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 @ 4:27 AM
Ignite Modification Date:
2025-12-25 @ 4:27 AM
NCT ID:
NCT02613520
Eligibility Criteria:
Inclusion Criteria:
* Healthy males and females, based on clinical and laboratory findings
* From the age 6 months to 45 years
* Adults with a Body Mass Index (BMI) 18 to 30 Kg/m2; or adolescents, children and infants with Z-score of the selected indicator (\[weight-for-height\], \[(height and BMI) for age\]) category within ±2SD as detailed in protocol
* Long term (at least one year) or permanent residence in the Bagamoyo town or nearby villages
* Agreement to release medical information and to inform the study doctor concerning contraindications for participation in the study
* Willingness to be attended to by a study clinician and take all necessary medications prescribed during study period
* Agreement to provide contact information of a third party household member or close friend to study team
* Availability through mobile phone 24 hours during the entire study period
* Agreement not to participate in another clinical trial during the study period
* Agreement not to donate blood during the study period
* Able and willing to complete the study visit schedule over the study follow up period, including the hospitalizations required for protocol compliance
* Willingness to undergo HIV, hepatitis B (HBV) and hepatitis C (HCV) tests
* Volunteer (subjects 18 years of age and older) and parent or guardian signing informed consent (for subjects \<18 years of age) is able to demonstrate their understanding of the study by responding correctly to 10 out of 10 true/false statements (in a maximum of two attempts for those who failed to respond correctly to all true/false statements in the first attempt)
* Signed written informed consent, in accordance with local practice, provided by adult volunteers, parents or legal representatives and relevant assent for children participants as applicable
* Free from malaria parasitaemia by blood smear at enrolment
* Free from helminth infections at enrolment, or diagnosed with helminthes and treated appropriately to eliminate infestation
* Female volunteers aged 9 years and above must be non-pregnant (as demonstrated by a negative serum pregnancy test), and provide consent / assent of their willingness to take protocol-defined measures not to become pregnant during the study and safety follow-up period
Exclusion Criteria:
* Previous receipt of an investigational malaria vaccine or drug in the last 5 years
* Participation in any other clinical study involving investigational medicinal products within 30 days prior to the onset of the study or during the study period
* History of arrhythmias or prolonged QT-interval or other cardiac disease, or Clinically significant abnormalities in electrocardiogram (ECG) at screening
* Positive family history in a 1st or 2nd degree relative for cardiac disease at age \<50 years old
* A history of psychiatric disease
* Suffering from any chronic illness including; diabetes mellitus, cancer or HIV/AIDS
* Any confirmed or suspected immunosuppressive or immune-deficient condition, including asplenia
* History of drug or alcohol abuse interfering with normal social function
* The use of chronic immunosuppressive drugs or other immune modifying drugs within three months of study onset (inhaled and topical corticosteroids are allowed) and during the study period
* Any clinically significant deviation from the normal range in biochemistry or hematology blood tests or in urine analysis
* Positive HIV, hepatitis B virus or hepatitis C virus tests
* Volunteers who are suspected as having clinically active TB by history or physical examination with positive QuantiFERON-TB Gold Test In-Tube assay
* Symptoms, physical signs and laboratory values suggestive of systemic disorders including renal, hepatic, blood, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric, and other conditions which could interfere with the interpretation of the study results or compromise the health of the volunteers
* Any medical, social condition, or occupational reason that, in the judgment of the investigator, is a contraindication to protocol participation or impairs the volunteer's ability to give informed consent, increases the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
45 Years
Study:
NCT02613520
Study Brief:
Protocol Section:
NCT02613520