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 @ 5:06 AM
Ignite Modification Date:
2025-12-25 @ 5:06 AM
NCT ID:
NCT02014727
Eligibility Criteria:
Inclusion Criteria:
1. Age \> 20 and \< 45 years healthy female and male
2. General good health based on history and clinical examination.
3. Written informed consent obtained before any trial procedure.
4. Female and male volunteers practicing contraception before and up to four (4) weeks after the third vaccination.
5. Available to participate in follow-up for the duration of trial.
6. Reachable by phone during the whole trial period.
7. Volunteers should be affiliated to a social security regimen
Exclusion Criteria:
1. Positive pregnancy test
2. Active breast feeding
3. Previous participation in any malaria vaccine trial
4. History of blood transfusion within the last 6 months
5. Symptoms, physical signs or laboratory values suggestive of systemic disorders, including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric and other conditions, which could interfere with the interpretation of the trial results or compromise the health of the volunteers.
6. Any clinically significant laboratory abnormalities on screened blood samples outside the normal range, as defined at the clinical trial site.
7. Enrolment in any other clinical trial during the whole trial period
8. Intake of chronic medication, especially immunosuppressive agents (steroids, immunomodulating or immunosuppressive drugs) during the thirteen weeks preceding the screening visit or during the trial period except topical steroid use including intranasal.
9. Any confirmed or suspected immunosuppressive or immunodeficiency condition during the whole trial period
10. Volunteers unable to be closely followed for social, geographic or psychological reasons.
11. Previous history of drug or alcohol abuse interfering with normal social function during a period of one year prior to enrolment in the trial.
12. History of anaphylaxis or Known severe hypersensitivity to any of the vaccine components (adjuvant or antigen or excipient)
13. Vaccination or gamma globulin: 4 weeks prior and after each vaccination if a vaccination is necessary during this period, the volunteer will be withdrawn from the study.
14. Positive HIV, HBV (Ag HBS) and HCV tests.
15. History of malaria or travel in malaria endemic areas within the past twenty-six weeks.
16. Positive serology for malaria antigen PfAMA-1
17. Intention to travel to malaria endemic countries during the trial period.
\-
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
45 Years
Study:
NCT02014727
Study Brief:
Protocol Section:
NCT02014727