Trial Outcomes & Findings for Phase 3 Study of BK1310 in Healthy Infants (NCT NCT02992925)
NCT ID: NCT02992925
Last Updated: 2026-01-06
Results Overview
Antibody prevalence rate is defined as the percentage of participants whose criteria of each antibody titer: Anti-diphtheria antibody concentrations: \>=0.1 IU/mL, Anti-PT antibody concentrations: \>=10.0 EU/mL, Anti-FHA antibody concentrations: \>=10.0 EU/mL, Anti-tetanus antibody concentrations: \>=0.01 IU/mL, Anti-poliovirus serotype 1, 2 and 3, antibody titers (fold) \>=8
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
370 participants
Primary outcome timeframe
4 weeks after the primary immunization (Visit 4)
Results posted on
2026-01-06
Participant Flow
Participant milestones
| Measure |
BK1310-High
(Cohort 1) DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310-Low
(Cohort 1) DPT-IPV-Hib-Low(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310
(Cohort 2) DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals.
|
ActHIB® and Tetrabik (Control)
(Cohort 2) Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals.
|
|---|---|---|---|---|
|
Cohort 1
STARTED
|
15
|
15
|
0
|
0
|
|
Cohort 1
COMPLETED
|
15
|
15
|
0
|
0
|
|
Cohort 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Cohort 2
STARTED
|
0
|
0
|
171
|
169
|
|
Cohort 2
COMPLETED
|
0
|
0
|
170
|
167
|
|
Cohort 2
NOT COMPLETED
|
0
|
0
|
1
|
2
|
Reasons for withdrawal
| Measure |
BK1310-High
(Cohort 1) DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310-Low
(Cohort 1) DPT-IPV-Hib-Low(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310
(Cohort 2) DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals.
|
ActHIB® and Tetrabik (Control)
(Cohort 2) Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals.
|
|---|---|---|---|---|
|
Cohort 2
Physician Decision
|
0
|
0
|
1
|
0
|
|
Cohort 2
Withdrawal by parent/guardian
|
0
|
0
|
0
|
2
|
Baseline Characteristics
Phase 3 Study of BK1310 in Healthy Infants
Baseline characteristics by cohort
| Measure |
BK1310-High
n=15 Participants
(Cohort 1) DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310-Low
n=15 Participants
(Cohort 1) DPT-IPV-Hib-Low(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310
n=170 Participants
(Cohort 2) DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals.
|
ActHIB® and Tetrabik (Control)
n=165 Participants
(Cohort 2) Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals.
|
Total
n=365 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
>=2 and <3 months
|
7 Participants
n=37 Participants
|
6 Participants
n=56 Participants
|
154 Participants
n=82 Participants
|
145 Participants
n=31 Participants
|
312 Participants
n=5 Participants
|
|
Age, Customized
>=3 months
|
8 Participants
n=37 Participants
|
9 Participants
n=56 Participants
|
16 Participants
n=82 Participants
|
20 Participants
n=31 Participants
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=37 Participants
|
8 Participants
n=56 Participants
|
86 Participants
n=82 Participants
|
79 Participants
n=31 Participants
|
181 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=37 Participants
|
7 Participants
n=56 Participants
|
84 Participants
n=82 Participants
|
86 Participants
n=31 Participants
|
184 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian (Japanese)
|
15 Participants
n=37 Participants
|
15 Participants
n=56 Participants
|
170 Participants
n=82 Participants
|
165 Participants
n=31 Participants
|
365 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeks after the primary immunization (Visit 4)Population: For antibody analysis at Visit 4, number of subjects decreased from 370 to 365. BK1310 group: due to physician decision (n=1).Control group: due to withdrawal by parent/guardian (n=2) and deviation in blood collection timing (n=2). In control group number of subjects further decreased due to insufficient sample volume (diphtheria: n=2, PT: n=1, FHA: n=1, tetanus: n=1, polio serotype1: n=5, polio serotype2: n=4, polio serotype3: n=4）
Antibody prevalence rate is defined as the percentage of participants whose criteria of each antibody titer: Anti-diphtheria antibody concentrations: \>=0.1 IU/mL, Anti-PT antibody concentrations: \>=10.0 EU/mL, Anti-FHA antibody concentrations: \>=10.0 EU/mL, Anti-tetanus antibody concentrations: \>=0.01 IU/mL, Anti-poliovirus serotype 1, 2 and 3, antibody titers (fold) \>=8
Outcome measures
| Measure |
BK1310-High
n=15 Participants
(Cohort 1) DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310-Low
n=15 Participants
(Cohort 1) DPT-IPV-Hib-Low(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310
n=170 Participants
(Cohort 2) DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals.
|
ActHIB® and Tetrabik (Control)
n=165 Participants
(Cohort 2) Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals.
|
|---|---|---|---|---|
|
Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP
Antibody prevalence rate against anti-PRP with 1 μg/mL or higher
|
100.0 percentage of participants
Interval 78.2 to 100.0
|
100.0 percentage of participants
Interval 78.2 to 100.0
|
100.0 percentage of participants
Interval 97.9 to 100.0
|
93.3 percentage of participants
Interval 88.4 to 96.6
|
|
Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP
Antibody prevalence rate against diphtheria toxin
|
100.0 percentage of participants
Interval 78.2 to 100.0
|
100.0 percentage of participants
Interval 78.2 to 100.0
|
97.6 percentage of participants
Interval 94.1 to 99.4
|
98.8 percentage of participants
Interval 95.6 to 99.9
|
|
Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP
Antibody prevalence rate against pertussis （PT）
|
100.0 percentage of participants
Interval 78.2 to 100.0
|
100.0 percentage of participants
Interval 78.2 to 100.0
|
99.4 percentage of participants
Interval 96.8 to 100.0
|
100.0 percentage of participants
Interval 97.8 to 100.0
|
|
Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP
Antibody prevalence rate against pertussis (FHA)
|
100.0 percentage of participants
Interval 78.2 to 100.0
|
100.0 percentage of participants
Interval 78.2 to 100.0
|
97.6 percentage of participants
Interval 94.1 to 99.4
|
99.4 percentage of participants
Interval 96.6 to 100.0
|
|
Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP
Antibody prevalence rate against tetanus toxin
|
100.0 percentage of participants
Interval 78.2 to 100.0
|
100.0 percentage of participants
Interval 78.2 to 100.0
|
100.0 percentage of participants
Interval 97.9 to 100.0
|
100.0 percentage of participants
Interval 97.8 to 100.0
|
|
Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP
Antibody prevalence rate against polio virus serotype 1
|
100.0 percentage of participants
Interval 78.2 to 100.0
|
100.0 percentage of participants
Interval 78.2 to 100.0
|
100.0 percentage of participants
Interval 97.9 to 100.0
|
100.0 percentage of participants
Interval 97.7 to 100.0
|
|
Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP
Antibody prevalence rate against polio virus serotype 2
|
100.0 percentage of participants
Interval 78.2 to 100.0
|
100.0 percentage of participants
Interval 78.2 to 100.0
|
100.0 percentage of participants
Interval 97.9 to 100.0
|
100.0 percentage of participants
Interval 97.7 to 100.0
|
|
Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP
Antibody prevalence rate against polio virus serotype 3
|
100.0 percentage of participants
Interval 78.2 to 100.0
|
100.0 percentage of participants
Interval 78.2 to 100.0
|
100.0 percentage of participants
Interval 97.9 to 100.0
|
100.0 percentage of participants
Interval 97.7 to 100.0
|
SECONDARY outcome
Timeframe: 4 weeks after the primary immunization (Visit 4)Population: For antibody analysis at Visit 4, number of subjects decreased from 370 to 365. BK1310 group: due to physician decision (n=1).Control group: due to withdrawal by parent/guardian (n=2) and deviation in blood collection timing (n=2).
Outcome measures
| Measure |
BK1310-High
n=15 Participants
(Cohort 1) DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310-Low
n=15 Participants
(Cohort 1) DPT-IPV-Hib-Low(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310
n=170 Participants
(Cohort 2) DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals.
|
ActHIB® and Tetrabik (Control)
n=165 Participants
(Cohort 2) Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals.
|
|---|---|---|---|---|
|
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 78.2 to 100.0
|
100.0 percentage of participants
Interval 78.2 to 100.0
|
100.0 percentage of participants
Interval 97.9 to 100.0
|
100.0 percentage of participants
Interval 97.8 to 100.0
|
SECONDARY outcome
Timeframe: 4 weeks after the primary immunization (Visit 4)Population: For antibody analysis at Visit 4, number of subjects decreased from 370 to 365. BK1310 group: due to physician decision (n=1).Control group: due to withdrawal by parent/guardian (n=2) and deviation in blood collection timing (n=2).
Outcome measures
| Measure |
BK1310-High
n=15 Participants
(Cohort 1) DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310-Low
n=15 Participants
(Cohort 1) DPT-IPV-Hib-Low(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310
n=170 Participants
(Cohort 2) DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals.
|
ActHIB® and Tetrabik (Control)
n=165 Participants
(Cohort 2) Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals.
|
|---|---|---|---|---|
|
Geometric Mean Antibody Titer of Anti-PRP Antibody
|
17.613 µg/mL
Interval 10.911 to 28.432
|
23.097 µg/mL
Interval 14.545 to 36.68
|
17.832 µg/mL
Interval 15.251 to 20.85
|
6.245 µg/mL
Interval 5.177 to 7.533
|
SECONDARY outcome
Timeframe: 4 weeks after the booster dose (Visit 6)Population: Only subjects in cohort 1 were analyzed. Visit 6 was not conducted in Cohort 2（Arm；BK-1310，ActHIB® and Tetrabik）, and the data of Cohort 2 were not collected. Therefore, no data of Cohort 2 are available.
Outcome measures
| Measure |
BK1310-High
n=15 Participants
(Cohort 1) DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310-Low
n=15 Participants
(Cohort 1) DPT-IPV-Hib-Low(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310
(Cohort 2) DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals.
|
ActHIB® and Tetrabik (Control)
(Cohort 2) Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals.
|
|---|---|---|---|---|
|
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 78.2 to 100.0
|
100.0 percentage of participants
Interval 78.2 to 100.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 weeks after the booster dose (Visit 6)Population: Only subjects in cohort 1 were analyzed. Visit 6 was not conducted in Cohort 2（Arm；BK-1310，ActHIB® and Tetrabik）, and the data of Cohort 2 were not collected. Therefore, no data of Cohort 2 are available.
Outcome measures
| Measure |
BK1310-High
n=15 Participants
(Cohort 1) DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310-Low
n=15 Participants
(Cohort 1) DPT-IPV-Hib-Low(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310
(Cohort 2) DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals.
|
ActHIB® and Tetrabik (Control)
(Cohort 2) Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals.
|
|---|---|---|---|---|
|
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 78.2 to 100.0
|
100.0 percentage of participants
Interval 78.2 to 100.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 weeks after the booster dose (Visit 6)Population: Only subjects in cohort 1 were analyzed. Visit 6 was not conducted in Cohort 2（Arm；BK-1310，ActHIB® and Tetrabik）, and the data of Cohort 2 were not collected. Therefore, no data of Cohort 2 are available.
Outcome measures
| Measure |
BK1310-High
n=15 Participants
(Cohort 1) DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310-Low
n=15 Participants
(Cohort 1) DPT-IPV-Hib-Low(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310
(Cohort 2) DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals.
|
ActHIB® and Tetrabik (Control)
(Cohort 2) Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals.
|
|---|---|---|---|---|
|
Geometric Mean Antibody Titer of Anti-PRP Antibody
|
69.937 µg/mL
Interval 46.971 to 104.132
|
54.333 µg/mL
Interval 33.441 to 88.276
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 weeks after the primary immunization (Visit 4)Population: For antibody analysis at Visit 4, number of subjects decreased from 370 to 365. BK1310 group: due to physician decision (n=1).Control group: due to withdrawal by parent/guardian (n=2) and deviation in blood collection timing (n=2). In control group number of subjects further decreased due to insufficient sample volume (diphtheria: n=2）
Outcome measures
| Measure |
BK1310-High
n=15 Participants
(Cohort 1) DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310-Low
n=15 Participants
(Cohort 1) DPT-IPV-Hib-Low(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310
n=170 Participants
(Cohort 2) DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals.
|
ActHIB® and Tetrabik (Control)
n=163 Participants
(Cohort 2) Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals.
|
|---|---|---|---|---|
|
Geometric Mean Antibody Titer Against Diphtheria Toxin
|
1.1640 IU/mL
Interval 0.7205 to 1.8806
|
0.8058 IU/mL
Interval 0.4842 to 1.3411
|
0.8767 IU/mL
Interval 0.7484 to 1.0269
|
0.7010 IU/mL
Interval 0.6 to 0.8189
|
SECONDARY outcome
Timeframe: 4 weeks after the primary immunization (Visit 4)Population: For antibody analysis at Visit 4, number of subjects decreased from 370 to 365. BK1310 group: due to physician decision (n=1).Control group: due to withdrawal by parent/guardian (n=2) and deviation in blood collection timing (n=2). In control group number of subjects further decreased due to insufficient sample volume (PT: n=1）
Outcome measures
| Measure |
BK1310-High
n=15 Participants
(Cohort 1) DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310-Low
n=15 Participants
(Cohort 1) DPT-IPV-Hib-Low(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310
n=170 Participants
(Cohort 2) DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals.
|
ActHIB® and Tetrabik (Control)
n=164 Participants
(Cohort 2) Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals.
|
|---|---|---|---|---|
|
Geometric Mean Antibody Titer Against Pertussis （PT）
|
208.80 EU/mL
Interval 161.19 to 270.48
|
180.78 EU/mL
Interval 114.4 to 285.69
|
175.35 EU/mL
Interval 158.6 to 193.87
|
184.17 EU/mL
Interval 169.75 to 199.82
|
SECONDARY outcome
Timeframe: 4 weeks after the primary immunization (Visit 4)Population: For antibody analysis at Visit 4, number of subjects decreased from 370 to 365. BK1310 group: due to physician decision (n=1).Control group: due to withdrawal by parent/guardian (n=2) and deviation in blood collection timing (n=2). In control group number of subjects further decreased due to insufficient sample volume (FHA: n=1）
Outcome measures
| Measure |
BK1310-High
n=15 Participants
(Cohort 1) DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310-Low
n=15 Participants
(Cohort 1) DPT-IPV-Hib-Low(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310
n=170 Participants
(Cohort 2) DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals.
|
ActHIB® and Tetrabik (Control)
n=164 Participants
(Cohort 2) Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals.
|
|---|---|---|---|---|
|
Geometric Mean Antibody Titer Against Pertussis （FHA）
|
67.41 EU/mL
Interval 48.46 to 93.77
|
49.99 EU/mL
Interval 35.86 to 69.69
|
57.59 EU/mL
Interval 51.87 to 63.93
|
83.64 EU/mL
Interval 75.81 to 92.28
|
SECONDARY outcome
Timeframe: 4 weeks after the primary immunization (Visit 4)Population: For antibody analysis at Visit 4, number of subjects decreased from 370 to 365. BK1310 group: due to physician decision (n=1).Control group: due to withdrawal by parent/guardian (n=2) and deviation in blood collection timing (n=2). In control group number of subjects further decreased due to insufficient sample volume (tetanus: n=1）
Outcome measures
| Measure |
BK1310-High
n=15 Participants
(Cohort 1) DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310-Low
n=15 Participants
(Cohort 1) DPT-IPV-Hib-Low(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310
n=170 Participants
(Cohort 2) DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals.
|
ActHIB® and Tetrabik (Control)
n=164 Participants
(Cohort 2) Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals.
|
|---|---|---|---|---|
|
Geometric Mean Antibody Titer Against Tetanus Toxin
|
0.5320 IU/mL
Interval 0.2901 to 0.9755
|
0.4032 IU/mL
Interval 0.2406 to 0.6757
|
0.4950 IU/mL
Interval 0.4305 to 0.5693
|
0.2807 IU/mL
Interval 0.2261 to 0.3485
|
SECONDARY outcome
Timeframe: Baseline and 4 weeks after the primary immunization (Visit 4)Population: For antibody analysis at Visit 4, number of subjects decreased from 370 to 361. BK1310 group: due to physician decision (n=1). Control group: due to withdrawal by parent/guardian (n=2), deviation in blood collection timing (n=2), insufficient sample volume (n=4). In control group number of subjects further decreased due to insufficient sample volume (polio serotype1: n=1）
Outcome measures
| Measure |
BK1310-High
n=15 Participants
(Cohort 1) DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310-Low
n=15 Participants
(Cohort 1) DPT-IPV-Hib-Low(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310
n=170 Participants
(Cohort 2) DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals.
|
ActHIB® and Tetrabik (Control)
n=161 Participants
(Cohort 2) Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals.
|
|---|---|---|---|---|
|
Fold Change in Geometric Mean Antibody Titer Against Polio Virus
Geometric mean antibody titer against polio virus serotype 1
|
933.60 fold change
Interval 350.43 to 2487.27
|
588.13 fold change
Interval 282.89 to 1222.76
|
742.01 fold change
Interval 579.83 to 949.55
|
885.67 fold change
Interval 698.16 to 1123.54
|
|
Fold Change in Geometric Mean Antibody Titer Against Polio Virus
Geometric mean antibody titer against polio virus serotype 2
|
1824.56 fold change
Interval 1369.18 to 2431.4
|
1955.52 fold change
Interval 1403.94 to 2723.79
|
2137.58 fold change
Interval 1871.07 to 2442.06
|
1978.66 fold change
Interval 1681.86 to 2327.85
|
|
Fold Change in Geometric Mean Antibody Titer Against Polio Virus
Geometric mean antibody titer against polio virus serotype 3
|
851.19 fold change
Interval 494.94 to 1463.86
|
1320.32 fold change
Interval 813.95 to 2141.7
|
1430.55 fold change
Interval 1230.96 to 1662.49
|
1551.43 fold change
Interval 1339.55 to 1796.81
|
SECONDARY outcome
Timeframe: 4 weeks after the booster dose (Visit 6)Population: Only subjects in cohort 1 were analyzed. Visit 6 was not conducted in Cohort 2（Arm；BK-1310，ActHIB® and Tetrabik）, and the data of Cohort 2 were not collected. Therefore, no data of Cohort 2 are available.
Antibody prevalence rate is defined as the percentage of participants whose criteria of each antibody titer: Anti-diphtheria antibody concentrations: \>=0.1 IU/mL, Anti-PT antibody concentrations: \>=10.0 EU/mL, Anti-FHA antibody concentrations: \>=10.0 EU/mL, Anti-tetanus antibody concentrations: \>=0.01 IU/mL, Anti-poliovirus serotype 1,2 and 3 antibody titers (fold) \>=8
Outcome measures
| Measure |
BK1310-High
n=15 Participants
(Cohort 1) DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310-Low
n=15 Participants
(Cohort 1) DPT-IPV-Hib-Low(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310
(Cohort 2) DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals.
|
ActHIB® and Tetrabik (Control)
(Cohort 2) Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals.
|
|---|---|---|---|---|
|
Antibody Prevalence Rate Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus
Antibody prevalence rate against diphtheria toxin
|
100.0 percentage of participants
Interval 78.2 to 100.0
|
100.0 percentage of participants
Interval 78.2 to 100.0
|
—
|
—
|
|
Antibody Prevalence Rate Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus
Antibody prevalence rate against pertussis （PT）
|
100.0 percentage of participants
Interval 78.2 to 100.0
|
100.0 percentage of participants
Interval 78.2 to 100.0
|
—
|
—
|
|
Antibody Prevalence Rate Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus
Antibody prevalence rate against pertussis （FHA）
|
100.0 percentage of participants
Interval 78.2 to 100.0
|
100.0 percentage of participants
Interval 78.2 to 100.0
|
—
|
—
|
|
Antibody Prevalence Rate Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus
Antibody prevalence rate against tetanus toxin
|
100.0 percentage of participants
Interval 78.2 to 100.0
|
100.0 percentage of participants
Interval 78.2 to 100.0
|
—
|
—
|
|
Antibody Prevalence Rate Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus
Antibody prevalence rate against polio virus serotype 1
|
100.0 percentage of participants
Interval 78.2 to 100.0
|
100.0 percentage of participants
Interval 78.2 to 100.0
|
—
|
—
|
|
Antibody Prevalence Rate Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus
Antibody prevalence rate against polio virus serotype 2
|
100.0 percentage of participants
Interval 78.2 to 100.0
|
100.0 percentage of participants
Interval 78.2 to 100.0
|
—
|
—
|
|
Antibody Prevalence Rate Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus
Antibody prevalence rate against polio virus serotype 3
|
100.0 percentage of participants
Interval 78.2 to 100.0
|
100.0 percentage of participants
Interval 78.2 to 100.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 weeks after the booster dose (Visit 6)Population: Only subjects in cohort 1 were analyzed. Visit 6 was not conducted in Cohort 2（Arm；BK-1310，ActHIB® and Tetrabik）, and the data of Cohort 2 were not collected. Therefore, no data of Cohort 2 are available.
Outcome measures
| Measure |
BK1310-High
n=15 Participants
(Cohort 1) DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310-Low
n=15 Participants
(Cohort 1) DPT-IPV-Hib-Low(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310
(Cohort 2) DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals.
|
ActHIB® and Tetrabik (Control)
(Cohort 2) Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals.
|
|---|---|---|---|---|
|
Geometric Mean Antibody Titer Against Diphtheria Toxin
|
12.9090 IU/mL
Interval 8.0735 to 20.6406
|
10.2457 IU/mL
Interval 6.2247 to 16.8642
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 weeks after the booster dose (Visit 6)Population: Only subjects in cohort 1 were analyzed. Visit 6 was not conducted in Cohort 2（Arm；BK-1310，ActHIB® and Tetrabik）, and the data of Cohort 2 were not collected. Therefore, no data of Cohort 2 are available.
Outcome measures
| Measure |
BK1310-High
n=15 Participants
(Cohort 1) DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310-Low
n=15 Participants
(Cohort 1) DPT-IPV-Hib-Low(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310
(Cohort 2) DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals.
|
ActHIB® and Tetrabik (Control)
(Cohort 2) Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals.
|
|---|---|---|---|---|
|
Geometric Mean Antibody Titer Against Pertussis （PT）
|
230.34 EU/mL
Interval 167.63 to 316.52
|
223.85 EU/mL
Interval 146.3 to 342.5
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 weeks after the booster dose (Visit 6)Population: Only subjects in cohort 1 were analyzed. Visit 6 was not conducted in Cohort 2（Arm；BK-1310，ActHIB® and Tetrabik）, and the data of Cohort 2 were not collected. Therefore, no data of Cohort 2 are available.
Outcome measures
| Measure |
BK1310-High
n=15 Participants
(Cohort 1) DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310-Low
n=15 Participants
(Cohort 1) DPT-IPV-Hib-Low(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310
(Cohort 2) DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals.
|
ActHIB® and Tetrabik (Control)
(Cohort 2) Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals.
|
|---|---|---|---|---|
|
Geometric Mean Antibody Titer Against Pertussis （FHA）
|
122.20 EU/mL
Interval 73.26 to 203.83
|
85.52 EU/mL
Interval 53.89 to 135.72
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 weeks after the booster dose (Visit 6)Population: Only subjects in cohort 1 were analyzed. Visit 6 was not conducted in Cohort 2（Arm；BK-1310，ActHIB® and Tetrabik）, and the data of Cohort 2 were not collected. Therefore, no data of Cohort 2 are available.
Outcome measures
| Measure |
BK1310-High
n=15 Participants
(Cohort 1) DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310-Low
n=15 Participants
(Cohort 1) DPT-IPV-Hib-Low(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310
(Cohort 2) DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals.
|
ActHIB® and Tetrabik (Control)
(Cohort 2) Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals.
|
|---|---|---|---|---|
|
Geometric Mean Antibody Titer Against Tetanus Toxin
|
1.1670 IU/mL
Interval 0.7576 to 1.7976
|
1.0640 IU/mL
Interval 0.6375 to 1.7759
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 4 weeks after the primary immunization (Visit 6)Population: Only subjects in cohort 1 were analyzed. Visit 6 was not conducted in Cohort 2（Arm；BK-1310，ActHIB® and Tetrabik）, and the data of Cohort 2 were not collected. Therefore, no data of Cohort 2 are available.
Outcome measures
| Measure |
BK1310-High
n=15 Participants
(Cohort 1) DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310-Low
n=15 Participants
(Cohort 1) DPT-IPV-Hib-Low(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310
(Cohort 2) DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals.
|
ActHIB® and Tetrabik (Control)
(Cohort 2) Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals.
|
|---|---|---|---|---|
|
Fold Change in Geometric Mean Antibody Titer Against Polio Virus
Geometric mean antibody titer against polio virus serotype 1
|
4597.60 fold change
Interval 2689.05 to 7860.76
|
1910.85 fold change
Interval 1167.05 to 3128.69
|
—
|
—
|
|
Fold Change in Geometric Mean Antibody Titer Against Polio Virus
Geometric mean antibody titer against polio virus serotype 2
|
7822.06 fold change
Interval 5970.43 to 10247.94
|
6501.99 fold change
Interval 4322.77 to 9779.82
|
—
|
—
|
|
Fold Change in Geometric Mean Antibody Titer Against Polio Virus
Geometric mean antibody titer against polio virus serotype 3
|
4815.04 fold change
Interval 3378.24 to 6862.93
|
4096.00 fold change
Interval 2357.39 to 7116.87
|
—
|
—
|
Adverse Events
BK1310-High
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
BK1310-Low
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
BK1310
Serious events: 8 serious events
Other events: 162 other events
Deaths: 0 deaths
ActHIB® and Tetrabik (Control)
Serious events: 5 serious events
Other events: 163 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BK1310-High
n=15 participants at risk
(Cohort 1) DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310-Low
n=15 participants at risk
(Cohort 1) DPT-IPV-Hib-Low(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310
n=171 participants at risk
(Cohort 2) DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals.
|
ActHIB® and Tetrabik (Control)
n=169 participants at risk
(Cohort 2) Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals.
|
|---|---|---|---|---|
|
Immune system disorders
Anaphylactic reaction
|
6.7%
1/15 • Through study completion, an average of 1 year
|
0.00%
0/15 • Through study completion, an average of 1 year
|
0.00%
0/171 • Through study completion, an average of 1 year
|
0.00%
0/169 • Through study completion, an average of 1 year
|
|
Infections and infestations
Adenovirus infection
|
0.00%
0/15 • Through study completion, an average of 1 year
|
0.00%
0/15 • Through study completion, an average of 1 year
|
0.00%
0/171 • Through study completion, an average of 1 year
|
0.59%
1/169 • Through study completion, an average of 1 year
|
|
Infections and infestations
Bronchitis bacterial
|
0.00%
0/15 • Through study completion, an average of 1 year
|
0.00%
0/15 • Through study completion, an average of 1 year
|
0.58%
1/171 • Through study completion, an average of 1 year
|
0.00%
0/169 • Through study completion, an average of 1 year
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.00%
0/15 • Through study completion, an average of 1 year
|
0.00%
0/15 • Through study completion, an average of 1 year
|
0.00%
0/171 • Through study completion, an average of 1 year
|
0.59%
1/169 • Through study completion, an average of 1 year
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.00%
0/15 • Through study completion, an average of 1 year
|
0.00%
0/15 • Through study completion, an average of 1 year
|
0.58%
1/171 • Through study completion, an average of 1 year
|
1.2%
2/169 • Through study completion, an average of 1 year
|
|
Infections and infestations
Respiratory syncytial virus bronchitis
|
0.00%
0/15 • Through study completion, an average of 1 year
|
0.00%
0/15 • Through study completion, an average of 1 year
|
0.58%
1/171 • Through study completion, an average of 1 year
|
0.00%
0/169 • Through study completion, an average of 1 year
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/15 • Through study completion, an average of 1 year
|
0.00%
0/15 • Through study completion, an average of 1 year
|
1.8%
3/171 • Through study completion, an average of 1 year
|
0.00%
0/169 • Through study completion, an average of 1 year
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/15 • Through study completion, an average of 1 year
|
0.00%
0/15 • Through study completion, an average of 1 year
|
1.2%
2/171 • Through study completion, an average of 1 year
|
0.00%
0/169 • Through study completion, an average of 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infantile haemangioma
|
0.00%
0/15 • Through study completion, an average of 1 year
|
0.00%
0/15 • Through study completion, an average of 1 year
|
0.00%
0/171 • Through study completion, an average of 1 year
|
0.59%
1/169 • Through study completion, an average of 1 year
|
|
Vascular disorders
Kawasaki's disease
|
0.00%
0/15 • Through study completion, an average of 1 year
|
0.00%
0/15 • Through study completion, an average of 1 year
|
0.58%
1/171 • Through study completion, an average of 1 year
|
0.00%
0/169 • Through study completion, an average of 1 year
|
Other adverse events
| Measure |
BK1310-High
n=15 participants at risk
(Cohort 1) DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310-Low
n=15 participants at risk
(Cohort 1) DPT-IPV-Hib-Low(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310
n=171 participants at risk
(Cohort 2) DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals.
|
ActHIB® and Tetrabik (Control)
n=169 participants at risk
(Cohort 2) Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals.
|
|---|---|---|---|---|
|
Infections and infestations
Influenza
|
0.00%
0/15 • Through study completion, an average of 1 year
|
6.7%
1/15 • Through study completion, an average of 1 year
|
0.00%
0/171 • Through study completion, an average of 1 year
|
0.00%
0/169 • Through study completion, an average of 1 year
|
|
Infections and infestations
Nasopharyngitis
|
73.3%
11/15 • Through study completion, an average of 1 year
|
40.0%
6/15 • Through study completion, an average of 1 year
|
22.8%
39/171 • Through study completion, an average of 1 year
|
18.3%
31/169 • Through study completion, an average of 1 year
|
|
Infections and infestations
Otitis media acute
|
13.3%
2/15 • Through study completion, an average of 1 year
|
13.3%
2/15 • Through study completion, an average of 1 year
|
1.8%
3/171 • Through study completion, an average of 1 year
|
1.8%
3/169 • Through study completion, an average of 1 year
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/15 • Through study completion, an average of 1 year
|
6.7%
1/15 • Through study completion, an average of 1 year
|
1.8%
3/171 • Through study completion, an average of 1 year
|
3.0%
5/169 • Through study completion, an average of 1 year
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
6.7%
1/15 • Through study completion, an average of 1 year
|
0.00%
0/15 • Through study completion, an average of 1 year
|
0.58%
1/171 • Through study completion, an average of 1 year
|
0.59%
1/169 • Through study completion, an average of 1 year
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/15 • Through study completion, an average of 1 year
|
0.00%
0/15 • Through study completion, an average of 1 year
|
8.2%
14/171 • Through study completion, an average of 1 year
|
4.7%
8/169 • Through study completion, an average of 1 year
|
|
Infections and infestations
Upper respiratory tract infection
|
13.3%
2/15 • Through study completion, an average of 1 year
|
6.7%
1/15 • Through study completion, an average of 1 year
|
4.7%
8/171 • Through study completion, an average of 1 year
|
6.5%
11/169 • Through study completion, an average of 1 year
|
|
Infections and infestations
Viral rash
|
0.00%
0/15 • Through study completion, an average of 1 year
|
13.3%
2/15 • Through study completion, an average of 1 year
|
0.00%
0/171 • Through study completion, an average of 1 year
|
0.59%
1/169 • Through study completion, an average of 1 year
|
|
Metabolism and nutrition disorders
Decreased appetite
|
13.3%
2/15 • Through study completion, an average of 1 year
|
13.3%
2/15 • Through study completion, an average of 1 year
|
11.1%
19/171 • Through study completion, an average of 1 year
|
11.2%
19/169 • Through study completion, an average of 1 year
|
|
Nervous system disorders
Hypersomnia
|
33.3%
5/15 • Through study completion, an average of 1 year
|
6.7%
1/15 • Through study completion, an average of 1 year
|
30.4%
52/171 • Through study completion, an average of 1 year
|
20.7%
35/169 • Through study completion, an average of 1 year
|
|
Psychiatric disorders
Insomnia
|
26.7%
4/15 • Through study completion, an average of 1 year
|
20.0%
3/15 • Through study completion, an average of 1 year
|
16.4%
28/171 • Through study completion, an average of 1 year
|
13.6%
23/169 • Through study completion, an average of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
6.7%
1/15 • Through study completion, an average of 1 year
|
0.00%
0/15 • Through study completion, an average of 1 year
|
1.8%
3/171 • Through study completion, an average of 1 year
|
0.59%
1/169 • Through study completion, an average of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/15 • Through study completion, an average of 1 year
|
6.7%
1/15 • Through study completion, an average of 1 year
|
0.58%
1/171 • Through study completion, an average of 1 year
|
1.2%
2/169 • Through study completion, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
20.0%
3/15 • Through study completion, an average of 1 year
|
0.00%
0/15 • Through study completion, an average of 1 year
|
0.58%
1/171 • Through study completion, an average of 1 year
|
1.2%
2/169 • Through study completion, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
0.00%
0/15 • Through study completion, an average of 1 year
|
13.3%
2/15 • Through study completion, an average of 1 year
|
7.6%
13/171 • Through study completion, an average of 1 year
|
7.1%
12/169 • Through study completion, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/15 • Through study completion, an average of 1 year
|
6.7%
1/15 • Through study completion, an average of 1 year
|
1.2%
2/171 • Through study completion, an average of 1 year
|
1.8%
3/169 • Through study completion, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Eczema
|
13.3%
2/15 • Through study completion, an average of 1 year
|
13.3%
2/15 • Through study completion, an average of 1 year
|
8.8%
15/171 • Through study completion, an average of 1 year
|
3.0%
5/169 • Through study completion, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
6.7%
1/15 • Through study completion, an average of 1 year
|
6.7%
1/15 • Through study completion, an average of 1 year
|
0.58%
1/171 • Through study completion, an average of 1 year
|
0.00%
0/169 • Through study completion, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Eczema infantile
|
0.00%
0/15 • Through study completion, an average of 1 year
|
20.0%
3/15 • Through study completion, an average of 1 year
|
5.3%
9/171 • Through study completion, an average of 1 year
|
4.7%
8/169 • Through study completion, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/15 • Through study completion, an average of 1 year
|
6.7%
1/15 • Through study completion, an average of 1 year
|
5.3%
9/171 • Through study completion, an average of 1 year
|
5.9%
10/169 • Through study completion, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
6.7%
1/15 • Through study completion, an average of 1 year
|
0.00%
0/15 • Through study completion, an average of 1 year
|
1.2%
2/171 • Through study completion, an average of 1 year
|
0.59%
1/169 • Through study completion, an average of 1 year
|
|
Gastrointestinal disorders
Diarrhoea
|
13.3%
2/15 • Through study completion, an average of 1 year
|
0.00%
0/15 • Through study completion, an average of 1 year
|
2.3%
4/171 • Through study completion, an average of 1 year
|
3.0%
5/169 • Through study completion, an average of 1 year
|
|
Gastrointestinal disorders
Faeces soft
|
0.00%
0/15 • Through study completion, an average of 1 year
|
6.7%
1/15 • Through study completion, an average of 1 year
|
0.00%
0/171 • Through study completion, an average of 1 year
|
0.00%
0/169 • Through study completion, an average of 1 year
|
|
General disorders
Crying
|
26.7%
4/15 • Through study completion, an average of 1 year
|
6.7%
1/15 • Through study completion, an average of 1 year
|
26.3%
45/171 • Through study completion, an average of 1 year
|
24.3%
41/169 • Through study completion, an average of 1 year
|
|
General disorders
Injection site erythema
|
80.0%
12/15 • Through study completion, an average of 1 year
|
66.7%
10/15 • Through study completion, an average of 1 year
|
77.8%
133/171 • Through study completion, an average of 1 year
|
73.4%
124/169 • Through study completion, an average of 1 year
|
|
General disorders
Injection site induration
|
86.7%
13/15 • Through study completion, an average of 1 year
|
46.7%
7/15 • Through study completion, an average of 1 year
|
53.8%
92/171 • Through study completion, an average of 1 year
|
39.1%
66/169 • Through study completion, an average of 1 year
|
|
General disorders
Injection site pain
|
13.3%
2/15 • Through study completion, an average of 1 year
|
0.00%
0/15 • Through study completion, an average of 1 year
|
11.7%
20/171 • Through study completion, an average of 1 year
|
7.1%
12/169 • Through study completion, an average of 1 year
|
|
General disorders
Injection site swelling
|
60.0%
9/15 • Through study completion, an average of 1 year
|
26.7%
4/15 • Through study completion, an average of 1 year
|
35.1%
60/171 • Through study completion, an average of 1 year
|
32.5%
55/169 • Through study completion, an average of 1 year
|
|
General disorders
Irritability postvaccinal
|
13.3%
2/15 • Through study completion, an average of 1 year
|
13.3%
2/15 • Through study completion, an average of 1 year
|
15.8%
27/171 • Through study completion, an average of 1 year
|
10.1%
17/169 • Through study completion, an average of 1 year
|
|
General disorders
Pyrexia
|
66.7%
10/15 • Through study completion, an average of 1 year
|
60.0%
9/15 • Through study completion, an average of 1 year
|
66.7%
114/171 • Through study completion, an average of 1 year
|
61.5%
104/169 • Through study completion, an average of 1 year
|
|
Infections and infestations
Bronchitis
|
0.00%
0/15 • Through study completion, an average of 1 year
|
13.3%
2/15 • Through study completion, an average of 1 year
|
6.4%
11/171 • Through study completion, an average of 1 year
|
4.1%
7/169 • Through study completion, an average of 1 year
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/15 • Through study completion, an average of 1 year
|
6.7%
1/15 • Through study completion, an average of 1 year
|
2.3%
4/171 • Through study completion, an average of 1 year
|
4.7%
8/169 • Through study completion, an average of 1 year
|
|
Infections and infestations
Dermatitis infected
|
6.7%
1/15 • Through study completion, an average of 1 year
|
0.00%
0/15 • Through study completion, an average of 1 year
|
0.00%
0/171 • Through study completion, an average of 1 year
|
0.00%
0/169 • Through study completion, an average of 1 year
|
|
Infections and infestations
Exanthema subitum
|
0.00%
0/15 • Through study completion, an average of 1 year
|
6.7%
1/15 • Through study completion, an average of 1 year
|
1.2%
2/171 • Through study completion, an average of 1 year
|
1.2%
2/169 • Through study completion, an average of 1 year
|
|
Infections and infestations
Gastroenteritis
|
6.7%
1/15 • Through study completion, an average of 1 year
|
13.3%
2/15 • Through study completion, an average of 1 year
|
2.3%
4/171 • Through study completion, an average of 1 year
|
2.4%
4/169 • Through study completion, an average of 1 year
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.00%
0/15 • Through study completion, an average of 1 year
|
6.7%
1/15 • Through study completion, an average of 1 year
|
2.3%
4/171 • Through study completion, an average of 1 year
|
2.4%
4/169 • Through study completion, an average of 1 year
|
|
Infections and infestations
Hordeolum
|
0.00%
0/15 • Through study completion, an average of 1 year
|
6.7%
1/15 • Through study completion, an average of 1 year
|
0.58%
1/171 • Through study completion, an average of 1 year
|
0.00%
0/169 • Through study completion, an average of 1 year
|
|
Infections and infestations
Impetigo
|
6.7%
1/15 • Through study completion, an average of 1 year
|
0.00%
0/15 • Through study completion, an average of 1 year
|
2.9%
5/171 • Through study completion, an average of 1 year
|
1.8%
3/169 • Through study completion, an average of 1 year
|
|
Eye disorders
Eye discharge
|
0.00%
0/15 • Through study completion, an average of 1 year
|
6.7%
1/15 • Through study completion, an average of 1 year
|
0.58%
1/171 • Through study completion, an average of 1 year
|
1.2%
2/169 • Through study completion, an average of 1 year
|
|
Gastrointestinal disorders
Constipation
|
13.3%
2/15 • Through study completion, an average of 1 year
|
6.7%
1/15 • Through study completion, an average of 1 year
|
4.7%
8/171 • Through study completion, an average of 1 year
|
2.4%
4/169 • Through study completion, an average of 1 year
|
Additional Information
Clinical Trials, Information Desk
Tanabe Pharma Corporation / The Research Foundation for Microbial Diseases of Osaka University
Phone: Please email
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER