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:
2025-12-26 @ 10:16 PM
Ignite Modification Date:
2025-12-26 @ 10:16 PM
NCT ID:
NCT02119312
Eligibility Criteria:
Inclusion Criteria:
* Good general health status as demonstrated by medical history, physical exam, and screening laboratory tests;
* No history of certain chronic medical illnesses (e.g. diabetes, epilepsy, autoimmune disease, hepatitis, heart disease);
* HIV, Hepatitis B and C negative;
* Low risk for coronary heart disease;
* Ability and willingness to provide informed consent;
* Reliable access to the MCTC and associated sites; and
* If participant is biologically female she must not be pregnant and must agree to consistently use an effective form of birth control 21 days prior to enrollment in an active clinical study and for the duration of that study.
Exclusion Criteria:
* Prior receipt of an investigational malaria vaccine;
* Chronic use of systemic antibiotics or immunosuppressive medications with anti-malarial effects;
* Chronic medical condition, physical examination findings, other clinically significant abnormal laboratory results, or past medical history that may have clinically significant implications for current health status;
* History of systemic anaphylaxis;
* History of, or known active cardiac disease;
* Elevated (moderate of high) risk of coronary heart disease;
* Clinically significant ECG findings;
* Chronic or active neurological disease;
* History of splenectomy or functional asplenia;
* History of psoriasis or porphyria;
* History of diagnosed ocular disease;
* Positive history of HIV, Hepatitis B and/or C;
* Pregnant or lactating females or females who intend to become pregnant during study period;
* Certain psychiatric conditions that could affect study compliance; and
* Suspected or known current alcohol and/or drug abuse.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT02119312
Study Brief:
Protocol Section:
NCT02119312