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 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
NCT ID:
NCT01360112
Eligibility Criteria:
* INCLUSION CRITERIA:
All of the following criteria must be fulfilled for a volunteer to participate in the study:
1. Age between 3 months and 50 years, inclusive
2. Good general health as a result of review of medical history and/or clinical testing at the time of screening
3. Available for the duration of the study (1 year)
4. Willingness to participate in the study as evidenced by signing the informed consent document, or by fingerprinting the consent document with the signature of a witness
5. Known resident of the village of the study
6. Willingness to allow stored laboratory specimens to be used for future research.
7. In addition to the above criteria, the expanded adult cohort must be willing to consider participation in a future malaria vaccine trial.
EXCLUSION CRITERIA:
A volunteer will be excluded from participating in this study if any one of the following criteria is fulfilled:
1. Pregnancy as determined by history or a positive urine Beta-hCG test at any point during the study.
2. Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the subject to understand and cooperate with the study protocol.
3. Other condition that, in the opinion of the investigator, would jeopardize the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol.
4. Participation in another investigational vaccine or drug trial while this study is ongoing.
5. Previous receipt of experimental malaria vaccine.
6. Baseline hemoglobin \< 8.5 g/dL
In addition to above criteria, a volunteer will be excluded from participating in the transmission blocking assay part of the study if the following criteria is fulfilled:
7. History of reactions to mosquito bites with severe itching or swelling, or lasting longer than 3 days
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
3 Months
Maximum Age:
50 Years
Study:
NCT01360112
Study Brief:
Protocol Section:
NCT01360112