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 @ 9:19 PM
Ignite Modification Date:
2025-12-24 @ 9:19 PM
NCT ID:
NCT02806804
Eligibility Criteria:
Inclusion Criteria:
* healthy subjects more than 3 years old, and the subjects can be informed consent, and sign the informed consent.
* the subjects and his guardians can obey the demands of the scheme .
* Axillary temperature less than 37℃
Exclusion Criteria:
* The people who has flu or influenza-like symptoms(fever \<axillary temperature ≥38 ℃\>, cough or sore throat) within 3 months
* The people who has vaccinated influenza vaccine in 3years.
* The people who has a vaccine allergies, or who allergic to any kind of composition in experimental vaccine, such as eggs, ovalbumin etc.
* The people who has serious side effects to vaccine, such as allergy, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain.
* the subject who has symptoms of acute infection within a week.
* Autoimmune diseases or Immune function defect, people has immunosuppressive therapy, cytotoxic treatment or inhaled corticosteroids in the past 6 months.
* People has congenital malformations, developmental disorder or serious chronic diseases( such as Down's syndrome, diabetes, Sickle cell anemia or nerve system disease)
* People has asthma Unstable that need emergency treatment, hospitalization, intubation, oral or intravenous corticosteroid in the past 2 years.
* Diagnosed abnormal coagulation(Lack of clotting factors,Clotting disorders,Platelet abnormality) or significant bruising or coagulopathy
* people has history or family history of convulsions, seizures, encephalopathy and psychiatric.
* alienia, functional asplenia, and alienia or splenectomy in any situation.
* Serious neurological disorders such as Green Barry syndrome.
* people who has received blood products or immunoglobulin products in the past one months.
* people who has received other study drug in the past one month.
* people who received live attenuated vaccine, subunit vaccine or inactivated vaccine.
* people who has received allergy treatment in in the past 14 days.
* People who is on anti-TB treatment.
* People whose axillary temperature is more than 37℃ before the vaccination.
* People who is pregnant.
* Any factors unsuitable for clinical trail according to the researchers.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
60 Years
Study:
NCT02806804
Study Brief:
Protocol Section:
NCT02806804