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CompletedNCT03188692Updated Jan 6, 2026Results posted

Safety and Efficacy of BK1310 Intramuscular Injection in Healthy Infants

A Phase 3 interventional study of DPT-IPV-Hib (Combined Vaccine) in Immunization, sponsored by Tanabe Pharma Corporation. Completed at 3 sites in Japan. Open to participants aged 2 Months to 43 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-06.

Sponsored by Tanabe Pharma Corporation · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
33
Allocation
Not applicable
Ages
2 Months to 43 Months
Sex
All
01

Study summary

The purpose of this study is to evaluate the safety and efficacy of an intramuscular injection of BK1310 in healthy infants.

02

Conditions studied

  • Immunization

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Keywords

  • Haemophilus influenza type b
  • Adsorbed Diphtheria-Purified Pertussis-Tetanus-Inactivate
  • poliovirus combined vaccine
  • Hib
  • DPT-IPV
  • Intramuscular
03

In context

Haemophilus Infections

54 studies on the registry are indexed under Haemophilus Infections; 5 are open to participants now.

This study's enrollment of 33 is below the median of 357 across 50 interventional studies indexed under Haemophilus Infections.

Browse Haemophilus Infections studies →

Lead sponsor

Tanabe Pharma Corporation is the lead sponsor of 91 studies on the registry; 1 is open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Months to 43 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy infants aged ≥2 and \<43 months at the first vaccination of the study drug (recommended: ≥2 and \<7 months). Those who are applicable of the following conditions must be carefully observed before the enrollment: infants with known underlying disease such as cardiovascular disease, renal disease, hepatic disease, blood dyscrasia, respiratory disease or developmental disorder. Infants who developed fever within 2 days after any previous vaccination. Infants with history of convulsions.
  • Written informed consent is obtained from a legal guardian (parent)

Exclusion criteria

Exclusion Criteria:

  • With past diagnosis of immunodeficiency or currently under immunosuppressive treatment
  • Have close relatives (the third degree of kinship) diagnosed with congenital immunodeficiency
  • Possibility of anaphylaxis due to food or pharmaceuticals
  • With diagnosis of thrombocytopenia and/or coagulopathy or currently under treatment of the antiplatelet agents and/or anticoagulant agents.
  • With experience of Hib infection, diphtheria, pertussis, tetanus or acute poliomyelitis
  • With experience of Hib, diphteria, pertussis, tetanus or polio vaccination.
  • Administered a live vaccine within 27 days before the first vaccination of the study drug, or inactivated vaccine or toxoid within 6 days before vaccination
  • Administered transfusion, immunosuppressant (excluding drugs for external use), or immunoglobulin formulation
  • Administered corticosteroid 2 mg/kg per day or more as prednisolone (excluding drugs for external use)
  • Participated in other studies within 12 weeks before obtaining consent
  • With the gestational age \<37 weeks or weighed less than 2500 grams at birth.
  • Considered to be not eligible by the principal investigators (sub-investigators) of the enrollment.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
33 participants (actual)

Study arms

  • Experimental
    BK1310

    Biological: DPT-IPV-Hib (Combined Vaccine)

Interventions

  • BiologicalDPT-IPV-Hib (Combined Vaccine)

    0.5mL, intramuscular injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.

    Also known as: BK1310

06

What researchers measure

Primary outcomes

  1. 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 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

    Time frame: 4 weeks after the primary immunization (Visit 4)

Secondary outcomes

  1. Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody

    Time frame: 4 weeks after the primary immunization (Visit 4)

  2. Geometric Mean Antibody Titer of Anti-PRP Antibody

    Time frame: 4 weeks after the primary immunization (Visit 4)

  3. Anti-PRP Antibody Prevalence Rate With 1 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody

    Time frame: 4 weeks after the booster dose (Visit 6)

  4. Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody

    Time frame: 4 weeks after the booster dose (Visit 6)

  5. Geometric Mean Antibody Titer of Anti-PRP Antibody

    Time frame: 4 weeks after the booster dose (Visit 6)

  6. Geometric Mean Antibody Titer Against Diphtheria Toxin

    Time frame: 4 weeks after the primary immunization (Visit 4)

  7. Geometric Mean Antibody Titer Against Pertussis （PT）

    Time frame: 4 weeks after the primary immunization (Visit 4)

  8. Geometric Mean Antibody Titer Against Pertussis （FHA）

    Time frame: 4 weeks after the primary immunization (Visit 4)

  9. Geometric Mean Antibody Titer Against Tetanus Toxin

    Time frame: 4 weeks after the primary immunization (Visit 4)

  10. Fold Change in Geometric Mean Antibody Titer Against Polio Virus

    Time frame: Baseline and 4 weeks after the primary immunization (Visit 4)

  11. 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 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

    Time frame: 4 weeks after the booster dose (Visit 6)

  12. Geometric Mean Antibody Titer Against Diphtheria Toxin

    Time frame: 4 weeks after the booster dose (Visit 6)

  13. Geometric Mean Antibody Titer Against Pertussis （PT）

    Time frame: 4 weeks after the booster dose (Visit 6)

  14. Geometric Mean Antibody Titer Against Pertussis （FHA）

    Time frame: 4 weeks after the booster dose (Visit 6)

  15. Geometric Mean Antibody Titer Against Tetanus Toxin

    Time frame: 4 weeks after the booster dose (Visit 6)

  16. Fold Change in Geometric Mean Antibody Titer Against Polio Virus

    Time frame: Baseline and 4 weeks after the primary immunization (Visit 6)

07

Results

Posted Jan 3, 2025

Participant flow

Participant flow — Overall Study
MilestoneBK1310
Started33
Completed33
Not completed0

Outcome measures

PrimaryAntibody 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 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

Time frame:
4 weeks after the primary immunization (Visit 4)
Reported as:
Number · percentage of participants
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
percentage of participantsBK1310
Antibody prevalence rate against anti-PRP with 1 μg/mL or higher97.0 (84.2 to 99.9)
Antibody prevalence rate against diphtheria toxin93.9 (79.8 to 99.3)
Antibody prevalence rate against pertussis （PT）100.0 (89.4 to 100.0)
Antibody prevalence rate against pertussis (FHA)97.0 (84.2 to 99.9)
Antibody prevalence rate against tetanus toxin100.0 (89.4 to 100.0)
Antibody prevalence rate against polio virus serotype 1100.0 (89.4 to 100.0)
Antibody prevalence rate against polio virus serotype 2100.0 (89.4 to 100.0)
Antibody prevalence rate against polio virus serotype 3100.0 (89.4 to 100.0)
SecondaryAnti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody
Time frame:
4 weeks after the primary immunization (Visit 4)
Reported as:
Number · percentage of participants
Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody
percentage of participantsBK1310
Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody100.0 (89.4 to 100.0)
SecondaryGeometric Mean Antibody Titer of Anti-PRP Antibody
Time frame:
4 weeks after the primary immunization (Visit 4)
Reported as:
Geometric mean · µg/mL
Geometric Mean Antibody Titer of Anti-PRP Antibody
µg/mLBK1310
Geometric Mean Antibody Titer of Anti-PRP Antibody13.522 (8.628 to 21.192)
SecondaryAnti-PRP Antibody Prevalence Rate With 1 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody
Time frame:
4 weeks after the booster dose (Visit 6)
Reported as:
Number · percentage of participants
Anti-PRP Antibody Prevalence Rate With 1 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody
percentage of participantsBK1310
Anti-PRP Antibody Prevalence Rate With 1 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody100.0 (89.4 to 100.0)
SecondaryAnti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody
Time frame:
4 weeks after the booster dose (Visit 6)
Reported as:
Number · percentage of participants
Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody
percentage of participantsBK1310
Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody100.0 (89.4 to 100.0)
SecondaryGeometric Mean Antibody Titer of Anti-PRP Antibody
Time frame:
4 weeks after the booster dose (Visit 6)
Reported as:
Geometric mean · µg/mL
Geometric Mean Antibody Titer of Anti-PRP Antibody
µg/mLBK1310
Geometric Mean Antibody Titer of Anti-PRP Antibody28.509 (20.866 to 38.952)
SecondaryGeometric Mean Antibody Titer Against Diphtheria Toxin
Time frame:
4 weeks after the primary immunization (Visit 4)
Reported as:
Geometric mean · IU/mL
Geometric Mean Antibody Titer Against Diphtheria Toxin
IU/mLBK1310
Geometric Mean Antibody Titer Against Diphtheria Toxin1.0818 (0.7157 to 1.6352)
SecondaryGeometric Mean Antibody Titer Against Pertussis （PT）
Time frame:
4 weeks after the primary immunization (Visit 4)
Reported as:
Geometric mean · EU/mL
Geometric Mean Antibody Titer Against Pertussis （PT）
EU/mLBK1310
Geometric Mean Antibody Titer Against Pertussis （PT）128.03 (106.09 to 154.51)
SecondaryGeometric Mean Antibody Titer Against Pertussis （FHA）
Time frame:
4 weeks after the primary immunization (Visit 4)
Reported as:
Geometric mean · EU/mL
Geometric Mean Antibody Titer Against Pertussis （FHA）
EU/mLBK1310
Geometric Mean Antibody Titer Against Pertussis （FHA）53.64 (44.01 to 65.40)
SecondaryGeometric Mean Antibody Titer Against Tetanus Toxin
Time frame:
4 weeks after the primary immunization (Visit 4)
Reported as:
Geometric mean · IU/mL
Geometric Mean Antibody Titer Against Tetanus Toxin
IU/mLBK1310
Geometric Mean Antibody Titer Against Tetanus Toxin0.3068 (0.2091 to 0.4502)
SecondaryFold Change in Geometric Mean Antibody Titer Against Polio Virus
Time frame:
Baseline and 4 weeks after the primary immunization (Visit 4)
Reported as:
Geometric mean · fold change
Fold Change in Geometric Mean Antibody Titer Against Polio Virus
fold changeBK1310
Geometric mean antibody titer against polio virus serotype 1551.06 (348.74 to 870.74)
Geometric mean antibody titer against polio virus serotype 21510.29 (1046.26 to 2180.11)
Geometric mean antibody titer against polio virus serotype 31290.16 (937.99 to 1774.55)
SecondaryAntibody 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 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

Time frame:
4 weeks after the booster dose (Visit 6)
Reported as:
Number · percentage of participants
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
percentage of participantsBK1310
Antibody prevalence rate against diphtheria toxin100.0 (89.4 to 100.0)
Antibody prevalence rate against pertussis （PT）100.0 (89.4 to 100.0)
Antibody prevalence rate against pertussis （FHA）100.0 (89.4 to 100.0)
Antibody prevalence rate against tetanus toxin100.0 (89.4 to 100.0)
Antibody prevalence rate against polio virus serotype 1100.0 (89.4 to 100.0)
Antibody prevalence rate against polio virus serotype 2100.0 (89.4 to 100.0)
Antibody prevalence rate against polio virus serotype 3100.0 (89.4 to 100.0)
SecondaryGeometric Mean Antibody Titer Against Diphtheria Toxin
Time frame:
4 weeks after the booster dose (Visit 6)
Reported as:
Geometric mean · IU/mL
Geometric Mean Antibody Titer Against Diphtheria Toxin
IU/mLBK1310
Geometric Mean Antibody Titer Against Diphtheria Toxin9.6485 (7.2551 to 12.8316)
SecondaryGeometric Mean Antibody Titer Against Pertussis （PT）
Time frame:
4 weeks after the booster dose (Visit 6)
Reported as:
Geometric mean · EU/mL
Geometric Mean Antibody Titer Against Pertussis （PT）
EU/mLBK1310
Geometric Mean Antibody Titer Against Pertussis （PT）173.17 (140.90 to 212.84)
SecondaryGeometric Mean Antibody Titer Against Pertussis （FHA）
Time frame:
4 weeks after the booster dose (Visit 6)
Reported as:
Geometric mean · EU/mL
Geometric Mean Antibody Titer Against Pertussis （FHA）
EU/mLBK1310
Geometric Mean Antibody Titer Against Pertussis （FHA）114.19 (89.14 to 146.28)
SecondaryGeometric Mean Antibody Titer Against Tetanus Toxin
Time frame:
4 weeks after the booster dose (Visit 6)
Reported as:
Geometric mean · IU/mL
Geometric Mean Antibody Titer Against Tetanus Toxin
IU/mLBK1310
Geometric Mean Antibody Titer Against Tetanus Toxin1.8293 (1.2107 to 2.7640)
SecondaryFold Change in Geometric Mean Antibody Titer Against Polio Virus
Time frame:
Baseline and 4 weeks after the primary immunization (Visit 6)
Reported as:
Geometric mean · fold change
Fold Change in Geometric Mean Antibody Titer Against Polio Virus
fold changeBK1310
Geometric mean antibody titer against polio virus serotype 11642.66 (1162.23 to 2321.68)
Geometric mean antibody titer against polio virus serotype 28910.01 (6877.46 to 11543.27)
Geometric mean antibody titer against polio virus serotype 35000.58 (3839.01 to 6513.60)

Adverse events

Collected over Through study completion, an average of 1 year. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
BK13100/33 (0%)2/33 (6.1%)33/33 (100%)
Most frequent serious events
Most frequent serious events
EventBK1310
BronchiolitisInfections and infestations1/33
BronchitisInfections and infestations1/33
Exanthema subitumInfections and infestations1/33
Most frequent other events
Showing 10 of 25
Most frequent other events
EventBK1310
PyrexiaGeneral disorders25/33
Injection site erythemaGeneral disorders16/33
CryingGeneral disorders11/33
Upper respiratory tract inflammationRespiratory, thoracic and mediastinal disorders11/33
HypersomniaNervous system disorders10/33
InsomniaPsychiatric disorders7/33
Injection site swellingGeneral disorders6/33
Injection site indurationGeneral disorders5/33
BronchitisInfections and infestations5/33
ConjunctivitisInfections and infestations5/33

Baseline characteristics

Age, Customized
Age, Customized(Participants)BK1310
>=2 and <3 months27
>=3 months6
Sex: Female, Male
Sex: Female, Male(Participants)BK1310
Female10
Male23
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)BK1310
Asian (Japanese)33
08

Study locations

3 sites
  • Investigational site 1
    Chiba, Japan
  • Investigational site 2
    Tokyo, Japan
  • Investigational site 3
    Tokyo, Japan
09

References and documents

Study documents

  • Study protocol · May 24, 2017
  • Statistical analysis plan · Nov 9, 2018

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03188692
Lead sponsor
Tanabe Pharma Corporation
Collaborators
The Research Foundation for Microbial Diseases of Osaka University
Responsible party
Sponsor
First posted
Jun 15, 2017
Start date
Jun 23, 2017
Primary completion
Nov 2, 2017
Completion
Aug 9, 2018
Results posted
Jan 3, 2025
Last update
Jan 6, 2026

Study contacts

General Manager
study director · Tanabe Pharma Corporation

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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