Trial Outcomes & Findings for Safety and Immunogenicity Study of GSK Biologicals' Seasonal Influenza Candidate Vaccine (GSK2321138A) (NCT NCT01204671)
NCT ID: NCT01204671
Last Updated: 2018-09-24
Results Overview
Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. HI antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
4659 participants
Primary outcome timeframe
At Day 0 (D 0), and at Day 21 (D 21)
Results posted on
2018-09-24
Participant Flow
A total of 4659 subjects (all aged 18 years and older at the time of their first vaccination as part of this study) were enrolled in this study, of which 4656 were vaccinated. The study vaccine dose was not administrated but subject number was allocated for the other 3 subjects.
Subjects receiving the GSK2321138A and Fluarix™ vaccines were followed in a double-blinded manner throughout the entire study period, from Day 0 to Day 180. Subjects receiving the GSK2604409A vaccine were followed in an open manner until Day 21 only.
Participant milestones
| Measure |
GSK2321138A Lot 1 Group
Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
GSK2321138A Lot 2 Group
Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
GSK2321138A Lot 3 Group
Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix Group
Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
GSK2604409A Group
Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1012
|
1013
|
1011
|
1010
|
610
|
|
Overall Study
COMPLETED
|
998
|
998
|
998
|
997
|
606
|
|
Overall Study
NOT COMPLETED
|
14
|
15
|
13
|
13
|
4
|
Reasons for withdrawal
| Measure |
GSK2321138A Lot 1 Group
Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
GSK2321138A Lot 2 Group
Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
GSK2321138A Lot 3 Group
Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix Group
Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
GSK2604409A Group
Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
3
|
3
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
4
|
5
|
3
|
|
Overall Study
Lost to Follow-up
|
7
|
8
|
6
|
4
|
0
|
|
Overall Study
Unknown Completion Status
|
1
|
1
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Safety and Immunogenicity Study of GSK Biologicals' Seasonal Influenza Candidate Vaccine (GSK2321138A)
Baseline characteristics by cohort
| Measure |
GSK2321138A Lot 1 Group
n=1012 Participants
Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
GSK2321138A Lot 2 Group
n=1013 Participants
Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
GSK2321138A Lot 3 Group
n=1011 Participants
Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix Group
n=1010 Participants
Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
GSK2604409A Group
n=610 Participants
Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
Total
n=4656 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
57.7 Years
STANDARD_DEVIATION 17.90 • n=5 Participants
|
58.0 Years
STANDARD_DEVIATION 17.41 • n=7 Participants
|
57.9 Years
STANDARD_DEVIATION 17.80 • n=5 Participants
|
58.1 Years
STANDARD_DEVIATION 17.83 • n=4 Participants
|
58.1 Years
STANDARD_DEVIATION 17.92 • n=21 Participants
|
58.0 Years
STANDARD_DEVIATION 17.75 • n=10 Participants
|
|
Sex: Female, Male
Female
|
598 Participants
n=5 Participants
|
578 Participants
n=7 Participants
|
569 Participants
n=5 Participants
|
548 Participants
n=4 Participants
|
343 Participants
n=21 Participants
|
2636 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
414 Participants
n=5 Participants
|
435 Participants
n=7 Participants
|
442 Participants
n=5 Participants
|
462 Participants
n=4 Participants
|
267 Participants
n=21 Participants
|
2020 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: At Day 0 (D 0), and at Day 21 (D 21)Population: The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available, and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.
Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. HI antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.
Outcome measures
| Measure |
GSK2321138A Group
n=1809 Participants
Subjects received one dose of the GSK2321138A vaccine, Lot 1, 2 or 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix Group
n=608 Participants
Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
GSK2604409A Group
n=534 Participants
Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix Group
Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
GSK2604409A Group
Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|
|
Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease
Yamagata Strain - D 21
|
601.8 Titer
Interval 573.3 to 631.6
|
386.6 Titer
Interval 351.5 to 425.3
|
582.5 Titer
Interval 534.6 to 634.7
|
—
|
—
|
|
Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease
H1N1 Strain - D 0
|
14.7 Titer
Interval 13.8 to 15.6
|
15.6 Titer
Interval 14.1 to 17.3
|
14.4 Titer
Interval 12.9 to 16.0
|
—
|
—
|
|
Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease
H1N1 Strain - D 21
|
201.1 Titer
Interval 188.1 to 215.1
|
218.4 Titer
Interval 194.2 to 245.6
|
213.0 Titer
Interval 187.6 to 241.9
|
—
|
—
|
|
Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease
H3N2 Strain - D 0
|
34.0 Titer
Interval 31.8 to 36.3
|
38.1 Titer
Interval 34.1 to 42.7
|
35.7 Titer
Interval 31.6 to 40.3
|
—
|
—
|
|
Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease
H3N2 Strain - D 21
|
314.7 Titer
Interval 296.8 to 333.6
|
298.2 Titer
Interval 268.4 to 331.3
|
340.4 Titer
Interval 304.3 to 380.9
|
—
|
—
|
|
Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease
Victoria Strain - D 0
|
73.8 Titer
Interval 69.1 to 78.8
|
73.6 Titer
Interval 65.5 to 82.8
|
71.7 Titer
Interval 63.4 to 81.0
|
—
|
—
|
|
Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease
Victoria Strain - D 21
|
404.6 Titer
Interval 386.6 to 423.4
|
393.8 Titer
Interval 362.7 to 427.6
|
258.5 Titer
Interval 234.6 to 284.8
|
—
|
—
|
|
Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease
Yamagata Strain - D 0
|
101.4 Titer
Interval 94.5 to 108.8
|
100.9 Titer
Interval 89.3 to 113.9
|
99.8 Titer
Interval 87.7 to 113.5
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 21 (D 21)Population: The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available, and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.
A seroconverted subject was a vaccinated subject who had either a pre-vaccination hemagglutination inhibition (HI) antibody titer \< 1:10 and a post-vaccination titer above or equal (\>=) 1:40, or a pre-vaccination HI antibody titer \>= 1:10 and at least a 4-fold increase in post-vaccination HI antibody titer. Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.
Outcome measures
| Measure |
GSK2321138A Group
n=1801 Participants
Subjects received one dose of the GSK2321138A vaccine, Lot 1, 2 or 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix Group
n=605 Participants
Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
GSK2604409A Group
n=530 Participants
Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix Group
Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
GSK2604409A Group
Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|
|
Number of Seroconverted Subjects Against 4 Strains of Influenza Disease
H1N1 Strain - D 21
|
1396 Participants
|
467 Participants
|
425 Participants
|
—
|
—
|
|
Number of Seroconverted Subjects Against 4 Strains of Influenza Disease
H3N2 Strain - D 21
|
1287 Participants
|
398 Participants
|
371 Participants
|
—
|
—
|
|
Number of Seroconverted Subjects Against 4 Strains of Influenza Disease
Victoria Strain - D 21
|
1046 Participants
|
335 Participants
|
252 Participants
|
—
|
—
|
|
Number of Seroconverted Subjects Against 4 Strains of Influenza Disease
Yamagata Strain - D 21
|
1112 Participants
|
276 Participants
|
313 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 0 (D 0), and at Day 21 (D 21)Population: The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available, and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.
A seropositive subject was a vaccinated subject with hemagglutination inhibition (HI) antibody titer above or equal (\>=) the reference cut-off value of 1:10. Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.
Outcome measures
| Measure |
GSK2321138A Group
n=1809 Participants
Subjects received one dose of the GSK2321138A vaccine, Lot 1, 2 or 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix Group
n=608 Participants
Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
GSK2604409A Group
n=534 Participants
Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix Group
Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
GSK2604409A Group
Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|
|
Number of Seropositive Subjects Against 4 Strains of Influenza Disease
H3N2 Strain - D 21
|
1783 Participants
|
594 Participants
|
528 Participants
|
—
|
—
|
|
Number of Seropositive Subjects Against 4 Strains of Influenza Disease
H1N1 Strain - D 0
|
967 Participants
|
352 Participants
|
291 Participants
|
—
|
—
|
|
Number of Seropositive Subjects Against 4 Strains of Influenza Disease
H1N1 Strain - D 21
|
1738 Participants
|
586 Participants
|
514 Participants
|
—
|
—
|
|
Number of Seropositive Subjects Against 4 Strains of Influenza Disease
H3N2 Strain - D 0
|
1416 Participants
|
488 Participants
|
425 Participants
|
—
|
—
|
|
Number of Seropositive Subjects Against 4 Strains of Influenza Disease
Victoria Strain - D 0
|
1541 Participants
|
511 Participants
|
452 Participants
|
—
|
—
|
|
Number of Seropositive Subjects Against 4 Strains of Influenza Disease
Victoria Strain - D 21
|
1795 Participants
|
601 Participants
|
518 Participants
|
—
|
—
|
|
Number of Seropositive Subjects Against 4 Strains of Influenza Disease
Yamagata Strain - D 0
|
1554 Participants
|
525 Participants
|
457 Participants
|
—
|
—
|
|
Number of Seropositive Subjects Against 4 Strains of Influenza Disease
Yamagata Strain - D 21
|
1794 Participants
|
597 Participants
|
532 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 0 (D 0), and at Day 21 (D 21)Population: The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available, and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.
A seroprotected subject was a vaccinated subject who had hemagglutination inhibition (HI) antibody titer above or equal (\>=) 1:40. Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.
Outcome measures
| Measure |
GSK2321138A Group
n=1809 Participants
Subjects received one dose of the GSK2321138A vaccine, Lot 1, 2 or 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix Group
n=608 Participants
Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
GSK2604409A Group
n=534 Participants
Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix Group
Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
GSK2604409A Group
Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease
H1N1 Strain - D 0
|
514 Participants
|
167 Participants
|
139 Participants
|
—
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease
H1N1 Strain - D 21
|
1651 Participants
|
558 Participants
|
495 Participants
|
—
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease
H3N2 Strain - D 0
|
965 Participants
|
353 Participants
|
285 Participants
|
—
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease
H3N2 Strain - D 21
|
1751 Participants
|
583 Participants
|
517 Participants
|
—
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease
Victoria Strain - D 0
|
1423 Participants
|
477 Participants
|
412 Participants
|
—
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease
Victoria Strain - D 21
|
1788 Participants
|
599 Participants
|
513 Participants
|
—
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease
Yamagata Strain - D 0
|
1494 Participants
|
497 Participants
|
441 Participants
|
—
|
—
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease
Yamagata Strain - D 21
|
1792 Participants
|
595 Participants
|
532 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 21 (D 21)Population: The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available, and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.
Increase in hemagglutination inhibition (HI) antibodies is presented in terms of mean geometric increase (MGI), defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer , expressed using "fold increase" as unit . Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.
Outcome measures
| Measure |
GSK2321138A Group
n=1801 Participants
Subjects received one dose of the GSK2321138A vaccine, Lot 1, 2 or 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix Group
n=605 Participants
Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
GSK2604409A Group
n=530 Participants
Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix Group
Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
GSK2604409A Group
Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|
|
Increase in Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease
H1N1 Strain - D 21
|
13.69 fold change
Interval 12.7 to 14.76
|
13.92 fold change
Interval 12.23 to 15.84
|
14.88 fold change
Interval 12.91 to 17.16
|
—
|
—
|
|
Increase in Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease
H3N2 Strain - D 21
|
9.28 fold change
Interval 8.64 to 9.96
|
7.84 fold change
Interval 6.93 to 8.88
|
9.52 fold change
Interval 8.33 to 10.89
|
—
|
—
|
|
Increase in Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease
Victoria Strain - D 21
|
5.48 fold change
Interval 5.12 to 5.85
|
5.37 fold change
Interval 4.75 to 6.06
|
3.60 fold change
Interval 3.25 to 3.98
|
—
|
—
|
|
Increase in Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease
Yamagata Strain - D 21
|
5.93 fold change
Interval 5.53 to 6.36
|
3.84 fold change
Interval 3.42 to 4.3
|
5.84 fold change
Interval 5.13 to 6.65
|
—
|
—
|
SECONDARY outcome
Timeframe: Within the 7-day (Days 0-6) follow-up period after vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, solely on subjects with available results.
Assessed solicited local symptoms post vaccination were pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity. Grade 3 pain = significant pain at rest/ that prevented normal every day activities. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Outcome measures
| Measure |
GSK2321138A Group
n=1008 Participants
Subjects received one dose of the GSK2321138A vaccine, Lot 1, 2 or 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix Group
n=1003 Participants
Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
GSK2604409A Group
n=1004 Participants
Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix Group
n=1003 Participants
Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
GSK2604409A Group
n=607 Participants
Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Grade 3 Pain
|
13 Participants
|
6 Participants
|
5 Participants
|
12 Participants
|
3 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Any Swelling
|
26 Participants
|
20 Participants
|
16 Participants
|
21 Participants
|
8 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Any Pain
|
377 Participants
|
362 Participants
|
357 Participants
|
369 Participants
|
190 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Any Redness
|
24 Participants
|
12 Participants
|
22 Participants
|
17 Participants
|
12 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Grade 3 Redness (≥ 100 mm)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Grade 3 Swelling (≥ 100 mm)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within the 7-day (Days 0-6) follow-up period after vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, solely on subjects with available results.
Assessed solicited local symptoms post vaccination were pain, redness and swelling at the injection site.
Outcome measures
| Measure |
GSK2321138A Group
n=377 Participants
Subjects received one dose of the GSK2321138A vaccine, Lot 1, 2 or 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix Group
n=362 Participants
Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
GSK2604409A Group
n=357 Participants
Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix Group
n=369 Participants
Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
GSK2604409A Group
n=190 Participants
Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|
|
Number of Days With Solicited Local Symptoms
Pain
|
2.0 Day
Interval 1.0 to 2.0
|
2.0 Day
Interval 1.0 to 3.0
|
2.0 Day
Interval 1.0 to 2.0
|
2.0 Day
Interval 1.0 to 3.0
|
2.0 Day
Interval 1.0 to 2.0
|
|
Number of Days With Solicited Local Symptoms
Redness
|
2.0 Day
Interval 1.0 to 2.5
|
2.5 Day
Interval 1.5 to 4.5
|
2.0 Day
Interval 1.0 to 4.0
|
1.0 Day
Interval 1.0 to 2.0
|
1.0 Day
Interval 1.0 to 2.5
|
|
Number of Days With Solicited Local Symptoms
Swelling
|
2.0 Day
Interval 1.0 to 3.0
|
2.0 Day
Interval 1.0 to 3.0
|
2.0 Day
Interval 1.5 to 3.0
|
2.0 Day
Interval 1.0 to 3.0
|
2.5 Day
Interval 1.0 to 3.0
|
SECONDARY outcome
Timeframe: Within the 7-day (Days 0-6) follow-up period after vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, solely on subjects with available results.
Assessed solicited general symptoms post vaccination were fatigue, gastrointestinal symptoms (Gastr.), headache, joint pain at other location (Joint Pain), muscle aches, shivering, and temperature \[axillary temperature above or equal to (\>=) 37.5 degrees Celsius (°C)\]. Any = occurrence of a symptom regardless of intensity or relationship to vaccination. Grade 3 = symptom which prevented normal every day activities. Grade 3 temperature = axillary temperature \> 39°C. Related = symptom assessed as causally related to study vaccination.
Outcome measures
| Measure |
GSK2321138A Group
n=1008 Participants
Subjects received one dose of the GSK2321138A vaccine, Lot 1, 2 or 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix Group
n=1001 Participants
Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
GSK2604409A Group
n=1002 Participants
Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix Group
n=1003 Participants
Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
GSK2604409A Group
n=607 Participants
Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Joint Pain
|
67 Participants
|
54 Participants
|
51 Participants
|
61 Participants
|
29 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue
|
152 Participants
|
154 Participants
|
171 Participants
|
185 Participants
|
90 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue
|
109 Participants
|
107 Participants
|
118 Participants
|
132 Participants
|
64 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache
|
163 Participants
|
162 Participants
|
155 Participants
|
164 Participants
|
80 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue
|
9 Participants
|
4 Participants
|
8 Participants
|
6 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastr.
|
64 Participants
|
63 Participants
|
70 Participants
|
65 Participants
|
36 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastr.
|
5 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastr.
|
37 Participants
|
34 Participants
|
38 Participants
|
35 Participants
|
19 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache
|
10 Participants
|
8 Participants
|
8 Participants
|
8 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache
|
87 Participants
|
92 Participants
|
98 Participants
|
97 Participants
|
48 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Joint Pain
|
96 Participants
|
84 Participants
|
74 Participants
|
104 Participants
|
57 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Joint Pain
|
6 Participants
|
5 Participants
|
3 Participants
|
7 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Muscle Aches
|
165 Participants
|
172 Participants
|
156 Participants
|
195 Participants
|
98 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Muscle Aches
|
5 Participants
|
2 Participants
|
7 Participants
|
8 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Muscle Aches
|
117 Participants
|
130 Participants
|
109 Participants
|
137 Participants
|
61 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Shivering
|
45 Participants
|
32 Participants
|
48 Participants
|
50 Participants
|
26 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Shivering
|
3 Participants
|
2 Participants
|
6 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Shivering
|
31 Participants
|
19 Participants
|
32 Participants
|
30 Participants
|
19 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Temperature (≥ 37.5°C)
|
19 Participants
|
21 Participants
|
8 Participants
|
12 Participants
|
9 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Temperature (> 39.0°C)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Temperature
|
11 Participants
|
16 Participants
|
3 Participants
|
5 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Within the 7-day (Days 0-6) follow-up period after vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, solely on subjects with available results.
Assessed solicited general symptoms post vaccination were fatigue, gastrointestinal symptoms (Gastr.), headache, joint pain at other location (Joint Pain), muscle aches, shivering, and temperature \[defined as axillary temperature above or equal to (≥) 37.5 degrees Celsius (°C)\].
Outcome measures
| Measure |
GSK2321138A Group
n=165 Participants
Subjects received one dose of the GSK2321138A vaccine, Lot 1, 2 or 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix Group
n=172 Participants
Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
GSK2604409A Group
n=171 Participants
Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix Group
n=195 Participants
Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
GSK2604409A Group
n=98 Participants
Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|
|
Number of Days With Solicited General Symptoms
Shivering
|
2.0 Day
Interval 1.0 to 2.0
|
2.0 Day
Interval 1.0 to 2.0
|
2.0 Day
Interval 1.0 to 3.0
|
1.0 Day
Interval 1.0 to 2.0
|
1.5 Day
Interval 1.0 to 2.0
|
|
Number of Days With Solicited General Symptoms
Fatigue
|
2.0 Day
Interval 1.0 to 3.0
|
2.0 Day
Interval 1.0 to 3.0
|
2.0 Day
Interval 1.0 to 3.0
|
2.0 Day
Interval 1.0 to 3.0
|
2.0 Day
Interval 1.0 to 3.0
|
|
Number of Days With Solicited General Symptoms
Gastr.
|
2.0 Day
Interval 1.0 to 3.0
|
2.0 Day
Interval 1.0 to 3.0
|
2.0 Day
Interval 1.0 to 3.0
|
2.0 Day
Interval 1.0 to 3.0
|
2.0 Day
Interval 1.0 to 2.5
|
|
Number of Days With Solicited General Symptoms
Headache
|
1.0 Day
Interval 1.0 to 3.0
|
2.0 Day
Interval 1.0 to 3.0
|
2.0 Day
Interval 1.0 to 2.0
|
2.0 Day
Interval 1.0 to 2.0
|
1.0 Day
Interval 1.0 to 3.0
|
|
Number of Days With Solicited General Symptoms
Joint Pain
|
2.0 Day
Interval 1.0 to 4.0
|
2.0 Day
Interval 1.0 to 4.0
|
2.0 Day
Interval 1.0 to 4.0
|
2.0 Day
Interval 1.0 to 3.0
|
2.0 Day
Interval 1.0 to 3.0
|
|
Number of Days With Solicited General Symptoms
Muscle Aches
|
2.0 Day
Interval 1.0 to 3.0
|
2.0 Day
Interval 1.0 to 3.0
|
2.0 Day
Interval 1.0 to 3.0
|
2.0 Day
Interval 1.0 to 3.0
|
2.0 Day
Interval 1.0 to 3.0
|
|
Number of Days With Solicited General Symptoms
Temperature
|
1.0 Day
Interval 1.0 to 2.0
|
1.0 Day
Interval 1.0 to 3.0
|
1.0 Day
Interval 1.0 to 1.0
|
1.0 Day
Interval 1.0 to 2.0
|
2.0 Day
Interval 1.0 to 2.0
|
SECONDARY outcome
Timeframe: Within the 21-day (Days 0-20) follow-up period after vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
Unsolicited AEs cover 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 unsolicited AE = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 unsolicited AE = unsolicited AE that prevented normal everyday activity Related unsolicited AE = unsolicited AE assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
GSK2321138A Group
n=1012 Participants
Subjects received one dose of the GSK2321138A vaccine, Lot 1, 2 or 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix Group
n=1013 Participants
Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
GSK2604409A Group
n=1011 Participants
Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix Group
n=1010 Participants
Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
GSK2604409A Group
n=610 Participants
Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Any Unsolicited AE(s)
|
125 Participants
|
120 Participants
|
134 Participants
|
138 Participants
|
92 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Grade 3 Unsolicited AE(s)
|
11 Participants
|
12 Participants
|
16 Participants
|
7 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Related Unsolicited AE(s)
|
17 Participants
|
20 Participants
|
27 Participants
|
26 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: From the beginning of the study (Day 0) to study end (Day 180)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
Medically-attended events (MAEs) refer to non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. If a MAE was leading to hospitalisation (or met any other serious adverse event criterion), it was reported as serious adverse event. Related MAE = MAE assessed by the investigator as related to the vaccination. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.
Outcome measures
| Measure |
GSK2321138A Group
n=3036 Participants
Subjects received one dose of the GSK2321138A vaccine, Lot 1, 2 or 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix Group
n=1010 Participants
Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
GSK2604409A Group
n=610 Participants
Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix Group
Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
GSK2604409A Group
Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|
|
Number of Subjects With Any and Related Adverse Events With Medically-attended Events (MAEs)
Any MAE(s)
|
688 Participants
|
216 Participants
|
52 Participants
|
—
|
—
|
|
Number of Subjects With Any and Related Adverse Events With Medically-attended Events (MAEs)
Related MAE(s)
|
11 Participants
|
4 Participants
|
5 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From the beginning of the study (Day 0) to study end (Day 180)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
Potential immune-mediated diseases (pIMDs) are a subset of adverse events that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Related pIMD = pIMD assessed by the investigator as related to the vaccination. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.
Outcome measures
| Measure |
GSK2321138A Group
n=3036 Participants
Subjects received one dose of the GSK2321138A vaccine, Lot 1, 2 or 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix Group
n=1010 Participants
Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
GSK2604409A Group
n=610 Participants
Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix Group
Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
GSK2604409A Group
Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|
|
Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs)
Any pIMD(s)
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs)
Related pIMD(s)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From the beginning of the study (Day 0) to study end (Day 180)Population: The analysis was performed 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. Any SAE = any SAE regardless of intensity or relationship to vaccination. Related SAE = SAE assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
GSK2321138A Group
n=1012 Participants
Subjects received one dose of the GSK2321138A vaccine, Lot 1, 2 or 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix Group
n=1013 Participants
Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
GSK2604409A Group
n=1011 Participants
Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix Group
n=1010 Participants
Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
GSK2604409A Group
n=610 Participants
Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|
|
Number of Subjects With Any and Related Serious Adverse Events (SAEs)
Any SAE(s)
|
28 Participants
|
20 Participants
|
22 Participants
|
26 Participants
|
1 Participants
|
|
Number of Subjects With Any and Related Serious Adverse Events (SAEs)
Related SAE(s)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
GSK2321138A Lot 1 Group
Serious events: 28 serious events
Other events: 485 other events
Deaths: 0 deaths
GSK2321138A Lot 2 Group
Serious events: 20 serious events
Other events: 472 other events
Deaths: 0 deaths
GSK2321138A Lot 3 Group
Serious events: 22 serious events
Other events: 482 other events
Deaths: 0 deaths
Fluarix Group
Serious events: 26 serious events
Other events: 500 other events
Deaths: 0 deaths
GSK2604409A Group
Serious events: 1 serious events
Other events: 275 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GSK2321138A Lot 1 Group
n=1008 participants at risk；n=1012 participants at risk
Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
GSK2321138A Lot 2 Group
n=1003 participants at risk；n=1013 participants at risk
Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
GSK2321138A Lot 3 Group
n=1004 participants at risk；n=1011 participants at risk
Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix Group
n=1003 participants at risk；n=1010 participants at risk
Subjects received one dose of the 1 dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
GSK2604409A Group
n=607 participants at risk；n=610 participants at risk
Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Cardiac disorders
Cardiac failure
|
0.20%
2/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.10%
1/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.10%
1/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Cardiac disorders
Myocardial infarction
|
0.10%
1/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.20%
2/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.20%
2/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.10%
1/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Eye disorders
Diplopia
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Gastrointestinal disorders
Acute abdomen
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.10%
1/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Gastrointestinal disorders
Intestinal infarction
|
0.10%
1/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.10%
1/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
General disorders
Death
|
0.10%
1/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
General disorders
Sudden death
|
0.10%
1/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.10%
1/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Hepatobiliary disorders
Jaundice
|
0.10%
1/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Infections and infestations
Central nervous system infection
|
0.10%
1/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Infections and infestations
Device related infection
|
0.10%
1/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Infections and infestations
Erysipelas
|
0.10%
1/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Infections and infestations
Gastroenteritis
|
0.10%
1/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Infections and infestations
Groin abscess
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.30%
3/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.20%
2/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Infections and infestations
Tooth abscess
|
0.10%
1/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Infections and infestations
Urinary tract infection
|
0.20%
2/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.10%
1/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Nervous system disorders
Dizziness
|
0.10%
1/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.10%
1/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.10%
1/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Investigations
Ammonia increased
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.10%
1/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.20%
2/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.10%
1/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric adenoma
|
0.20%
2/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.10%
1/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer (
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer stage unspecified
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.10%
1/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.30%
3/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.20%
2/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.20%
2/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Nervous system disorders
Coma hepatic
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Nervous system disorders
Headache
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.10%
1/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.10%
1/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.10%
1/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.20%
2/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.10%
1/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.10%
1/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.10%
1/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/1012 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1013 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1011 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.00%
0/1010 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
0.16%
1/610 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
Other adverse events
| Measure |
GSK2321138A Lot 1 Group
n=1008 participants at risk；n=1012 participants at risk
Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
GSK2321138A Lot 2 Group
n=1003 participants at risk；n=1013 participants at risk
Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
GSK2321138A Lot 3 Group
n=1004 participants at risk；n=1011 participants at risk
Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
Fluarix Group
n=1003 participants at risk；n=1010 participants at risk
Subjects received one dose of the 1 dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
GSK2604409A Group
n=607 participants at risk；n=610 participants at risk
Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|
|
General disorders
Pain
|
37.4%
377/1008 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
36.1%
362/1003 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
35.6%
357/1004 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
36.8%
369/1003 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
31.3%
190/607 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
General disorders
Fatigue
|
15.1%
152/1008 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
15.4%
154/1003 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
17.0%
171/1004 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
18.4%
185/1003 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
14.8%
90/607 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
General disorders
Gastrointestinal symptoms
|
6.3%
64/1008 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
6.3%
63/1003 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
7.0%
70/1004 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
6.5%
65/1003 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
5.9%
36/607 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
General disorders
Headache
|
16.2%
163/1008 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
16.2%
162/1003 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
15.4%
155/1004 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
16.4%
164/1003 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
13.2%
80/607 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
General disorders
Joint pain
|
9.5%
96/1008 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
8.4%
84/1003 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
7.4%
74/1004 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
10.4%
104/1003 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
9.4%
57/607 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
|
General disorders
Muscle aches
|
16.4%
165/1008 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
17.1%
172/1003 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
15.5%
156/1004 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
19.4%
195/1003 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
16.1%
98/607 • Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
|
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