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 @ 3:45 AM
Ignite Modification Date:
2025-12-25 @ 3:45 AM
NCT ID:
NCT02503202
Eligibility Criteria:
Inclusion Criteria:
* Not of reproductive potential, or of reproductive potential and agrees to avoid becoming pregnant or impregnating a partner for 2 months following study vaccination.
Exclusion Criteria:
* Is currently participating in or has participated in an interventional clinical trial with an investigational compound or device within 90 days of participation in this trial.
* Has previously been randomized in another clinical trial and received V920 or any other Ebola vaccine.
* Has been exposed to Ebola virus at any time prior to study entry.
* Is pregnant or breastfeeding or plans to conceive within 2 months following study vaccination.
* Has direct household exposure to a pregnant or lactating woman at the time of participation in this trial.
* Has had a fever (≥100.5ºF/38.0ºC) within 48 hours prior to study entry.
* Has received systemic corticosteroids (equivalent of ≥2 mg/kg total daily dose of prednisone or ≥20 mg/day for persons weighing \>10 kg) for ≥14 consecutive days and has not completed treatment at least 30 days prior to study entry.
* Has received systemic corticosteroids exceeding physiologic replacement doses (\~5 mg/day prednisone equivalent) within 14 days prior to study entry.
* Has received any live virus vaccine within 30 days prior to study entry or any other (nonlive virus) vaccine within 14 days prior to study entry.
* Has known or suspected impairment of immunological function (e.g., HIV positive).
* Has direct household exposure to a person with known or suspected impairment of immunological function (e.g., HIV positive).
* Has a clinically significant history of intravenous (IV) drug abuse within 12 months prior to study entry.
* Has a known allergy/sensitivity or contraindication to investigational product(s) or its/their excipients (e.g., albumin).
* Has a history of malignancy \<=5 years prior to study entry except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
* Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is investigational site or sponsor staff directly involved with this trial.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02503202
Study Brief:
Protocol Section:
NCT02503202