Trial Outcomes & Findings for Safety Study of Four Candidate Influenza Vaccines to Prevent Influenza Disease in the Elderly Population (NCT NCT00318149)
NCT ID: NCT00318149
Last Updated: 2018-08-08
Results Overview
The frequency was expressed as the geometric mean of influenza-specific CD4 T-cells, expressing at least 2 markers among CD40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α) and Interferon-γ (IFN-γ ) upon in vitro stimulation.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
425 participants
Primary outcome timeframe
At Day 21
Results posted on
2018-08-08
Participant Flow
Participant milestones
| Measure |
Fluarix 18-40 Y Group
Subjects (aged 18-40 years) received 1 dose of the Fluarix vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix ≥65 Y Group
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix-AS25 Group
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS25, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix-AS50 Group
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS50, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix- AS01B Group
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01B, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix- AS01E Group
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01E, administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
75
|
50
|
75
|
75
|
75
|
75
|
|
Overall Study
COMPLETED
|
75
|
50
|
75
|
75
|
75
|
73
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
Fluarix 18-40 Y Group
Subjects (aged 18-40 years) received 1 dose of the Fluarix vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix ≥65 Y Group
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix-AS25 Group
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS25, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix-AS50 Group
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS50, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix- AS01B Group
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01B, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix- AS01E Group
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01E, administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
2
|
Baseline Characteristics
Safety Study of Four Candidate Influenza Vaccines to Prevent Influenza Disease in the Elderly Population
Baseline characteristics by cohort
| Measure |
Fluarix 18-40 Y Group
n=75 Participants
Subjects (aged 18-40 years) received 1 dose of the Fluarix vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix ≥65 Y Group
n=50 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix-AS25 Group
n=75 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS25, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix-AS50 Group
n=75 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS50, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix- AS01B Group
n=75 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01B, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix- AS01E Group
n=75 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01E, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Total
n=425 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
25.9 Years
STANDARD_DEVIATION 5.47 • n=5 Participants
|
69.3 Years
STANDARD_DEVIATION 3.31 • n=7 Participants
|
69.2 Years
STANDARD_DEVIATION 2.98 • n=5 Participants
|
69.1 Years
STANDARD_DEVIATION 3.51 • n=4 Participants
|
69.5 Years
STANDARD_DEVIATION 3.3 • n=21 Participants
|
69.5 Years
STANDARD_DEVIATION 4.06 • n=8 Participants
|
61.66 Years
STANDARD_DEVIATION 17.02 • n=8 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
29 Participants
n=8 Participants
|
193 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
46 Participants
n=8 Participants
|
232 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · Asian - Central/South Asian heritage
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · White - Caucasian/European heritage
|
72 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
75 Participants
n=21 Participants
|
75 Participants
n=8 Participants
|
422 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · Other
|
2 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
|
2 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: At Day 21Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available (subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination).
The frequency was expressed as the geometric mean of influenza-specific CD4 T-cells, expressing at least 2 markers among CD40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α) and Interferon-γ (IFN-γ ) upon in vitro stimulation.
Outcome measures
| Measure |
Fluarix- AS01E Group
n=74 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01E, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix 18-40 Y Group
n=75 Participants
Subjects (aged 18-40 years) received 1 dose of the Fluarix vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix ≥65 Y Group
n=49 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix-AS25 Group
n=70 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS25, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix-AS50 Group
n=73 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS50, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix- AS01B Group
n=74 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01B, administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|
|
Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T-cells Expressing at Least 2 Markers
|
2428.78 T-cells/million cells
Standard Deviation 2693.71
|
3229.25 T-cells/million cells
Standard Deviation 1643.2
|
1646.05 T-cells/million cells
Standard Deviation 1557.22
|
3056.06 T-cells/million cells
Standard Deviation 2059.35
|
2589.31 T-cells/million cells
Standard Deviation 2110.15
|
2454.93 T-cells/million cells
Standard Deviation 1758.20
|
SECONDARY outcome
Timeframe: At Day 0 and at Day 21Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available (subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination).
Titers are presented as geometric mean titers (GMTs). The 3 flu strains assessed were A/New Caledonia (H1N1), A/New York (H3N2) and B/Jiangsu (B). Seropositivity was defined as a serum HI titer greater than or equal to (≥) 1:10.
Outcome measures
| Measure |
Fluarix- AS01E Group
n=75 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01E, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix 18-40 Y Group
n=75 Participants
Subjects (aged 18-40 years) received 1 dose of the Fluarix vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix ≥65 Y Group
n=49 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix-AS25 Group
n=74 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS25, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix-AS50 Group
n=75 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS50, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix- AS01B Group
n=75 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01B, administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease
A/New Caledonia, Day 0
|
33.5 Titers
Interval 24.5 to 45.9
|
20.7 Titers
Interval 14.3 to 30.2
|
23.5 Titers
Interval 16.2 to 34.1
|
23.9 Titers
Interval 17.6 to 32.5
|
24.1 Titers
Interval 18.1 to 32.3
|
33.9 Titers
Interval 24.5 to 46.9
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease
A/New Caledonia, Day 21
|
166.8 Titers
Interval 130.1 to 213.9
|
728.4 Titers
Interval 549.2 to 966.0
|
86.5 Titers
Interval 58.7 to 127.4
|
151.9 Titers
Interval 115.1 to 200.5
|
223.2 Titers
Interval 170.5 to 292.3
|
151.4 Titers
Interval 118.4 to 193.6
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease
A/New York, Day 0
|
17.2 Titers
Interval 12.9 to 22.9
|
16.5 Titers
Interval 12.8 to 21.4
|
12.0 Titers
Interval 9.2 to 15.6
|
13.0 Titers
Interval 10.1 to 16.7
|
16.0 Titers
Interval 12.1 to 21.2
|
15.5 Titers
Interval 12.3 to 19.6
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease
A/New York, Day 21
|
249.3 Titers
Interval 181.7 to 342.0
|
151.3 Titers
Interval 119.8 to 191.1
|
98.9 Titers
Interval 65.1 to 150.3
|
249.7 Titers
Interval 186.2 to 334.8
|
240.3 Titers
Interval 176.0 to 328.0
|
202.5 Titers
Interval 157.6 to 260.2
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease
B/Jiangsu, Day 0
|
30.0 Titers
Interval 23.2 to 38.8
|
25.2 Titers
Interval 18.9 to 33.6
|
31.4 Titers
Interval 21.8 to 45.2
|
27.7 Titers
Interval 21.1 to 36.5
|
38.7 Titers
Interval 27.7 to 54.0
|
39.2 Titers
Interval 30.2 to 51.0
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease
B/Jiangsu, Day 21
|
202.6 Titers
Interval 161.2 to 254.6
|
349.5 Titers
Interval 270.7 to 451.2
|
134.1 Titers
Interval 100.2 to 179.4
|
237.1 Titers
Interval 185.1 to 303.8
|
293.1 Titers
Interval 234.1 to 366.8
|
205.4 Titers
Interval 171.3 to 246.2
|
SECONDARY outcome
Timeframe: At Day 90 and Day 180Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence included all subjects from the ATP cohort for immunogenicity who had not received any medication or vaccine forbidden by the protocol during the study period and who had available assay results for at least 1 tested antigen at the Day 90 or Day 180 time points.
Titers are presented as geometric mean titers (GMTs). The 3 flu strains assessed were A/New Caledonia (H1N1), A/New York (H3N2) and B/Jiangsu (B). Seropositivity was defined as a serum HI titer of ≥ 1:10.
Outcome measures
| Measure |
Fluarix- AS01E Group
n=74 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01E, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix 18-40 Y Group
n=75 Participants
Subjects (aged 18-40 years) received 1 dose of the Fluarix vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix ≥65 Y Group
n=49 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix-AS25 Group
n=74 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS25, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix-AS50 Group
n=74 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS50, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix- AS01B Group
n=74 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01B, administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|
|
Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease
A/New Caledonia, Day 90
|
105.9 Titers
Interval 84.3 to 133.0
|
496.4 Titers
Interval 370.1 to 665.7
|
76.7 Titers
Interval 54.1 to 108.8
|
94.2 Titers
Interval 74.7 to 118.8
|
135.3 Titers
Interval 102.4 to 178.7
|
97.4 Titers
Interval 78.1 to 121.4
|
|
Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease
A/New Caledonia, Day 180
|
81.9 Titers
Interval 65.1 to 103.0
|
354.7 Titers
Interval 260.3 to 483.5
|
62.9 Titers
Interval 45.4 to 87.1
|
66.9 Titers
Interval 53.3 to 84.1
|
89.1 Titers
Interval 67.2 to 118.2
|
70.5 Titers
Interval 56.5 to 87.9
|
|
Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease
A/New York, Day 90
|
114.8 Titers
Interval 85.1 to 154.8
|
130.5 Titers
Interval 100.8 to 168.9
|
60.7 Titers
Interval 41.4 to 89.1
|
99.2 Titers
Interval 75.2 to 131.0
|
116.4 Titers
Interval 88.6 to 153.0
|
93.3 Titers
Interval 73.2 to 119.0
|
|
Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease
A/New York, Day 180
|
70.4 Titers
Interval 53.0 to 93.4
|
96.5 Titers
Interval 73.5 to 126.6
|
43.8 Titers
Interval 30.2 to 63.7
|
66.3 Titers
Interval 50.5 to 87.1
|
71.8 Titers
Interval 55.6 to 92.7
|
59.5 Titers
Interval 46.8 to 75.6
|
|
Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease
B/Jiangsu, Day 90
|
144.2 Titers
Interval 116.6 to 178.4
|
208.2 Titers
Interval 161.0 to 269.3
|
131.3 Titers
Interval 98.1 to 175.8
|
145.6 Titers
Interval 110.7 to 191.6
|
213.0 Titers
Interval 173.0 to 262.1
|
147.1 Titers
Interval 120.7 to 179.2
|
|
Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease
B/Jiangsu, Day 180
|
91.4 Titers
Interval 74.3 to 112.3
|
140.3 Titers
Interval 109.0 to 180.5
|
94.5 Titers
Interval 69.2 to 129.0
|
91.6 Titers
Interval 71.4 to 117.6
|
128.0 Titers
Interval 102.6 to 159.8
|
111.0 Titers
Interval 88.3 to 139.6
|
SECONDARY outcome
Timeframe: At Day 21Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available (subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination).
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer \<1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 flu strains assessed were A/New Caledonia (H1N1), A/New York (H3N2) and B/Jiangsu (B).
Outcome measures
| Measure |
Fluarix- AS01E Group
n=75 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01E, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix 18-40 Y Group
n=75 Participants
Subjects (aged 18-40 years) received 1 dose of the Fluarix vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix ≥65 Y Group
n=49 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix-AS25 Group
n=74 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS25, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix-AS50 Group
n=75 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS50, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix- AS01B Group
n=75 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01B, administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|
|
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease
A/New Caledonia (H1N1)
|
39 Participants
|
58 Participants
|
15 Participants
|
41 Participants
|
56 Participants
|
36 Participants
|
|
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease
A/New York (H3N2)
|
60 Participants
|
57 Participants
|
34 Participants
|
67 Participants
|
62 Participants
|
64 Participants
|
|
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease
B/Jiangsu (B).
|
53 Participants
|
61 Participants
|
22 Participants
|
54 Participants
|
50 Participants
|
49 Participants
|
SECONDARY outcome
Timeframe: At Day 90 and Day 180Population: The analysis was performed on the According-To-Protocol cohort for persistence included all subjects from the ATP cohort for immunogenicity who had not received any medication or vaccine forbidden by the protocol during the study period and who had available assay results for at least 1 tested antigen at the Day 90 or Day 180 time points.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer \<1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 flu strains assessed were A/New Caledonia (H1N1), A/New York (H3N2) and B/Jiangsu (B).
Outcome measures
| Measure |
Fluarix- AS01E Group
n=74 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01E, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix 18-40 Y Group
n=75 Participants
Subjects (aged 18-40 years) received 1 dose of the Fluarix vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix ≥65 Y Group
n=49 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix-AS25 Group
n=74 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS25, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix-AS50 Group
n=74 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS50, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix- AS01B Group
n=74 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01B, administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|
|
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease
A/New Caledonia, Day 90
|
28 Participants
|
56 Participants
|
16 Participants
|
32 Participants
|
38 Participants
|
25 Participants
|
|
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease
A/New Caledonia, Day 180
|
15 Participants
|
54 Participants
|
10 Participants
|
20 Participants
|
25 Participants
|
16 Participants
|
|
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease
A/New York, Day 90
|
48 Participants
|
55 Participants
|
29 Participants
|
56 Participants
|
55 Participants
|
47 Participants
|
|
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease
A/New York, Day 180
|
35 Participants
|
48 Participants
|
17 Participants
|
40 Participants
|
40 Participants
|
35 Participants
|
|
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease
B/Jiangsu, Day 90
|
44 Participants
|
53 Participants
|
16 Participants
|
38 Participants
|
44 Participants
|
33 Participants
|
|
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease
B/Jiangsu, Day 180
|
25 Participants
|
45 Participants
|
16 Participants
|
28 Participants
|
33 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: At Day 21Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available (subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination).
The seroconversion factor (SCF) was defined as the fold change in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to pre-vaccination time point. The 3 flu strains assessed were A/New Caledonia (H1N1), A/New York (H3N2) and B/Jiangsu (B).
Outcome measures
| Measure |
Fluarix- AS01E Group
n=75 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01E, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix 18-40 Y Group
n=75 Participants
Subjects (aged 18-40 years) received 1 dose of the Fluarix vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix ≥65 Y Group
n=49 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix-AS25 Group
n=74 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS25, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix-AS50 Group
n=75 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS50, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix- AS01B Group
n=75 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01B, administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|
|
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease
A/New Caledonia
|
5.0 Fold change
Interval 3.6 to 6.9
|
35.1 Fold change
Interval 21.9 to 56.4
|
3.7 Fold change
Interval 2.4 to 5.7
|
6.4 Fold change
Interval 4.5 to 9.0
|
9.2 Fold change
Interval 6.4 to 13.3
|
4.5 Fold change
Interval 3.3 to 6.1
|
|
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease
A/New York
|
14.5 Fold change
Interval 10.4 to 20.2
|
9.2 Fold change
Interval 7.1 to 11.8
|
8.2 Fold change
Interval 5.7 to 11.8
|
19.2 Fold change
Interval 14.6 to 25.3
|
15.0 Fold change
Interval 11.2 to 20.2
|
13.1 Fold change
Interval 10.0 to 17.1
|
|
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease
B/Jiangsu
|
6.7 Fold change
Interval 5.1 to 8.9
|
13.9 Fold change
Interval 10.1 to 19.1
|
4.3 Fold change
Interval 3.0 to 6.1
|
8.5 Fold change
Interval 6.5 to 11.2
|
7.6 Fold change
Interval 5.6 to 10.2
|
5.2 Fold change
Interval 4.2 to 6.5
|
SECONDARY outcome
Timeframe: At Day 90 and Day 180Population: The analysis was performed on the According-To-Protocol cohort for persistence included all subjects from the ATP cohort for immunogenicity who had not received any medication or vaccine forbidden by the protocol during the study period and who had available assay results for at least 1 tested antigen at the Day 90 or Day 180 time points.
The seroconversion factor (SCF) was defined as the fold change in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to pre-vaccination time point. The 3 flu strains assessed were A/New Caledonia (H1N1), A/New York (H3N2) and B/Jiangsu (B).
Outcome measures
| Measure |
Fluarix- AS01E Group
n=74 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01E, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix 18-40 Y Group
n=75 Participants
Subjects (aged 18-40 years) received 1 dose of the Fluarix vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix ≥65 Y Group
n=49 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix-AS25 Group
n=74 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS25, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix-AS50 Group
n=74 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS50, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix- AS01B Group
n=74 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01B, administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|
|
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease
A/New Caledonia, Day 180
|
2.4 Fold change
Interval 1.8 to 3.2
|
17.1 Fold change
Interval 11.2 to 26.0
|
2.7 Fold change
Interval 1.9 to 3.7
|
2.8 Fold change
Interval 2.2 to 3.6
|
3.7 Fold change
Interval 2.6 to 5.4
|
2.1 Fold change
Interval 1.6 to 2.8
|
|
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease
A/New York, Day 90
|
6.6 Fold change
Interval 5.0 to 8.6
|
7.9 Fold change
Interval 6.3 to 10.0
|
5.1 Fold change
Interval 3.7 to 7.0
|
7.6 Fold change
Interval 6.1 to 9.6
|
7.3 Fold change
Interval 5.7 to 9.2
|
6.2 Fold change
Interval 4.8 to 7.9
|
|
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease
A/New Caledonia, Day 90
|
3.1 Fold change
Interval 2.3 to 4.1
|
23.9 Fold change
Interval 15.6 to 36.8
|
3.3 Fold change
Interval 2.3 to 4.7
|
3.9 Fold change
Interval 3.0 to 5.2
|
5.7 Fold change
Interval 4.0 to 8.1
|
2.9 Fold change
Interval 2.2 to 3.9
|
|
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease
A/New York, Day 180
|
4.1 Fold change
Interval 3.2 to 5.3
|
5.8 Fold change
Interval 4.7 to 7.3
|
3.7 Fold change
Interval 2.7 to 4.9
|
5.1 Fold change
Interval 4.2 to 6.3
|
4.5 Fold change
Interval 3.5 to 5.8
|
3.9 Fold change
Interval 3.1 to 5.0
|
|
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease
B/Jiangsu, Day 90
|
4.8 Fold change
Interval 3.7 to 6.1
|
8.3 Fold change
Interval 6.2 to 11.0
|
4.2 Fold change
Interval 3.0 to 5.9
|
5.3 Fold change
Interval 4.2 to 6.6
|
5.6 Fold change
Interval 4.3 to 7.2
|
3.7 Fold change
Interval 3.0 to 4.6
|
|
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease
B/Jiangsu, Day 180
|
3.1 Fold change
Interval 2.5 to 3.9
|
5.4 Fold change
Interval 4.3 to 7.0
|
3 Fold change
Interval 2.2 to 4.1
|
3.3 Fold change
Interval 2.6 to 4.1
|
3.3 Fold change
Interval 2.6 to 4.3
|
2.8 Fold change
Interval 2.2 to 3.6
|
SECONDARY outcome
Timeframe: At Day 0 and at Day 21Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available (subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination).
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 3 flu strains assessed were A/New Caledonia (H1N1), A/New York (H3N2) and B/Jiangsu (B).
Outcome measures
| Measure |
Fluarix- AS01E Group
n=75 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01E, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix 18-40 Y Group
n=75 Participants
Subjects (aged 18-40 years) received 1 dose of the Fluarix vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix ≥65 Y Group
n=49 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix-AS25 Group
n=74 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS25, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix-AS50 Group
n=75 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS50, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix- AS01B Group
n=75 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01B, administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|
|
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease
A/New Caledonia, Day 0
|
41 Participants
|
27 Participants
|
18 Participants
|
32 Participants
|
33 Participants
|
41 Participants
|
|
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease
A/New Caledonia, Day 21
|
70 Participants
|
75 Participants
|
35 Participants
|
67 Participants
|
74 Participants
|
73 Participants
|
|
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease
A/New York, Day 0
|
23 Participants
|
24 Participants
|
9 Participants
|
16 Participants
|
24 Participants
|
24 Participants
|
|
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease
A/New York, Day 21
|
70 Participants
|
70 Participants
|
40 Participants
|
70 Participants
|
70 Participants
|
72 Participants
|
|
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease
B/Jiangsu, Day 0
|
40 Participants
|
35 Participants
|
23 Participants
|
37 Participants
|
40 Participants
|
45 Participants
|
|
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease
B/Jiangsu, Day 21
|
73 Participants
|
75 Participants
|
46 Participants
|
71 Participants
|
74 Participants
|
75 Participants
|
SECONDARY outcome
Timeframe: At Day 90 and Day 180Population: The analysis was performed on the According-To-Protocol cohort for persistence included all subjects from the ATP cohort for immunogenicity who had not received any medication or vaccine forbidden by the protocol during the study period and who had available assay results for at least 1 tested antigen at the Day 90 or Day 180 time points.
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 3 flu strains assessed were A/New Caledonia (H1N1), A/New York (H3N2) and B/Jiangsu (B).
Outcome measures
| Measure |
Fluarix- AS01E Group
n=74 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01E, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix 18-40 Y Group
n=75 Participants
Subjects (aged 18-40 years) received 1 dose of the Fluarix vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix ≥65 Y Group
n=49 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix-AS25 Group
n=74 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS25, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix-AS50 Group
n=74 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS50, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix- AS01B Group
n=74 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01B, administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|
|
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease
A/New Caledonia, Day 90
|
69 Participants
|
75 Participants
|
37 Participants
|
66 Participants
|
68 Participants
|
71 Participants
|
|
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease
A/New Caledonia, Day 180
|
62 Participants
|
72 Participants
|
34 Participants
|
58 Participants
|
62 Participants
|
60 Participants
|
|
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease
A/New York, Day 90
|
65 Participants
|
68 Participants
|
35 Participants
|
64 Participants
|
67 Participants
|
62 Participants
|
|
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease
A/New York, Day 180
|
54 Participants
|
64 Participants
|
28 Participants
|
54 Participants
|
58 Participants
|
54 Participants
|
|
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease
B/Jiangsu, Day 90
|
67 Participants
|
71 Participants
|
47 Participants
|
66 Participants
|
72 Participants
|
72 Participants
|
|
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease
B/Jiangsu, Day 180
|
63 Participants
|
67 Participants
|
41 Participants
|
63 Participants
|
70 Participants
|
69 Participants
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) follow-up period after vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects who received the vaccine dose.
Assessed solicited local symptoms were haematoma, pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = pain which prevented normal everyday activity. Grade 3 haematoma/redness/swelling = haematoma/redness/swelling spreading beyond 50 millimeters (mm).
Outcome measures
| Measure |
Fluarix- AS01E Group
n=75 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01E, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix 18-40 Y Group
n=75 Participants
Subjects (aged 18-40 years) received 1 dose of the Fluarix vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix ≥65 Y Group
n=50 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix-AS25 Group
n=75 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS25, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix-AS50 Group
n=75 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS50, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix- AS01B Group
n=75 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01B, administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Redness, > 50 mm
|
4 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
9 Participants
|
5 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Haematoma, Any
|
1 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
6 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Haematoma, > 50 mm
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Pain, Any
|
42 Participants
|
58 Participants
|
8 Participants
|
53 Participants
|
54 Participants
|
51 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Pain, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Redness, Any
|
11 Participants
|
12 Participants
|
5 Participants
|
11 Participants
|
22 Participants
|
17 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Swelling, Any
|
9 Participants
|
9 Participants
|
1 Participants
|
14 Participants
|
15 Participants
|
12 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Swelling, > 50 mm
|
3 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
6 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) follow-up period after vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects who received the vaccine dose.
Assessed solicited general symptoms were fatigue, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], headache, joint pain, muscle aches and shivering. Any = occurrence of any general symptom regardless of intensity grade and relationship to vaccination. Grade 3 = symptoms that prevented normal activity. Grade 3 fever = fever \>39°C. Related = general symptom assessed by the investigator as causally related to the study vaccination.
Outcome measures
| Measure |
Fluarix- AS01E Group
n=75 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01E, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix 18-40 Y Group
n=75 Participants
Subjects (aged 18-40 years) received 1 dose of the Fluarix vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix ≥65 Y Group
n=50 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix-AS25 Group
n=75 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS25, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix-AS50 Group
n=75 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS50, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix- AS01B Group
n=75 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01B, administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Fatigue, Grade 3
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
5 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Fatigue, Related
|
19 Participants
|
26 Participants
|
7 Participants
|
27 Participants
|
34 Participants
|
31 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Fever (axillary), Related
|
4 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
5 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Muscle aches, Grade 3
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Fatigue, Any
|
22 Participants
|
34 Participants
|
7 Participants
|
31 Participants
|
34 Participants
|
31 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Fever (axillary), Any
|
4 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
6 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Fever (axillary), Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Headache, Any
|
14 Participants
|
24 Participants
|
12 Participants
|
28 Participants
|
27 Participants
|
21 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Headache, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Headache, Related
|
14 Participants
|
17 Participants
|
8 Participants
|
26 Participants
|
25 Participants
|
20 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Joint pain, Any
|
17 Participants
|
5 Participants
|
4 Participants
|
19 Participants
|
13 Participants
|
23 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Joint pain, Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Joint pain, Related
|
14 Participants
|
4 Participants
|
2 Participants
|
17 Participants
|
12 Participants
|
20 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Muscle aches, Any
|
21 Participants
|
14 Participants
|
3 Participants
|
25 Participants
|
25 Participants
|
26 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Muscle aches, Related
|
18 Participants
|
11 Participants
|
2 Participants
|
24 Participants
|
25 Participants
|
25 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Shivering, Any
|
13 Participants
|
6 Participants
|
3 Participants
|
18 Participants
|
21 Participants
|
27 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Shivering, Grade 3
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Shivering, Related
|
13 Participants
|
4 Participants
|
2 Participants
|
18 Participants
|
20 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: During the 21-day (Days 0-20) follow-up period after vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects who received the vaccine dose.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 =event that prevented normal everyday activity. Related = event assessed by the investigator as causally related to the study vaccination.
Outcome measures
| Measure |
Fluarix- AS01E Group
n=75 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01E, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix 18-40 Y Group
n=75 Participants
Subjects (aged 18-40 years) received 1 dose of the Fluarix vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix ≥65 Y Group
n=50 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix-AS25 Group
n=75 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS25, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix-AS50 Group
n=75 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS50, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix- AS01B Group
n=75 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01B, administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Any AEs
|
24 Participants
|
37 Participants
|
6 Participants
|
27 Participants
|
26 Participants
|
31 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Grade 3 AEs
|
3 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
6 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Related AEs
|
5 Participants
|
11 Participants
|
2 Participants
|
9 Participants
|
14 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: During the entire study period (Day 0 - Day 180)Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects who received the vaccine dose.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Outcome measures
| Measure |
Fluarix- AS01E Group
n=75 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01E, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix 18-40 Y Group
n=75 Participants
Subjects (aged 18-40 years) received 1 dose of the Fluarix vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix ≥65 Y Group
n=50 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix-AS25 Group
n=75 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS25, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix-AS50 Group
n=75 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS50, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix- AS01B Group
n=75 Participants
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01B, administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs).
|
6 Participants
|
0 Participants
|
3 Participants
|
5 Participants
|
6 Participants
|
4 Participants
|
Adverse Events
Fluarix 18-40 Y Group
Serious events: 0 serious events
Other events: 37 other events
Deaths: 0 deaths
Fluarix ≥65 Y Group
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Fluarix-AS25 Group
Serious events: 5 serious events
Other events: 27 other events
Deaths: 0 deaths
Fluarix-AS50 Group
Serious events: 6 serious events
Other events: 26 other events
Deaths: 0 deaths
Fluarix- AS01B Group
Serious events: 4 serious events
Other events: 31 other events
Deaths: 0 deaths
Fluarix- AS01E Group
Serious events: 6 serious events
Other events: 24 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Fluarix 18-40 Y Group
n=75 participants at risk
Subjects (aged 18-40 years) received 1 dose of the Fluarix vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix ≥65 Y Group
n=50 participants at risk
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix-AS25 Group
n=75 participants at risk
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS25, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix-AS50 Group
n=75 participants at risk
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS50, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix- AS01B Group
n=75 participants at risk
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01B, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix- AS01E Group
n=75 participants at risk
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01E, administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|
|
General disorders
Malaise
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
General disorders
Oedema peripheral
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Nervous system disorders
Syncope
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Nervous system disorders
Transient ischemic attack
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
2.0%
1/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
2.0%
1/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
2.7%
2/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
2.0%
1/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
Other adverse events
| Measure |
Fluarix 18-40 Y Group
n=75 participants at risk
Subjects (aged 18-40 years) received 1 dose of the Fluarix vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix ≥65 Y Group
n=50 participants at risk
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix-AS25 Group
n=75 participants at risk
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS25, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix-AS50 Group
n=75 participants at risk
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS50, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix- AS01B Group
n=75 participants at risk
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01B, administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix- AS01E Group
n=75 participants at risk
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01E, administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
5.3%
4/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
General disorders
Influenza-like illness
|
4.0%
3/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
2.0%
1/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
5.3%
4/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
2.7%
2/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Infections and infestations
Nasopharyngitis
|
6.7%
5/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
2.0%
1/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
4.0%
3/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
2.7%
2/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
4.0%
3/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
2.7%
2/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Nervous system disorders
Headache
|
13.3%
10/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
4.0%
3/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
5.3%
4/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
2.7%
2/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.0%
3/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Gastrointestinal disorders
Nausea
|
2.7%
2/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
2.7%
2/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
2.7%
2/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
General disorders
Asthenia
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
General disorders
Chills
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
General disorders
Fatigue
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
General disorders
Feeling hot
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
General disorders
Injection site discolouration
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
General disorders
Injection site induration
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
General disorders
Injection site irritation
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
General disorders
Injection site pruritus
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
2.0%
1/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
General disorders
Injection site reaction
|
2.7%
2/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
2.0%
1/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
2.7%
2/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
General disorders
Injection site warmth
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
General disorders
Malaise
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
2.7%
2/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
General disorders
Oedema peripheral
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
General disorders
Pain
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
2.0%
1/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
4.0%
3/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Infections and infestations
Campylobacter infeection
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Infections and infestations
Cystitis
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Infections and infestations
Herpes simplex
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Infections and infestations
Pharyngitis
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Infections and infestations
Rhinitis
|
2.7%
2/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
4.0%
2/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
2.7%
2/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Infections and infestations
Sinusitis
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
2.7%
2/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
4.0%
3/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Infections and infestations
Urinary tract infections
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
2.7%
2/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.7%
2/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
2.7%
2/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Nervous system disorders
Migraine
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
2.7%
2/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Nervous system disorders
Syncope
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
2.7%
2/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Psychiatric disorders
Listless
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Reproductive system and breast disorders
Scrotal ulcer
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.7%
2/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
4.0%
3/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
2.7%
2/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Vascular disorders
Flushing
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
|
Vascular disorders
Hypertension
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/50 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
2.7%
2/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
1.3%
1/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
0.00%
0/75 • Unsolicited AEs: during the 21-day (Days 0-20) post-vaccination period; SAEs: during the entire study period (Days 0-180).
For the solicited local and general symptoms occurring during the 7-day (Days 0-6) post-vaccination period, please refer to outcome measures 10 and 11 from the Outcome Measures section above.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER