Confirmatory Study of BK1310 in Healthy Infants

Tanabe Pharma Corporation

Status and phase: Completed; Phase 3

Conditions: Bacterial Meningitis; Poliomyelitis; Diphtheria; Pertussis; Tetanus

Treatments: Biological: DPT-IPV-Hib; Biological: DPT-IPV; Biological: Hib vaccine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03891758

jRCT2080224611 (Registry Identifier)

BK1310-J03

Details and patient eligibility

About

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.

Enrollment: 267 patients

Sex: All

Ages: 2 to 42 months old

Volunteers: Accepts Healthy Volunteers

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)

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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267 participants in 2 patient groups

BK1310

Experimental group

Treatment:

Biological: DPT-IPV-Hib

ActHIB® and Tetrabik

Active Comparator group

Treatment:

Biological: Hib vaccine

Biological: DPT-IPV