Phase 3 Study of BK1310 in Healthy Infants

Phase 3

Completed

• Conditions: Immunization; Infection
• Interventions: Biological: Hib vaccine; Biological: DPT-IPV-Hib-High（Combined Vaccine）; Biological: DPT-IPV-Hib-Low（Combined Vaccine）; Biological: DPT-IPV

• Registration Number: NCT02992925
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

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 Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-12-01
• Study First Submitted QC: 2016-12-12
• Study First Posted: 2016-12-14
• Primary Completion: 2017-12
• Study Completion: 2018-11
• Results First Submitted: 2024-03-26
• Status Verified: 2024-11
• Results First Submitted QC: 2024-11-18
• Last Update Submitted: 2024-11-18
• Results First Posted: 2025-01-07
• Last Update Posted: 2025-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 370

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)

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 2: BK1310-High or -Low	DPT-IPV-Hib-Low（Combined Vaccine）	Either BK1310-High or -Low will be chosen based on the result of cohort 1
Cohort 2: ActHIB® and Tetrabik	Hib vaccine	-
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	DPT-IPV-Hib-High（Combined Vaccine）	Either BK1310-High or -Low will be chosen based on the result of cohort 1
Cohort 2: ActHIB® and Tetrabik	DPT-IPV	-

Primary Outcome Measures

Name	Time	Method
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	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 Outcome Measures

Name	Time	Method
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)	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