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 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT02509494
Eligibility Criteria:
Inclusion Criteria Stage 1 and 2:
* Documented community engagement from community leader and a signed inform consent form (ICF) from each participant must be available
* Participant Stage 1 must be 18 years or older at screening and be resident in selected study community with no intention to move from study area within the next 5 months
* Participant must be healthy with no abnormalities in laboratory screening tests within 28 days before Dose 1 vaccination
* Female participants of childbearing potential must use adequate birth control measures and must have a negative pregnancy test at screening and immediately prior to each study vaccination
* Participant must pass the test of understanding (TOU)
Additional Inclusion criteria Stage 2:
* One year or older at screening (children of enrolled parents are eligible)
* Parent/legal guardian (for children) must pass the TOU before signing the ICF
* Subjects aged 7 years and older will be asked to give positive assent in the presence of a witness
Exclusion Criteria:
* Diagnosed with EVD or under quarantine/exposed to Ebola or body temperature equal of \>= 38 degree Celsius (fever)
* Having an acute illness (mild in nature that can be treated at home) or any clinically significant acute/chronic medical condition or having a decreased number of red blood cells/hemoglobin in the blood (anemia)
* Previously participated in another Ebola interventional study or received any Ad26/MVA-based candidate vaccine
* Vaccinated with live attenuated vaccines within 30 days or with inactivated vaccines 15 days before Dose 1 vaccination
* Treated with an immunosuppressive drug at the time of screening
Additional exclusion criteria:
\- Children up to 5 years of age with severe malnutrition (underweight or Z-score weight \<2)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Year
Study:
NCT02509494
Study Brief:
Protocol Section:
NCT02509494