comparator
n=106 Participants
Licensed QII Active Comparator: Biological/Vaccine: Licensed QII Active Comparator Licensed Quadrivalent Influenza vaccine, 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.
|
Group A aQII-1 Investigational
n=105 Participants
aQII-1: Biological/Vaccine: Investigational aQII-1 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group E aQII-9 Investigational
n=99 Participants
aQII-9 Investigational: Biological/Vaccine: Investigational aQII-9 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group C aQII-6 Investigational
n=102 Participants
aQII-6 Investigational: Biological/Vaccine: Investigational aQII-6 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group F aQII-10 Investigational
n=97 Participants
aQII-10 Investigational: Biological/Vaccine: Investigational aQII-10 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group B aQII-3 Investigational
n=94 Participants
aQII-3 Investigational: Biological/Vaccine: Investigational aQII-3 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group D aQII-7 Investigational
n=102 Participants
aQII-7 Investigational: Biological/Vaccine: Investigational aQII-7 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group G aQII-11 Investigational
aQII-11 Investigational: Biological/Vaccine: Investigational aQII-11 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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 Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay
A/H1N1 Day 181 (aQII/QII)
|
0.86 Ratio
Interval 0.64 to 1.15
|
0.71 Ratio
Interval 0.53 to 0.96
|
0.78 Ratio
Interval 0.58 to 1.05
|
0.84 Ratio
Interval 0.62 to 1.12
|
0.71 Ratio
Interval 0.52 to 0.95
|
0.77 Ratio
Interval 0.57 to 1.04
|
0.78 Ratio
Interval 0.58 to 1.05
|
—
|
|
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay
B/Yamagata Day 181 (aQII/QII)
|
1.06 Ratio
Interval 0.85 to 1.33
|
1.07 Ratio
Interval 0.85 to 1.34
|
0.99 Ratio
Interval 0.79 to 1.25
|
1.02 Ratio
Interval 0.81 to 1.28
|
0.99 Ratio
Interval 0.79 to 1.24
|
1.08 Ratio
Interval 0.86 to 1.36
|
1.09 Ratio
Interval 0.87 to 1.37
|
—
|
|
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay
B/Victoria Day 181 (aQII/QII)
|
0.96 Ratio
Interval 0.71 to 1.3
|
1.07 Ratio
Interval 0.79 to 1.45
|
1.01 Ratio
Interval 0.74 to 1.37
|
1.03 Ratio
Interval 0.76 to 1.39
|
1.01 Ratio
Interval 0.74 to 1.37
|
1.23 Ratio
Interval 0.9 to 1.68
|
1.05 Ratio
Interval 0.77 to 1.42
|
—
|
SECONDARY outcome
Timeframe: 180 days post-vaccinationPopulation: The analysis population is PPS Immunogenicity.
Outcome measures
| Measure |
Group H Licensed QII Active Comparator
n=94 Participants
Licensed QII Active Comparator: Biological/Vaccine: Licensed QII Active Comparator Licensed Quadrivalent Influenza vaccine, 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.
|
Group A aQII-1 Investigational
n=106 Participants
aQII-1: Biological/Vaccine: Investigational aQII-1 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group E aQII-9 Investigational
n=105 Participants
aQII-9 Investigational: Biological/Vaccine: Investigational aQII-9 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group C aQII-6 Investigational
n=99 Participants
aQII-6 Investigational: Biological/Vaccine: Investigational aQII-6 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group F aQII-10 Investigational
n=102 Participants
aQII-10 Investigational: Biological/Vaccine: Investigational aQII-10 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group B aQII-3 Investigational
n=97 Participants
aQII-3 Investigational: Biological/Vaccine: Investigational aQII-3 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group D aQII-7 Investigational
n=94 Participants
aQII-7 Investigational: Biological/Vaccine: Investigational aQII-7 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group G aQII-11 Investigational
n=102 Participants
aQII-11 Investigational: Biological/Vaccine: Investigational aQII-11 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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 HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay)
B/Yamagata Day 181
|
42.6 percentage
Interval 32.4 to 53.2
|
42.5 percentage
Interval 32.9 to 52.4
|
49.5 percentage
Interval 39.6 to 59.5
|
44.4 percentage
Interval 34.5 to 54.8
|
40.2 percentage
Interval 30.6 to 50.4
|
40.2 percentage
Interval 30.4 to 50.7
|
44.7 percentage
Interval 34.4 to 55.3
|
44.1 percentage
Interval 34.3 to 54.3
|
|
Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay)
B/Victoria Day 181
|
71.3 percentage
Interval 61.0 to 80.1
|
75.5 percentage
Interval 66.2 to 83.3
|
74.3 percentage
Interval 64.8 to 82.3
|
71.7 percentage
Interval 61.8 to 80.3
|
72.5 percentage
Interval 62.8 to 80.9
|
74.2 percentage
Interval 64.3 to 82.6
|
73.4 percentage
Interval 63.3 to 82.0
|
71.6 percentage
Interval 61.8 to 80.1
|
|
Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay)
A/H1N1 Day 181
|
87.2 percentage
Interval 78.8 to 93.2
|
85.8 percentage
Interval 77.7 to 91.9
|
80.0 percentage
Interval 71.1 to 87.2
|
82.8 percentage
Interval 73.9 to 89.7
|
87.3 percentage
Interval 79.2 to 93.0
|
80.4 percentage
Interval 71.1 to 87.8
|
83.0 percentage
Interval 73.8 to 89.9
|
81.4 percentage
Interval 72.4 to 88.4
|
SECONDARY outcome
Timeframe: 180 days post-vaccinationPopulation: The analysis population is PPS Immunogenicity.
Outcome measures
| Measure |
Group H Licensed QII Active Comparator
n=94 Participants
Licensed QII Active Comparator: Biological/Vaccine: Licensed QII Active Comparator Licensed Quadrivalent Influenza vaccine, 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.
|
Group A aQII-1 Investigational
n=106 Participants
aQII-1: Biological/Vaccine: Investigational aQII-1 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group E aQII-9 Investigational
n=105 Participants
aQII-9 Investigational: Biological/Vaccine: Investigational aQII-9 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group C aQII-6 Investigational
n=99 Participants
aQII-6 Investigational: Biological/Vaccine: Investigational aQII-6 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group F aQII-10 Investigational
n=102 Participants
aQII-10 Investigational: Biological/Vaccine: Investigational aQII-10 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group B aQII-3 Investigational
n=97 Participants
aQII-3 Investigational: Biological/Vaccine: Investigational aQII-3 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group D aQII-7 Investigational
n=94 Participants
aQII-7 Investigational: Biological/Vaccine: Investigational aQII-7 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group G aQII-11 Investigational
n=102 Participants
aQII-11 Investigational: Biological/Vaccine: Investigational aQII-11 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay
B/Victoria Day 181
|
175.30 titer
Interval 146.4 to 209.9
|
180.26 titer
Interval 152.1 to 213.6
|
209.57 titer
Interval 176.8 to 248.4
|
246.04 titer
Interval 206.4 to 293.3
|
238.56 titer
Interval 200.7 to 283.6
|
199.67 titer
Interval 167.3 to 238.4
|
286.95 titer
Interval 239.7 to 343.5
|
218.44 titer
Interval 183.8 to 259.6
|
|
Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay
A/H1N1 Day 181
|
516.06 titer
Interval 382.5 to 696.2
|
529.64 titer
Interval 399.8 to 701.7
|
427.95 titer
Interval 322.9 to 567.2
|
615.44 titer
Interval 459.8 to 823.7
|
562.64 titer
Interval 422.6 to 749.1
|
518.67 titer
Interval 386.8 to 695.5
|
644.81 titer
Interval 478.4 to 869.0
|
493.66 titer
Interval 370.8 to 657.3
|
|
Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay
A/H3N2 Day 181
|
73.72 titer
Interval 60.7 to 89.5
|
70.50 titer
Interval 58.7 to 84.6
|
74.71 titer
Interval 62.2 to 89.7
|
91.77 titer
Interval 76.0 to 110.9
|
83.3 titer
Interval 69.2 to 100.3
|
85.11 titer
Interval 70.4 to 103.0
|
90.00 titer
Interval 74.2 to 109.2
|
63.44 titer
Interval 52.7 to 76.4
|
|
Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay
B/Yamagata Day 181
|
26.19 titer
Interval 22.8 to 30.1
|
26.38 titer
Interval 23.1 to 30.1
|
28.53 titer
Interval 25.0 to 32.5
|
31.48 titer
Interval 27.5 to 36.1
|
31.3 titer
Interval 27.4 to 35.8
|
27.82 titer
Interval 24.3 to 31.9
|
30.96 titer
Interval 26.9 to 35.6
|
32.20 titer
Interval 28.2 to 36.8
|
SECONDARY outcome
Timeframe: 180 days post-vaccinationPopulation: The analysis population is PPS Immunogenicity.
Outcome measures
| Measure |
Group H Licensed QII Active Comparator
n=106 Participants
Licensed QII Active Comparator: Biological/Vaccine: Licensed QII Active Comparator Licensed Quadrivalent Influenza vaccine, 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.
|
Group A aQII-1 Investigational
n=105 Participants
aQII-1: Biological/Vaccine: Investigational aQII-1 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group E aQII-9 Investigational
n=99 Participants
aQII-9 Investigational: Biological/Vaccine: Investigational aQII-9 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group C aQII-6 Investigational
n=102 Participants
aQII-6 Investigational: Biological/Vaccine: Investigational aQII-6 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group F aQII-10 Investigational
n=97 Participants
aQII-10 Investigational: Biological/Vaccine: Investigational aQII-10 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group B aQII-3 Investigational
n=94 Participants
aQII-3 Investigational: Biological/Vaccine: Investigational aQII-3 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group D aQII-7 Investigational
n=102 Participants
aQII-7 Investigational: Biological/Vaccine: Investigational aQII-7 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group G aQII-11 Investigational
aQII-11 Investigational: Biological/Vaccine: Investigational aQII-11 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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 Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay
A/H1N1 Day 181 (aQII/QII)
|
1.03 Ratio
Interval 0.68 to 1.55
|
0.83 Ratio
Interval 0.55 to 1.25
|
1.19 Ratio
Interval 0.79 to 1.81
|
1.09 Ratio
Interval 0.72 to 1.65
|
1.01 Ratio
Interval 0.66 to 1.53
|
1.25 Ratio
Interval 0.82 to 1.9
|
0.96 Ratio
Interval 0.63 to 1.45
|
—
|
|
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay
A/H3N2 Day 181 (aQII/QII)
|
0.96 Ratio
Interval 0.73 to 1.25
|
1.01 Ratio
Interval 0.78 to 1.32
|
1.24 Ratio
Interval 0.95 to 1.63
|
1.13 Ratio
Interval 0.86 to 1.48
|
1.15 Ratio
Interval 0.88 to 1.51
|
1.22 Ratio
Interval 0.93 to 1.6
|
0.86 Ratio
Interval 0.66 to 1.13
|
—
|
|
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay
B/Yamagata Day 181 (aQII/QII)
|
1.01 Ratio
Interval 0.83 to 1.22
|
1.09 Ratio
Interval 0.9 to 1.32
|
1.20 Ratio
Interval 0.99 to 1.46
|
1.19 Ratio
Interval 0.99 to 1.45
|
1.06 Ratio
Interval 0.87 to 1.29
|
1.18 Ratio
Interval 0.97 to 1.44
|
1.23 Ratio
Interval 1.01 to 1.49
|
—
|
|
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay
B/Victoria Day 181 (aQII/QII)
|
1.03 Ratio
Interval 0.8 to 1.32
|
1.20 Ratio
Interval 0.93 to 1.53
|
1.40 Ratio
Interval 1.09 to 1.8
|
1.36 Ratio
Interval 1.06 to 1.75
|
1.14 Ratio
Interval 0.89 to 1.47
|
1.64 Ratio
Interval 1.27 to 2.11
|
1.25 Ratio
Interval 0.97 to 1.6
|
—
|
Adverse Events
Group H Licensed QII Active Comparator
Serious events: 8 serious events
Other events: 55 other events
Deaths: 1 deaths
Group A aQII-1 Investigational
Serious events: 1 serious events
Other events: 74 other events
Deaths: 0 deaths
Group E aQII-9 Investigational
Serious events: 1 serious events
Other events: 80 other events
Deaths: 0 deaths
Group C aQII-6 Investigational
Serious events: 3 serious events
Other events: 79 other events
Deaths: 0 deaths
Group F aQII-10 Investigational
Serious events: 5 serious events
Other events: 91 other events
Deaths: 1 deaths
Group B aQII-3 Investigational
Serious events: 3 serious events
Other events: 81 other events
Deaths: 1 deaths
Group D aQII-7 Investigational
Serious events: 2 serious events
Other events: 72 other events
Deaths: 1 deaths
Group G aQII-11 Investigational
Serious events: 2 serious events
Other events: 89 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group H Licensed QII Active Comparator
n=97 participants at risk
Licensed QII Active Comparator: Biological/Vaccine: Licensed QII Active Comparator Licensed Quadrivalent Influenza vaccine, 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.
|
Group A aQII-1 Investigational
n=107 participants at risk
aQII-1: Biological/Vaccine: Investigational aQII-1 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group E aQII-9 Investigational
n=108 participants at risk
aQII-9 Investigational: Biological/Vaccine: Investigational aQII-9 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group C aQII-6 Investigational
n=103 participants at risk
aQII-6 Investigational: Biological/Vaccine: Investigational aQII-6 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group F aQII-10 Investigational
n=106 participants at risk
aQII-10 Investigational: Biological/Vaccine: Investigational aQII-10 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group B aQII-3 Investigational
n=107 participants at risk
aQII-3 Investigational: Biological/Vaccine: Investigational aQII-3 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group D aQII-7 Investigational
n=101 participants at risk
aQII-7 Investigational: Biological/Vaccine: Investigational aQII-7 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group G aQII-11 Investigational
n=109 participants at risk
aQII-11 Investigational: Biological/Vaccine: Investigational aQII-11 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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
death
|
0.00%
0/97 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/107 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/108 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/103 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/106 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/107 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.99%
1/101 • Number of events 1 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/109 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
|
Hepatobiliary disorders
biliary colic
|
0.00%
0/97 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/107 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.93%
1/108 • Number of events 1 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/103 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/106 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/107 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/101 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/109 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
|
Eye disorders
retinal detachment
|
0.00%
0/97 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/107 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/108 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/103 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.94%
1/106 • Number of events 1 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/107 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/101 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/109 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
|
Gastrointestinal disorders
intestinal obstruction
|
0.00%
0/97 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/107 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/108 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.97%
1/103 • Number of events 1 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/106 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/107 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/101 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/109 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
|
Hepatobiliary disorders
cholecystitis acute
|
0.00%
0/97 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/107 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/108 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.97%
1/103 • Number of events 1 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/106 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/107 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/101 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/109 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
|
Immune system disorders
drug hypersensitivity
|
1.0%
1/97 • Number of events 1 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/107 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/108 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/103 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/106 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/107 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/101 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/109 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
|
Infections and infestations
pneumonia
|
0.00%
0/97 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/107 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/108 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/103 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.94%
1/106 • Number of events 1 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/107 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.99%
1/101 • Number of events 1 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/109 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
|
Infections and infestations
appendicitis
|
1.0%
1/97 • Number of events 1 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/107 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/108 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/103 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/106 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/107 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/101 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/109 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
|
Infections and infestations
cellulitis
|
0.00%
0/97 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/107 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/108 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/103 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/106 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/107 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/101 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.92%
1/109 • Number of events 1 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
|
Infections and infestations
diverticulitis
|
0.00%
0/97 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/107 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/108 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.97%
1/103 • Number of events 1 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/106 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/107 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/101 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/109 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
|
Infections and infestations
pyelonephritis
|
1.0%
1/97 • Number of events 1 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/107 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/108 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/103 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/106 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/107 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/101 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/109 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
|
Infections and infestations
sepsis
|
0.00%
0/97 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/107 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/108 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/103 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/106 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.93%
1/107 • Number of events 1 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/101 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/109 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
|
Injury, poisoning and procedural complications
ankle fracture
|
0.00%
0/97 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/107 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/108 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/103 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/106 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.93%
1/107 • Number of events 1 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/101 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/109 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
|
Injury, poisoning and procedural complications
bone contusion
|
0.00%
0/97 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/107 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/108 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/103 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/106 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/107 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/101 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.92%
1/109 • Number of events 1 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
|
Injury, poisoning and procedural complications
face injury
|
0.00%
0/97 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/107 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/108 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/103 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.94%
1/106 • Number of events 1 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/107 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/101 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/109 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
|
Injury, poisoning and procedural complications
skin laceration
|
0.00%
0/97 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/107 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/108 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/103 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/106 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.93%
1/107 • Number of events 1 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/101 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/109 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
|
Metabolism and nutrition disorders
hypoglycaemia
|
1.0%
1/97 • Number of events 1 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/107 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/108 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/103 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/106 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/107 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/101 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/109 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
1.0%
1/97 • Number of events 1 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/107 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/108 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/103 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/106 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/107 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/101 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/109 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
|
Musculoskeletal and connective tissue disorders
polymyalgia rheumatica
|
0.00%
0/97 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/107 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/108 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/103 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.94%
1/106 • Number of events 1 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/107 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/101 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/109 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
adenocarcinoma of colon
|
1.0%
1/97 • Number of events 1 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/107 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/108 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/103 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/106 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/107 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/101 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/109 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
breast cancer female
|
1.0%
1/97 • Number of events 1 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/107 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/108 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/103 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/106 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/107 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/101 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/109 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
colorectal adenocarcinoma
|
0.00%
0/97 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/107 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/108 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.97%
1/103 • Number of events 1 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/106 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/107 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/101 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/109 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
oesophageal adenocarcinoma
|
0.00%
0/97 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.93%
1/107 • Number of events 1 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/108 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/103 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/106 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/107 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/101 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/109 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
squamous cell carcinoma
|
1.0%
1/97 • Number of events 1 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/107 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/108 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/103 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/106 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/107 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/101 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/109 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
|
Nervous system disorders
syncope
|
0.00%
0/97 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/107 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/108 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/103 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.94%
1/106 • Number of events 1 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/107 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/101 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/109 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
|
Vascular disorders
hypertension
|
1.0%
1/97 • Number of events 1 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/107 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/108 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/103 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/106 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/107 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/101 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
0.00%
0/109 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
Other adverse events
| Measure |
Group H Licensed QII Active Comparator
n=97 participants at risk
Licensed QII Active Comparator: Biological/Vaccine: Licensed QII Active Comparator Licensed Quadrivalent Influenza vaccine, 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.
|
Group A aQII-1 Investigational
n=107 participants at risk
aQII-1: Biological/Vaccine: Investigational aQII-1 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group E aQII-9 Investigational
n=108 participants at risk
aQII-9 Investigational: Biological/Vaccine: Investigational aQII-9 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group C aQII-6 Investigational
n=103 participants at risk
aQII-6 Investigational: Biological/Vaccine: Investigational aQII-6 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group F aQII-10 Investigational
n=106 participants at risk
aQII-10 Investigational: Biological/Vaccine: Investigational aQII-10 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group B aQII-3 Investigational
n=107 participants at risk
aQII-3 Investigational: Biological/Vaccine: Investigational aQII-3 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group D aQII-7 Investigational
n=101 participants at risk
aQII-7 Investigational: Biological/Vaccine: Investigational aQII-7 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
|
Group G aQII-11 Investigational
n=109 participants at risk
aQII-11 Investigational: Biological/Vaccine: Investigational aQII-11 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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
|
7.2%
7/97 • Number of events 7 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
7.5%
8/107 • Number of events 8 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
9.3%
10/108 • Number of events 10 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
11.7%
12/103 • Number of events 12 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
17.9%
19/106 • Number of events 20 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
8.4%
9/107 • Number of events 9 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
9.9%
10/101 • Number of events 10 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
14.7%
16/109 • Number of events 17 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
|
General disorders
chills
|
8.2%
8/97 • Number of events 8 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
5.6%
6/107 • Number of events 6 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
8.3%
9/108 • Number of events 9 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
9.7%
10/103 • Number of events 11 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
17.0%
18/106 • Number of events 19 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
9.3%
10/107 • Number of events 10 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
12.9%
13/101 • Number of events 13 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
18.3%
20/109 • Number of events 21 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
|
General disorders
fatigue
|
25.8%
25/97 • Number of events 27 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
23.4%
25/107 • Number of events 25 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
31.5%
34/108 • Number of events 36 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
35.0%
36/103 • Number of events 37 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
38.7%
41/106 • Number of events 42 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
25.2%
27/107 • Number of events 29 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
30.7%
31/101 • Number of events 31 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
43.1%
47/109 • Number of events 48 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
|
General disorders
induration
|
1.0%
1/97 • Number of events 1 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
8.4%
9/107 • Number of events 9 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
9.3%
10/108 • Number of events 10 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
6.8%
7/103 • Number of events 7 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
13.2%
14/106 • Number of events 14 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
8.4%
9/107 • Number of events 9 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
9.9%
10/101 • Number of events 10 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
13.8%
15/109 • Number of events 15 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
|
General disorders
injection site pain
|
29.9%
29/97 • Number of events 29 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
49.5%
53/107 • Number of events 53 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
56.5%
61/108 • Number of events 61 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
64.1%
66/103 • Number of events 66 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
66.0%
70/106 • Number of events 70 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
49.5%
53/107 • Number of events 53 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
52.5%
53/101 • Number of events 53 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
65.1%
71/109 • Number of events 71 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
|
Infections and infestations
upper respiratory tract infection
|
1.0%
1/97 • Number of events 1 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
7.5%
8/107 • Number of events 8 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
3.7%
4/108 • Number of events 4 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
3.9%
4/103 • Number of events 4 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
5.7%
6/106 • Number of events 6 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
4.7%
5/107 • Number of events 5 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
5.0%
5/101 • Number of events 5 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
3.7%
4/109 • Number of events 4 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
|
Metabolism and nutrition disorders
loss of appetite
|
4.1%
4/97 • Number of events 4 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
10.3%
11/107 • Number of events 11 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
7.4%
8/108 • Number of events 8 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
13.6%
14/103 • Number of events 14 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
13.2%
14/106 • Number of events 14 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
5.6%
6/107 • Number of events 6 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
8.9%
9/101 • Number of events 9 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
19.3%
21/109 • Number of events 21 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
12.4%
12/97 • Number of events 13 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
17.8%
19/107 • Number of events 20 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
17.6%
19/108 • Number of events 19 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
20.4%
21/103 • Number of events 21 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
31.1%
33/106 • Number of events 34 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
23.4%
25/107 • Number of events 28 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
21.8%
22/101 • Number of events 24 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
22.9%
25/109 • Number of events 27 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
13.4%
13/97 • Number of events 13 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
15.0%
16/107 • Number of events 16 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
18.5%
20/108 • Number of events 20 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
23.3%
24/103 • Number of events 24 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
32.1%
34/106 • Number of events 35 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
22.4%
24/107 • Number of events 25 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
18.8%
19/101 • Number of events 19 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
24.8%
27/109 • Number of events 27 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
|
Nervous system disorders
headache
|
18.6%
18/97 • Number of events 18 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
25.2%
27/107 • Number of events 27 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
25.9%
28/108 • Number of events 28 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
29.1%
30/103 • Number of events 31 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
39.6%
42/106 • Number of events 43 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
29.0%
31/107 • Number of events 32 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
28.7%
29/101 • Number of events 29 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
35.8%
39/109 • Number of events 41 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
|
Skin and subcutaneous tissue disorders
erythema
|
1.0%
1/97 • Number of events 1 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
2.8%
3/107 • Number of events 3 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
8.3%
9/108 • Number of events 9 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
6.8%
7/103 • Number of events 7 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
11.3%
12/106 • Number of events 12 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
9.3%
10/107 • Number of events 10 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
8.9%
9/101 • Number of events 9 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
16.5%
18/109 • Number of events 18 • Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place