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 @ 3:44 AM
Ignite Modification Date:
2025-12-25 @ 3:44 AM
NCT ID:
NCT02680002
Eligibility Criteria:
Inclusion Criteria:
* Male or nonpregnant female
* Provide written informed consent prior to study-related procedures
* Stable health status
* Access to consistent and reliable means of telephone contact
* Able to understand and comply with planned study procedures
* Agree to stay in contact with site, and no plans to move from study area for study duration
Exclusion Criteria:
* Allergic to eggs, other vaccine components, or squalene-based adjuvants
* Women with positive pregnancy test within 24 hours of vaccination, or are breastfeeding
* Females of childbearing potential who refuse acceptable birth control, if sexually active, have not used birth control for 2 months prior to study entry
* Have immunosuppression or use anticancer chemotherapy or radiation therapy within preceding 36 months
* Have an active neoplastic disease or history of hematologic malignancy
* Have long term use (≥14 consecutive days) of glucocorticoids (\>20 mg/day) or high-dose inhaled steroids (\>800 mcg/day) within preceding 6 months
* Diagnosis of schizophrenia, bipolar disease, or major psychiatric diagnosis
* Have been hospitalized for psychiatric illness, attempted suicide or deemed danger to self or others within past 10 years
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
49 Years
Study:
NCT02680002
Study Brief:
Protocol Section:
NCT02680002