Randomized, Double Blind, Multicenter, Phase III Study to Evaluate the Effectiveness(Immunogeneicity) and Safety of 'GC1107' Administered Intramuscularly in Healthy Adults
Randomized, Double Blind, Multicenter, Phase III Study to Evaluate the Effectiveness(Immunogeneicity) and Safety of 'GC1107' Administered Intramuscularly in Healthy Adults
The purpose of this study is to evaluate the effectiveness(immunogeneicity) and safety of 'GC1107' administered intramuscularly in healthy Adults.
Randomized, double blind, multicenter, phaseⅢ study
Inclusion Criteria:
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)
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.