NCT03891758

Confirmatory Study of BK1310 in Healthy Infants

Phase 3 Study of BK1310 Compared With ActHIB® and Tetrabik in Healthy Infants: A Randomized, Assessor-blind, Active-controlled

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 267 (actual)
• Sponsor: Tanabe Pharma Corporation · Industry
• Sex: All
• Age: 2 Months – 42 Months
• Healthy volunteers: Accepted

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.

Conditions

• Tetanus
• Diphtheria
• Pertussis
• Poliomyelitis
• Bacterial Meningitis

Interventions

Type	Name	Description
BIOLOGICAL	DPT-IPV-Hib	0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
BIOLOGICAL	Hib vaccine	0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
BIOLOGICAL	DPT-IPV	0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.

Timeline

• Start date: 2019-04-01
• Primary completion: 2019-09-18
• Completion: 2020-08-10
• First posted: 2019-03-27
• Last updated: 2026-01-06
• Results posted: 2025-01-06

Locations

1 site across 1 country: Japan