To Evaluate the Effectiveness(Immunogeneicity) and Safety of 'GC1107' Administered Intramuscularly in Healthy Adults

This is an interventional prevention trial for Bacterial Infections Read More

Inclusion Criteria:

• healthy Korean adults (age: over 18 years)
• who got the basic vaccination of DTP(Diphtheria, tetanus, pertussis) in the past
• Subjects willing to provide written informed consent and able to comply with the requirements for the study

Exclusion Criteria:

• subjects who have already got the additional vaccination of Td within 5 years

• subjects with antitoxin of diphtheria and tetanus ≥1.0 IU/mL (ELISA)

  • only applicable in step I
• subjects who have not recovered from the acute disease within 2 weeks
• subjects who have the medical history of allergic disease related to the components of investigational drug
• who got the treatment of blood product and immunoglobulin product within 3 months
• females who are pregnant
• females who are breastfeeding
• subjects who are infected from the diphtheria and tetanus
• subjects who have experienced the severe adverse events for the diphtheria and tetanus vaccination
• Subjects who are scheduled to participate in other clinical trial studies during the study
• Subjects who have participated in any other clinical trials within 4 weeks of the administration of the study
• Those who take the other medicine that affects this study or are vaccinated other vaccines
• 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 37.4) 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.