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 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 12:02 AM
NCT ID:
NCT01226758
Eligibility Criteria:
Inclusion Criteria:
* General good health determined by a screening evaluation ≤120 days prior to IMP administration and on the day of admittance to quarantine
* Using methods of contraception, (e.g. spermicidal gel plus condom) for the entire duration of the study, up to the Study Completion visit, and refrain from fathering a child in the three months following study drug administration.
* Negative HIV, hepatitis B and C antibody screens
* Negative class A drugs, alcohol and nicotine screen
* Seronegative (≤10 HAI) for challenge virus
* Have not been vaccinated for influenza virus since 2006 (as determined in the medical history) or had a known influenza-like illness in the current season, defined as in the last 12 months
Exclusion Criteria:
* Presence of any significant acute or chronic, uncontrolled medical or psychiatric illness, including but not exclusive to the conditions listed in Appendix 2, that in the view of the Investigator is associated with increased risk of complications of respiratory viral illness
* Abnormal pulmonary function as evidenced by clinically significant abnormalities in spirometry
* Presence of household member or close contact who is: less than 3 years of age; known immunodeficient; receiving immunosuppressants; undergoing/soon to undergo chemotherapy; diagnosed with emphysema or COPD; is elderly residing in a nursing home; severe lung disease or medical condition; received a transplant (bone marrow or solid organ)
* History of asthma, COPD, pulmonary hypertension, reactive airway disease, or any chronic lung condition of any aetiology
* Any laboratory test or ECG which is abnormal and deemed by the investigator to be clinically significant
* Venous access inadequate for phlebotomy demands
* Regular daily smokers during the 6 months prior to study entry or those who have a significant history of any tobacco use at any time
* Subject is diabetic
* History or evidence of autoimmune disease or known impaired immune responsiveness
* Recent and/or recurrent history of autonomic dysfunction
* Receipt of systemic glucocorticoids, antiviral drugs, immunoglobulins or blood transfusions within 1 month, or any other cytotoxic or immunosuppressive drug within 6 months prior to vaccination. Receipt of any systemic chemotherapy agent at any time
* Presence of any febrile illness or symptoms of upper or lower tract respiratory infection in the 28 days prior to viral inoculation
* Any anatomic or neurological abnormality impairing the gag reflex or associated with an increased risk of aspiration, or history suggestive of such a problem or any abnormality significantly altering the anatomy of the nose or nasopharynx
* Known IgA deficiency, immotile cilia syndrome, or Kartagener's syndrome
* Nasal or sinus surgery within 30 days prior to vaccination
* Significant history of seasonal hay fever or a seasonal allergic rhinitis (SAR), or perennial allergic rhinitis (PAR), or chronic nasal or sinus condition
* Acute and/or chronic use of any medication or other product for symptoms of rhinitis or nasal congestion or for any chronic nasopharyngeal complaint, or chronic use of any intranasal medication for any indication
* Use of any prescription drugs, herbal supplements, within 4 weeks prior to vaccine administration
* Receipt of any investigational drug within 3 months, or prior participation in a clinical trial of any influenza vaccine, medication or experimental Influenza viral challenge delivered directly to the respiratory tract within 1 year
* Previous exposure to the IMP or similar substance
* History of multiple and recurring allergies and/or adverse reaction to any components of the IMP and challenge virus preparation
* History of allergy or intolerance to the following drugs: oseltamivir or zanamivir.
* Allergic to gentamicin
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT01226758
Study Brief:
Protocol Section:
NCT01226758