Multicenter, evaluator-blind, randomized, parallel-group, comparative study to evaluate immunogenicity and safety by intramuscular injection of KD-370 in infants

INTERVENTION: Intervention name : KD‐370 Dosage And administration of the intervention : 0.5 mL/dose, 4 doses in total, intramuscular injection Control intervention name : KD‐370 Dosage And administration of the control intervention : 0.5 mL/dose, 4 doses in total, subcutaneous injection CONDITION: Prevention of pertussis, diphtheria, tetanus, acute poliomyelitis, and invasive disease caused bay Haemophilus influenzae type b PRIMARY OUTCOME: Seropositivity rates against polyribosyl ribitol phosphate (>= 1 mcg/mL), pertussis toxin, filamentous hemagglutinin, diphtheria toxin, tetanus toxoid, poliovirus types 1, 2, and 3 (Sabin strain) after primary immunization SECONDARY OUTCOME: ‐ Seropositivity rate (>= 0.15 mcg/mL) against polyribosyl ribitol phosphate after primary immunization; ‐ Seropositivity rates against poliovirus types 1 (Mahoney strain), 2 (MEF‐1 strain), and 3 (Saukett strain) after primary immunization; ‐ Seropositivity rates against polyribosyl ribitol phosphate (>= 1 mcg/mL and >= 0.15 mcg/mL), pertussis toxin, filamentous hemagglutinin, diphtheria toxin, tetanus toxoid, poliovirus types 1, 2, and 3 (Sabin strain), poliovirus types 1 (Mahoney strain), 2 (MEF‐1 strain), and 3 (Saukett strain) after booster immunization; ‐ The geometric mean titers against polyribosyl ribitol phosphate, pertussis toxin, filamentous hemagglutinin, diphtheria toxin, tetanus toxoid, poliovirus types 1, 2, and 3 (Sabin strain), and poliovirus types 1 (Mahoney strain), 2 (MEF‐1 strain), and 3 (Saukett strain) after primary immunization; ‐ The geometric mean titers against polyribosyl ribitol phosphate, pertussis toxin, filamentous hemagglutinin, diphtheria toxin, tetanus toxoid, poliovirus types 1, 2, and 3 (Sabin strain), and poliovirus types 1 (Mahoney strain), 2 (MEF‐1 strain), and 3 (Saukett strain) after booster immunization INCLUSION CRITERIA: ‐ Infants who are able to receive 4 doses of the investigational drug at defined intervals between the age of 2 months and 60 months ‐ Infants who obtain written informed consent from their legally acceptable representatives