Confirmatory Study of BK1310 in Healthy Infants
Phase 3 Study of BK1310 Compared With ActHIB® and Tetrabik in Healthy Infants: A Randomized, Assessor-blind, Active-controlled
2 other identifiers
interventional
267
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2019
CompletedFirst Posted
Study publicly available on registry
March 27, 2019
CompletedStudy Start
First participant enrolled
April 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 18, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 10, 2020
CompletedResults Posted
Study results publicly available
January 6, 2025
CompletedJanuary 6, 2026
December 1, 2025
6 months
March 24, 2019
March 26, 2024
December 15, 2025
Conditions
Keywords
Outcome Measures
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
4 weeks after the primary immunization (Visit 4)
Secondary Outcomes (14)
Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody
4weeks after the primary immunization (Visit 4)
Geometric Mean Antibody Titer of Anti-PRP Antibody
4weeks after the primary immunization (Visit 4)
Anti-PRP Antibody Prevalence Rate With 1 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody
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
4 weeks after the booster dose (Visit 6)
Geometric Mean Antibody Titer of Anti-PRP Antibody
4 weeks after the booster dose (Visit 6)
- +9 more secondary outcomes
Study Arms (2)
BK1310
EXPERIMENTALActHIB® and Tetrabik
ACTIVE COMPARATORInterventions
0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Investigational Site
Fukuoka, Fukuoka, Japan
Related Publications (1)
Nakano T, Hasegawa M, Endo M, Matsuda K, Tamai H. Immunogenicity and safety of adsorbed diphtheria-purified pertussis-tetanus-inactivated polio (Sabin strain)-Haemophilus type b conjugate combined vaccine (DPT-IPV-Hib) in healthy Japanese Infants >/= 2 and < 43 months of Age: A phase III, multicenter, active controlled, assessor-blinded, randomized, parallel-group study. Vaccine. 2024 Apr 30;42(12):3134-3143. doi: 10.1016/j.vaccine.2023.03.077. Epub 2024 Apr 6.
PMID: 38582691RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trials, Information Desk
- Organization
- Tanabe Pharma Corporation / The Research Foundation for Microbial Diseases of Osaka University
Study Officials
- STUDY DIRECTOR
General Manager
Tanabe Pharma Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2019
First Posted
March 27, 2019
Study Start
April 1, 2019
Primary Completion
September 18, 2019
Study Completion
August 10, 2020
Last Updated
January 6, 2026
Results First Posted
January 6, 2025
Record last verified: 2025-12