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 @ 12:26 AM
Ignite Modification Date:
2025-12-25 @ 12:26 AM
NCT ID:
NCT00320658
Eligibility Criteria:
Inclusion Criteria:
* Good general health
* Willing to be followed for the duration of the study
* Willing to use acceptable methods of contraception
Exclusion Criteria:
* Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, may affect the ability of the volunteer to understand and cooperate with the study
* Liver disease (ALT greater than upper limit of normal \[ULN\])
* Kidney disease (serum creatinine greater than ULN)
* Hematologic disease (absolute neutrophil count of less than 1,500 cells/mm3; hemoglobin less than lower limit of normal, by sex; OR platelet count less than 140,000 mm3)
* Clinically significant neurologic, heart, lung, liver, rheumatologic, autoimmune, or kidney disease
* Participation in another investigational vaccine or drug trial within 30 days of study entry or while this study is ongoing
* Active drug or alcohol abuse causing medical, occupational, or family problems during the 12 months prior to study entry
* History of severe allergic reaction or anaphylaxis
* HIV-1 infected
* Hepatitis C virus infected
* Hepatitis B surface antigen positive
* Known immunodeficiency syndrome
* Use of corticosteroids or immunosuppressive drugs within 30 days prior to study entry. Participants who have used topical or nasal corticosteroids are not excluded.
* Live vaccine within 4 weeks prior to study entry
* Killed vaccine within 2 weeks prior to study entry
* Blood products within 6 months prior to study entry
* Absence of spleen
* Previously received an investigational malaria vaccine
* Received antimalarial prophylaxis during the 12 months prior to study entry
* Received chloroquine or other aminoquinolines within 12 weeks of study entry
* Prior malaria infection
* Known allergy to nickel
* Pre-existing autoimmune or antibody-mediated disease. More information about this criterion can be found in the protocol.
* Any medical, psychiatric, social, or occupational condition or other responsibility that, in the opinion of the investigator, would interfere with the study
* Other condition that, in the opinion of the investigator, would affect the volunteer's participation in the study
* Pregnancy or breastfeeding
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT00320658
Study Brief:
Protocol Section:
NCT00320658