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 @ 1:59 PM
Ignite Modification Date:
2025-12-24 @ 1:59 PM
NCT ID:
NCT00994695
Eligibility Criteria:
Inclusion Criteria:
1. Age between 2-29 years, both sexes, living in the selected villages of Butajira area
2. A written informed consent signed by the individual (\>=18y) or caretaker/guardian (2 to 17 years of age) as 18 is the legal age of maturity in Ethiopia. Assent from children/adolescents aged 12-17 years old.
3. Free of obvious health problems ascertained by medical history and clinical examination on the day of enrolment
Exclusion Criteria:
1. Those who are unlikely to complete the follow up at 4-weeks post-vaccination.
2. Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
3. Administration of blood transfusion within 2 years prior to enrolment or planned use during the study period.
4. Verbal report of previous vaccination with meningococcal serogroup A, C, Y or W135 vaccines since 1999.
5. Confirmed or suspected immunosuppressive or immunodeficient condition including HIV infection.
6. A family history of congenital or hereditary immunodeficiency.
7. History of allergic reaction to any component of the vaccine
8. Presence of any fever (defined as axillary temperature of 37.5 degree centigrade or more) and/or severe illness on the day of enrolment/ vaccination.
9. Pregnancy.
10. lactation
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
29 Years
Study:
NCT00994695
Study Brief:
Protocol Section:
NCT00994695