A multicenter, phase III, evaluator-blinded, randomized, active-controlled, parallel-group comparative study to evaluate the immunogenicity and safety of KD2-396 compared with Quintovac Aqueous Suspension Injection (DTaP-sIPV/Hib) and Bimmugen Injection (HB vaccine) in infants aged >=2 months and <7 months at the time of the first dose

未提供0 个研究点目标入组 540 人开始时间: 待定

适应症

试验速览

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•History of pertussis, diphtheria, tetanus, poliomyelitis (polio), Hib infection, or hepatitis B (as reported by a legal representative)
•Receipt of any vaccine against pertussis, diphtheria, tetanus, poliomyelitis (polio), or Hib infection
•Receipt of hepatitis B vaccine and hepatitis B immune globulin to prevent vertical transmission
•History of anaphylaxis due to components of the investigational products
•Subjects with fibrodysplasia ossificans progressiva
•Participants in another clinical trial and receipt of another investigational product within 120 days prior to the administration of the study drug
•Receipt of a blood transfusion or a gamma globulin preparation within 90 days prior to the first dose of the study drug, or high-dose gamma globulin therapy (>=200 mg/kg) within 180 days prior to the first dose
•Receipt of treatment* affecting immune function within 180 days prior to the first dose of the study drug
•Radiation therapy, immunosuppressants (topical drugs permitted), immunosuppressive therapy, antirheumatic drugs, adrenocorticotropic hormone agents, and adrenocortical steroid preparations (defined as a treatment for>=14 consecutive days at a prednisolone-equivalent dose of >=2 mg/kg/day for those weighing < 10 kg, or >= 20 mg/day for those weighing >= 10 kg; topical drugs are permitted)
•Others: Subjects deemed inappropriate for participation by the investigator or subinvestigator

发起方

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