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 @ 7:49 PM
Ignite Modification Date:
2025-12-24 @ 7:49 PM
NCT ID:
NCT02330003
Eligibility Criteria:
Inclusion Criteria:
* Healthy male subjects between 20 and 55 years of age at screening
* Body weight of ≥ 55kg and within ±20% of ideal body weight (ideal body weight = (height cm - 100)\*0.9) at screening
* Subjects with no congenital or chronic disease who were considered suitable for the study after screening assessments (investigator's opinion, medical history, physical examination, laboratory test, chest X-ray, and ECG) conducted within 28 days prior to vaccination
* Subjects who were given, and fully understood, the information about the study, made a voluntary decision, and provided written informed consent, to participate in the study and comply with all applicable study requirements
Exclusion Criteria:
* Subjects who have known or suspected infection with HAV, HBV, HCV, HIV or VDRL
* Subjects who have concurrent or a past history of immune deficiency disease
* Subject who had participated in blood donation within 1 week prior to vaccination, or are planning to participate in blood donation from Day 1 until Month 7 post-vaccination
* Subject with a history of Guillain-Barre syndrome
* Subject with hemophilia or thrombocytopenia, or being treated with an anticoagulant, who are at increased risk of serious bleeding during intramuscular injection
* Subjects who have concurrent or a past history of, malignant tumor of internal organ or blood vessels or skin metastasis
* Subjects with known allergy to a drug, food or latex, who had a history of anaphylaxis
* Subjects who had an acute fever with body temperature \> 38.0 Cº within 72 hours prior to administration of the study vaccine or symptoms of suspected acute disease within 14 days prior to administration of the study vaccine
* Subjects who received another experimental drug or vaccine within 28 days before administration of the study vaccine or are planning to receive another experimental drug or vaccine during the study.
* Subjects who had previously received immunoglobulin or blood-derived products within the last 3 months prior to administration of the study vaccine, or are expecting to be treated with immunoglobulin or blood-derived products during the study
* Subjects who had received, or are scheduled to receive, systemic immunosuppressive therapy, radiation therapy or high-dose corticosteroid therapy within the last 6 months prior to administration of the study
* Subjects with a history of, or suspected, drug abuse based on subject interview and physical examination.
* Subjects with excessive consumption of caffeine and alcohol and excessive smoking
* Subject with a known allergy to eggs, chicken, or any components of the study vaccine
* Subjects who in the investigator's opinion, may not be suitable for vaccination or who may interfere with the objective assessment of the study outcomes.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
55 Years
Study:
NCT02330003
Study Brief:
Protocol Section:
NCT02330003