Randomized, Double Blind, Multicenter, Phase II/III Study to Evaluate the Effectiveness(Immunogenicity) and Safety of 'GC1107' Administered Intramuscularly in Healthy Children
Randomized, Double Blind, Multicenter, Phase II/III Study to Evaluate the Effectiveness(Immunogenicity) and Safety of 'GC1107' Administered Intramuscularly in Healthy Children
The purpose of this study is to evaluate the effectiveness(immunogenicity) and safety of 'GC1107' administered intramuscularly in healthy children
Randomized, double blind, multicenter, phase Ⅱ/Ⅲ study
Inclusion Criteria:
healthy Korean children(age: 10 ~ 17)
who got the basic vaccination(5 times vaccination of diphtheria and tetanus until 6 years old.)
Subjects willing to provide written informed consent and able to comply with the requirements for the study or informed consent was obtained from the subject's legal guardian
Exclusion Criteria:
Subjects with antitoxin of diphtheria and tetanus ≥1.0IU/mL (ELISA)
subjects who have not recovered from the acute disease within 2 weeks
who has experienced the temporary platelet decrease or has the medical history of neurologic complication
who has the medical history of allergic disease related to the components of investigational drug
who has experienced the severe adverse events for the diphtheria and tetanus vaccination
who got the vaccination of diphtheria and tetanus within 5 years
who has not recovered from the acute disease within 2 weeks
who got the treatment of blood product within 3 months
who got the immunoglobulin should have the wash-out period
who be infected from the diphtheria and tetanus
Subjects who are scheduled to participate in other clinical trial studies during the study.
Current participation in a clinical study involving any other drugs including vaccine within 4 weeks of enrollment of the study vaccine.
Subjects who have participated in any other clinical trials within 4 weeks of the administration of the study
Subject who have received adrenocortical hormones or immunosuppressive drug within 4weeks of enrollment
Subjects with a history of chronic disease obstacles to the study.
Subjects who have episode of acute febrile (at least 37.5) after injection of vaccine during the study
Subject who have plan of operation during the study.
Individuals with other clinically significant medical or psychological condition who are considered by the investigator to be ineligible for the study.