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 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 1:20 AM
NCT ID:
NCT05313893
Eligibility Criteria:
Inclusion Criteria:
* Aged 3-8 years old
* Healthy subjects judged from medical history and clinical examination
* Subjects themselves or their guardians able to understand and sign theinformed consent
* Subjects themselves or their guardians can and will comply with therequirements of the protocol
* Subjects have received ≥2 doses of trivalent or quadrivalent infuenzavaccine before enrollment (Doses need not have been received duringsame or consecutive seasons); Subjects have not received infuenzavaccine before enrollment
* Subjects with temperature \<=37.0°C on axillary setting
Exclusion Criteria:
* Any prior administration of other research medicine/vaccine in last 30 days
* Any prior administration of influenza vaccine in last 6 month
* Any prior administration of immunodepressant or corticosteroids in last 3 months
* Any prior administration of blood products in last 3 months
* Any prior administration of any attenuated live vaccine in last 14 days
* Any prior administration of subunit or inactivated vaccines in last 7 days
* Subject who developed guillain-Barre syndrome post influenza vaccination
* Subject who is allergic to any ingredient of the vaccine
* Subject with acute febrile illness or infectious disease
* Thrombocytopenia, blood coagulation disorder or bleeding difficulties withintramuscular injection
* Subject with damaged or low immune function which has already beenknown
* Subject with congenital heart disease or other birth defects unsuitable for vaccination.
* Subject with respiratory diseases (including pneumonia, tuberculosis, severe asthma, etc.), heart, liver and kidney diseases, mental disorders, or chronic infections.
* Any medical, psychological, social or other condition judged byinvestigator, that may interfere subject's compliance with the protocol
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
8 Years
Study:
NCT05313893
Study Brief:
Protocol Section:
NCT05313893