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 @ 3:39 AM
Ignite Modification Date:
2025-12-25 @ 3:39 AM
NCT ID:
NCT01201902
Eligibility Criteria:
Inclusion Criteria:
* Healthy adults age 18 and older.
* Are able to understand and comply with planned study procedures.
* Provide written informed consent prior to initiation of any study procedures.
Exclusion Criteria:
* Have a known allergy to eggs, chickens or other components of the vaccine(including MF59).
* Have immunosuppression including immunodeficiency disease.
* Have a history of Guillain-Barre Syndrome.
* Have a diagnosis of thrombocytopenia.
* Have a chronic disease that the investigator believes may interfere with successful completion of the study. (Excluding regulating hypertension)
* Hemophilia Patients or Are receiving anti-coagulating agents. Low-dose aspirin (100mg/day) purpose of prevention is allowed.
* Are receiving anti-viral agents.
* Have an acute fever, a temperature greater than 38℃(100.4 degrees Fahrenheit) within 72 hours of vaccination or Have a symptom of acute febrile illness within 14 days prior to vaccination in this study.
* Received below agents or expect to receive agents within following periods. A. Have immunosuppression therapy, radiotherapy, use of high-dose glucocorticoids or prednisolone(≥15mg/day) within 6 months prior to vaccination in this study.Inhaled, nasal and topical steroids are allowed) B. Have a history of receiving immunoglobulin or other blood product within 3 months prior to vaccination in this study.
C. Received an experimental agent within 1 month prior to vaccination in this study.
D. Received any vaccines(live licensed and inactivated licensed) within 1 month prior to vaccination in this study. (Excluding seasonal Influenza vaccine)
* Those who are not eligible to receive vaccine injection in the arm deltoid muscle.
* Pregnant females, Nursing mom, Those women who have a chance to become pregnant, but not taking a proper contraception.
* Not agree to abstain from drinking following 7 days of vaccination.
* Have any condition (clinically regardful medical or psychological condition) that would, in the opinion of the site investigator, render them unable to meet the requirements of the protocol.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01201902
Study Brief:
Protocol Section:
NCT01201902