Trial Outcomes & Findings for A Study on the Safety, Tolerability and Immune Response of Meningococcal Combined ABCWY Vaccine in Healthy Infants (NCT NCT05082285)
NCT ID: NCT05082285
Last Updated: 2026-06-26
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
726 participants
Primary outcome timeframe
At Day 331 (1 month after the third vaccination)
Results posted on
2026-06-26
Participant Flow
A total of 726 participants were enrolled, of which 724 entered into the exposed set and started the study.
Participant milestones
| Measure |
MenACWY-7B Low Dose Group
Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.
|
MenACWY-7B High Dose Group
Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.
|
ABCWY-1Gen Group
Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.
|
MenB+MenACWY-TT Group
Participants received a single dose of the meningococcal group B (MenB) vaccine and the meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine on Day 1, Day 61 and Day 301.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
188
|
179
|
175
|
182
|
|
Overall Study
COMPLETED
|
183
|
163
|
169
|
170
|
|
Overall Study
NOT COMPLETED
|
5
|
16
|
6
|
12
|
Reasons for withdrawal
| Measure |
MenACWY-7B Low Dose Group
Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.
|
MenACWY-7B High Dose Group
Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.
|
ABCWY-1Gen Group
Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.
|
MenB+MenACWY-TT Group
Participants received a single dose of the meningococcal group B (MenB) vaccine and the meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine on Day 1, Day 61 and Day 301.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event (AE) requiring expedited reporting
|
0
|
1
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
1
|
|
Overall Study
Consent withdrawal not due to AE
|
3
|
8
|
3
|
8
|
|
Overall Study
Migrated / Moved from the study area
|
1
|
5
|
1
|
2
|
|
Overall Study
Other
|
1
|
1
|
1
|
0
|
Baseline Characteristics
A Study on the Safety, Tolerability and Immune Response of Meningococcal Combined ABCWY Vaccine in Healthy Infants
Baseline characteristics by cohort
| Measure |
MenACWY-7B Low Dose Group
n=188 Participants
Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.
|
MenACWY-7B High Dose Group
n=179 Participants
Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.
|
ABCWY-1Gen Group
n=175 Participants
Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.
|
MenB+MenACWY-TT Group
n=182 Participants
Participants received a single dose of the meningococcal group B (MenB) vaccine and the meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine on Day 1, Day 61 and Day 301.
|
Total
n=724 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
62.2 DAYS
STANDARD_DEVIATION 10.7 • n=20 Participants
|
62.3 DAYS
STANDARD_DEVIATION 10.0 • n=20 Participants
|
63.6 DAYS
STANDARD_DEVIATION 10.6 • n=40 Participants
|
64.5 DAYS
STANDARD_DEVIATION 11.3 • n=6 Participants
|
63.2 DAYS
STANDARD_DEVIATION 10.7 • n=7 Participants
|
|
Sex: Female, Male
Female
|
95 Participants
n=20 Participants
|
97 Participants
n=20 Participants
|
86 Participants
n=40 Participants
|
84 Participants
n=6 Participants
|
362 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
93 Participants
n=20 Participants
|
82 Participants
n=20 Participants
|
89 Participants
n=40 Participants
|
98 Participants
n=6 Participants
|
362 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White
|
133 Participants
n=20 Participants
|
132 Participants
n=20 Participants
|
124 Participants
n=40 Participants
|
131 Participants
n=6 Participants
|
520 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
35 Participants
n=20 Participants
|
29 Participants
n=20 Participants
|
37 Participants
n=40 Participants
|
33 Participants
n=6 Participants
|
134 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Other
|
19 Participants
n=20 Participants
|
17 Participants
n=20 Participants
|
12 Participants
n=40 Participants
|
16 Participants
n=6 Participants
|
64 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to Day 7Population: Analysis was performed on the Exposed Set (ES), which included all participants who received at least 1 dose of the study intervention and had solicited adverse event data available for the specified duration.
The solicited administration site events include tenderness (administration site pain), erythema (redness), induration and swelling. Any solicited administration site events = occurrence of the event regardless of intensity grade. Data for solicited administration site events is presented for each intervention administered in each arm group.
Outcome measures
| Measure |
MenB Group
n=182 Participants
Participants received a single dose of MenB vaccine as a control on Day 1, Day 61 and Day 301.
|
MenACWY-TT Group
n=182 Participants
Participants received a single dose of MenACWY-TT vaccine as a control on Day 1, Day 61 and Day 301.
|
MenACWY-7B Low Dose Group
n=188 Participants
Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.
|
MenACWY-7B High Dose Group
n=179 Participants
Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.
|
ABCWY-1Gen Group
n=175 Participants
Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.
|
|---|---|---|---|---|---|
|
Number of Participants Reporting Any Solicited Administration Site Events After the First Vaccination Administered on Day 1
Erythema
|
81 Participants
|
39 Participants
|
74 Participants
|
74 Participants
|
84 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the First Vaccination Administered on Day 1
Induration
|
91 Participants
|
43 Participants
|
93 Participants
|
80 Participants
|
108 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the First Vaccination Administered on Day 1
Swelling
|
66 Participants
|
32 Participants
|
55 Participants
|
57 Participants
|
70 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the First Vaccination Administered on Day 1
Tenderness
|
103 Participants
|
77 Participants
|
108 Participants
|
100 Participants
|
95 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to Day 7Population: Analysis was performed on the ES. Only participants with solicited adverse event data available for the specified duration were included in this analysis.
The solicited systemic events included diarrhoea, drowsiness (somnolence), fever (pyrexia), irritability/fussiness, loss of appetite, and vomiting. Fever is defined as temperature \>38.0°C/100.4°F. Any solicited systemic events = occurrence of the event regardless of intensity grade.
Outcome measures
| Measure |
MenB Group
n=182 Participants
Participants received a single dose of MenB vaccine as a control on Day 1, Day 61 and Day 301.
|
MenACWY-TT Group
Participants received a single dose of MenACWY-TT vaccine as a control on Day 1, Day 61 and Day 301.
|
MenACWY-7B Low Dose Group
n=188 Participants
Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.
|
MenACWY-7B High Dose Group
n=179 Participants
Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.
|
ABCWY-1Gen Group
n=175 Participants
Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.
|
|---|---|---|---|---|---|
|
Number of Participants Reporting Any Solicited Systemic Events After the First Vaccination Administered on Day 1
Diarrhoea
|
36 Participants
|
—
|
30 Participants
|
36 Participants
|
32 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events After the First Vaccination Administered on Day 1
Drowsiness
|
112 Participants
|
—
|
93 Participants
|
95 Participants
|
79 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events After the First Vaccination Administered on Day 1
Fever
|
41 Participants
|
—
|
50 Participants
|
43 Participants
|
39 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events After the First Vaccination Administered on Day 1
Irritability/Fussiness
|
140 Participants
|
—
|
127 Participants
|
132 Participants
|
118 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events After the First Vaccination Administered on Day 1
Loss of appetite
|
54 Participants
|
—
|
54 Participants
|
47 Participants
|
36 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events After the First Vaccination Administered on Day 1
Vomiting
|
29 Participants
|
—
|
24 Participants
|
30 Participants
|
26 Participants
|
PRIMARY outcome
Timeframe: From Day 61 to Day 67Population: Analysis was performed on the ES. Only participants with solicited adverse event data available for the specified duration were included in this analysis.
Outcome measures
| Measure |
MenB Group
n=126 Participants
Participants received a single dose of MenB vaccine as a control on Day 1, Day 61 and Day 301.
|
MenACWY-TT Group
n=126 Participants
Participants received a single dose of MenACWY-TT vaccine as a control on Day 1, Day 61 and Day 301.
|
MenACWY-7B Low Dose Group
n=137 Participants
Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.
|
MenACWY-7B High Dose Group
n=121 Participants
Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.
|
ABCWY-1Gen Group
n=118 Participants
Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.
|
|---|---|---|---|---|---|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Second Vaccination Administered on Day 61
Erythema
|
72 Participants
|
35 Participants
|
77 Participants
|
62 Participants
|
61 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Second Vaccination Administered on Day 61
Induration
|
79 Participants
|
38 Participants
|
81 Participants
|
65 Participants
|
74 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Second Vaccination Administered on Day 61
Swelling
|
59 Participants
|
32 Participants
|
57 Participants
|
45 Participants
|
43 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Second Vaccination Administered on Day 61
Tenderness
|
71 Participants
|
51 Participants
|
73 Participants
|
61 Participants
|
53 Participants
|
PRIMARY outcome
Timeframe: From Day 61 to Day 67Population: Analysis was performed on the ES. Only participants with solicited adverse event data available for the specified duration were included in this analysis.
Outcome measures
| Measure |
MenB Group
n=126 Participants
Participants received a single dose of MenB vaccine as a control on Day 1, Day 61 and Day 301.
|
MenACWY-TT Group
Participants received a single dose of MenACWY-TT vaccine as a control on Day 1, Day 61 and Day 301.
|
MenACWY-7B Low Dose Group
n=137 Participants
Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.
|
MenACWY-7B High Dose Group
n=121 Participants
Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.
|
ABCWY-1Gen Group
n=118 Participants
Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.
|
|---|---|---|---|---|---|
|
Number of Participants Reporting Any Solicited Systemic Events After the Second Vaccination Administered on Day 61
Loss of appetite
|
35 Participants
|
—
|
35 Participants
|
23 Participants
|
26 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events After the Second Vaccination Administered on Day 61
Vomiting
|
13 Participants
|
—
|
17 Participants
|
14 Participants
|
14 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events After the Second Vaccination Administered on Day 61
Fever
|
43 Participants
|
—
|
46 Participants
|
45 Participants
|
27 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events After the Second Vaccination Administered on Day 61
Irritability/Fussiness
|
92 Participants
|
—
|
93 Participants
|
78 Participants
|
69 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events After the Second Vaccination Administered on Day 61
Diarrhea
|
25 Participants
|
—
|
13 Participants
|
20 Participants
|
15 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events After the Second Vaccination Administered on Day 61
Drowsiness
|
51 Participants
|
—
|
48 Participants
|
42 Participants
|
39 Participants
|
PRIMARY outcome
Timeframe: From Day 301 to Day 307Population: Analysis was performed on the ES. Only participants with solicited adverse event data available for the specified duration were included in this analysis.
Outcome measures
| Measure |
MenB Group
n=111 Participants
Participants received a single dose of MenB vaccine as a control on Day 1, Day 61 and Day 301.
|
MenACWY-TT Group
n=111 Participants
Participants received a single dose of MenACWY-TT vaccine as a control on Day 1, Day 61 and Day 301.
|
MenACWY-7B Low Dose Group
n=118 Participants
Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.
|
MenACWY-7B High Dose Group
n=109 Participants
Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.
|
ABCWY-1Gen Group
n=114 Participants
Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.
|
|---|---|---|---|---|---|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Third Vaccination Administered on Day 301
Erythema
|
60 Participants
|
37 Participants
|
63 Participants
|
62 Participants
|
58 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Third Vaccination Administered on Day 301
Induration
|
74 Participants
|
46 Participants
|
77 Participants
|
63 Participants
|
75 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Third Vaccination Administered on Day 301
Swelling
|
62 Participants
|
39 Participants
|
57 Participants
|
48 Participants
|
43 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Third Vaccination Administered on Day 301
Tenderness
|
72 Participants
|
52 Participants
|
70 Participants
|
67 Participants
|
63 Participants
|
PRIMARY outcome
Timeframe: From Day 301 to Day 307Population: Analysis was performed on the ES. Only participants with solicited adverse event data available for the specified duration were included in this analysis.
Outcome measures
| Measure |
MenB Group
n=111 Participants
Participants received a single dose of MenB vaccine as a control on Day 1, Day 61 and Day 301.
|
MenACWY-TT Group
Participants received a single dose of MenACWY-TT vaccine as a control on Day 1, Day 61 and Day 301.
|
MenACWY-7B Low Dose Group
n=118 Participants
Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.
|
MenACWY-7B High Dose Group
n=109 Participants
Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.
|
ABCWY-1Gen Group
n=114 Participants
Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.
|
|---|---|---|---|---|---|
|
Number of Participants Reporting Any Solicited Systemic Events After the Third Vaccination Administered on Day 301
Diarrhea
|
14 Participants
|
—
|
15 Participants
|
14 Participants
|
15 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events After the Third Vaccination Administered on Day 301
Drowsiness
|
42 Participants
|
—
|
39 Participants
|
38 Participants
|
27 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events After the Third Vaccination Administered on Day 301
Fever
|
41 Participants
|
—
|
34 Participants
|
36 Participants
|
30 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events After the Third Vaccination Administered on Day 301
Irritability/Fussiness
|
72 Participants
|
—
|
62 Participants
|
62 Participants
|
63 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events After the Third Vaccination Administered on Day 301
Loss of appetite
|
43 Participants
|
—
|
39 Participants
|
37 Participants
|
27 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events After the Third Vaccination Administered on Day 301
Vomiting
|
9 Participants
|
—
|
12 Participants
|
14 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to Day 30Population: Analysis was performed on ES. Only participants with unsolicited adverse event data available for the specified duration were included in this analysis.
Unsolicited AEs includes any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event. Assessed unsolicited AEs include serious adverse events (SAEs), AEs leading to withdrawal, AEs of special interest (AESIs), and medically attended AEs (MAAEs). Any = occurrence of the event regardless of the intensity grade.
Outcome measures
| Measure |
MenB Group
n=182 Participants
Participants received a single dose of MenB vaccine as a control on Day 1, Day 61 and Day 301.
|
MenACWY-TT Group
Participants received a single dose of MenACWY-TT vaccine as a control on Day 1, Day 61 and Day 301.
|
MenACWY-7B Low Dose Group
n=188 Participants
Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.
|
MenACWY-7B High Dose Group
n=179 Participants
Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.
|
ABCWY-1Gen Group
n=175 Participants
Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.
|
|---|---|---|---|---|---|
|
Number of Participants Reporting Any Unsolicited Adverse Events (AEs) After the First Vaccination Administered on Day 1
|
36 Participants
|
—
|
35 Participants
|
35 Participants
|
48 Participants
|
PRIMARY outcome
Timeframe: From Day 61 to Day 90Population: Analysis was performed on the ES. Only participants with unsolicited adverse event data available for the specified duration were included in this analysis.
Outcome measures
| Measure |
MenB Group
n=126 Participants
Participants received a single dose of MenB vaccine as a control on Day 1, Day 61 and Day 301.
|
MenACWY-TT Group
Participants received a single dose of MenACWY-TT vaccine as a control on Day 1, Day 61 and Day 301.
|
MenACWY-7B Low Dose Group
n=137 Participants
Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.
|
MenACWY-7B High Dose Group
n=121 Participants
Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.
|
ABCWY-1Gen Group
n=118 Participants
Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.
|
|---|---|---|---|---|---|
|
Number of Participants Reporting Any Unsolicited AEs After the Second Vaccination Administered on Day 61
|
30 Participants
|
—
|
36 Participants
|
29 Participants
|
38 Participants
|
PRIMARY outcome
Timeframe: From Day 301 to Day 330Population: Analysis was performed on the ES. Only participants with unsolicited adverse event data available for the specified duration were included in this analysis.
Outcome measures
| Measure |
MenB Group
n=111 Participants
Participants received a single dose of MenB vaccine as a control on Day 1, Day 61 and Day 301.
|
MenACWY-TT Group
Participants received a single dose of MenACWY-TT vaccine as a control on Day 1, Day 61 and Day 301.
|
MenACWY-7B Low Dose Group
n=118 Participants
Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.
|
MenACWY-7B High Dose Group
n=109 Participants
Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.
|
ABCWY-1Gen Group
n=114 Participants
Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.
|
|---|---|---|---|---|---|
|
Number of Participants Reporting Any Unsolicited AEs After the Third Vaccination Administered on Day 301
|
28 Participants
|
—
|
32 Participants
|
38 Participants
|
34 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to Day 481Population: Analysis was performed on the ES.
MAAEs are defined as symptoms or illnesses requiring a hospitalization, or an emergency room visit, or visit to/by a health care provider. An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation in order to characterize and understand it. AEs leading to withdrawal are defined as AEs due which the participant is considered to have withdrawn from the study as no new study procedure has been performed or no new information has been collected for them since the date of withdrawal/last contact.
Outcome measures
| Measure |
MenB Group
n=182 Participants
Participants received a single dose of MenB vaccine as a control on Day 1, Day 61 and Day 301.
|
MenACWY-TT Group
Participants received a single dose of MenACWY-TT vaccine as a control on Day 1, Day 61 and Day 301.
|
MenACWY-7B Low Dose Group
n=188 Participants
Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.
|
MenACWY-7B High Dose Group
n=179 Participants
Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.
|
ABCWY-1Gen Group
n=175 Participants
Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.
|
|---|---|---|---|---|---|
|
Number of Participants Reporting MAAEs, SAEs, AEs Leading to Withdrawal, and AESIs
MAAEs
|
119 Participants
|
—
|
130 Participants
|
116 Participants
|
123 Participants
|
|
Number of Participants Reporting MAAEs, SAEs, AEs Leading to Withdrawal, and AESIs
SAEs
|
17 Participants
|
—
|
17 Participants
|
11 Participants
|
30 Participants
|
|
Number of Participants Reporting MAAEs, SAEs, AEs Leading to Withdrawal, and AESIs
AEs leading to withdrawal
|
1 Participants
|
—
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting MAAEs, SAEs, AEs Leading to Withdrawal, and AESIs
AESIs
|
0 Participants
|
—
|
1 Participants
|
6 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: At Day 91 (1 month after the second vaccination)Population: Analysis was performed on the Full Analysis Set (FAS) which included all participants who received at least 1 dose of the study intervention and have post-vaccination immunogenicity data available for the specified timepoint were included in this analysis.
The immune response to the MenACWY-7B vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenB vaccine was evaluated by measuring bactericidal activity using an hSBA against all serogroup B indicator strains fHbp, NadA, NHBA, PorA, fHbp V1.13, fHbp V2 and fHbp V3.
Outcome measures
| Measure |
MenB Group
n=79 Participants
Participants received a single dose of MenB vaccine as a control on Day 1, Day 61 and Day 301.
|
MenACWY-TT Group
Participants received a single dose of MenACWY-TT vaccine as a control on Day 1, Day 61 and Day 301.
|
MenACWY-7B Low Dose Group
n=86 Participants
Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.
|
MenACWY-7B High Dose Group
n=72 Participants
Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.
|
ABCWY-1Gen Group
n=72 Participants
Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Human Serum Bactericidal Assay (hSBA) Titers ≥ Lower Limit of Quantitation (LLOQ) for Each Serogroup B Indicator Strain at 1 Month After the Second Vaccination
fHbp
|
91.1 Percentage of participants
Interval 82.6 to 96.4
|
—
|
96.5 Percentage of participants
Interval 90.0 to 99.3
|
91.7 Percentage of participants
Interval 82.7 to 96.9
|
77.8 Percentage of participants
Interval 66.4 to 86.7
|
|
Percentage of Participants With Human Serum Bactericidal Assay (hSBA) Titers ≥ Lower Limit of Quantitation (LLOQ) for Each Serogroup B Indicator Strain at 1 Month After the Second Vaccination
NadA
|
96.1 Percentage of participants
Interval 89.0 to 99.2
|
—
|
88.2 Percentage of participants
Interval 79.4 to 94.2
|
88.2 Percentage of participants
Interval 78.1 to 94.8
|
82.1 Percentage of participants
Interval 70.8 to 90.4
|
|
Percentage of Participants With Human Serum Bactericidal Assay (hSBA) Titers ≥ Lower Limit of Quantitation (LLOQ) for Each Serogroup B Indicator Strain at 1 Month After the Second Vaccination
NHBA
|
68.4 Percentage of participants
Interval 56.9 to 78.4
|
—
|
95.3 Percentage of participants
Interval 88.5 to 98.7
|
92.9 Percentage of participants
Interval 84.1 to 97.6
|
42.0 Percentage of participants
Interval 30.2 to 54.5
|
|
Percentage of Participants With Human Serum Bactericidal Assay (hSBA) Titers ≥ Lower Limit of Quantitation (LLOQ) for Each Serogroup B Indicator Strain at 1 Month After the Second Vaccination
PorA
|
82.3 Percentage of participants
Interval 72.1 to 90.0
|
—
|
94.2 Percentage of participants
Interval 87.0 to 98.1
|
85.7 Percentage of participants
Interval 75.3 to 92.9
|
84.3 Percentage of participants
Interval 73.6 to 91.9
|
|
Percentage of Participants With Human Serum Bactericidal Assay (hSBA) Titers ≥ Lower Limit of Quantitation (LLOQ) for Each Serogroup B Indicator Strain at 1 Month After the Second Vaccination
fHbp V1.13
|
21.7 Percentage of participants
Interval 7.5 to 43.7
|
—
|
78.1 Percentage of participants
Interval 60.0 to 90.7
|
78.8 Percentage of participants
Interval 61.1 to 91.0
|
13.3 Percentage of participants
Interval 3.8 to 30.7
|
|
Percentage of Participants With Human Serum Bactericidal Assay (hSBA) Titers ≥ Lower Limit of Quantitation (LLOQ) for Each Serogroup B Indicator Strain at 1 Month After the Second Vaccination
fHbp V2
|
3.8 Percentage of participants
Interval 0.1 to 19.6
|
—
|
94.6 Percentage of participants
Interval 81.8 to 99.3
|
91.7 Percentage of participants
Interval 77.5 to 98.2
|
3.3 Percentage of participants
Interval 0.1 to 17.2
|
|
Percentage of Participants With Human Serum Bactericidal Assay (hSBA) Titers ≥ Lower Limit of Quantitation (LLOQ) for Each Serogroup B Indicator Strain at 1 Month After the Second Vaccination
fHbp V3
|
3.8 Percentage of participants
Interval 0.1 to 19.6
|
—
|
91.9 Percentage of participants
Interval 78.1 to 98.3
|
100 Percentage of participants
Interval 90.3 to 100.0
|
6.7 Percentage of participants
Interval 0.8 to 22.1
|
PRIMARY outcome
Timeframe: At Day 301 (pre-third vaccination)Population: Analysis was performed on the FAS. Only participants with post-vaccination immunogenicity data available for the specified timepoint were included in this analysis.
Outcome measures
| Measure |
MenB Group
n=78 Participants
Participants received a single dose of MenB vaccine as a control on Day 1, Day 61 and Day 301.
|
MenACWY-TT Group
Participants received a single dose of MenACWY-TT vaccine as a control on Day 1, Day 61 and Day 301.
|
MenACWY-7B Low Dose Group
n=75 Participants
Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.
|
MenACWY-7B High Dose Group
n=75 Participants
Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.
|
ABCWY-1Gen Group
n=74 Participants
Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.
|
|---|---|---|---|---|---|
|
Percentage of Participants With hSBA Titers ≥ LLOQ for Each Serogroup B Indicator Strain at Pre-third Vaccination
fHbp V3
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
—
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
6.5 Percentage of participants
Interval 0.8 to 21.4
|
|
Percentage of Participants With hSBA Titers ≥ LLOQ for Each Serogroup B Indicator Strain at Pre-third Vaccination
fHbp
|
3.9 Percentage of participants
Interval 0.8 to 11.1
|
—
|
4.1 Percentage of participants
Interval 0.9 to 11.5
|
6.7 Percentage of participants
Interval 2.2 to 14.9
|
4.1 Percentage of participants
Interval 0.9 to 11.5
|
|
Percentage of Participants With hSBA Titers ≥ LLOQ for Each Serogroup B Indicator Strain at Pre-third Vaccination
NadA
|
18.3 Percentage of participants
Interval 10.1 to 29.3
|
—
|
9.0 Percentage of participants
Interval 3.4 to 18.5
|
13.7 Percentage of participants
Interval 6.8 to 23.8
|
18.5 Percentage of participants
Interval 9.9 to 30.0
|
|
Percentage of Participants With hSBA Titers ≥ LLOQ for Each Serogroup B Indicator Strain at Pre-third Vaccination
NHBA
|
1.3 Percentage of participants
Interval 0.0 to 6.9
|
—
|
9.3 Percentage of participants
Interval 3.8 to 18.3
|
13.3 Percentage of participants
Interval 6.6 to 23.2
|
2.7 Percentage of participants
Interval 0.3 to 9.5
|
|
Percentage of Participants With hSBA Titers ≥ LLOQ for Each Serogroup B Indicator Strain at Pre-third Vaccination
PorA
|
3.8 Percentage of participants
Interval 0.8 to 10.8
|
—
|
8.0 Percentage of participants
Interval 3.0 to 16.6
|
8.0 Percentage of participants
Interval 3.0 to 16.6
|
8.1 Percentage of participants
Interval 3.0 to 16.8
|
|
Percentage of Participants With hSBA Titers ≥ LLOQ for Each Serogroup B Indicator Strain at Pre-third Vaccination
fHbp V1.13
|
4.0 Percentage of participants
Interval 0.1 to 20.4
|
—
|
3.0 Percentage of participants
Interval 0.1 to 15.8
|
6.5 Percentage of participants
Interval 0.8 to 21.4
|
9.7 Percentage of participants
Interval 2.0 to 25.8
|
|
Percentage of Participants With hSBA Titers ≥ LLOQ for Each Serogroup B Indicator Strain at Pre-third Vaccination
fHbp V2
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
—
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: At Day 331 (1 month after the third vaccination)Population: Analysis was performed on the FAS. Only participants with post-vaccination immunogenicity data available for the specified timepoint were included in this analysis.
Outcome measures
| Measure |
MenB Group
n=77 Participants
Participants received a single dose of MenB vaccine as a control on Day 1, Day 61 and Day 301.
|
MenACWY-TT Group
Participants received a single dose of MenACWY-TT vaccine as a control on Day 1, Day 61 and Day 301.
|
MenACWY-7B Low Dose Group
n=76 Participants
Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.
|
MenACWY-7B High Dose Group
n=73 Participants
Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.
|
ABCWY-1Gen Group
n=72 Participants
Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.
|
|---|---|---|---|---|---|
|
Percentage of Participants With hSBA Titers ≥ LLOQ for Each Serogroup B Indicator Strain at 1 Month After the Third Vaccination
fHbp
|
81.8 Percentage of participants
Interval 71.4 to 89.7
|
—
|
85.1 Percentage of participants
Interval 75.0 to 92.3
|
89.0 Percentage of participants
Interval 79.5 to 95.1
|
73.2 Percentage of participants
Interval 61.4 to 83.1
|
|
Percentage of Participants With hSBA Titers ≥ LLOQ for Each Serogroup B Indicator Strain at 1 Month After the Third Vaccination
NadA
|
98.6 Percentage of participants
Interval 92.6 to 100.0
|
—
|
88.6 Percentage of participants
Interval 78.7 to 94.9
|
91.4 Percentage of participants
Interval 82.3 to 96.8
|
91.3 Percentage of participants
Interval 82.0 to 96.7
|
|
Percentage of Participants With hSBA Titers ≥ LLOQ for Each Serogroup B Indicator Strain at 1 Month After the Third Vaccination
NHBA
|
92.1 Percentage of participants
Interval 83.6 to 97.0
|
—
|
100 Percentage of participants
Interval 95.3 to 100.0
|
100 Percentage of participants
Interval 95.1 to 100.0
|
83.1 Percentage of participants
Interval 72.3 to 91.0
|
|
Percentage of Participants With hSBA Titers ≥ LLOQ for Each Serogroup B Indicator Strain at 1 Month After the Third Vaccination
PorA
|
88.2 Percentage of participants
Interval 78.7 to 94.4
|
—
|
96.0 Percentage of participants
Interval 88.8 to 99.2
|
97.3 Percentage of participants
Interval 90.5 to 99.7
|
79.2 Percentage of participants
Interval 68.0 to 87.8
|
|
Percentage of Participants With hSBA Titers ≥ LLOQ for Each Serogroup B Indicator Strain at 1 Month After the Third Vaccination
fHbp V1.13
|
65.2 Percentage of participants
Interval 42.7 to 83.6
|
—
|
90.6 Percentage of participants
Interval 75.0 to 98.0
|
96.0 Percentage of participants
Interval 79.6 to 99.9
|
34.5 Percentage of participants
Interval 17.9 to 54.3
|
|
Percentage of Participants With hSBA Titers ≥ LLOQ for Each Serogroup B Indicator Strain at 1 Month After the Third Vaccination
fHbp V2
|
8.3 Percentage of participants
Interval 1.0 to 27.0
|
—
|
85.3 Percentage of participants
Interval 68.9 to 95.0
|
92.6 Percentage of participants
Interval 75.7 to 99.1
|
6.9 Percentage of participants
Interval 0.8 to 22.8
|
|
Percentage of Participants With hSBA Titers ≥ LLOQ for Each Serogroup B Indicator Strain at 1 Month After the Third Vaccination
fHbp V3
|
16.7 Percentage of participants
Interval 4.7 to 37.4
|
—
|
85.3 Percentage of participants
Interval 68.9 to 95.0
|
92.6 Percentage of participants
Interval 75.7 to 99.1
|
20.7 Percentage of participants
Interval 8.0 to 39.7
|
PRIMARY outcome
Timeframe: At Day 91 (1 month after the second vaccination)Population: Analysis was performed on the FAS. Only participants with post-vaccination immunogenicity data available for the specified timepoint were included in this analysis.
The immune response to the MenACWY-7B vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenB vaccine against serogroup B indicator strains is determined using hSBA GMTs.
Outcome measures
| Measure |
MenB Group
n=79 Participants
Participants received a single dose of MenB vaccine as a control on Day 1, Day 61 and Day 301.
|
MenACWY-TT Group
Participants received a single dose of MenACWY-TT vaccine as a control on Day 1, Day 61 and Day 301.
|
MenACWY-7B Low Dose Group
n=86 Participants
Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.
|
MenACWY-7B High Dose Group
n=72 Participants
Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.
|
ABCWY-1Gen Group
n=72 Participants
Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.
|
|---|---|---|---|---|---|
|
hSBA Geometric Mean Titers (GMTs) for Each Serogroup B Indicator Strain at 1 Month After the Second Vaccination
fHbp
|
45.7 Titer
Interval 35.4 to 59.0
|
—
|
118.6 Titer
Interval 94.0 to 149.6
|
111.8 Titer
Interval 86.2 to 145.1
|
30.2 Titer
Interval 23.2 to 39.3
|
|
hSBA Geometric Mean Titers (GMTs) for Each Serogroup B Indicator Strain at 1 Month After the Second Vaccination
NadA
|
148.3 Titer
Interval 105.4 to 208.8
|
—
|
65.6 Titer
Interval 48.1 to 89.4
|
79.9 Titer
Interval 56.3 to 113.5
|
65.7 Titer
Interval 46.1 to 93.8
|
|
hSBA Geometric Mean Titers (GMTs) for Each Serogroup B Indicator Strain at 1 Month After the Second Vaccination
NHBA
|
7.5 Titer
Interval 6.1 to 9.3
|
—
|
45.4 Titer
Interval 37.4 to 55.2
|
45.4 Titer
Interval 36.5 to 56.6
|
4.5 Titer
Interval 3.6 to 5.7
|
|
hSBA Geometric Mean Titers (GMTs) for Each Serogroup B Indicator Strain at 1 Month After the Second Vaccination
PorA
|
8.6 Titer
Interval 6.7 to 11.1
|
—
|
15.0 Titer
Interval 11.9 to 18.8
|
14.3 Titer
Interval 11.1 to 18.5
|
6.4 Titer
Interval 5.0 to 8.3
|
|
hSBA Geometric Mean Titers (GMTs) for Each Serogroup B Indicator Strain at 1 Month After the Second Vaccination
fHbp V1.13
|
3.9 Titer
Interval 2.3 to 6.7
|
—
|
39.5 Titer
Interval 24.6 to 63.4
|
36.2 Titer
Interval 23.4 to 55.9
|
3.8 Titer
Interval 2.3 to 6.1
|
|
hSBA Geometric Mean Titers (GMTs) for Each Serogroup B Indicator Strain at 1 Month After the Second Vaccination
fHbp V2
|
2.0 Titer
Interval 1.5 to 2.7
|
—
|
17.4 Titer
Interval 13.6 to 22.2
|
17.4 Titer
Interval 13.7 to 22.1
|
2.1 Titer
Interval 1.6 to 2.8
|
|
hSBA Geometric Mean Titers (GMTs) for Each Serogroup B Indicator Strain at 1 Month After the Second Vaccination
fHbp V3
|
1.5 Titer
Interval 1.1 to 2.1
|
—
|
23.1 Titer
Interval 17.6 to 30.4
|
23.1 Titer
Interval 17.7 to 30.2
|
1.5 Titer
Interval 1.1 to 2.1
|
PRIMARY outcome
Timeframe: At Day 301 (pre-third vaccination)Population: Analysis was performed on the FAS. Only participants with post-vaccination immunogenicity data available for the specified timepoint were included in this analysis.
Outcome measures
| Measure |
MenB Group
n=78 Participants
Participants received a single dose of MenB vaccine as a control on Day 1, Day 61 and Day 301.
|
MenACWY-TT Group
Participants received a single dose of MenACWY-TT vaccine as a control on Day 1, Day 61 and Day 301.
|
MenACWY-7B Low Dose Group
n=75 Participants
Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.
|
MenACWY-7B High Dose Group
n=75 Participants
Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.
|
ABCWY-1Gen Group
n=74 Participants
Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.
|
|---|---|---|---|---|---|
|
hSBA GMTs for Each Serogroup B Indicator Strain at Pre-third Vaccination
PorA
|
2.6 Titer
Interval 2.4 to 2.8
|
—
|
2.9 Titer
Interval 2.6 to 3.2
|
2.7 Titer
Interval 2.4 to 2.9
|
2.8 Titer
Interval 2.5 to 3.1
|
|
hSBA GMTs for Each Serogroup B Indicator Strain at Pre-third Vaccination
fHbp V1.13
|
3.1 Titer
Interval 2.8 to 3.4
|
—
|
3.2 Titer
Interval 3.0 to 3.5
|
3.3 Titer
Interval 3.1 to 3.6
|
3.4 Titer
Interval 3.2 to 3.7
|
|
hSBA GMTs for Each Serogroup B Indicator Strain at Pre-third Vaccination
fHbp V3
|
2.0 Titer
Interval 1.7 to 2.5
|
—
|
2.0 Titer
Interval 1.6 to 2.3
|
2.0 Titer
Interval 1.7 to 2.3
|
2.4 Titer
Interval 2.0 to 2.9
|
|
hSBA GMTs for Each Serogroup B Indicator Strain at Pre-third Vaccination
fHbp V2
|
2.5 Titer
Interval 2.5 to 2.5
|
—
|
2.5 Titer
Interval 2.5 to 2.5
|
2.5 Titer
Interval 2.5 to 2.5
|
2.5 Titer
Interval 2.5 to 2.5
|
|
hSBA GMTs for Each Serogroup B Indicator Strain at Pre-third Vaccination
fHbp
|
6.0 Titer
Interval 5.5 to 6.6
|
—
|
6.3 Titer
Interval 5.8 to 6.8
|
6.5 Titer
Interval 6.0 to 7.1
|
6.1 Titer
Interval 5.6 to 6.7
|
|
hSBA GMTs for Each Serogroup B Indicator Strain at Pre-third Vaccination
NadA
|
6.6 Titer
Interval 5.0 to 8.5
|
—
|
4.5 Titer
Interval 3.4 to 5.9
|
5.6 Titer
Interval 4.3 to 7.2
|
6.8 Titer
Interval 5.2 to 8.9
|
|
hSBA GMTs for Each Serogroup B Indicator Strain at Pre-third Vaccination
NHBA
|
3.4 Titer
Interval 2.9 to 3.8
|
—
|
4.0 Titer
Interval 3.5 to 4.5
|
4.2 Titer
Interval 3.7 to 4.8
|
3.5 Titer
Interval 3.0 to 4.0
|
PRIMARY outcome
Timeframe: At Day 331 (1 month after the third vaccination)Population: Analysis was performed on the FAS. Only participants with post-vaccination immunogenicity data available for the specified timepoint were included in this analysis.
Outcome measures
| Measure |
MenB Group
n=77 Participants
Participants received a single dose of MenB vaccine as a control on Day 1, Day 61 and Day 301.
|
MenACWY-TT Group
Participants received a single dose of MenACWY-TT vaccine as a control on Day 1, Day 61 and Day 301.
|
MenACWY-7B Low Dose Group
n=76 Participants
Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.
|
MenACWY-7B High Dose Group
n=73 Participants
Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.
|
ABCWY-1Gen Group
n=72 Participants
Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.
|
|---|---|---|---|---|---|
|
hSBA GMTs for Each Serogroup B Indicator Strain at 1 Month After the Third Vaccination
fHbp
|
60.1 Titer
Interval 42.6 to 84.9
|
—
|
106.9 Titer
Interval 76.5 to 149.2
|
149.3 Titer
Interval 106.0 to 210.3
|
47.0 Titer
Interval 33.0 to 67.1
|
|
hSBA GMTs for Each Serogroup B Indicator Strain at 1 Month After the Third Vaccination
NadA
|
816.3 Titer
Interval 525.4 to 1268.5
|
—
|
277.4 Titer
Interval 182.7 to 421.1
|
417.2 Titer
Interval 272.1 to 639.9
|
395.2 Titer
Interval 252.9 to 617.6
|
|
hSBA GMTs for Each Serogroup B Indicator Strain at 1 Month After the Third Vaccination
NHBA
|
21.2 Titer
Interval 17.1 to 26.2
|
—
|
70.8 Titer
Interval 57.8 to 86.7
|
83.2 Titer
Interval 67.5 to 102.6
|
13.2 Titer
Interval 10.6 to 16.4
|
|
hSBA GMTs for Each Serogroup B Indicator Strain at 1 Month After the Third Vaccination
PorA
|
18.9 Titer
Interval 13.9 to 25.8
|
—
|
30.3 Titer
Interval 22.5 to 40.7
|
34.0 Titer
Interval 25.1 to 46.1
|
11.4 Titer
Interval 8.3 to 15.7
|
|
hSBA GMTs for Each Serogroup B Indicator Strain at 1 Month After the Third Vaccination
fHbp V1.13
|
18.7 Titer
Interval 10.7 to 32.6
|
—
|
116.1 Titer
Interval 71.9 to 187.5
|
144.5 Titer
Interval 87.2 to 239.4
|
7.5 Titer
Interval 4.6 to 12.3
|
|
hSBA GMTs for Each Serogroup B Indicator Strain at 1 Month After the Third Vaccination
fHbp V2
|
3.0 Titer
Interval 2.0 to 4.4
|
—
|
19.3 Titer
Interval 13.9 to 26.8
|
22.5 Titer
Interval 15.8 to 31.9
|
2.8 Titer
Interval 2.0 to 4.0
|
|
hSBA GMTs for Each Serogroup B Indicator Strain at 1 Month After the Third Vaccination
fHbp V3
|
3.0 Titer
Interval 1.8 to 4.9
|
—
|
23.1 Titer
Interval 15.1 to 35.4
|
39.2 Titer
Interval 24.9 to 61.9
|
3.7 Titer
Interval 2.3 to 5.8
|
PRIMARY outcome
Timeframe: At Day 331 (1 month after the third vaccination) compared to Day 301 (pre-third vaccination)Population: Analysis was performed on the FAS. Only participants with post-vaccination immunogenicity data available for the specified timepoint were included in this analysis.
The immune response to the MenACWY-7B vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenB vaccine against serogroup B indicator strains is determined using hSBA GMRs. Within-group ratios of hSBA GMTs against each of the N.meningitidis serogroup B indicator strain at Day 331 compared to Day 301.
Outcome measures
| Measure |
MenB Group
n=73 Participants
Participants received a single dose of MenB vaccine as a control on Day 1, Day 61 and Day 301.
|
MenACWY-TT Group
Participants received a single dose of MenACWY-TT vaccine as a control on Day 1, Day 61 and Day 301.
|
MenACWY-7B Low Dose Group
n=71 Participants
Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.
|
MenACWY-7B High Dose Group
n=70 Participants
Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.
|
ABCWY-1Gen Group
n=69 Participants
Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.
|
|---|---|---|---|---|---|
|
hSBA Geometric Mean Ratios (GMRs) for Each Serogroup B Indicator Strain
fHbp
|
10.0 Ratio
Interval 7.1 to 14.2
|
—
|
15.3 Ratio
Interval 10.9 to 21.5
|
21.0 Ratio
Interval 14.9 to 29.6
|
7.3 Ratio
Interval 5.1 to 10.4
|
|
hSBA Geometric Mean Ratios (GMRs) for Each Serogroup B Indicator Strain
NadA
|
100.7 Ratio
Interval 61.3 to 165.4
|
—
|
44.1 Ratio
Interval 27.0 to 72.0
|
59.6 Ratio
Interval 37.0 to 96.0
|
45.2 Ratio
Interval 27.2 to 75.0
|
|
hSBA Geometric Mean Ratios (GMRs) for Each Serogroup B Indicator Strain
NHBA
|
6.3 Ratio
Interval 5.2 to 7.8
|
—
|
16.6 Ratio
Interval 13.5 to 20.3
|
19.3 Ratio
Interval 15.7 to 23.8
|
3.6 Ratio
Interval 2.9 to 4.4
|
|
hSBA Geometric Mean Ratios (GMRs) for Each Serogroup B Indicator Strain
PorA
|
7.2 Ratio
Interval 5.3 to 9.8
|
—
|
9.8 Ratio
Interval 7.2 to 13.2
|
12.2 Ratio
Interval 9.0 to 16.5
|
4.2 Ratio
Interval 3.1 to 5.7
|
|
hSBA Geometric Mean Ratios (GMRs) for Each Serogroup B Indicator Strain
fHbp V1.13
|
6.2 Ratio
Interval 3.5 to 10.9
|
—
|
37.8 Ratio
Interval 22.3 to 64.1
|
41.3 Ratio
Interval 24.5 to 69.4
|
2.2 Ratio
Interval 1.3 to 3.7
|
|
hSBA Geometric Mean Ratios (GMRs) for Each Serogroup B Indicator Strain
fHbp V2
|
1.2 Ratio
Interval 0.8 to 1.8
|
—
|
8.1 Ratio
Interval 5.7 to 11.6
|
8.7 Ratio
Interval 6.0 to 12.7
|
1.2 Ratio
Interval 0.8 to 1.7
|
|
hSBA Geometric Mean Ratios (GMRs) for Each Serogroup B Indicator Strain
fHbp V3
|
1.5 Ratio
Interval 0.9 to 2.3
|
—
|
12.0 Ratio
Interval 7.9 to 18.2
|
19.9 Ratio
Interval 13.1 to 30.3
|
1.6 Ratio
Interval 1.1 to 2.5
|
PRIMARY outcome
Timeframe: At Day 91 (1 month after the second vaccination)Population: Analysis was performed on the FAS. Only participants with post-vaccination immunogenicity data available for the specified timepoint were included in this analysis.
The immune response to the MenACWY-7B vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenACWY-TT vaccine is evaluated by measuring bactericidal activity using an hSBA against serogroups A, C, W and Y.
Outcome measures
| Measure |
MenB Group
n=114 Participants
Participants received a single dose of MenB vaccine as a control on Day 1, Day 61 and Day 301.
|
MenACWY-TT Group
Participants received a single dose of MenACWY-TT vaccine as a control on Day 1, Day 61 and Day 301.
|
MenACWY-7B Low Dose Group
n=129 Participants
Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.
|
MenACWY-7B High Dose Group
n=116 Participants
Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.
|
ABCWY-1Gen Group
n=109 Participants
Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.
|
|---|---|---|---|---|---|
|
Percentage of Participants With hSBA Titers ≥ LLOQ for Each A, C, W and Y Serogroup at 1 Month After the Second Vaccination
Men A
|
100 Percentage of participants
Interval 96.8 to 100.0
|
—
|
95.3 Percentage of participants
Interval 90.2 to 98.3
|
93.8 Percentage of participants
Interval 87.5 to 97.5
|
94.4 Percentage of participants
Interval 88.3 to 97.9
|
|
Percentage of Participants With hSBA Titers ≥ LLOQ for Each A, C, W and Y Serogroup at 1 Month After the Second Vaccination
Men C
|
98.2 Percentage of participants
Interval 93.6 to 99.8
|
—
|
99.2 Percentage of participants
Interval 95.7 to 100.0
|
98.2 Percentage of participants
Interval 93.8 to 99.8
|
98.2 Percentage of participants
Interval 93.5 to 99.8
|
|
Percentage of Participants With hSBA Titers ≥ LLOQ for Each A, C, W and Y Serogroup at 1 Month After the Second Vaccination
Men W
|
99.1 Percentage of participants
Interval 95.1 to 100.0
|
—
|
99.2 Percentage of participants
Interval 95.8 to 100.0
|
99.1 Percentage of participants
Interval 95.2 to 100.0
|
98.1 Percentage of participants
Interval 93.5 to 99.8
|
|
Percentage of Participants With hSBA Titers ≥ LLOQ for Each A, C, W and Y Serogroup at 1 Month After the Second Vaccination
Men Y
|
96.5 Percentage of participants
Interval 91.3 to 99.0
|
—
|
86.8 Percentage of participants
Interval 79.7 to 92.1
|
89.7 Percentage of participants
Interval 82.6 to 94.5
|
89.8 Percentage of participants
Interval 82.5 to 94.8
|
PRIMARY outcome
Timeframe: At Day 301 (pre-third vaccination)Population: Analysis was performed on the FAS. Only participants with post-vaccination immunogenicity data available for the specified timepoint were included in this analysis.
Outcome measures
| Measure |
MenB Group
n=108 Participants
Participants received a single dose of MenB vaccine as a control on Day 1, Day 61 and Day 301.
|
MenACWY-TT Group
Participants received a single dose of MenACWY-TT vaccine as a control on Day 1, Day 61 and Day 301.
|
MenACWY-7B Low Dose Group
n=114 Participants
Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.
|
MenACWY-7B High Dose Group
n=109 Participants
Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.
|
ABCWY-1Gen Group
n=113 Participants
Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.
|
|---|---|---|---|---|---|
|
Percentage of Participants With hSBA Titers ≥ LLOQ for Each A, C, W and Y Serogroup at Pre-third Vaccination
Men A
|
76.6 Percentage of participants
Interval 67.5 to 84.3
|
—
|
11.6 Percentage of participants
Interval 6.3 to 19.0
|
12.8 Percentage of participants
Interval 7.2 to 20.6
|
9.7 Percentage of participants
Interval 5.0 to 16.8
|
|
Percentage of Participants With hSBA Titers ≥ LLOQ for Each A, C, W and Y Serogroup at Pre-third Vaccination
Men C
|
84.1 Percentage of participants
Interval 75.8 to 90.5
|
—
|
44.7 Percentage of participants
Interval 35.4 to 54.3
|
47.7 Percentage of participants
Interval 38.1 to 57.5
|
54.1 Percentage of participants
Interval 44.3 to 63.6
|
|
Percentage of Participants With hSBA Titers ≥ LLOQ for Each A, C, W and Y Serogroup at Pre-third Vaccination
Men W
|
93.5 Percentage of participants
Interval 87.1 to 97.4
|
—
|
44.7 Percentage of participants
Interval 35.4 to 54.3
|
53.7 Percentage of participants
Interval 43.8 to 63.3
|
34.5 Percentage of participants
Interval 25.8 to 44.0
|
|
Percentage of Participants With hSBA Titers ≥ LLOQ for Each A, C, W and Y Serogroup at Pre-third Vaccination
Men Y
|
88.0 Percentage of participants
Interval 80.3 to 93.4
|
—
|
24.6 Percentage of participants
Interval 17.0 to 33.5
|
30.3 Percentage of participants
Interval 21.8 to 39.8
|
23.0 Percentage of participants
Interval 15.6 to 31.9
|
PRIMARY outcome
Timeframe: At Day 331 (1 month after the third vaccination)Population: Analysis was performed on the FAS. Only participants with post-vaccination immunogenicity data available for the specified timepoint were included in this analysis.
Outcome measures
| Measure |
MenB Group
n=103 Participants
Participants received a single dose of MenB vaccine as a control on Day 1, Day 61 and Day 301.
|
MenACWY-TT Group
Participants received a single dose of MenACWY-TT vaccine as a control on Day 1, Day 61 and Day 301.
|
MenACWY-7B Low Dose Group
n=114 Participants
Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.
|
MenACWY-7B High Dose Group
n=102 Participants
Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.
|
ABCWY-1Gen Group
n=109 Participants
Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.
|
|---|---|---|---|---|---|
|
Percentage of Participants With hSBA Titers ≥ LLOQ for Each A, C, W and Y Serogroup at 1 Month After the Third Vaccination
Men A
|
99.0 Percentage of participants
Interval 94.7 to 100.0
|
—
|
98.2 Percentage of participants
Interval 93.8 to 99.8
|
99.0 Percentage of participants
Interval 94.7 to 100.0
|
94.4 Percentage of participants
Interval 88.2 to 97.9
|
|
Percentage of Participants With hSBA Titers ≥ LLOQ for Each A, C, W and Y Serogroup at 1 Month After the Third Vaccination
Men C
|
99.0 Percentage of participants
Interval 94.7 to 100.0
|
—
|
99.1 Percentage of participants
Interval 95.2 to 100.0
|
100 Percentage of participants
Interval 96.4 to 100.0
|
97.2 Percentage of participants
Interval 92.0 to 99.4
|
|
Percentage of Participants With hSBA Titers ≥ LLOQ for Each A, C, W and Y Serogroup at 1 Month After the Third Vaccination
Men W
|
100 Percentage of participants
Interval 96.4 to 100.0
|
—
|
100 Percentage of participants
Interval 96.8 to 100.0
|
100 Percentage of participants
Interval 96.4 to 100.0
|
98.1 Percentage of participants
Interval 93.4 to 99.8
|
|
Percentage of Participants With hSBA Titers ≥ LLOQ for Each A, C, W and Y Serogroup at 1 Month After the Third Vaccination
Men Y
|
100 Percentage of participants
Interval 96.5 to 100.0
|
—
|
99.1 Percentage of participants
Interval 95.2 to 100.0
|
100 Percentage of participants
Interval 96.4 to 100.0
|
98.2 Percentage of participants
Interval 93.5 to 99.8
|
PRIMARY outcome
Timeframe: At Day 91 (1 month after the second vaccination)Population: Analysis was performed on the FAS. Only participants with post-vaccination immunogenicity data available for the specified timepoint were included in this analysis.
The immune response to the MenACWY-7B vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenACWY-TT vaccine against serogroups A, C, W and Y is determined using hSBA GMTs.
Outcome measures
| Measure |
MenB Group
n=114 Participants
Participants received a single dose of MenB vaccine as a control on Day 1, Day 61 and Day 301.
|
MenACWY-TT Group
Participants received a single dose of MenACWY-TT vaccine as a control on Day 1, Day 61 and Day 301.
|
MenACWY-7B Low Dose Group
n=129 Participants
Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.
|
MenACWY-7B High Dose Group
n=116 Participants
Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.
|
ABCWY-1Gen Group
n=109 Participants
Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.
|
|---|---|---|---|---|---|
|
hSBA GMTs for Each A, C, W and Y Serogroup at 1 Month After the Second Vaccination
Men A
|
266.5 Titer
Interval 218.2 to 325.5
|
—
|
89.8 Titer
Interval 74.9 to 107.5
|
98.1 Titer
Interval 80.7 to 119.3
|
74.4 Titer
Interval 60.8 to 91.1
|
|
hSBA GMTs for Each A, C, W and Y Serogroup at 1 Month After the Second Vaccination
Men C
|
233.1 Titer
Interval 187.9 to 289.1
|
—
|
277.0 Titer
Interval 228.9 to 335.3
|
280.1 Titer
Interval 228.7 to 342.9
|
265.5 Titer
Interval 214.6 to 328.4
|
|
hSBA GMTs for Each A, C, W and Y Serogroup at 1 Month After the Second Vaccination
Men W
|
226.8 Titer
Interval 182.3 to 282.0
|
—
|
388.9 Titer
Interval 320.5 to 471.8
|
365.5 Titer
Interval 296.2 to 451.1
|
207.8 Titer
Interval 167.1 to 258.2
|
|
hSBA GMTs for Each A, C, W and Y Serogroup at 1 Month After the Second Vaccination
Men Y
|
94.4 Titer
Interval 74.7 to 119.3
|
—
|
51.5 Titer
Interval 41.7 to 63.7
|
52.6 Titer
Interval 42.1 to 65.8
|
56.7 Titer
Interval 44.7 to 71.7
|
PRIMARY outcome
Timeframe: At Day 301 (pre-third vaccination)Population: Analysis was performed on the FAS. Only participants with post-vaccination immunogenicity data available for the specified timepoint were included in this analysis.
Outcome measures
| Measure |
MenB Group
n=108 Participants
Participants received a single dose of MenB vaccine as a control on Day 1, Day 61 and Day 301.
|
MenACWY-TT Group
Participants received a single dose of MenACWY-TT vaccine as a control on Day 1, Day 61 and Day 301.
|
MenACWY-7B Low Dose Group
n=114 Participants
Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.
|
MenACWY-7B High Dose Group
n=109 Participants
Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.
|
ABCWY-1Gen Group
n=113 Participants
Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.
|
|---|---|---|---|---|---|
|
hSBA GMTs for Each A, C, W and Y Serogroup at Pre-third Vaccination
Men A
|
37.0 Titer
Interval 31.5 to 43.5
|
—
|
6.4 Titer
Interval 5.5 to 7.5
|
6.7 Titer
Interval 5.7 to 7.8
|
6.2 Titer
Interval 5.3 to 7.2
|
|
hSBA GMTs for Each A, C, W and Y Serogroup at Pre-third Vaccination
Men C
|
25.1 Titer
Interval 20.2 to 31.2
|
—
|
7.8 Titer
Interval 6.4 to 9.6
|
8.3 Titer
Interval 6.8 to 10.3
|
8.1 Titer
Interval 6.6 to 10.0
|
|
hSBA GMTs for Each A, C, W and Y Serogroup at Pre-third Vaccination
Men W
|
54.4 Titer
Interval 43.3 to 68.3
|
—
|
8.6 Titer
Interval 7.0 to 10.7
|
11.9 Titer
Interval 9.6 to 14.9
|
6.8 Titer
Interval 5.4 to 8.4
|
|
hSBA GMTs for Each A, C, W and Y Serogroup at Pre-third Vaccination
Men Y
|
35.2 Titer
Interval 29.6 to 41.9
|
—
|
6.9 Titer
Interval 5.8 to 8.1
|
7.7 Titer
Interval 6.5 to 9.1
|
6.5 Titer
Interval 5.5 to 7.7
|
PRIMARY outcome
Timeframe: At Day 331 (1 month after the third vaccination)Population: Analysis was performed on the FAS. Only participants with post-vaccination immunogenicity data available for the specified timepoint were included in this analysis.
Outcome measures
| Measure |
MenB Group
n=103 Participants
Participants received a single dose of MenB vaccine as a control on Day 1, Day 61 and Day 301.
|
MenACWY-TT Group
Participants received a single dose of MenACWY-TT vaccine as a control on Day 1, Day 61 and Day 301.
|
MenACWY-7B Low Dose Group
n=114 Participants
Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.
|
MenACWY-7B High Dose Group
n=102 Participants
Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.
|
ABCWY-1Gen Group
n=109 Participants
Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.
|
|---|---|---|---|---|---|
|
hSBA GMTs for Each A, C, W and Y Serogroup at 1 Month After the Third Vaccination
Men A
|
1028.1 Titer
Interval 832.2 to 1270.0
|
—
|
133.7 Titer
Interval 110.0 to 162.5
|
174.6 Titer
Interval 142.1 to 214.6
|
113.8 Titer
Interval 93.1 to 139.0
|
|
hSBA GMTs for Each A, C, W and Y Serogroup at 1 Month After the Third Vaccination
Men Y
|
1230.2 Titer
Interval 969.3 to 1561.3
|
—
|
522.6 Titer
Interval 419.5 to 651.0
|
601.6 Titer
Interval 476.5 to 759.6
|
485.7 Titer
Interval 387.7 to 608.5
|
|
hSBA GMTs for Each A, C, W and Y Serogroup at 1 Month After the Third Vaccination
Men C
|
1356.6 Titer
Interval 1060.5 to 1735.3
|
—
|
511.0 Titer
Interval 407.0 to 641.6
|
681.9 Titer
Interval 536.7 to 866.4
|
487.3 Titer
Interval 386.1 to 614.9
|
|
hSBA GMTs for Each A, C, W and Y Serogroup at 1 Month After the Third Vaccination
Men W
|
1826.0 Titer
Interval 1488.2 to 2240.5
|
—
|
975.4 Titer
Interval 810.2 to 1174.3
|
1260.8 Titer
Interval 1034.6 to 1536.6
|
652.0 Titer
Interval 537.8 to 790.4
|
PRIMARY outcome
Timeframe: At Day 331 (1 month after the third vaccination) compared to Day 301 (pre-third vaccination)Population: Analysis was performed on the FAS. Only participants with post-vaccination immunogenicity data available for the specified timepoint were included in this analysis.
Outcome measures
| Measure |
MenB Group
n=103 Participants
Participants received a single dose of MenB vaccine as a control on Day 1, Day 61 and Day 301.
|
MenACWY-TT Group
Participants received a single dose of MenACWY-TT vaccine as a control on Day 1, Day 61 and Day 301.
|
MenACWY-7B Low Dose Group
n=110 Participants
Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.
|
MenACWY-7B High Dose Group
n=101 Participants
Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.
|
ABCWY-1Gen Group
n=108 Participants
Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.
|
|---|---|---|---|---|---|
|
hSBA GMRs for Each A, C, W and Y Serogroup
Men A
|
27.1 Ratio
Interval 21.1 to 34.8
|
—
|
20.6 Ratio
Interval 16.3 to 26.1
|
25.9 Ratio
Interval 20.3 to 33.1
|
18.7 Ratio
Interval 14.8 to 23.7
|
|
hSBA GMRs for Each A, C, W and Y Serogroup
Men C
|
54.7 Ratio
Interval 42.7 to 70.2
|
—
|
63.7 Ratio
Interval 50.5 to 80.3
|
85.3 Ratio
Interval 66.9 to 108.7
|
62.1 Ratio
Interval 49.0 to 78.6
|
|
hSBA GMRs for Each A, C, W and Y Serogroup
Men W
|
36.5 Ratio
Interval 28.6 to 46.6
|
—
|
113.6 Ratio
Interval 90.5 to 142.5
|
109.3 Ratio
Interval 86.1 to 138.8
|
102.4 Ratio
Interval 81.3 to 128.9
|
|
hSBA GMRs for Each A, C, W and Y Serogroup
Men Y
|
37.0 Ratio
Interval 29.1 to 47.0
|
—
|
76.3 Ratio
Interval 60.9 to 95.7
|
82.8 Ratio
Interval 65.4 to 104.8
|
78.2 Ratio
Interval 62.3 to 98.2
|
Adverse Events
MenACWY-7B Low Dose Group
Serious events: 17 serious events
Other events: 186 other events
Deaths: 0 deaths
MenACWY-7B High Dose Group
Serious events: 11 serious events
Other events: 177 other events
Deaths: 1 deaths
ABCWY-1Gen Group
Serious events: 30 serious events
Other events: 173 other events
Deaths: 1 deaths
MenB+MenACWY-TT Group
Serious events: 17 serious events
Other events: 181 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
MenACWY-7B Low Dose Group
n=188 participants at risk
Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.
|
MenACWY-7B High Dose Group
n=179 participants at risk
Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.
|
ABCWY-1Gen Group
n=175 participants at risk
Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.
|
MenB+MenACWY-TT Group
n=182 participants at risk
Participants received a single dose of the meningococcal group B (MenB) vaccine and the meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine on Day 1, Day 61 and Day 301.
|
|---|---|---|---|---|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Congenital, familial and genetic disorders
Arnold-Chiari malformation
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
General disorders
Pyrexia
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Immune system disorders
Milk allergy
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Abscess limb
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Amoebic dysentery
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Bronchiolitis
|
1.1%
2/188 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.1%
2/175 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Bronchitis
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
COVID-19
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.1%
2/175 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Dysentery
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Ear infection
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Gastroenteritis
|
1.6%
3/188 • Number of events 3 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
2.3%
4/175 • Number of events 4 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.6%
3/182 • Number of events 3 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Influenza
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Klebsiella sepsis
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Lower respiratory tract infection
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Mastoiditis
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Otitis media
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Pneumonia
|
1.1%
2/188 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.1%
2/179 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
2.3%
4/175 • Number of events 5 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
2.7%
5/182 • Number of events 6 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Pneumonia bacterial
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Respiratory syncytial virus bronchitis
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Rhinovirus infection
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Streptococcal sepsis
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.1%
2/175 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Viral infection
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Investigations
Respiratory syncytial virus test positive
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Musculoskeletal and connective tissue disorders
Facial asymmetry
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Nervous system disorders
Febrile convulsion
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
2.2%
4/179 • Number of events 4 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
2.3%
4/175 • Number of events 4 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Nervous system disorders
Fontanelle bulging
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Renal and urinary disorders
Nephrocalcinosis
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Renal and urinary disorders
Urinary tract inflammation
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.1%
2/182 • Number of events 3 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
Other adverse events
| Measure |
MenACWY-7B Low Dose Group
n=188 participants at risk
Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.
|
MenACWY-7B High Dose Group
n=179 participants at risk
Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.
|
ABCWY-1Gen Group
n=175 participants at risk
Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.
|
MenB+MenACWY-TT Group
n=182 participants at risk
Participants received a single dose of the meningococcal group B (MenB) vaccine and the meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine on Day 1, Day 61 and Day 301.
|
|---|---|---|---|---|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Eye disorders
Visual impairment
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Endocrine disorders
Precocious puberty
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Eye disorders
Anisometropia
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Eye disorders
Blepharitis
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Eye disorders
Chalazion
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Eye disorders
Eye allergy
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Eye disorders
Eye movement disorder
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Congenital, familial and genetic disorders
Brachycephaly
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Congenital, familial and genetic disorders
Congenital naevus
|
1.1%
2/188 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Eye disorders
Hypermetropia
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Eye disorders
Lacrimation increased
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Congenital, familial and genetic disorders
Congenital nail disorder
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Congenital, familial and genetic disorders
Naevus flammeus
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Eye disorders
Myopia
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Congenital, familial and genetic disorders
Plagiocephaly
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.1%
2/175 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.1%
2/182 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Eye disorders
Strabismus
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Congenital, familial and genetic disorders
Talipes
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Congenital, familial and genetic disorders
Tethered oral tissue
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Blood and lymphatic system disorders
Anaemia
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.1%
2/175 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Blood and lymphatic system disorders
Hypochromic anaemia
|
1.1%
2/188 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.1%
2/182 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Eye disorders
Corneal erosion
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Eye disorders
Dacryostenosis acquired
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Eye disorders
Eczema eyelids
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Eye disorders
Erythema of eyelid
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.1%
2/175 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.1%
2/179 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Gastrointestinal disorders
Angular cheilitis
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Gastrointestinal disorders
Constipation
|
2.7%
5/188 • Number of events 5 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.1%
2/179 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
4.0%
7/175 • Number of events 8 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
4.4%
8/182 • Number of events 10 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Gastrointestinal disorders
Diarrhoea
|
26.1%
49/188 • Number of events 61 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
33.0%
59/179 • Number of events 76 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
29.7%
52/175 • Number of events 69 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
34.1%
62/182 • Number of events 84 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Gastrointestinal disorders
Dyschezia
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Gastrointestinal disorders
Enteritis
|
1.1%
2/188 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.1%
2/175 • Number of events 4 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Gastrointestinal disorders
Flatulence
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
2.2%
4/182 • Number of events 5 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Gastrointestinal disorders
Food poisoning
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Gastrointestinal disorders
Food protein-induced enterocolitis syndrome
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.6%
3/188 • Number of events 3 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.7%
3/179 • Number of events 3 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
2.2%
4/182 • Number of events 4 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Gastrointestinal disorders
Haematochezia
|
0.53%
1/188 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Gastrointestinal disorders
Infant dyschezia
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Gastrointestinal disorders
Infantile colic
|
2.7%
5/188 • Number of events 5 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.7%
3/179 • Number of events 3 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
2.9%
5/175 • Number of events 6 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Gastrointestinal disorders
Mucous stools
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Gastrointestinal disorders
Nausea
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Gastrointestinal disorders
Oral pain
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Gastrointestinal disorders
Sandifer's syndrome
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Gastrointestinal disorders
Teething
|
2.7%
5/188 • Number of events 5 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.1%
2/179 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
2.3%
4/175 • Number of events 4 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Gastrointestinal disorders
Vomiting
|
27.1%
51/188 • Number of events 60 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
25.7%
46/179 • Number of events 62 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
22.9%
40/175 • Number of events 54 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
25.8%
47/182 • Number of events 56 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
General disorders
Administration site erythema
|
67.0%
126/188 • Number of events 220 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
64.8%
116/179 • Number of events 201 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
69.1%
121/175 • Number of events 213 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
70.9%
129/182 • Number of events 245 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
General disorders
Administration site induration
|
73.9%
139/188 • Number of events 253 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
65.9%
118/179 • Number of events 209 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
78.3%
137/175 • Number of events 259 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
75.8%
138/182 • Number of events 288 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
General disorders
Administration site pain
|
76.1%
143/188 • Number of events 255 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
70.9%
127/179 • Number of events 230 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
71.4%
125/175 • Number of events 213 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
76.4%
139/182 • Number of events 267 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
General disorders
Administration site swelling
|
53.2%
100/188 • Number of events 172 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
48.6%
87/179 • Number of events 153 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
54.9%
96/175 • Number of events 158 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
65.4%
119/182 • Number of events 216 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
General disorders
Catheter site dermatitis
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
General disorders
Crying
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
General disorders
Discomfort
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.1%
2/179 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
2.3%
4/175 • Number of events 8 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
General disorders
Injection site bruising
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
General disorders
Injection site discolouration
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
General disorders
Injection site induration
|
3.7%
7/188 • Number of events 7 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
2.2%
4/179 • Number of events 4 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
3.4%
6/175 • Number of events 8 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
3.3%
6/182 • Number of events 6 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
General disorders
Injection site mass
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 4 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
General disorders
Injection site swelling
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
General disorders
Malaise
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
General disorders
Pyrexia
|
46.8%
88/188 • Number of events 145 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
47.5%
85/179 • Number of events 140 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
41.7%
73/175 • Number of events 115 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
52.7%
96/182 • Number of events 147 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
General disorders
Vaccination site reaction
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Immune system disorders
Food allergy
|
2.1%
4/188 • Number of events 4 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.1%
2/175 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.1%
2/182 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Immune system disorders
Hypersensitivity
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Immune system disorders
Milk allergy
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.1%
2/179 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.7%
3/175 • Number of events 4 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.1%
2/182 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Abscess limb
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Abscess neck
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Acute sinusitis
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Amoebic dysentery
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Anal candidiasis
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Blastocystis infection
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Body tinea
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.7%
3/179 • Number of events 3 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Bronchiolitis
|
6.9%
13/188 • Number of events 17 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
8.4%
15/179 • Number of events 21 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
6.9%
12/175 • Number of events 16 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
9.9%
18/182 • Number of events 21 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Bronchitis
|
5.9%
11/188 • Number of events 15 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
8.4%
15/179 • Number of events 27 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
7.4%
13/175 • Number of events 20 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
7.1%
13/182 • Number of events 20 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
COVID-19
|
5.9%
11/188 • Number of events 11 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
6.1%
11/179 • Number of events 11 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
4.0%
7/175 • Number of events 7 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
4.9%
9/182 • Number of events 9 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.1%
2/179 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Candida infection
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Candida nappy rash
|
2.1%
4/188 • Number of events 4 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Conjunctivitis
|
12.2%
23/188 • Number of events 30 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
12.3%
22/179 • Number of events 28 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
10.3%
18/175 • Number of events 23 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
11.0%
20/182 • Number of events 27 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Conjunctivitis bacterial
|
2.7%
5/188 • Number of events 5 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
2.2%
4/179 • Number of events 4 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Coronavirus infection
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Croup infectious
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Dacryocystitis
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Dermatitis infected
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Dysentery
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Ear infection
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.1%
2/179 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.7%
3/175 • Number of events 3 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
2.2%
4/182 • Number of events 4 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Eczema impetiginous
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Enterovirus infection
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Erythema infectiosum
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Exanthema subitum
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.1%
2/179 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Eye infection
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Febrile infection
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Folliculitis
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Fungal infection
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Fungal skin infection
|
1.6%
3/188 • Number of events 3 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.1%
2/179 • Number of events 3 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.7%
3/175 • Number of events 3 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Furuncle
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Gastroenteritis
|
13.8%
26/188 • Number of events 39 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
13.4%
24/179 • Number of events 30 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
16.6%
29/175 • Number of events 37 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
10.4%
19/182 • Number of events 28 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Gastroenteritis Escherichia coli
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Gastroenteritis viral
|
1.1%
2/188 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Gianotti-Crosti syndrome
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Giardiasis
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.1%
2/182 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
3.2%
6/188 • Number of events 6 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
3.4%
6/179 • Number of events 7 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
5.7%
10/175 • Number of events 10 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.6%
3/182 • Number of events 5 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Herpangina
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.7%
3/179 • Number of events 3 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.1%
2/175 • Number of events 3 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.1%
2/182 • Number of events 3 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Impetigo
|
1.1%
2/188 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.7%
3/179 • Number of events 3 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.6%
3/182 • Number of events 3 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Infection parasitic
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Influenza
|
2.1%
4/188 • Number of events 4 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.6%
3/182 • Number of events 4 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Laryngitis
|
3.2%
6/188 • Number of events 8 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
4.5%
8/179 • Number of events 13 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
5.7%
10/175 • Number of events 12 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
4.9%
9/182 • Number of events 11 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Laryngitis viral
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Latent tuberculosis
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Lower respiratory tract infection
|
7.4%
14/188 • Number of events 16 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
2.8%
5/179 • Number of events 5 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
5.1%
9/175 • Number of events 11 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
3.8%
7/182 • Number of events 10 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Mycoplasma infection
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Nasopharyngitis
|
15.4%
29/188 • Number of events 43 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
16.8%
30/179 • Number of events 54 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
9.1%
16/175 • Number of events 21 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
11.5%
21/182 • Number of events 33 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Norovirus infection
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Onychomycosis
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Oral candidiasis
|
3.2%
6/188 • Number of events 7 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
2.2%
4/179 • Number of events 4 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
2.9%
5/175 • Number of events 5 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
3.8%
7/182 • Number of events 7 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Oral herpes
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.7%
3/179 • Number of events 3 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Otitis externa
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.7%
3/179 • Number of events 4 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Otitis media
|
5.3%
10/188 • Number of events 12 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
8.9%
16/179 • Number of events 22 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
7.4%
13/175 • Number of events 17 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
5.5%
10/182 • Number of events 10 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Otitis media acute
|
4.8%
9/188 • Number of events 13 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
9.5%
17/179 • Number of events 22 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
6.9%
12/175 • Number of events 20 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
7.1%
13/182 • Number of events 21 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Otitis media chronic
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Parasitic gastroenteritis
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Paronychia
|
1.1%
2/188 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Periorbital cellulitis
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Pharyngitis
|
1.6%
3/188 • Number of events 5 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
2.2%
4/179 • Number of events 4 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
2.3%
4/175 • Number of events 5 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
3.8%
7/182 • Number of events 9 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Pharyngitis bacterial
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.1%
2/175 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Pharyngotonsillitis
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.1%
2/175 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Pneumonia
|
1.6%
3/188 • Number of events 4 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
2.2%
4/179 • Number of events 4 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.7%
3/175 • Number of events 3 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.1%
2/182 • Number of events 3 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Pneumonia viral
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Pyoderma
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Rash pustular
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.1%
2/175 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Respiratory syncytial virus bronchitis
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.1%
2/179 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Respiratory syncytial virus infection
|
1.6%
3/188 • Number of events 3 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.1%
2/182 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Respiratory tract infection
|
7.4%
14/188 • Number of events 27 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
4.5%
8/179 • Number of events 11 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
8.0%
14/175 • Number of events 18 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
10.4%
19/182 • Number of events 26 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Respiratory tract infection bacterial
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Respiratory tract infection viral
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Rhinitis
|
3.2%
6/188 • Number of events 9 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
3.4%
6/175 • Number of events 9 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
2.7%
5/182 • Number of events 7 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Roseola
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Scabies
|
1.1%
2/188 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Scarlet fever
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Sinusitis
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Skin bacterial infection
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Skin candida
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Skin infection
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Streptococcal infection
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Subglottic laryngitis
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.1%
2/175 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Suspected COVID-19
|
1.1%
2/188 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Tinea capitis
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Tinea faciei
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Tonsillitis
|
1.1%
2/188 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.1%
2/179 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
2.9%
5/175 • Number of events 5 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.6%
3/182 • Number of events 3 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Tracheitis
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Tracheobronchitis
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Upper respiratory tract infection
|
22.9%
43/188 • Number of events 80 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
17.3%
31/179 • Number of events 57 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
27.4%
48/175 • Number of events 111 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
24.2%
44/182 • Number of events 84 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Urinary tract infection
|
1.1%
2/188 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.7%
3/179 • Number of events 4 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
2.9%
5/175 • Number of events 5 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.1%
2/182 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Urinary tract infection viral
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Varicella
|
1.1%
2/188 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.1%
2/179 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Varicella zoster virus infection
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Viral diarrhoea
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Viral infection
|
4.8%
9/188 • Number of events 13 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
2.8%
5/179 • Number of events 6 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
4.0%
7/175 • Number of events 8 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
2.2%
4/182 • Number of events 4 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Viral pharyngitis
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Viral rash
|
1.6%
3/188 • Number of events 4 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.1%
2/179 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.6%
3/182 • Number of events 3 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Viral skin infection
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Viral tonsillitis
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Infections and infestations
Viral upper respiratory tract infection
|
9.6%
18/188 • Number of events 33 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
8.9%
16/179 • Number of events 41 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
5.1%
9/175 • Number of events 21 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
4.9%
9/182 • Number of events 16 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
1.1%
2/188 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Injury, poisoning and procedural complications
Contusion
|
1.6%
3/188 • Number of events 3 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Injury, poisoning and procedural complications
Exposure to communicable disease
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Injury, poisoning and procedural complications
Fall
|
0.53%
1/188 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.1%
2/175 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Injury, poisoning and procedural complications
Foreign body in mouth
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Injury, poisoning and procedural complications
Head injury
|
0.53%
1/188 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
2.2%
4/179 • Number of events 4 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
2.9%
5/175 • Number of events 5 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.6%
3/182 • Number of events 3 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Injury, poisoning and procedural complications
Immunisation reaction
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.1%
2/179 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Injury, poisoning and procedural complications
Mouth injury
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Injury, poisoning and procedural complications
Nail injury
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Injury, poisoning and procedural complications
Nasal injury
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Injury, poisoning and procedural complications
Wound
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Investigations
Activated partial thromboplastin time shortened
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Investigations
Cardiac murmur
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Investigations
Coagulation test abnormal
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Metabolism and nutrition disorders
Dairy intolerance
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Metabolism and nutrition disorders
Decreased appetite
|
47.3%
89/188 • Number of events 128 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
45.8%
82/179 • Number of events 107 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
34.9%
61/175 • Number of events 90 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
52.7%
96/182 • Number of events 133 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.1%
2/179 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Metabolism and nutrition disorders
Food intolerance
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.1%
2/179 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.1%
2/182 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Metabolism and nutrition disorders
Lactose intolerance
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.1%
2/179 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Metabolism and nutrition disorders
Underweight
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Metabolism and nutrition disorders
Weight gain poor
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Metabolism and nutrition disorders
Zinc deficiency
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Musculoskeletal and connective tissue disorders
Acquired plagiocephaly
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Musculoskeletal and connective tissue disorders
Growth retardation
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Musculoskeletal and connective tissue disorders
Infantile postural asymmetry
|
1.1%
2/188 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Nervous system disorders
Hypertonia
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infantile haemangioma
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.1%
2/175 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Nervous system disorders
Epilepsy
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Nervous system disorders
Febrile convulsion
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Nervous system disorders
Hypotonia
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Nervous system disorders
Hypotonic-hyporesponsive episode
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Nervous system disorders
Movement disorder
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Nervous system disorders
Muscle contractions involuntary
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Nervous system disorders
Nystagmus
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Nervous system disorders
Psychomotor skills impaired
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Nervous system disorders
Seizure
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Nervous system disorders
Somnolence
|
59.0%
111/188 • Number of events 181 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
67.0%
120/179 • Number of events 176 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
50.9%
89/175 • Number of events 146 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
74.2%
135/182 • Number of events 205 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Nervous system disorders
Tremor
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Pregnancy, puerperium and perinatal conditions
Umbilical granuloma
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Psychiatric disorders
Apathy
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Psychiatric disorders
Behaviour disorder
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Psychiatric disorders
Breath holding
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Psychiatric disorders
Initial insomnia
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Psychiatric disorders
Irritability
|
84.0%
158/188 • Number of events 292 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
84.9%
152/179 • Number of events 276 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
82.3%
144/175 • Number of events 253 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
89.0%
162/182 • Number of events 307 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Psychiatric disorders
Poor quality sleep
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Psychiatric disorders
Psychomotor retardation
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Psychiatric disorders
Sleep terror
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Renal and urinary disorders
Pyelocaliectasis
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Reproductive system and breast disorders
Breast mass
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Reproductive system and breast disorders
Genital labial adhesions
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.1%
2/182 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Respiratory, thoracic and mediastinal disorders
Aphonia
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
1.1%
2/188 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.1%
2/182 • Number of events 7 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.1%
2/175 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
2.7%
5/188 • Number of events 8 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.6%
3/182 • Number of events 3 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Respiratory, thoracic and mediastinal disorders
Catarrh
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.7%
5/188 • Number of events 7 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.7%
3/179 • Number of events 3 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
5.7%
10/175 • Number of events 10 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
4.9%
9/182 • Number of events 10 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.2%
6/188 • Number of events 6 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
2.3%
4/175 • Number of events 5 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
2.2%
4/182 • Number of events 4 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive sleep apnoea syndrome
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.1%
2/179 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
2.3%
4/175 • Number of events 4 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.1%
2/182 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.1%
2/175 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
3.2%
6/188 • Number of events 6 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
3.4%
6/179 • Number of events 6 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
4.0%
7/175 • Number of events 7 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
3.8%
7/182 • Number of events 7 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
2.7%
5/188 • Number of events 5 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
3.4%
6/179 • Number of events 6 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
2.9%
5/175 • Number of events 5 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
4.4%
8/182 • Number of events 9 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.7%
3/179 • Number of events 3 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
8.0%
15/188 • Number of events 16 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
7.3%
13/179 • Number of events 19 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
3.4%
6/175 • Number of events 8 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
7.7%
14/182 • Number of events 14 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Skin and subcutaneous tissue disorders
Eczema
|
5.3%
10/188 • Number of events 11 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
5.0%
9/179 • Number of events 11 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
2.9%
5/175 • Number of events 5 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
5.5%
10/182 • Number of events 10 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.1%
2/179 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Skin and subcutaneous tissue disorders
Lipohypertrophy
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
1.1%
2/188 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.6%
3/182 • Number of events 3 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Skin and subcutaneous tissue disorders
Papulopustular rosacea
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Skin and subcutaneous tissue disorders
Perioral dermatitis
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.1%
2/175 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Skin and subcutaneous tissue disorders
Pityriasis alba
|
1.1%
2/188 • Number of events 3 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.3%
8/188 • Number of events 10 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
6.1%
11/179 • Number of events 13 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
4.0%
7/175 • Number of events 7 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
4.9%
9/182 • Number of events 10 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.57%
1/175 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/182 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.1%
2/179 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.7%
3/175 • Number of events 3 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.53%
1/188 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.56%
1/179 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
1.1%
2/175 • Number of events 2 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
2.2%
4/182 • Number of events 4 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
|
Vascular disorders
Pallor
|
0.00%
0/188 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/179 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.00%
0/175 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
0.55%
1/182 • Number of events 1 • Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481
|
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