NCT02992925CompletedPhase 3
Phase 3 Study of BK1310 in Healthy Infants
Tanabe Pharma Corporation3 sites in 1 country370 target enrollmentStarted: November 1, 2016Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Tanabe Pharma Corporation
- Enrollment
- 370
- Locations
- 3
- Primary Endpoint
- 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
Study Overview
Brief Summary
The purpose of this study is to:
- (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.
Detailed Description
<Cohort 1>
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 2 Months to 43 Months (Child)
- Sex
- 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
- •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 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.
Arms & Interventions
Cohort 1: BK1310-High
Experimental
Intervention: DPT-IPV-Hib-High（Combined Vaccine） (Biological)
Cohort 1: BK1310-Low
Experimental
Intervention: DPT-IPV-Hib-Low（Combined Vaccine） (Biological)
Cohort 2: BK1310-High or -Low
Experimental
Either BK1310-High or -Low will be chosen based on the result of cohort 1
Intervention: DPT-IPV-Hib-High（Combined Vaccine） (Biological)
Cohort 2: BK1310-High or -Low
Experimental
Either BK1310-High or -Low will be chosen based on the result of cohort 1
Intervention: DPT-IPV-Hib-Low（Combined Vaccine） (Biological)
Cohort 2: ActHIB® and Tetrabik
Active Comparator
Intervention: Hib vaccine (Biological)
Cohort 2: ActHIB® and Tetrabik
Active Comparator
Intervention: DPT-IPV (Biological)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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))
- 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))
- Geometric Mean Antibody Titer Against Diphtheria Toxin(4 weeks after the booster dose (Visit 6))
- Geometric Mean Antibody Titer Against Pertussis （PT）(4 weeks after the booster dose (Visit 6))
- Geometric Mean Antibody Titer Against Pertussis （FHA）(4 weeks after the booster dose (Visit 6))
- Geometric Mean Antibody Titer Against Tetanus Toxin(4 weeks after the booster dose (Visit 6))
- Fold Change in Geometric Mean Antibody Titer Against Polio Virus(Baseline and 4 weeks after the primary immunization (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(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 primary immunization (Visit 4))
- Geometric Mean Antibody Titer of Anti-PRP Antibody(4 weeks after the primary immunization (Visit 4))
- Geometric Mean Antibody Titer Against Diphtheria Toxin(4 weeks after the primary immunization (Visit 4))
- Geometric Mean Antibody Titer Against Pertussis （PT）(4 weeks after the primary immunization (Visit 4))
- Geometric Mean Antibody Titer Against Pertussis （FHA）(4 weeks after the primary immunization (Visit 4))
- Geometric Mean Antibody Titer Against Tetanus Toxin(4 weeks after the primary immunization (Visit 4))
- Fold Change in Geometric Mean Antibody Titer Against Polio Virus(Baseline and 4 weeks after the primary immunization (Visit 4))
Investigators
Study Sites (3)
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