Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2025-12-24 @ 4:43 PM
NCT ID:
NCT02361866
Eligibility Criteria:
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02361866
Study Brief:
Protocol Section:
NCT02361866