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 @ 7:19 PM
Ignite Modification Date:
2025-12-24 @ 7:19 PM
NCT ID:
NCT00755703
Eligibility Criteria:
Inclusion Criteria:
* Healthy males and females in good general health, 19-49 years of age
* Subjects must provide written consent
* Willing to participate through study completion
* Willing to undergo nasal washes and swabs and provide urine and blood samples per protocol for safety and immunogenicity analysis
* Female of child-bearing age must have a negative urine pregnancy test and be stable on a reliable means of contraception.
* Meet screening criteria for hematology, chemistry and urinalysis
Exclusion Criteria:
* Pregnant (or possibly pregnant) and lactating women
* Any flu/cold symptoms and/or fever greater than 101 degrees in 3 days prior to study enrollment
* Any intranasal steroid medication administered in the 10 days prior to study enrollment
* History of chronic rhinitis or presence of pre-existing nasal septal defects, nasal polyps or other gross abnormalities
* Any previous nasal cautery or significant surgery for nasal septal defects
* Any regular past or current use of intranasal illicit drugs or history of intravenous illicit drug use
* Asthma that is greater than mild in severity
* Diagnosed active Hepatitis B or C
* HIV positive at screening
* Known or suspected malignancy, leukemia, or lymphoma
* Immunosuppressed, altered or compromised immune status as a consequence of disease or treatment with systemic corticosteroids
* Receipt of an influenza vaccine within the past 6 months
* Receipt of any vaccine in the past 30 days
* Receipt of any investigational drug in the past 30 days
* Known Diabetes mellitus
* History of anaphylaxis or angioedema
* Hypertension that is not well controlled
* Any medical, psychiatric, or social condition, or occupational or other responsibility that, in the judgment of the investigator would serve to interfere or serve as a contraindication to, protocol adherence, assessment of safety or reactogenicity, or a participants's ability to give informed consent
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
49 Years
Study:
NCT00755703
Study Brief:
Protocol Section:
NCT00755703