Trial Outcomes & Findings for Confirmatory Study of BK1310 in Healthy Infants (NCT NCT03891758)
NCT ID: NCT03891758
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
COMPLETED
PHASE3
267 participants
4 weeks after the primary immunization (Visit 4)
2026-01-06
Participant Flow
Participant milestones
| Measure |
ActHIB® and Tetrabik (Control)
Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310
DPT-IPV-Hib (Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
|---|---|---|
|
Overall Study
STARTED
|
134
|
133
|
|
Overall Study
COMPLETED
|
132
|
131
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
ActHIB® and Tetrabik (Control)
Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310
DPT-IPV-Hib (Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
|
Overall Study
Withdrawal by parent/guardian
|
2
|
0
|
Baseline Characteristics
Confirmatory Study of BK1310 in Healthy Infants
Baseline characteristics by cohort
| Measure |
BK1310
n=133 Participants
DPT-IPV-Hib (Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
ActHIB® and Tetrabik (Control)
n=133 Participants
Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
Total
n=266 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
>=2 and <3 months
|
124 Participants
n=9 Participants
|
125 Participants
n=6 Participants
|
249 Participants
n=9 Participants
|
|
Age, Customized
>=3 months
|
9 Participants
n=9 Participants
|
8 Participants
n=6 Participants
|
17 Participants
n=9 Participants
|
|
Sex: Female, Male
Female
|
73 Participants
n=9 Participants
|
62 Participants
n=6 Participants
|
135 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=9 Participants
|
71 Participants
n=6 Participants
|
131 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Asian (Japanese)
|
133 Participants
n=9 Participants
|
133 Participants
n=6 Participants
|
266 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: 4 weeks after the primary immunization (Visit 4)Population: For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1) . In BK1310 group number of subjects further decreased due to insufficient sample volume (polio serotype1,2 and 3: n=2 each). In control group number of subjects further decreased due to insufficient sample volume (polio serotype1,2 and 3: n=1 each).
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 |
ActHIB® and Tetrabik (Control)
n=133 Participants
Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310
n=133 Participants
DPT-IPV-Hib (Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
|---|---|---|
|
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
|
88.7 percentage of participants
Interval 82.1 to 93.5
|
100.0 percentage of participants
Interval 97.3 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
|
99.2 percentage of participants
Interval 95.9 to 100.0
|
100.0 percentage of participants
Interval 97.3 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 97.2 to 100.0
|
100.0 percentage of participants
Interval 97.2 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 diphtheria toxin
|
98.5 percentage of participants
Interval 94.7 to 99.8
|
99.2 percentage of participants
Interval 95.9 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 （PT）
|
100.0 percentage of participants
Interval 97.3 to 100.0
|
100.0 percentage of participants
Interval 97.3 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 97.3 to 100.0
|
100.0 percentage of participants
Interval 97.3 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 97.2 to 100.0
|
100.0 percentage of participants
Interval 97.2 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 97.2 to 100.0
|
100.0 percentage of participants
Interval 97.2 to 100.0
|
SECONDARY outcome
Timeframe: 4weeks after the primary immunization (Visit 4)Population: For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1) .
Outcome measures
| Measure |
ActHIB® and Tetrabik (Control)
n=133 Participants
Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310
n=133 Participants
DPT-IPV-Hib (Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
|---|---|---|
|
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 97.3 to 100.0
|
100.0 percentage of participants
Interval 97.3 to 100.0
|
SECONDARY outcome
Timeframe: 4weeks after the primary immunization (Visit 4)Population: For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1) .
Outcome measures
| Measure |
ActHIB® and Tetrabik (Control)
n=133 Participants
Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310
n=133 Participants
DPT-IPV-Hib (Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
|---|---|---|
|
Geometric Mean Antibody Titer of Anti-PRP Antibody
|
6.698 µg/mL
Interval 5.357 to 8.374
|
23.688 µg/mL
Interval 20.208 to 27.768
|
SECONDARY outcome
Timeframe: 4 weeks after the booster dose (Visit 6)Population: For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1) . For antibody analysis at Visit 6, number of subjects decreased from 266 to 264. BK1310 group: due to Adverse event (n=2, onty 1 patient was able to collect a sample at discontinuation. The data at this time point was included in Visit 6). Control group: due to withdrawal by parent/guardian (n=1) .
Outcome measures
| Measure |
ActHIB® and Tetrabik (Control)
n=132 Participants
Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310
n=132 Participants
DPT-IPV-Hib (Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
|---|---|---|
|
Anti-PRP Antibody Prevalence Rate With 1 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody
|
98.5 percentage of participants
Interval 94.6 to 99.8
|
100.0 percentage of participants
Interval 97.2 to 100.0
|
SECONDARY outcome
Timeframe: 4 weeks after the booster dose (Visit 6)Population: For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1) . For antibody analysis at Visit 6, number of subjects decreased from 266 to 264. BK1310 group: due to Adverse event (n=2, onty 1 patient was able to collect a sample at discontinuation. The data at this time point was included in Visit 6). Control group: due to withdrawal by parent/guardian (n=1) .
Outcome measures
| Measure |
ActHIB® and Tetrabik (Control)
n=132 Participants
Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310
n=132 Participants
DPT-IPV-Hib (Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
|---|---|---|
|
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 97.2 to 100.0
|
100.0 percentage of participants
Interval 97.2 to 100.0
|
SECONDARY outcome
Timeframe: 4 weeks after the booster dose (Visit 6)Population: For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1) . For antibody analysis at Visit 6, number of subjects decreased from 266 to 264. BK1310 group: due to Adverse event (n=2, onty 1 patient was able to collect a sample at discontinuation. The data at this time point was included in Visit 6). Control group: due to withdrawal by parent/guardian (n=1) .
Outcome measures
| Measure |
ActHIB® and Tetrabik (Control)
n=132 Participants
Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310
n=132 Participants
DPT-IPV-Hib (Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
|---|---|---|
|
Geometric Mean Antibody Titer of Anti-PRP Antibody
|
34.246 µg/mL
Interval 28.835 to 40.672
|
56.545 µg/mL
Interval 47.963 to 66.661
|
SECONDARY outcome
Timeframe: 4 weeks after the primary immunization (Visit 4)Population: For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1) .
Outcome measures
| Measure |
ActHIB® and Tetrabik (Control)
n=133 Participants
Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310
n=133 Participants
DPT-IPV-Hib (Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
|---|---|---|
|
Geometric Mean Antibody Titer Against Diphtheria Toxin
|
1.283 IU/mL
Interval 1.05 to 1.567
|
1.841 IU/mL
Interval 1.533 to 2.211
|
SECONDARY outcome
Timeframe: 4 weeks after the primary immunization (Visit 4)Population: For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1) .
Outcome measures
| Measure |
ActHIB® and Tetrabik (Control)
n=133 Participants
Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310
n=133 Participants
DPT-IPV-Hib (Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
|---|---|---|
|
Geometric Mean Antibody Titer Against Pertussis
pertussis （PT）
|
200.24 EU/mL
Interval 183.42 to 218.61
|
155.30 EU/mL
Interval 141.53 to 170.41
|
|
Geometric Mean Antibody Titer Against Pertussis
pertussis （FHA）
|
85.24 EU/mL
Interval 76.96 to 94.4
|
56.48 EU/mL
Interval 51.07 to 62.46
|
SECONDARY outcome
Timeframe: 4 weeks after the primary immunization (Visit 4)Population: For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1) .
Outcome measures
| Measure |
ActHIB® and Tetrabik (Control)
n=133 Participants
Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310
n=133 Participants
DPT-IPV-Hib (Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
|---|---|---|
|
Geometric Mean Antibody Titer Against Tetanus Toxin
|
0.158 IU/mL
Interval 0.124 to 0.203
|
0.473 IU/mL
Interval 0.408 to 0.548
|
SECONDARY outcome
Timeframe: 4 weeks after the primary immunization (Visit 4)Population: For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1) . In BK1310 group number of subjects further decreased due to insufficient sample volume (polio serotype1,2 and 3: n=2 each). In control group number of subjects further decreased due to insufficient sample volume (polio serotype1,2 and 3: n=1 each).
Outcome measures
| Measure |
ActHIB® and Tetrabik (Control)
n=132 Participants
Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310
n=131 Participants
DPT-IPV-Hib (Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
|---|---|---|
|
Geometric Mean Antibody Titer Against Polio Virus
polio virus serotype 1
|
663.98 IU/mL
Interval 512.66 to 859.96
|
684.95 IU/mL
Interval 539.57 to 869.49
|
|
Geometric Mean Antibody Titer Against Polio Virus
polio virus serotype 2
|
1767.97 IU/mL
Interval 1498.47 to 2085.94
|
2026.44 IU/mL
Interval 1733.39 to 2369.04
|
|
Geometric Mean Antibody Titer Against Polio Virus
polio virus serotype 3
|
2075.06 IU/mL
Interval 1777.9 to 2421.9
|
1729.00 IU/mL
Interval 1487.12 to 2010.23
|
SECONDARY outcome
Timeframe: 4 weeks after the booster dose (Visit 6)Population: For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1). For antibody analysis at Visit 6, number of subjects decreased from 266 to 264. BK1310 group: due to Adverse event (n=2). Control group: due to withdrawal by parent/guardian (n=1) .In BK1310 group number of subjects further decreased due to insufficient sample volume (tetanus: n=1, polio serotype1,2 and 3: n=1 each).
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 |
ActHIB® and Tetrabik (Control)
n=132 Participants
Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310
n=132 Participants
DPT-IPV-Hib (Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
|---|---|---|
|
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 97.2 to 100.0
|
100.0 percentage of participants
Interval 97.2 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 97.2 to 100.0
|
100.0 percentage of participants
Interval 97.2 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 97.2 to 100.0
|
100.0 percentage of participants
Interval 97.2 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 diphtheria toxin
|
100.0 percentage of participants
Interval 97.2 to 100.0
|
100.0 percentage of participants
Interval 97.2 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 97.2 to 100.0
|
100.0 percentage of participants
Interval 97.2 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 97.2 to 100.0
|
100.0 percentage of participants
Interval 97.2 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
|
99.2 percentage of participants
Interval 95.9 to 100.0
|
100.0 percentage of participants
Interval 97.2 to 100.0
|
SECONDARY outcome
Timeframe: 4 weeks after the booster dose (Visit 6)Population: For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1) . For antibody analysis at Visit 6, number of subjects decreased from 266 to 264. BK1310 group: due to Adverse event (n=2, onty 1 patient was able to collect a sample at discontinuation. The data at this time point was included in Visit 6). Control group: due to withdrawal by parent/guardian (n=1) .
Outcome measures
| Measure |
ActHIB® and Tetrabik (Control)
n=132 Participants
Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310
n=132 Participants
DPT-IPV-Hib (Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
|---|---|---|
|
Geometric Mean Antibody Titer Against Diphtheria Toxin
|
8.961 IU/mL
Interval 8.035 to 9.994
|
9.766 IU/mL
Interval 8.758 to 10.89
|
SECONDARY outcome
Timeframe: 4 weeks after the booster dose (Visit 6)Population: For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1) . For antibody analysis at Visit 6, number of subjects decreased from 266 to 264. BK1310 group: due to Adverse event (n=2, onty 1 patient was able to collect a sample at discontinuation. The data at this time point was included in Visit 6). Control group: due to withdrawal by parent/guardian (n=1) .
Outcome measures
| Measure |
ActHIB® and Tetrabik (Control)
n=132 Participants
Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310
n=132 Participants
DPT-IPV-Hib (Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
|---|---|---|
|
Geometric Mean Antibody Titer Against Pertussis
Geometric mean antibody titer against pertussis （PT）
|
279.62 EU/mL
Interval 254.28 to 307.49
|
209.05 EU/mL
Interval 189.4 to 230.74
|
|
Geometric Mean Antibody Titer Against Pertussis
Geometric mean antibody titer against pertussis （FHA）
|
221.34 EU/mL
Interval 194.79 to 251.51
|
144.73 EU/mL
Interval 128.04 to 163.59
|
SECONDARY outcome
Timeframe: 4 weeks after the booster dose (Visit 6)Population: For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1) . For antibody analysis at Visit 6, number of subjects decreased from 266 to 264. BK1310 group: due to Adverse event (n=2). Control group: due to withdrawal by parent/guardian (n=1) .In BK1310 group number of subjects further decreased due to insufficient sample volume (n=1).
Outcome measures
| Measure |
ActHIB® and Tetrabik (Control)
n=132 Participants
Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310
n=131 Participants
DPT-IPV-Hib (Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
|---|---|---|
|
Geometric Mean Antibody Titer Against Tetanus Toxin
|
0.598 IU/mL
Interval 0.457 to 0.783
|
1.904 IU/mL
Interval 1.595 to 2.272
|
SECONDARY outcome
Timeframe: Baseline and 4 weeks after the primary immunization (Visit 6)Population: For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1) . For antibody analysis at Visit 6, number of subjects decreased from 266 to 264. BK1310 group: due to Adverse event (n=2). Control group: due to withdrawal by parent/guardian (n=1) .In BK1310 group number of subjects further decreased due to insufficient sample volume (polio serotype1,2 and 3: n=1 each).
Outcome measures
| Measure |
ActHIB® and Tetrabik (Control)
n=132 Participants
Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
BK1310
n=131 Participants
DPT-IPV-Hib (Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
|---|---|---|
|
Fold Change in Geometric Mean Antibody Titer Against Polio Virus
Geometric mean antibody titer against polio virus serotype 3
|
7355.96 fold change
Interval 6324.16 to 8556.09
|
6439.23 fold change
Interval 5472.88 to 7576.21
|
|
Fold Change in Geometric Mean Antibody Titer Against Polio Virus
Geometric mean antibody titer against polio virus serotype 1
|
2662.91 fold change
Interval 2254.04 to 3145.95
|
2524.05 fold change
Interval 2110.26 to 3018.98
|
|
Fold Change in Geometric Mean Antibody Titer Against Polio Virus
Geometric mean antibody titer against polio virus serotype 2
|
7512.10 fold change
Interval 6425.09 to 8783.01
|
8821.88 fold change
Interval 7678.48 to 10135.54
|
Adverse Events
BK1310
ActHIB® and Tetrabik (Control)
Serious adverse events
| Measure |
BK1310
n=133 participants at risk
DPT-IPV-Hib (Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
ActHIB® and Tetrabik (Control)
n=134 participants at risk
Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
|---|---|---|
|
Congenital, familial and genetic disorders
Cholangiectasis congenital
|
0.00%
0/133 • Through study completion, an average of 1 year
|
0.75%
1/134 • Through study completion, an average of 1 year
|
|
Infections and infestations
Adenovirus infection
|
0.75%
1/133 • Through study completion, an average of 1 year
|
0.75%
1/134 • Through study completion, an average of 1 year
|
|
Infections and infestations
Enterocolitis bacterial
|
0.75%
1/133 • Through study completion, an average of 1 year
|
0.00%
0/134 • Through study completion, an average of 1 year
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/133 • Through study completion, an average of 1 year
|
0.75%
1/134 • Through study completion, an average of 1 year
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.00%
0/133 • Through study completion, an average of 1 year
|
0.75%
1/134 • Through study completion, an average of 1 year
|
|
Infections and infestations
Influenza
|
0.00%
0/133 • Through study completion, an average of 1 year
|
0.75%
1/134 • Through study completion, an average of 1 year
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/133 • Through study completion, an average of 1 year
|
0.75%
1/134 • Through study completion, an average of 1 year
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.75%
1/133 • Through study completion, an average of 1 year
|
0.00%
0/134 • Through study completion, an average of 1 year
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/133 • Through study completion, an average of 1 year
|
2.2%
3/134 • Through study completion, an average of 1 year
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/133 • Through study completion, an average of 1 year
|
0.75%
1/134 • Through study completion, an average of 1 year
|
|
Infections and infestations
Urinary tract infection
|
0.75%
1/133 • Through study completion, an average of 1 year
|
0.00%
0/134 • Through study completion, an average of 1 year
|
|
Injury, poisoning and procedural complications
Fractured skull depressed
|
0.75%
1/133 • Through study completion, an average of 1 year
|
0.00%
0/134 • Through study completion, an average of 1 year
|
|
Nervous system disorders
Febrile convulsion
|
0.75%
1/133 • Through study completion, an average of 1 year
|
1.5%
2/134 • Through study completion, an average of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.75%
1/133 • Through study completion, an average of 1 year
|
0.75%
1/134 • Through study completion, an average of 1 year
|
|
Vascular disorders
Kawasaki's disease
|
2.3%
3/133 • Through study completion, an average of 1 year
|
0.00%
0/134 • Through study completion, an average of 1 year
|
Other adverse events
| Measure |
BK1310
n=133 participants at risk
DPT-IPV-Hib (Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
ActHIB® and Tetrabik (Control)
n=134 participants at risk
Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
|---|---|---|
|
General disorders
Crying
|
27.8%
37/133 • Through study completion, an average of 1 year
|
28.4%
38/134 • Through study completion, an average of 1 year
|
|
General disorders
Injection site erythema
|
78.9%
105/133 • Through study completion, an average of 1 year
|
79.9%
107/134 • Through study completion, an average of 1 year
|
|
General disorders
Injection site induration
|
47.4%
63/133 • Through study completion, an average of 1 year
|
53.7%
72/134 • Through study completion, an average of 1 year
|
|
General disorders
Injection site pain
|
13.5%
18/133 • Through study completion, an average of 1 year
|
19.4%
26/134 • Through study completion, an average of 1 year
|
|
General disorders
Injection site swelling
|
30.8%
41/133 • Through study completion, an average of 1 year
|
35.1%
47/134 • Through study completion, an average of 1 year
|
|
General disorders
Irritability postvaccinal
|
30.1%
40/133 • Through study completion, an average of 1 year
|
34.3%
46/134 • Through study completion, an average of 1 year
|
|
General disorders
Pyrexia
|
68.4%
91/133 • Through study completion, an average of 1 year
|
65.7%
88/134 • Through study completion, an average of 1 year
|
|
Infections and infestations
Bronchitis
|
14.3%
19/133 • Through study completion, an average of 1 year
|
13.4%
18/134 • Through study completion, an average of 1 year
|
|
Infections and infestations
Conjunctivitis
|
5.3%
7/133 • Through study completion, an average of 1 year
|
4.5%
6/134 • Through study completion, an average of 1 year
|
|
Infections and infestations
Gastroenteritis
|
6.0%
8/133 • Through study completion, an average of 1 year
|
6.0%
8/134 • Through study completion, an average of 1 year
|
|
Infections and infestations
Nasopharyngitis
|
29.3%
39/133 • Through study completion, an average of 1 year
|
28.4%
38/134 • Through study completion, an average of 1 year
|
|
Infections and infestations
Otitis media
|
6.0%
8/133 • Through study completion, an average of 1 year
|
5.2%
7/134 • Through study completion, an average of 1 year
|
|
Infections and infestations
Pharyngitis
|
5.3%
7/133 • Through study completion, an average of 1 year
|
5.2%
7/134 • Through study completion, an average of 1 year
|
|
Infections and infestations
Upper respiratory tract infection
|
17.3%
23/133 • Through study completion, an average of 1 year
|
15.7%
21/134 • Through study completion, an average of 1 year
|
|
Metabolism and nutrition disorders
Decreased appetite
|
15.8%
21/133 • Through study completion, an average of 1 year
|
17.2%
23/134 • Through study completion, an average of 1 year
|
|
Nervous system disorders
Hypersomnia
|
27.1%
36/133 • Through study completion, an average of 1 year
|
23.1%
31/134 • Through study completion, an average of 1 year
|
|
Psychiatric disorders
Insomnia
|
18.0%
24/133 • Through study completion, an average of 1 year
|
20.9%
28/134 • Through study completion, an average of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
9.8%
13/133 • Through study completion, an average of 1 year
|
12.7%
17/134 • Through study completion, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
3.8%
5/133 • Through study completion, an average of 1 year
|
8.2%
11/134 • Through study completion, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Eczema
|
9.8%
13/133 • Through study completion, an average of 1 year
|
12.7%
17/134 • Through study completion, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Eczema infantile
|
10.5%
14/133 • Through study completion, an average of 1 year
|
5.2%
7/134 • 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER