Trial Outcomes & Findings for Safety and Efficacy of BK1310 Intramuscular Injection in Healthy Infants (NCT NCT03188692)
NCT ID: NCT03188692
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
33 participants
Primary outcome timeframe
4 weeks after the primary immunization (Visit 4)
Results posted on
2026-01-06
Participant Flow
Participant milestones
| Measure |
BK1310
DPT-IPV-Hib (Combined Vaccine): 0.5mL, intramuscular injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
|---|---|
|
Overall Study
STARTED
|
33
|
|
Overall Study
COMPLETED
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of BK1310 Intramuscular Injection in Healthy Infants
Baseline characteristics by cohort
| Measure |
BK1310
n=33 Participants
DPT-IPV-Hib (Combined Vaccine): 0.5mL, intramuscular injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
|---|---|
|
Age, Customized
>=2 and <3 months
|
27 Participants
n=37 Participants
|
|
Age, Customized
>=3 months
|
6 Participants
n=37 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=37 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=37 Participants
|
|
Race/Ethnicity, Customized
Asian (Japanese)
|
33 Participants
n=37 Participants
|
PRIMARY outcome
Timeframe: 4 weeks after the primary immunization (Visit 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
n=33 Participants
DPT-IPV-Hib (Combined Vaccine): 0.5mL, intramuscular 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
|
97.0 percentage of participants
Interval 84.2 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 diphtheria toxin
|
93.9 percentage of participants
Interval 79.8 to 99.3
|
|
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 89.4 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)
|
97.0 percentage of participants
Interval 84.2 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 tetanus toxin
|
100.0 percentage of participants
Interval 89.4 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 89.4 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 89.4 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 89.4 to 100.0
|
SECONDARY outcome
Timeframe: 4 weeks after the primary immunization (Visit 4)Outcome measures
| Measure |
BK1310
n=33 Participants
DPT-IPV-Hib (Combined Vaccine): 0.5mL, intramuscular 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 89.4 to 100.0
|
SECONDARY outcome
Timeframe: 4 weeks after the primary immunization (Visit 4)Outcome measures
| Measure |
BK1310
n=33 Participants
DPT-IPV-Hib (Combined Vaccine): 0.5mL, intramuscular injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
|---|---|
|
Geometric Mean Antibody Titer of Anti-PRP Antibody
|
13.522 µg/mL
Interval 8.628 to 21.192
|
SECONDARY outcome
Timeframe: 4 weeks after the booster dose (Visit 6)Outcome measures
| Measure |
BK1310
n=33 Participants
DPT-IPV-Hib (Combined Vaccine): 0.5mL, intramuscular 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
|
100.0 percentage of participants
Interval 89.4 to 100.0
|
SECONDARY outcome
Timeframe: 4 weeks after the booster dose (Visit 6)Outcome measures
| Measure |
BK1310
n=33 Participants
DPT-IPV-Hib (Combined Vaccine): 0.5mL, intramuscular 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 89.4 to 100.0
|
SECONDARY outcome
Timeframe: 4 weeks after the booster dose (Visit 6)Outcome measures
| Measure |
BK1310
n=33 Participants
DPT-IPV-Hib (Combined Vaccine): 0.5mL, intramuscular injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
|---|---|
|
Geometric Mean Antibody Titer of Anti-PRP Antibody
|
28.509 µg/mL
Interval 20.866 to 38.952
|
SECONDARY outcome
Timeframe: 4 weeks after the primary immunization (Visit 4)Outcome measures
| Measure |
BK1310
n=33 Participants
DPT-IPV-Hib (Combined Vaccine): 0.5mL, intramuscular injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
|---|---|
|
Geometric Mean Antibody Titer Against Diphtheria Toxin
|
1.0818 IU/mL
Interval 0.7157 to 1.6352
|
SECONDARY outcome
Timeframe: 4 weeks after the primary immunization (Visit 4)Outcome measures
| Measure |
BK1310
n=33 Participants
DPT-IPV-Hib (Combined Vaccine): 0.5mL, intramuscular injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
|---|---|
|
Geometric Mean Antibody Titer Against Pertussis （PT）
|
128.03 EU/mL
Interval 106.09 to 154.51
|
SECONDARY outcome
Timeframe: 4 weeks after the primary immunization (Visit 4)Outcome measures
| Measure |
BK1310
n=33 Participants
DPT-IPV-Hib (Combined Vaccine): 0.5mL, intramuscular injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
|---|---|
|
Geometric Mean Antibody Titer Against Pertussis （FHA）
|
53.64 EU/mL
Interval 44.01 to 65.4
|
SECONDARY outcome
Timeframe: 4 weeks after the primary immunization (Visit 4)Outcome measures
| Measure |
BK1310
n=33 Participants
DPT-IPV-Hib (Combined Vaccine): 0.5mL, intramuscular injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
|---|---|
|
Geometric Mean Antibody Titer Against Tetanus Toxin
|
0.3068 IU/mL
Interval 0.2091 to 0.4502
|
SECONDARY outcome
Timeframe: Baseline and 4 weeks after the primary immunization (Visit 4)Outcome measures
| Measure |
BK1310
n=33 Participants
DPT-IPV-Hib (Combined Vaccine): 0.5mL, intramuscular 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 1
|
551.06 fold change
Interval 348.74 to 870.74
|
|
Fold Change in Geometric Mean Antibody Titer Against Polio Virus
Geometric mean antibody titer against polio virus serotype 2
|
1510.29 fold change
Interval 1046.26 to 2180.11
|
|
Fold Change in Geometric Mean Antibody Titer Against Polio Virus
Geometric mean antibody titer against polio virus serotype 3
|
1290.16 fold change
Interval 937.99 to 1774.55
|
SECONDARY outcome
Timeframe: 4 weeks after the booster dose (Visit 6)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
n=33 Participants
DPT-IPV-Hib (Combined Vaccine): 0.5mL, intramuscular 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 3
|
100.0 percentage of participants
Interval 89.4 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 89.4 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 89.4 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 89.4 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 89.4 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 89.4 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 89.4 to 100.0
|
SECONDARY outcome
Timeframe: 4 weeks after the booster dose (Visit 6)Outcome measures
| Measure |
BK1310
n=33 Participants
DPT-IPV-Hib (Combined Vaccine): 0.5mL, intramuscular injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
|---|---|
|
Geometric Mean Antibody Titer Against Diphtheria Toxin
|
9.6485 IU/mL
Interval 7.2551 to 12.8316
|
SECONDARY outcome
Timeframe: 4 weeks after the booster dose (Visit 6)Outcome measures
| Measure |
BK1310
n=33 Participants
DPT-IPV-Hib (Combined Vaccine): 0.5mL, intramuscular injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
|---|---|
|
Geometric Mean Antibody Titer Against Pertussis （PT）
|
173.17 EU/mL
Interval 140.9 to 212.84
|
SECONDARY outcome
Timeframe: 4 weeks after the booster dose (Visit 6)Outcome measures
| Measure |
BK1310
n=33 Participants
DPT-IPV-Hib (Combined Vaccine): 0.5mL, intramuscular injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
|---|---|
|
Geometric Mean Antibody Titer Against Pertussis （FHA）
|
114.19 EU/mL
Interval 89.14 to 146.28
|
SECONDARY outcome
Timeframe: 4 weeks after the booster dose (Visit 6)Outcome measures
| Measure |
BK1310
n=33 Participants
DPT-IPV-Hib (Combined Vaccine): 0.5mL, intramuscular injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
|---|---|
|
Geometric Mean Antibody Titer Against Tetanus Toxin
|
1.8293 IU/mL
Interval 1.2107 to 2.764
|
SECONDARY outcome
Timeframe: Baseline and 4 weeks after the primary immunization (Visit 6)Outcome measures
| Measure |
BK1310
n=33 Participants
DPT-IPV-Hib (Combined Vaccine): 0.5mL, intramuscular 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 1
|
1642.66 fold change
Interval 1162.23 to 2321.68
|
|
Fold Change in Geometric Mean Antibody Titer Against Polio Virus
Geometric mean antibody titer against polio virus serotype 2
|
8910.01 fold change
Interval 6877.46 to 11543.27
|
|
Fold Change in Geometric Mean Antibody Titer Against Polio Virus
Geometric mean antibody titer against polio virus serotype 3
|
5000.58 fold change
Interval 3839.01 to 6513.6
|
Adverse Events
BK1310
Serious events: 2 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BK1310
n=33 participants at risk
DPT-IPV-Hib (Combined Vaccine): 0.5mL, intramuscular injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
|---|---|
|
Infections and infestations
Bronchiolitis
|
3.0%
1/33 • Through study completion, an average of 1 year
|
|
Infections and infestations
Bronchitis
|
3.0%
1/33 • Through study completion, an average of 1 year
|
|
Infections and infestations
Exanthema subitum
|
3.0%
1/33 • Through study completion, an average of 1 year
|
Other adverse events
| Measure |
BK1310
n=33 participants at risk
DPT-IPV-Hib (Combined Vaccine): 0.5mL, intramuscular injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
33.3%
11/33 • Through study completion, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Asteatosis
|
6.1%
2/33 • Through study completion, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
9.1%
3/33 • Through study completion, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
6.1%
2/33 • Through study completion, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Eczema infantile
|
9.1%
3/33 • Through study completion, an average of 1 year
|
|
Gastrointestinal disorders
Constipation
|
6.1%
2/33 • Through study completion, an average of 1 year
|
|
General disorders
Crying
|
33.3%
11/33 • Through study completion, an average of 1 year
|
|
General disorders
Injection site erythema
|
48.5%
16/33 • Through study completion, an average of 1 year
|
|
General disorders
Injection site induration
|
15.2%
5/33 • Through study completion, an average of 1 year
|
|
General disorders
Injection site swelling
|
18.2%
6/33 • Through study completion, an average of 1 year
|
|
General disorders
Irritability postvaccinal
|
12.1%
4/33 • Through study completion, an average of 1 year
|
|
General disorders
Pyrexia
|
75.8%
25/33 • Through study completion, an average of 1 year
|
|
Infections and infestations
Bronchitis
|
15.2%
5/33 • Through study completion, an average of 1 year
|
|
Infections and infestations
Conjunctivitis
|
15.2%
5/33 • Through study completion, an average of 1 year
|
|
Infections and infestations
Gastroenteritis
|
15.2%
5/33 • Through study completion, an average of 1 year
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
6.1%
2/33 • Through study completion, an average of 1 year
|
|
Infections and infestations
Otitis media
|
6.1%
2/33 • Through study completion, an average of 1 year
|
|
Infections and infestations
Rhinitis
|
9.1%
3/33 • Through study completion, an average of 1 year
|
|
Infections and infestations
Upper respiratory tract infection
|
6.1%
2/33 • Through study completion, an average of 1 year
|
|
Infections and infestations
Viral upper respiratory tract infection
|
6.1%
2/33 • Through study completion, an average of 1 year
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
9.1%
3/33 • Through study completion, an average of 1 year
|
|
Metabolism and nutrition disorders
Decreased appetite
|
15.2%
5/33 • Through study completion, an average of 1 year
|
|
Nervous system disorders
Hypersomnia
|
30.3%
10/33 • Through study completion, an average of 1 year
|
|
Psychiatric disorders
Insomnia
|
21.2%
7/33 • Through study completion, an average of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
15.2%
5/33 • 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