Phase 3 Study of BK1310 in Healthy Infants

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.

<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.

Inclusion Criteria:

• Healthy infants aged ≥2 and <43 months at the first vaccination of the study drug (recommended: ≥2 and <7 months). Those who are applicable of the following conditions must be carefully observed before the enrollment: infants with known underlying disease such as cardiovascular disease, renal disease, hepatic disease, blood dyscrasia, respiratory disease or developmental disorder. Infants who developed fever within 2 days after any previous vaccination. Infants with history of convulsions.
• Written informed consent is obtained from a legal guardian (parent)

Exclusion Criteria:

• With past diagnosis of immunodeficiency or currently under immunosuppressive treatment
• Have close relatives (the third degree of kinship) diagnosed with congenital immunodeficiency
• 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.
• Administered a live vaccine within 27 days before the first vaccination of the study drug, or inactivated vaccine or toxoid within 6 days before vaccination
• Administered transfusion, immunosuppressant (excluding drugs for external use), or immunoglobulin formulation
• Administered corticosteroid 2 mg/kg per day or more as prednisolone (excluding drugs for external use)
• Participated in other studies within 12 weeks before obtaining consent
• With the gestational age <37 weeks or weighed less than 2500 grams at birth.
• Considered to be not eligible by the principal investigators (sub-investigators) of the enrollment.