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 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
NCT ID:
NCT03964012
Eligibility Criteria:
Inclusion Criteria:
1. Male or non-pregnant female 2 through 29 years of age, inclusive, at the time of study IP administration.
2. Written informed consent obtained from subjects at least 18 years of age or from their parent/guardian for subjects less than 18 years of age with additional subject assent obtained as appropriate for participating community (i.e. subjects at least 13 years of age in Mali or at least 12 years of age in The Gambia).
3. Subject or parent/guardian with subject reside in study site area and are able and willing to adhere to all protocol visits and procedures.
4. Female subjects of childbearing potential must have practiced adequate contraception for 28 days prior to study IP administration and agree to continue adequate contraception until completion of their Day 29 visit.
5. Female subjects of childbearing potential must have a negative pregnancy test within 24 hours prior to study IP administration
Exclusion Criteria:
1. Acute illness, at the time of study IP administration (once acute illness is resolved, if appropriate, as per investigator assessment, subject may be re-revaluated for eligibility).
2. Recorded fever (for eligibility purpose defined as a body temperature greater than 37.5°C) within 3 days prior to study IP administration (once fever/acute illness is resolved, if appropriate, as per investigator assessment, subject may be re-revaluated for eligibility).
3. Previous immunization with a Neisseria meningitidis vaccine other than MenAfriVac® during the previous five years.
4. Current or previous, confirmed disease caused by Neisseria meningitidis.
5. Household contact with or intimate exposure to an individual with any laboratory confirmed Neisseria meningitidis infection within 90 days prior to study IP administration.
6. Known hypersensitivity to any component of the study IPs (i.e., NmCV-5 or Menactra®).
7. History of significant hypersensitivity reactions to any previous vaccine.
8. Administration of any vaccine other than study IPs within 28 days prior to study IP administration or planned administration prior to completion of the study Day 29 visit.
9. Administration of any investigational drug within 30 days prior to study IP administration or planned administration during the study period.
10. Unwilling to avoid (or their child to avoid, if the subject) the ingestion of herbal or other traditional medications during the study period.
11. Administration of immunoglobulin or any blood product within 90 days prior to study IP administration or planned administration during the study period.
12. Administration of immunosuppressants or other immune modifying agents within 90 days prior to study IP administration
13. Administration of systemic antibiotic treatment within 3 days prior to study IP administration.
14. Any history of or evidence for chronic clinically significant (as per investigator assessment) disorder or disease (including, but not limited to, immunodeficiency, autoimmunity, malnutrition, congenital abnormality, bleeding disorder, and pulmonary, cardiovascular, metabolic, neurologic, renal, or hepatic disease).
15. Any history of human immunodeficiency virus, chronic hepatitis B or chronic hepatitis C infections.
16. History of meningitis, seizures, Guillain-Barré syndrome (GBS), or other neurological disorders.
17. History of or family history of congenital or hereditary immunodeficiency.
18. Any condition that in the opinion of the investigator might compromise the safety or well-being of the subject or compromise adherence to protocol procedures or interfere with planned safety and immunogenicity assessments.
19. Pregnancy
20. Previous inclusion in the study of five immediate family members (i.e., biological father, mother, subject, and brothers and sisters may be included up to a maximum of five members from the same immediate family).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
29 Years
Study:
NCT03964012
Study Brief:
Protocol Section:
NCT03964012