Confirmatory Study of BK1310 in Healthy Infants

Phase 3 Completed 267 enrolled Tanabe Pharma Corporation The Research Foundation for Microbial Diseases of Osaka University · collab

RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start: 2019-04-01
Primary completion: 2019-09-18
Completion: 2020-08-10

Outcome

Met primary endpoint

paper The non-inferiority of the DPT-IPV-Hib group to the Hib + DPT-IPV group was verified for all measured antibodies. PMID 38582691 ↗

Publications

Results Nakano T, Hasegawa M, Endo M, Matsuda K, Tamai H. Immunogenicity and safety of adsorbed diphtheria-purified pertussis-tetanus-inactivated polio (Sabin strain)-Haemophilus type b conjugate combined vaccine (DPT-IPV-Hib) in healthy Japanese Infants >/= 2 and < 43 months of Age: A phase III, multicenter, active controlled, assessor-blinded, randomized, parallel-group study. Vaccine. 2024 Apr 30;42(12):3134-3143. doi: 10.1016/j.vaccine.2023.03.077. Epub 2024 Apr 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	ActHIB	Vaccine	0.5 ml	Subcutaneous
Subject	Gobik	Vaccine	0.5 ml	Subcutaneous
Comparator	Tetrabik	Vaccine	0.5 ml	Subcutaneous