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:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2025-12-25 @ 1:21 AM
NCT ID:
NCT02677493
Eligibility Criteria:
Inclusion Criteria:
* Healthy men and women at the age of 19 or older.
* Women of childbearing potential must have a negative pregnancy test (urine HCG) at the screening visit.
* Subjects who were given, and fully understood, the information about the study, and have provided voluntary written informed consent to participate in the study and to comply with all applicable study requirements.
Exclusion Criteria:
* Subjects with known allergy to eggs, chicken, or any components of the study vaccine.
* Subjects who had received an influenza vaccine within the last 6 months prior to study entry.
* Subjects who have immune function disorders including immunodeficiency diseases or relevant family history.
* Subjects who donated blood within 1 week prior to vaccination or plan to donate blood during the period from Day 1 to Month 7 of vaccination.
* Subjects with a history of Guillain-Barre syndrome.
* Subjects with Down's syndrome or cytogenetic disorders.
* Subjects who are considered by the investigator to have difficulties in study participation due to severe chronic diseases (e.g., cardiovascular diseases except controlled hypertension and respiratory diseases with respiratory failure, metabolic diseases, renal function disorders, hemoglobinopathy, etc.).
* Subjects with hemophilia or coagulation disorder, who are at increased risk of serious bleeding during intramuscular injection.
* Subjects who had an acute fever with body temperature \> 38.0 ºC within 72 hours prior to administration of the study vaccine.
* Subjects who had received another vaccine within 28 days before administration of the study vaccine or are planning to receive another vaccine during the study.
* Subjects who had received immunosuppressants or immune modifying drugs within 3 months prior to the investigational product vaccination.
1. Azathioprine, cyclosporin, interferon, G-CSF, tacrolimus, everolimus, sirolimus, etc.
2. High dose corticosteroids (a subject taking high doses, which is defined as 2mg/kg/day or higher of prednisolone administered for longer than 14 consecutive days, is not eligible for this study. The use of inhaled, nasal and topical corticosteroids is allowed, regardless of doses).
* Subjects who had previously received immunoglobulin or blood-derived products within the last 3 months prior to administration of the study vaccine, or are scheduled to receive a treatment with blood-derived products during the study.
* Subjects who had participated in another clinical trial within the 30 days before administration of the study vaccine.
* Female subjects of childbearing potential who do not agree to use an acceptable method of birth control\* for this study during the study period.
* Medically acceptable methods of birth control: condom, injectable or implantable contraceptives, intrauterine device, or oral contraceptives, etc.
* Subjects with other clinically significant medical or psychiatric illness who in the investigator's opinion, are not be suitable for the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT02677493
Study Brief:
Protocol Section:
NCT02677493