Phase 3 Study of BK1310 in Healthy Infants

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Immunization; Infection

Clinical Trial Details

NCT number	NCT02992925
Study type	Interventional
Source	Mitsubishi Tanabe Pharma Corporation
Contact
Status	Completed
Phase	Phase 3
Start date	November 2016
Completion date	November 2018

View Details

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