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 @ 5:49 PM
Ignite Modification Date:
2025-12-24 @ 5:49 PM
NCT ID:
NCT03445468
Eligibility Criteria:
Inclusion Criteria:
* Healthy men or women aged from 3 years to \< 19 years
* Subjects were born after full term pregnancy (37 weeks)
* Woman of childbearing potential must have a negative result from Urine Human Chorionic Gonadotropin(HCG) test at the screening visit.
* Voluntary written informed consent was obtained from the subject and the subject's legally acceptable representative (consent of legally acceptable representative was required for subjects younger than 7 years of age)
Exclusion Criteria:
* Subject with a known serious allergy reaction after influenza vaccination or to any component vaccine including eggs
* Subject who had received an influenza vaccine within the last 6 months
* Subject who has, or has a family history of, an immune system disorder including immune deficiency disease
* Subject with a history of Guillain-Barre syndrome
* Subject with Down's syndrome or cytogenetic disorders.
* Subject with severe chronic disease which in the investigator's opinion would not make the subject a good candidate for the clinical trial
* Subject with hemophilia or being treated with an anticoagulant, who are at increased risk of serious bleeding during intramuscular injection
* Subject who had an acute fever with body temperature \> 38.0 Cº within 72 hours prior to administration of the study vaccine
* Subject who had previously received another vaccine within 28 days before administration of the study drug, or is scheduled to receive another vaccine during the study period.
* Subject who had received immunosuppressant or immune modifying drug within the last 3 months prior to administration of the study vaccine
* Subject who had previously received immunoglobulin or blood-derived products within the last 3 months prior to administration of the study vaccine, or is expecting to be treated with immunoglobulin or blood-derived products during the study.
* Subject who had participated in another experimental study within 28 days prior to administration of the study vaccine
* Subject with other clinically significant medical or psychological condition who in the investigator's opinion would not be suitable for the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
18 Years
Study:
NCT03445468
Study Brief:
Protocol Section:
NCT03445468