Trial Outcomes & Findings for Exploratory Clinical Study of MT-2301 (NCT NCT02140047)
NCT ID: NCT02140047
Last Updated: 2026-01-07
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
154 participants
Primary outcome timeframe
4 weeks after the primary immunization (Visit 4)
Results posted on
2026-01-07
Participant Flow
Participant milestones
| Measure |
MT-2301-Low
Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate-Low
|
MT-2301-High
Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate-High
|
ActHIB
Haemophilus influenza type b conjugate vaccine
|
|---|---|---|---|
|
Overall Study
STARTED
|
52
|
52
|
50
|
|
Overall Study
COMPLETED
|
51
|
51
|
50
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
MT-2301-Low
Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate-Low
|
MT-2301-High
Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate-High
|
ActHIB
Haemophilus influenza type b conjugate vaccine
|
|---|---|---|---|
|
Overall Study
Withdrawal by parent/guardian
|
1
|
1
|
0
|
Baseline Characteristics
Exploratory Clinical Study of MT-2301
Baseline characteristics by cohort
| Measure |
MT-2301-Low
n=52 Participants
Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate-Low
|
MT-2301-High
n=52 Participants
Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate-High
|
ActHIB
n=50 Participants
Haemophilus influenza type b conjugate vaccine
|
Total
n=154 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
>=2 and <3 months
|
43 Participants
n=37 Participants
|
39 Participants
n=56 Participants
|
37 Participants
n=95 Participants
|
119 Participants
n=61 Participants
|
|
Age, Customized
>=3 months
|
9 Participants
n=37 Participants
|
13 Participants
n=56 Participants
|
13 Participants
n=95 Participants
|
35 Participants
n=61 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=37 Participants
|
21 Participants
n=56 Participants
|
20 Participants
n=95 Participants
|
64 Participants
n=61 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=37 Participants
|
31 Participants
n=56 Participants
|
30 Participants
n=95 Participants
|
90 Participants
n=61 Participants
|
|
Race/Ethnicity, Customized
Asian (Japanese)
|
52 Participants
n=37 Participants
|
52 Participants
n=56 Participants
|
50 Participants
n=95 Participants
|
154 Participants
n=61 Participants
|
PRIMARY outcome
Timeframe: 4 weeks after the primary immunization (Visit 4)Population: For antibody analysis at Visit 4, number of subjects 154.
Outcome measures
| Measure |
MT-2301-Low
n=52 Participants
Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate-Low
|
MT-2301-High
n=52 Participants
Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate-High
|
ActHIB
n=50 Participants
Haemophilus influenza type b conjugate vaccine
|
|---|---|---|---|
|
Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Defined as the Percentage of Participants With the Antibody Against Anti-PRP
|
100.0 percentage of participants
Interval 93.2 to 100.0
|
96.2 percentage of participants
Interval 86.8 to 99.5
|
94.0 percentage of participants
Interval 83.5 to 98.7
|
SECONDARY outcome
Timeframe: 4 weeks after the primary immunization (Visit 4)Population: For antibody analysis at Visit 4, number of subjects 154.
Outcome measures
| Measure |
MT-2301-Low
n=52 Participants
Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate-Low
|
MT-2301-High
n=52 Participants
Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate-High
|
ActHIB
n=50 Participants
Haemophilus influenza type b conjugate vaccine
|
|---|---|---|---|
|
Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody
|
100.0 percentage of participants
Interval 93.2 to 100.0
|
100.0 percentage of participants
Interval 93.2 to 100.0
|
100.0 percentage of participants
Interval 92.9 to 100.0
|
SECONDARY outcome
Timeframe: 4 weeks after the primary immunization (Visit 4)Population: For antibody analysis at Visit 4, number of subjects 154.
Outcome measures
| Measure |
MT-2301-Low
n=52 Participants
Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate-Low
|
MT-2301-High
n=52 Participants
Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate-High
|
ActHIB
n=50 Participants
Haemophilus influenza type b conjugate vaccine
|
|---|---|---|---|
|
Geometric Mean Antibody Titer of Anti-PRP Antibody
|
21.120 µg/mL
Interval 16.233 to 27.495
|
13.724 µg/mL
Interval 10.077 to 18.69
|
7.374 µg/mL
Interval 5.212 to 10.434
|
SECONDARY outcome
Timeframe: 4 weeks after the booster dose (Visit 6)Population: For antibody analysis at Visit 6, number of subjects decreased from 154 to 152.MT-2301-Low group: due to withdrawal by parent/guardian (n=1) . MT-2301-High group: due to withdrawal by parent/guardian (n=1) .
Outcome measures
| Measure |
MT-2301-Low
n=51 Participants
Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate-Low
|
MT-2301-High
n=51 Participants
Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate-High
|
ActHIB
n=50 Participants
Haemophilus influenza type b conjugate vaccine
|
|---|---|---|---|
|
Anti-PRP Antibody Prevalence Rate With 1 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody
|
100.0 percentage of participants
Interval 93.0 to 100.0
|
100.0 percentage of participants
Interval 93.0 to 100.0
|
100.0 percentage of participants
Interval 92.9 to 100.0
|
SECONDARY outcome
Timeframe: 4 weeks after the booster dose (Visit 6)Population: For antibody analysis at Visit 6, number of subjects decreased from 154 to 152.MT-2301-Low group: due to withdrawal by parent/guardian (n=1) . MT-2301-High group: due to withdrawal by parent/guardian (n=1) .
Outcome measures
| Measure |
MT-2301-Low
n=51 Participants
Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate-Low
|
MT-2301-High
n=51 Participants
Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate-High
|
ActHIB
n=50 Participants
Haemophilus influenza type b conjugate vaccine
|
|---|---|---|---|
|
Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody
|
100.0 percentage of participants
Interval 93.0 to 100.0
|
100.0 percentage of participants
Interval 93.0 to 100.0
|
100.0 percentage of participants
Interval 92.9 to 100.0
|
SECONDARY outcome
Timeframe: 4 weeks after the booster dose (Visit 6)Population: For antibody analysis at Visit 6, number of subjects decreased from 154 to 152.MT-2301-Low group: due to withdrawal by parent/guardian (n=1) . MT-2301-High group: due to withdrawal by parent/guardian (n=1) .
Outcome measures
| Measure |
MT-2301-Low
n=51 Participants
Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate-Low
|
MT-2301-High
n=51 Participants
Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate-High
|
ActHIB
n=50 Participants
Haemophilus influenza type b conjugate vaccine
|
|---|---|---|---|
|
Geometric Mean Antibody Titer of Anti-PRP Antibody
|
65.086 µg/mL
Interval 52.241 to 81.089
|
48.448 µg/mL
Interval 35.066 to 66.936
|
39.752 µg/mL
Interval 29.379 to 53.787
|
SECONDARY outcome
Timeframe: 4 weeks after the primary immunization (Visit 4)Population: For antibody analysis at Visit 4, number of subjects 154. MT-2301-High group number of subjects further decreased due to insufficient sample volume (diphtheria :n=1)
Outcome measures
| Measure |
MT-2301-Low
n=52 Participants
Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate-Low
|
MT-2301-High
n=51 Participants
Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate-High
|
ActHIB
n=50 Participants
Haemophilus influenza type b conjugate vaccine
|
|---|---|---|---|
|
Geometric Mean Antibody Titer Against Diphtheria Toxin
|
1.026 IU/mL
Interval 0.746 to 1.41
|
1.016 IU/mL
Interval 0.777 to 1.329
|
1.110 IU/mL
Interval 0.824 to 1.497
|
SECONDARY outcome
Timeframe: 4 weeks after the primary immunization (Visit 4)Population: For antibody analysis at Visit 4, number of subjects 154.
Outcome measures
| Measure |
MT-2301-Low
n=52 Participants
Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate-Low
|
MT-2301-High
n=52 Participants
Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate-High
|
ActHIB
n=50 Participants
Haemophilus influenza type b conjugate vaccine
|
|---|---|---|---|
|
Geometric Mean Antibody Titer Against Pertussis
pertussis （PT）
|
189.03 U/mL
Interval 162.6 to 219.77
|
191.62 U/mL
Interval 168.87 to 217.43
|
203.58 U/mL
Interval 181.78 to 227.98
|
|
Geometric Mean Antibody Titer Against Pertussis
pertussis （FHA）
|
54.82 U/mL
Interval 47.23 to 63.62
|
44.50 U/mL
Interval 37.24 to 53.18
|
68.75 U/mL
Interval 57.37 to 82.37
|
SECONDARY outcome
Timeframe: 4 weeks after the primary immunization (Visit 4)Population: For antibody analysis at Visit 4, number of subjects 154.
Outcome measures
| Measure |
MT-2301-Low
n=52 Participants
Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate-Low
|
MT-2301-High
n=52 Participants
Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate-High
|
ActHIB
n=50 Participants
Haemophilus influenza type b conjugate vaccine
|
|---|---|---|---|
|
Geometric Mean Antibody Titer Against Tetanus Toxin
|
0.575 U/mL
Interval 0.449 to 0.738
|
0.497 U/mL
Interval 0.374 to 0.66
|
0.542 U/mL
Interval 0.373 to 0.786
|
SECONDARY outcome
Timeframe: 4 weeks after the primary immunization (Visit 4)Population: For antibody analysis at Visit 4, number of subjects 154. MT-2301-High group number of subjects further decreased due to insufficient sample volume (polio serotype1,2 and 3: n=3 each) . MT-2301-Low group number of subjects further decreased due to insufficient sample volume (polio serotype1,2 and 3: n=2 each). ActHIV group number of subjects further decreased due to insufficient sample volume (polio serotype1,2 and 3: n=1 each).
Outcome measures
| Measure |
MT-2301-Low
n=50 Participants
Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate-Low
|
MT-2301-High
n=49 Participants
Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate-High
|
ActHIB
n=49 Participants
Haemophilus influenza type b conjugate vaccine
|
|---|---|---|---|
|
Fold Change in Geometric Mean Antibody Titer Against Polio Virus
polio virus serotype 1
|
1468.4 fold change
Interval 1017.4 to 2119.2
|
1554.3 fold change
Interval 1094.5 to 2207.3
|
1790.5 fold change
Interval 1192.6 to 2688.0
|
|
Fold Change in Geometric Mean Antibody Titer Against Polio Virus
polio virus serotype 2
|
2272.4 fold change
Interval 1809.2 to 2854.2
|
2776.0 fold change
Interval 2266.4 to 3400.2
|
2896.3 fold change
Interval 2311.9 to 3628.4
|
|
Fold Change in Geometric Mean Antibody Titer Against Polio Virus
polio virus serotype 3
|
2574.4 fold change
Interval 2061.6 to 3214.7
|
1976.8 fold change
Interval 1569.1 to 2490.6
|
2198.1 fold change
Interval 1699.9 to 2842.3
|
SECONDARY outcome
Timeframe: 4 weeks after the booster dose (Visit 6)Population: For antibody analysis at Visit 6, number of subjects 152.
Outcome measures
| Measure |
MT-2301-Low
n=51 Participants
Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate-Low
|
MT-2301-High
n=51 Participants
Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate-High
|
ActHIB
n=50 Participants
Haemophilus influenza type b conjugate vaccine
|
|---|---|---|---|
|
Geometric Mean Antibody Titer Against Diphtheria Toxin
|
9.831 IU/mL
Interval 7.856 to 12.302
|
10.102 IU/mL
Interval 8.195 to 12.454
|
9.511 IU/mL
Interval 7.616 to 11.876
|
SECONDARY outcome
Timeframe: 4 weeks after the booster dose (Visit 6)Population: For antibody analysis at Visit 6, number of subjects 152.
Outcome measures
| Measure |
MT-2301-Low
n=51 Participants
Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate-Low
|
MT-2301-High
n=51 Participants
Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate-High
|
ActHIB
n=50 Participants
Haemophilus influenza type b conjugate vaccine
|
|---|---|---|---|
|
Geometric Mean Antibody Titer Against Pertussis
pertussis （PT）
|
239.48 U/mL
Interval 200.45 to 286.11
|
233.12 U/mL
Interval 200.58 to 270.94
|
262.73 U/mL
Interval 223.61 to 308.69
|
|
Geometric Mean Antibody Titer Against Pertussis
pertussis （FHA）
|
124.84 U/mL
Interval 104.61 to 148.99
|
119.41 U/mL
Interval 98.56 to 144.68
|
158.85 U/mL
Interval 126.24 to 199.89
|
SECONDARY outcome
Timeframe: 4 weeks after the booster dose (Visit 6)Population: For antibody analysis at Visit 6, number of subjects 152.
Outcome measures
| Measure |
MT-2301-Low
n=51 Participants
Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate-Low
|
MT-2301-High
n=51 Participants
Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate-High
|
ActHIB
n=50 Participants
Haemophilus influenza type b conjugate vaccine
|
|---|---|---|---|
|
Geometric Mean Antibody Titer Against Tetanus Toxin
|
1.750 U/mL
Interval 1.412 to 2.169
|
1.726 U/mL
Interval 1.374 to 2.169
|
2.051 U/mL
Interval 1.429 to 2.943
|
SECONDARY outcome
Timeframe: 4 weeks after the booster dose (Visit 6)Population: For antibody analysis at Visit 6, number of subjects 152. MT-2301-High group number of subjects further decreased due to insufficient sample volume (polio serotype1: n=1) . ActHIV group number of subjects further decreased due to insufficient sample volume (polio serotype1,2 and 3: n=1 each).
Outcome measures
| Measure |
MT-2301-Low
n=51 Participants
Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate-Low
|
MT-2301-High
n=51 Participants
Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate-High
|
ActHIB
n=50 Participants
Haemophilus influenza type b conjugate vaccine
|
|---|---|---|---|
|
Fold Change in Geometric Mean Antibody Titer Against Polio Virus
polio virus serotype 1
|
3479.6 fold change
Interval 2487.6 to 4867.2
|
4544.8 fold change
Interval 3303.0 to 6253.5
|
4685.1 fold change
Interval 3194.4 to 6873.7
|
|
Fold Change in Geometric Mean Antibody Titer Against Polio Virus
polio virus serotype 2
|
8360.7 fold change
Interval 6703.5 to 10427.7
|
9908.9 fold change
Interval 8030.0 to 12227.5
|
10642.5 fold change
Interval 8809.5 to 12856.9
|
|
Fold Change in Geometric Mean Antibody Titer Against Polio Virus
polio virus serotype 3
|
6681.2 fold change
Interval 5410.1 to 8250.9
|
7448.6 fold change
Interval 5811.4 to 9546.9
|
7578.8 fold change
Interval 5756.2 to 9978.6
|
Adverse Events
MT-2301-Low
Serious events: 4 serious events
Other events: 52 other events
Deaths: 0 deaths
MT-2301-High
Serious events: 2 serious events
Other events: 52 other events
Deaths: 0 deaths
ActHIB
Serious events: 2 serious events
Other events: 49 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MT-2301-Low
n=52 participants at risk
Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate-Low
|
MT-2301-High
n=52 participants at risk
Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate-High
|
ActHIB
n=50 participants at risk
Haemophilus influenza type b conjugate vaccine
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
1.9%
1/52 • Through study completion, an average of 1 year
|
0.00%
0/52 • Through study completion, an average of 1 year
|
0.00%
0/50 • Through study completion, an average of 1 year
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.9%
1/52 • Through study completion, an average of 1 year
|
0.00%
0/52 • Through study completion, an average of 1 year
|
0.00%
0/50 • Through study completion, an average of 1 year
|
|
General disorders
Pyrexia
|
1.9%
1/52 • Through study completion, an average of 1 year
|
0.00%
0/52 • Through study completion, an average of 1 year
|
0.00%
0/50 • Through study completion, an average of 1 year
|
|
Immune system disorders
Food allergy
|
0.00%
0/52 • Through study completion, an average of 1 year
|
0.00%
0/52 • Through study completion, an average of 1 year
|
2.0%
1/50 • Through study completion, an average of 1 year
|
|
Infections and infestations
Bronchitis
|
0.00%
0/52 • Through study completion, an average of 1 year
|
1.9%
1/52 • Through study completion, an average of 1 year
|
0.00%
0/50 • Through study completion, an average of 1 year
|
|
Infections and infestations
Gingivitis
|
1.9%
1/52 • Through study completion, an average of 1 year
|
0.00%
0/52 • Through study completion, an average of 1 year
|
0.00%
0/50 • Through study completion, an average of 1 year
|
|
Infections and infestations
Pneumonia
|
0.00%
0/52 • Through study completion, an average of 1 year
|
0.00%
0/52 • Through study completion, an average of 1 year
|
2.0%
1/50 • Through study completion, an average of 1 year
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
1.9%
1/52 • Through study completion, an average of 1 year
|
0.00%
0/52 • Through study completion, an average of 1 year
|
0.00%
0/50 • Through study completion, an average of 1 year
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
1.9%
1/52 • Through study completion, an average of 1 year
|
0.00%
0/52 • Through study completion, an average of 1 year
|
0.00%
0/50 • Through study completion, an average of 1 year
|
|
Nervous system disorders
Febrile convulsion
|
0.00%
0/52 • Through study completion, an average of 1 year
|
1.9%
1/52 • Through study completion, an average of 1 year
|
0.00%
0/50 • Through study completion, an average of 1 year
|
Other adverse events
| Measure |
MT-2301-Low
n=52 participants at risk
Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate-Low
|
MT-2301-High
n=52 participants at risk
Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate-High
|
ActHIB
n=50 participants at risk
Haemophilus influenza type b conjugate vaccine
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
5.8%
3/52 • Through study completion, an average of 1 year
|
5.8%
3/52 • Through study completion, an average of 1 year
|
12.0%
6/50 • Through study completion, an average of 1 year
|
|
Gastrointestinal disorders
Diarrhoea
|
5.8%
3/52 • Through study completion, an average of 1 year
|
1.9%
1/52 • Through study completion, an average of 1 year
|
10.0%
5/50 • Through study completion, an average of 1 year
|
|
General disorders
Crying
|
25.0%
13/52 • Through study completion, an average of 1 year
|
25.0%
13/52 • Through study completion, an average of 1 year
|
32.0%
16/50 • Through study completion, an average of 1 year
|
|
General disorders
Injection site bruising
|
5.8%
3/52 • Through study completion, an average of 1 year
|
0.00%
0/52 • Through study completion, an average of 1 year
|
0.00%
0/50 • Through study completion, an average of 1 year
|
|
General disorders
Injection site erythema
|
75.0%
39/52 • Through study completion, an average of 1 year
|
78.8%
41/52 • Through study completion, an average of 1 year
|
72.0%
36/50 • Through study completion, an average of 1 year
|
|
General disorders
Injection site induration
|
65.4%
34/52 • Through study completion, an average of 1 year
|
57.7%
30/52 • Through study completion, an average of 1 year
|
44.0%
22/50 • Through study completion, an average of 1 year
|
|
General disorders
Injection site pain
|
15.4%
8/52 • Through study completion, an average of 1 year
|
17.3%
9/52 • Through study completion, an average of 1 year
|
16.0%
8/50 • Through study completion, an average of 1 year
|
|
General disorders
Injection site swelling
|
50.0%
26/52 • Through study completion, an average of 1 year
|
40.4%
21/52 • Through study completion, an average of 1 year
|
34.0%
17/50 • Through study completion, an average of 1 year
|
|
General disorders
Irritability postvaccinal
|
36.5%
19/52 • Through study completion, an average of 1 year
|
46.2%
24/52 • Through study completion, an average of 1 year
|
44.0%
22/50 • Through study completion, an average of 1 year
|
|
General disorders
Pyrexia
|
76.9%
40/52 • Through study completion, an average of 1 year
|
69.2%
36/52 • Through study completion, an average of 1 year
|
82.0%
41/50 • Through study completion, an average of 1 year
|
|
Infections and infestations
Bronchitis
|
13.5%
7/52 • Through study completion, an average of 1 year
|
7.7%
4/52 • Through study completion, an average of 1 year
|
8.0%
4/50 • Through study completion, an average of 1 year
|
|
Infections and infestations
Conjunctivitis
|
15.4%
8/52 • Through study completion, an average of 1 year
|
9.6%
5/52 • Through study completion, an average of 1 year
|
6.0%
3/50 • Through study completion, an average of 1 year
|
|
Infections and infestations
Exanthema subitum
|
11.5%
6/52 • Through study completion, an average of 1 year
|
5.8%
3/52 • Through study completion, an average of 1 year
|
10.0%
5/50 • Through study completion, an average of 1 year
|
|
Infections and infestations
Gastroenteritis
|
9.6%
5/52 • Through study completion, an average of 1 year
|
11.5%
6/52 • Through study completion, an average of 1 year
|
4.0%
2/50 • Through study completion, an average of 1 year
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
11.5%
6/52 • Through study completion, an average of 1 year
|
5.8%
3/52 • Through study completion, an average of 1 year
|
10.0%
5/50 • Through study completion, an average of 1 year
|
|
Infections and infestations
Herpangina
|
5.8%
3/52 • Through study completion, an average of 1 year
|
1.9%
1/52 • Through study completion, an average of 1 year
|
2.0%
1/50 • Through study completion, an average of 1 year
|
|
Infections and infestations
Nasopharyngitis
|
26.9%
14/52 • Through study completion, an average of 1 year
|
32.7%
17/52 • Through study completion, an average of 1 year
|
18.0%
9/50 • Through study completion, an average of 1 year
|
|
Infections and infestations
Otitis media
|
9.6%
5/52 • Through study completion, an average of 1 year
|
9.6%
5/52 • Through study completion, an average of 1 year
|
8.0%
4/50 • Through study completion, an average of 1 year
|
|
Infections and infestations
Pharyngitis
|
7.7%
4/52 • Through study completion, an average of 1 year
|
3.8%
2/52 • Through study completion, an average of 1 year
|
2.0%
1/50 • Through study completion, an average of 1 year
|
|
Infections and infestations
Respiratory syncytial virus infection
|
3.8%
2/52 • Through study completion, an average of 1 year
|
5.8%
3/52 • Through study completion, an average of 1 year
|
10.0%
5/50 • Through study completion, an average of 1 year
|
|
Infections and infestations
Upper respiratory tract infection
|
1.9%
1/52 • Through study completion, an average of 1 year
|
1.9%
1/52 • Through study completion, an average of 1 year
|
8.0%
4/50 • Through study completion, an average of 1 year
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
11.5%
6/52 • Through study completion, an average of 1 year
|
9.6%
5/52 • Through study completion, an average of 1 year
|
6.0%
3/50 • Through study completion, an average of 1 year
|
|
Metabolism and nutrition disorders
Decreased appetite
|
17.3%
9/52 • Through study completion, an average of 1 year
|
21.2%
11/52 • Through study completion, an average of 1 year
|
24.0%
12/50 • Through study completion, an average of 1 year
|
|
Nervous system disorders
Hypersomnia
|
36.5%
19/52 • Through study completion, an average of 1 year
|
40.4%
21/52 • Through study completion, an average of 1 year
|
22.0%
11/50 • Through study completion, an average of 1 year
|
|
Psychiatric disorders
Insomnia
|
21.2%
11/52 • Through study completion, an average of 1 year
|
25.0%
13/52 • Through study completion, an average of 1 year
|
36.0%
18/50 • Through study completion, an average of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
5.8%
3/52 • Through study completion, an average of 1 year
|
5.8%
3/52 • Through study completion, an average of 1 year
|
22.0%
11/50 • Through study completion, an average of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
13.5%
7/52 • Through study completion, an average of 1 year
|
7.7%
4/52 • Through study completion, an average of 1 year
|
2.0%
1/50 • Through study completion, an average of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
30.8%
16/52 • Through study completion, an average of 1 year
|
38.5%
20/52 • Through study completion, an average of 1 year
|
28.0%
14/50 • Through study completion, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
13.5%
7/52 • Through study completion, an average of 1 year
|
17.3%
9/52 • Through study completion, an average of 1 year
|
4.0%
2/50 • Through study completion, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Eczema
|
21.2%
11/52 • Through study completion, an average of 1 year
|
9.6%
5/52 • Through study completion, an average of 1 year
|
16.0%
8/50 • Through study completion, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Eczema infantile
|
5.8%
3/52 • Through study completion, an average of 1 year
|
5.8%
3/52 • Through study completion, an average of 1 year
|
10.0%
5/50 • Through study completion, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
15.4%
8/52 • Through study completion, an average of 1 year
|
13.5%
7/52 • Through study completion, an average of 1 year
|
10.0%
5/50 • Through study completion, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.8%
3/52 • Through study completion, an average of 1 year
|
3.8%
2/52 • Through study completion, an average of 1 year
|
2.0%
1/50 • Through study completion, an average of 1 year
|
|
Eye disorders
Eye discharge
|
5.8%
3/52 • Through study completion, an average of 1 year
|
0.00%
0/52 • Through study completion, an average of 1 year
|
4.0%
2/50 • Through study completion, an average of 1 year
|
Additional Information
Clinical Trials, Information Desk
Tanabe Pharma Corporation
Phone: +81-3-5960-9608
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER