NCT02992925

Phase 3 Study of BK1310 in Healthy Infants

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 370 (actual)
• Sponsor: Tanabe Pharma Corporation · Industry
• Sex: All
• Age: 2 Months – 43 Months
• Healthy volunteers: Accepted

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.

Conditions

• Immunization; Infection

Interventions

Type	Name	Description
BIOLOGICAL	DPT-IPV-Hib-High（Combined Vaccine）
BIOLOGICAL	DPT-IPV-Hib-Low（Combined Vaccine）
BIOLOGICAL	Hib vaccine
BIOLOGICAL	DPT-IPV

Timeline

• Start date: 2016-11-01
• Primary completion: 2017-12-01
• Completion: 2018-11-01
• First posted: 2016-12-14
• Last updated: 2026-01-06
• Results posted: 2025-01-07

Locations

3 sites across 1 country: Japan