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:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2025-12-24 @ 1:12 PM
NCT ID:
NCT03368495
Eligibility Criteria:
Inclusion Criteria:
* Age 12 to 24 months at the time of enrollment
* Healthy child, determined by clinical history
* Availability to do study visits and blood sampling on days 28 + 7 and 56 + 14
* Informed consent signed by parents
Exclusion Criteria:
* Previous vaccination against yellow fever, measles, mumps, or rubella
* History of yellow fever, measles, mumps or rubella
* Contraindication for any of the study vaccines: yellow fever vaccine or triple viral vaccine, including:
1. Allergy to eggs, gelatin, or neomycin
2. Weakened immunological function, including HIV infection, primary immunodeficiencies, having received immunosuppressive doses of oral or injectable corticosteroids (or equivalent), having received immunomodulators or chemotherapeutic agents
3. Thymus disease
4. Serious illness/fever (mild illness without fever is not an exclusion criterion)
* Administration of immunoglobulins or other blood derivative within 6 months of enrollment in the study or during the study
a. Exception: children with a history of Kawasaki disease who received gammaglobulin cannot be enrolled if they received it in the previous 11 months.
* Administration of any other attenuated viral vaccine (i.e., for chickenpox) in the month prior to enrollment, or if the administration of any other attenuated viral vaccine is expected during the study (up to 3 months)
* Not being available for the entire study period (up to 3 months), or not able to make the scheduled visits or complete the study procedures
* Participating in another clinical drug trial of a drug, vaccine, or medical device
* Any condition that, in opinion of the study staff, represents a health risk to the participant or interferes with the evaluation of the response to the vaccine (i.e., children in percentile ≤ 3 in the height/weight tables will be considered undernourished and cannot be selected)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Months
Maximum Age:
24 Months
Study:
NCT03368495
Study Brief:
Protocol Section:
NCT03368495