Trial Outcomes & Findings for A Study to Find the Dose and Assess the Immune Response and Safety of a Vaccine Against Influenza in Healthy Younger and Older Adults (NCT NCT06431607)
NCT ID: NCT06431607
Last Updated: 2026-03-10
Results Overview
SCR is defined as the percentage of dosed participants who have either an anti-vaccine antibody pre-dose titer \< 1:10 and a post-dose anti-vaccine antibody titer \>= 1:40 or a pre-dose anti-vaccine antibody titer \>= 1:10 and at least a 4-fold increase in post-dose anti-vaccine antibody titer. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
845 participants
Primary outcome timeframe
From Day 1 (baseline) to Day 29
Results posted on
2026-03-10
Participant Flow
A total of 845 participants were included in enrolled set out of which only 833 were included in exposed set and started the study.
Participant milestones
| Measure |
Part 1 OA: Flu mRNA_7_OA
OA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Flu mRNA_1_Younger Adults (YA)
YA participants received a single dose of Flu mRNA study intervention F2G22B/DL001Z administered at Day 1.
|
Part 1 YA: Flu mRNA_2_YA
YA participants received a single dose of Flu mRNA study intervention F2H23D/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_3_YA
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
Part 1 OA: Flu mRNA_5_Older Adults (OA)
OA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 OA: Flu mRNA_6_OA
OA participants received a single dose of Flu mRNA study intervention F2H23A/DL001Z-NH administered at Day 1.
|
Part 1 OA: Flu mRNA_8_OA
OA participants received a single dose of Flu mRNA study intervention F2H23G/DL001Z administered at Day 1.
|
Part 1 OA: Comparator_1_OA
OA participants received a single dose of Comparator 1 (Fluzone HD Quadrivalent) administered at Day 1.
|
Part 2 OA: Flu mRNA_10_OA
OA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 OA: Comparator_2_OA
OA participants received a single dose of Comparator 2 (Fluzone HD) administered at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
53
|
50
|
50
|
48
|
50
|
52
|
81
|
80
|
51
|
52
|
51
|
53
|
82
|
80
|
|
Overall Study
COMPLETED
|
53
|
49
|
49
|
47
|
50
|
47
|
77
|
77
|
51
|
52
|
50
|
53
|
81
|
78
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
1
|
0
|
5
|
4
|
3
|
0
|
0
|
1
|
0
|
1
|
2
|
Reasons for withdrawal
| Measure |
Part 1 OA: Flu mRNA_7_OA
OA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Flu mRNA_1_Younger Adults (YA)
YA participants received a single dose of Flu mRNA study intervention F2G22B/DL001Z administered at Day 1.
|
Part 1 YA: Flu mRNA_2_YA
YA participants received a single dose of Flu mRNA study intervention F2H23D/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_3_YA
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
Part 1 OA: Flu mRNA_5_Older Adults (OA)
OA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 OA: Flu mRNA_6_OA
OA participants received a single dose of Flu mRNA study intervention F2H23A/DL001Z-NH administered at Day 1.
|
Part 1 OA: Flu mRNA_8_OA
OA participants received a single dose of Flu mRNA study intervention F2H23G/DL001Z administered at Day 1.
|
Part 1 OA: Comparator_1_OA
OA participants received a single dose of Comparator 1 (Fluzone HD Quadrivalent) administered at Day 1.
|
Part 2 OA: Flu mRNA_10_OA
OA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 OA: Comparator_2_OA
OA participants received a single dose of Comparator 2 (Fluzone HD) administered at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
0
|
0
|
5
|
4
|
3
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Other
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Study to Find the Dose and Assess the Immune Response and Safety of a Vaccine Against Influenza in Healthy Younger and Older Adults
Baseline characteristics by cohort
| Measure |
Part 1 YA: Flu mRNA_1_Younger Adults (YA)
n=50 Participants
YA participants received a single dose of Flu mRNA study intervention F2G22B/DL001Z administered at Day 1.
|
Part 1 YA: Flu mRNA_2_YA
n=50 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23D/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_3_YA
n=48 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
n=50 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
n=52 Participants
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=81 Participants
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=80 Participants
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
Part 1 OA: Flu mRNA_5_Older Adults (OA)
n=51 Participants
OA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 OA: Flu mRNA_6_OA
n=52 Participants
OA participants received a single dose of Flu mRNA study intervention F2H23A/DL001Z-NH administered at Day 1.
|
Part 1 OA: Flu mRNA_7_OA
n=53 Participants
OA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 OA: Flu mRNA_8_OA
n=51 Participants
OA participants received a single dose of Flu mRNA study intervention F2H23G/DL001Z administered at Day 1.
|
Part 1 OA: Comparator_1_OA
n=53 Participants
OA participants received a single dose of Comparator 1 (Fluzone HD Quadrivalent) administered at Day 1.
|
Part 2 OA: Flu mRNA_10_OA
n=82 Participants
OA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 OA: Comparator_2_OA
n=80 Participants
OA participants received a single dose of Comparator 2 (Fluzone HD) administered at Day 1.
|
Total
n=833 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
18-64 years
|
50 Participants
n=68 Participants
|
50 Participants
n=69 Participants
|
48 Participants
n=137 Participants
|
50 Participants
n=88 Participants
|
52 Participants
n=127 Participants
|
81 Participants
n=605 Participants
|
80 Participants
n=9 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=63 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
411 Participants
n=78 Participants
|
|
Age, Customized
65-84 years
|
0 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
0 Participants
n=88 Participants
|
0 Participants
n=127 Participants
|
0 Participants
n=605 Participants
|
0 Participants
n=9 Participants
|
51 Participants
n=72 Participants
|
52 Participants
n=6 Participants
|
53 Participants
n=63 Participants
|
51 Participants
n=10 Participants
|
53 Participants
n=9 Participants
|
82 Participants
n=4 Participants
|
80 Participants
n=6 Participants
|
422 Participants
n=78 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=68 Participants
|
26 Participants
n=69 Participants
|
29 Participants
n=137 Participants
|
26 Participants
n=88 Participants
|
26 Participants
n=127 Participants
|
41 Participants
n=605 Participants
|
34 Participants
n=9 Participants
|
33 Participants
n=72 Participants
|
32 Participants
n=6 Participants
|
31 Participants
n=63 Participants
|
32 Participants
n=10 Participants
|
34 Participants
n=9 Participants
|
46 Participants
n=4 Participants
|
53 Participants
n=6 Participants
|
472 Participants
n=78 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=68 Participants
|
24 Participants
n=69 Participants
|
19 Participants
n=137 Participants
|
24 Participants
n=88 Participants
|
26 Participants
n=127 Participants
|
40 Participants
n=605 Participants
|
46 Participants
n=9 Participants
|
18 Participants
n=72 Participants
|
20 Participants
n=6 Participants
|
22 Participants
n=63 Participants
|
19 Participants
n=10 Participants
|
19 Participants
n=9 Participants
|
36 Participants
n=4 Participants
|
27 Participants
n=6 Participants
|
361 Participants
n=78 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
0 Participants
n=88 Participants
|
1 Participants
n=127 Participants
|
0 Participants
n=605 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=63 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=78 Participants
|
|
Race/Ethnicity, Customized
WHITE
|
36 Participants
n=68 Participants
|
41 Participants
n=69 Participants
|
39 Participants
n=137 Participants
|
41 Participants
n=88 Participants
|
40 Participants
n=127 Participants
|
55 Participants
n=605 Participants
|
56 Participants
n=9 Participants
|
48 Participants
n=72 Participants
|
47 Participants
n=6 Participants
|
43 Participants
n=63 Participants
|
45 Participants
n=10 Participants
|
42 Participants
n=9 Participants
|
78 Participants
n=4 Participants
|
68 Participants
n=6 Participants
|
679 Participants
n=78 Participants
|
|
Race/Ethnicity, Customized
MULTIPLE
|
0 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
2 Participants
n=137 Participants
|
1 Participants
n=88 Participants
|
0 Participants
n=127 Participants
|
2 Participants
n=605 Participants
|
3 Participants
n=9 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=63 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
8 Participants
n=78 Participants
|
|
Race/Ethnicity, Customized
NOT REPORTED
|
0 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
1 Participants
n=88 Participants
|
0 Participants
n=127 Participants
|
0 Participants
n=605 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=72 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=63 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=9 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
4 Participants
n=78 Participants
|
|
Race/Ethnicity, Customized
UNKNOWN
|
0 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
1 Participants
n=88 Participants
|
0 Participants
n=127 Participants
|
3 Participants
n=605 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=63 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
5 Participants
n=78 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=68 Participants
|
1 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
0 Participants
n=88 Participants
|
0 Participants
n=127 Participants
|
1 Participants
n=605 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=72 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=63 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=9 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=6 Participants
|
8 Participants
n=78 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
14 Participants
n=68 Participants
|
8 Participants
n=69 Participants
|
7 Participants
n=137 Participants
|
6 Participants
n=88 Participants
|
11 Participants
n=127 Participants
|
20 Participants
n=605 Participants
|
19 Participants
n=9 Participants
|
2 Participants
n=72 Participants
|
4 Participants
n=6 Participants
|
10 Participants
n=63 Participants
|
5 Participants
n=10 Participants
|
10 Participants
n=9 Participants
|
1 Participants
n=4 Participants
|
11 Participants
n=6 Participants
|
128 Participants
n=78 Participants
|
PRIMARY outcome
Timeframe: At Day 29Population: The analysis was performed on the Per Protocol Set (PPS), which included all eligible participants who received the study intervention dose according to the protocol, had immunogenicity results at Day 29 , without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination before Day 29. Only participants with data available for specified analysis at the specified timepoints are included.
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Outcome measures
| Measure |
Part 1 YA: Flu mRNA_3_YA
n=43 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
n=48 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
n=46 Participants
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=46 Participants
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=44 Participants
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
|---|---|---|---|---|---|
|
Part 1 YA: Geometric Mean Titer (GMT) of Antigen 1 Antibody Titer
Flu B1 Assay 2
|
295.76 Titers
Interval 193.56 to 451.92
|
386.60 Titers
Interval 267.98 to 557.71
|
233.20 Titers
Interval 150.86 to 360.48
|
426.08 Titers
Interval 322.9 to 562.22
|
218.57 Titers
Interval 130.91 to 364.95
|
|
Part 1 YA: Geometric Mean Titer (GMT) of Antigen 1 Antibody Titer
Flu A2 Assay 2
|
610.46 Titers
Interval 429.06 to 868.56
|
785.44 Titers
Interval 517.15 to 1192.91
|
339.89 Titers
Interval 220.53 to 523.85
|
255.26 Titers
Interval 170.13 to 382.98
|
538.16 Titers
Interval 322.66 to 897.61
|
|
Part 1 YA: Geometric Mean Titer (GMT) of Antigen 1 Antibody Titer
Flu B1 Assay 1
|
478.84 Titers
Interval 389.39 to 588.85
|
617.33 Titers
Interval 505.74 to 753.53
|
621.06 Titers
Interval 492.21 to 783.63
|
784.42 Titers
Interval 619.98 to 992.48
|
445.59 Titers
Interval 356.3 to 557.27
|
|
Part 1 YA: Geometric Mean Titer (GMT) of Antigen 1 Antibody Titer
Flu A1 Assay 2
|
368.66 Titers
Interval 190.2 to 714.57
|
411.88 Titers
Interval 253.32 to 669.68
|
141.82 Titers
Interval 80.12 to 251.05
|
31.90 Titers
Interval 19.57 to 51.98
|
187.08 Titers
Interval 117.37 to 298.21
|
|
Part 1 YA: Geometric Mean Titer (GMT) of Antigen 1 Antibody Titer
Flu A1 Assay 1
|
83.98 Titers
Interval 51.98 to 135.68
|
98.65 Titers
Interval 66.43 to 146.49
|
70.86 Titers
Interval 48.13 to 104.31
|
12.40 Titers
Interval 8.96 to 17.16
|
54.78 Titers
Interval 37.38 to 80.3
|
|
Part 1 YA: Geometric Mean Titer (GMT) of Antigen 1 Antibody Titer
Flu A2 Assay 1
|
148.81 Titers
Interval 108.94 to 203.26
|
123.34 Titers
Interval 86.84 to 175.18
|
55.70 Titers
Interval 39.66 to 78.23
|
14.79 Titers
Interval 10.46 to 20.91
|
106.98 Titers
Interval 78.98 to 144.91
|
PRIMARY outcome
Timeframe: At Day 29Population: The analysis was performed on the PPS. Only participants with data available for specified analysis at the specified timepoints were included.
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Outcome measures
| Measure |
Part 1 YA: Flu mRNA_3_YA
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=76 Participants
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=78 Participants
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
|---|---|---|---|---|---|
|
Part 2 YA: GMT of Antigen 1 Antibody Titer
Flu A1 Assay 1
|
—
|
—
|
—
|
132.71 Titers
Interval 91.94 to 191.56
|
108.18 Titers
Interval 80.76 to 144.91
|
|
Part 2 YA: GMT of Antigen 1 Antibody Titer
Flu A2 Assay 1
|
—
|
—
|
—
|
172.12 Titers
Interval 131.13 to 225.92
|
105.82 Titers
Interval 82.44 to 135.85
|
|
Part 2 YA: GMT of Antigen 1 Antibody Titer
Flu B1 Assay 1
|
—
|
—
|
—
|
578.89 Titers
Interval 483.72 to 692.77
|
755.99 Titers
Interval 631.56 to 904.94
|
|
Part 2 YA: GMT of Antigen 1 Antibody Titer
Flu A1 Assay 2
|
—
|
—
|
—
|
270.34 Titers
Interval 200.31 to 364.86
|
182.79 Titers
Interval 136.59 to 244.63
|
|
Part 2 YA: GMT of Antigen 1 Antibody Titer
Flu A2 Assay 2
|
—
|
—
|
—
|
471.51 Titers
Interval 353.82 to 628.33
|
225.28 Titers
Interval 170.99 to 296.81
|
|
Part 2 YA: GMT of Antigen 1 Antibody Titer
Flu B1 Assay 2
|
—
|
—
|
—
|
315.66 Titers
Interval 257.87 to 386.39
|
321.42 Titers
Interval 262.4 to 393.71
|
PRIMARY outcome
Timeframe: At Day 29Population: The analysis was performed on the PPS. Only participants with data available for specified analysis at the specified timepoints were included.
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Outcome measures
| Measure |
Part 1 YA: Flu mRNA_3_YA
n=52 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
n=46 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
n=50 Participants
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=46 Participants
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=47 Participants
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
|---|---|---|---|---|---|
|
Part 1 OA: GMT of Antigen 1 Antibody Titer
Flu A1 Assay 1
|
61.63 Titers
Interval 40.28 to 94.3
|
71.94 Titers
Interval 47.59 to 108.73
|
47.87 Titers
Interval 31.6 to 72.52
|
56.14 Titers
Interval 33.34 to 94.53
|
49.53 Titers
Interval 33.58 to 73.07
|
|
Part 1 OA: GMT of Antigen 1 Antibody Titer
Flu A2 Assay 1
|
89.59 Titers
Interval 64.32 to 124.8
|
123.80 Titers
Interval 85.97 to 178.29
|
51.64 Titers
Interval 36.94 to 72.19
|
79.97 Titers
Interval 51.98 to 123.03
|
142.16 Titers
Interval 102.1 to 197.93
|
|
Part 1 OA: GMT of Antigen 1 Antibody Titer
Flu B1 Assay 1
|
726.42 Titers
Interval 624.19 to 845.4
|
1013.45 Titers
Interval 833.64 to 1232.05
|
676.53 Titers
Interval 548.39 to 834.61
|
640.00 Titers
Interval 523.34 to 782.66
|
769.56 Titers
Interval 637.4 to 929.12
|
|
Part 1 OA: GMT of Antigen 1 Antibody Titer
Flu A1 Assay 2
|
151.45 Titers
Interval 84.74 to 270.65
|
162.60 Titers
Interval 93.77 to 281.95
|
144.68 Titers
Interval 79.26 to 264.1
|
141.77 Titers
Interval 78.95 to 254.58
|
223.26 Titers
Interval 132.25 to 376.9
|
|
Part 1 OA: GMT of Antigen 1 Antibody Titer
Flu A2 Assay 2
|
527.10 Titers
Interval 359.33 to 773.2
|
371.24 Titers
Interval 239.24 to 576.07
|
324.67 Titers
Interval 218.88 to 481.58
|
518.27 Titers
Interval 326.37 to 823.0
|
772.17 Titers
Interval 545.3 to 1093.42
|
|
Part 1 OA: GMT of Antigen 1 Antibody Titer
Flu B1 Assay 2
|
446.32 Titers
Interval 348.99 to 570.79
|
416.69 Titers
Interval 307.74 to 564.21
|
343.97 Titers
Interval 255.9 to 462.34
|
355.59 Titers
Interval 268.71 to 470.56
|
348.96 Titers
Interval 245.6 to 495.83
|
PRIMARY outcome
Timeframe: At Day 29Population: The analysis was performed on the PPS. Only participants with data available for specified analysis at the specified timepoints were included.
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Outcome measures
| Measure |
Part 1 YA: Flu mRNA_3_YA
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=79 Participants
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=77 Participants
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
|---|---|---|---|---|---|
|
Part 2 OA: GMT of Antigen 1 Antibody Titer
Flu A1 Assay 1
|
—
|
—
|
—
|
104.98 Titers
Interval 73.67 to 149.61
|
156.42 Titers
Interval 116.46 to 210.1
|
|
Part 2 OA: GMT of Antigen 1 Antibody Titer
Flu A2 Assay 1
|
—
|
—
|
—
|
231.42 Titers
Interval 176.16 to 304.03
|
230.39 Titers
Interval 170.12 to 312.03
|
|
Part 2 OA: GMT of Antigen 1 Antibody Titer
Flu B1 Assay 1
|
—
|
—
|
—
|
666.48 Titers
Interval 569.47 to 780.02
|
1028.40 Titers
Interval 861.77 to 1227.25
|
|
Part 2 OA: GMT of Antigen 1 Antibody Titer
Flu A1 Assay 2
|
—
|
—
|
—
|
200.83 Titers
Interval 147.7 to 273.07
|
242.03 Titers
Interval 175.91 to 333.01
|
|
Part 2 OA: GMT of Antigen 1 Antibody Titer
Flu A2 Assay 2
|
—
|
—
|
—
|
536.97 Titers
Interval 401.61 to 717.94
|
438.50 Titers
Interval 323.75 to 593.92
|
|
Part 2 OA: GMT of Antigen 1 Antibody Titer
Flu B1 Assay 2
|
—
|
—
|
—
|
343.27 Titers
Interval 284.36 to 414.38
|
413.59 Titers
Interval 344.16 to 497.03
|
PRIMARY outcome
Timeframe: From Day 1 (baseline) to Day 29Population: The analysis was performed on the Per Protocol Set (PPS), which included all eligible participants who received the study intervention dose according to the protocol, had immunogenicity results at both Day 1 and Day 29 , without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination beforeDay 29 and for whom data were available for the specified analysis at the specified timepoints.
GMI is defined as the geometric mean of the ratios of the post dosing titer over the Day 1 titer. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Outcome measures
| Measure |
Part 1 YA: Flu mRNA_3_YA
n=43 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
n=48 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
n=46 Participants
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=46 Participants
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=44 Participants
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
|---|---|---|---|---|---|
|
Part 1 YA: Geometric Mean Increase (GMI) of Antigen 1 Antibody Titers
Flu A1 Assay 1
|
7.26 Ratio
Interval 4.68 to 11.27
|
7.56 Ratio
Interval 5.26 to 10.85
|
4.28 Ratio
Interval 2.73 to 6.7
|
0.91 Ratio
Interval 0.8 to 1.04
|
6.16 Ratio
Interval 4.06 to 9.37
|
|
Part 1 YA: Geometric Mean Increase (GMI) of Antigen 1 Antibody Titers
Flu A2 Assay 1
|
8.81 Ratio
Interval 5.93 to 13.1
|
7.39 Ratio
Interval 5.25 to 10.4
|
3.71 Ratio
Interval 2.58 to 5.34
|
1.02 Ratio
Interval 0.95 to 1.09
|
7.06 Ratio
Interval 4.83 to 10.32
|
|
Part 1 YA: Geometric Mean Increase (GMI) of Antigen 1 Antibody Titers
Flu B1 Assay 1
|
2.72 Ratio
Interval 2.06 to 3.59
|
4.15 Ratio
Interval 3.1 to 5.54
|
3.94 Ratio
Interval 2.95 to 5.27
|
3.88 Ratio
Interval 2.76 to 5.47
|
2.36 Ratio
Interval 1.74 to 3.21
|
|
Part 1 YA: Geometric Mean Increase (GMI) of Antigen 1 Antibody Titers
Flu A1 Assay 2
|
14.58 Ratio
Interval 9.05 to 23.5
|
11.70 Ratio
Interval 6.91 to 19.79
|
6.21 Ratio
Interval 3.56 to 10.82
|
1.44 Ratio
Interval 1.11 to 1.87
|
10.04 Ratio
Interval 6.08 to 16.58
|
|
Part 1 YA: Geometric Mean Increase (GMI) of Antigen 1 Antibody Titers
Flu A2 Assay 2
|
5.07 Ratio
Interval 3.12 to 8.22
|
5.57 Ratio
Interval 3.63 to 8.54
|
2.66 Ratio
Interval 1.75 to 4.05
|
2.43 Ratio
Interval 1.56 to 3.8
|
3.19 Ratio
Interval 1.91 to 5.34
|
|
Part 1 YA: Geometric Mean Increase (GMI) of Antigen 1 Antibody Titers
Flu B1 Assay 2
|
8.39 Ratio
Interval 4.92 to 14.29
|
7.39 Ratio
Interval 4.41 to 12.4
|
8.37 Ratio
Interval 5.01 to 14.0
|
10.18 Ratio
Interval 5.42 to 19.12
|
9.19 Ratio
Interval 4.94 to 17.1
|
PRIMARY outcome
Timeframe: From Day 1 (baseline) to Day 29Population: The analysis was performed on the PPS. Only participants with data available for the specified analysis at the specified duration were included.
GMI is defined as the geometric mean of the ratios of the post dosing titer over the Day 1 titer. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Outcome measures
| Measure |
Part 1 YA: Flu mRNA_3_YA
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=76 Participants
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=78 Participants
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
|---|---|---|---|---|---|
|
Part 2 YA: GMI of Antigen 1 Antibody Titers
Flu A1 Assay 2
|
—
|
—
|
—
|
7.76 Ratio
Interval 5.93 to 10.15
|
5.11 Ratio
Interval 3.71 to 7.04
|
|
Part 2 YA: GMI of Antigen 1 Antibody Titers
Flu 2 Assay 2
|
—
|
—
|
—
|
13.52 Ratio
Interval 10.0 to 18.27
|
6.18 Ratio
Interval 4.57 to 8.37
|
|
Part 2 YA: GMI of Antigen 1 Antibody Titers
Flu B1 Assay 2
|
—
|
—
|
—
|
2.80 Ratio
Interval 2.3 to 3.42
|
2.98 Ratio
Interval 2.51 to 3.55
|
|
Part 2 YA: GMI of Antigen 1 Antibody Titers
Flu A1 Assay 1
|
—
|
—
|
—
|
11.58 Ratio
Interval 8.48 to 15.81
|
8.59 Ratio
Interval 6.0 to 12.28
|
|
Part 2 YA: GMI of Antigen 1 Antibody Titers
Flu A2 Assay 1
|
—
|
—
|
—
|
6.59 Ratio
Interval 5.0 to 8.69
|
4.89 Ratio
Interval 3.49 to 6.86
|
|
Part 2 YA: GMI of Antigen 1 Antibody Titers
Flu B1 Assay 1
|
—
|
—
|
—
|
2.79 Ratio
Interval 2.31 to 3.37
|
3.29 Ratio
Interval 2.71 to 3.99
|
PRIMARY outcome
Timeframe: From Day 1 (baseline) to Day 29Population: The analysis was performed on the PPS. Only participants with data available for specified analysis at the specified timepoints were included.
GMI is defined as the geometric mean of the ratios of the post dosing titer over the Day 1 titer. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Outcome measures
| Measure |
Part 1 YA: Flu mRNA_3_YA
n=52 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
n=46 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
n=50 Participants
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=46 Participants
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=47 Participants
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
|---|---|---|---|---|---|
|
Part 1 OA: GMI of Antigen 1 Antibody Titers
Flu B1 Assay 2
|
5.13 Ratio
Interval 3.47 to 7.61
|
3.23 Ratio
Interval 1.92 to 5.41
|
4.24 Ratio
Interval 2.58 to 6.97
|
4.25 Ratio
Interval 2.58 to 7.01
|
4.49 Ratio
Interval 2.68 to 7.53
|
|
Part 1 OA: GMI of Antigen 1 Antibody Titers
Flu A1 Assay 1
|
3.11 Ratio
Interval 2.27 to 4.25
|
3.47 Ratio
Interval 2.51 to 4.79
|
2.14 Ratio
Interval 1.5 to 3.07
|
2.96 Ratio
Interval 2.08 to 4.21
|
4.74 Ratio
Interval 3.5 to 6.43
|
|
Part 1 OA: GMI of Antigen 1 Antibody Titers
Flu A2 Assay 1
|
5.37 Ratio
Interval 3.77 to 7.64
|
5.25 Ratio
Interval 3.81 to 7.23
|
2.99 Ratio
Interval 2.2 to 4.07
|
5.17 Ratio
Interval 3.61 to 7.4
|
8.00 Ratio
Interval 5.59 to 11.45
|
|
Part 1 OA: GMI of Antigen 1 Antibody Titers
Flu B1 Assay 1
|
2.38 Ratio
Interval 1.82 to 3.11
|
2.72 Ratio
Interval 2.12 to 3.49
|
2.11 Ratio
Interval 1.61 to 2.77
|
2.26 Ratio
Interval 1.9 to 2.67
|
2.98 Ratio
Interval 2.24 to 3.96
|
|
Part 1 OA: GMI of Antigen 1 Antibody Titers
Flu A1 Assay 2
|
7.37 Ratio
Interval 4.7 to 11.54
|
5.05 Ratio
Interval 3.28 to 7.76
|
3.84 Ratio
Interval 2.19 to 6.72
|
5.57 Ratio
Interval 3.47 to 8.97
|
10.86 Ratio
Interval 7.02 to 16.8
|
|
Part 1 OA: GMI of Antigen 1 Antibody Titers
Flu A2 Assay 2
|
4.23 Ratio
Interval 2.85 to 6.26
|
2.83 Ratio
Interval 1.86 to 4.31
|
2.79 Ratio
Interval 1.86 to 4.18
|
4.38 Ratio
Interval 2.3 to 8.32
|
6.44 Ratio
Interval 4.1 to 10.13
|
PRIMARY outcome
Timeframe: From Day 1 (baseline) to Day 29Population: The analysis was performed on the PPS. Only participants with data available for specified analysis at the specified timepoints were included.
GMI is defined as the geometric mean of the ratios of the post dosing titer over the Day 1 titer. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Outcome measures
| Measure |
Part 1 YA: Flu mRNA_3_YA
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=79 Participants
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=77 Participants
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
|---|---|---|---|---|---|
|
Part 2 OA: GMI of Antigen 1 Antibody Titers
Flu A1 Assay 1
|
—
|
—
|
—
|
8.01 Ratio
Interval 5.75 to 11.14
|
8.30 Ratio
Interval 5.77 to 11.93
|
|
Part 2 OA: GMI of Antigen 1 Antibody Titers
Flu A2 Assay 1
|
—
|
—
|
—
|
8.26 Ratio
Interval 6.19 to 11.02
|
6.61 Ratio
Interval 4.67 to 9.34
|
|
Part 2 OA: GMI of Antigen 1 Antibody Titers
Flu B1 Assay 1
|
—
|
—
|
—
|
2.21 Ratio
Interval 1.87 to 2.6
|
3.33 Ratio
Interval 2.64 to 4.21
|
|
Part 2 OA: GMI of Antigen 1 Antibody Titers
Flu A1 Assay 2
|
—
|
—
|
—
|
5.64 Ratio
Interval 4.24 to 7.51
|
5.20 Ratio
Interval 3.73 to 7.24
|
|
Part 2 OA: GMI of Antigen 1 Antibody Titers
Flu A2 Assay 2
|
—
|
—
|
—
|
11.02 Ratio
Interval 8.2 to 14.81
|
7.12 Ratio
Interval 5.15 to 9.84
|
|
Part 2 OA: GMI of Antigen 1 Antibody Titers
Flu B1 Assay 2
|
—
|
—
|
—
|
2.42 Ratio
Interval 2.05 to 2.84
|
2.57 Ratio
Interval 2.09 to 3.16
|
PRIMARY outcome
Timeframe: From Day 1 (baseline) to Day 29Population: The analysis was performed on the PPS. Only participants with data available for the specified analysis at the specified duration were included.
SCR is defined as the percentage of dosed participants who have either an anti-vaccine antibody pre-dose titer \< 1:10 and a post-dose anti-vaccine antibody titer \>= 1:40 or a pre-dose anti-vaccine antibody titer \>= 1:10 and at least a 4-fold increase in post-dose anti-vaccine antibody titer. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Outcome measures
| Measure |
Part 1 YA: Flu mRNA_3_YA
n=43 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
n=48 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
n=46 Participants
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=46 Participants
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=44 Participants
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
|---|---|---|---|---|---|
|
Part 1 YA: Percentage of Participants With Antigen 1 Antibody Seroconversion Rate (SCR)
Flu A1 Assay 1
|
69.8 Percentage of participants
Interval 53.9 to 82.8
|
64.6 Percentage of participants
Interval 49.5 to 77.8
|
45.7 Percentage of participants
Interval 30.9 to 61.0
|
0 Percentage of participants
Interval 0.0 to 7.9
|
52.3 Percentage of participants
Interval 36.7 to 67.5
|
|
Part 1 YA: Percentage of Participants With Antigen 1 Antibody Seroconversion Rate (SCR)
Flu A2 Assay 1
|
74.4 Percentage of participants
Interval 58.8 to 86.5
|
66.7 Percentage of participants
Interval 51.6 to 79.6
|
45.7 Percentage of participants
Interval 30.9 to 61.0
|
0 Percentage of participants
Interval 0.0 to 7.7
|
63.6 Percentage of participants
Interval 47.8 to 77.6
|
|
Part 1 YA: Percentage of Participants With Antigen 1 Antibody Seroconversion Rate (SCR)
Flu B1 Assay 1
|
41.9 Percentage of participants
Interval 27.0 to 57.9
|
54.2 Percentage of participants
Interval 39.2 to 68.6
|
47.8 Percentage of participants
Interval 32.9 to 63.1
|
45.7 Percentage of participants
Interval 30.9 to 61.0
|
29.5 Percentage of participants
Interval 16.8 to 45.2
|
|
Part 1 YA: Percentage of Participants With Antigen 1 Antibody Seroconversion Rate (SCR)
Flu A1 Assay 2
|
86.4 Percentage of participants
Interval 65.1 to 97.1
|
90.9 Percentage of participants
Interval 70.8 to 98.9
|
56.5 Percentage of participants
Interval 34.5 to 76.8
|
0 Percentage of participants
Interval 0.0 to 14.8
|
75.0 Percentage of participants
Interval 50.9 to 91.3
|
|
Part 1 YA: Percentage of Participants With Antigen 1 Antibody Seroconversion Rate (SCR)
Flu A2 Assay 2
|
63.6 Percentage of participants
Interval 40.7 to 82.8
|
68.2 Percentage of participants
Interval 45.1 to 86.1
|
34.8 Percentage of participants
Interval 16.4 to 57.3
|
34.8 Percentage of participants
Interval 16.4 to 57.3
|
40.0 Percentage of participants
Interval 19.1 to 63.9
|
|
Part 1 YA: Percentage of Participants With Antigen 1 Antibody Seroconversion Rate (SCR)
Flu B1 Assay 2
|
81.8 Percentage of participants
Interval 59.7 to 94.8
|
68.2 Percentage of participants
Interval 45.1 to 86.1
|
73.9 Percentage of participants
Interval 51.6 to 89.8
|
69.6 Percentage of participants
Interval 47.1 to 86.8
|
70.0 Percentage of participants
Interval 45.7 to 88.1
|
PRIMARY outcome
Timeframe: From Day 1 (baseline) to Day 29Population: The analysis was performed on the PPS. Only participants with data available for specified analysis at the specified timepoints were included.
SCR is defined as the percentage of dosed participants who have either an anti-vaccine antibody pre-dose titer \< 1:10 and a post-dose anti-vaccine antibody titer \>= 1:40 or a pre-dose anti-vaccine antibody titer \>= 1:10 and at least a 4-fold increase in post-dose anti-vaccine antibody titer. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Outcome measures
| Measure |
Part 1 YA: Flu mRNA_3_YA
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=76 Participants
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=78 Participants
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
|---|---|---|---|---|---|
|
Part 2 YA: Percentage of Participants With Antigen 1 Antibody SCR
Flu A1 Assay 1
|
—
|
—
|
—
|
76.3 Percentage of participants
Interval 65.2 to 85.3
|
62.8 Percentage of participants
Interval 51.1 to 73.5
|
|
Part 2 YA: Percentage of Participants With Antigen 1 Antibody SCR
Flu A2 Assay 1
|
—
|
—
|
—
|
66.7 Percentage of participants
Interval 54.8 to 77.1
|
44.9 Percentage of participants
Interval 33.6 to 56.6
|
|
Part 2 YA: Percentage of Participants With Antigen 1 Antibody SCR
Flu B1 Assay 1
|
—
|
—
|
—
|
42.1 Percentage of participants
Interval 30.9 to 54.0
|
47.4 Percentage of participants
Interval 35.8 to 59.2
|
|
Part 2 YA: Percentage of Participants With Antigen 1 Antibody SCR
Flu A1 Assay 2
|
—
|
—
|
—
|
73.7 Percentage of participants
Interval 62.3 to 83.1
|
48.7 Percentage of participants
Interval 37.2 to 60.3
|
|
Part 2 YA: Percentage of Participants With Antigen 1 Antibody SCR
Flu A2 Assay 2
|
—
|
—
|
—
|
84.2 Percentage of participants
Interval 74.0 to 91.6
|
56.4 Percentage of participants
Interval 44.7 to 67.6
|
|
Part 2 YA: Percentage of Participants With Antigen 1 Antibody SCR
Flu B1 Assay 2
|
—
|
—
|
—
|
34.2 Percentage of participants
Interval 23.7 to 46.0
|
41.0 Percentage of participants
Interval 30.0 to 52.7
|
PRIMARY outcome
Timeframe: From Day 1 (baseline) to Day 29Population: The analysis was performed on the PPS. Only participants with data available for specified analysis at the specified timepoints were included.
SCR is defined as the percentage of dosed participants who have either an anti-vaccine antibody pre-dose titer \< 1:10 and a post-dose anti-vaccine antibody titer \>= 1:40 or a pre-dose anti-vaccine antibody titer \>= 1:10 and at least a 4-fold increase in post-dose anti-vaccine antibody titer. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Outcome measures
| Measure |
Part 1 YA: Flu mRNA_3_YA
n=52 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
n=46 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
n=50 Participants
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=46 Participants
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=47 Participants
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
|---|---|---|---|---|---|
|
Part 1 OA: Percentage of Participants With Antigen 1 Antibody SCR
Flu A1 Assay 1
|
31.4 Percentage of participants
Interval 19.1 to 45.9
|
39.1 Percentage of participants
Interval 25.1 to 54.6
|
18.4 Percentage of participants
Interval 8.8 to 32.0
|
40.0 Percentage of participants
Interval 25.7 to 55.7
|
53.2 Percentage of participants
Interval 38.1 to 67.9
|
|
Part 1 OA: Percentage of Participants With Antigen 1 Antibody SCR
Flu A2 Assay 1
|
50.0 Percentage of participants
Interval 35.8 to 64.2
|
63.0 Percentage of participants
Interval 47.5 to 76.8
|
24.0 Percentage of participants
Interval 13.1 to 38.2
|
56.5 Percentage of participants
Interval 41.1 to 71.1
|
74.5 Percentage of participants
Interval 59.7 to 86.1
|
|
Part 1 OA: Percentage of Participants With Antigen 1 Antibody SCR
Flu B1 Assay 1
|
19.2 Percentage of participants
Interval 9.6 to 32.5
|
34.8 Percentage of participants
Interval 21.4 to 50.2
|
26.0 Percentage of participants
Interval 14.6 to 40.3
|
21.7 Percentage of participants
Interval 10.9 to 36.4
|
46.8 Percentage of participants
Interval 32.1 to 61.9
|
|
Part 1 OA: Percentage of Participants With Antigen 1 Antibody SCR
Flu A1 Assay 2
|
68.0 Percentage of participants
Interval 46.5 to 85.1
|
57.1 Percentage of participants
Interval 34.0 to 78.2
|
37.5 Percentage of participants
Interval 18.8 to 59.4
|
56.5 Percentage of participants
Interval 34.5 to 76.8
|
87.5 Percentage of participants
Interval 67.6 to 97.3
|
|
Part 1 OA: Percentage of Participants With Antigen 1 Antibody SCR
Flu A2 Assay 2
|
52.0 Percentage of participants
Interval 31.3 to 72.2
|
38.1 Percentage of participants
Interval 18.1 to 61.6
|
29.2 Percentage of participants
Interval 12.6 to 51.1
|
52.2 Percentage of participants
Interval 30.6 to 73.2
|
79.2 Percentage of participants
Interval 57.8 to 92.9
|
|
Part 1 OA: Percentage of Participants With Antigen 1 Antibody SCR
Flu B1 Assay 2
|
64.0 Percentage of participants
Interval 42.5 to 82.0
|
42.9 Percentage of participants
Interval 21.8 to 66.0
|
54.2 Percentage of participants
Interval 32.8 to 74.4
|
60.9 Percentage of participants
Interval 38.5 to 80.3
|
54.2 Percentage of participants
Interval 32.8 to 74.4
|
PRIMARY outcome
Timeframe: From Day 1 (baseline) to Day 29Population: The analysis was performed on the PPS. Only participants with data available for specified analysis at the specified timepoints were included.
SCR is defined as the percentage of dosed participants who have either an anti-vaccine antibody pre-dose titer \< 1:10 and a post-dose anti-vaccine antibody titer \>= 1:40 or a pre-dose anti-vaccine antibody titer \>= 1:10 and at least a 4-fold increase in post-dose anti-vaccine antibody titer. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Outcome measures
| Measure |
Part 1 YA: Flu mRNA_3_YA
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=79 Participants
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=77 Participants
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
|---|---|---|---|---|---|
|
Part 2 OA: Percentage of Participants With Antigen 1 Antibody SCR
Flu A1 Assay 1
|
—
|
—
|
—
|
63.3 Percentage of participants
Interval 51.7 to 73.9
|
63.6 Percentage of participants
Interval 51.9 to 74.3
|
|
Part 2 OA: Percentage of Participants With Antigen 1 Antibody SCR
Flu A2 Assay 1
|
—
|
—
|
—
|
74.7 Percentage of participants
Interval 63.6 to 83.8
|
61.8 Percentage of participants
Interval 50.0 to 72.8
|
|
Part 2 OA: Percentage of Participants With Antigen 1 Antibody SCR
Flu B1 Assay 1
|
—
|
—
|
—
|
24.3 Percentage of participants
Interval 15.1 to 35.7
|
41.9 Percentage of participants
Interval 30.5 to 53.9
|
|
Part 2 OA: Percentage of Participants With Antigen 1 Antibody SCR
Flu A1 Assay 2
|
—
|
—
|
—
|
54.4 Percentage of participants
Interval 42.8 to 65.7
|
51.9 Percentage of participants
Interval 40.3 to 63.5
|
|
Part 2 OA: Percentage of Participants With Antigen 1 Antibody SCR
Flu A2 Assay 2
|
—
|
—
|
—
|
75.9 Percentage of participants
Interval 65.0 to 84.9
|
62.3 Percentage of participants
Interval 50.6 to 73.1
|
|
Part 2 OA: Percentage of Participants With Antigen 1 Antibody SCR
Flu B1 Assay 2
|
—
|
—
|
—
|
29.1 Percentage of participants
Interval 19.4 to 40.4
|
35.1 Percentage of participants
Interval 24.5 to 46.8
|
PRIMARY outcome
Timeframe: At Day 1Population: The analysis was performed on the Per Protocol Set (PPS), which included all eligible participants who received the study intervention dose according to the protocol, had immunogenicity results at Day 1, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination before Day 29. Only participants with data available for the specified analysis at the specified timepoints are included.
SPR is defined as the percentage of dosed participants with a anti-vaccine antibody titer \>= 1:40. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Outcome measures
| Measure |
Part 1 YA: Flu mRNA_3_YA
n=43 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
n=48 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
n=46 Participants
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=46 Participants
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=44 Participants
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
|---|---|---|---|---|---|
|
Part 1 YA: Percentage of Participants With Antigen 1 Antibody Seroprotection Rate (SPR)
Flu A1 Assay 1
|
20.9 Percentage of participants
Interval 10.0 to 36.0
|
25.0 Percentage of participants
Interval 13.6 to 39.6
|
30.4 Percentage of participants
Interval 17.7 to 45.8
|
23.9 Percentage of participants
Interval 12.6 to 38.8
|
13.6 Percentage of participants
Interval 5.2 to 27.4
|
|
Part 1 YA: Percentage of Participants With Antigen 1 Antibody Seroprotection Rate (SPR)
Flu A2 Assay 1
|
37.2 Percentage of participants
Interval 23.0 to 53.3
|
33.3 Percentage of participants
Interval 20.4 to 48.4
|
30.4 Percentage of participants
Interval 17.7 to 45.8
|
23.9 Percentage of participants
Interval 12.6 to 38.8
|
20.5 Percentage of participants
Interval 9.8 to 35.3
|
|
Part 1 YA: Percentage of Participants With Antigen 1 Antibody Seroprotection Rate (SPR)
Flu B1 Assay 1
|
95.3 Percentage of participants
Interval 84.2 to 99.4
|
95.8 Percentage of participants
Interval 85.7 to 99.5
|
97.8 Percentage of participants
Interval 88.5 to 99.9
|
95.7 Percentage of participants
Interval 85.2 to 99.5
|
97.7 Percentage of participants
Interval 88.0 to 99.9
|
|
Part 1 YA: Percentage of Participants With Antigen 1 Antibody Seroprotection Rate (SPR)
Flu A1 Assay 2
|
36.4 Percentage of participants
Interval 17.2 to 59.3
|
59.1 Percentage of participants
Interval 36.4 to 79.3
|
21.7 Percentage of participants
Interval 7.5 to 43.7
|
39.1 Percentage of participants
Interval 19.7 to 61.5
|
30.0 Percentage of participants
Interval 11.9 to 54.3
|
|
Part 1 YA: Percentage of Participants With Antigen 1 Antibody Seroprotection Rate (SPR)
Flu A2 Assay 2
|
95.5 Percentage of participants
Interval 77.2 to 99.9
|
100 Percentage of participants
Interval 84.6 to 100.0
|
100 Percentage of participants
Interval 85.2 to 100.0
|
91.3 Percentage of participants
Interval 72.0 to 98.9
|
100 Percentage of participants
Interval 83.2 to 100.0
|
|
Part 1 YA: Percentage of Participants With Antigen 1 Antibody Seroprotection Rate (SPR)
Flu B1 Assay 2
|
50.0 Percentage of participants
Interval 28.2 to 71.8
|
63.6 Percentage of participants
Interval 40.7 to 82.8
|
43.5 Percentage of participants
Interval 23.2 to 65.5
|
56.5 Percentage of participants
Interval 34.5 to 76.8
|
35.0 Percentage of participants
Interval 15.4 to 59.2
|
PRIMARY outcome
Timeframe: At Day 1Population: The analysis was performed on the PPS. Only participants with data available for the specified analysis at the specified timepoints were included.
SPR is defined as the percentage of dosed participants with a anti-vaccine antibody titer \>= 1:40. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Outcome measures
| Measure |
Part 1 YA: Flu mRNA_3_YA
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=76 Participants
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=78 Participants
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
|---|---|---|---|---|---|
|
Part 2 YA: Percentage of Participants With Antigen 1 Antibody SPR
Flu A1 Assay 2
|
—
|
—
|
—
|
47.4 Percentage of participants
Interval 35.8 to 59.2
|
50.0 Percentage of participants
Interval 38.5 to 61.5
|
|
Part 2 YA: Percentage of Participants With Antigen 1 Antibody SPR
Flu B1 Assay 1
|
—
|
—
|
—
|
100 Percentage of participants
Interval 95.3 to 100.0
|
100 Percentage of participants
Interval 95.3 to 100.0
|
|
Part 2 YA: Percentage of Participants With Antigen 1 Antibody SPR
Flu A1 Assay 1
|
—
|
—
|
—
|
21.1 Percentage of participants
Interval 12.5 to 31.9
|
25.6 Percentage of participants
Interval 16.4 to 36.8
|
|
Part 2 YA: Percentage of Participants With Antigen 1 Antibody SPR
Flu A2 Assay 1
|
—
|
—
|
—
|
40.0 Percentage of participants
Interval 28.9 to 52.0
|
37.2 Percentage of participants
Interval 26.5 to 48.9
|
|
Part 2 YA: Percentage of Participants With Antigen 1 Antibody SPR
Flu A2 Assay 2
|
—
|
—
|
—
|
46.1 Percentage of participants
Interval 34.5 to 57.9
|
43.6 Percentage of participants
Interval 32.4 to 55.3
|
|
Part 2 YA: Percentage of Participants With Antigen 1 Antibody SPR
Flu B1 Assay 2
|
—
|
—
|
—
|
93.4 Percentage of participants
Interval 85.3 to 97.8
|
87.2 Percentage of participants
Interval 77.7 to 93.7
|
PRIMARY outcome
Timeframe: At Day 1Population: The analysis was performed on the PPS. Only participants with data available for specified analysis at the specified timepoints were included.
SPR is defined as the percentage of dosed participants with a anti-vaccine antibody titer \>= 1:40. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Outcome measures
| Measure |
Part 1 YA: Flu mRNA_3_YA
n=52 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
n=46 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
n=50 Participants
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=46 Participants
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=47 Participants
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
|---|---|---|---|---|---|
|
Part 1 OA: Percentage of Participants With Antigen 1 Antibody SPR
Flu A1 Assay 1
|
37.3 Percentage of participants
Interval 24.1 to 51.9
|
32.6 Percentage of participants
Interval 19.5 to 48.0
|
42.9 Percentage of participants
Interval 28.8 to 57.8
|
33.3 Percentage of participants
Interval 20.0 to 49.0
|
14.9 Percentage of participants
Interval 6.2 to 28.3
|
|
Part 1 OA: Percentage of Participants With Antigen 1 Antibody SPR
Flu A2 Assay 1
|
25.0 Percentage of participants
Interval 14.0 to 38.9
|
39.1 Percentage of participants
Interval 25.1 to 54.6
|
28.0 Percentage of participants
Interval 16.2 to 42.5
|
32.6 Percentage of participants
Interval 19.5 to 48.0
|
31.9 Percentage of participants
Interval 19.1 to 47.1
|
|
Part 1 OA: Percentage of Participants With Antigen 1 Antibody SPR
Flu B1 Assay 1
|
98.1 Percentage of participants
Interval 89.7 to 100.0
|
97.8 Percentage of participants
Interval 88.5 to 99.9
|
98.0 Percentage of participants
Interval 89.4 to 99.9
|
100 Percentage of participants
Interval 92.3 to 100.0
|
97.9 Percentage of participants
Interval 88.7 to 99.9
|
|
Part 1 OA: Percentage of Participants With Antigen 1 Antibody SPR
Flu A1 Assay 2
|
36.0 Percentage of participants
Interval 18.0 to 57.5
|
52.4 Percentage of participants
Interval 29.8 to 74.3
|
50.0 Percentage of participants
Interval 29.1 to 70.9
|
43.5 Percentage of participants
Interval 23.2 to 65.5
|
29.2 Percentage of participants
Interval 12.6 to 51.1
|
|
Part 1 OA: Percentage of Participants With Antigen 1 Antibody SPR
Flu A2 Assay 2
|
96.0 Percentage of participants
Interval 79.6 to 99.9
|
95.2 Percentage of participants
Interval 76.2 to 99.9
|
91.7 Percentage of participants
Interval 73.0 to 99.0
|
91.3 Percentage of participants
Interval 72.0 to 98.9
|
95.8 Percentage of participants
Interval 78.9 to 99.9
|
|
Part 1 OA: Percentage of Participants With Antigen 1 Antibody SPR
Flu B1 Assay 2
|
84.0 Percentage of participants
Interval 63.9 to 95.5
|
90.5 Percentage of participants
Interval 69.6 to 98.8
|
79.2 Percentage of participants
Interval 57.8 to 92.9
|
82.6 Percentage of participants
Interval 61.2 to 95.0
|
79.2 Percentage of participants
Interval 57.8 to 92.9
|
PRIMARY outcome
Timeframe: At Day 1Population: The analysis was performed on the PPS. Only participants with data available for specified analysis at the specified timepoints were included.
SPR is defined as the percentage of dosed participants with a anti-vaccine antibody titer \>= 1:40. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Outcome measures
| Measure |
Part 1 YA: Flu mRNA_3_YA
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=79 Participants
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=77 Participants
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
|---|---|---|---|---|---|
|
Part 2 OA: Percentage of Participants With Antigen 1 Antibody SPR
Flu A1 Assay 1
|
—
|
—
|
—
|
22.8 Percentage of participants
Interval 14.1 to 33.6
|
35.1 Percentage of participants
Interval 24.5 to 46.8
|
|
Part 2 OA: Percentage of Participants With Antigen 1 Antibody SPR
Flu A2 Assay 1
|
—
|
—
|
—
|
43.0 Percentage of participants
Interval 31.9 to 54.7
|
53.9 Percentage of participants
Interval 42.1 to 65.5
|
|
Part 2 OA: Percentage of Participants With Antigen 1 Antibody SPR
Flu B1 Assay 1
|
—
|
—
|
—
|
100 Percentage of participants
Interval 95.1 to 100.0
|
100 Percentage of participants
Interval 95.2 to 100.0
|
|
Part 2 OA: Percentage of Participants With Antigen 1 Antibody SPR
Flu A1 Assay 2
|
—
|
—
|
—
|
48.1 Percentage of participants
Interval 36.7 to 59.6
|
54.5 Percentage of participants
Interval 42.8 to 65.9
|
|
Part 2 OA: Percentage of Participants With Antigen 1 Antibody SPR
Flu A2 Assay 2
|
—
|
—
|
—
|
53.2 Percentage of participants
Interval 41.6 to 64.5
|
64.9 Percentage of participants
Interval 53.2 to 75.5
|
|
Part 2 OA: Percentage of Participants With Antigen 1 Antibody SPR
Flu B1 Assay 2
|
—
|
—
|
—
|
94.9 Percentage of participants
Interval 87.5 to 98.6
|
97.4 Percentage of participants
Interval 90.9 to 99.7
|
PRIMARY outcome
Timeframe: At Day 29Population: The analysis was performed on the PPS. Only participants with data available for the specified analysis at the specified timepoints were included.
SPR is defined as the percentage of dosed participants with a anti-vaccine antibody titer \>= 1:40. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Outcome measures
| Measure |
Part 1 YA: Flu mRNA_3_YA
n=43 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
n=48 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
n=46 Participants
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=46 Participants
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=44 Participants
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
|---|---|---|---|---|---|
|
Part 1 YA: Percentage of Participants With Antigen 1 Antibody SPR
Flu A1 Assay 1
|
76.7 Percentage of participants
Interval 61.4 to 88.2
|
81.3 Percentage of participants
Interval 67.4 to 91.1
|
73.9 Percentage of participants
Interval 58.9 to 85.7
|
20.0 Percentage of participants
Interval 9.6 to 34.6
|
65.9 Percentage of participants
Interval 50.1 to 79.5
|
|
Part 1 YA: Percentage of Participants With Antigen 1 Antibody SPR
Flu A2 Assay 1
|
95.3 Percentage of participants
Interval 84.2 to 99.4
|
85.4 Percentage of participants
Interval 72.2 to 93.9
|
76.1 Percentage of participants
Interval 61.2 to 87.4
|
26.1 Percentage of participants
Interval 14.3 to 41.1
|
86.4 Percentage of participants
Interval 72.6 to 94.8
|
|
Part 1 YA: Percentage of Participants With Antigen 1 Antibody SPR
Flu B1 Assay 1
|
100 Percentage of participants
Interval 91.8 to 100.0
|
100 Percentage of participants
Interval 92.6 to 100.0
|
100 Percentage of participants
Interval 92.3 to 100.0
|
100 Percentage of participants
Interval 92.3 to 100.0
|
100 Percentage of participants
Interval 92.0 to 100.0
|
|
Part 1 YA: Percentage of Participants With Antigen 1 Antibody SPR
Flu A1 Assay 2
|
90.9 Percentage of participants
Interval 70.8 to 98.9
|
100 Percentage of participants
Interval 84.6 to 100.0
|
87.0 Percentage of participants
Interval 66.4 to 97.2
|
43.5 Percentage of participants
Interval 23.2 to 65.5
|
95.0 Percentage of participants
Interval 75.1 to 99.9
|
|
Part 1 YA: Percentage of Participants With Antigen 1 Antibody SPR
Flu A2 Assay 2
|
100 Percentage of participants
Interval 84.6 to 100.0
|
100 Percentage of participants
Interval 84.6 to 100.0
|
95.7 Percentage of participants
Interval 78.1 to 99.9
|
100 Percentage of participants
Interval 85.2 to 100.0
|
100 Percentage of participants
Interval 83.2 to 100.0
|
|
Part 1 YA: Percentage of Participants With Antigen 1 Antibody SPR
Flu B1 Assay 2
|
100 Percentage of participants
Interval 84.6 to 100.0
|
100 Percentage of participants
Interval 84.6 to 100.0
|
95.7 Percentage of participants
Interval 78.1 to 99.9
|
100 Percentage of participants
Interval 85.2 to 100.0
|
95.0 Percentage of participants
Interval 75.1 to 99.9
|
PRIMARY outcome
Timeframe: At Day 29Population: The analysis was performed on the PPS. Only participants with data available for specified analysis at the specified timepoints were included.
SPR is defined as the percentage of dosed participants with a anti-vaccine antibody titer \>= 1:40. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Outcome measures
| Measure |
Part 1 YA: Flu mRNA_3_YA
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=76 Participants
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=78 Participants
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
|---|---|---|---|---|---|
|
Part 2 YA: Percentage of Participants With Antigen 1 Antibody SPR
Flu A1 Assay 1
|
—
|
—
|
—
|
82.9 Percentage of participants
Interval 72.5 to 90.6
|
87.2 Percentage of participants
Interval 77.7 to 93.7
|
|
Part 2 YA: Percentage of Participants With Antigen 1 Antibody SPR
Flu A2 Assay 1
|
—
|
—
|
—
|
94.7 Percentage of participants
Interval 87.1 to 98.5
|
85.9 Percentage of participants
Interval 76.2 to 92.7
|
|
Part 2 YA: Percentage of Participants With Antigen 1 Antibody SPR
Flu B1 Assay 1
|
—
|
—
|
—
|
100 Percentage of participants
Interval 95.3 to 100.0
|
100 Percentage of participants
Interval 95.3 to 100.0
|
|
Part 2 YA: Percentage of Participants With Antigen 1 Antibody SPR
Flu A1 Assay 2
|
—
|
—
|
—
|
96.1 Percentage of participants
Interval 88.9 to 99.2
|
92.3 Percentage of participants
Interval 84.0 to 97.1
|
|
Part 2 YA: Percentage of Participants With Antigen 1 Antibody SPR
Flu A2 Assay 2
|
—
|
—
|
—
|
98.7 Percentage of participants
Interval 92.9 to 100.0
|
93.6 Percentage of participants
Interval 85.7 to 97.9
|
|
Part 2 YA: Percentage of Participants With Antigen 1 Antibody SPR
Flu B1 Assay 2
|
—
|
—
|
—
|
100 Percentage of participants
Interval 95.3 to 100.0
|
100 Percentage of participants
Interval 95.4 to 100.0
|
PRIMARY outcome
Timeframe: At Day 29Population: The analysis was performed on the PPS. Only participants with data available for specified analysis at the specified timepoints were included.
SPR is defined as the percentage of dosed participants with a anti-vaccine antibody titer \>= 1:40. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Outcome measures
| Measure |
Part 1 YA: Flu mRNA_3_YA
n=52 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
n=46 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
n=50 Participants
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=46 Participants
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=47 Participants
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
|---|---|---|---|---|---|
|
Part 1 OA: Percentage of Participants With Antigen 1 Antibody SPR
Flu A1 Assay 1
|
61.5 Percentage of participants
Interval 47.0 to 74.7
|
69.6 Percentage of participants
Interval 54.2 to 82.3
|
58.0 Percentage of participants
Interval 43.2 to 71.8
|
60.9 Percentage of participants
Interval 45.4 to 74.9
|
66.0 Percentage of participants
Interval 50.7 to 79.1
|
|
Part 1 OA: Percentage of Participants With Antigen 1 Antibody SPR
Flu A2 Assay 1
|
82.7 Percentage of participants
Interval 69.7 to 91.8
|
91.3 Percentage of participants
Interval 79.2 to 97.6
|
64.0 Percentage of participants
Interval 49.2 to 77.1
|
76.1 Percentage of participants
Interval 61.2 to 87.4
|
93.6 Percentage of participants
Interval 82.5 to 98.7
|
|
Part 1 OA: Percentage of Participants With Antigen 1 Antibody SPR
Flu B1 Assay 1
|
100 Percentage of participants
Interval 93.2 to 100.0
|
100 Percentage of participants
Interval 92.3 to 100.0
|
100 Percentage of participants
Interval 92.9 to 100.0
|
100 Percentage of participants
Interval 92.3 to 100.0
|
100 Percentage of participants
Interval 92.5 to 100.0
|
|
Part 1 OA: Percentage of Participants With Antigen 1 Antibody SPR
Flu A1 Assay 2
|
88.0 Percentage of participants
Interval 68.8 to 97.5
|
85.7 Percentage of participants
Interval 63.7 to 97.0
|
91.7 Percentage of participants
Interval 73.0 to 99.0
|
87.0 Percentage of participants
Interval 66.4 to 97.2
|
95.8 Percentage of participants
Interval 78.9 to 99.9
|
|
Part 1 OA: Percentage of Participants With Antigen 1 Antibody SPR
Flu A2 Assay 2
|
100 Percentage of participants
Interval 86.3 to 100.0
|
100 Percentage of participants
Interval 83.9 to 100.0
|
100 Percentage of participants
Interval 85.8 to 100.0
|
100 Percentage of participants
Interval 85.2 to 100.0
|
100 Percentage of participants
Interval 85.8 to 100.0
|
|
Part 1 OA: Percentage of Participants With Antigen 1 Antibody SPR
Flu B1 Assay 2
|
100 Percentage of participants
Interval 86.3 to 100.0
|
100 Percentage of participants
Interval 83.9 to 100.0
|
100 Percentage of participants
Interval 85.8 to 100.0
|
100 Percentage of participants
Interval 85.2 to 100.0
|
100 Percentage of participants
Interval 85.8 to 100.0
|
PRIMARY outcome
Timeframe: At Day 29Population: The analysis was performed on the PPS. Only participants with data available for specified analysis at the specified timepoints were included.
SPR is defined as the percentage of dosed participants with a anti-vaccine antibody titer \>= 1:40. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Outcome measures
| Measure |
Part 1 YA: Flu mRNA_3_YA
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=79 Participants
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=77 Participants
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
|---|---|---|---|---|---|
|
Part 2 OA: Percentage of Participants With Antigen 1 Antibody SPR
Flu A1 Assay 1
|
—
|
—
|
—
|
78.5 Percentage of participants
Interval 67.8 to 86.9
|
90.9 Percentage of participants
Interval 82.2 to 96.3
|
|
Part 2 OA: Percentage of Participants With Antigen 1 Antibody SPR
Flu A2 Assay 1
|
—
|
—
|
—
|
97.5 Percentage of participants
Interval 91.2 to 99.7
|
94.8 Percentage of participants
Interval 87.2 to 98.6
|
|
Part 2 OA: Percentage of Participants With Antigen 1 Antibody SPR
Flu B1 Assay 1
|
—
|
—
|
—
|
100 Percentage of participants
Interval 95.3 to 100.0
|
100 Percentage of participants
Interval 95.3 to 100.0
|
|
Part 2 OA: Percentage of Participants With Antigen 1 Antibody SPR
Flu A1 Assay 2
|
—
|
—
|
—
|
84.8 Percentage of participants
Interval 75.0 to 91.9
|
92.2 Percentage of participants
Interval 83.8 to 97.1
|
|
Part 2 OA: Percentage of Participants With Antigen 1 Antibody SPR
Flu A2 Assay 2
|
—
|
—
|
—
|
97.5 Percentage of participants
Interval 91.2 to 99.7
|
96.1 Percentage of participants
Interval 89.0 to 99.2
|
|
Part 2 OA: Percentage of Participants With Antigen 1 Antibody SPR
Flu B1 Assay 2
|
—
|
—
|
—
|
100 Percentage of participants
Interval 95.4 to 100.0
|
100 Percentage of participants
Interval 95.3 to 100.0
|
SECONDARY outcome
Timeframe: At Day 29Population: The analysis was performed on the PPS. Only participants with data available for the specified analysis at the specified timepoints were included.
Outcome measures
| Measure |
Part 1 YA: Flu mRNA_3_YA
n=20 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
n=21 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
n=22 Participants
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=23 Participants
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=20 Participants
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
|---|---|---|---|---|---|
|
Part 1 YA: GMT of Antigen 2 Antibody Titer
Flu A1
|
2400.60 Titers
Interval 1116.08 to 5163.5
|
3058.88 Titers
Interval 1777.21 to 5264.84
|
187.25 Titers
Interval 103.77 to 337.91
|
156.45 Titers
Interval 76.45 to 320.18
|
1296.33 Titers
Interval 685.93 to 2449.89
|
|
Part 1 YA: GMT of Antigen 2 Antibody Titer
Flu A2
|
1351.68 Titers
Interval 869.39 to 2101.5
|
1163.34 Titers
Interval 870.57 to 1554.58
|
380.65 Titers
Interval 258.2 to 561.16
|
264.10 Titers
Interval 194.21 to 359.14
|
1519.65 Titers
Interval 1169.78 to 1974.15
|
|
Part 1 YA: GMT of Antigen 2 Antibody Titer
Flu B1
|
720.88 Titers
Interval 452.43 to 1148.63
|
589.08 Titers
Interval 433.03 to 801.35
|
368.33 Titers
Interval 260.07 to 521.65
|
128.03 Titers
Interval 87.98 to 186.34
|
604.43 Titers
Interval 381.03 to 958.81
|
SECONDARY outcome
Timeframe: At Day 29Population: The analysis was performed on the PPS. Only participants with data available for specified analysis at the specified timepoints were included.
Outcome measures
| Measure |
Part 1 YA: Flu mRNA_3_YA
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=37 Participants
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=39 Participants
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
|---|---|---|---|---|---|
|
Part 2 YA: GMT of Antigen 2 Antibody Titer
Flu A1
|
—
|
—
|
—
|
950.09 Titers
Interval 585.04 to 1542.91
|
131.47 Titers
Interval 92.56 to 186.74
|
|
Part 2 YA: GMT of Antigen 2 Antibody Titer
FLU A2
|
—
|
—
|
—
|
202.44 Titers
Interval 132.64 to 308.97
|
83.26 Titers
Interval 48.51 to 142.9
|
|
Part 2 YA: GMT of Antigen 2 Antibody Titer
Flu B1
|
—
|
—
|
—
|
799.38 Titers
Interval 611.44 to 1045.09
|
413.77 Titers
Interval 313.99 to 545.25
|
SECONDARY outcome
Timeframe: At Day 29Population: The analysis was performed on the PPS. Only participants with data available for specified analysis at the specified timepoints were included.
Outcome measures
| Measure |
Part 1 YA: Flu mRNA_3_YA
n=24 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
n=20 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
n=23 Participants
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=20 Participants
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=23 Participants
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
|---|---|---|---|---|---|
|
Part 1 OA: GMT of Antigen 2 Antibody Titer
Flu B1
|
861.06 Titers
Interval 572.92 to 1294.12
|
681.68 Titers
Interval 503.14 to 923.58
|
400.50 Titers
Interval 326.23 to 491.68
|
597.33 Titers
Interval 400.28 to 891.37
|
408.07 Titers
Interval 258.76 to 643.54
|
|
Part 1 OA: GMT of Antigen 2 Antibody Titer
Flu A2
|
1521.90 Titers
Interval 1111.75 to 2083.35
|
1307.12 Titers
Interval 961.93 to 1776.19
|
407.67 Titers
Interval 289.09 to 574.88
|
974.84 Titers
Interval 632.98 to 1501.31
|
1477.87 Titers
Interval 1095.38 to 1993.93
|
|
Part 1 OA: GMT of Antigen 2 Antibody Titer
Flu A1
|
1860.40 Titers
Interval 928.3 to 3728.42
|
1600.51 Titers
Interval 850.68 to 3011.29
|
179.53 Titers
Interval 88.07 to 365.96
|
1359.58 Titers
Interval 713.32 to 2591.33
|
1464.19 Titers
Interval 821.97 to 2608.18
|
SECONDARY outcome
Timeframe: At Day 29Population: The analysis was performed on the PPS. Only participants with data available for specified analysis at the specified timepoints were included.
Outcome measures
| Measure |
Part 1 YA: Flu mRNA_3_YA
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=39 Participants
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=40 Participants
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
|---|---|---|---|---|---|
|
Part 2 OA: GMT of Antigen 2 Antibody Titer
Flu A1
|
—
|
—
|
—
|
739.45 Titers
Interval 469.03 to 1165.79
|
116.25 Titers
Interval 83.44 to 161.98
|
|
Part 2 OA: GMT of Antigen 2 Antibody Titer
FLU A2
|
—
|
—
|
—
|
241.50 Titers
Interval 159.09 to 366.59
|
70.51 Titers
Interval 46.9 to 106.01
|
|
Part 2 OA: GMT of Antigen 2 Antibody Titer
Flu B1
|
—
|
—
|
—
|
733.35 Titers
Interval 541.6 to 993.01
|
589.57 Titers
Interval 462.4 to 751.72
|
SECONDARY outcome
Timeframe: From Day 1 (baseline) to Day 29Population: The analysis was performed on the PPS. Only participants with data available for specified analysis at the specified timepoints were included.
Outcome measures
| Measure |
Part 1 YA: Flu mRNA_3_YA
n=20 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
n=21 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
n=22 Participants
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=23 Participants
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=20 Participants
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
|---|---|---|---|---|---|
|
Part 1 YA: GMI of Antigen 2 Antibody Titer
Flu A1
|
15.29 Ratio
Interval 10.05 to 23.27
|
15.30 Ratio
Interval 11.51 to 20.33
|
1.44 Ratio
Interval 0.99 to 2.09
|
1.25 Ratio
Interval 1.09 to 1.42
|
12.45 Ratio
Interval 7.78 to 19.94
|
|
Part 1 YA: GMI of Antigen 2 Antibody Titer
Flu A2
|
5.26 Ratio
Interval 3.96 to 6.99
|
3.83 Ratio
Interval 2.88 to 5.1
|
1.83 Ratio
Interval 1.46 to 2.3
|
1.24 Ratio
Interval 1.06 to 1.45
|
5.69 Ratio
Interval 4.51 to 7.18
|
|
Part 1 YA: GMI of Antigen 2 Antibody Titer
Flu B1
|
2.79 Ratio
Interval 1.95 to 3.98
|
3.49 Ratio
Interval 2.58 to 4.73
|
2.49 Ratio
Interval 1.68 to 3.69
|
0.75 Ratio
Interval 0.65 to 0.88
|
3.98 Ratio
Interval 2.69 to 5.88
|
SECONDARY outcome
Timeframe: From Day 1 (baseline) to Day 29Population: The analysis was performed on the PPS. Only participants with data available for specified analysis at the specified timepoints were included.
Outcome measures
| Measure |
Part 1 YA: Flu mRNA_3_YA
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=37 Participants
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=39 Participants
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
|---|---|---|---|---|---|
|
Part 2 YA: GMI of Antigen 2 Antibody Titer
Flu A1
|
—
|
—
|
—
|
7.55 Ratio
Interval 5.44 to 10.49
|
0.88 Ratio
Interval 0.73 to 1.06
|
|
Part 2 YA: GMI of Antigen 2 Antibody Titer
FLU A2
|
—
|
—
|
—
|
7.29 Ratio
Interval 5.13 to 10.36
|
2.47 Ratio
Interval 1.61 to 3.77
|
|
Part 2 YA: GMI of Antigen 2 Antibody Titer
Flu B2
|
—
|
—
|
—
|
5.40 Ratio
Interval 4.33 to 6.74
|
2.96 Ratio
Interval 2.19 to 3.99
|
SECONDARY outcome
Timeframe: From Day 1 (baseline) to Day 29Population: The analysis was performed on the PPS. Only participants with data available for specified analysis at the specified timepoints were included.
Outcome measures
| Measure |
Part 1 YA: Flu mRNA_3_YA
n=24 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
n=20 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
n=23 Participants
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=20 Participants
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=23 Participants
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
|---|---|---|---|---|---|
|
Part 1 OA: GMI of Antigen 2 Antibody Titer
Flu A1
|
11.63 Ratio
Interval 7.16 to 18.88
|
9.62 Ratio
Interval 6.14 to 15.06
|
1.42 Ratio
Interval 1.19 to 1.7
|
7.42 Ratio
Interval 4.38 to 12.58
|
9.34 Ratio
Interval 6.01 to 14.51
|
|
Part 1 OA: GMI of Antigen 2 Antibody Titer
Flu A2
|
4.36 Ratio
Interval 3.13 to 6.08
|
3.62 Ratio
Interval 2.42 to 5.43
|
1.65 Ratio
Interval 1.29 to 2.11
|
3.60 Ratio
Interval 2.89 to 4.47
|
5.64 Ratio
Interval 3.78 to 8.42
|
|
Part 1 OA: GMI of Antigen 2 Antibody Titer
Flu B1
|
3.13 Ratio
Interval 2.25 to 4.36
|
2.16 Ratio
Interval 1.61 to 2.89
|
2.06 Ratio
Interval 1.37 to 3.09
|
2.72 Ratio
Interval 2.12 to 3.49
|
3.31 Ratio
Interval 2.22 to 4.92
|
SECONDARY outcome
Timeframe: From Day 1 (baseline) to Day 29Population: The analysis was performed on the PPS. Only participants with data available for specified analysis at the specified timepoints were included.
Outcome measures
| Measure |
Part 1 YA: Flu mRNA_3_YA
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=39 Participants
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=40 Participants
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
|---|---|---|---|---|---|
|
Part 2 OA: GMI of Antigen 2 Antibody Titer
Flu A1
|
—
|
—
|
—
|
5.06 Ratio
Interval 3.48 to 7.36
|
1.04 Ratio
Interval 0.88 to 1.24
|
|
Part 2 OA: GMI of Antigen 2 Antibody Titer
FLU A2
|
—
|
—
|
—
|
8.05 Ratio
Interval 5.9 to 10.98
|
1.87 Ratio
Interval 1.5 to 2.32
|
|
Part 2 OA: GMI of Antigen 2 Antibody Titer
Flu B1
|
—
|
—
|
—
|
4.00 Ratio
Interval 3.16 to 5.08
|
2.71 Ratio
Interval 2.17 to 3.4
|
SECONDARY outcome
Timeframe: From Day 1 (baseline) to Day 29Population: The analysis was performed on the PPS. Only participants with data available for specified analysis at the specified timepoints were included.
Outcome measures
| Measure |
Part 1 YA: Flu mRNA_3_YA
n=20 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
n=21 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
n=22 Participants
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=23 Participants
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=20 Participants
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
|---|---|---|---|---|---|
|
Part 1 YA: Percentage of Participants With Antigen 2 Antibody SCR
Flu A1
|
95.0 Percentage of participants
Interval 75.1 to 99.9
|
95.2 Percentage of participants
Interval 76.2 to 99.9
|
4.5 Percentage of participants
Interval 0.1 to 22.8
|
0 Percentage of participants
Interval 0.0 to 14.8
|
85.0 Percentage of participants
Interval 62.1 to 96.8
|
|
Part 1 YA: Percentage of Participants With Antigen 2 Antibody SCR
Flu A2
|
70.0 Percentage of participants
Interval 45.7 to 88.1
|
57.1 Percentage of participants
Interval 34.0 to 78.2
|
4.5 Percentage of participants
Interval 0.1 to 22.8
|
0 Percentage of participants
Interval 0.0 to 14.8
|
75.0 Percentage of participants
Interval 50.9 to 91.3
|
|
Part 1 YA: Percentage of Participants With Antigen 2 Antibody SCR
Flu B1
|
25.0 Percentage of participants
Interval 8.7 to 49.1
|
33.3 Percentage of participants
Interval 14.6 to 57.0
|
22.7 Percentage of participants
Interval 7.8 to 45.4
|
0 Percentage of participants
Interval 0.0 to 14.8
|
40.0 Percentage of participants
Interval 19.1 to 63.9
|
SECONDARY outcome
Timeframe: From Day 1 (baseline) to Day 29Population: The analysis was performed on the PPS. Only participants with data available for specified analysis at the specified timepoints were included.
Outcome measures
| Measure |
Part 1 YA: Flu mRNA_3_YA
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=37 Participants
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=39 Participants
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
|---|---|---|---|---|---|
|
Part 2 YA: Percentage of Participants With Antigen 2 Antibody SCR
Flu B1
|
—
|
—
|
—
|
59.5 Percentage of participants
Interval 42.1 to 75.2
|
28.2 Percentage of participants
Interval 15.0 to 44.9
|
|
Part 2 YA: Percentage of Participants With Antigen 2 Antibody SCR
Flu A1
|
—
|
—
|
—
|
70.3 Percentage of participants
Interval 53.0 to 84.1
|
2.6 Percentage of participants
Interval 0.1 to 13.5
|
|
Part 2 YA: Percentage of Participants With Antigen 2 Antibody SCR
FLU A2
|
—
|
—
|
—
|
64.9 Percentage of participants
Interval 47.5 to 79.8
|
7.7 Percentage of participants
Interval 1.6 to 20.9
|
SECONDARY outcome
Timeframe: From Day 1 (baseline) to Day 29Population: The analysis was performed on the PPS. Only participants with data available for specified analysis at the specified timepoints were included.
Outcome measures
| Measure |
Part 1 YA: Flu mRNA_3_YA
n=24 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
n=20 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
n=23 Participants
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=20 Participants
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=23 Participants
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
|---|---|---|---|---|---|
|
Part 1 OA: Percentage of Participants With Antigen 2 Antibody SCR
Flu A1
|
79.2 Percentage of participants
Interval 57.8 to 92.9
|
95.0 Percentage of participants
Interval 75.1 to 99.9
|
0 Percentage of participants
Interval 0.0 to 14.8
|
60.0 Percentage of participants
Interval 36.1 to 80.9
|
78.3 Percentage of participants
Interval 56.3 to 92.5
|
|
Part 1 OA: Percentage of Participants With Antigen 2 Antibody SCR
Flu A2
|
62.5 Percentage of participants
Interval 40.6 to 81.2
|
25.0 Percentage of participants
Interval 8.7 to 49.1
|
13.0 Percentage of participants
Interval 2.8 to 33.6
|
50.0 Percentage of participants
Interval 27.2 to 72.8
|
56.5 Percentage of participants
Interval 34.5 to 76.8
|
|
Part 1 OA: Percentage of Participants With Antigen 2 Antibody SCR
Flu B1
|
33.3 Percentage of participants
Interval 15.6 to 55.3
|
20.0 Percentage of participants
Interval 5.7 to 43.7
|
21.7 Percentage of participants
Interval 7.5 to 43.7
|
25.0 Percentage of participants
Interval 8.7 to 49.1
|
34.8 Percentage of participants
Interval 16.4 to 57.3
|
SECONDARY outcome
Timeframe: From Day 1 (baseline) to Day 29Population: The analysis was performed on the PPS. Only participants with data available for specified analysis at the specified timepoints were included.
Outcome measures
| Measure |
Part 1 YA: Flu mRNA_3_YA
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=39 Participants
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=40 Participants
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
|---|---|---|---|---|---|
|
Part 2 OA: Percentage of Participants With Antigen 2 Antibody SCR
Flu A1
|
—
|
—
|
—
|
56.4 Percentage of participants
Interval 39.6 to 72.2
|
0 Percentage of participants
Interval 0.0 to 8.8
|
|
Part 2 OA: Percentage of Participants With Antigen 2 Antibody SCR
FLU A2
|
—
|
—
|
—
|
71.8 Percentage of participants
Interval 55.1 to 85.0
|
7.5 Percentage of participants
Interval 1.6 to 20.4
|
|
Part 2 OA: Percentage of Participants With Antigen 2 Antibody SCR
Flu B1
|
—
|
—
|
—
|
48.7 Percentage of participants
Interval 32.4 to 65.2
|
22.5 Percentage of participants
Interval 10.8 to 38.5
|
SECONDARY outcome
Timeframe: Day 1 to Day 7Population: The analysis was performed on the Exposed Set (ES), which included all participants who received a study intervention and with data available for specified analysis at the specified duration were included.
Assessed solicited administration site events included pain, redness (erythema), swelling, lymphadenopathy (defined as localized axillary, cervical or supraclavicular swelling or tenderness ipsilateral to the injection arm). Any = occurrence of the event regardless of intensity grade.
Outcome measures
| Measure |
Part 1 YA: Flu mRNA_3_YA
n=48 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
n=50 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
n=51 Participants
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=50 Participants
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=50 Participants
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
|---|---|---|---|---|---|
|
Part 1 YA: Number of Participants Reporting Any Solicited Administration Site Adverse Events (AEs)
Pain
|
30 Participants
|
33 Participants
|
21 Participants
|
25 Participants
|
31 Participants
|
|
Part 1 YA: Number of Participants Reporting Any Solicited Administration Site Adverse Events (AEs)
Erythema
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
|
Part 1 YA: Number of Participants Reporting Any Solicited Administration Site Adverse Events (AEs)
Swelling
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
|
Part 1 YA: Number of Participants Reporting Any Solicited Administration Site Adverse Events (AEs)
Lymphadenopathy
|
10 Participants
|
9 Participants
|
5 Participants
|
4 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 7Population: The analysis was performed on the ES, which included all participants who received a study intervention and with data available for specified analysis at the specified duration were included.
Assessed solicited administration site events included pain, redness (Erythema), swelling, lymphadenopathy (defined as localized axillary, cervical or supraclavicular swelling or tenderness ipsilateral to the injection arm). Any = occurrence of the event regardless of intensity grade.
Outcome measures
| Measure |
Part 1 YA: Flu mRNA_3_YA
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=81 Participants
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=80 Participants
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
|---|---|---|---|---|---|
|
Part 2 YA: Number of Participants Reporting Any Solicited Administration Site AEs
Pain
|
—
|
—
|
—
|
46 Participants
|
23 Participants
|
|
Part 2 YA: Number of Participants Reporting Any Solicited Administration Site AEs
Erythema
|
—
|
—
|
—
|
3 Participants
|
0 Participants
|
|
Part 2 YA: Number of Participants Reporting Any Solicited Administration Site AEs
Swelling
|
—
|
—
|
—
|
3 Participants
|
1 Participants
|
|
Part 2 YA: Number of Participants Reporting Any Solicited Administration Site AEs
Lymphadenopathy
|
—
|
—
|
—
|
17 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 7Population: The analysis was performed on the ES, which included all participants who received a study intervention and with data available for specified analysis at the specified duration were included.
Assessed solicited administration site events included pain, redness (Erythema), swelling, lymphadenopathy (defined as localized axillary, cervical or supraclavicular swelling or tenderness ipsilateral to the injection arm). Any = occurrence of the event regardless of intensity grade.
Outcome measures
| Measure |
Part 1 YA: Flu mRNA_3_YA
n=53 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
n=51 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
n=53 Participants
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=51 Participants
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=52 Participants
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
|---|---|---|---|---|---|
|
Part 1 OA: Number of Participants Reporting Any Solicited Administration Site AEs
Pain
|
36 Participants
|
35 Participants
|
21 Participants
|
27 Participants
|
31 Participants
|
|
Part 1 OA: Number of Participants Reporting Any Solicited Administration Site AEs
Erythema
|
5 Participants
|
4 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
|
Part 1 OA: Number of Participants Reporting Any Solicited Administration Site AEs
Swelling
|
4 Participants
|
1 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
|
Part 1 OA: Number of Participants Reporting Any Solicited Administration Site AEs
Lymphadenopathy
|
12 Participants
|
6 Participants
|
7 Participants
|
11 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 7Population: The analysis was performed on the ES, which included all participants who received a study intervention and with data available for specified analysis at the specified duration were included.
Assessed solicited administration site events included pain, redness (Erythema), swelling, lymphadenopathy (defined as localized axillary, cervical or supraclavicular swelling or tenderness ipsilateral to the injection arm). Any = occurrence of the event regardless of intensity grade.
Outcome measures
| Measure |
Part 1 YA: Flu mRNA_3_YA
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=82 Participants
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=80 Participants
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
|---|---|---|---|---|---|
|
Part 2 OA: Number of Participants Reporting Any Solicited Administration Site AEs
Pain
|
—
|
—
|
—
|
42 Participants
|
21 Participants
|
|
Part 2 OA: Number of Participants Reporting Any Solicited Administration Site AEs
Erythema
|
—
|
—
|
—
|
3 Participants
|
1 Participants
|
|
Part 2 OA: Number of Participants Reporting Any Solicited Administration Site AEs
Swelling
|
—
|
—
|
—
|
5 Participants
|
2 Participants
|
|
Part 2 OA: Number of Participants Reporting Any Solicited Administration Site AEs
Lymphadenopathy
|
—
|
—
|
—
|
14 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 7Population: The analysis was performed on the ES, which included all participants who received a study intervention and with data available at the specified duration.
Assessed solicited systemic events included fever (pyrexia) which is defined as axillary temperature greater than or equal to (\>=) 38.0°C/100.4°F, chills, headache, fatigue (tiredness), myalgia (muscle joint), and arthralgia (joint pain). Any = occurrence of the event regardless of intensity grade.
Outcome measures
| Measure |
Part 1 YA: Flu mRNA_3_YA
n=48 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
n=50 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
n=51 Participants
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=50 Participants
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=50 Participants
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
|---|---|---|---|---|---|
|
Part 1 YA: Number of Participants Reporting Any Solicited Systemic AEs
Arthralgia
|
12 Participants
|
11 Participants
|
4 Participants
|
6 Participants
|
13 Participants
|
|
Part 1 YA: Number of Participants Reporting Any Solicited Systemic AEs
Chills
|
16 Participants
|
19 Participants
|
6 Participants
|
5 Participants
|
15 Participants
|
|
Part 1 YA: Number of Participants Reporting Any Solicited Systemic AEs
Fatigue
|
21 Participants
|
23 Participants
|
19 Participants
|
17 Participants
|
24 Participants
|
|
Part 1 YA: Number of Participants Reporting Any Solicited Systemic AEs
Headache
|
22 Participants
|
22 Participants
|
13 Participants
|
15 Participants
|
24 Participants
|
|
Part 1 YA: Number of Participants Reporting Any Solicited Systemic AEs
Myalgia
|
24 Participants
|
26 Participants
|
13 Participants
|
20 Participants
|
27 Participants
|
|
Part 1 YA: Number of Participants Reporting Any Solicited Systemic AEs
Fever
|
6 Participants
|
5 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 7Population: The analysis was performed on the ES, which included all participants who received a study intervention and with data available for specified analysis at the specified duration were included.
Assessed solicited systemic events included fever (pyrexia) which is defined as axillary temperature \>= 38.0°C/100.4°F, chills, headache, fatigue (tiredness), myalgia (muscle joint), and arthralgia (joint pain). Any = occurrence of the event regardless of intensity grade.
Outcome measures
| Measure |
Part 1 YA: Flu mRNA_3_YA
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=81 Participants
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=80 Participants
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
|---|---|---|---|---|---|
|
Part 2 YA: Number of Participants Reporting Any Solicited Systemic AEs
Arthralgia
|
—
|
—
|
—
|
26 Participants
|
6 Participants
|
|
Part 2 YA: Number of Participants Reporting Any Solicited Systemic AEs
Chills
|
—
|
—
|
—
|
30 Participants
|
6 Participants
|
|
Part 2 YA: Number of Participants Reporting Any Solicited Systemic AEs
Fatigue
|
—
|
—
|
—
|
33 Participants
|
21 Participants
|
|
Part 2 YA: Number of Participants Reporting Any Solicited Systemic AEs
Headache
|
—
|
—
|
—
|
33 Participants
|
16 Participants
|
|
Part 2 YA: Number of Participants Reporting Any Solicited Systemic AEs
Myalgia
|
—
|
—
|
—
|
39 Participants
|
21 Participants
|
|
Part 2 YA: Number of Participants Reporting Any Solicited Systemic AEs
Fever
|
—
|
—
|
—
|
19 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 7Population: The analysis was performed on the ES, which included all participants who received a study intervention and with data available for specified analysis at the specified duration were included.
Assessed solicited systemic events included fever (pyrexia) which is defined as axillary temperature \>= 38.0°C/100.4°F, chills, headache, fatigue (tiredness), myalgia (muscle joint), and arthralgia (joint pain). Any = occurrence of the event regardless of intensity grade.
Outcome measures
| Measure |
Part 1 YA: Flu mRNA_3_YA
n=53 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
n=51 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
n=53 Participants
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=51 Participants
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=52 Participants
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
|---|---|---|---|---|---|
|
Part 1 OA: Number of Participants Reporting Any Solicited Systemic AEs
Arthralgia
|
16 Participants
|
13 Participants
|
9 Participants
|
12 Participants
|
12 Participants
|
|
Part 1 OA: Number of Participants Reporting Any Solicited Systemic AEs
Chills
|
14 Participants
|
10 Participants
|
3 Participants
|
11 Participants
|
11 Participants
|
|
Part 1 OA: Number of Participants Reporting Any Solicited Systemic AEs
Fatigue
|
25 Participants
|
26 Participants
|
19 Participants
|
28 Participants
|
23 Participants
|
|
Part 1 OA: Number of Participants Reporting Any Solicited Systemic AEs
Headache
|
18 Participants
|
18 Participants
|
12 Participants
|
16 Participants
|
11 Participants
|
|
Part 1 OA: Number of Participants Reporting Any Solicited Systemic AEs
Myalgia
|
26 Participants
|
27 Participants
|
20 Participants
|
23 Participants
|
24 Participants
|
|
Part 1 OA: Number of Participants Reporting Any Solicited Systemic AEs
Fever
|
8 Participants
|
4 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 7Population: The analysis was performed on the ES, which included all participants who received a study intervention and with data available for specified analysis at the specified duration were included.
Assessed solicited systemic events included fever (pyrexia) which is defined as axillary temperature \>= 38.0°C/100.4°F, chills, headache, fatigue (tiredness), myalgia (muscle joint), and arthralgia (joint pain). Any = occurrence of the event regardless of intensity grade.
Outcome measures
| Measure |
Part 1 YA: Flu mRNA_3_YA
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=82 Participants
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=80 Participants
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
|---|---|---|---|---|---|
|
Part 2 OA: Number of Participants Reporting Any Solicited Systemic AEs
Arthralgia
|
—
|
—
|
—
|
17 Participants
|
5 Participants
|
|
Part 2 OA: Number of Participants Reporting Any Solicited Systemic AEs
Chills
|
—
|
—
|
—
|
21 Participants
|
5 Participants
|
|
Part 2 OA: Number of Participants Reporting Any Solicited Systemic AEs
Fatigue
|
—
|
—
|
—
|
28 Participants
|
11 Participants
|
|
Part 2 OA: Number of Participants Reporting Any Solicited Systemic AEs
Headache
|
—
|
—
|
—
|
19 Participants
|
9 Participants
|
|
Part 2 OA: Number of Participants Reporting Any Solicited Systemic AEs
Myalgia
|
—
|
—
|
—
|
31 Participants
|
10 Participants
|
|
Part 2 OA: Number of Participants Reporting Any Solicited Systemic AEs
Fever
|
—
|
—
|
—
|
5 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 28Population: The analysis was performed on the ES, which included all participants who received a study intervention and with data available for specified analysis at the specified duration were included.
An unsolicited AE is defined as an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow up for solicited events. Unsolicited AEs include both serious and non-serious AEs. Any = occurrence the event regardless of intensity grade.
Outcome measures
| Measure |
Part 1 YA: Flu mRNA_3_YA
n=48 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
n=50 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
n=52 Participants
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=50 Participants
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=50 Participants
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
|---|---|---|---|---|---|
|
Part 1 YA: Number of Participants Reporting Any Unsolicited AEs
|
6 Participants
|
9 Participants
|
5 Participants
|
4 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 28Population: The analysis was performed on the ES, which included all participants who received a study intervention and with data available for specified analysis at the specified duration were included.
An unsolicited AE is defined as an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow up for solicited events. Unsolicited AEs include both serious and non-serious AEs. Any = occurrence the event regardless of intensity grade.
Outcome measures
| Measure |
Part 1 YA: Flu mRNA_3_YA
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=81 Participants
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=80 Participants
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
|---|---|---|---|---|---|
|
Part 2 YA: Number of Participants Reporting Any Unsolicited AEs
|
—
|
—
|
—
|
13 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 28Population: The analysis was performed on the ES, which included all participants who received a study intervention and with data available for specified analysis at the specified duration were included.
An unsolicited AE is defined as an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow up for solicited events. Unsolicited AEs include both serious and non-serious AEs. Any = occurrence the event regardless of intensity grade.
Outcome measures
| Measure |
Part 1 YA: Flu mRNA_3_YA
n=53 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
n=51 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
n=53 Participants
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=51 Participants
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=52 Participants
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
|---|---|---|---|---|---|
|
Part 1 OA: Number of Participants Reporting Any Unsolicited AEs
|
5 Participants
|
6 Participants
|
10 Participants
|
7 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 28Population: The analysis was performed on the ES, which included all participants who received a study intervention and with data available for specified analysis at the specified duration were included.
An unsolicited AE is defined as an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow up for solicited events. Unsolicited AEs include both serious and non-serious AEs. Any = occurrence the event regardless of intensity grade.
Outcome measures
| Measure |
Part 1 YA: Flu mRNA_3_YA
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=82 Participants
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=80 Participants
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
|---|---|---|---|---|---|
|
Part 2 OA: Number of Participants Reporting Any Unsolicited AEs
|
—
|
—
|
—
|
9 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 183Population: The analysis was performed on the ES, which included all participants who received a study intervention.
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, is an abnormal pregnancy outcome, or is a suspected transmission of any infectious agent via an authorized medicinal product. Any = occurrence the event regardless of intensity grade.
Outcome measures
| Measure |
Part 1 YA: Flu mRNA_3_YA
n=48 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
n=50 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
n=52 Participants
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=50 Participants
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=50 Participants
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
|---|---|---|---|---|---|
|
Part 1 YA: Number of Participants Reporting Serious Adverse Events (SAEs)
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 183Population: The analysis was performed on the ES, which included all participants who received a study intervention.
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, is an abnormal pregnancy outcome, or is a suspected transmission of any infectious agent via an authorized medicinal product. Any = occurrence the event regardless of intensity grade.
Outcome measures
| Measure |
Part 1 YA: Flu mRNA_3_YA
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=81 Participants
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=80 Participants
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
|---|---|---|---|---|---|
|
Part 2 YA: Number of Participants Reporting SAEs
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 183Population: The analysis was performed on the ES, which included all participants who received a study intervention.
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, is an abnormal pregnancy outcome, or is a suspected transmission of any infectious agent via an authorized medicinal product. Any = occurrence the event regardless of intensity grade.
Outcome measures
| Measure |
Part 1 YA: Flu mRNA_3_YA
n=53 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
n=51 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
n=53 Participants
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=51 Participants
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=52 Participants
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
|---|---|---|---|---|---|
|
Part 1 OA: Number of Participants Reporting SAEs
|
3 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 183Population: The analysis was performed on the ES, which included all participants who received a study intervention.
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, is an abnormal pregnancy outcome, or is a suspected transmission of any infectious agent via an authorized medicinal product. Any = occurrence the event regardless of intensity grade.
Outcome measures
| Measure |
Part 1 YA: Flu mRNA_3_YA
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=82 Participants
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=80 Participants
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
|---|---|---|---|---|---|
|
Part 2 OA: Number of Participants Reporting SAEs
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 183Population: The analysis was performed on the ES, which included all participants who received a study intervention.
The following events were considered as AESI in this study: severe hypersensitivity reactions within 24 hours after study intervention administration, myocarditis/pericarditis and potential immune-mediated diseases (pIMDs). Any = occurrence the event regardless of intensity grade.
Outcome measures
| Measure |
Part 1 YA: Flu mRNA_3_YA
n=48 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
n=50 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
n=52 Participants
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=50 Participants
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=50 Participants
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
|---|---|---|---|---|---|
|
Part 1 YA: Number of Participants Reporting AEs of Special Interest (AESIs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 183Population: The analysis was performed on the ES, which included all participants who received a study intervention.
The following events were considered as AESI in this study: severe hypersensitivity reactions within 24 hours after study intervention administration, myocarditis/pericarditis and potential immune-mediated diseases (pIMDs). Any = occurrence the event regardless of intensity grade.
Outcome measures
| Measure |
Part 1 YA: Flu mRNA_3_YA
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=81 Participants
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=80 Participants
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
|---|---|---|---|---|---|
|
Part 2 YA: Number of Participants Reporting AESIs
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 183Population: The analysis was performed on the ES, which included all participants who received a study intervention.
The following events were considered as AESI in this study: severe hypersensitivity reactions within 24 hours after study intervention administration, myocarditis/pericarditis and potential immune-mediated diseases (pIMDs). Any = occurrence the event regardless of intensity grade.
Outcome measures
| Measure |
Part 1 YA: Flu mRNA_3_YA
n=53 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
n=51 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
n=53 Participants
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=51 Participants
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=52 Participants
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
|---|---|---|---|---|---|
|
Part 1 OA: Number of Participants Reporting AESIs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 183Population: The analysis was performed on the ES, which included all participants who received a study intervention.
The following events were considered as AESI in this study: severe hypersensitivity reactions within 24 hours after study intervention administration, myocarditis/pericarditis and potential immune-mediated diseases (pIMDs). Any = occurrence the event regardless of intensity grade.
Outcome measures
| Measure |
Part 1 YA: Flu mRNA_3_YA
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=82 Participants
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=80 Participants
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
|---|---|---|---|---|---|
|
Part 2 OA: Number of Participants Reporting AESIs
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 183Population: The analysis was performed on the ES, which included all participants who received a study intervention.
MAE is defined as an AE that results in an unscheduled visit to a medical professional (e.g., physician's office visits, emergency room visits or hospitalization). Any = occurrence the event regardless of intensity grade.
Outcome measures
| Measure |
Part 1 YA: Flu mRNA_3_YA
n=48 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
n=50 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
n=52 Participants
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=50 Participants
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=50 Participants
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
|---|---|---|---|---|---|
|
Part 1 YA: Number of Participants Reporting Medically Attended Adverse Events (MAAEs)
|
4 Participants
|
7 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 183Population: The analysis was performed on the ES, which included all participants who received a study intervention.
MAE is defined as an AE that results in an unscheduled visit to a medical professional (e.g., physician's office visits, emergency room visits or hospitalization). Any = occurrence the event regardless of intensity grade.
Outcome measures
| Measure |
Part 1 YA: Flu mRNA_3_YA
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=81 Participants
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=80 Participants
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
|---|---|---|---|---|---|
|
Part 2 YA: Number of Participants Reporting MAAEs
|
—
|
—
|
—
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 183Population: The analysis was performed on the ES, which included all participants who received a study intervention.
MAE is defined as an AE that results in an unscheduled visit to a medical professional (e.g., physician's office visits, emergency room visits or hospitalization). Any = occurrence the event regardless of intensity grade.
Outcome measures
| Measure |
Part 1 YA: Flu mRNA_3_YA
n=53 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
n=51 Participants
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
n=53 Participants
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=51 Participants
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=52 Participants
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
|---|---|---|---|---|---|
|
Part 1 OA: Number of Participants Reporting MAAEs
|
6 Participants
|
5 Participants
|
8 Participants
|
8 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 183Population: The analysis was performed on the ES, which included all participants who received a study intervention.
MAE is defined as an AE that results in an unscheduled visit to a medical professional (e.g., physician's office visits, emergency room visits or hospitalization). Any = occurrence the event regardless of intensity grade.
Outcome measures
| Measure |
Part 1 YA: Flu mRNA_3_YA
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=82 Participants
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=80 Participants
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
|---|---|---|---|---|---|
|
Part 2 OA: Number of Participants Reporting MAAEs
|
—
|
—
|
—
|
7 Participants
|
4 Participants
|
Adverse Events
Part 1 YA: Flu mRNA_1_Younger Adults (YA)
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Part 1 YA: Flu mRNA_2_YA
Serious events: 1 serious events
Other events: 33 other events
Deaths: 0 deaths
Part 1 YA: Flu mRNA_3_YA
Serious events: 1 serious events
Other events: 33 other events
Deaths: 0 deaths
Part 1 YA: Flu mRNA_4_YA
Serious events: 2 serious events
Other events: 34 other events
Deaths: 0 deaths
Part 1 YA: Comparator_1_YA
Serious events: 2 serious events
Other events: 29 other events
Deaths: 0 deaths
Part 2 YA: Flu mRNA_9_YA
Serious events: 0 serious events
Other events: 54 other events
Deaths: 0 deaths
Part 2 YA: Comparator_2_YA
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
Part 1 OA: Flu mRNA_5_Older Adults (OA)
Serious events: 3 serious events
Other events: 37 other events
Deaths: 0 deaths
Part 1 OA: Flu mRNA_6_OA
Serious events: 2 serious events
Other events: 39 other events
Deaths: 0 deaths
Part 1 OA: Flu mRNA_7_OA
Serious events: 3 serious events
Other events: 39 other events
Deaths: 0 deaths
Part 1 OA: Flu mRNA_8_OA
Serious events: 1 serious events
Other events: 40 other events
Deaths: 0 deaths
Part 1 OA: Comparator_1_OA
Serious events: 0 serious events
Other events: 36 other events
Deaths: 0 deaths
Part 2 OA: Flu mRNA_10_OA
Serious events: 0 serious events
Other events: 48 other events
Deaths: 0 deaths
Part 2 OA: Comparator_2_OA
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 1 YA: Flu mRNA_1_Younger Adults (YA)
n=50 participants at risk
YA participants received a single dose of Flu mRNA study intervention F2G22B/DL001Z administered at Day 1.
|
Part 1 YA: Flu mRNA_2_YA
n=50 participants at risk
YA participants received a single dose of Flu mRNA study intervention F2H23D/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_3_YA
n=48 participants at risk
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
n=50 participants at risk
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
n=52 participants at risk
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=81 participants at risk
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=80 participants at risk
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
Part 1 OA: Flu mRNA_5_Older Adults (OA)
n=51 participants at risk
OA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 OA: Flu mRNA_6_OA
n=52 participants at risk
OA participants received a single dose of Flu mRNA study intervention F2H23A/DL001Z-NH administered at Day 1.
|
Part 1 OA: Flu mRNA_7_OA
n=53 participants at risk
OA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 OA: Flu mRNA_8_OA
n=51 participants at risk
OA participants received a single dose of Flu mRNA study intervention F2H23G/DL001Z administered at Day 1.
|
Part 1 OA: Comparator_1_OA
n=53 participants at risk
OA participants received a single dose of Comparator 1 (Fluzone HD Quadrivalent) administered at Day 1.
|
Part 2 OA: Flu mRNA_10_OA
n=82 participants at risk
OA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 OA: Comparator_2_OA
n=80 participants at risk
OA participants received a single dose of Comparator 2 (Fluzone HD) administered at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/51 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Lemierre syndrome
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Ophthalmic herpes zoster
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Sepsis
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/51 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.1%
1/48 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/51 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/51 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.9%
1/53 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.9%
1/52 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer stage IV
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.9%
1/52 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.9%
1/52 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.9%
1/52 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/51 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Nervous system disorders
Syncope
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.9%
1/53 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.9%
1/53 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.1%
1/48 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
Other adverse events
| Measure |
Part 1 YA: Flu mRNA_1_Younger Adults (YA)
n=50 participants at risk
YA participants received a single dose of Flu mRNA study intervention F2G22B/DL001Z administered at Day 1.
|
Part 1 YA: Flu mRNA_2_YA
n=50 participants at risk
YA participants received a single dose of Flu mRNA study intervention F2H23D/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_3_YA
n=48 participants at risk
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 YA: Flu mRNA_4_YA
n=50 participants at risk
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 YA: Comparator_1_YA
n=52 participants at risk
YA participants received a single dose of Comparator 1 (\[FDQ23A-NH (Flu D-QIV)\] administered at Day 1.
|
Part 2 YA: Flu mRNA_9_YA
n=81 participants at risk
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 YA: Comparator_2_YA
n=80 participants at risk
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
|
Part 1 OA: Flu mRNA_5_Older Adults (OA)
n=51 participants at risk
OA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
|
Part 1 OA: Flu mRNA_6_OA
n=52 participants at risk
OA participants received a single dose of Flu mRNA study intervention F2H23A/DL001Z-NH administered at Day 1.
|
Part 1 OA: Flu mRNA_7_OA
n=53 participants at risk
OA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
|
Part 1 OA: Flu mRNA_8_OA
n=51 participants at risk
OA participants received a single dose of Flu mRNA study intervention F2H23G/DL001Z administered at Day 1.
|
Part 1 OA: Comparator_1_OA
n=53 participants at risk
OA participants received a single dose of Comparator 1 (Fluzone HD Quadrivalent) administered at Day 1.
|
Part 2 OA: Flu mRNA_10_OA
n=82 participants at risk
OA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
|
Part 2 OA: Comparator_2_OA
n=80 participants at risk
OA participants received a single dose of Comparator 2 (Fluzone HD) administered at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.2%
1/80 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
8.0%
4/50 • Number of events 4 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
18.0%
9/50 • Number of events 9 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
20.8%
10/48 • Number of events 10 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
20.0%
10/50 • Number of events 10 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
9.6%
5/52 • Number of events 5 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
21.0%
17/81 • Number of events 17 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
10.0%
8/80 • Number of events 8 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
21.6%
11/51 • Number of events 11 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
21.2%
11/52 • Number of events 11 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
22.6%
12/53 • Number of events 12 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
11.8%
6/51 • Number of events 6 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
13.2%
7/53 • Number of events 7 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
17.1%
14/82 • Number of events 14 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Blood and lymphatic system disorders
Polycythaemia
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.9%
1/52 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/51 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.9%
1/53 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.2%
1/80 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Eye disorders
Cataract
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.9%
1/53 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.2%
1/82 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Eye disorders
Eye discharge
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.9%
1/53 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Eye disorders
Vision blurred
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.9%
1/52 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.2%
1/82 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.0%
2/50 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.2%
1/80 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.2%
1/82 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.2%
1/80 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/51 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.9%
1/52 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.9%
1/53 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
3.7%
3/81 • Number of events 3 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
3.8%
3/80 • Number of events 3 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/51 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/50 • Number of events 3 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.2%
1/81 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.2%
1/80 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Administration site erythema
|
4.0%
2/50 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
8.0%
4/50 • Number of events 4 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.9%
1/52 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
3.7%
3/81 • Number of events 3 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
11.8%
6/51 • Number of events 6 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
3.8%
2/52 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
9.4%
5/53 • Number of events 5 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
7.8%
4/51 • Number of events 4 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
3.8%
2/53 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
3.7%
3/82 • Number of events 3 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.2%
1/80 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Administration site pain
|
50.0%
25/50 • Number of events 25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
62.0%
31/50 • Number of events 31 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
62.5%
30/48 • Number of events 30 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
66.0%
33/50 • Number of events 33 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
40.4%
21/52 • Number of events 21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
56.8%
46/81 • Number of events 46 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
28.7%
23/80 • Number of events 23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
52.9%
27/51 • Number of events 27 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
59.6%
31/52 • Number of events 31 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
67.9%
36/53 • Number of events 36 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
68.6%
35/51 • Number of events 35 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
39.6%
21/53 • Number of events 21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
51.2%
42/82 • Number of events 42 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
26.2%
21/80 • Number of events 21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Administration site swelling
|
4.0%
2/50 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
8.0%
4/50 • Number of events 4 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.1%
1/48 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.9%
1/52 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
3.7%
3/81 • Number of events 3 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.2%
1/80 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
7.8%
4/51 • Number of events 4 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
5.8%
3/52 • Number of events 3 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
7.5%
4/53 • Number of events 4 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/51 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
7.5%
4/53 • Number of events 4 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
6.1%
5/82 • Number of events 5 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.5%
2/80 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Chest pain
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.9%
1/52 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.2%
1/80 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Chills
|
10.0%
5/50 • Number of events 5 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
30.0%
15/50 • Number of events 15 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
33.3%
16/48 • Number of events 16 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
38.0%
19/50 • Number of events 19 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
11.5%
6/52 • Number of events 6 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
37.0%
30/81 • Number of events 30 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
7.5%
6/80 • Number of events 6 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
21.6%
11/51 • Number of events 11 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
21.2%
11/52 • Number of events 11 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
26.4%
14/53 • Number of events 14 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
19.6%
10/51 • Number of events 10 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
5.7%
3/53 • Number of events 3 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
25.6%
21/82 • Number of events 21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
6.2%
5/80 • Number of events 5 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Fatigue
|
34.0%
17/50 • Number of events 17 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
48.0%
24/50 • Number of events 24 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
43.8%
21/48 • Number of events 22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
46.0%
23/50 • Number of events 23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
36.5%
19/52 • Number of events 19 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
40.7%
33/81 • Number of events 33 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
26.2%
21/80 • Number of events 21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
54.9%
28/51 • Number of events 29 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
44.2%
23/52 • Number of events 23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
47.2%
25/53 • Number of events 25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
51.0%
26/51 • Number of events 26 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
35.8%
19/53 • Number of events 19 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
34.1%
28/82 • Number of events 28 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
13.8%
11/80 • Number of events 12 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Injection site bruising
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.1%
1/48 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Injection site erythema
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/51 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Injection site pain
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/51 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Injection site pruritus
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.0%
2/50 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/51 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Pain
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/51 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Pyrexia
|
4.0%
2/50 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
12.5%
6/48 • Number of events 6 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
10.0%
5/50 • Number of events 5 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
23.5%
19/81 • Number of events 19 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
5.9%
3/51 • Number of events 3 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
5.8%
3/52 • Number of events 3 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
15.1%
8/53 • Number of events 8 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
7.8%
4/51 • Number of events 4 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
6.1%
5/82 • Number of events 5 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Swelling
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.9%
1/52 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.9%
1/53 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Hepatobiliary disorders
Metabolic dysfunction-associated liver disease
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.1%
1/48 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Immune system disorders
Nutritional supplement allergy
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.2%
1/80 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Bronchitis
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.2%
1/81 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.9%
1/53 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.2%
1/81 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
COVID-19
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/51 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
3.8%
2/53 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/51 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
3.8%
2/53 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Cellulitis
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/51 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Ear infection
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.2%
1/80 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.2%
1/80 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.9%
1/52 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.2%
1/80 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Influenza
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.2%
1/81 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.2%
1/80 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.2%
1/82 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.2%
1/82 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.9%
1/52 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Oral herpes
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.2%
1/82 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/51 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.9%
1/53 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.1%
1/48 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.9%
1/53 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.2%
1/82 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Sinusitis
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.2%
1/81 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.2%
1/80 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.2%
1/80 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Thrombophlebitis septic
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Upper respiratory tract infection
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.0%
2/50 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.9%
1/52 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.2%
1/81 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.2%
1/80 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/51 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.9%
1/53 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.9%
1/53 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.2%
1/80 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.1%
1/48 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/51 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.9%
1/52 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Viral infection
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.2%
1/80 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/51 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Investigations
Influenza A virus test positive
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.2%
1/81 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/51 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/51 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/51 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.2%
1/80 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/51 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.9%
1/53 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.2%
1/81 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.2%
1/80 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.2%
1/82 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.2%
1/82 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Investigations
Influenza B virus test positive
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.2%
1/81 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.2%
1/81 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.1%
1/48 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.9%
1/52 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.1%
1/48 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.9%
1/53 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/51 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/51 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.9%
1/53 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.0%
6/50 • Number of events 6 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
26.0%
13/50 • Number of events 13 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
27.1%
13/48 • Number of events 13 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
22.0%
11/50 • Number of events 11 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
7.7%
4/52 • Number of events 4 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
32.1%
26/81 • Number of events 26 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
7.5%
6/80 • Number of events 6 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
23.5%
12/51 • Number of events 12 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
23.1%
12/52 • Number of events 12 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
30.2%
16/53 • Number of events 16 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
25.5%
13/51 • Number of events 13 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
17.0%
9/53 • Number of events 9 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
20.7%
17/82 • Number of events 17 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
6.2%
5/80 • Number of events 5 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.2%
1/81 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.9%
1/53 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.9%
1/53 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
40.0%
20/50 • Number of events 20 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
54.0%
27/50 • Number of events 27 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
50.0%
24/48 • Number of events 24 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
52.0%
26/50 • Number of events 26 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
26.9%
14/52 • Number of events 14 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
48.1%
39/81 • Number of events 39 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
26.2%
21/80 • Number of events 21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
45.1%
23/51 • Number of events 23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
46.2%
24/52 • Number of events 24 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
49.1%
26/53 • Number of events 26 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
52.9%
27/51 • Number of events 27 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
37.7%
20/53 • Number of events 20 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
37.8%
31/82 • Number of events 31 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
12.5%
10/80 • Number of events 10 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.9%
1/53 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.2%
1/81 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/51 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of thyroid gland
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.2%
1/82 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Nervous system disorders
Aphasia
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/51 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.5%
2/81 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.2%
1/80 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Nervous system disorders
Headache
|
30.0%
15/50 • Number of events 15 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
48.0%
24/50 • Number of events 25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
45.8%
22/48 • Number of events 23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
44.0%
22/50 • Number of events 22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
26.9%
14/52 • Number of events 14 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
40.7%
33/81 • Number of events 33 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
20.0%
16/80 • Number of events 16 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
31.4%
16/51 • Number of events 16 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
21.2%
11/52 • Number of events 11 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
35.8%
19/53 • Number of events 19 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
35.3%
18/51 • Number of events 18 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
24.5%
13/53 • Number of events 14 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
24.4%
20/82 • Number of events 20 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
11.2%
9/80 • Number of events 9 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Nervous system disorders
Migraine
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.2%
1/80 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/51 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Nervous system disorders
Presyncope
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.9%
1/53 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.9%
1/53 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/51 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.9%
1/53 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.2%
1/80 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/51 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Renal and urinary disorders
Renal disorder
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/51 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.2%
1/80 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.5%
2/80 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.9%
1/53 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.4%
2/82 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.2%
1/80 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.9%
1/52 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.2%
1/81 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.2%
1/80 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.4%
2/82 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal odour
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.2%
1/80 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.9%
1/52 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.2%
1/81 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.4%
2/82 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/51 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.2%
1/82 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/51 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.9%
1/52 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.2%
1/80 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.2%
1/81 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/51 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Vascular disorders
Haematoma
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/51 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Vascular disorders
Hot flush
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Vascular disorders
Hypertension
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.9%
1/52 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.0%
1/51 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Vascular disorders
Hypotension
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/50 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/81 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/52 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.9%
1/53 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/80 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
Additional Information
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