Safety and Efficacy of BK1310 Intramuscular Injection in Healthy Infants

Phase 3 Study of BK1310 Intramuscular Injection in Healthy Infants

The purpose of this study is to evaluate the safety and efficacy of an intramuscular injection of BK1310 in healthy infants.

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 diagnosis of thrombocytopenia and/or coagulopathy or currently under treatment of the antiplatelet agents and/or anticoagulant agents.
• 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.