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 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT01973218
Eligibility Criteria:
Inclusion Criteria:
1. Adolescents 11-17 years of age inclusive who have given their written assent and whose parent or legal guardian has given written informed consent at the time of enrollment;
2. Available for all the visits scheduled in the study (i.e. not planning to leave the area before the end of the study period);
3. In good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator;
4. With a negative urine pregnancy test (for female subjects only).
Exclusion Criteria:
1. History of any meningococcal vaccine administration;
2. Current or previous, confirmed or suspected disease caused by N. meningitidis;
3. Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment;
4. Pregnancy or nursing (breastfeeding) mothers;
5. Female subjects who have not used or do not plan to use acceptable birth control measures, for the 2 months duration of the study;
6. Any serious chronic or progressive disease;
7. Family members and household members of research staff;
8. Any condition which in the opinion of the investigator may interfere with the evaluation of the study objectives;
9. Significant acute or chronic infection within the previous 7 days or fever within 3 days prior to enrolment;
10. Antibiotics within 6 days prior to enrollment;
11. Known or suspected impairment/alteration of the immune system, immunosuppressive therapy;
12. Receipt of blood, blood products and/or plasma derivatives, or a parenteral immunoglobulin preparation within the previous 90 days;
13. History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component;
14. Receipt of or intent to immunize with any other vaccine(s) within 30 days prior and throughout the study period;
15. Participation in another clinical trial within the last 90 days or planned for during study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
11 Years
Maximum Age:
17 Years
Study:
NCT01973218
Study Brief:
Protocol Section:
NCT01973218