Trial Outcomes & Findings for Study of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed in Healthy Subjects (NCT NCT02587520)
NCT ID: NCT02587520
Last Updated: 2022-03-23
Results Overview
A solicited reaction (SR) is an adverse event (AE) that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. An SR is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature \& onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or onset post-vaccination. Solicited injection site reactions: Pain, Erythema, Swelling, Upper limb edema, Extensive limb swelling and solicited systemic reactions: Fever, Headache, Malaise, Myalgia. Number of participants with at least one solicited injection site reactions and systemic reactions were reported.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
1363 participants
Primary outcome timeframe
Within 7 days after vaccination
Results posted on
2022-03-23
Participant Flow
Study participants were enrolled in 20 centers in the Unites States (US) from 22 October 2015 to 15 August 2016.
A total of 1363 participants were randomized in a 1:1:1 ratio to 1 of the 6 formulation study groups. Randomization was stratified by age (adolescents: age 10-18 years, adults: age 19-64 years, and older adults: age greater than equal to \[\>=\] 65 years).
Participant milestones
| Measure |
Adolescents: SP0173 Formulation 1
Healthy participants aged 10-18 years received a single dose of the SP0173 Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed (Tdap) vaccine.
|
Adolescents: SP0173 Formulation 2
Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.
|
Adolescents: SP0173 Formulation 3
Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.
|
Adolescents: SP0173 Formulation 4
Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.
|
Adolescents: Adacel®
Healthy participants aged 10-18 years received Adacel®.
|
Adolescents: Boostrix®
Healthy participants aged 10-18 years received Boostrix®.
|
Adults: SP0173 Formulation 1
Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.
|
Adults: SP0173 Formulation 2
Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.
|
Adults: SP0173 Formulation 3
Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.
|
Adults: SP0173 Formulation 4
Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.
|
Adults: Adacel®
Healthy participants aged 19-64 years received Adacel®.
|
Adults: Boostrix®
Healthy participants aged 19-64 years received Boostrix®.
|
Older Adults: SP0173 Formulation 1
Healthy participants aged \>=65 years received a single dose of the SP0173 Tdap vaccine.
|
Older Adults: SP0173 Formulation 2
Healthy participants aged \>=65 years received a single dose of the SP0173 Tdap vaccine.
|
Older Adults: SP0173 Formulation 3
Healthy subjects aged \>=65 years received a single dose of the SP0173 Tdap vaccine.
|
Older Adults: SP0173 Formulation 4
Healthy subjects aged \>= 65 years received a single dose of the SP0173 Tdap vaccine.
|
Older Adults: Adacel®
Healthy participants aged \>=65 years received Adacel®.
|
Older Adults: Boostrix®
Healthy participants aged \>=65 years received Boostrix®.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
80
|
71
|
78
|
79
|
75
|
75
|
76
|
73
|
76
|
76
|
76
|
73
|
77
|
74
|
78
|
72
|
76
|
78
|
|
Overall Study
Safety Analysis Set (SafAS)
|
79
|
71
|
77
|
77
|
75
|
75
|
76
|
73
|
76
|
76
|
76
|
72
|
77
|
73
|
78
|
72
|
76
|
78
|
|
Overall Study
COMPLETED
|
78
|
69
|
77
|
74
|
75
|
72
|
73
|
71
|
73
|
71
|
73
|
69
|
77
|
73
|
78
|
72
|
76
|
78
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
1
|
5
|
0
|
3
|
3
|
2
|
3
|
5
|
3
|
4
|
0
|
1
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Adolescents: SP0173 Formulation 1
Healthy participants aged 10-18 years received a single dose of the SP0173 Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed (Tdap) vaccine.
|
Adolescents: SP0173 Formulation 2
Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.
|
Adolescents: SP0173 Formulation 3
Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.
|
Adolescents: SP0173 Formulation 4
Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.
|
Adolescents: Adacel®
Healthy participants aged 10-18 years received Adacel®.
|
Adolescents: Boostrix®
Healthy participants aged 10-18 years received Boostrix®.
|
Adults: SP0173 Formulation 1
Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.
|
Adults: SP0173 Formulation 2
Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.
|
Adults: SP0173 Formulation 3
Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.
|
Adults: SP0173 Formulation 4
Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.
|
Adults: Adacel®
Healthy participants aged 19-64 years received Adacel®.
|
Adults: Boostrix®
Healthy participants aged 19-64 years received Boostrix®.
|
Older Adults: SP0173 Formulation 1
Healthy participants aged \>=65 years received a single dose of the SP0173 Tdap vaccine.
|
Older Adults: SP0173 Formulation 2
Healthy participants aged \>=65 years received a single dose of the SP0173 Tdap vaccine.
|
Older Adults: SP0173 Formulation 3
Healthy subjects aged \>=65 years received a single dose of the SP0173 Tdap vaccine.
|
Older Adults: SP0173 Formulation 4
Healthy subjects aged \>= 65 years received a single dose of the SP0173 Tdap vaccine.
|
Older Adults: Adacel®
Healthy participants aged \>=65 years received Adacel®.
|
Older Adults: Boostrix®
Healthy participants aged \>=65 years received Boostrix®.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
2
|
0
|
0
|
2
|
0
|
1
|
1
|
1
|
3
|
3
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
1
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
0
|
2
|
0
|
1
|
1
|
1
|
0
|
2
|
2
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Study of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed in Healthy Subjects
Baseline characteristics by cohort
| Measure |
Adolescents: SP0173 Formulation 1
n=80 Participants
Healthy participants aged 10-18 years received a single dose of the SP0173 Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed (Tdap) vaccine.
|
Adolescents: SP0173 Formulation 2
n=71 Participants
Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.
|
Adolescents: SP0173 Formulation 3
n=78 Participants
Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.
|
Adolescents: SP0173 Formulation 4
n=79 Participants
Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.
|
Adolescents: Adacel®
n=75 Participants
Healthy participants aged 10-18 years received Adacel®.
|
Adolescents: Boostrix®
n=75 Participants
Healthy participants aged 10-18 years received Boostrix®.
|
Adults: SP0173 Formulation 1
n=76 Participants
Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.
|
Adults: SP0173 Formulation 2
n=73 Participants
Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.
|
Adults: SP0173 Formulation 3
n=76 Participants
Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.
|
Adults: SP0173 Formulation 4
n=76 Participants
Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.
|
Adults: Adacel®
n=76 Participants
Healthy participants aged 19-64 years received Adacel®.
|
Adults: Boostrix®
n=73 Participants
Healthy participants aged 19-64 years received Boostrix®.
|
Older Adults: SP0173 Formulation 1
n=77 Participants
Healthy participants aged \>=65 years received a single dose of the SP0173 Tdap vaccine.
|
Older Adults: SP0173 Formulation 2
n=74 Participants
Healthy participants aged \>=65 years received a single dose of the SP0173 Tdap vaccine.
|
Older Adults: SP0173 Formulation 3
n=78 Participants
Healthy subjects aged \>=65 years received a single dose of the SP0173 Tdap vaccine.
|
Older Adults: SP0173 Formulation 4
n=72 Participants
Healthy subjects aged \>= 65 years received a single dose of the SP0173 Tdap vaccine.
|
Older Adults: Adacel®
n=76 Participants
Healthy participants aged \>=65 years received Adacel®.
|
Older Adults: Boostrix®
n=78 Participants
Healthy participants aged \>=65 years received Boostrix®.
|
Total
n=1363 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
3 Participants
n=667 Participants
|
|
Age, Continuous
|
10.8 years
STANDARD_DEVIATION 1.3 • n=5 Participants
|
11.0 years
STANDARD_DEVIATION 1.3 • n=7 Participants
|
11.1 years
STANDARD_DEVIATION 1.6 • n=5 Participants
|
10.8 years
STANDARD_DEVIATION 1.4 • n=4 Participants
|
10.8 years
STANDARD_DEVIATION 1.5 • n=21 Participants
|
11.1 years
STANDARD_DEVIATION 1.6 • n=8 Participants
|
42.5 years
STANDARD_DEVIATION 12.5 • n=8 Participants
|
41.2 years
STANDARD_DEVIATION 12.1 • n=24 Participants
|
40.1 years
STANDARD_DEVIATION 12.8 • n=42 Participants
|
42.1 years
STANDARD_DEVIATION 13.0 • n=42 Participants
|
41.3 years
STANDARD_DEVIATION 12.7 • n=42 Participants
|
42.5 years
STANDARD_DEVIATION 13.2 • n=42 Participants
|
71.3 years
STANDARD_DEVIATION 5.4 • n=36 Participants
|
71.8 years
STANDARD_DEVIATION 5.4 • n=36 Participants
|
70.9 years
STANDARD_DEVIATION 4.8 • n=24 Participants
|
70.8 years
STANDARD_DEVIATION 5.1 • n=135 Participants
|
70.9 years
STANDARD_DEVIATION 5.0 • n=136 Participants
|
71.3 years
STANDARD_DEVIATION 4.8 • n=44 Participants
|
41.2 years
STANDARD_DEVIATION 25.9 • n=667 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
40 Participants
n=8 Participants
|
43 Participants
n=8 Participants
|
46 Participants
n=24 Participants
|
38 Participants
n=42 Participants
|
39 Participants
n=42 Participants
|
44 Participants
n=42 Participants
|
36 Participants
n=42 Participants
|
37 Participants
n=36 Participants
|
38 Participants
n=36 Participants
|
51 Participants
n=24 Participants
|
38 Participants
n=135 Participants
|
46 Participants
n=136 Participants
|
45 Participants
n=44 Participants
|
726 Participants
n=667 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
35 Participants
n=8 Participants
|
33 Participants
n=8 Participants
|
27 Participants
n=24 Participants
|
38 Participants
n=42 Participants
|
37 Participants
n=42 Participants
|
32 Participants
n=42 Participants
|
37 Participants
n=42 Participants
|
40 Participants
n=36 Participants
|
36 Participants
n=36 Participants
|
27 Participants
n=24 Participants
|
34 Participants
n=135 Participants
|
30 Participants
n=136 Participants
|
33 Participants
n=44 Participants
|
637 Participants
n=667 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
17 Participants
n=8 Participants
|
19 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
15 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
11 Participants
n=36 Participants
|
12 Participants
n=36 Participants
|
13 Participants
n=24 Participants
|
15 Participants
n=135 Participants
|
12 Participants
n=136 Participants
|
13 Participants
n=44 Participants
|
179 Participants
n=667 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
23 Participants
n=8 Participants
|
18 Participants
n=24 Participants
|
24 Participants
n=42 Participants
|
18 Participants
n=42 Participants
|
23 Participants
n=42 Participants
|
19 Participants
n=42 Participants
|
7 Participants
n=36 Participants
|
8 Participants
n=36 Participants
|
8 Participants
n=24 Participants
|
5 Participants
n=135 Participants
|
6 Participants
n=136 Participants
|
10 Participants
n=44 Participants
|
203 Participants
n=667 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
76 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
71 Participants
n=21 Participants
|
69 Participants
n=8 Participants
|
59 Participants
n=8 Participants
|
54 Participants
n=24 Participants
|
68 Participants
n=42 Participants
|
65 Participants
n=42 Participants
|
61 Participants
n=42 Participants
|
63 Participants
n=42 Participants
|
64 Participants
n=36 Participants
|
59 Participants
n=36 Participants
|
64 Participants
n=24 Participants
|
55 Participants
n=135 Participants
|
63 Participants
n=136 Participants
|
61 Participants
n=44 Participants
|
1171 Participants
n=667 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
3 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
4 Participants
n=44 Participants
|
13 Participants
n=667 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
8 Participants
n=667 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
16 Participants
n=667 Participants
|
|
Race (NIH/OMB)
White
|
71 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
63 Participants
n=21 Participants
|
65 Participants
n=8 Participants
|
48 Participants
n=8 Participants
|
51 Participants
n=24 Participants
|
46 Participants
n=42 Participants
|
53 Participants
n=42 Participants
|
52 Participants
n=42 Participants
|
51 Participants
n=42 Participants
|
69 Participants
n=36 Participants
|
64 Participants
n=36 Participants
|
70 Participants
n=24 Participants
|
66 Participants
n=135 Participants
|
69 Participants
n=136 Participants
|
68 Participants
n=44 Participants
|
1109 Participants
n=667 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
24 Participants
n=667 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
PRIMARY outcome
Timeframe: Within 7 days after vaccinationPopulation: Safety analysis set that was defined as those participants who had received study vaccine. All participants had their safety analyzed according to the vaccine they actually received. Here, "number analyzed"= number of participants with available data for each specified category.
A solicited reaction (SR) is an adverse event (AE) that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. An SR is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature \& onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or onset post-vaccination. Solicited injection site reactions: Pain, Erythema, Swelling, Upper limb edema, Extensive limb swelling and solicited systemic reactions: Fever, Headache, Malaise, Myalgia. Number of participants with at least one solicited injection site reactions and systemic reactions were reported.
Outcome measures
| Measure |
Adolescents: SP0173 Formulation 1
n=79 Participants
Healthy participants aged 10-18 years received a single dose of the SP0173 Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed (Tdap) vaccine.
|
Adolescents: SP0173 Formulation 2
n=71 Participants
Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.
|
Adolescents: SP0173 Formulation 3
n=77 Participants
Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.
|
Adolescents: SP0173 Formulation 4
n=77 Participants
Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.
|
Adolescents: Adacel®
n=75 Participants
Healthy participants aged 10-18 years received Adacel®.
|
Adolescents: Boostrix®
n=75 Participants
Healthy participants aged 10-18 years received Boostrix®.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years
Injection site erythema
|
9 Participants
|
4 Participants
|
10 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years
Injection site swelling
|
7 Participants
|
4 Participants
|
8 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years
Upper limb edema
|
45 Participants
|
41 Participants
|
49 Participants
|
46 Participants
|
48 Participants
|
33 Participants
|
|
Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years
Extensive limb swelling
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years
Fever
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years
Headache
|
21 Participants
|
14 Participants
|
19 Participants
|
25 Participants
|
20 Participants
|
27 Participants
|
|
Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years
Malaise
|
14 Participants
|
17 Participants
|
14 Participants
|
18 Participants
|
12 Participants
|
17 Participants
|
|
Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years
Myalgia
|
42 Participants
|
35 Participants
|
38 Participants
|
42 Participants
|
52 Participants
|
38 Participants
|
|
Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years
Injection site pain
|
59 Participants
|
51 Participants
|
50 Participants
|
49 Participants
|
59 Participants
|
48 Participants
|
PRIMARY outcome
Timeframe: Within 7 days after vaccinationPopulation: Analysis was performed on safety analysis set. Here, "number analyzed"=number of participants with available data for each specified category.
An SR is an AE that is prelisted in the eCRF and considered to be related to vaccination. An SR is therefore an ADR observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or onset post-vaccination. Solicited injection site reactions: Pain, Erythema, Swelling, Upper limb edema, Extensive limb swelling and systemic reactions: Fever, Headache, Malaise, Myalgia. Number of participants with at least one solicited injection site reactions and systemic reactions were reported.
Outcome measures
| Measure |
Adolescents: SP0173 Formulation 1
n=76 Participants
Healthy participants aged 10-18 years received a single dose of the SP0173 Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed (Tdap) vaccine.
|
Adolescents: SP0173 Formulation 2
n=73 Participants
Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.
|
Adolescents: SP0173 Formulation 3
n=76 Participants
Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.
|
Adolescents: SP0173 Formulation 4
n=76 Participants
Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.
|
Adolescents: Adacel®
n=76 Participants
Healthy participants aged 10-18 years received Adacel®.
|
Adolescents: Boostrix®
n=72 Participants
Healthy participants aged 10-18 years received Boostrix®.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years
Extensive limb swelling
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years
Upper limb edema
|
28 Participants
|
37 Participants
|
41 Participants
|
37 Participants
|
35 Participants
|
31 Participants
|
|
Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years
Injection site pain
|
38 Participants
|
34 Participants
|
49 Participants
|
42 Participants
|
49 Participants
|
35 Participants
|
|
Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years
Injection site erythema
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
5 Participants
|
2 Participants
|
|
Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years
Injection site swelling
|
1 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years
Fever
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years
Headache
|
16 Participants
|
11 Participants
|
19 Participants
|
19 Participants
|
19 Participants
|
19 Participants
|
|
Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years
Malaise
|
18 Participants
|
9 Participants
|
16 Participants
|
19 Participants
|
23 Participants
|
15 Participants
|
|
Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years
Myalgia
|
32 Participants
|
29 Participants
|
35 Participants
|
36 Participants
|
39 Participants
|
28 Participants
|
PRIMARY outcome
Timeframe: Within 7 days after vaccinationPopulation: Analysis was performed on safety analysis set. Here, "number analyzed"=number of participants with available data for each specified category.
An SR is an AE that is prelisted in the eCRF and considered to be related to vaccination. An SR is therefore an ADR observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or onset post-vaccination. Solicited injection site reactions: Pain, Erythema, Swelling, Upper limb edema, Extensive limb swelling and systemic reactions: Fever, Headache, Malaise, Myalgia. Number of participants with at least one solicited injection site reactions and systemic reactions were reported.
Outcome measures
| Measure |
Adolescents: SP0173 Formulation 1
n=77 Participants
Healthy participants aged 10-18 years received a single dose of the SP0173 Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed (Tdap) vaccine.
|
Adolescents: SP0173 Formulation 2
n=73 Participants
Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.
|
Adolescents: SP0173 Formulation 3
n=78 Participants
Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.
|
Adolescents: SP0173 Formulation 4
n=72 Participants
Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.
|
Adolescents: Adacel®
n=76 Participants
Healthy participants aged 10-18 years received Adacel®.
|
Adolescents: Boostrix®
n=78 Participants
Healthy participants aged 10-18 years received Boostrix®.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years
Injection site pain
|
21 Participants
|
34 Participants
|
34 Participants
|
34 Participants
|
28 Participants
|
25 Participants
|
|
Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years
Injection site erythema
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years
Injection site swelling
|
1 Participants
|
6 Participants
|
6 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years
Upper limb edema
|
38 Participants
|
43 Participants
|
36 Participants
|
38 Participants
|
32 Participants
|
40 Participants
|
|
Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years
Extensive limb swelling
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years
Fever
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years
Headache
|
6 Participants
|
10 Participants
|
20 Participants
|
12 Participants
|
11 Participants
|
14 Participants
|
|
Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years
Malaise
|
6 Participants
|
12 Participants
|
14 Participants
|
9 Participants
|
8 Participants
|
6 Participants
|
|
Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years
Myalgia
|
12 Participants
|
21 Participants
|
30 Participants
|
23 Participants
|
23 Participants
|
17 Participants
|
Adverse Events
Adolescents: SP0173 Formulation 1
Serious events: 0 serious events
Other events: 71 other events
Deaths: 0 deaths
Adolescents: SP0173 Formulation 2
Serious events: 0 serious events
Other events: 64 other events
Deaths: 0 deaths
Adolescents: SP0173 Formulation 3
Serious events: 0 serious events
Other events: 67 other events
Deaths: 0 deaths
Adolescents: SP0173 Formulation 4
Serious events: 1 serious events
Other events: 68 other events
Deaths: 0 deaths
Adolescents: Adacel®
Serious events: 0 serious events
Other events: 71 other events
Deaths: 0 deaths
Adolescents: Boostrix®
Serious events: 0 serious events
Other events: 66 other events
Deaths: 0 deaths
Adults: SP0173 Formulation 1
Serious events: 1 serious events
Other events: 52 other events
Deaths: 0 deaths
Adults: SP0173 Formulation 2
Serious events: 1 serious events
Other events: 53 other events
Deaths: 0 deaths
Adults: SP0173 Formulation 3
Serious events: 1 serious events
Other events: 67 other events
Deaths: 0 deaths
Adults: SP0173 Formulation 4
Serious events: 1 serious events
Other events: 54 other events
Deaths: 0 deaths
Adults: Adacel®
Serious events: 0 serious events
Other events: 62 other events
Deaths: 0 deaths
Adults: Boostrix®
Serious events: 2 serious events
Other events: 50 other events
Deaths: 1 deaths
Older Adults: SP0173 Formulation 1
Serious events: 0 serious events
Other events: 53 other events
Deaths: 0 deaths
Older Adults: SP0173 Formulation 2
Serious events: 3 serious events
Other events: 60 other events
Deaths: 0 deaths
Older Adults: SP0173 Formulation 3
Serious events: 4 serious events
Other events: 58 other events
Deaths: 0 deaths
Older Adults: SP0173 Formulation 4
Serious events: 1 serious events
Other events: 53 other events
Deaths: 0 deaths
Older Adults: Adacel®
Serious events: 2 serious events
Other events: 49 other events
Deaths: 0 deaths
Older Adults: Boostrix®
Serious events: 2 serious events
Other events: 56 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adolescents: SP0173 Formulation 1
n=79 participants at risk
Healthy participants aged 10-18 years received a single dose of the SP0173 Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed (Tdap) vaccine.
|
Adolescents: SP0173 Formulation 2
n=71 participants at risk
Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.
|
Adolescents: SP0173 Formulation 3
n=77 participants at risk
Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.
|
Adolescents: SP0173 Formulation 4
n=77 participants at risk
Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.
|
Adolescents: Adacel®
n=75 participants at risk
Healthy participants aged 10-18 years received Adacel®.
|
Adolescents: Boostrix®
n=75 participants at risk
Healthy participants aged 10-18 years received Boostrix®.
|
Adults: SP0173 Formulation 1
n=76 participants at risk
Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.
|
Adults: SP0173 Formulation 2
n=73 participants at risk
Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.
|
Adults: SP0173 Formulation 3
n=76 participants at risk
Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.
|
Adults: SP0173 Formulation 4
n=76 participants at risk
Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.
|
Adults: Adacel®
n=76 participants at risk
Healthy participants aged 19-64 years received Adacel®.
|
Adults: Boostrix®
n=72 participants at risk
Healthy participants aged 19-64 years received Boostrix®.
|
Older Adults: SP0173 Formulation 1
n=77 participants at risk
Healthy participants aged \>= 65 years received a single dose of the SP0173 Tdap vaccine.
|
Older Adults: SP0173 Formulation 2
n=73 participants at risk
Healthy participants aged \>= 65 years received a single dose of the SP0173 Tdap vaccine.
|
Older Adults: SP0173 Formulation 3
n=78 participants at risk
Healthy participants aged \>= 65 years received a single dose of the SP0173 Tdap vaccine.
|
Older Adults: SP0173 Formulation 4
n=72 participants at risk
Healthy participants aged \>= 65 years received a single dose of the SP0173 Tdap vaccine.
|
Older Adults: Adacel®
n=76 participants at risk
Healthy participants aged \>= 65 years received Adacel®.
|
Older Adults: Boostrix®
n=78 participants at risk
Healthy participants aged \>= 65 years received Boostrix®.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Drug Withdrawal Syndrome
|
0.00%
0/79 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/71 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/75 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/75 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/73 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/72 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/73 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/78 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/72 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
1.3%
1/78 • Number of events 1 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/79 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/71 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/75 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/75 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/73 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/72 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/73 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
1.3%
1/78 • Number of events 1 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/72 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/78 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.00%
0/79 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/71 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/75 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/75 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/73 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/72 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/73 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/78 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/72 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
1.3%
1/76 • Number of events 1 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/78 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/79 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/71 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/75 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/75 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/73 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/72 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
1.4%
1/73 • Number of events 1 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/78 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/72 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/78 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
|
Cardiac disorders
Ventricular Fibrillation
|
0.00%
0/79 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/71 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/75 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/75 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/73 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
1.4%
1/72 • Number of events 1 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/73 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/78 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/72 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/78 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
|
General disorders
Device Dislocation
|
0.00%
0/79 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/71 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/75 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/75 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/73 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/72 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/73 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
1.3%
1/78 • Number of events 1 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/72 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/78 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
|
Immune system disorders
Drug Hypersensitivity
|
0.00%
0/79 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/71 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/75 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/75 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/73 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/72 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/73 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
1.3%
1/78 • Number of events 1 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/72 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/78 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
|
Nervous system disorders
Embolic Cerebral Infarction
|
0.00%
0/79 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/71 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/75 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/75 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/73 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/72 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/73 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/78 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/72 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
1.3%
1/76 • Number of events 1 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/78 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
|
Infections and infestations
Appendicitis Perforated
|
0.00%
0/79 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/71 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/75 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/75 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/73 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
1.3%
1/76 • Number of events 1 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/72 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/73 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/78 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/72 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/78 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/79 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/71 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/75 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/75 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/73 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
1.3%
1/76 • Number of events 1 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/72 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/73 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/78 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/72 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/78 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
0.00%
0/79 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/71 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/75 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/75 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/73 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/72 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
1.4%
1/73 • Number of events 1 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/78 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/72 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/78 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/79 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/71 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
1.3%
1/77 • Number of events 1 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/75 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/75 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/73 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/72 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/73 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/78 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/72 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/78 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer Recurrent
|
0.00%
0/79 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/71 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/75 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/75 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/73 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/72 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/73 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/78 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/72 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
1.3%
1/78 • Number of events 1 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/79 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/71 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/75 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/75 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/73 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/72 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/73 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/78 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
1.4%
1/72 • Number of events 1 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/78 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
|
Psychiatric disorders
Post-Traumatic Stress Disorder
|
0.00%
0/79 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/71 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/75 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/75 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/73 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
1.4%
1/72 • Number of events 1 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/73 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/78 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/72 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/78 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/79 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/71 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/75 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/75 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/73 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/72 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/73 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
1.3%
1/78 • Number of events 1 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/72 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/78 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/79 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/71 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/75 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/75 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
1.4%
1/73 • Number of events 1 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/72 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/73 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/78 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/72 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/78 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/79 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/71 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/75 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/75 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
1.3%
1/76 • Number of events 1 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/73 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/72 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/73 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/78 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/72 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/78 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
|
Vascular disorders
Aortic Stenosis
|
0.00%
0/79 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/71 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/75 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/75 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/73 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/72 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
1.4%
1/73 • Number of events 1 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/78 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/72 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/78 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
Other adverse events
| Measure |
Adolescents: SP0173 Formulation 1
n=79 participants at risk
Healthy participants aged 10-18 years received a single dose of the SP0173 Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed (Tdap) vaccine.
|
Adolescents: SP0173 Formulation 2
n=71 participants at risk
Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.
|
Adolescents: SP0173 Formulation 3
n=77 participants at risk
Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.
|
Adolescents: SP0173 Formulation 4
n=77 participants at risk
Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.
|
Adolescents: Adacel®
n=75 participants at risk
Healthy participants aged 10-18 years received Adacel®.
|
Adolescents: Boostrix®
n=75 participants at risk
Healthy participants aged 10-18 years received Boostrix®.
|
Adults: SP0173 Formulation 1
n=76 participants at risk
Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.
|
Adults: SP0173 Formulation 2
n=73 participants at risk
Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.
|
Adults: SP0173 Formulation 3
n=76 participants at risk
Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.
|
Adults: SP0173 Formulation 4
n=76 participants at risk
Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.
|
Adults: Adacel®
n=76 participants at risk
Healthy participants aged 19-64 years received Adacel®.
|
Adults: Boostrix®
n=72 participants at risk
Healthy participants aged 19-64 years received Boostrix®.
|
Older Adults: SP0173 Formulation 1
n=77 participants at risk
Healthy participants aged \>= 65 years received a single dose of the SP0173 Tdap vaccine.
|
Older Adults: SP0173 Formulation 2
n=73 participants at risk
Healthy participants aged \>= 65 years received a single dose of the SP0173 Tdap vaccine.
|
Older Adults: SP0173 Formulation 3
n=78 participants at risk
Healthy participants aged \>= 65 years received a single dose of the SP0173 Tdap vaccine.
|
Older Adults: SP0173 Formulation 4
n=72 participants at risk
Healthy participants aged \>= 65 years received a single dose of the SP0173 Tdap vaccine.
|
Older Adults: Adacel®
n=76 participants at risk
Healthy participants aged \>= 65 years received Adacel®.
|
Older Adults: Boostrix®
n=78 participants at risk
Healthy participants aged \>= 65 years received Boostrix®.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
3.8%
3/79 • Number of events 3 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
4.2%
3/71 • Number of events 3 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
5.2%
4/77 • Number of events 4 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
1.3%
1/77 • Number of events 1 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
4.0%
3/75 • Number of events 3 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
1.3%
1/75 • Number of events 1 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/73 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/72 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/73 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/78 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/72 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/78 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
|
General disorders
Change In Limb Circumference
|
57.0%
45/79 • Number of events 45 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
57.7%
41/71 • Number of events 41 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
63.6%
49/77 • Number of events 49 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
59.7%
46/77 • Number of events 46 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
64.0%
48/75 • Number of events 48 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
44.0%
33/75 • Number of events 33 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
36.8%
28/76 • Number of events 28 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
50.7%
37/73 • Number of events 37 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
53.9%
41/76 • Number of events 41 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
48.7%
37/76 • Number of events 37 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
46.1%
35/76 • Number of events 35 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
43.1%
31/72 • Number of events 31 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
49.4%
38/77 • Number of events 38 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
58.9%
43/73 • Number of events 43 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
46.2%
36/78 • Number of events 36 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
52.8%
38/72 • Number of events 38 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
42.1%
32/76 • Number of events 32 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
51.3%
40/78 • Number of events 40 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
|
General disorders
Injection Site Erythema
|
11.4%
9/79 • Number of events 9 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
5.6%
4/71 • Number of events 4 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
13.0%
10/77 • Number of events 10 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
1.3%
1/77 • Number of events 1 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
5.3%
4/75 • Number of events 4 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
2.7%
2/75 • Number of events 2 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
2.6%
2/76 • Number of events 2 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
1.4%
1/73 • Number of events 1 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
2.6%
2/76 • Number of events 2 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
6.6%
5/76 • Number of events 5 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
2.8%
2/72 • Number of events 2 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
1.4%
1/73 • Number of events 1 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
2.6%
2/78 • Number of events 2 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
2.8%
2/72 • Number of events 2 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
3.9%
3/76 • Number of events 3 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
1.3%
1/78 • Number of events 1 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
|
General disorders
Injection Site Pain
|
74.7%
59/79 • Number of events 59 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
71.8%
51/71 • Number of events 51 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
64.9%
50/77 • Number of events 50 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
63.6%
49/77 • Number of events 49 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
78.7%
59/75 • Number of events 59 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
64.0%
48/75 • Number of events 48 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
50.0%
38/76 • Number of events 38 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
46.6%
34/73 • Number of events 34 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
64.5%
49/76 • Number of events 49 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
55.3%
42/76 • Number of events 42 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
64.5%
49/76 • Number of events 49 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
48.6%
35/72 • Number of events 35 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
28.6%
22/77 • Number of events 22 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
46.6%
34/73 • Number of events 34 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
43.6%
34/78 • Number of events 34 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
47.2%
34/72 • Number of events 34 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
36.8%
28/76 • Number of events 28 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
32.1%
25/78 • Number of events 25 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
|
General disorders
Injection Site Swelling
|
8.9%
7/79 • Number of events 7 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
5.6%
4/71 • Number of events 4 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
10.4%
8/77 • Number of events 8 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
1.3%
1/75 • Number of events 1 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
5.3%
4/75 • Number of events 4 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
1.3%
1/76 • Number of events 1 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
4.1%
3/73 • Number of events 3 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
5.3%
4/76 • Number of events 4 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
1.3%
1/76 • Number of events 1 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
3.9%
3/76 • Number of events 3 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
1.4%
1/72 • Number of events 1 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
1.3%
1/77 • Number of events 1 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
8.2%
6/73 • Number of events 6 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
7.7%
6/78 • Number of events 6 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
2.8%
2/72 • Number of events 2 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
1.3%
1/76 • Number of events 1 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
2.6%
2/78 • Number of events 2 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
|
General disorders
Malaise
|
17.7%
14/79 • Number of events 14 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
23.9%
17/71 • Number of events 17 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
18.2%
14/77 • Number of events 14 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
23.4%
18/77 • Number of events 18 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
16.0%
12/75 • Number of events 12 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
22.7%
17/75 • Number of events 17 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
23.7%
18/76 • Number of events 18 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
12.3%
9/73 • Number of events 9 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
21.1%
16/76 • Number of events 16 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
25.0%
19/76 • Number of events 19 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
30.3%
23/76 • Number of events 23 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
20.8%
15/72 • Number of events 15 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
7.8%
6/77 • Number of events 6 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
16.4%
12/73 • Number of events 12 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
17.9%
14/78 • Number of events 14 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
12.5%
9/72 • Number of events 9 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
10.5%
8/76 • Number of events 8 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
7.7%
6/78 • Number of events 6 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
|
Infections and infestations
Pharyngitis
|
3.8%
3/79 • Number of events 3 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
9.9%
7/71 • Number of events 10 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
3.9%
3/77 • Number of events 3 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
6.5%
5/77 • Number of events 5 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
4.0%
3/75 • Number of events 5 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
2.7%
2/75 • Number of events 2 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/73 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/72 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/73 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/78 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/72 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/78 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
|
Infections and infestations
Pharyngitis Streptococcal
|
6.3%
5/79 • Number of events 5 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
5.6%
4/71 • Number of events 4 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
6.5%
5/77 • Number of events 7 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
6.5%
5/77 • Number of events 5 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
2.7%
2/75 • Number of events 2 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
5.3%
4/75 • Number of events 5 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
1.4%
1/73 • Number of events 1 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
1.3%
1/76 • Number of events 1 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
1.3%
1/76 • Number of events 1 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/72 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/73 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/78 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/72 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/78 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
|
Infections and infestations
Viral Pharyngitis
|
3.8%
3/79 • Number of events 3 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
5.6%
4/71 • Number of events 4 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
2.6%
2/77 • Number of events 3 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
2.6%
2/77 • Number of events 2 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/75 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
1.3%
1/75 • Number of events 1 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/73 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/72 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/73 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/78 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/72 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/78 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
53.2%
42/79 • Number of events 42 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
49.3%
35/71 • Number of events 35 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
49.4%
38/77 • Number of events 38 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
54.5%
42/77 • Number of events 42 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
69.3%
52/75 • Number of events 52 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
50.7%
38/75 • Number of events 38 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
42.1%
32/76 • Number of events 32 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
39.7%
29/73 • Number of events 29 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
46.1%
35/76 • Number of events 35 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
47.4%
36/76 • Number of events 36 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
51.3%
39/76 • Number of events 39 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
38.9%
28/72 • Number of events 28 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
15.6%
12/77 • Number of events 12 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
28.8%
21/73 • Number of events 21 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
39.7%
31/78 • Number of events 31 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
31.9%
23/72 • Number of events 23 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
30.3%
23/76 • Number of events 23 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
23.1%
18/78 • Number of events 18 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
|
Nervous system disorders
Headache
|
29.1%
23/79 • Number of events 25 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
21.1%
15/71 • Number of events 15 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
24.7%
19/77 • Number of events 21 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
32.5%
25/77 • Number of events 26 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
29.3%
22/75 • Number of events 22 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
38.7%
29/75 • Number of events 30 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
21.1%
16/76 • Number of events 16 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
15.1%
11/73 • Number of events 11 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
25.0%
19/76 • Number of events 19 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
25.0%
19/76 • Number of events 19 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
25.0%
19/76 • Number of events 19 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
26.4%
19/72 • Number of events 21 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
7.8%
6/77 • Number of events 6 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
13.7%
10/73 • Number of events 10 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
25.6%
20/78 • Number of events 20 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
16.7%
12/72 • Number of events 12 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
14.5%
11/76 • Number of events 11 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
17.9%
14/78 • Number of events 15 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.3%
1/79 • Number of events 1 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
5.6%
4/71 • Number of events 4 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
5.2%
4/77 • Number of events 4 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
3.9%
3/77 • Number of events 3 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
2.7%
2/75 • Number of events 3 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/75 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
1.4%
1/73 • Number of events 1 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
2.6%
2/76 • Number of events 2 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
1.3%
1/76 • Number of events 1 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
2.6%
2/76 • Number of events 2 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
1.4%
1/72 • Number of events 1 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/73 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
2.6%
2/78 • Number of events 2 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
1.4%
1/72 • Number of events 1 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
2.6%
2/78 • Number of events 2 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
2.5%
2/79 • Number of events 2 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
7.0%
5/71 • Number of events 5 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
2.6%
2/77 • Number of events 2 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
2.6%
2/77 • Number of events 2 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
5.3%
4/75 • Number of events 5 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/75 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
1.3%
1/76 • Number of events 1 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
2.7%
2/73 • Number of events 2 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
5.3%
4/76 • Number of events 5 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
1.3%
1/76 • Number of events 1 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
2.8%
2/72 • Number of events 2 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/77 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/73 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
1.3%
1/78 • Number of events 1 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/72 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/76 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
0.00%
0/78 • Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
|
Additional Information
Results disclosure agreements
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Restriction type: OTHER