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 @ 9:59 PM
Ignite Modification Date:
2025-12-24 @ 9:59 PM
NCT ID:
NCT03293732
Eligibility Criteria:
Inclusion Criteria:
1. Non-smoking adult aged between 20-40 years old;
2. Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, chest X-rays, ophthalmoscopy, cardiac echo, and electrocardiogram;
3. Body Mass Index (BMI) between 18.5 and 25, inclusive, (BMI will be calculated as weight in kilogram \[kg\]/height in meters2 \[m2\]);
4. Normal hematology, biochemistry and urinalysis determinations;
5. Subject is willing and able to comply with study procedures and sign informed consent
Exclusion Criteria:
1. Subject with serious underlying chronic illness;
2. Documented evidence of allergic rhinitis;
3. Subject with acute sinusitis or chronic sinusitis accompanying acute symptoms within 3 days prior to enrollment;
4. Immunosuppressed subjects as result of illness or treatment;
5. Female subject of childbearing potential who:
* is lactating; or
* has positive urine pregnancy test at Visit 2 or Visit 3; or
* refuse to adopt reliable method of contraception during the study;
6. Subject received blood products or immunoglobulin within 3 months prior enrollment;
7. Subjects with long-term use of steroids, including parenteral steroids or high dose inhaled steroids within 28 days prior to enrollment;
8. Subject has received any intranasal medication or nasal topical treatment within 7 days prior to enrollment;
9. Subject has received any investigational agent within 28 days or 5 half- lives, whichever is longer, prior to the first dose of investigational product;
10. Subject has previously experienced anaphylaxis;
11. Subject has allergy to eggs or prior influenza vaccine;
12. Subject with laboratory-confirmed influenza or has been vaccinated against influenza within 6 months prior to enrollment;
13. Subject with acute respiratory illness or administered antibiotics or antivirals within 7 days prior to enrollment;
14. Subject with body temperature high than 38°C within 3 days prior to enrollment;
15. Subject with documented history of Bell's palsy or neurological disorder.
16. Subject with documented history of diarrhea within one month prior to study enrollment
17. A positive test for HIV antibody.
18. Subject has received Chinese medication or herbal medication within 28 days prior to enrollment
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
40 Years
Study:
NCT03293732
Study Brief:
Protocol Section:
NCT03293732