Phase 3 Study of BK1310 in Healthy Infants
Study Details
Study Description
Brief Summary
The purpose of this study is to:
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(cohort 1) evaluate safety and immunogenicity (Haemophilus influenzae type b, Hib) of BK1310.
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(cohort 2) evaluate efficacy and safety of BK1310 using ActHIB® and Tetrabik as a control in healthy infants.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
<Cohort 1>
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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.
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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>
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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.
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Arm: ActHIB® and Tetrabik. Intervention: Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cohort 1: BK1310-High
|
Biological: DPT-IPV-Hib-High（Combined Vaccine）
Other Names:
|
| Experimental: Cohort 1: BK1310-Low
|
Biological: DPT-IPV-Hib-Low（Combined Vaccine）
Other Names:
|
| Experimental: Cohort 2: BK1310-High or -Low Either BK1310-High or -Low will be chosen based on the result of cohort 1 |
Biological: DPT-IPV-Hib-High（Combined Vaccine）
Other Names:
Biological: DPT-IPV-Hib-Low（Combined Vaccine）
Other Names:
|
| Active Comparator: Cohort 2: ActHIB® and Tetrabik
|
Biological: Hib vaccine
Other Names:
Biological: DPT-IPV
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Antibody prevalence rate against anti-PRP with 1 μg/mL or higher, diphtheria toxin, pertussis, tetanus toxin, and polio virus [4 weeks after the primary immunization (Visit 4)]
Secondary Outcome Measures
- Anti-PRP antibody prevalence rate with 0.15 μg/mL or higher [4 weeks after the primary immunization (Visit 4)]
- Geometric mean antibody titer of anti-PRP antibody [4 weeks after the primary immunization (Visit 4)]
- Anti-PRP antibody prevalence rate with 1 μg/mL or higher [4 weeks after the booster dose (Visit 6)]
- Anti-PRP antibody prevalence rate with 0.15 μg/mL or higher [4 weeks after the booster dose (Visit 6)]
- Geometric mean antibody titer of anti-PRP antibody [4 weeks after the booster dose (Visit 6)]
- Geometric mean antibody titer against diphtheria toxin, pertussis, tetanus toxin, and polio virus [4 weeks after the primary immunization (Visit 4)]
- Antibody prevalence rate against diphtheria toxin, pertussis, tetanus toxin, and polio virus [4 weeks after the booster dose (Visit 6)]
- Geometric mean antibody titer against diphtheria toxin, pertussis, tetanus toxin, and polio virus [4 weeks after the booster dose (Visit 6)]
- Number of participants with adverse events and adverse reactions [Through the first dose (Visit 1) to 4 weeks after the booster dose (Visit 6)]
Cohort 1
- Number of participants with adverse events and adverse reactions [Through the first dose (Visit 1) to 4 weeks after the primary immunization (Visit 4)]
Cohort 2
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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Written informed consent is obtained from a legal guardian (parent)
Exclusion Criteria:
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With past diagnosis of immunodeficiency or currently under immunosuppressive treatment
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Have close relatives (the third degree of kinship) diagnosed with congenital immunodeficiency
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Possibility of anaphylaxis due to food or pharmaceuticals
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With experience of Hib infection, diphtheria, pertussis, tetanus or acute poliomyelitis
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With experience of Hib, diphteria, pertussis, tetanus or polio vaccination.
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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
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Administered transfusion, immunosuppressant (excluding drugs for external use), or immunoglobulin formulation
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Administered corticosteroid 2 mg/kg per day or more as prednisolone (excluding drugs for external use)
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Participated in other studies within 12 weeks before obtaining consent
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With the gestational age <37 weeks or weighed less than 2500 grams at birth.
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Considered to be not eligible by the principal investigators (sub-investigators) of the enrollment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fukuoka-shi | Fukuoka | Japan | ||
| 2 | Kasuga-shi | Fukuoka | Japan | ||
| 3 | Sendai-shi | Miyagi | Japan |
Sponsors and Collaborators
- Mitsubishi Tanabe Pharma Corporation
- The Research Foundation for Microbial Diseases of Osaka University
Investigators
- Study Director: General Manager, Mitsubishi Tanabe Pharma Corporation
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BK1310-J01