Trial Outcomes & Findings for A Study on the Safety, Reactogenicity and Immune Response of a Vaccine Against Influenza in Healthy Younger and Older Adults (NCT NCT05446740)
NCT ID: NCT05446740
Last Updated: 2026-03-10
Results Overview
Assessed solicited administration site events included pain, erythema/redness, swelling and Lymphadenopathy (defined as localized axillary, cervical or supraclavicular swelling or tenderness ipsilateral to the injection arm). Any = occurrence of the event regardless of intensity grade.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
324 participants
Primary outcome timeframe
Day 1 to Day 7
Results posted on
2026-03-10
Participant Flow
As described in the protocol and analysis plan, all participants receiving either FDQ21A-NH or FDQ22A-NH are analyzed together as a pooled group throughout the study.
Participant milestones
| Measure |
Flu mRNA_Dose Level 7_YA
On Day 1, YA participants received Flu mRNA at Dose Level 7, which corresponds to a higher concentration than Dose Level 6.
|
Flu mRNA_ Dose Level 8_YA
On Day 1, YA participants received Flu mRNA at Dose Level 8, which corresponds to a higher concentration than Dose Level 7.
|
Flu mRNA_Dose Level 9_YA
On Day 1, YA participants received Flu mRNA at Dose Level 9, which corresponds to a higher concentration than Dose Level 8.
|
Flu mRNA_Dose Level 10_YA
On Day 1, YA participants received Flu mRNA at Dose Level 10, the highest concentration evaluated in the study.
|
Flu mRNA_Dose Level 5_YA
On Day 1, YA participants received Flu mRNA at Dose Level 5, which corresponds to a higher concentration than Dose Level 4.
|
Flu mRNA_Dose Level 6_YA
On Day 1, YA participants received Flu mRNA at Dose Level 6, which corresponds to a higher concentration than Dose Level 5.
|
Flu mRNA_Dose Level 1_Younger Adults (YA)
On Day 1, YA adult participants received Flu mRNA at Dose Level 1, the lowest concentration evaluated in the study.
|
Flu mRNA_Dose Level 2 _YA
On Day 1, YA participants received Flu mRNA at Dose Level 2, which corresponds to a higher concentration than Dose Level 1.
|
Flu mRNA_Dose Level 3_YA
On Day 1, YA participants received Flu mRNA at Dose Level 3, which corresponds to a higher concentration than Dose Level 2.
|
Flu mRNA_Dose Level 4_YA
On Day 1, YA participants received Flu mRNA at Dose Level 4, which corresponds to a higher concentration than Dose Level 3.
|
Pooled Control_YA
On Day 1, YA participants received a single dose of FDQ21A - NH or FDQ22A -NH administered as a control and were analyzed together as pooled group throughout the study.
|
Flu mRNA_Dose Level 7_Older Adults (OA)
On Day 1, OA participants received Flu mRNA at Dose Level 7.
|
Control_OA
On Day 1, OA participants received a single dose of FDQ21A-NH administered at as a control.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
24
|
24
|
25
|
24
|
24
|
24
|
24
|
24
|
24
|
24
|
35
|
32
|
16
|
|
Overall Study
COMPLETED
|
22
|
24
|
25
|
23
|
24
|
24
|
24
|
24
|
24
|
24
|
35
|
32
|
16
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Flu mRNA_Dose Level 7_YA
On Day 1, YA participants received Flu mRNA at Dose Level 7, which corresponds to a higher concentration than Dose Level 6.
|
Flu mRNA_ Dose Level 8_YA
On Day 1, YA participants received Flu mRNA at Dose Level 8, which corresponds to a higher concentration than Dose Level 7.
|
Flu mRNA_Dose Level 9_YA
On Day 1, YA participants received Flu mRNA at Dose Level 9, which corresponds to a higher concentration than Dose Level 8.
|
Flu mRNA_Dose Level 10_YA
On Day 1, YA participants received Flu mRNA at Dose Level 10, the highest concentration evaluated in the study.
|
Flu mRNA_Dose Level 5_YA
On Day 1, YA participants received Flu mRNA at Dose Level 5, which corresponds to a higher concentration than Dose Level 4.
|
Flu mRNA_Dose Level 6_YA
On Day 1, YA participants received Flu mRNA at Dose Level 6, which corresponds to a higher concentration than Dose Level 5.
|
Flu mRNA_Dose Level 1_Younger Adults (YA)
On Day 1, YA adult participants received Flu mRNA at Dose Level 1, the lowest concentration evaluated in the study.
|
Flu mRNA_Dose Level 2 _YA
On Day 1, YA participants received Flu mRNA at Dose Level 2, which corresponds to a higher concentration than Dose Level 1.
|
Flu mRNA_Dose Level 3_YA
On Day 1, YA participants received Flu mRNA at Dose Level 3, which corresponds to a higher concentration than Dose Level 2.
|
Flu mRNA_Dose Level 4_YA
On Day 1, YA participants received Flu mRNA at Dose Level 4, which corresponds to a higher concentration than Dose Level 3.
|
Pooled Control_YA
On Day 1, YA participants received a single dose of FDQ21A - NH or FDQ22A -NH administered as a control and were analyzed together as pooled group throughout the study.
|
Flu mRNA_Dose Level 7_Older Adults (OA)
On Day 1, OA participants received Flu mRNA at Dose Level 7.
|
Control_OA
On Day 1, OA participants received a single dose of FDQ21A-NH administered at as a control.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
The Age Continuous analysis is presented separately for YA and OA.
Baseline characteristics by cohort
| Measure |
Flu mRNA_Dose Level 1_Younger Adults (YA)
n=24 Participants
On Day 1, YA adult participants received Flu mRNA at Dose Level 1, the lowest concentration evaluated in the study.
|
Flu mRNA_Dose Level 2 _YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 2, which corresponds to a higher concentration than Dose Level 1.
|
Flu mRNA_Dose Level 3_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 3, which corresponds to a higher concentration than Dose Level 2.
|
Flu mRNA_Dose Level 4_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 4, which corresponds to a higher concentration than Dose Level 3.
|
Flu mRNA_Dose Level 5_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 5, which corresponds to a higher concentration than Dose Level 4.
|
Flu mRNA_Dose Level 6_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 6, which corresponds to a higher concentration than Dose Level 5.
|
Flu mRNA_Dose Level 7_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 7, which corresponds to a higher concentration than Dose Level 6.
|
Flu mRNA_ Dose Level 8_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 8, which corresponds to a higher concentration than Dose Level 7.
|
Flu mRNA_Dose Level 9_YA
n=25 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 9, which corresponds to a higher concentration than Dose Level 8.
|
Flu mRNA_Dose Level 10_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 10, the highest concentration evaluated in the study.
|
Pooled Control_YA
n=35 Participants
On Day 1, YA participants received a single dose of FDQ21A - NH or FDQ22A -NH administered as a control and were analyzed together as pooled group throughout the study.
|
Flu mRNA_Dose Level 7_Older Adults (OA)
n=32 Participants
On Day 1, OA participants received Flu mRNA at Dose Level 7.
|
Control_OA
n=16 Participants
On Day 1, OA participants received a single dose of FDQ21A-NH administered at as a control.
|
Total
n=324 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
YA
|
30.2 Years
STANDARD_DEVIATION 8.5 • n=24 Participants • The Age Continuous analysis is presented separately for YA and OA.
|
32.5 Years
STANDARD_DEVIATION 7.6 • n=24 Participants • The Age Continuous analysis is presented separately for YA and OA.
|
34.6 Years
STANDARD_DEVIATION 7.3 • n=24 Participants • The Age Continuous analysis is presented separately for YA and OA.
|
35.7 Years
STANDARD_DEVIATION 7.8 • n=24 Participants • The Age Continuous analysis is presented separately for YA and OA.
|
30.5 Years
STANDARD_DEVIATION 9.5 • n=24 Participants • The Age Continuous analysis is presented separately for YA and OA.
|
30.7 Years
STANDARD_DEVIATION 8.1 • n=24 Participants • The Age Continuous analysis is presented separately for YA and OA.
|
29.8 Years
STANDARD_DEVIATION 7.6 • n=24 Participants • The Age Continuous analysis is presented separately for YA and OA.
|
35.8 Years
STANDARD_DEVIATION 7.1 • n=24 Participants • The Age Continuous analysis is presented separately for YA and OA.
|
27.8 Years
STANDARD_DEVIATION 5.7 • n=25 Participants • The Age Continuous analysis is presented separately for YA and OA.
|
29.1 Years
STANDARD_DEVIATION 5.8 • n=24 Participants • The Age Continuous analysis is presented separately for YA and OA.
|
32.0 Years
STANDARD_DEVIATION 7.8 • n=35 Participants • The Age Continuous analysis is presented separately for YA and OA.
|
—
|
—
|
31.7 Years
STANDARD_DEVIATION 7.9 • n=276 Participants • The Age Continuous analysis is presented separately for YA and OA.
|
|
Age, Continuous
OA
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
66.8 Years
STANDARD_DEVIATION 4.1 • n=32 Participants • The Age Continuous analysis is presented separately for YA and OA.
|
67.9 Years
STANDARD_DEVIATION 4.6 • n=16 Participants • The Age Continuous analysis is presented separately for YA and OA.
|
67.2 Years
STANDARD_DEVIATION 4.3 • n=48 Participants • The Age Continuous analysis is presented separately for YA and OA.
|
|
Sex: Female, Male
Female
|
17 Participants
n=24 Participants
|
16 Participants
n=24 Participants
|
11 Participants
n=24 Participants
|
15 Participants
n=24 Participants
|
15 Participants
n=24 Participants
|
11 Participants
n=24 Participants
|
15 Participants
n=24 Participants
|
14 Participants
n=24 Participants
|
20 Participants
n=25 Participants
|
11 Participants
n=24 Participants
|
22 Participants
n=35 Participants
|
20 Participants
n=32 Participants
|
5 Participants
n=16 Participants
|
192 Participants
n=324 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=24 Participants
|
8 Participants
n=24 Participants
|
13 Participants
n=24 Participants
|
9 Participants
n=24 Participants
|
9 Participants
n=24 Participants
|
13 Participants
n=24 Participants
|
9 Participants
n=24 Participants
|
10 Participants
n=24 Participants
|
5 Participants
n=25 Participants
|
13 Participants
n=24 Participants
|
13 Participants
n=35 Participants
|
12 Participants
n=32 Participants
|
11 Participants
n=16 Participants
|
132 Participants
n=324 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=16 Participants
|
3 Participants
n=324 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=25 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=16 Participants
|
1 Participants
n=324 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=25 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=32 Participants
|
1 Participants
n=16 Participants
|
4 Participants
n=324 Participants
|
|
Race/Ethnicity, Customized
White
|
24 Participants
n=24 Participants
|
24 Participants
n=24 Participants
|
23 Participants
n=24 Participants
|
24 Participants
n=24 Participants
|
24 Participants
n=24 Participants
|
22 Participants
n=24 Participants
|
24 Participants
n=24 Participants
|
24 Participants
n=24 Participants
|
21 Participants
n=25 Participants
|
24 Participants
n=24 Participants
|
35 Participants
n=35 Participants
|
32 Participants
n=32 Participants
|
15 Participants
n=16 Participants
|
316 Participants
n=324 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 7Population: The analysis was performed on the Exposed Set (ES), which included all participants who received a study intervention and for whom solicited administration site events data were available for the specified duration.
Assessed solicited administration site events included pain, erythema/redness, swelling and Lymphadenopathy (defined as localized axillary, cervical or supraclavicular swelling or tenderness ipsilateral to the injection arm). Any = occurrence of the event regardless of intensity grade.
Outcome measures
| Measure |
Flu mRNA_Dose Level 6_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 6, which corresponds to a higher concentration than Dose Level 5.
|
Flu mRNA_Dose Level 7_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 7, which corresponds to a higher concentration than Dose Level 6.
|
Flu mRNA_ Dose Level 8_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 8, which corresponds to a higher concentration than Dose Level 7.
|
Flu mRNA_Dose Level 9_YA
n=25 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 9, which corresponds to a higher concentration than Dose Level 8.
|
Flu mRNA_Dose Level 10_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 10, the highest concentration evaluated in the study.
|
Flu mRNA_Dose Level 5_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 5, which corresponds to a higher concentration than Dose Level 4.
|
Flu mRNA_Dose Level 1_Younger Adults (YA)
n=24 Participants
On Day 1, YA adult participants received Flu mRNA at Dose Level 1, the lowest concentration evaluated in the study.
|
Flu mRNA_Dose Level 2 _YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 2, which corresponds to a higher concentration than Dose Level 1.
|
Flu mRNA_Dose Level 3_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 3, which corresponds to a higher concentration than Dose Level 2
|
Flu mRNA_Dose Level 4_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 4, which corresponds to a higher concentration than Dose Level 3.
|
Pooled Control_YA
n=35 Participants
On Day 1, YA participants received a single dose of FDQ21A - NH or FDQ22A -NH administered as a control and were analyzed together as pooled group throughout the study.
|
Flu mRNA_Dose Level 7_Older Adults (OA)
n=32 Participants
On Day 1, OA participants received Flu mRNA at Dose Level 7.
|
Control_OA
n=16 Participants
On Day 1, OA participants received a single dose of FDQ21A-NH administered at as a control.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Any Solicited Administration Site Events
Erythema
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events
Pain
|
19 Participants
|
21 Participants
|
21 Participants
|
25 Participants
|
24 Participants
|
16 Participants
|
5 Participants
|
6 Participants
|
8 Participants
|
14 Participants
|
25 Participants
|
14 Participants
|
7 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events
Swelling
|
0 Participants
|
0 Participants
|
2 Participants
|
5 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events
Lymphadenopathy
|
4 Participants
|
7 Participants
|
9 Participants
|
9 Participants
|
12 Participants
|
5 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
9 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 7Population: The analysis was performed on the ES, which included all participants who received a study intervention and for whom solicited systemic events data were available for the specified duration.
Assessed solicited systemic events included fever, chills, headache, myalgia, arthralgia and fatigue. Any = occurrence of the symptom regardless of intensity grade.
Outcome measures
| Measure |
Flu mRNA_Dose Level 6_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 6, which corresponds to a higher concentration than Dose Level 5.
|
Flu mRNA_Dose Level 7_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 7, which corresponds to a higher concentration than Dose Level 6.
|
Flu mRNA_ Dose Level 8_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 8, which corresponds to a higher concentration than Dose Level 7.
|
Flu mRNA_Dose Level 9_YA
n=25 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 9, which corresponds to a higher concentration than Dose Level 8.
|
Flu mRNA_Dose Level 10_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 10, the highest concentration evaluated in the study.
|
Flu mRNA_Dose Level 5_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 5, which corresponds to a higher concentration than Dose Level 4.
|
Flu mRNA_Dose Level 1_Younger Adults (YA)
n=24 Participants
On Day 1, YA adult participants received Flu mRNA at Dose Level 1, the lowest concentration evaluated in the study.
|
Flu mRNA_Dose Level 2 _YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 2, which corresponds to a higher concentration than Dose Level 1.
|
Flu mRNA_Dose Level 3_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 3, which corresponds to a higher concentration than Dose Level 2
|
Flu mRNA_Dose Level 4_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 4, which corresponds to a higher concentration than Dose Level 3.
|
Pooled Control_YA
n=35 Participants
On Day 1, YA participants received a single dose of FDQ21A - NH or FDQ22A -NH administered as a control and were analyzed together as pooled group throughout the study.
|
Flu mRNA_Dose Level 7_Older Adults (OA)
n=32 Participants
On Day 1, OA participants received Flu mRNA at Dose Level 7.
|
Control_OA
n=16 Participants
On Day 1, OA participants received a single dose of FDQ21A-NH administered at as a control.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Any Solicited Systemic Events
Chills
|
4 Participants
|
9 Participants
|
4 Participants
|
14 Participants
|
10 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events
Fatigue
|
11 Participants
|
16 Participants
|
15 Participants
|
22 Participants
|
22 Participants
|
12 Participants
|
8 Participants
|
8 Participants
|
12 Participants
|
9 Participants
|
19 Participants
|
6 Participants
|
2 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events
Headache
|
9 Participants
|
14 Participants
|
12 Participants
|
19 Participants
|
19 Participants
|
7 Participants
|
11 Participants
|
6 Participants
|
4 Participants
|
9 Participants
|
13 Participants
|
12 Participants
|
4 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events
Myalgia
|
5 Participants
|
15 Participants
|
13 Participants
|
20 Participants
|
20 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
5 Participants
|
13 Participants
|
5 Participants
|
1 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events
Fever
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
8 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events
Arthralgia
|
3 Participants
|
4 Participants
|
7 Participants
|
6 Participants
|
15 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 28Population: The analysis was performed on the ES, which included all participants who received a study intervention and for whom unsolicited AEs data were available for the specified duration.
An unsolicited AEs is an AEs that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow up for solicited events. Unsolicited AEs must have been communicated by a participant who has signed the informed consent or through his/her caregiver. Unsolicited AEs include both serious and non-serious AEs. Any = occurrence of the symptom regardless of intensity grade or relation to study vaccination.
Outcome measures
| Measure |
Flu mRNA_Dose Level 6_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 6, which corresponds to a higher concentration than Dose Level 5.
|
Flu mRNA_Dose Level 7_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 7, which corresponds to a higher concentration than Dose Level 6.
|
Flu mRNA_ Dose Level 8_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 8, which corresponds to a higher concentration than Dose Level 7.
|
Flu mRNA_Dose Level 9_YA
n=25 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 9, which corresponds to a higher concentration than Dose Level 8.
|
Flu mRNA_Dose Level 10_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 10, the highest concentration evaluated in the study.
|
Flu mRNA_Dose Level 5_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 5, which corresponds to a higher concentration than Dose Level 4.
|
Flu mRNA_Dose Level 1_Younger Adults (YA)
n=24 Participants
On Day 1, YA adult participants received Flu mRNA at Dose Level 1, the lowest concentration evaluated in the study.
|
Flu mRNA_Dose Level 2 _YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 2, which corresponds to a higher concentration than Dose Level 1.
|
Flu mRNA_Dose Level 3_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 3, which corresponds to a higher concentration than Dose Level 2
|
Flu mRNA_Dose Level 4_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 4, which corresponds to a higher concentration than Dose Level 3.
|
Pooled Control_YA
n=35 Participants
On Day 1, YA participants received a single dose of FDQ21A - NH or FDQ22A -NH administered as a control and were analyzed together as pooled group throughout the study.
|
Flu mRNA_Dose Level 7_Older Adults (OA)
n=32 Participants
On Day 1, OA participants received Flu mRNA at Dose Level 7.
|
Control_OA
n=16 Participants
On Day 1, OA participants received a single dose of FDQ21A-NH administered at as a control.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Any Unsolicited Adverse Events (AEs)
|
16 Participants
|
12 Participants
|
16 Participants
|
15 Participants
|
13 Participants
|
13 Participants
|
13 Participants
|
13 Participants
|
14 Participants
|
17 Participants
|
24 Participants
|
14 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 183Population: The analysis was performed on the ES, which included all participants who received a study intervention and for whom data were available for the specified duration.
An SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant, or resulted in abnormal pregnancy outcomes, or in other situations that were considered serious per medical or scientific judgment.
Outcome measures
| Measure |
Flu mRNA_Dose Level 6_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 6, which corresponds to a higher concentration than Dose Level 5.
|
Flu mRNA_Dose Level 7_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 7, which corresponds to a higher concentration than Dose Level 6.
|
Flu mRNA_ Dose Level 8_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 8, which corresponds to a higher concentration than Dose Level 7.
|
Flu mRNA_Dose Level 9_YA
n=25 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 9, which corresponds to a higher concentration than Dose Level 8.
|
Flu mRNA_Dose Level 10_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 10, the highest concentration evaluated in the study.
|
Flu mRNA_Dose Level 5_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 5, which corresponds to a higher concentration than Dose Level 4.
|
Flu mRNA_Dose Level 1_Younger Adults (YA)
n=24 Participants
On Day 1, YA adult participants received Flu mRNA at Dose Level 1, the lowest concentration evaluated in the study.
|
Flu mRNA_Dose Level 2 _YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 2, which corresponds to a higher concentration than Dose Level 1.
|
Flu mRNA_Dose Level 3_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 3, which corresponds to a higher concentration than Dose Level 2
|
Flu mRNA_Dose Level 4_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 4, which corresponds to a higher concentration than Dose Level 3.
|
Pooled Control_YA
n=35 Participants
On Day 1, YA participants received a single dose of FDQ21A - NH or FDQ22A -NH administered as a control and were analyzed together as pooled group throughout the study.
|
Flu mRNA_Dose Level 7_Older Adults (OA)
n=32 Participants
On Day 1, OA participants received Flu mRNA at Dose Level 7.
|
Control_OA
n=16 Participants
On Day 1, OA participants received a single dose of FDQ21A-NH administered at as a control.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Serious Adverse Events (SAEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 183Population: The analysis was performed on the ES, which included all participants who received a study intervention and for whom data were available for the specified duration.
The following events were considered as AESI in this study: severe hypersensitivity reactions within 24 hours after study intervention administration, myocarditis/pericarditis and potential immune-mediated diseases (pIMDs).
Outcome measures
| Measure |
Flu mRNA_Dose Level 6_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 6, which corresponds to a higher concentration than Dose Level 5.
|
Flu mRNA_Dose Level 7_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 7, which corresponds to a higher concentration than Dose Level 6.
|
Flu mRNA_ Dose Level 8_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 8, which corresponds to a higher concentration than Dose Level 7.
|
Flu mRNA_Dose Level 9_YA
n=25 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 9, which corresponds to a higher concentration than Dose Level 8.
|
Flu mRNA_Dose Level 10_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 10, the highest concentration evaluated in the study.
|
Flu mRNA_Dose Level 5_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 5, which corresponds to a higher concentration than Dose Level 4.
|
Flu mRNA_Dose Level 1_Younger Adults (YA)
n=24 Participants
On Day 1, YA adult participants received Flu mRNA at Dose Level 1, the lowest concentration evaluated in the study.
|
Flu mRNA_Dose Level 2 _YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 2, which corresponds to a higher concentration than Dose Level 1.
|
Flu mRNA_Dose Level 3_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 3, which corresponds to a higher concentration than Dose Level 2
|
Flu mRNA_Dose Level 4_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 4, which corresponds to a higher concentration than Dose Level 3.
|
Pooled Control_YA
n=35 Participants
On Day 1, YA participants received a single dose of FDQ21A - NH or FDQ22A -NH administered as a control and were analyzed together as pooled group throughout the study.
|
Flu mRNA_Dose Level 7_Older Adults (OA)
n=32 Participants
On Day 1, OA participants received Flu mRNA at Dose Level 7.
|
Control_OA
n=16 Participants
On Day 1, OA participants received a single dose of FDQ21A-NH administered at as a control.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting AEs of Special Interest (AESIs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 8 compared to baseline (Day 1)Population: The analysis was performed on the ES, which included all participants who received a study intervention and for whom data were available for the specified duration.
Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participants condition. Normal or missing values refer to laboratory values that were within normal range or missing at baseline.
Outcome measures
| Measure |
Flu mRNA_Dose Level 6_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 6, which corresponds to a higher concentration than Dose Level 5.
|
Flu mRNA_Dose Level 7_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 7, which corresponds to a higher concentration than Dose Level 6.
|
Flu mRNA_ Dose Level 8_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 8, which corresponds to a higher concentration than Dose Level 7.
|
Flu mRNA_Dose Level 9_YA
n=25 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 9, which corresponds to a higher concentration than Dose Level 8.
|
Flu mRNA_Dose Level 10_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 10, the highest concentration evaluated in the study.
|
Flu mRNA_Dose Level 5_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 5, which corresponds to a higher concentration than Dose Level 4.
|
Flu mRNA_Dose Level 1_Younger Adults (YA)
n=24 Participants
On Day 1, YA adult participants received Flu mRNA at Dose Level 1, the lowest concentration evaluated in the study.
|
Flu mRNA_Dose Level 2 _YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 2, which corresponds to a higher concentration than Dose Level 1.
|
Flu mRNA_Dose Level 3_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 3, which corresponds to a higher concentration than Dose Level 2
|
Flu mRNA_Dose Level 4_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 4, which corresponds to a higher concentration than Dose Level 3.
|
Pooled Control_YA
n=35 Participants
On Day 1, YA participants received a single dose of FDQ21A - NH or FDQ22A -NH administered as a control and were analyzed together as pooled group throughout the study.
|
Flu mRNA_Dose Level 7_Older Adults (OA)
n=32 Participants
On Day 1, OA participants received Flu mRNA at Dose Level 7.
|
Control_OA
n=16 Participants
On Day 1, OA participants received a single dose of FDQ21A-NH administered at as a control.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Shift From Abnormal Non-clinically Significant and Normal or Missing Laboratory Value on Day 1 to Clinically Significant Abnormal Laboratory Value on Day 8 for Hematology, Clinical Chemistry, Coagulation and Urine Analysis
Abnormal non-significant to clinically significant
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Shift From Abnormal Non-clinically Significant and Normal or Missing Laboratory Value on Day 1 to Clinically Significant Abnormal Laboratory Value on Day 8 for Hematology, Clinical Chemistry, Coagulation and Urine Analysis
Normal or missing to clinically significant
|
0 Participants
|
8 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: At Day 29 compared to baseline (Day 1)Population: The analysis was performed on the ES, which included all participants who received a study intervention and for whom data were available for the specified duration.
Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participants condition. Normal or missing values refer to laboratory values that were within normal range or missing at baseline.
Outcome measures
| Measure |
Flu mRNA_Dose Level 6_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 6, which corresponds to a higher concentration than Dose Level 5.
|
Flu mRNA_Dose Level 7_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 7, which corresponds to a higher concentration than Dose Level 6.
|
Flu mRNA_ Dose Level 8_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 8, which corresponds to a higher concentration than Dose Level 7.
|
Flu mRNA_Dose Level 9_YA
n=25 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 9, which corresponds to a higher concentration than Dose Level 8.
|
Flu mRNA_Dose Level 10_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 10, the highest concentration evaluated in the study.
|
Flu mRNA_Dose Level 5_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 5, which corresponds to a higher concentration than Dose Level 4.
|
Flu mRNA_Dose Level 1_Younger Adults (YA)
n=24 Participants
On Day 1, YA adult participants received Flu mRNA at Dose Level 1, the lowest concentration evaluated in the study.
|
Flu mRNA_Dose Level 2 _YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 2, which corresponds to a higher concentration than Dose Level 1.
|
Flu mRNA_Dose Level 3_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 3, which corresponds to a higher concentration than Dose Level 2
|
Flu mRNA_Dose Level 4_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 4, which corresponds to a higher concentration than Dose Level 3.
|
Pooled Control_YA
n=35 Participants
On Day 1, YA participants received a single dose of FDQ21A - NH or FDQ22A -NH administered as a control and were analyzed together as pooled group throughout the study.
|
Flu mRNA_Dose Level 7_Older Adults (OA)
n=32 Participants
On Day 1, OA participants received Flu mRNA at Dose Level 7.
|
Control_OA
n=16 Participants
On Day 1, OA participants received a single dose of FDQ21A-NH administered at as a control.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Shift From Abnormal Non-clinically Significant and Normal or Missing Laboratory Value on Day 1 to Clinically Significant Abnormal Laboratory Value on Day 29 for Hematology,Clinical Chemistry, Coagulation and Urine Analysis
Abnormal non-significant to clinically significant
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants Reporting Shift From Abnormal Non-clinically Significant and Normal or Missing Laboratory Value on Day 1 to Clinically Significant Abnormal Laboratory Value on Day 29 for Hematology,Clinical Chemistry, Coagulation and Urine Analysis
Normal or missing to clinically significant
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 1Population: The analysis was performed on the Per Protocol Set (PPS), which included all eligible participants who received the study intervention per protocol, had recorded anti-vaccine antibody titers immunogenicity results pre- and post-dose, without intercurrent conditions, did not use prohibited medications or vaccinations before Day 22, and for whom data were available for the specified analysis at the specified timepoints. Blood sample results that deviated from the analysis criteria were excluded.
Outcome measures
| Measure |
Flu mRNA_Dose Level 6_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 6, which corresponds to a higher concentration than Dose Level 5.
|
Flu mRNA_Dose Level 7_YA
n=23 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 7, which corresponds to a higher concentration than Dose Level 6.
|
Flu mRNA_ Dose Level 8_YA
n=23 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 8, which corresponds to a higher concentration than Dose Level 7.
|
Flu mRNA_Dose Level 9_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 9, which corresponds to a higher concentration than Dose Level 8.
|
Flu mRNA_Dose Level 10_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 10, the highest concentration evaluated in the study.
|
Flu mRNA_Dose Level 5_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 5, which corresponds to a higher concentration than Dose Level 4.
|
Flu mRNA_Dose Level 1_Younger Adults (YA)
n=23 Participants
On Day 1, YA adult participants received Flu mRNA at Dose Level 1, the lowest concentration evaluated in the study.
|
Flu mRNA_Dose Level 2 _YA
n=22 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 2, which corresponds to a higher concentration than Dose Level 1.
|
Flu mRNA_Dose Level 3_YA
n=23 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 3, which corresponds to a higher concentration than Dose Level 2
|
Flu mRNA_Dose Level 4_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 4, which corresponds to a higher concentration than Dose Level 3.
|
Pooled Control_YA
n=34 Participants
On Day 1, YA participants received a single dose of FDQ21A - NH or FDQ22A -NH administered as a control and were analyzed together as pooled group throughout the study.
|
Flu mRNA_Dose Level 7_Older Adults (OA)
n=29 Participants
On Day 1, OA participants received Flu mRNA at Dose Level 7.
|
Control_OA
n=16 Participants
On Day 1, OA participants received a single dose of FDQ21A-NH administered at as a control.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMT) of Anti-vaccine Antibody Titers
|
16.33 Titers
Interval 9.82 to 27.16
|
43.78 Titers
Interval 22.19 to 86.38
|
21.23 Titers
Interval 12.15 to 37.11
|
41.78 Titers
Interval 22.9 to 76.26
|
54.14 Titers
Interval 31.83 to 92.06
|
16.33 Titers
Interval 9.58 to 27.84
|
29.59 Titers
Interval 16.05 to 54.56
|
53.97 Titers
Interval 28.15 to 103.48
|
31.43 Titers
Interval 17.67 to 55.91
|
28.67 Titers
Interval 15.56 to 52.82
|
30.07 Titers
Interval 17.46 to 51.78
|
38.65 Titers
Interval 25.05 to 59.63
|
40.82 Titers
Interval 19.9 to 83.75
|
PRIMARY outcome
Timeframe: At Day 22Population: The analysis was performed on the Per Protocol Set (PPS), which included all eligible participants who received the study intervention per protocol, had recorded anti-vaccine antibody titers immunogenicity results pre- and post-dose, without intercurrent conditions, did not use prohibited medications or vaccinations before Day 22, and for whom data were available for the specified analysis at the specified timepoints. Blood sample results that deviated from the analysis criteria were excluded.
Outcome measures
| Measure |
Flu mRNA_Dose Level 6_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 6, which corresponds to a higher concentration than Dose Level 5.
|
Flu mRNA_Dose Level 7_YA
n=23 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 7, which corresponds to a higher concentration than Dose Level 6.
|
Flu mRNA_ Dose Level 8_YA
n=23 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 8, which corresponds to a higher concentration than Dose Level 7.
|
Flu mRNA_Dose Level 9_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 9, which corresponds to a higher concentration than Dose Level 8.
|
Flu mRNA_Dose Level 10_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 10, the highest concentration evaluated in the study.
|
Flu mRNA_Dose Level 5_YA
n=23 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 5, which corresponds to a higher concentration than Dose Level 4.
|
Flu mRNA_Dose Level 1_Younger Adults (YA)
n=23 Participants
On Day 1, YA adult participants received Flu mRNA at Dose Level 1, the lowest concentration evaluated in the study.
|
Flu mRNA_Dose Level 2 _YA
n=22 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 2, which corresponds to a higher concentration than Dose Level 1.
|
Flu mRNA_Dose Level 3_YA
n=23 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 3, which corresponds to a higher concentration than Dose Level 2
|
Flu mRNA_Dose Level 4_YA
n=23 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 4, which corresponds to a higher concentration than Dose Level 3.
|
Pooled Control_YA
n=32 Participants
On Day 1, YA participants received a single dose of FDQ21A - NH or FDQ22A -NH administered as a control and were analyzed together as pooled group throughout the study.
|
Flu mRNA_Dose Level 7_Older Adults (OA)
n=29 Participants
On Day 1, OA participants received Flu mRNA at Dose Level 7.
|
Control_OA
n=16 Participants
On Day 1, OA participants received a single dose of FDQ21A-NH administered at as a control.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
GMT of Anti-vaccine Antibody Titers
|
574.09 Titers
Interval 258.11 to 1276.91
|
1144.59 Titers
Interval 520.12 to 2518.84
|
655.57 Titers
Interval 308.11 to 1394.83
|
1124.85 Titers
Interval 568.42 to 2226.0
|
923.79 Titers
Interval 427.53 to 1996.07
|
509.49 Titers
Interval 228.62 to 1135.46
|
269.00 Titers
Interval 120.5 to 600.47
|
314.88 Titers
Interval 139.83 to 709.07
|
420.90 Titers
Interval 191.0 to 927.55
|
436.90 Titers
Interval 198.46 to 961.79
|
313.07 Titers
Interval 151.79 to 645.71
|
571.29 Titers
Interval 384.74 to 848.3
|
245.66 Titers
Interval 159.33 to 378.76
|
PRIMARY outcome
Timeframe: From Day 1 to Day 22Population: The analysis was performed on the Per Protocol Set (PPS), which included all eligible participants who received the study intervention per protocol, had recorded anti-vaccine antibody titers immunogenicity results pre- and post-dose, without intercurrent conditions, did not use prohibited medications or vaccinations before Day 22, and for whom data were available for the specified analysis at the specified timepoints. Blood sample results that deviated from the analysis criteria were excluded.
GMI is defined as the geometric mean of the ratios of the post-dose anti-vaccine antibody titers over the Day 1 anti-vaccine antibody titers.
Outcome measures
| Measure |
Flu mRNA_Dose Level 6_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 6, which corresponds to a higher concentration than Dose Level 5.
|
Flu mRNA_Dose Level 7_YA
n=23 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 7, which corresponds to a higher concentration than Dose Level 6.
|
Flu mRNA_ Dose Level 8_YA
n=23 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 8, which corresponds to a higher concentration than Dose Level 7.
|
Flu mRNA_Dose Level 9_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 9, which corresponds to a higher concentration than Dose Level 8.
|
Flu mRNA_Dose Level 10_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 10, the highest concentration evaluated in the study.
|
Flu mRNA_Dose Level 5_YA
n=23 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 5, which corresponds to a higher concentration than Dose Level 4.
|
Flu mRNA_Dose Level 1_Younger Adults (YA)
n=23 Participants
On Day 1, YA adult participants received Flu mRNA at Dose Level 1, the lowest concentration evaluated in the study.
|
Flu mRNA_Dose Level 2 _YA
n=22 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 2, which corresponds to a higher concentration than Dose Level 1.
|
Flu mRNA_Dose Level 3_YA
n=23 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 3, which corresponds to a higher concentration than Dose Level 2
|
Flu mRNA_Dose Level 4_YA
n=23 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 4, which corresponds to a higher concentration than Dose Level 3.
|
Pooled Control_YA
n=32 Participants
On Day 1, YA participants received a single dose of FDQ21A - NH or FDQ22A -NH administered as a control and were analyzed together as pooled group throughout the study.
|
Flu mRNA_Dose Level 7_Older Adults (OA)
n=29 Participants
On Day 1, OA participants received Flu mRNA at Dose Level 7.
|
Control_OA
n=16 Participants
On Day 1, OA participants received a single dose of FDQ21A-NH administered at as a control.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Increase (GMI) of Anti-vaccine Antibody Titers From Day 1 (Baseline) to Day 22
|
18.40 Ratio
Interval 8.27 to 40.92
|
36.68 Ratio
Interval 16.67 to 80.72
|
21.01 Ratio
Interval 9.87 to 44.7
|
36.05 Ratio
Interval 18.22 to 71.34
|
29.61 Ratio
Interval 13.7 to 63.97
|
16.33 Ratio
Interval 7.33 to 36.39
|
8.62 Ratio
Interval 3.86 to 19.24
|
10.09 Ratio
Interval 4.48 to 22.72
|
13.49 Ratio
Interval 6.12 to 29.73
|
14.00 Ratio
Interval 6.36 to 30.82
|
10.03 Ratio
Interval 4.86 to 20.69
|
14.50 Ratio
Interval 9.76 to 21.53
|
6.23 Ratio
Interval 4.04 to 9.61
|
PRIMARY outcome
Timeframe: From Day 1 to Day 22Population: The analysis was performed on the Per Protocol Set (PPS), which included all eligible participants who received the study intervention per protocol, had recorded anti-vaccine antibody titers immunogenicity results pre- and post-dose, without intercurrent conditions, did not use prohibited medications or vaccinations before Day 22, and for whom data were available for the specified analysis at the specified timepoints. Blood sample results that deviated from the analysis criteria were excluded.
SCR is defined as the percentage of dosed participants who have either an anti-vaccine antibody pre-dose titer \< 1:10 and a post-dose anti-vaccine antibody titer ≥ 1:40 or a pre-dose anti-vaccine antibody titer ≥ 1:10 and at least a 4-fold increase in post-dose anti-vaccine antibody titer.
Outcome measures
| Measure |
Flu mRNA_Dose Level 6_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 6, which corresponds to a higher concentration than Dose Level 5.
|
Flu mRNA_Dose Level 7_YA
n=23 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 7, which corresponds to a higher concentration than Dose Level 6.
|
Flu mRNA_ Dose Level 8_YA
n=23 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 8, which corresponds to a higher concentration than Dose Level 7.
|
Flu mRNA_Dose Level 9_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 9, which corresponds to a higher concentration than Dose Level 8.
|
Flu mRNA_Dose Level 10_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 10, the highest concentration evaluated in the study.
|
Flu mRNA_Dose Level 5_YA
n=23 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 5, which corresponds to a higher concentration than Dose Level 4.
|
Flu mRNA_Dose Level 1_Younger Adults (YA)
n=23 Participants
On Day 1, YA adult participants received Flu mRNA at Dose Level 1, the lowest concentration evaluated in the study.
|
Flu mRNA_Dose Level 2 _YA
n=22 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 2, which corresponds to a higher concentration than Dose Level 1.
|
Flu mRNA_Dose Level 3_YA
n=23 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 3, which corresponds to a higher concentration than Dose Level 2
|
Flu mRNA_Dose Level 4_YA
n=23 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 4, which corresponds to a higher concentration than Dose Level 3.
|
Pooled Control_YA
n=32 Participants
On Day 1, YA participants received a single dose of FDQ21A - NH or FDQ22A -NH administered as a control and were analyzed together as pooled group throughout the study.
|
Flu mRNA_Dose Level 7_Older Adults (OA)
n=29 Participants
On Day 1, OA participants received Flu mRNA at Dose Level 7.
|
Control_OA
n=16 Participants
On Day 1, OA participants received a single dose of FDQ21A-NH administered at as a control.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Anti-vaccine Antibody Seroconversion Rate (SCR)
|
95.8 Percentage of participants
Interval 78.9 to 99.9
|
87.0 Percentage of participants
Interval 66.4 to 97.2
|
95.7 Percentage of participants
Interval 78.1 to 99.9
|
95.8 Percentage of participants
Interval 78.9 to 99.9
|
95.8 Percentage of participants
Interval 78.9 to 99.9
|
95.7 Percentage of participants
Interval 78.1 to 99.9
|
47.8 Percentage of participants
Interval 26.8 to 69.4
|
50.0 Percentage of participants
Interval 28.2 to 71.8
|
82.6 Percentage of participants
Interval 61.2 to 95.0
|
78.3 Percentage of participants
Interval 56.3 to 92.5
|
59.4 Percentage of participants
Interval 40.6 to 76.3
|
89.7 Percentage of participants
Interval 72.6 to 97.8
|
56.3 Percentage of participants
Interval 29.9 to 80.2
|
PRIMARY outcome
Timeframe: At Day 22Population: The analysis was performed on the Per Protocol Set (PPS), which included all eligible participants who received the study intervention per protocol, had recorded anti-vaccine antibody titers immunogenicity results pre- and post-dose, without intercurrent conditions, did not use prohibited medications or vaccinations before Day 22, and for whom data were available for the specified analysis at the specified timepoints. Blood sample results that deviated from the analysis criteria were excluded.
SPR is defined as the percentage of dosed participants with a anti-vaccine antibody titer ≥ 1:40.
Outcome measures
| Measure |
Flu mRNA_Dose Level 6_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 6, which corresponds to a higher concentration than Dose Level 5.
|
Flu mRNA_Dose Level 7_YA
n=23 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 7, which corresponds to a higher concentration than Dose Level 6.
|
Flu mRNA_ Dose Level 8_YA
n=23 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 8, which corresponds to a higher concentration than Dose Level 7.
|
Flu mRNA_Dose Level 9_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 9, which corresponds to a higher concentration than Dose Level 8.
|
Flu mRNA_Dose Level 10_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 10, the highest concentration evaluated in the study.
|
Flu mRNA_Dose Level 5_YA
n=23 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 5, which corresponds to a higher concentration than Dose Level 4.
|
Flu mRNA_Dose Level 1_Younger Adults (YA)
n=23 Participants
On Day 1, YA adult participants received Flu mRNA at Dose Level 1, the lowest concentration evaluated in the study.
|
Flu mRNA_Dose Level 2 _YA
n=22 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 2, which corresponds to a higher concentration than Dose Level 1.
|
Flu mRNA_Dose Level 3_YA
n=23 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 3, which corresponds to a higher concentration than Dose Level 2
|
Flu mRNA_Dose Level 4_YA
n=23 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 4, which corresponds to a higher concentration than Dose Level 3.
|
Pooled Control_YA
n=32 Participants
On Day 1, YA participants received a single dose of FDQ21A - NH or FDQ22A -NH administered as a control and were analyzed together as pooled group throughout the study.
|
Flu mRNA_Dose Level 7_Older Adults (OA)
n=29 Participants
On Day 1, OA participants received Flu mRNA at Dose Level 7.
|
Control_OA
n=16 Participants
On Day 1, OA participants received a single dose of FDQ21A-NH administered at as a control.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Anti-vaccine Antibody Seroprotection Rate (SPR)
|
100 Percentage of participants
Interval 85.8 to 100.0
|
100 Percentage of participants
Interval 85.2 to 100.0
|
100 Percentage of participants
Interval 85.2 to 100.0
|
100 Percentage of participants
Interval 85.8 to 100.0
|
100 Percentage of participants
Interval 85.8 to 100.0
|
100 Percentage of participants
Interval 85.2 to 100.0
|
95.7 Percentage of participants
Interval 78.1 to 99.9
|
100 Percentage of participants
Interval 84.6 to 100.0
|
100 Percentage of participants
Interval 85.2 to 100.0
|
100 Percentage of participants
Interval 85.2 to 100.0
|
100 Percentage of participants
Interval 89.1 to 100.0
|
96.6 Percentage of participants
Interval 82.2 to 99.9
|
93.8 Percentage of participants
Interval 69.8 to 99.8
|
SECONDARY outcome
Timeframe: At Day 62 and Day 183Population: The analysis was performed on the Per Protocol Set (PPS), which included all eligible participants who received the study intervention per protocol, had recorded anti-HI immunogenicity results pre- and post-dose, without intercurrent conditions, did not use prohibited medications or vaccinations before Day 22, and for whom data were available for the specified analysis at the specified timepoints. Blood sample results that deviated from the analysis criteria were excluded.
Outcome measures
| Measure |
Flu mRNA_Dose Level 6_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 6, which corresponds to a higher concentration than Dose Level 5.
|
Flu mRNA_Dose Level 7_YA
n=14 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 7, which corresponds to a higher concentration than Dose Level 6.
|
Flu mRNA_ Dose Level 8_YA
n=17 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 8, which corresponds to a higher concentration than Dose Level 7.
|
Flu mRNA_Dose Level 9_YA
n=20 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 9, which corresponds to a higher concentration than Dose Level 8.
|
Flu mRNA_Dose Level 10_YA
On Day 1, YA participants received Flu mRNA at Dose Level 10, the highest concentration evaluated in the study.
|
Flu mRNA_Dose Level 5_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 5, which corresponds to a higher concentration than Dose Level 4.
|
Flu mRNA_Dose Level 1_Younger Adults (YA)
n=21 Participants
On Day 1, YA adult participants received Flu mRNA at Dose Level 1, the lowest concentration evaluated in the study.
|
Flu mRNA_Dose Level 2 _YA
n=19 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 2, which corresponds to a higher concentration than Dose Level 1.
|
Flu mRNA_Dose Level 3_YA
n=23 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 3, which corresponds to a higher concentration than Dose Level 2
|
Flu mRNA_Dose Level 4_YA
n=21 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 4, which corresponds to a higher concentration than Dose Level 3.
|
Pooled Control_YA
n=23 Participants
On Day 1, YA participants received a single dose of FDQ21A - NH or FDQ22A -NH administered as a control and were analyzed together as pooled group throughout the study.
|
Flu mRNA_Dose Level 7_Older Adults (OA)
n=15 Participants
On Day 1, OA participants received Flu mRNA at Dose Level 7.
|
Control_OA
n=10 Participants
On Day 1, OA participants received a single dose of FDQ21A-NH administered at as a control.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
GMT of Anti-vaccine Antibody Titers
Post-dosing at Day 183
|
206.82 Titers
Interval 91.11 to 469.51
|
202.41 Titers
Interval 77.59 to 527.99
|
208.90 Titers
Interval 95.63 to 456.32
|
307.75 Titers
Interval 154.52 to 612.91
|
—
|
173.18 Titers
Interval 76.23 to 393.4
|
139.93 Titers
Interval 59.67 to 328.15
|
119.60 Titers
Interval 50.66 to 282.35
|
183.46 Titers
Interval 78.33 to 429.7
|
200.75 Titers
Interval 86.89 to 463.83
|
192.15 Titers
Interval 88.73 to 416.14
|
158.15 Titers
Interval 82.85 to 301.9
|
122.32 Titers
Interval 48.12 to 310.94
|
|
GMT of Anti-vaccine Antibody Titers
Post-dosing at Day 62
|
315.45 Titers
Interval 143.12 to 695.29
|
585.92 Titers
Interval 254.77 to 1347.5
|
340.76 Titers
Interval 162.66 to 713.89
|
703.32 Titers
Interval 363.72 to 1360.01
|
—
|
315.22 Titers
Interval 143.52 to 692.32
|
180.49 Titers
Interval 81.0 to 402.16
|
165.29 Titers
Interval 73.19 to 373.31
|
253.76 Titers
Interval 116.06 to 554.84
|
325.51 Titers
Interval 147.74 to 717.15
|
223.85 Titers
Interval 106.67 to 469.74
|
304.72 Titers
Interval 183.75 to 505.31
|
193.62 Titers
Interval 108.73 to 344.78
|
SECONDARY outcome
Timeframe: From Day 1 to Day 62Population: The analysis was performed on the Per Protocol Set (PPS), which included all eligible participants who received the study intervention per protocol, had recorded anti-vaccine antibody titers immunogenicity results pre- and post-dose, without intercurrent conditions, did not use prohibited medications or vaccinations before Day 22, and for whom data were available for the specified analysis at the specified timepoints. Blood sample results that deviated from the analysis criteria were excluded.
GMI is defined as the geometric mean of the ratios of the post-dose anti-vaccine antibody titer over the Day 1 anti-vaccine antibody titer.
Outcome measures
| Measure |
Flu mRNA_Dose Level 6_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 6, which corresponds to a higher concentration than Dose Level 5.
|
Flu mRNA_Dose Level 7_YA
n=14 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 7, which corresponds to a higher concentration than Dose Level 6.
|
Flu mRNA_ Dose Level 8_YA
n=17 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 8, which corresponds to a higher concentration than Dose Level 7.
|
Flu mRNA_Dose Level 9_YA
n=20 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 9, which corresponds to a higher concentration than Dose Level 8.
|
Flu mRNA_Dose Level 10_YA
On Day 1, YA participants received Flu mRNA at Dose Level 10, the highest concentration evaluated in the study.
|
Flu mRNA_Dose Level 5_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 5, which corresponds to a higher concentration than Dose Level 4.
|
Flu mRNA_Dose Level 1_Younger Adults (YA)
n=21 Participants
On Day 1, YA adult participants received Flu mRNA at Dose Level 1, the lowest concentration evaluated in the study.
|
Flu mRNA_Dose Level 2 _YA
n=19 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 2, which corresponds to a higher concentration than Dose Level 1.
|
Flu mRNA_Dose Level 3_YA
n=23 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 3, which corresponds to a higher concentration than Dose Level 2
|
Flu mRNA_Dose Level 4_YA
n=21 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 4, which corresponds to a higher concentration than Dose Level 3.
|
Pooled Control_YA
n=23 Participants
On Day 1, YA participants received a single dose of FDQ21A - NH or FDQ22A -NH administered as a control and were analyzed together as pooled group throughout the study.
|
Flu mRNA_Dose Level 7_Older Adults (OA)
n=15 Participants
On Day 1, OA participants received Flu mRNA at Dose Level 7.
|
Control_OA
n=10 Participants
On Day 1, OA participants received a single dose of FDQ21A-NH administered at as a control.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
GMI of Anti-vaccine Antibody Titers From Day 1 (Baseline) to Day 62
|
12.01 Ratio
Interval 5.45 to 26.48
|
22.31 Ratio
Interval 9.7 to 51.31
|
12.98 Ratio
Interval 6.19 to 27.19
|
26.78 Ratio
Interval 13.85 to 51.79
|
—
|
12.00 Ratio
Interval 5.47 to 26.36
|
6.87 Ratio
Interval 3.08 to 15.32
|
6.29 Ratio
Interval 2.79 to 14.22
|
9.66 Ratio
Interval 4.42 to 21.13
|
12.40 Ratio
Interval 5.63 to 27.31
|
8.52 Ratio
Interval 4.06 to 17.89
|
8.05 Ratio
Interval 4.85 to 13.34
|
5.11 Ratio
Interval 2.87 to 9.1
|
SECONDARY outcome
Timeframe: From Day 1 to Day 183Population: The analysis was performed on the Per Protocol Set (PPS), which included all eligible participants who received the study intervention per protocol, had recorded anti-vaccine antibody titers immunogenicity results pre- and post-dose, without intercurrent conditions, did not use prohibited medications or vaccinations before Day 22, and for whom data were available for the specified analysis at the specified timepoints. Blood sample results that deviated from the analysis criteria were excluded.
GMI is defined as the geometric mean of the ratios of the post-dose anti-vaccine antibody titer over the Day 1 anti-vaccine antibody titer.
Outcome measures
| Measure |
Flu mRNA_Dose Level 6_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 6, which corresponds to a higher concentration than Dose Level 5.
|
Flu mRNA_Dose Level 7_YA
n=8 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 7, which corresponds to a higher concentration than Dose Level 6.
|
Flu mRNA_ Dose Level 8_YA
n=15 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 8, which corresponds to a higher concentration than Dose Level 7.
|
Flu mRNA_Dose Level 9_YA
n=20 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 9, which corresponds to a higher concentration than Dose Level 8.
|
Flu mRNA_Dose Level 10_YA
On Day 1, YA participants received Flu mRNA at Dose Level 10, the highest concentration evaluated in the study.
|
Flu mRNA_Dose Level 5_YA
n=23 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 5, which corresponds to a higher concentration than Dose Level 4.
|
Flu mRNA_Dose Level 1_Younger Adults (YA)
n=17 Participants
On Day 1, YA adult participants received Flu mRNA at Dose Level 1, the lowest concentration evaluated in the study.
|
Flu mRNA_Dose Level 2 _YA
n=17 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 2, which corresponds to a higher concentration than Dose Level 1.
|
Flu mRNA_Dose Level 3_YA
n=16 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 3, which corresponds to a higher concentration than Dose Level 2
|
Flu mRNA_Dose Level 4_YA
n=17 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 4, which corresponds to a higher concentration than Dose Level 3.
|
Pooled Control_YA
n=19 Participants
On Day 1, YA participants received a single dose of FDQ21A - NH or FDQ22A -NH administered as a control and were analyzed together as pooled group throughout the study.
|
Flu mRNA_Dose Level 7_Older Adults (OA)
n=12 Participants
On Day 1, OA participants received Flu mRNA at Dose Level 7.
|
Control_OA
n=6 Participants
On Day 1, OA participants received a single dose of FDQ21A-NH administered at as a control.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
GMI of Anti-vaccine Antibody Titers From Day 1 (Baseline) to Day 183
|
9.39 Ratio
Interval 4.14 to 21.32
|
9.19 Ratio
Interval 3.52 to 23.98
|
9.49 Ratio
Interval 4.34 to 20.72
|
13.98 Ratio
Interval 7.02 to 27.83
|
—
|
7.86 Ratio
Interval 3.46 to 17.87
|
6.35 Ratio
Interval 2.71 to 14.9
|
5.43 Ratio
Interval 2.3 to 12.82
|
8.33 Ratio
Interval 3.56 to 19.51
|
9.12 Ratio
Interval 3.95 to 21.06
|
8.73 Ratio
Interval 4.03 to 18.9
|
3.73 Ratio
Interval 1.95 to 7.12
|
2.88 Ratio
Interval 1.13 to 7.33
|
SECONDARY outcome
Timeframe: At Day 62 and Day 183Population: The analysis was performed on the Per Protocol Set (PPS), which included all eligible participants who received the study intervention per protocol, had recorded anti-HI immunogenicity results pre- and post-dose, without intercurrent conditions, did not use prohibited medications or vaccinations before Day 22, and for whom data were available for the specified analysis at the specified timepoints. Blood sample results that deviated from the analysis criteria were excluded.
SPR is defined as the percentage of dosed participants with a anti-vaccine antibody titers ≥ 1:40.
Outcome measures
| Measure |
Flu mRNA_Dose Level 6_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 6, which corresponds to a higher concentration than Dose Level 5.
|
Flu mRNA_Dose Level 7_YA
n=14 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 7, which corresponds to a higher concentration than Dose Level 6.
|
Flu mRNA_ Dose Level 8_YA
n=17 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 8, which corresponds to a higher concentration than Dose Level 7.
|
Flu mRNA_Dose Level 9_YA
n=20 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 9, which corresponds to a higher concentration than Dose Level 8.
|
Flu mRNA_Dose Level 10_YA
On Day 1, YA participants received Flu mRNA at Dose Level 10, the highest concentration evaluated in the study.
|
Flu mRNA_Dose Level 5_YA
n=24 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 5, which corresponds to a higher concentration than Dose Level 4.
|
Flu mRNA_Dose Level 1_Younger Adults (YA)
n=21 Participants
On Day 1, YA adult participants received Flu mRNA at Dose Level 1, the lowest concentration evaluated in the study.
|
Flu mRNA_Dose Level 2 _YA
n=19 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 2, which corresponds to a higher concentration than Dose Level 1.
|
Flu mRNA_Dose Level 3_YA
n=23 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 3, which corresponds to a higher concentration than Dose Level 2
|
Flu mRNA_Dose Level 4_YA
n=21 Participants
On Day 1, YA participants received Flu mRNA at Dose Level 4, which corresponds to a higher concentration than Dose Level 3.
|
Pooled Control_YA
n=23 Participants
On Day 1, YA participants received a single dose of FDQ21A - NH or FDQ22A -NH administered as a control and were analyzed together as pooled group throughout the study.
|
Flu mRNA_Dose Level 7_Older Adults (OA)
n=15 Participants
On Day 1, OA participants received Flu mRNA at Dose Level 7.
|
Control_OA
n=10 Participants
On Day 1, OA participants received a single dose of FDQ21A-NH administered at as a control.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Anti-vaccine Antibody SPR
Post-dosing at Day 62
|
100 Percentage of participants
Interval 85.8 to 100.0
|
100 Percentage of participants
Interval 76.8 to 100.0
|
100 Percentage of participants
Interval 80.5 to 100.0
|
100 Percentage of participants
Interval 83.2 to 100.0
|
—
|
95.8 Percentage of participants
Interval 78.9 to 99.9
|
95.2 Percentage of participants
Interval 76.2 to 99.9
|
100 Percentage of participants
Interval 82.4 to 100.0
|
100 Percentage of participants
Interval 85.2 to 100.0
|
100 Percentage of participants
Interval 83.9 to 100.0
|
100 Percentage of participants
Interval 85.2 to 100.0
|
93.3 Percentage of participants
Interval 68.1 to 99.8
|
90.0 Percentage of participants
Interval 55.5 to 99.7
|
|
Percentage of Participants With Anti-vaccine Antibody SPR
Post-dosing at Day 183
|
91.7 Percentage of participants
Interval 73.0 to 99.0
|
100 Percentage of participants
Interval 63.1 to 100.0
|
100 Percentage of participants
Interval 78.2 to 100.0
|
100 Percentage of participants
Interval 83.2 to 100.0
|
—
|
91.3 Percentage of participants
Interval 72.0 to 98.9
|
88.2 Percentage of participants
Interval 63.6 to 98.5
|
94.1 Percentage of participants
Interval 71.3 to 99.9
|
100 Percentage of participants
Interval 79.4 to 100.0
|
100 Percentage of participants
Interval 80.5 to 100.0
|
94.7 Percentage of participants
Interval 74.0 to 99.9
|
83.3 Percentage of participants
Interval 51.6 to 97.9
|
100 Percentage of participants
Interval 54.1 to 100.0
|
Adverse Events
Flu mRNA_Dose Level 1_Younger Adults (YA)
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Flu mRNA_Dose Level 2 _YA
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Flu mRNA_Dose Level 3_YA
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Flu mRNA_Dose Level 4_YA
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Flu mRNA_Dose Level 5_YA
Serious events: 2 serious events
Other events: 22 other events
Deaths: 0 deaths
Flu mRNA_Dose Level 6_YA
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Flu mRNA_Dose Level 7_YA
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Flu mRNA_ Dose Level 8_YA
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Flu mRNA_Dose Level 9_YA
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Flu mRNA_Dose Level 10_YA
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Pooled Control_YA
Serious events: 1 serious events
Other events: 32 other events
Deaths: 0 deaths
Flu mRNA_Dose Level 7_Older Adults (OA)
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
Control_OA
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Flu mRNA_Dose Level 1_Younger Adults (YA)
n=24 participants at risk
On Day 1, YA adult participants received Flu mRNA at Dose Level 1, the lowest concentration evaluated in the study.
|
Flu mRNA_Dose Level 2 _YA
n=24 participants at risk
On Day 1, YA participants received Flu mRNA at Dose Level 2, which corresponds to a higher concentration than Dose Level 1.
|
Flu mRNA_Dose Level 3_YA
n=24 participants at risk
On Day 1, YA participants received Flu mRNA at Dose Level 3, which corresponds to a higher concentration than Dose Level 2.
|
Flu mRNA_Dose Level 4_YA
n=24 participants at risk
On Day 1, YA participants received Flu mRNA at Dose Level 4, which corresponds to a higher concentration than Dose Level 3.
|
Flu mRNA_Dose Level 5_YA
n=24 participants at risk
On Day 1, YA participants received Flu mRNA at Dose Level 5, which corresponds to a higher concentration than Dose Level 4.
|
Flu mRNA_Dose Level 6_YA
n=24 participants at risk
On Day 1, YA participants received Flu mRNA at Dose Level 6, which corresponds to a higher concentration than Dose Level 5.
|
Flu mRNA_Dose Level 7_YA
n=24 participants at risk
On Day 1, YA participants received Flu mRNA at Dose Level 7, which corresponds to a higher concentration than Dose Level 6.
|
Flu mRNA_ Dose Level 8_YA
n=24 participants at risk
On Day 1, YA participants received Flu mRNA at Dose Level 8, which corresponds to a higher concentration than Dose Level 7.
|
Flu mRNA_Dose Level 9_YA
n=25 participants at risk
On Day 1, YA participants received Flu mRNA at Dose Level 9, which corresponds to a higher concentration than Dose Level 8.
|
Flu mRNA_Dose Level 10_YA
n=24 participants at risk
On Day 1, YA participants received Flu mRNA at Dose Level 10, the highest concentration evaluated in the study.
|
Pooled Control_YA
n=35 participants at risk
On Day 1, YA participants received a single dose of FDQ21A - NH or FDQ22A -NH administered as a control and were analyzed together as pooled group throughout the study.
|
Flu mRNA_Dose Level 7_Older Adults (OA)
n=32 participants at risk
On Day 1, OA participants received Flu mRNA at Dose Level 7.
|
Control_OA
n=16 participants at risk
On Day 1, OA participants received a single dose of FDQ21A-NH administered at as a control.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Abdominal infection
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
3.1%
1/32 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Injury, poisoning and procedural complications
Craniofacial fracture
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Injury, poisoning and procedural complications
Poisoning deliberate
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian germ cell teratoma benign
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Psychiatric disorders
Depression
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
2.9%
1/35 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
Other adverse events
| Measure |
Flu mRNA_Dose Level 1_Younger Adults (YA)
n=24 participants at risk
On Day 1, YA adult participants received Flu mRNA at Dose Level 1, the lowest concentration evaluated in the study.
|
Flu mRNA_Dose Level 2 _YA
n=24 participants at risk
On Day 1, YA participants received Flu mRNA at Dose Level 2, which corresponds to a higher concentration than Dose Level 1.
|
Flu mRNA_Dose Level 3_YA
n=24 participants at risk
On Day 1, YA participants received Flu mRNA at Dose Level 3, which corresponds to a higher concentration than Dose Level 2.
|
Flu mRNA_Dose Level 4_YA
n=24 participants at risk
On Day 1, YA participants received Flu mRNA at Dose Level 4, which corresponds to a higher concentration than Dose Level 3.
|
Flu mRNA_Dose Level 5_YA
n=24 participants at risk
On Day 1, YA participants received Flu mRNA at Dose Level 5, which corresponds to a higher concentration than Dose Level 4.
|
Flu mRNA_Dose Level 6_YA
n=24 participants at risk
On Day 1, YA participants received Flu mRNA at Dose Level 6, which corresponds to a higher concentration than Dose Level 5.
|
Flu mRNA_Dose Level 7_YA
n=24 participants at risk
On Day 1, YA participants received Flu mRNA at Dose Level 7, which corresponds to a higher concentration than Dose Level 6.
|
Flu mRNA_ Dose Level 8_YA
n=24 participants at risk
On Day 1, YA participants received Flu mRNA at Dose Level 8, which corresponds to a higher concentration than Dose Level 7.
|
Flu mRNA_Dose Level 9_YA
n=25 participants at risk
On Day 1, YA participants received Flu mRNA at Dose Level 9, which corresponds to a higher concentration than Dose Level 8.
|
Flu mRNA_Dose Level 10_YA
n=24 participants at risk
On Day 1, YA participants received Flu mRNA at Dose Level 10, the highest concentration evaluated in the study.
|
Pooled Control_YA
n=35 participants at risk
On Day 1, YA participants received a single dose of FDQ21A - NH or FDQ22A -NH administered as a control and were analyzed together as pooled group throughout the study.
|
Flu mRNA_Dose Level 7_Older Adults (OA)
n=32 participants at risk
On Day 1, OA participants received Flu mRNA at Dose Level 7.
|
Control_OA
n=16 participants at risk
On Day 1, OA participants received a single dose of FDQ21A-NH administered at as a control.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
16.7%
4/24 • Number of events 4 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
12.5%
3/24 • Number of events 3 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
20.8%
5/24 • Number of events 5 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
16.7%
4/24 • Number of events 4 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
29.2%
7/24 • Number of events 7 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
37.5%
9/24 • Number of events 9 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
36.0%
9/25 • Number of events 9 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
50.0%
12/24 • Number of events 12 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
28.6%
10/35 • Number of events 10 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Cardiac disorders
Palpitations
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
6.2%
1/16 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Eye disorders
Chalazion
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
3.1%
1/32 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
3.1%
1/32 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Eye disorders
Blepharospasm
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.0%
1/25 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Eye disorders
Dry eye
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.0%
1/25 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
3.1%
1/32 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
8.3%
2/24 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
6.2%
1/16 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.0%
1/25 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
12.5%
3/24 • Number of events 3 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
8.3%
2/24 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.0%
1/25 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
5.7%
2/35 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.0%
1/25 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
2.9%
1/35 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
6.2%
1/16 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Administration site acne
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Administration site erythema
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
8.3%
2/24 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
12.0%
3/25 • Number of events 3 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
25.0%
6/24 • Number of events 6 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
3.1%
1/32 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Administration site pain
|
20.8%
5/24 • Number of events 5 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
25.0%
6/24 • Number of events 6 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
33.3%
8/24 • Number of events 8 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
58.3%
14/24 • Number of events 14 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
66.7%
16/24 • Number of events 16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
79.2%
19/24 • Number of events 19 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
87.5%
21/24 • Number of events 21 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
87.5%
21/24 • Number of events 21 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
100.0%
25/25 • Number of events 25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
100.0%
24/24 • Number of events 24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
71.4%
25/35 • Number of events 25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
43.8%
14/32 • Number of events 14 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
43.8%
7/16 • Number of events 7 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Administration site pruritus
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
6.2%
1/16 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Administration site swelling
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
8.3%
2/24 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
20.0%
5/25 • Number of events 5 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
25.0%
6/24 • Number of events 6 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
12.5%
4/32 • Number of events 4 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Administration site warmth
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Asthenia
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
2.9%
1/35 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Chest pain
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Chills
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
8.3%
2/24 • Number of events 3 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
12.5%
3/24 • Number of events 3 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
16.7%
4/24 • Number of events 4 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
37.5%
9/24 • Number of events 9 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
16.7%
4/24 • Number of events 4 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
56.0%
14/25 • Number of events 14 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
41.7%
10/24 • Number of events 10 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
2.9%
1/35 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
9.4%
3/32 • Number of events 4 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Fatigue
|
33.3%
8/24 • Number of events 9 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
33.3%
8/24 • Number of events 8 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
50.0%
12/24 • Number of events 12 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
41.7%
10/24 • Number of events 10 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
50.0%
12/24 • Number of events 12 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
45.8%
11/24 • Number of events 12 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
66.7%
16/24 • Number of events 16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
62.5%
15/24 • Number of events 16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
88.0%
22/25 • Number of events 23 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
91.7%
22/24 • Number of events 22 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
57.1%
20/35 • Number of events 20 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
21.9%
7/32 • Number of events 8 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
12.5%
2/16 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Feeling hot
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
3.1%
1/32 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Hangover
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
8.3%
2/24 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Influenza like illness
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.0%
1/25 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Injection site bruising
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
2.9%
1/35 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
3.1%
1/32 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Injection site pruritus
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
3.1%
1/32 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Injection site reaction
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
5.7%
2/35 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Malaise
|
8.3%
2/24 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
8.3%
2/24 • Number of events 3 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
12.5%
3/24 • Number of events 3 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
25.0%
6/24 • Number of events 6 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
2.9%
1/35 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
3.1%
1/32 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Pyrexia
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
8.3%
2/24 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
8.0%
2/25 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
33.3%
8/24 • Number of events 8 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
5.7%
2/35 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
3.1%
1/32 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Swelling
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Temperature regulation disorder
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.0%
1/25 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
8.3%
2/24 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Vaccination site pain
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Vessel puncture site erythema
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
COVID-19
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
8.3%
2/24 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.0%
1/25 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Chlamydial infection
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
8.3%
2/24 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
2.9%
1/35 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
2.9%
1/35 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Nasopharyngitis
|
12.5%
3/24 • Number of events 3 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
8.3%
2/24 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
8.0%
2/25 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
5.7%
2/35 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
6.2%
2/32 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Omphalitis
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Oral herpes
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
2.9%
1/35 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Otitis media
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
3.1%
1/32 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
2.9%
1/35 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.0%
1/25 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Investigations
Blood urea increased
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Rhinitis
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Sinusitis
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
8.3%
2/24 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Tracheitis
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
6.2%
1/16 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
8.3%
2/24 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
8.3%
2/24 • Number of events 3 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
12.0%
3/25 • Number of events 3 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
2.9%
1/35 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
2.9%
1/35 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Injury, poisoning and procedural complications
Burns first degree
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
6.2%
1/16 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
3.1%
1/32 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Injury, poisoning and procedural complications
Iliotibial band syndrome
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Injury, poisoning and procedural complications
Immunisation reaction
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
2.9%
1/35 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Investigations
Alanine aminotransferase increased
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Investigations
Aspartate aminotransferase increased
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Investigations
C-reactive protein increased
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Investigations
Neutrophil count increased
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
6.2%
1/16 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
2/24 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
8.3%
2/24 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
12.5%
3/24 • Number of events 4 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
12.5%
3/24 • Number of events 4 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
12.5%
3/24 • Number of events 4 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
16.7%
4/24 • Number of events 5 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
16.7%
4/24 • Number of events 4 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
33.3%
8/24 • Number of events 8 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
24.0%
6/25 • Number of events 6 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
62.5%
15/24 • Number of events 15 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
11.4%
4/35 • Number of events 4 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
12.5%
4/32 • Number of events 4 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
18.8%
3/16 • Number of events 4 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.0%
1/25 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
6.2%
1/16 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Musculoskeletal and connective tissue disorders
Joint hyperextension
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
2.9%
1/35 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.0%
1/25 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
2.9%
1/35 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.5%
3/24 • Number of events 3 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
12.5%
3/24 • Number of events 3 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
16.7%
4/24 • Number of events 4 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
20.8%
5/24 • Number of events 6 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
20.8%
5/24 • Number of events 6 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
25.0%
6/24 • Number of events 6 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
62.5%
15/24 • Number of events 15 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
54.2%
13/24 • Number of events 13 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
80.0%
20/25 • Number of events 20 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
83.3%
20/24 • Number of events 20 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
37.1%
13/35 • Number of events 13 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
21.9%
7/32 • Number of events 7 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
6.2%
1/16 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
8.3%
2/24 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.0%
1/25 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
2.9%
1/35 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
3.1%
1/32 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
6.2%
1/16 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
6.2%
1/16 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.0%
1/25 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma of breast
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.0%
1/25 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.0%
1/25 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
2.9%
1/35 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Nervous system disorders
Headache
|
45.8%
11/24 • Number of events 12 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
33.3%
8/24 • Number of events 10 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
33.3%
8/24 • Number of events 10 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
41.7%
10/24 • Number of events 16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
37.5%
9/24 • Number of events 9 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
45.8%
11/24 • Number of events 13 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
58.3%
14/24 • Number of events 18 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
54.2%
13/24 • Number of events 16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
76.0%
19/25 • Number of events 19 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
79.2%
19/24 • Number of events 20 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
48.6%
17/35 • Number of events 19 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
37.5%
12/32 • Number of events 12 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
31.2%
5/16 • Number of events 6 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
2.9%
1/35 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
6.2%
1/16 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
2.9%
1/35 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
2.9%
1/35 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
8.0%
2/25 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
8.6%
3/35 • Number of events 3 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Reproductive system and breast disorders
Menstruation delayed
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.0%
1/25 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.0%
1/25 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
5.7%
2/35 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
6.2%
2/32 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
3.1%
1/32 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
12.5%
3/24 • Number of events 3 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
5.7%
2/35 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.3%
2/24 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
8.3%
2/24 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
25.0%
6/24 • Number of events 6 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
8.3%
2/24 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.0%
1/25 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
6.2%
2/32 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory symptom
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
2.9%
1/35 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
16.7%
4/24 • Number of events 4 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
6.2%
1/16 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
2.9%
1/35 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Skin and subcutaneous tissue disorders
Eczema
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Skin and subcutaneous tissue disorders
Hand dermatitis
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
8.3%
2/24 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
2.9%
1/35 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Skin and subcutaneous tissue disorders
Skin discomfort
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
2.9%
1/35 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Vascular disorders
Haematoma
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
1/24 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/35 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Vascular disorders
Hot flush
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/24 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
2.9%
1/35 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/32 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/16 • Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER