Trial Outcomes & Findings for A Study to Evaluate the Safety, Tolerability, Immunogenicity and Vaccine-like Viral Shedding of MEDI-534, Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3), in Healthy 6 to <24 Month-old Children and in 2 Month-old Infants (NCT NCT00686075)
NCT ID: NCT00686075
Last Updated: 2014-09-26
Results Overview
Solicited symptoms were predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms included fever greater than or equal to (\>=) 100.4 degrees Fahrenheit (F), runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, oropharyngeal inflammation (laryngitis), and epistaxis.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
1338 participants
Primary outcome timeframe
Within 28 days after Dose 1
Results posted on
2014-09-26
Participant Flow
A total of 720 participants were randomized in the study. An additional 618 participants were screened but not randomized in the study.
Participant milestones
| Measure |
MEDI-534, Cohort 1
Participants aged 6 to less than (\<) 24 months received MEDI-534, 10\^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 1
Participants aged 6 to \<24 months received placebo matched to MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 2
Participants aged 6 to \<24 months received MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 2
Participants aged 6 to \<24 months received placebo matched to MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 3
Participants aged 2 months received MEDI-534, 10\^4 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 3
Participants aged 2 months received placebo matched to MEDI-534, 10\^4 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 4
Participants aged 2 months received MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 4
Participants aged 2 months received placebo matched to MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 5
Participants aged 2 months received MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 5
Participants aged 2 months received placebo matched to MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
79
|
81
|
80
|
80
|
40
|
40
|
82
|
78
|
81
|
79
|
|
Overall Study
Treated
|
78
|
79
|
80
|
80
|
40
|
40
|
82
|
77
|
80
|
78
|
|
Overall Study
COMPLETED
|
71
|
71
|
74
|
71
|
36
|
37
|
82
|
76
|
75
|
69
|
|
Overall Study
NOT COMPLETED
|
8
|
10
|
6
|
9
|
4
|
3
|
0
|
2
|
6
|
10
|
Reasons for withdrawal
| Measure |
MEDI-534, Cohort 1
Participants aged 6 to less than (\<) 24 months received MEDI-534, 10\^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 1
Participants aged 6 to \<24 months received placebo matched to MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 2
Participants aged 6 to \<24 months received MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 2
Participants aged 6 to \<24 months received placebo matched to MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 3
Participants aged 2 months received MEDI-534, 10\^4 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 3
Participants aged 2 months received placebo matched to MEDI-534, 10\^4 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 4
Participants aged 2 months received MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 4
Participants aged 2 months received placebo matched to MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 5
Participants aged 2 months received MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 5
Participants aged 2 months received placebo matched to MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
3
|
3
|
7
|
1
|
0
|
0
|
2
|
4
|
6
|
|
Overall Study
Lost to Follow-up
|
3
|
6
|
3
|
2
|
3
|
3
|
0
|
0
|
2
|
3
|
|
Overall Study
Other
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study to Evaluate the Safety, Tolerability, Immunogenicity and Vaccine-like Viral Shedding of MEDI-534, Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3), in Healthy 6 to <24 Month-old Children and in 2 Month-old Infants
Baseline characteristics by cohort
| Measure |
MEDI-534, Cohort 1
n=79 Participants
Participants aged 6 to less than (\<) 24 months received MEDI-534, 10\^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 1
n=81 Participants
Participants aged 6 to \<24 months received placebo matched to MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 2
n=80 Participants
Participants aged 6 to \<24 months received MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 2
n=80 Participants
Participants aged 6 to \<24 months received placebo matched to MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 3
n=40 Participants
Participants aged 2 months received MEDI-534, 10\^4 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 3
n=40 Participants
Participants aged 2 months received placebo matched to MEDI-534, 10\^4 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 4
n=82 Participants
Participants aged 2 months received MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 4
n=78 Participants
Participants aged 2 months received placebo matched to MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 5
n=81 Participants
Participants aged 2 months received MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 5
n=79 Participants
Participants aged 2 months received placebo matched to MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
Total
n=720 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
Less than (<) 6 months
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
40 participants
n=21 Participants
|
40 participants
n=10 Participants
|
82 participants
n=115 Participants
|
78 participants
n=24 Participants
|
81 participants
n=42 Participants
|
79 participants
n=42 Participants
|
400 participants
n=42 Participants
|
|
Age, Customized
6 to <24 months
|
79 participants
n=5 Participants
|
81 participants
n=7 Participants
|
80 participants
n=5 Participants
|
80 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
0 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
320 participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
18 Participants
n=10 Participants
|
47 Participants
n=115 Participants
|
41 Participants
n=24 Participants
|
39 Participants
n=42 Participants
|
43 Participants
n=42 Participants
|
360 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
22 Participants
n=10 Participants
|
35 Participants
n=115 Participants
|
37 Participants
n=24 Participants
|
42 Participants
n=42 Participants
|
36 Participants
n=42 Participants
|
360 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Within 28 days after Dose 1Population: Dose 1 safety population included all randomized participants who received study vaccine Dose 1 and had safety follow-up data.
Solicited symptoms were predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms included fever greater than or equal to (\>=) 100.4 degrees Fahrenheit (F), runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, oropharyngeal inflammation (laryngitis), and epistaxis.
Outcome measures
| Measure |
MEDI-534, Cohort 1
n=78 Participants
Participants aged 6 to less than (\<) 24 months received MEDI-534, 10\^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 1
n=79 Participants
Participants aged 6 to \<24 months received placebo matched to MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 2
n=80 Participants
Participants aged 6 to \<24 months received MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 2
n=80 Participants
Participants aged 6 to \<24 months received placebo matched to MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 3
n=40 Participants
Participants aged 2 months received MEDI-534, 10\^4 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 3
n=40 Participants
Participants aged 2 months received placebo matched to MEDI-534, 10\^4 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 4
n=82 Participants
Participants aged 2 months received MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 4
n=77 Participants
Participants aged 2 months received placebo matched to MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 5
n=80 Participants
Participants aged 2 months received MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 5
n=78 Participants
Participants aged 2 months received placebo matched to MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Symptoms After Dose 1
Any solicited symptom
|
65 participants
|
68 participants
|
61 participants
|
59 participants
|
27 participants
|
24 participants
|
50 participants
|
48 participants
|
60 participants
|
53 participants
|
|
Number of Participants With Solicited Symptoms After Dose 1
Fever: 100.4 to 101.4 degrees F
|
13 participants
|
8 participants
|
10 participants
|
8 participants
|
4 participants
|
4 participants
|
6 participants
|
1 participants
|
4 participants
|
3 participants
|
|
Number of Participants With Solicited Symptoms After Dose 1
Fever: 103.2 to 104.9 degrees F
|
3 participants
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Solicited Symptoms After Dose 1
Fever: greater than (>) 104.9 degrees F
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Solicited Symptoms After Dose 1
Runny/stuffy nose
|
50 participants
|
51 participants
|
50 participants
|
40 participants
|
19 participants
|
15 participants
|
30 participants
|
36 participants
|
30 participants
|
30 participants
|
|
Number of Participants With Solicited Symptoms After Dose 1
Cough
|
27 participants
|
30 participants
|
33 participants
|
24 participants
|
11 participants
|
8 participants
|
19 participants
|
22 participants
|
17 participants
|
19 participants
|
|
Number of Participants With Solicited Symptoms After Dose 1
Drowsiness
|
26 participants
|
29 participants
|
21 participants
|
21 participants
|
10 participants
|
9 participants
|
15 participants
|
13 participants
|
16 participants
|
22 participants
|
|
Number of Participants With Solicited Symptoms After Dose 1
Oropharyngeal inflammation
|
9 participants
|
12 participants
|
7 participants
|
8 participants
|
2 participants
|
2 participants
|
5 participants
|
7 participants
|
3 participants
|
6 participants
|
|
Number of Participants With Solicited Symptoms After Dose 1
Fever: 101.5 to 103.1 degrees F
|
9 participants
|
8 participants
|
6 participants
|
8 participants
|
1 participants
|
3 participants
|
1 participants
|
4 participants
|
2 participants
|
2 participants
|
|
Number of Participants With Solicited Symptoms After Dose 1
Loss of appetite/decreased urine output
|
22 participants
|
26 participants
|
21 participants
|
21 participants
|
7 participants
|
7 participants
|
9 participants
|
6 participants
|
12 participants
|
12 participants
|
|
Number of Participants With Solicited Symptoms After Dose 1
Irritability/fussiness
|
40 participants
|
46 participants
|
41 participants
|
44 participants
|
16 participants
|
14 participants
|
29 participants
|
18 participants
|
41 participants
|
32 participants
|
|
Number of Participants With Solicited Symptoms After Dose 1
Epistaxis
|
4 participants
|
0 participants
|
4 participants
|
5 participants
|
1 participants
|
1 participants
|
2 participants
|
0 participants
|
0 participants
|
1 participants
|
PRIMARY outcome
Timeframe: Within 28 days after Dose 2Population: Dose 2 safety population included all randomized participants who received study vaccine Dose 2 same as Dose 1 and had safety follow-up data.
Solicited symptoms were predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms included fever \>=100.4 degrees F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, oropharyngeal inflammation (laryngitis), and epistaxis.
Outcome measures
| Measure |
MEDI-534, Cohort 1
n=63 Participants
Participants aged 6 to less than (\<) 24 months received MEDI-534, 10\^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 1
n=65 Participants
Participants aged 6 to \<24 months received placebo matched to MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 2
n=66 Participants
Participants aged 6 to \<24 months received MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 2
n=65 Participants
Participants aged 6 to \<24 months received placebo matched to MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 3
n=25 Participants
Participants aged 2 months received MEDI-534, 10\^4 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 3
n=26 Participants
Participants aged 2 months received placebo matched to MEDI-534, 10\^4 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 4
n=76 Participants
Participants aged 2 months received MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 4
n=71 Participants
Participants aged 2 months received placebo matched to MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 5
n=73 Participants
Participants aged 2 months received MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 5
n=70 Participants
Participants aged 2 months received placebo matched to MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Symptoms After Dose 2
Any solicited symptom
|
50 participants
|
53 participants
|
53 participants
|
45 participants
|
12 participants
|
19 participants
|
38 participants
|
42 participants
|
39 participants
|
41 participants
|
|
Number of Participants With Solicited Symptoms After Dose 2
Fever: 100.4 to 101.4 degrees F
|
16 participants
|
17 participants
|
10 participants
|
11 participants
|
1 participants
|
2 participants
|
8 participants
|
4 participants
|
1 participants
|
3 participants
|
|
Number of Participants With Solicited Symptoms After Dose 2
Cough
|
16 participants
|
23 participants
|
28 participants
|
22 participants
|
2 participants
|
7 participants
|
15 participants
|
21 participants
|
20 participants
|
20 participants
|
|
Number of Participants With Solicited Symptoms After Dose 2
Fever: 101.5 to 103.1 degrees F
|
13 participants
|
10 participants
|
9 participants
|
8 participants
|
0 participants
|
1 participants
|
3 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Solicited Symptoms After Dose 2
Fever: 103.2 to 104.9 degrees F
|
2 participants
|
1 participants
|
3 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Solicited Symptoms After Dose 2
Fever: >104.9 degrees F
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Solicited Symptoms After Dose 2
Runny/stuffy nose
|
41 participants
|
35 participants
|
38 participants
|
34 participants
|
10 participants
|
15 participants
|
25 participants
|
30 participants
|
25 participants
|
24 participants
|
|
Number of Participants With Solicited Symptoms After Dose 2
Epistaxis
|
4 participants
|
4 participants
|
2 participants
|
4 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Solicited Symptoms After Dose 2
Drowsiness
|
20 participants
|
13 participants
|
15 participants
|
15 participants
|
5 participants
|
4 participants
|
11 participants
|
7 participants
|
7 participants
|
10 participants
|
|
Number of Participants With Solicited Symptoms After Dose 2
Loss of appetite/decreased urine output
|
16 participants
|
17 participants
|
14 participants
|
17 participants
|
3 participants
|
4 participants
|
9 participants
|
11 participants
|
9 participants
|
9 participants
|
|
Number of Participants With Solicited Symptoms After Dose 2
Irritability/fussiness
|
33 participants
|
29 participants
|
35 participants
|
25 participants
|
8 participants
|
6 participants
|
13 participants
|
14 participants
|
22 participants
|
21 participants
|
|
Number of Participants With Solicited Symptoms After Dose 2
Oropharyngeal inflammation
|
9 participants
|
5 participants
|
4 participants
|
3 participants
|
2 participants
|
1 participants
|
4 participants
|
2 participants
|
7 participants
|
7 participants
|
PRIMARY outcome
Timeframe: Within 28 days after Dose 3Population: Dose 3 safety population included all randomized participants who received study vaccine Dose 3 same as previous doses and had safety follow-up data.
Solicited symptoms were predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms included fever \>=100.4 degrees F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, oropharyngeal inflammation (laryngitis), and epistaxis.
Outcome measures
| Measure |
MEDI-534, Cohort 1
n=60 Participants
Participants aged 6 to less than (\<) 24 months received MEDI-534, 10\^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 1
n=60 Participants
Participants aged 6 to \<24 months received placebo matched to MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 2
n=63 Participants
Participants aged 6 to \<24 months received MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 2
n=61 Participants
Participants aged 6 to \<24 months received placebo matched to MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 3
n=28 Participants
Participants aged 2 months received MEDI-534, 10\^4 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 3
n=30 Participants
Participants aged 2 months received placebo matched to MEDI-534, 10\^4 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 4
n=76 Participants
Participants aged 2 months received MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 4
n=70 Participants
Participants aged 2 months received placebo matched to MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 5
n=71 Participants
Participants aged 2 months received MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 5
n=68 Participants
Participants aged 2 months received placebo matched to MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Symptoms After Dose 3
Any solicited symptom
|
41 participants
|
45 participants
|
48 participants
|
45 participants
|
20 participants
|
17 participants
|
36 participants
|
33 participants
|
48 participants
|
41 participants
|
|
Number of Participants With Solicited Symptoms After Dose 3
Fever: 100.4 to 101.4 degrees F
|
8 participants
|
9 participants
|
9 participants
|
9 participants
|
3 participants
|
6 participants
|
7 participants
|
8 participants
|
10 participants
|
10 participants
|
|
Number of Participants With Solicited Symptoms After Dose 3
Fever: 101.5 to 103.1 degrees F
|
6 participants
|
8 participants
|
6 participants
|
9 participants
|
1 participants
|
0 participants
|
2 participants
|
1 participants
|
4 participants
|
4 participants
|
|
Number of Participants With Solicited Symptoms After Dose 3
Fever: 103.2 to 104.9 degrees F
|
0 participants
|
2 participants
|
2 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Solicited Symptoms After Dose 3
Fever: >104.9 degrees F
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Solicited Symptoms After Dose 3
Runny/stuffy nose
|
36 participants
|
35 participants
|
35 participants
|
28 participants
|
16 participants
|
15 participants
|
24 participants
|
21 participants
|
32 participants
|
31 participants
|
|
Number of Participants With Solicited Symptoms After Dose 3
Cough
|
22 participants
|
14 participants
|
20 participants
|
17 participants
|
10 participants
|
10 participants
|
14 participants
|
15 participants
|
25 participants
|
23 participants
|
|
Number of Participants With Solicited Symptoms After Dose 3
Drowsiness
|
12 participants
|
9 participants
|
11 participants
|
9 participants
|
2 participants
|
6 participants
|
4 participants
|
4 participants
|
7 participants
|
9 participants
|
|
Number of Participants With Solicited Symptoms After Dose 3
Loss of appetite/decreased urine output
|
13 participants
|
15 participants
|
8 participants
|
11 participants
|
8 participants
|
4 participants
|
8 participants
|
10 participants
|
11 participants
|
11 participants
|
|
Number of Participants With Solicited Symptoms After Dose 3
Irritability/fussiness
|
23 participants
|
25 participants
|
29 participants
|
28 participants
|
11 participants
|
8 participants
|
11 participants
|
11 participants
|
20 participants
|
14 participants
|
|
Number of Participants With Solicited Symptoms After Dose 3
Oropharyngeal inflammation
|
9 participants
|
4 participants
|
4 participants
|
2 participants
|
1 participants
|
3 participants
|
2 participants
|
4 participants
|
8 participants
|
6 participants
|
|
Number of Participants With Solicited Symptoms After Dose 3
Epistaxis
|
2 participants
|
1 participants
|
2 participants
|
4 participants
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Within 28 days after Dose 1Population: Dose 1 safety population included all randomized participants who received study vaccine Dose 1 and had safety follow-up data.
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent adverse events (TEAEs) for Dose 1 are events between administration of Dose 1 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TEAEs (spontaneously reported events) after Dose 1 were reported.
Outcome measures
| Measure |
MEDI-534, Cohort 1
n=78 Participants
Participants aged 6 to less than (\<) 24 months received MEDI-534, 10\^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 1
n=79 Participants
Participants aged 6 to \<24 months received placebo matched to MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 2
n=80 Participants
Participants aged 6 to \<24 months received MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 2
n=80 Participants
Participants aged 6 to \<24 months received placebo matched to MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 3
n=40 Participants
Participants aged 2 months received MEDI-534, 10\^4 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 3
n=40 Participants
Participants aged 2 months received placebo matched to MEDI-534, 10\^4 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 4
n=82 Participants
Participants aged 2 months received MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 4
n=77 Participants
Participants aged 2 months received placebo matched to MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 5
n=80 Participants
Participants aged 2 months received MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 5
n=78 Participants
Participants aged 2 months received placebo matched to MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 1
|
51 participants
|
51 participants
|
47 participants
|
35 participants
|
15 participants
|
15 participants
|
20 participants
|
26 participants
|
29 participants
|
21 participants
|
PRIMARY outcome
Timeframe: Within 28 days after Dose 2Population: Dose 2 safety population included all randomized participants who received study vaccine Dose 2 same as Dose 1 and had safety follow-up data.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-Emergent Adverse Events (TEAEs) for Dose 2 are events between administration of Dose 2 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TEAEs (spontaneously reported events) after Dose 2 were reported.
Outcome measures
| Measure |
MEDI-534, Cohort 1
n=63 Participants
Participants aged 6 to less than (\<) 24 months received MEDI-534, 10\^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 1
n=65 Participants
Participants aged 6 to \<24 months received placebo matched to MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 2
n=66 Participants
Participants aged 6 to \<24 months received MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 2
n=65 Participants
Participants aged 6 to \<24 months received placebo matched to MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 3
n=25 Participants
Participants aged 2 months received MEDI-534, 10\^4 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 3
n=26 Participants
Participants aged 2 months received placebo matched to MEDI-534, 10\^4 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 4
n=76 Participants
Participants aged 2 months received MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 4
n=71 Participants
Participants aged 2 months received placebo matched to MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 5
n=73 Participants
Participants aged 2 months received MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 5
n=70 Participants
Participants aged 2 months received placebo matched to MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 2
|
31 participants
|
41 participants
|
31 participants
|
27 participants
|
9 participants
|
10 participants
|
21 participants
|
21 participants
|
25 participants
|
24 participants
|
PRIMARY outcome
Timeframe: Within 28 days after Dose 3Population: Dose 3 safety population included all randomized participants who received study vaccine Dose 3 same as previous doses and had safety follow-up data.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-Emergent Adverse Events (TEAEs) for Dose 3 are events between administration of Dose 3 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TEAEs (spontaneously reported events) after Dose 3 were reported.
Outcome measures
| Measure |
MEDI-534, Cohort 1
n=60 Participants
Participants aged 6 to less than (\<) 24 months received MEDI-534, 10\^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 1
n=60 Participants
Participants aged 6 to \<24 months received placebo matched to MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 2
n=63 Participants
Participants aged 6 to \<24 months received MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 2
n=61 Participants
Participants aged 6 to \<24 months received placebo matched to MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 3
n=28 Participants
Participants aged 2 months received MEDI-534, 10\^4 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 3
n=30 Participants
Participants aged 2 months received placebo matched to MEDI-534, 10\^4 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 4
n=76 Participants
Participants aged 2 months received MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 4
n=70 Participants
Participants aged 2 months received placebo matched to MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 5
n=71 Participants
Participants aged 2 months received MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 5
n=68 Participants
Participants aged 2 months received placebo matched to MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 3
|
34 participants
|
35 participants
|
33 participants
|
25 participants
|
11 participants
|
10 participants
|
25 participants
|
22 participants
|
29 participants
|
27 participants
|
PRIMARY outcome
Timeframe: Within 28 days after Dose 1Population: Dose 1 safety population included all randomized participants who received study vaccine Dose 1 and had safety follow-up data.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-Emergent Serious Adverse Events (TESAEs) are serious events between administration of Dose 1 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TESAEs (spontaneously reported events) after Dose 1 were reported.
Outcome measures
| Measure |
MEDI-534, Cohort 1
n=78 Participants
Participants aged 6 to less than (\<) 24 months received MEDI-534, 10\^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 1
n=79 Participants
Participants aged 6 to \<24 months received placebo matched to MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 2
n=80 Participants
Participants aged 6 to \<24 months received MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 2
n=80 Participants
Participants aged 6 to \<24 months received placebo matched to MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 3
n=40 Participants
Participants aged 2 months received MEDI-534, 10\^4 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 3
n=40 Participants
Participants aged 2 months received placebo matched to MEDI-534, 10\^4 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 4
n=82 Participants
Participants aged 2 months received MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 4
n=77 Participants
Participants aged 2 months received placebo matched to MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 5
n=80 Participants
Participants aged 2 months received MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 5
n=78 Participants
Participants aged 2 months received placebo matched to MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 1
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
1 participants
|
PRIMARY outcome
Timeframe: Within 28 days after Dose 2Population: Dose 2 safety population included all randomized participants who received study vaccine Dose 2 same as Dose 1 and had safety follow-up data.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-Emergent Serious Adverse Events (TESAEs) are serious events between administration of Dose 2 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TESAEs (spontaneously reported events) after Dose 2 were reported.
Outcome measures
| Measure |
MEDI-534, Cohort 1
n=63 Participants
Participants aged 6 to less than (\<) 24 months received MEDI-534, 10\^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 1
n=65 Participants
Participants aged 6 to \<24 months received placebo matched to MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 2
n=66 Participants
Participants aged 6 to \<24 months received MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 2
n=65 Participants
Participants aged 6 to \<24 months received placebo matched to MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 3
n=25 Participants
Participants aged 2 months received MEDI-534, 10\^4 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 3
n=26 Participants
Participants aged 2 months received placebo matched to MEDI-534, 10\^4 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 4
n=76 Participants
Participants aged 2 months received MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 4
n=71 Participants
Participants aged 2 months received placebo matched to MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 5
n=73 Participants
Participants aged 2 months received MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 5
n=70 Participants
Participants aged 2 months received placebo matched to MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 2
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Within 28 days after Dose 3Population: Dose 3 safety population included all randomized participants who received study vaccine Dose 3 same as previous doses and had safety follow-up data.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-Emergent Serious Adverse Events (TESAEs) are serious events between administration of Dose 3 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TESAEs (spontaneously reported events) after Dose 3 were reported.
Outcome measures
| Measure |
MEDI-534, Cohort 1
n=60 Participants
Participants aged 6 to less than (\<) 24 months received MEDI-534, 10\^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 1
n=60 Participants
Participants aged 6 to \<24 months received placebo matched to MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 2
n=63 Participants
Participants aged 6 to \<24 months received MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 2
n=61 Participants
Participants aged 6 to \<24 months received placebo matched to MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 3
n=28 Participants
Participants aged 2 months received MEDI-534, 10\^4 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 3
n=30 Participants
Participants aged 2 months received placebo matched to MEDI-534, 10\^4 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 4
n=76 Participants
Participants aged 2 months received MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 4
n=70 Participants
Participants aged 2 months received placebo matched to MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 5
n=71 Participants
Participants aged 2 months received MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 5
n=68 Participants
Participants aged 2 months received placebo matched to MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 3
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Within 28 days after Dose 1Population: Dose 1 safety population included all randomized participants who received study vaccine Dose 1 and had safety follow-up data.
An MA-LRI was a healthcare provider-confirmed diagnosis of one or more of the following events: wheezing, pneumonia, croup (laryngotracheobronchitis), rhonchi (not cleared with cough or suctioning), rales (not cleared with cough or suctioning), bronchitis, bronchiolitis, and apnea.
Outcome measures
| Measure |
MEDI-534, Cohort 1
n=78 Participants
Participants aged 6 to less than (\<) 24 months received MEDI-534, 10\^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 1
n=79 Participants
Participants aged 6 to \<24 months received placebo matched to MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 2
n=80 Participants
Participants aged 6 to \<24 months received MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 2
n=80 Participants
Participants aged 6 to \<24 months received placebo matched to MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 3
n=40 Participants
Participants aged 2 months received MEDI-534, 10\^4 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 3
n=40 Participants
Participants aged 2 months received placebo matched to MEDI-534, 10\^4 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 4
n=82 Participants
Participants aged 2 months received MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 4
n=77 Participants
Participants aged 2 months received placebo matched to MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 5
n=80 Participants
Participants aged 2 months received MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 5
n=78 Participants
Participants aged 2 months received placebo matched to MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 1
|
2 participants
|
2 participants
|
4 participants
|
4 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
2 participants
|
PRIMARY outcome
Timeframe: Within 28 days after Dose 2Population: Dose 2 safety population included all randomized participants who received study vaccine Dose 2 same as Dose 1 and had safety follow-up data.
An MA-LRI was a healthcare provider-confirmed diagnosis of one or more of the following events: wheezing, pneumonia, croup (laryngotracheobronchitis), rhonchi (not cleared with cough or suctioning), rales (not cleared with cough or suctioning), bronchitis, bronchiolitis, and apnea.
Outcome measures
| Measure |
MEDI-534, Cohort 1
n=63 Participants
Participants aged 6 to less than (\<) 24 months received MEDI-534, 10\^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 1
n=65 Participants
Participants aged 6 to \<24 months received placebo matched to MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 2
n=66 Participants
Participants aged 6 to \<24 months received MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 2
n=65 Participants
Participants aged 6 to \<24 months received placebo matched to MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 3
n=25 Participants
Participants aged 2 months received MEDI-534, 10\^4 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 3
n=26 Participants
Participants aged 2 months received placebo matched to MEDI-534, 10\^4 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 4
n=76 Participants
Participants aged 2 months received MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 4
n=71 Participants
Participants aged 2 months received placebo matched to MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 5
n=73 Participants
Participants aged 2 months received MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 5
n=70 Participants
Participants aged 2 months received placebo matched to MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 2
|
3 participants
|
3 participants
|
1 participants
|
3 participants
|
1 participants
|
2 participants
|
0 participants
|
2 participants
|
3 participants
|
1 participants
|
PRIMARY outcome
Timeframe: Within 28 days after Dose 3Population: Dose 3 safety population included all randomized participants who received study vaccine Dose 3 same as previous doses and had safety follow-up data.
An MA-LRI was a healthcare provider-confirmed diagnosis of one or more of the following events: wheezing, pneumonia, croup (laryngotracheobronchitis), rhonchi (not cleared with cough or suctioning), rales (not cleared with cough or suctioning), bronchitis, bronchiolitis, and apnea.
Outcome measures
| Measure |
MEDI-534, Cohort 1
n=60 Participants
Participants aged 6 to less than (\<) 24 months received MEDI-534, 10\^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 1
n=60 Participants
Participants aged 6 to \<24 months received placebo matched to MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 2
n=63 Participants
Participants aged 6 to \<24 months received MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 2
n=61 Participants
Participants aged 6 to \<24 months received placebo matched to MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 3
n=28 Participants
Participants aged 2 months received MEDI-534, 10\^4 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 3
n=30 Participants
Participants aged 2 months received placebo matched to MEDI-534, 10\^4 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 4
n=76 Participants
Participants aged 2 months received MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 4
n=70 Participants
Participants aged 2 months received placebo matched to MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 5
n=71 Participants
Participants aged 2 months received MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 5
n=68 Participants
Participants aged 2 months received placebo matched to MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 3
|
3 participants
|
0 participants
|
7 participants
|
3 participants
|
2 participants
|
2 participants
|
1 participants
|
1 participants
|
7 participants
|
4 participants
|
SECONDARY outcome
Timeframe: 7, 12 and 28 days after Dose 1, 2 and 3Population: Shedding population included all randomized participants who received study vaccine and had valid shedding data after the specified dose. 'N' (number of participants analyzed) = participants who were evaluable for this measure; and 'n' = participants who were evaluable for this measure at given time points for each group, respectively.
Nasal wash specimens were collected to assess vaccine virus recovery in the upper respiratory tract on 7, 12 and 28 days after each dosing.
Outcome measures
| Measure |
MEDI-534, Cohort 1
n=76 Participants
Participants aged 6 to less than (\<) 24 months received MEDI-534, 10\^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 1
n=78 Participants
Participants aged 6 to \<24 months received placebo matched to MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 2
n=78 Participants
Participants aged 6 to \<24 months received MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 2
n=79 Participants
Participants aged 6 to \<24 months received placebo matched to MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 3
n=40 Participants
Participants aged 2 months received MEDI-534, 10\^4 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 3
n=40 Participants
Participants aged 2 months received placebo matched to MEDI-534, 10\^4 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 4
n=82 Participants
Participants aged 2 months received MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 4
n=77 Participants
Participants aged 2 months received placebo matched to MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 5
n=78 Participants
Participants aged 2 months received MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 5
n=76 Participants
Participants aged 2 months received placebo matched to MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Shed Vaccine-Type Virus
Dose 1: Day 7 (n=76,76,78,79,40,39,82,77,78,75)
|
33 participants
|
0 participants
|
41 participants
|
0 participants
|
22 participants
|
0 participants
|
50 participants
|
0 participants
|
52 participants
|
0 participants
|
|
Number of Participants Who Shed Vaccine-Type Virus
Dose 1: Day 12 (n=75,78,78,78,40,40,81,76,78,76)
|
21 participants
|
0 participants
|
14 participants
|
0 participants
|
16 participants
|
0 participants
|
29 participants
|
0 participants
|
22 participants
|
0 participants
|
|
Number of Participants Who Shed Vaccine-Type Virus
Dose 1: Day 28 (n=76,77,77,78,39,40,82,76,77,76)
|
2 participants
|
0 participants
|
1 participants
|
0 participants
|
3 participants
|
0 participants
|
4 participants
|
0 participants
|
5 participants
|
0 participants
|
|
Number of Participants Who Shed Vaccine-Type Virus
Dose 2: Day 12 (n=63,65,65,64,25,25,76,71,72,68)
|
2 participants
|
0 participants
|
1 participants
|
0 participants
|
3 participants
|
0 participants
|
7 participants
|
0 participants
|
4 participants
|
0 participants
|
|
Number of Participants Who Shed Vaccine-Type Virus
Dose 2: Day 28 (n=63,65,65,65,25,26,76,71,73,68)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Who Shed Vaccine-Type Virus
Dose 3: Day 7 (n=58,59,62,59,28,30,75,70,69,68)
|
6 participants
|
0 participants
|
1 participants
|
0 participants
|
4 participants
|
1 participants
|
18 participants
|
0 participants
|
11 participants
|
0 participants
|
|
Number of Participants Who Shed Vaccine-Type Virus
Dose 3: Day 28 (n=60,60,63,61,28,30,76,70,71,68)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Who Shed Vaccine-Type Virus
Dose 2: Day 7 (n=62,65,65,63,25,26,75,70,72,68)
|
9 participants
|
0 participants
|
6 participants
|
0 participants
|
5 participants
|
0 participants
|
20 participants
|
0 participants
|
13 participants
|
0 participants
|
|
Number of Participants Who Shed Vaccine-Type Virus
Dose 3: Day 12 (n=59,60,61,61,28,29,76,70,70,68)
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
5 participants
|
0 participants
|
4 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 28 after Dose 3Population: Immunogenicity population included all randomized participants who received study vaccine for the specified dose and had valid immunogenicity data. 'N' (number of participants analyzed) = participants evaluable for this measure; and 'n' = participants evaluable for specified virus type, for each group, respectively.
Seroresponse was defined as a \>=4-fold rise from Baseline in neutralizing antibody titer, regardless of Baseline serostatus. Respiratory Syncytial Virus (RSV) and hPIV3 antibody titers were determined by using microneutralization assay and hemagglutination inhibition assay, respectively. Clopper-pearson exact confidence interval was reported.
Outcome measures
| Measure |
MEDI-534, Cohort 1
n=55 Participants
Participants aged 6 to less than (\<) 24 months received MEDI-534, 10\^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 1
n=53 Participants
Participants aged 6 to \<24 months received placebo matched to MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 2
n=51 Participants
Participants aged 6 to \<24 months received MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 2
n=53 Participants
Participants aged 6 to \<24 months received placebo matched to MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 3
n=20 Participants
Participants aged 2 months received MEDI-534, 10\^4 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 3
n=22 Participants
Participants aged 2 months received placebo matched to MEDI-534, 10\^4 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 4
n=68 Participants
Participants aged 2 months received MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 4
n=59 Participants
Participants aged 2 months received placebo matched to MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 5
n=63 Participants
Participants aged 2 months received MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 5
n=61 Participants
Participants aged 2 months received placebo matched to MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a Seroresponse to Respiratory Syncytial Virus (RSV) and Human Parainfluenza Virus Type 3 (hPIV3) After Dose 3
RSV (n=44, 51, 50, 51, 19, 19, 68, 59, 63, 61)
|
29.5 percentage of participants
Interval 16.8 to 45.2
|
17.6 percentage of participants
Interval 8.4 to 30.9
|
36.0 percentage of participants
Interval 22.9 to 50.8
|
25.5 percentage of participants
Interval 14.3 to 39.6
|
15.8 percentage of participants
Interval 3.4 to 39.6
|
5.3 percentage of participants
Interval 0.1 to 26.0
|
7.4 percentage of participants
Interval 2.4 to 16.3
|
3.4 percentage of participants
Interval 0.4 to 11.7
|
0.0 percentage of participants
Interval 0.0 to 5.7
|
0.0 percentage of participants
Interval 0.0 to 5.9
|
|
Percentage of Participants With a Seroresponse to Respiratory Syncytial Virus (RSV) and Human Parainfluenza Virus Type 3 (hPIV3) After Dose 3
hPIV3 (n=55, 53, 51, 53, 20, 22, 65, 59, 57, 52)
|
67.3 percentage of participants
Interval 53.3 to 79.3
|
7.5 percentage of participants
Interval 2.1 to 18.2
|
86.3 percentage of participants
Interval 73.7 to 94.3
|
11.3 percentage of participants
Interval 4.3 to 23.0
|
35.0 percentage of participants
Interval 15.4 to 59.2
|
4.5 percentage of participants
Interval 0.1 to 22.8
|
16.9 percentage of participants
Interval 8.8 to 28.3
|
5.1 percentage of participants
Interval 1.1 to 14.1
|
19.3 percentage of participants
Interval 10.0 to 31.9
|
5.8 percentage of participants
Interval 1.2 to 15.9
|
SECONDARY outcome
Timeframe: Within 28 days after any dosePopulation: Shedding population included all randomized participants who received study vaccine and had valid shedding data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Nasal wash samples with vaccine-type virus were evaluated for genotypic stability, defined as the presence of the entire RSV-Fusion (RSV F) insert based on the RSV F sequence results. If the insert was absent or truncated, the recovered virus was counted as genotypically unstable. Nasal wash samples were categorized as genotypically stable, genotypically unstable or undetermined genotypic stability.
Outcome measures
| Measure |
MEDI-534, Cohort 1
n=81 nasal wash samples
Participants aged 6 to less than (\<) 24 months received MEDI-534, 10\^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 1
Participants aged 6 to \<24 months received placebo matched to MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 2
n=67 nasal wash samples
Participants aged 6 to \<24 months received MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 2
Participants aged 6 to \<24 months received placebo matched to MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 3
n=59 nasal wash samples
Participants aged 2 months received MEDI-534, 10\^4 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 3
n=1 nasal wash samples
Participants aged 2 months received placebo matched to MEDI-534, 10\^4 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 4
n=141 nasal wash samples
Participants aged 2 months received MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 4
Participants aged 2 months received placebo matched to MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 5
n=117 nasal wash samples
Participants aged 2 months received MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 5
Participants aged 2 months received placebo matched to MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Genotypic Stability of Recovered Vaccine-Type Virus
Undetermined genotypic stability
|
4 nasal wash samples
|
—
|
0 nasal wash samples
|
—
|
5 nasal wash samples
|
0 nasal wash samples
|
6 nasal wash samples
|
—
|
7 nasal wash samples
|
—
|
|
Genotypic Stability of Recovered Vaccine-Type Virus
Genotypically unstable
|
0 nasal wash samples
|
—
|
0 nasal wash samples
|
—
|
0 nasal wash samples
|
0 nasal wash samples
|
0 nasal wash samples
|
—
|
0 nasal wash samples
|
—
|
|
Genotypic Stability of Recovered Vaccine-Type Virus
Genotypically stable
|
77 nasal wash samples
|
—
|
67 nasal wash samples
|
—
|
54 nasal wash samples
|
1 nasal wash samples
|
135 nasal wash samples
|
—
|
110 nasal wash samples
|
—
|
SECONDARY outcome
Timeframe: Day 0 to Day 365Population: Safety population included all randomized participants who received study vaccine and had any safety follow-up data.
An MA-LRI was a healthcare provider-confirmed diagnosis of one or more of the following events: wheezing, pneumonia, croup (laryngotracheobronchitis), rhonchi (not cleared with cough or suctioning), rales (not cleared with cough or suctioning), bronchitis, bronchiolitis, and apnea. MA-LRIs occurring within 28 days post any dose and after 28 days post any dose were summarized separately.
Outcome measures
| Measure |
MEDI-534, Cohort 1
n=78 Participants
Participants aged 6 to less than (\<) 24 months received MEDI-534, 10\^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 1
n=79 Participants
Participants aged 6 to \<24 months received placebo matched to MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 2
n=80 Participants
Participants aged 6 to \<24 months received MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 2
n=80 Participants
Participants aged 6 to \<24 months received placebo matched to MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 3
n=40 Participants
Participants aged 2 months received MEDI-534, 10\^4 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 3
n=40 Participants
Participants aged 2 months received placebo matched to MEDI-534, 10\^4 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 4
n=82 Participants
Participants aged 2 months received MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 4
n=77 Participants
Participants aged 2 months received placebo matched to MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 5
n=80 Participants
Participants aged 2 months received MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 5
n=78 Participants
Participants aged 2 months received placebo matched to MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) Through 365 Days After Randomization
Within 28 days post any dose
|
8 participants
|
5 participants
|
12 participants
|
10 participants
|
3 participants
|
4 participants
|
2 participants
|
3 participants
|
10 participants
|
7 participants
|
|
Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) Through 365 Days After Randomization
After 28 days post any dose
|
16 participants
|
16 participants
|
18 participants
|
10 participants
|
6 participants
|
7 participants
|
13 participants
|
20 participants
|
23 participants
|
15 participants
|
SECONDARY outcome
Timeframe: Day 0 to Day 365Population: Safety population included all randomized participants who received study vaccine and had any safety follow-up data.
An SNMC was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. Examples of SNMCs include diabetes, asthma, autoimmune disease (for example, lupus, rheumatoid arthritis), and neurological disease (for example, epilepsy, autism).
Outcome measures
| Measure |
MEDI-534, Cohort 1
n=78 Participants
Participants aged 6 to less than (\<) 24 months received MEDI-534, 10\^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 1
n=79 Participants
Participants aged 6 to \<24 months received placebo matched to MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 2
n=80 Participants
Participants aged 6 to \<24 months received MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 2
n=80 Participants
Participants aged 6 to \<24 months received placebo matched to MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 3
n=40 Participants
Participants aged 2 months received MEDI-534, 10\^4 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 3
n=40 Participants
Participants aged 2 months received placebo matched to MEDI-534, 10\^4 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 4
n=82 Participants
Participants aged 2 months received MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 4
n=77 Participants
Participants aged 2 months received placebo matched to MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 5
n=80 Participants
Participants aged 2 months received MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 5
n=78 Participants
Participants aged 2 months received placebo matched to MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Significant New Medical Conditions (SNMCs) Through 365 Days After Randomization
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
3 participants
|
1 participants
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Day 0 to Day 365Population: Safety population included all randomized participants who received study vaccine and had any safety follow-up data.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-Emergent Serious Adverse Events (TESAEs) are serious events after administration of drug which were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TESAEs (spontaneously reported events) within 365 days after randomization were reported.
Outcome measures
| Measure |
MEDI-534, Cohort 1
n=78 Participants
Participants aged 6 to less than (\<) 24 months received MEDI-534, 10\^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 1
n=79 Participants
Participants aged 6 to \<24 months received placebo matched to MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 2
n=80 Participants
Participants aged 6 to \<24 months received MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 2
n=80 Participants
Participants aged 6 to \<24 months received placebo matched to MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 3
n=40 Participants
Participants aged 2 months received MEDI-534, 10\^4 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 3
n=40 Participants
Participants aged 2 months received placebo matched to MEDI-534, 10\^4 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 4
n=82 Participants
Participants aged 2 months received MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 4
n=77 Participants
Participants aged 2 months received placebo matched to MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 5
n=80 Participants
Participants aged 2 months received MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 5
n=78 Participants
Participants aged 2 months received placebo matched to MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) Through 365 Days After Randomization
|
6 participants
|
5 participants
|
5 participants
|
1 participants
|
1 participants
|
2 participants
|
3 participants
|
4 participants
|
9 participants
|
3 participants
|
Adverse Events
MEDI-534, Cohort 1
Serious events: 6 serious events
Other events: 65 other events
Deaths: 0 deaths
Placebo, Cohort 1
Serious events: 5 serious events
Other events: 66 other events
Deaths: 0 deaths
MEDI-534, Cohort 2
Serious events: 5 serious events
Other events: 59 other events
Deaths: 0 deaths
Placebo, Cohort 2
Serious events: 1 serious events
Other events: 55 other events
Deaths: 0 deaths
MEDI-534, Cohort 3
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
Placebo, Cohort 3
Serious events: 2 serious events
Other events: 27 other events
Deaths: 0 deaths
MEDI-534, Cohort 4
Serious events: 3 serious events
Other events: 45 other events
Deaths: 0 deaths
Placebo, Cohort 4
Serious events: 4 serious events
Other events: 42 other events
Deaths: 0 deaths
MEDI-534, Cohort 5
Serious events: 9 serious events
Other events: 50 other events
Deaths: 0 deaths
Placebo, Cohort 5
Serious events: 3 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MEDI-534, Cohort 1
n=78 participants at risk
Participants aged 6 to less than (\<) 24 months received MEDI-534, 10\^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 1
n=79 participants at risk
Participants aged 6 to \<24 months received placebo matched to MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 2
n=80 participants at risk
Participants aged 6 to \<24 months received MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 2
n=80 participants at risk
Participants aged 6 to \<24 months received placebo matched to MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 3
n=40 participants at risk
Participants aged 2 months received MEDI-534, 10\^4 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 3
n=40 participants at risk
Participants aged 2 months received placebo matched to MEDI-534, 10\^4 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 4
n=82 participants at risk
Participants aged 2 months received MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 4
n=77 participants at risk
Participants aged 2 months received placebo matched to MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 5
n=80 participants at risk
Participants aged 2 months received MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 5
n=78 participants at risk
Participants aged 2 months received placebo matched to MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Abscess
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Anal abscess
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Bronchiolitis
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
2.5%
1/40 • Number of events 1 • Day 0 to Day 365
|
2.4%
2/82 • Number of events 2 • Day 0 to Day 365
|
2.6%
2/77 • Number of events 2 • Day 0 to Day 365
|
2.5%
2/80 • Number of events 2 • Day 0 to Day 365
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
|
Infections and infestations
Cellulitis
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
2.5%
1/40 • Number of events 1 • Day 0 to Day 365
|
2.5%
1/40 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Croup infectious
|
0.00%
0/78 • Day 0 to Day 365
|
1.3%
1/79 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Gastroenteritis
|
3.8%
3/78 • Number of events 3 • Day 0 to Day 365
|
1.3%
1/79 • Number of events 1 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
1.3%
1/77 • Number of events 1 • Day 0 to Day 365
|
3.8%
3/80 • Number of events 3 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Measles
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
1.2%
1/82 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Parainfluenzae virus infection
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Pneumonia
|
2.6%
2/78 • Number of events 2 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
1.3%
1/77 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Tonsillitis
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Viral infection
|
0.00%
0/78 • Day 0 to Day 365
|
1.3%
1/79 • Number of events 1 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
|
Nervous system disorders
Febrile convulsion
|
0.00%
0/78 • Day 0 to Day 365
|
2.5%
2/79 • Number of events 2 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.3%
1/78 • Number of events 2 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
Other adverse events
| Measure |
MEDI-534, Cohort 1
n=78 participants at risk
Participants aged 6 to less than (\<) 24 months received MEDI-534, 10\^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 1
n=79 participants at risk
Participants aged 6 to \<24 months received placebo matched to MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 2
n=80 participants at risk
Participants aged 6 to \<24 months received MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 2
n=80 participants at risk
Participants aged 6 to \<24 months received placebo matched to MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 3
n=40 participants at risk
Participants aged 2 months received MEDI-534, 10\^4 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 3
n=40 participants at risk
Participants aged 2 months received placebo matched to MEDI-534, 10\^4 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 4
n=82 participants at risk
Participants aged 2 months received MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 4
n=77 participants at risk
Participants aged 2 months received placebo matched to MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
|
MEDI-534, Cohort 5
n=80 participants at risk
Participants aged 2 months received MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
Placebo, Cohort 5
n=78 participants at risk
Participants aged 2 months received placebo matched to MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
2.5%
1/40 • Number of events 1 • Day 0 to Day 365
|
1.2%
1/82 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
2.6%
2/78 • Number of events 2 • Day 0 to Day 365
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/78 • Day 0 to Day 365
|
1.3%
1/79 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/78 • Day 0 to Day 365
|
1.3%
1/79 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
1.2%
1/82 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/78 • Day 0 to Day 365
|
1.3%
1/79 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/78 • Day 0 to Day 365
|
1.3%
1/79 • Number of events 1 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
1.3%
1/77 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
2.5%
1/40 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Ear and labyrinth disorders
Otorrhoea
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
1.2%
1/82 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Ear and labyrinth disorders
Tympanic membrane hyperaemia
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Eye disorders
Conjunctivitis
|
7.7%
6/78 • Number of events 7 • Day 0 to Day 365
|
5.1%
4/79 • Number of events 4 • Day 0 to Day 365
|
5.0%
4/80 • Number of events 4 • Day 0 to Day 365
|
3.8%
3/80 • Number of events 4 • Day 0 to Day 365
|
10.0%
4/40 • Number of events 4 • Day 0 to Day 365
|
2.5%
1/40 • Number of events 1 • Day 0 to Day 365
|
4.9%
4/82 • Number of events 4 • Day 0 to Day 365
|
9.1%
7/77 • Number of events 8 • Day 0 to Day 365
|
2.5%
2/80 • Number of events 2 • Day 0 to Day 365
|
6.4%
5/78 • Number of events 5 • Day 0 to Day 365
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/78 • Day 0 to Day 365
|
1.3%
1/79 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
|
Eye disorders
Eye discharge
|
0.00%
0/78 • Day 0 to Day 365
|
1.3%
1/79 • Number of events 2 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
2.6%
2/77 • Number of events 2 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Eye disorders
Eye pruritus
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
1.3%
1/77 • Number of events 1 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Eye disorders
Eye swelling
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
1.3%
1/77 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Eye disorders
Lacrimation increased
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
2.5%
2/79 • Number of events 2 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
2.5%
1/40 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
1.3%
1/77 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Eye disorders
Ocular hyperaemia
|
2.6%
2/78 • Number of events 2 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/78 • Day 0 to Day 365
|
1.3%
1/79 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
3.9%
3/77 • Number of events 3 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/78 • Day 0 to Day 365
|
1.3%
1/79 • Number of events 1 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 3 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
2.5%
1/40 • Number of events 1 • Day 0 to Day 365
|
1.2%
1/82 • Number of events 1 • Day 0 to Day 365
|
1.3%
1/77 • Number of events 2 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Gastrointestinal disorders
Constipation
|
2.6%
2/78 • Number of events 3 • Day 0 to Day 365
|
1.3%
1/79 • Number of events 1 • Day 0 to Day 365
|
2.5%
2/80 • Number of events 3 • Day 0 to Day 365
|
6.2%
5/80 • Number of events 6 • Day 0 to Day 365
|
2.5%
1/40 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
2.4%
2/82 • Number of events 2 • Day 0 to Day 365
|
6.5%
5/77 • Number of events 5 • Day 0 to Day 365
|
5.0%
4/80 • Number of events 4 • Day 0 to Day 365
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
|
Gastrointestinal disorders
Diarrhoea
|
15.4%
12/78 • Number of events 14 • Day 0 to Day 365
|
20.3%
16/79 • Number of events 26 • Day 0 to Day 365
|
21.2%
17/80 • Number of events 23 • Day 0 to Day 365
|
21.2%
17/80 • Number of events 24 • Day 0 to Day 365
|
10.0%
4/40 • Number of events 4 • Day 0 to Day 365
|
7.5%
3/40 • Number of events 5 • Day 0 to Day 365
|
4.9%
4/82 • Number of events 5 • Day 0 to Day 365
|
2.6%
2/77 • Number of events 2 • Day 0 to Day 365
|
8.8%
7/80 • Number of events 7 • Day 0 to Day 365
|
6.4%
5/78 • Number of events 7 • Day 0 to Day 365
|
|
Gastrointestinal disorders
Flatulence
|
5.1%
4/78 • Number of events 4 • Day 0 to Day 365
|
1.3%
1/79 • Number of events 1 • Day 0 to Day 365
|
5.0%
4/80 • Number of events 7 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 2 • Day 0 to Day 365
|
7.5%
3/40 • Number of events 4 • Day 0 to Day 365
|
2.5%
1/40 • Number of events 1 • Day 0 to Day 365
|
1.2%
1/82 • Number of events 1 • Day 0 to Day 365
|
3.9%
3/77 • Number of events 3 • Day 0 to Day 365
|
2.5%
2/80 • Number of events 2 • Day 0 to Day 365
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
2.5%
1/40 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Gastrointestinal disorders
Infantile colic
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
1.3%
1/77 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Gastrointestinal disorders
Nausea
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Gastrointestinal disorders
Oral pain
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Gastrointestinal disorders
Regurgitation
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Gastrointestinal disorders
Teething
|
26.9%
21/78 • Number of events 40 • Day 0 to Day 365
|
25.3%
20/79 • Number of events 53 • Day 0 to Day 365
|
27.5%
22/80 • Number of events 44 • Day 0 to Day 365
|
18.8%
15/80 • Number of events 39 • Day 0 to Day 365
|
2.5%
1/40 • Number of events 1 • Day 0 to Day 365
|
2.5%
1/40 • Number of events 1 • Day 0 to Day 365
|
3.7%
3/82 • Number of events 4 • Day 0 to Day 365
|
9.1%
7/77 • Number of events 8 • Day 0 to Day 365
|
3.8%
3/80 • Number of events 4 • Day 0 to Day 365
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
|
Gastrointestinal disorders
Tongue geographic
|
0.00%
0/78 • Day 0 to Day 365
|
1.3%
1/79 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
2.6%
2/77 • Number of events 2 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
1.3%
1/77 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Gastrointestinal disorders
Vomiting
|
10.3%
8/78 • Number of events 9 • Day 0 to Day 365
|
16.5%
13/79 • Number of events 20 • Day 0 to Day 365
|
12.5%
10/80 • Number of events 12 • Day 0 to Day 365
|
13.8%
11/80 • Number of events 17 • Day 0 to Day 365
|
10.0%
4/40 • Number of events 5 • Day 0 to Day 365
|
7.5%
3/40 • Number of events 3 • Day 0 to Day 365
|
3.7%
3/82 • Number of events 3 • Day 0 to Day 365
|
3.9%
3/77 • Number of events 4 • Day 0 to Day 365
|
7.5%
6/80 • Number of events 9 • Day 0 to Day 365
|
3.8%
3/78 • Number of events 4 • Day 0 to Day 365
|
|
Gastrointestinal disorders
Vomiting projectile
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
General disorders
Feeling hot
|
0.00%
0/78 • Day 0 to Day 365
|
1.3%
1/79 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
General disorders
Influenza like illness
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
|
General disorders
Injection site pain
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
2.5%
1/40 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
General disorders
Irritability
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
1.2%
1/82 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
General disorders
Pain
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
|
General disorders
Vaccination site pain
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
2.5%
1/40 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
General disorders
Vessel puncture site haemorrhage
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
1.3%
1/77 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Hepatobiliary disorders
Jaundice
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Immune system disorders
Food allergy
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Immune system disorders
Multiple allergies
|
0.00%
0/78 • Day 0 to Day 365
|
1.3%
1/79 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
|
Immune system disorders
Seasonal allergy
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
1.3%
1/79 • Number of events 3 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Acarodermatitis
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/78 • Day 0 to Day 365
|
1.3%
1/79 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Adenoiditis
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Adenoviral conjunctivitis
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Adenovirus infection
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Body tinea
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Bronchiolitis
|
3.8%
3/78 • Number of events 3 • Day 0 to Day 365
|
3.8%
3/79 • Number of events 3 • Day 0 to Day 365
|
5.0%
4/80 • Number of events 4 • Day 0 to Day 365
|
7.5%
6/80 • Number of events 6 • Day 0 to Day 365
|
7.5%
3/40 • Number of events 3 • Day 0 to Day 365
|
5.0%
2/40 • Number of events 2 • Day 0 to Day 365
|
1.2%
1/82 • Number of events 1 • Day 0 to Day 365
|
1.3%
1/77 • Number of events 1 • Day 0 to Day 365
|
7.5%
6/80 • Number of events 7 • Day 0 to Day 365
|
3.8%
3/78 • Number of events 3 • Day 0 to Day 365
|
|
Infections and infestations
Bronchitis
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
3.8%
3/80 • Number of events 3 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
2.5%
1/40 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
|
Infections and infestations
Candida nappy rash
|
0.00%
0/78 • Day 0 to Day 365
|
1.3%
1/79 • Number of events 1 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
3.8%
3/78 • Number of events 3 • Day 0 to Day 365
|
|
Infections and infestations
Candidiasis
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
5.0%
2/40 • Number of events 2 • Day 0 to Day 365
|
2.5%
1/40 • Number of events 1 • Day 0 to Day 365
|
1.2%
1/82 • Number of events 1 • Day 0 to Day 365
|
1.3%
1/77 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Cellulitis
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
1.3%
1/79 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Conjunctivitis bacterial
|
2.6%
2/78 • Number of events 2 • Day 0 to Day 365
|
1.3%
1/79 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Conjunctivitis infective
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
2.5%
1/40 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Conjunctivitis viral
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
|
Infections and infestations
Coxsackie viral infection
|
0.00%
0/78 • Day 0 to Day 365
|
1.3%
1/79 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Croup infectious
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
1.3%
1/79 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
2.5%
2/80 • Number of events 2 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Dermatitis infected
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Eczema infected
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Enterovirus infection
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Exanthema subitum
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
2.4%
2/82 • Number of events 2 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Fungal infection
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
1.3%
1/77 • Number of events 1 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/78 • Day 0 to Day 365
|
1.3%
1/79 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
1.3%
1/77 • Number of events 1 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
|
Infections and infestations
Furuncle
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Gastroenteritis
|
2.6%
2/78 • Number of events 2 • Day 0 to Day 365
|
1.3%
1/79 • Number of events 1 • Day 0 to Day 365
|
3.8%
3/80 • Number of events 4 • Day 0 to Day 365
|
2.5%
2/80 • Number of events 5 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
3.9%
3/77 • Number of events 3 • Day 0 to Day 365
|
2.5%
2/80 • Number of events 2 • Day 0 to Day 365
|
6.4%
5/78 • Number of events 5 • Day 0 to Day 365
|
|
Infections and infestations
Gastroenteritis viral
|
3.8%
3/78 • Number of events 3 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
2.5%
1/40 • Number of events 1 • Day 0 to Day 365
|
2.5%
1/40 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Genital candidiasis
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
2.5%
2/80 • Number of events 2 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Herpangina
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
2.5%
1/40 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Impetigo
|
0.00%
0/78 • Day 0 to Day 365
|
2.5%
2/79 • Number of events 3 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Influenza
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
5.1%
4/79 • Number of events 4 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
2.5%
2/80 • Number of events 2 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
1.2%
1/82 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Laryngitis
|
0.00%
0/78 • Day 0 to Day 365
|
1.3%
1/79 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Nasopharyngitis
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
2.5%
2/79 • Number of events 3 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
3.8%
3/80 • Number of events 3 • Day 0 to Day 365
|
5.0%
2/40 • Number of events 2 • Day 0 to Day 365
|
2.5%
1/40 • Number of events 1 • Day 0 to Day 365
|
6.1%
5/82 • Number of events 6 • Day 0 to Day 365
|
6.5%
5/77 • Number of events 5 • Day 0 to Day 365
|
6.2%
5/80 • Number of events 8 • Day 0 to Day 365
|
9.0%
7/78 • Number of events 13 • Day 0 to Day 365
|
|
Infections and infestations
Omphalitis
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
1.2%
1/82 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/78 • Day 0 to Day 365
|
5.1%
4/79 • Number of events 5 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
2.5%
1/40 • Number of events 1 • Day 0 to Day 365
|
5.0%
2/40 • Number of events 2 • Day 0 to Day 365
|
6.1%
5/82 • Number of events 5 • Day 0 to Day 365
|
5.2%
4/77 • Number of events 4 • Day 0 to Day 365
|
5.0%
4/80 • Number of events 4 • Day 0 to Day 365
|
1.3%
1/78 • Number of events 2 • Day 0 to Day 365
|
|
Infections and infestations
Oral herpes
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Otitis externa
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Otitis media
|
14.1%
11/78 • Number of events 16 • Day 0 to Day 365
|
13.9%
11/79 • Number of events 16 • Day 0 to Day 365
|
13.8%
11/80 • Number of events 12 • Day 0 to Day 365
|
17.5%
14/80 • Number of events 15 • Day 0 to Day 365
|
5.0%
2/40 • Number of events 2 • Day 0 to Day 365
|
2.5%
1/40 • Number of events 1 • Day 0 to Day 365
|
2.4%
2/82 • Number of events 2 • Day 0 to Day 365
|
1.3%
1/77 • Number of events 1 • Day 0 to Day 365
|
7.5%
6/80 • Number of events 6 • Day 0 to Day 365
|
2.6%
2/78 • Number of events 2 • Day 0 to Day 365
|
|
Infections and infestations
Otitis media acute
|
9.0%
7/78 • Number of events 7 • Day 0 to Day 365
|
12.7%
10/79 • Number of events 12 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
6.2%
5/80 • Number of events 5 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
5.0%
2/40 • Number of events 2 • Day 0 to Day 365
|
1.2%
1/82 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
|
Infections and infestations
Paronychia
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Pertussis
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Pharyngitis
|
5.1%
4/78 • Number of events 4 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
5.0%
4/80 • Number of events 4 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
5.0%
2/40 • Number of events 2 • Day 0 to Day 365
|
2.5%
1/40 • Number of events 1 • Day 0 to Day 365
|
7.3%
6/82 • Number of events 7 • Day 0 to Day 365
|
3.9%
3/77 • Number of events 3 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/78 • Day 0 to Day 365
|
2.5%
2/79 • Number of events 2 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
2.5%
2/80 • Number of events 2 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Pharyngotonsillitis
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Pneumonia
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
1.2%
1/82 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
1.3%
1/77 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Rhinitis
|
3.8%
3/78 • Number of events 3 • Day 0 to Day 365
|
2.5%
2/79 • Number of events 2 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Scarlet fever
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Sinusitis
|
5.1%
4/78 • Number of events 4 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
2.5%
2/80 • Number of events 2 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
2.5%
1/40 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Skin candida
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
1.2%
1/82 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Tinea infection
|
0.00%
0/78 • Day 0 to Day 365
|
1.3%
1/79 • Number of events 1 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Tonsillitis
|
2.6%
2/78 • Number of events 2 • Day 0 to Day 365
|
5.1%
4/79 • Number of events 4 • Day 0 to Day 365
|
5.0%
4/80 • Number of events 5 • Day 0 to Day 365
|
3.8%
3/80 • Number of events 5 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
2.5%
1/40 • Number of events 1 • Day 0 to Day 365
|
1.2%
1/82 • Number of events 1 • Day 0 to Day 365
|
5.2%
4/77 • Number of events 5 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
3.8%
3/78 • Number of events 3 • Day 0 to Day 365
|
|
Infections and infestations
Tonsillitis streptococcal
|
0.00%
0/78 • Day 0 to Day 365
|
1.3%
1/79 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Tracheitis
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
2.5%
1/40 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Upper respiratory tract infection
|
19.2%
15/78 • Number of events 19 • Day 0 to Day 365
|
32.9%
26/79 • Number of events 31 • Day 0 to Day 365
|
27.5%
22/80 • Number of events 29 • Day 0 to Day 365
|
16.2%
13/80 • Number of events 14 • Day 0 to Day 365
|
10.0%
4/40 • Number of events 5 • Day 0 to Day 365
|
17.5%
7/40 • Number of events 7 • Day 0 to Day 365
|
18.3%
15/82 • Number of events 18 • Day 0 to Day 365
|
15.6%
12/77 • Number of events 13 • Day 0 to Day 365
|
17.5%
14/80 • Number of events 18 • Day 0 to Day 365
|
17.9%
14/78 • Number of events 17 • Day 0 to Day 365
|
|
Infections and infestations
Viral infection
|
5.1%
4/78 • Number of events 5 • Day 0 to Day 365
|
1.3%
1/79 • Number of events 1 • Day 0 to Day 365
|
5.0%
4/80 • Number of events 4 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
5.0%
2/40 • Number of events 2 • Day 0 to Day 365
|
1.2%
1/82 • Number of events 1 • Day 0 to Day 365
|
1.3%
1/77 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
2.6%
2/78 • Number of events 2 • Day 0 to Day 365
|
|
Infections and infestations
Viral pharyngitis
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
1.3%
1/79 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
2.5%
2/80 • Number of events 2 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
1.2%
1/82 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Viral rash
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
1.3%
1/79 • Number of events 1 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Infections and infestations
Viral upper respiratory tract infection
|
3.8%
3/78 • Number of events 3 • Day 0 to Day 365
|
6.3%
5/79 • Number of events 5 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
1.3%
1/77 • Number of events 1 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
|
Infections and infestations
Wound infection
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/78 • Day 0 to Day 365
|
1.3%
1/79 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
1.3%
1/78 • Number of events 3 • Day 0 to Day 365
|
1.3%
1/79 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
2.5%
2/80 • Number of events 2 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/78 • Day 0 to Day 365
|
1.3%
1/79 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
1.2%
1/82 • Number of events 1 • Day 0 to Day 365
|
2.6%
2/77 • Number of events 2 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/78 • Day 0 to Day 365
|
1.3%
1/79 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Injury, poisoning and procedural complications
Gingival injury
|
0.00%
0/78 • Day 0 to Day 365
|
1.3%
1/79 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/78 • Day 0 to Day 365
|
2.5%
2/79 • Number of events 2 • Day 0 to Day 365
|
5.0%
4/80 • Number of events 5 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Injury, poisoning and procedural complications
Joint sprain
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/78 • Day 0 to Day 365
|
1.3%
1/79 • Number of events 2 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
1.3%
1/77 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
1.3%
1/77 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Injury, poisoning and procedural complications
Tongue injury
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
2.5%
1/40 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
1.2%
1/82 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Investigations
Body temperature increased
|
7.7%
6/78 • Number of events 9 • Day 0 to Day 365
|
5.1%
4/79 • Number of events 4 • Day 0 to Day 365
|
11.2%
9/80 • Number of events 9 • Day 0 to Day 365
|
7.5%
6/80 • Number of events 7 • Day 0 to Day 365
|
2.5%
1/40 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
1.2%
1/82 • Number of events 1 • Day 0 to Day 365
|
1.3%
1/77 • Number of events 1 • Day 0 to Day 365
|
2.5%
2/80 • Number of events 2 • Day 0 to Day 365
|
2.6%
2/78 • Number of events 3 • Day 0 to Day 365
|
|
Investigations
Cardiac murmur
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Investigations
Occult blood
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Metabolism and nutrition disorders
Weight gain poor
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
2.6%
2/77 • Number of events 2 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
1.3%
1/77 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Nervous system disorders
Febrile convulsion
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Nervous system disorders
Headache
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Nervous system disorders
Poor quality sleep
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Psychiatric disorders
Insomnia
|
1.3%
1/78 • Number of events 3 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.4%
5/78 • Number of events 5 • Day 0 to Day 365
|
3.8%
3/79 • Number of events 5 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
3.8%
3/80 • Number of events 3 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
1.2%
1/82 • Number of events 1 • Day 0 to Day 365
|
2.6%
2/77 • Number of events 2 • Day 0 to Day 365
|
3.8%
3/80 • Number of events 3 • Day 0 to Day 365
|
3.8%
3/78 • Number of events 4 • Day 0 to Day 365
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/78 • Day 0 to Day 365
|
1.3%
1/79 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/78 • Day 0 to Day 365
|
1.3%
1/79 • Number of events 3 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal stenosis
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
2.5%
1/40 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.6%
2/78 • Number of events 2 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
2.5%
1/40 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
3.9%
3/77 • Number of events 3 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 2 • Day 0 to Day 365
|
2.6%
2/78 • Number of events 2 • Day 0 to Day 365
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.00%
0/78 • Day 0 to Day 365
|
1.3%
1/79 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/78 • Day 0 to Day 365
|
1.3%
1/79 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
1.3%
1/77 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
1.3%
1/79 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
2.6%
2/78 • Number of events 3 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/78 • Day 0 to Day 365
|
1.3%
1/79 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
1.2%
1/82 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
3.8%
3/78 • Number of events 5 • Day 0 to Day 365
|
1.3%
1/79 • Number of events 1 • Day 0 to Day 365
|
2.5%
2/80 • Number of events 3 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
7.5%
3/40 • Number of events 5 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
2.4%
2/82 • Number of events 2 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
5.0%
4/80 • Number of events 7 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
1.3%
1/77 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/78 • Day 0 to Day 365
|
3.8%
3/79 • Number of events 4 • Day 0 to Day 365
|
3.8%
3/80 • Number of events 3 • Day 0 to Day 365
|
2.5%
2/80 • Number of events 2 • Day 0 to Day 365
|
7.5%
3/40 • Number of events 4 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
1.2%
1/82 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
2.5%
2/80 • Number of events 3 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
1.3%
1/77 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.6%
2/78 • Number of events 2 • Day 0 to Day 365
|
1.3%
1/79 • Number of events 1 • Day 0 to Day 365
|
5.0%
4/80 • Number of events 4 • Day 0 to Day 365
|
3.8%
3/80 • Number of events 3 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
2.5%
2/80 • Number of events 2 • Day 0 to Day 365
|
2.6%
2/78 • Number of events 2 • Day 0 to Day 365
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
1.3%
1/77 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Skin and subcutaneous tissue disorders
Dandruff
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
1.3%
1/77 • Number of events 1 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
2.5%
1/40 • Number of events 1 • Day 0 to Day 365
|
1.2%
1/82 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
1.3%
1/79 • Number of events 2 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
5.0%
2/40 • Number of events 2 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
1.2%
1/82 • Number of events 1 • Day 0 to Day 365
|
2.6%
2/77 • Number of events 2 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
2.6%
2/78 • Number of events 3 • Day 0 to Day 365
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/78 • Day 0 to Day 365
|
1.3%
1/79 • Number of events 1 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
2.6%
2/78 • Number of events 2 • Day 0 to Day 365
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
2.6%
2/78 • Number of events 2 • Day 0 to Day 365
|
11.4%
9/79 • Number of events 9 • Day 0 to Day 365
|
6.2%
5/80 • Number of events 6 • Day 0 to Day 365
|
6.2%
5/80 • Number of events 7 • Day 0 to Day 365
|
2.5%
1/40 • Number of events 2 • Day 0 to Day 365
|
10.0%
4/40 • Number of events 4 • Day 0 to Day 365
|
2.4%
2/82 • Number of events 2 • Day 0 to Day 365
|
3.9%
3/77 • Number of events 3 • Day 0 to Day 365
|
7.5%
6/80 • Number of events 6 • Day 0 to Day 365
|
2.6%
2/78 • Number of events 2 • Day 0 to Day 365
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 2 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.6%
2/78 • Number of events 2 • Day 0 to Day 365
|
3.8%
3/79 • Number of events 3 • Day 0 to Day 365
|
3.8%
3/80 • Number of events 3 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
6.1%
5/82 • Number of events 6 • Day 0 to Day 365
|
7.8%
6/77 • Number of events 8 • Day 0 to Day 365
|
3.8%
3/80 • Number of events 3 • Day 0 to Day 365
|
2.6%
2/78 • Number of events 2 • Day 0 to Day 365
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Skin and subcutaneous tissue disorders
Heat rash
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
1.3%
1/77 • Number of events 1 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Skin and subcutaneous tissue disorders
Periorbital oedema
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
1.2%
1/82 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.0%
7/78 • Number of events 7 • Day 0 to Day 365
|
7.6%
6/79 • Number of events 6 • Day 0 to Day 365
|
2.5%
2/80 • Number of events 2 • Day 0 to Day 365
|
6.2%
5/80 • Number of events 6 • Day 0 to Day 365
|
5.0%
2/40 • Number of events 2 • Day 0 to Day 365
|
5.0%
2/40 • Number of events 2 • Day 0 to Day 365
|
4.9%
4/82 • Number of events 4 • Day 0 to Day 365
|
2.6%
2/77 • Number of events 2 • Day 0 to Day 365
|
6.2%
5/80 • Number of events 5 • Day 0 to Day 365
|
2.6%
2/78 • Number of events 4 • Day 0 to Day 365
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
1.2%
1/82 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Skin and subcutaneous tissue disorders
Seborrhoea
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
5.0%
2/40 • Number of events 2 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
1.2%
1/82 • Number of events 1 • Day 0 to Day 365
|
2.6%
2/77 • Number of events 2 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
1.3%
1/77 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/78 • Day 0 to Day 365
|
1.3%
1/79 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
1.2%
1/80 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
|
Skin and subcutaneous tissue disorders
Urticaria papular
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
0.00%
0/77 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
1.3%
1/78 • Number of events 1 • Day 0 to Day 365
|
|
Vascular disorders
Haematoma
|
0.00%
0/78 • Day 0 to Day 365
|
0.00%
0/79 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/40 • Day 0 to Day 365
|
0.00%
0/82 • Day 0 to Day 365
|
1.3%
1/77 • Number of events 1 • Day 0 to Day 365
|
0.00%
0/80 • Day 0 to Day 365
|
0.00%
0/78 • Day 0 to Day 365
|
Additional Information
Filip Dubovsky, Vice President, Clinical Development
MedImmune, LLC.
Phone: 301-398-0000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome. The PIs also agree for data to be presented first as a joint, multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER