Confirmatory Study of BK1310 in Healthy Infants
December 15, 2025 updated by: Tanabe Pharma Corporation
Phase 3 Study of BK1310 Compared With ActHIB® and Tetrabik in Healthy Infants: A Randomized, Assessor-blind, Active-controlled
The purpose of this study is to evaluate immunogenicity of BK1310 for all antigens (anti-PRP, diphtheria toxin, pertussis, tetanus toxin, and polio virus), after 3 times of injection, when compared noninferiority with co-administration of ActHIB® and Tetrabik, as well as efficacy and safety, in healthy infants.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
267
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Fukuoka
-
Fukuoka, Fukuoka, Japan
- Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 months to 3 years (Child)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Healthy infants aged ≥2 and <43 months at the first vaccination of the study drug (recommended: ≥2 and <7 months)
- Written informed consent is obtained from a legal guardian (parent)
Exclusion Criteria:
- Possibility of anaphylaxis due to food or pharmaceuticals
- With experience of Hib infection, diphtheria, pertussis, tetanus or acute poliomyelitis
- With experience of Hib, diphteria, pertussis, tetanus or polio vaccination.
- Participated in other studies within 12 weeks before obtaining consent
- Considered to be not eligible by the principal investigators (sub-investigators) of the enrollment
Additional screening criteria check may apply for qualification.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: BK1310
|
0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
Other Names:
|
|
Active Comparator: ActHIB® and Tetrabik
|
0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
Other Names:
0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
Time Frame: 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
|
4 weeks after the primary immunization (Visit 4)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 weeks after the booster dose (Visit 6)
|
|
|
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)
|
4 weeks after the booster dose (Visit 6)
|
|
|
Geometric Mean Antibody Titer of Anti-PRP Antibody
Time Frame: 4 weeks after the booster dose (Visit 6)
|
4 weeks after the booster dose (Visit 6)
|
|
|
Geometric Mean Antibody Titer Against Diphtheria Toxin
Time Frame: 4 weeks after the primary immunization (Visit 4)
|
4 weeks after the primary immunization (Visit 4)
|
|
|
Geometric Mean Antibody Titer Against Pertussis
Time Frame: 4 weeks after the primary immunization (Visit 4)
|
4 weeks after the primary immunization (Visit 4)
|
|
|
Geometric Mean Antibody Titer Against Tetanus Toxin
Time Frame: 4 weeks after the primary immunization (Visit 4)
|
4 weeks after the primary immunization (Visit 4)
|
|
|
Geometric Mean Antibody Titer Against Diphtheria Toxin
Time Frame: 4 weeks after the booster dose (Visit 6)
|
4 weeks after the booster dose (Visit 6)
|
|
|
Geometric Mean Antibody Titer Against Pertussis
Time Frame: 4 weeks after the booster dose (Visit 6)
|
4 weeks after the booster dose (Visit 6)
|
|
|
Geometric Mean Antibody Titer Against Tetanus Toxin
Time Frame: 4 weeks after the booster dose (Visit 6)
|
4 weeks after the booster dose (Visit 6)
|
|
|
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
Time Frame: 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
|
4 weeks after the booster dose (Visit 6)
|
|
Fold Change in Geometric Mean Antibody Titer Against Polio Virus
Time Frame: Baseline and 4 weeks after the primary immunization (Visit 6)
|
Baseline and 4 weeks after the primary immunization (Visit 6)
|
|
|
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: 4weeks after the primary immunization (Visit 4)
|
4weeks after the primary immunization (Visit 4)
|
|
|
Geometric Mean Antibody Titer of Anti-PRP Antibody
Time Frame: 4weeks after the primary immunization (Visit 4)
|
4weeks after the primary immunization (Visit 4)
|
|
|
Geometric Mean Antibody Titer Against Polio Virus
Time Frame: 4 weeks after the primary immunization (Visit 4)
|
4 weeks after the primary immunization (Visit 4)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: General Manager, Tanabe Pharma Corporation
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2019
Primary Completion (Actual)
September 18, 2019
Study Completion (Actual)
August 10, 2020
Study Registration Dates
First Submitted
March 24, 2019
First Submitted That Met QC Criteria
March 26, 2019
First Posted (Actual)
March 27, 2019
Study Record Updates
Last Update Posted (Estimated)
January 6, 2026
Last Update Submitted That Met QC Criteria
December 15, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neuroinflammatory Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neuromuscular Diseases
- Respiratory Tract Infections
- Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Diseases
- Enterovirus Infections
- Picornaviridae Infections
- Gram-Positive Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Negative Bacterial Infections
- Spinal Cord Diseases
- Central Nervous System Infections
- Actinomycetales Infections
- Myelitis
- Pasteurellaceae Infections
- Meningitis
- Central Nervous System Bacterial Infections
- Clostridium Infections
- Corynebacterium Infections
- Bordetella Infections
- Haemophilus Infections
- Poliomyelitis
- Diphtheria
- Tetanus
- Whooping Cough
- Meningitis, Bacterial
- HibTITER protein, Haemophilus influenzae
- Haemophilus influenza type b polysaccharide vaccine-tetanus toxin conjugate
Other Study ID Numbers
- BK1310-J03
- jRCT2080224611 (Registry Identifier: Japan Registry of Clinical Trials (jRCT))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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