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 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 1:06 AM
NCT ID:
NCT03853993
Eligibility Criteria:
Inclusion Criteria:
* Healthy volunteers aged ≥3 years;
* Proven legal identity;
* Participants or (and) guardians of the participants should be capable of understanding the written consent form, and such form should be signed prior to enrolment;
Exclusion Criteria:
* Prior vaccination with influenza vaccine of the current year;
* History of influenza within 6 months prior to study entry;
* Axillary temperature \> 37.0 °C;
* History of allergy to any vaccine, or any ingredient of the experimental vaccine, especially eggs, egg albumin, etc.;
* Serious adverse reaction(s) to vaccination, such as urticaria, dyspnea, angioneurotic edema, abdominal pain, etc.;
* Severe/uncontrollable nervous system disease (epilepsy, seizures or convulsions) or mental illness;
* Autoimmune disease or immunodeficiency/immunosuppressive, or any immunosuppressant receipt within 6 months prior to the study entry;
* History of asthma, thyroidectomy, angioedema, diabetes or malignancy;
* No spleen, or functional no spleen, or splenectomy.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
3 Years
Study:
NCT03853993
Study Brief:
Protocol Section:
NCT03853993