Trial Outcomes & Findings for Study to Evaluate an Influenza Vaccine Candidate (NCT NCT00540228)
NCT ID: NCT00540228
Last Updated: 2019-06-14
Results Overview
Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA). The seropositivity cut-off assay was 1:10. The results for Day 0 and Day 21 are the primary efficacy variables.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
1006 participants
Primary outcome timeframe
At Days 0, 21 and 180
Results posted on
2019-06-14
Participant Flow
Participant milestones
| Measure |
GSK1247446A 1 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 2 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 3 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 4 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
200
|
198
|
204
|
202
|
202
|
|
Overall Study
COMPLETED
|
197
|
197
|
204
|
202
|
202
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
GSK1247446A 1 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 2 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 3 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 4 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Study to Evaluate an Influenza Vaccine Candidate
Baseline characteristics by cohort
| Measure |
GSK1247446A 1 Group
n=200 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 2 Group
n=198 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 3 Group
n=204 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 4 Group
n=202 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix Group
n=202 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
Total
n=1006 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
40.5 Years
STANDARD_DEVIATION 14.14 • n=5 Participants
|
40.3 Years
STANDARD_DEVIATION 13.79 • n=7 Participants
|
39.7 Years
STANDARD_DEVIATION 14.37 • n=5 Participants
|
39.7 Years
STANDARD_DEVIATION 14.31 • n=4 Participants
|
40.1 Years
STANDARD_DEVIATION 14.11 • n=21 Participants
|
40.1 Years
STANDARD_DEVIATION 14.14 • n=10 Participants
|
|
Sex: Female, Male
Female
|
115 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
140 Participants
n=4 Participants
|
123 Participants
n=21 Participants
|
609 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
85 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
79 Participants
n=21 Participants
|
397 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: At Days 0, 21 and 180Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA). The seropositivity cut-off assay was 1:10. The results for Day 0 and Day 21 are the primary efficacy variables.
Outcome measures
| Measure |
Fluarix Group
n=187 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 1 Group
n=189 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 2 Group
n=190 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 3 Group
n=192 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 4 Group
n=192 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
SOLO, Day 21 [N=187;189;190;192;185]
|
191.0 titers
Interval 158.5 to 230.2
|
203.2 titers
Interval 171.7 to 240.3
|
155.8 titers
Interval 128.2 to 189.4
|
164.9 titers
Interval 137.6 to 197.8
|
151.1 titers
Interval 124.7 to 183.1
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
SOLO, Day 180 [N=189;190;192;192;187]
|
97.6 titers
Interval 82.5 to 115.5
|
81.3 titers
Interval 68.3 to 96.8
|
71.1 titers
Interval 58.8 to 86.1
|
76.3 titers
Interval 63.2 to 92.0
|
80.7 titers
Interval 66.7 to 97.5
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
WISC, Day 0 [N=187;189;190;192;185]
|
37.4 titers
Interval 30.2 to 46.4
|
29.4 titers
Interval 23.8 to 36.4
|
30.0 titers
Interval 24.3 to 37.2
|
29.9 titers
Interval 24.5 to 36.5
|
27.2 titers
Interval 22.6 to 32.8
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
WISC, Day 180 [N=189;190;192;192;187]
|
176.2 titers
Interval 151.7 to 204.6
|
174.3 titers
Interval 145.6 to 208.8
|
149.5 titers
Interval 125.3 to 178.3
|
164.0 titers
Interval 138.0 to 195.0
|
133.0 titers
Interval 112.5 to 157.3
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
MALA, Day 0 [N=187;189;190;192;185]
|
27.0 titers
Interval 22.2 to 32.7
|
25.8 titers
Interval 21.3 to 31.3
|
27.3 titers
Interval 22.6 to 32.9
|
22.6 titers
Interval 18.8 to 27.1
|
23.2 titers
Interval 19.5 to 27.8
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
MALA, Day 21 [N=187;189;190;192;185]
|
217.8 titers
Interval 184.3 to 257.4
|
225.8 titers
Interval 195.3 to 261.1
|
246.1 titers
Interval 210.9 to 287.2
|
195.5 titers
Interval 165.1 to 231.4
|
171.2 titers
Interval 144.2 to 203.2
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
MALA, Day 180 [N=189;190;192;192;187]
|
108.8 titers
Interval 93.1 to 127.0
|
106.6 titers
Interval 91.7 to 124.0
|
119.6 titers
Interval 103.7 to 138.0
|
97.2 titers
Interval 83.2 to 113.5
|
95.7 titers
Interval 82.1 to 111.7
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
SOLO, Day 0 [N=187;189;190;192;185]
|
15.1 titers
Interval 12.5 to 18.2
|
13.0 titers
Interval 10.9 to 15.5
|
12.3 titers
Interval 10.2 to 14.8
|
12.9 titers
Interval 10.6 to 15.8
|
14.9 titers
Interval 12.3 to 18.2
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
WISC, Day 21 [N=187;189;190;192;185]
|
335.3 titers
Interval 286.2 to 392.7
|
380.1 titers
Interval 321.3 to 449.8
|
326.4 titers
Interval 275.6 to 386.7
|
319.9 titers
Interval 270.0 to 379.1
|
273.9 titers
Interval 232.0 to 323.3
|
SECONDARY outcome
Timeframe: At Days 21 and 180Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine 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 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA).
Outcome measures
| Measure |
Fluarix Group
n=187 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 1 Group
n=189 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 2 Group
n=190 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 3 Group
n=192 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 4 Group
n=192 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|
|
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.
SOLO, Day 21 [N=187;189;190;192;185]
|
131 subjects
|
154 subjects
|
141 subjects
|
133 subjects
|
119 subjects
|
|
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.
SOLO, Day 180 [N=189;190;192;192;187]
|
110 subjects
|
117 subjects
|
108 subjects
|
102 subjects
|
102 subjects
|
|
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.
WISC, Day 21 [N=187;189;190;192;185]
|
118 subjects
|
150 subjects
|
147 subjects
|
142 subjects
|
142 subjects
|
|
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.
WISC, Day 180 [N=189;190;192;192;187]
|
100 subjects
|
112 subjects
|
97 subjects
|
112 subjects
|
106 subjects
|
|
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.
MALA, Day 180 [N=189;190;192;192;187]
|
88 subjects
|
99 subjects
|
99 subjects
|
98 subjects
|
102 subjects
|
|
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.
MALA, Day 21 [N=187;189;190;192;185]
|
125 subjects
|
136 subjects
|
127 subjects
|
128 subjects
|
127 subjects
|
SECONDARY outcome
Timeframe: At Days 21 and 180Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA).
Outcome measures
| Measure |
Fluarix Group
n=187 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 1 Group
n=189 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 2 Group
n=190 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 3 Group
n=192 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 4 Group
n=192 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|
|
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
WISC, Day 180 [N=189;190;192;192;187]
|
4.7 fold increase
Interval 3.9 to 5.8
|
6.0 fold increase
Interval 5.0 to 7.2
|
5.0 fold increase
Interval 4.2 to 6.1
|
5.4 fold increase
Interval 4.5 to 6.6
|
4.9 fold increase
Interval 4.1 to 5.9
|
|
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
MALA, Day 21 [N=187;189;190;192;185]
|
8.1 fold increase
Interval 6.6 to 9.9
|
8.7 fold increase
Interval 7.2 to 10.6
|
9.0 fold increase
Interval 7.3 to 11.2
|
8.7 fold increase
Interval 7.0 to 10.8
|
7.4 fold increase
Interval 6.1 to 8.9
|
|
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
SOLO, Day 21 [N=187;189;190;192;185]
|
12.7 fold increase
Interval 9.9 to 16.2
|
15.6 fold increase
Interval 12.7 to 19.2
|
12.7 fold increase
Interval 10.2 to 15.8
|
12.8 fold increase
Interval 10.1 to 16.1
|
10.1 fold increase
Interval 8.0 to 12.8
|
|
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
SOLO, Day 180 [N=189;190;192;192;187]
|
6.5 fold increase
Interval 5.2 to 8.0
|
6.4 fold increase
Interval 5.3 to 7.7
|
5.9 fold increase
Interval 4.8 to 7.2
|
5.9 fold increase
Interval 4.8 to 7.2
|
5.4 fold increase
Interval 4.4 to 6.7
|
|
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
WISC, Day 21 [N=187;189;190;192;185]
|
9.0 fold increase
Interval 7.2 to 11.2
|
12.9 fold increase
Interval 10.5 to 16.0
|
10.9 fold increase
Interval 8.9 to 13.3
|
10.7 fold increase
Interval 8.6 to 13.2
|
10.1 fold increase
Interval 10.1 to 12.3
|
|
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
MALA, Day 180 [N=189;190;192;192;187]
|
4.0 fold increase
Interval 3.3 to 4.8
|
4.2 fold increase
Interval 3.5 to 4.9
|
4.4 fold increase
Interval 3.6 to 5.3
|
4.4 fold increase
Interval 3.6 to 5.3
|
4.1 fold increase
Interval 3.5 to 4.8
|
SECONDARY outcome
Timeframe: At Days 0, 21 and 180Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA).
Outcome measures
| Measure |
Fluarix Group
n=187 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 1 Group
n=189 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 2 Group
n=190 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 3 Group
n=192 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 4 Group
n=192 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|
|
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.
SOLO, Day 0 [N=187;189;190;192;185]
|
50 subjects
|
45 subjects
|
46 subjects
|
43 subjects
|
52 subjects
|
|
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.
WISC, Day 21 [N=187;189;190;192;185]
|
183 subjects
|
183 subjects
|
186 subjects
|
185 subjects
|
184 subjects
|
|
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.
WISC, Day 180 [N=189;190;192;192;187]
|
183 subjects
|
175 subjects
|
175 subjects
|
175 subjects
|
173 subjects
|
|
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.
MALA, Day 0 [N=187;189;190;192;185]
|
88 subjects
|
80 subjects
|
88 subjects
|
81 subjects
|
86 subjects
|
|
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.
MALA, Day 21 [N=187;189;190;192;185]
|
178 subjects
|
183 subjects
|
186 subjects
|
180 subjects
|
180 subjects
|
|
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.
MALA, Day 180 [N=189;190;192;192;187]
|
169 subjects
|
174 subjects
|
177 subjects
|
167 subjects
|
171 subjects
|
|
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.
SOLO, Day 21 [N=187;189;190;192;185]
|
172 subjects
|
177 subjects
|
170 subjects
|
169 subjects
|
166 subjects
|
|
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.
SOLO, Day 180 [N=189;190;192;192;187]
|
159 subjects
|
157 subjects
|
144 subjects
|
144 subjects
|
151 subjects
|
|
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.
WISC, Day 0 [N=187;189;190;192;185]
|
95 subjects
|
90 subjects
|
90 subjects
|
96 subjects
|
91 subjects
|
SECONDARY outcome
Timeframe: At Days 0 and 21Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
Titers are presented as geometric mean titers (GMTs). The 4 influenza strains assessed were A/Wisconsin (WISC), B/Malaysia (MALA), A/Brisbane (BRIS) and B/Florida (FLOR). The seropositivity cut-off assay was 1:28.
Outcome measures
| Measure |
Fluarix Group
n=42 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 1 Group
n=47 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 2 Group
n=48 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 3 Group
n=44 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 4 Group
n=47 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
WISC, Day 0 [N=43;47;44;43;42]
|
212.5 titers
Interval 138.2 to 326.6
|
134.3 titers
Interval 94.6 to 190.8
|
136.3 titers
Interval 101.4 to 183.1
|
160.8 titers
Interval 111.0 to 232.9
|
148.0 titers
Interval 107.0 to 204.5
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
WISC, Day 21 [N=47;48;44;47;42]
|
864.0 titers
Interval 654.2 to 1140.9
|
1193.7 titers
Interval 876.6 to 1625.5
|
859.6 titers
Interval 637.8 to 1158.5
|
1027.9 titers
Interval 760.3 to 1389.8
|
842.3 titers
Interval 641.9 to 1105.2
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
MALA, Day 0 [N=46;48;44;44;42]
|
49.7 titers
Interval 35.2 to 70.0
|
34.1 titers
Interval 25.7 to 45.1
|
36.5 titers
Interval 25.9 to 51.3
|
33.3 titers
Interval 24.4 to 45.4
|
27.7 titers
Interval 21.1 to 36.2
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
MALA, Day 21 [N=44;48;43;42;42]
|
166.0 titers
Interval 111.2 to 247.7
|
162.5 titers
Interval 117.6 to 224.5
|
161.5 titers
Interval 128.6 to 202.9
|
141.0 titers
Interval 103.8 to 191.3
|
130.5 titers
Interval 98.7 to 172.7
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
BRIS, Day 0 [N=47;48;44;47;41]
|
466.8 titers
Interval 355.2 to 613.5
|
494.2 titers
Interval 389.0 to 627.7
|
365.9 titers
Interval 298.3 to 449.0
|
392.5 titers
Interval 319.1 to 482.8
|
445.7 titers
Interval 369.2 to 538.0
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
BRIS, Day 21 [N=47;48;44;47;42]
|
867.1 titers
Interval 658.9 to 1141.1
|
1151.5 titers
Interval 901.8 to 1470.4
|
847.5 titers
Interval 668.0 to 1075.3
|
884.2 titers
Interval 673.2 to 1161.2
|
1038.2 titers
Interval 799.3 to 1348.6
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
FLOR, Day 0 [N=45;48;44;47;42]
|
76.7 titers
Interval 51.1 to 115.3
|
48.9 titers
Interval 35.2 to 67.9
|
56.9 titers
Interval 38.6 to 83.9
|
51.0 titers
Interval 35.2 to 73.9
|
46.8 titers
Interval 32.7 to 66.9
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
FLOR, Day 21 [N=43;48;43;43;42]
|
131.1 titers
Interval 93.3 to 184.2
|
94.3 titers
Interval 68.8 to 129.3
|
113.6 titers
Interval 79.7 to 162.0
|
92.1 titers
Interval 60.6 to 139.9
|
82.7 titers
Interval 57.9 to 118.2
|
SECONDARY outcome
Timeframe: At Days 0, 21 and 180Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
The mean was calculated for CD4 T-cells (per million CD4 T-cells) producing at least two different cytokines (All Doubles), at least CD40L, at least INF gamma (IFN-γ), at least IL2 and at least TNF alpha (TNF-α).
Outcome measures
| Measure |
Fluarix Group
n=41 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 1 Group
n=46 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 2 Group
n=47 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 3 Group
n=43 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 4 Group
n=47 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
All Doubles, Day 0 [N=45;47;43;47;39]
|
1976.23 cells
Standard Deviation 1051.16
|
2106.16 cells
Standard Deviation 1274.90
|
2043.17 cells
Standard Deviation 894.18
|
2252.44 cells
Standard Deviation 1726.88
|
2103.66 cells
Standard Deviation 1370.89
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
All Doubles, Day 21 [N=45;45;40;45;39]
|
2489.15 cells
Standard Deviation 1468.71
|
3857.76 cells
Standard Deviation 2195.47
|
3366.93 cells
Standard Deviation 1693.40
|
3103.30 cells
Standard Deviation 1549.21
|
2827.84 cells
Standard Deviation 1561.60
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
CD40L, Day 0 [N=45;47;43;47;39]
|
1827.67 cells
Standard Deviation 1033.38
|
1914.96 cells
Standard Deviation 1241.38
|
1863.96 cells
Standard Deviation 830.55
|
2045.86 cells
Standard Deviation 1638.11
|
1954.13 cells
Standard Deviation 1290.77
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
CD40L, Day 21 [N=45;45;40;45;39]
|
2223.74 cells
Standard Deviation 1398.63
|
3337.89 cells
Standard Deviation 1982.59
|
2947.20 cells
Standard Deviation 1487.13
|
2624.30 cells
Standard Deviation 1316.60
|
2472.98 cells
Standard Deviation 1378.17
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
CD40L, Day 180 [N=46;42;42;43;41]
|
1560.76 cells
Standard Deviation 1009.77
|
2108.04 cells
Standard Deviation 1190.42
|
1758.95 cells
Standard Deviation 1093.80
|
1581.31 cells
Standard Deviation 1184.99
|
1731.00 cells
Standard Deviation 1331.05
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
IFN-γ, Day 0 [N=45;47;43;47;39]
|
1260.97 cells
Standard Deviation 809.24
|
1379.33 cells
Standard Deviation 987.07
|
1377.13 cells
Standard Deviation 741.31
|
1510.84 cells
Standard Deviation 1349.58
|
1342.57 cells
Standard Deviation 1040.63
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
IFN-γ, Day 21 [N=45;45;40;45;39]
|
1565.79 cells
Standard Deviation 1064.31
|
2525.91 cells
Standard Deviation 1615.78
|
2233.24 cells
Standard Deviation 1371.05
|
2056.40 cells
Standard Deviation 1205.90
|
1824.69 cells
Standard Deviation 1265.29
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
IFN-γ, Day 180 [N=46;42;42;43;41]
|
1299.95 cells
Standard Deviation 894.25
|
1792.74 cells
Standard Deviation 1075.76
|
1546.55 cells
Standard Deviation 1055.94
|
1335.62 cells
Standard Deviation 970.49
|
1440.09 cells
Standard Deviation 1199.84
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
IL2, Day 0 [N=45;47;43;47;39]
|
1572.69 cells
Standard Deviation 812.49
|
1684.24 cells
Standard Deviation 983.48
|
1657.28 cells
Standard Deviation 744.17
|
1796.33 cells
Standard Deviation 1354.89
|
1732.91 cells
Standard Deviation 1140.54
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
TNF-α, Day 0 [N=45;47;43;47;39]
|
1421.82 cells
Standard Deviation 781.48
|
1606.64 cells
Standard Deviation 1087.17
|
1522.70 cells
Standard Deviation 747.67
|
1712.42 cells
Standard Deviation 1355.23
|
1548.00 cells
Standard Deviation 1094.03
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
TNF-α, Day 180 [N=46;42;42;43;41]
|
1392.05 cells
Standard Deviation 933.32
|
1980.39 cells
Standard Deviation 1078.92
|
1654.90 cells
Standard Deviation 944.90
|
1454.40 cells
Standard Deviation 898.01
|
1627.67 cells
Standard Deviation 1155.63
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
All Doubles, Day 180 [N=46;42;42;43;41]
|
1952.02 cells
Standard Deviation 1240.63
|
2628.96 cells
Standard Deviation 1353.46
|
2249.88 cells
Standard Deviation 1325.73
|
1963.38 cells
Standard Deviation 1245.21
|
2153.12 cells
Standard Deviation 1473.45
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
IL2, Day 21 [N=45;45;40;45;39]
|
1933.10 cells
Standard Deviation 1153.35
|
3020.09 cells
Standard Deviation 1741.78
|
2634.64 cells
Standard Deviation 1415.24
|
2343.15 cells
Standard Deviation 1199.20
|
2256.02 cells
Standard Deviation 1251.58
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
IL2, Day 180 [N=46;42;42;43;41]
|
1581.73 cells
Standard Deviation 1028.49
|
2121.67 cells
Standard Deviation 1088.48
|
1816.26 cells
Standard Deviation 1116.55
|
1571.19 cells
Standard Deviation 987.96
|
1797.79 cells
Standard Deviation 1228.49
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
TNF-α, Day 21 [N=45;45;40;45;39]
|
1639.31 cells
Standard Deviation 975.93
|
2767.02 cells
Standard Deviation 1598.41
|
2337.38 cells
Standard Deviation 1068.82
|
2109.45 cells
Standard Deviation 1075.51
|
1990.60 cells
Standard Deviation 1157.58
|
SECONDARY outcome
Timeframe: At Days 0, 21 and 180Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
The mean was calculated for CD8 T-cells (per million CD8 T-cells) producing at least two different cytokines (All Doubles), at least CD40L, at least INF gamma (IFN-γ), at least IL2 and at least TNF alpha (TNF-α).
Outcome measures
| Measure |
Fluarix Group
n=41 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 1 Group
n=44 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 2 Group
n=46 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 3 Group
n=43 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 4 Group
n=45 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
All Doubles, Day 21 [N=44;43;40;42;38]
|
55.11 cells
Standard Deviation 126.17
|
47.18 cells
Standard Deviation 106.55
|
50.09 cells
Standard Deviation 101.55
|
38.53 cells
Standard Deviation 67.21
|
109.86 cells
Standard Deviation 282.04
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
CD40L, Day 0 [N=44;46;43;45;39]
|
7.05 cells
Standard Deviation 20.43
|
3.64 cells
Standard Deviation 12.37
|
5.91 cells
Standard Deviation 15.92
|
2.63 cells
Standard Deviation 8.06
|
16.27 cells
Standard Deviation 56.56
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
CD40L, Day 21 [N=44;43;40;42;38]
|
37.55 cells
Standard Deviation 117.41
|
8.82 cells
Standard Deviation 28.38
|
10.09 cells
Standard Deviation 21.58
|
6.45 cells
Standard Deviation 16.03
|
50.83 cells
Standard Deviation 193.00
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
CD40L, Day 180 [N=44;40;42;41;41]
|
2.27 cells
Standard Deviation 5.83
|
9.45 cells
Standard Deviation 35.59
|
15.88 cells
Standard Deviation 61.59
|
2.86 cells
Standard Deviation 8.48
|
1.68 cells
Standard Deviation 4.37
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
IFN-γ, Day 0 [N=44;46;43;45;39]
|
17.31 cells
Standard Deviation 38.50
|
29.50 cells
Standard Deviation 53.27
|
96.91 cells
Standard Deviation 375.61
|
14.42 cells
Standard Deviation 32.92
|
44.80 cells
Standard Deviation 137.59
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
IFN-γ, Day 21 [N=44;43;40;42;38]
|
32.11 cells
Standard Deviation 104.54
|
24.86 cells
Standard Deviation 61.18
|
48.07 cells
Standard Deviation 106.65
|
25.65 cells
Standard Deviation 49.98
|
64.98 cells
Standard Deviation 178.63
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
IFN-γ, Day 180 [N=44;40;42;41;41]
|
19.80 cells
Standard Deviation 37.25
|
38.18 cells
Standard Deviation 50.84
|
110.75 cells
Standard Deviation 303.91
|
20.62 cells
Standard Deviation 47.56
|
79.85 cells
Standard Deviation 239.36
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
IL2, Day 21 [N=44;46;43;45;39]
|
50.84 cells
Standard Deviation 116.74
|
36.98 cells
Standard Deviation 85.05
|
21.51 cells
Standard Deviation 42.47
|
31.28 cells
Standard Deviation 59.89
|
87.86 cells
Standard Deviation 244.84
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
IL2, Day 180 [N=44;40;42;41;41]
|
28.73 cells
Standard Deviation 55.08
|
27.36 cells
Standard Deviation 87.59
|
74.03 cells
Standard Deviation 183.59
|
24.50 cells
Standard Deviation 82.62
|
57.15 cells
Standard Deviation 136.73
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
TNF-α, Day 0 [N=44;46;43;45;39]
|
46.18 cells
Standard Deviation 91.78
|
42.98 cells
Standard Deviation 109.79
|
102.72 cells
Standard Deviation 391.96
|
15.42 cells
Standard Deviation 28.60
|
54.73 cells
Standard Deviation 156.41
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
TNF-α, Day 180 [N=44;40;42;41;41]
|
25.63 cells
Standard Deviation 56.06
|
34.70 cells
Standard Deviation 86.94
|
111.10 cells
Standard Deviation 299.67
|
33.60 cells
Standard Deviation 80.50
|
79.54 cells
Standard Deviation 208.13
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
All Doubles, Day 0 [N=44;46;43;45;39]
|
48.38 cells
Standard Deviation 82.57
|
50.02 cells
Standard Deviation 113.85
|
109.63 cells
Standard Deviation 405.09
|
17.33 cells
Standard Deviation 33.12
|
64.47 cells
Standard Deviation 181.32
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
All Doubles, Day 180 [N=44;40;42;41;41]
|
30.98 cells
Standard Deviation 62.35
|
44.32 cells
Standard Deviation 99.11
|
126.13 cells
Standard Deviation 323.68
|
36.31 cells
Standard Deviation 95.06
|
97.27 cells
Standard Deviation 258.53
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
IL2, Day 0 [N=44;46;43;45;39]
|
43.59 cells
Standard Deviation 81.53
|
35.59 cells
Standard Deviation 91.49
|
75.41 cells
Standard Deviation 309.22
|
8.81 cells
Standard Deviation 16.65
|
46.22 cells
Standard Deviation 130.46
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
TNF-α, Day 21 [N=44;43;40;42;38]
|
37.82 cells
Standard Deviation 110.79
|
37.93 cells
Standard Deviation 109.46
|
44.16 cells
Standard Deviation 99.17
|
31.55 cells
Standard Deviation 59.52
|
90.48 cells
Standard Deviation 239.47
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) post vaccination periodPopulation: The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects.
Assessed solicited local symptoms were ecchymosis, pain, redness and swelling at injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal everyday activity. Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site.
Outcome measures
| Measure |
Fluarix Group
n=202 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 1 Group
n=200 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 2 Group
n=198 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 3 Group
n=204 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 4 Group
n=202 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Any Ecchymosis
|
7 subjects
|
11 subjects
|
9 subjects
|
8 subjects
|
14 subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Grade 3 Ecchymosis
|
1 subjects
|
1 subjects
|
0 subjects
|
0 subjects
|
1 subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Any Pain
|
121 subjects
|
182 subjects
|
175 subjects
|
167 subjects
|
151 subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Grade 3 Pain
|
1 subjects
|
5 subjects
|
5 subjects
|
3 subjects
|
1 subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Any Redness
|
49 subjects
|
75 subjects
|
66 subjects
|
53 subjects
|
64 subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Grade 3 Redness
|
2 subjects
|
17 subjects
|
4 subjects
|
3 subjects
|
2 subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Any Swelling
|
27 subjects
|
69 subjects
|
54 subjects
|
49 subjects
|
48 subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Grade 3 Swelling
|
2 subjects
|
11 subjects
|
4 subjects
|
5 subjects
|
3 subjects
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) post vaccination periodPopulation: The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects.
Assessed solicited general symptoms were arthralgia, fatigue, fever \[oral temperature above (\>) 38.0 degrees Celsius (°C)\], headache, myalgia, nausea and shivering. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0°C. Related = symptom considered by the investigator to have a causal relationship to study vaccination.
Outcome measures
| Measure |
Fluarix Group
n=202 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 1 Group
n=200 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 2 Group
n=198 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 3 Group
n=204 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 4 Group
n=202 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Shivering
|
8 subjects
|
64 subjects
|
50 subjects
|
31 subjects
|
29 subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Nausea
|
0 subjects
|
1 subjects
|
2 subjects
|
3 subjects
|
0 subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Nausea
|
6 subjects
|
19 subjects
|
22 subjects
|
10 subjects
|
11 subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Shivering
|
12 subjects
|
74 subjects
|
53 subjects
|
40 subjects
|
34 subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Arthralgia
|
25 subjects
|
64 subjects
|
51 subjects
|
38 subjects
|
39 subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Arthralgia
|
1 subjects
|
4 subjects
|
4 subjects
|
2 subjects
|
0 subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Arthralgia
|
20 subjects
|
52 subjects
|
49 subjects
|
32 subjects
|
31 subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Shivering
|
2 subjects
|
4 subjects
|
5 subjects
|
1 subjects
|
1 subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Fatigue
|
47 subjects
|
103 subjects
|
90 subjects
|
86 subjects
|
78 subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Fatigue
|
2 subjects
|
5 subjects
|
4 subjects
|
2 subjects
|
2 subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Fatigue
|
34 subjects
|
81 subjects
|
83 subjects
|
72 subjects
|
62 subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Fever >38°C
|
3 subjects
|
27 subjects
|
16 subjects
|
8 subjects
|
6 subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Fever ≥ 39°C
|
0 subjects
|
2 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Fever
|
3 subjects
|
23 subjects
|
13 subjects
|
8 subjects
|
6 subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Headache
|
51 subjects
|
90 subjects
|
77 subjects
|
68 subjects
|
66 subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Headache
|
1 subjects
|
7 subjects
|
2 subjects
|
4 subjects
|
3 subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Headache
|
36 subjects
|
72 subjects
|
61 subjects
|
49 subjects
|
49 subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Myalgia
|
49 subjects
|
102 subjects
|
85 subjects
|
74 subjects
|
70 subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Myalgia
|
2 subjects
|
6 subjects
|
6 subjects
|
4 subjects
|
0 subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Myalgia
|
40 subjects
|
81 subjects
|
77 subjects
|
59 subjects
|
57 subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Nausea
|
11 subjects
|
25 subjects
|
28 subjects
|
12 subjects
|
13 subjects
|
SECONDARY outcome
Timeframe: From Day 0 to Day 180Population: The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects.
MSCs were defined as conditions prompting emergency room visits or physician visits that were not related to common diseases or routine visits. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 = event which prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination
Outcome measures
| Measure |
Fluarix Group
n=202 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 1 Group
n=200 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 2 Group
n=198 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 3 Group
n=204 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 4 Group
n=202 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs).
Subjects with any MSCs
|
45 subjects
|
70 subjects
|
56 subjects
|
53 subjects
|
64 subjects
|
|
Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs).
Subjects with grade 3 and related MSCs
|
1 subjects
|
2 subjects
|
2 subjects
|
0 subjects
|
0 subjects
|
|
Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs).
Subjects with related MSCs
|
1 subjects
|
5 subjects
|
2 subjects
|
0 subjects
|
0 subjects
|
SECONDARY outcome
Timeframe: During the 21-day (Days 0-20) post vaccination periodPopulation: The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects.
Unsolicited AE covers any AE 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 = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal activity Related = unsolicited AE assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
Fluarix Group
n=202 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 1 Group
n=200 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 2 Group
n=198 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 3 Group
n=204 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 4 Group
n=202 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Subjects with any AE(s)
|
80 subjects
|
85 subjects
|
91 subjects
|
70 subjects
|
82 subjects
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Subjects with grade 3 AE(s)
|
5 subjects
|
4 subjects
|
10 subjects
|
3 subjects
|
10 subjects
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Subjects with related AE(s)
|
14 subjects
|
37 subjects
|
41 subjects
|
25 subjects
|
19 subjects
|
SECONDARY outcome
Timeframe: From Day 0 to Day 180Population: The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Outcome measures
| Measure |
Fluarix Group
n=202 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 1 Group
n=200 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 2 Group
n=198 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 3 Group
n=204 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 4 Group
n=202 Participants
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs).
|
2 subjects
|
7 subjects
|
3 subjects
|
3 subjects
|
4 subjects
|
Adverse Events
GSK1247446A 1 Group
Serious events: 7 serious events
Other events: 182 other events
Deaths: 1 deaths
GSK1247446A 2 Group
Serious events: 3 serious events
Other events: 175 other events
Deaths: 0 deaths
GSK1247446A 3 Group
Serious events: 3 serious events
Other events: 167 other events
Deaths: 0 deaths
GSK1247446A 4 Group
Serious events: 4 serious events
Other events: 151 other events
Deaths: 0 deaths
Fluarix Group
Serious events: 2 serious events
Other events: 121 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GSK1247446A 1 Group
n=200 participants at risk
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 2 Group
n=198 participants at risk
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 3 Group
n=204 participants at risk
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 4 Group
n=202 participants at risk
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix Group
n=202 participants at risk
Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Angina unstable
|
0.00%
0/200 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/198 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/204 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.50%
1/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.50%
1/200 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/198 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/204 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.50%
1/200 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/198 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/204 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.50%
1/200 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/198 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/204 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/200 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/198 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.49%
1/204 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/200 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/198 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/204 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.50%
1/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.00%
0/200 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.51%
1/198 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/204 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/200 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/198 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/204 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.50%
1/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/200 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/198 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.49%
1/204 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/200 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.51%
1/198 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/204 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
Immune system disorders
Hypersensitivity
|
0.50%
1/200 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/198 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/204 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
Vascular disorders
Hypertension
|
0.00%
0/200 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.51%
1/198 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/204 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
Vascular disorders
Hypotension
|
0.50%
1/200 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/198 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/204 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
Psychiatric disorders
Mania
|
0.00%
0/200 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/198 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/204 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.50%
1/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
Nervous system disorders
Migraine
|
0.00%
0/200 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/198 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.49%
1/204 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
Nervous system disorders
Optic neuritis
|
0.50%
1/200 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/198 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/204 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/200 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/198 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/204 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.50%
1/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.50%
1/200 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/198 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/204 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/200 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.51%
1/198 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/204 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/200 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/198 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/204 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.50%
1/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
0.00%
0/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
Other adverse events
| Measure |
GSK1247446A 1 Group
n=200 participants at risk
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 2 Group
n=198 participants at risk
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 3 Group
n=204 participants at risk
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GSK1247446A 4 Group
n=202 participants at risk
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix Group
n=202 participants at risk
Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|
|
General disorders
Ecchymosis
|
5.5%
11/200 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
4.5%
9/198 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
3.9%
8/204 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
6.9%
14/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
3.5%
7/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
General disorders
Pain
|
91.0%
182/200 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
88.4%
175/198 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
81.9%
167/204 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
74.8%
151/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
59.9%
121/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
General disorders
Redness
|
37.5%
75/200 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
33.3%
66/198 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
26.0%
53/204 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
31.7%
64/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
24.3%
49/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
General disorders
Swelling
|
34.5%
69/200 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
27.3%
54/198 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
24.0%
49/204 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
23.8%
48/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
13.4%
27/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
General disorders
Arthralgia
|
32.0%
64/200 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
25.8%
51/198 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
18.6%
38/204 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
19.3%
39/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
12.4%
25/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
General disorders
Fatigue
|
51.5%
103/200 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
45.5%
90/198 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
42.2%
86/204 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
38.6%
78/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
23.3%
47/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
General disorders
Fever >38°C
|
13.5%
27/200 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
8.1%
16/198 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
3.9%
8/204 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
3.0%
6/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
1.5%
3/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
General disorders
Headache
|
45.0%
90/200 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
38.9%
77/198 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
33.3%
68/204 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
32.7%
66/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
25.2%
51/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
General disorders
Myalgia
|
51.0%
102/200 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
42.9%
85/198 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
36.3%
74/204 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
34.7%
70/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
24.3%
49/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
General disorders
Nausea
|
12.5%
25/200 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
14.1%
28/198 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
5.9%
12/204 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
6.4%
13/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
5.4%
11/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
General disorders
Shivering
|
37.0%
74/200 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
26.8%
53/198 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
19.6%
40/204 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
16.8%
34/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
5.9%
12/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
Nervous system disorders
Headache
|
7.0%
14/200 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
6.1%
12/198 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
7.8%
16/204 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
9.4%
19/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
6.9%
14/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
Infections and infestations
Rhinitis
|
2.5%
5/200 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
4.0%
8/198 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
2.9%
6/204 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
4.5%
9/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
6.4%
13/202 • SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
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