Confirmatory Study of BK1310 in Healthy Infants

Phase 3

Completed

• Conditions: Diphtheria; Pertussis; Tetanus; Poliomyelitis; Bacterial Meningitis
• Interventions: Biological: Hib vaccine; Biological: DPT-IPV-Hib; Biological: DPT-IPV

• Registration Number: NCT03891758
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-24
• Study First Submitted QC: 2019-03-26
• Study First Posted: 2019-03-27
• Study Start: 2019-04-01
• Primary Completion: 2019-09-18
• Study Completion: 2020-08-10
• 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: 2025-01-06
• Last Update Posted: 2025-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 267

Inclusion Criteria

• 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)

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ActHIB® and Tetrabik	Hib vaccine	-
ActHIB® and Tetrabik	DPT-IPV	-
BK1310	DPT-IPV-Hib	-

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	4 weeks after the booster dose (Visit 6)
Geometric Mean Antibody Titer Against Tetanus Toxin	4 weeks after the booster dose (Visit 6)
Geometric Mean Antibody Titer Against Polio Virus	4 weeks after the primary immunization (Visit 4)
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
Fold Change in Geometric Mean Antibody Titer Against Polio Virus	Baseline and 4 weeks after the primary immunization (Visit 6)

Trial Locations

Locations (1)

Investigational Site; 🇯🇵 Fukuoka-shi, Fukuoka, Japan