To Evaluate the Effectiveness(Immunogenicity) and Safety of 'GC1107' Administered Intramuscularly in Healthy Children

This is an interventional prevention trial for Bacterial Infections Read More

Inclusion Criteria:

• healthy Korean children(age: 10 ~ 17)

  • In the case of step1 (for step 1) 11~12 years
• 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)

  • only applicable in step 1
• 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.