Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
370 participants
INTERVENTIONAL
2016-11-30
2018-11-30
Brief Summary
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* (cohort 1) evaluate safety and immunogenicity (Haemophilus influenzae type b, Hib) of BK1310.
* (cohort 2) evaluate efficacy and safety of BK1310 using ActHIB® and Tetrabik as a control in healthy infants.
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Detailed Description
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* Arm: BK1310-High. Intervention: DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
* Arm: BK1310-Low. Intervention: DPT-IPV-Hib-Low(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
\<Cohort 2\>
* Arm: BK1310-High or Low. Intervention: DPT-IPV-Hib-High(Combined Vaccine) or DPT-IPV-Hib-Low(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals.
* Arm: ActHIB® and Tetrabik. Intervention: Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Cohort 1: BK1310-High
DPT-IPV-Hib-High（Combined Vaccine）
Cohort 1: BK1310-Low
DPT-IPV-Hib-Low（Combined Vaccine）
Cohort 2: BK1310-High or -Low
Either BK1310-High or -Low will be chosen based on the result of cohort 1
DPT-IPV-Hib-High（Combined Vaccine）
DPT-IPV-Hib-Low（Combined Vaccine）
Cohort 2: ActHIB® and Tetrabik
Hib vaccine
DPT-IPV
Interventions
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DPT-IPV-Hib-High（Combined Vaccine）
DPT-IPV-Hib-Low（Combined Vaccine）
Hib vaccine
DPT-IPV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Written informed consent is obtained from a legal guardian (parent)
Exclusion Criteria
* Have close relatives (the third degree of kinship) diagnosed with congenital immunodeficiency
* 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.
* 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.
2 Months
43 Months
ALL
Yes
Sponsors
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The Research Foundation for Microbial Diseases of Osaka University
OTHER
Tanabe Pharma Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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General Manager
Role: STUDY_DIRECTOR
Tanabe Pharma Corporation
Locations
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Fukuoka, Fukuoka, Japan
Kasuga-shi, Fukuoka, Japan
Sendai, Miyagi, Japan
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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BK1310-J01
Identifier Type: -
Identifier Source: org_study_id
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