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 @ 10:41 PM
Ignite Modification Date:
2025-12-24 @ 10:41 PM
NCT ID:
NCT00700635
Eligibility Criteria:
Inclusion Criteria :
* Aged 2 to \< 11 years on the day of inclusion.
* Provision of assent form signed by the subject (depending on age) and informed consent form signed by the parent(s) or another legally acceptable representative.
* Subject and parent/legal guardian able to attend all scheduled visits and comply with all trial procedures.
Exclusion Criteria :
* Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine.
* Participation in the active (i.e., treatment) portion of another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination.
* Planned participation in another clinical trial during the present trial period.
* Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy.
* Suspected or known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a product containing any of the substances present in the study vaccine .
* Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
* Receipt of blood or blood-derived products in the past 3 months.
* Received any vaccine (other than desensitization therapy for allergies or influenza vaccine within 2 weeks before vaccination) in the 4 weeks preceding the first trial vaccination.
* Planned receipt of any vaccine within the 4 weeks following any trial vaccination(s).
* Known human immunodeficiency virus (HIV), hepatitis B surface antigen (HBs antigen), or hepatitis C seropositivity.
* History of invasive meningococcal infection (confirmed either clinically, serologically, or microbiologically).
* Thrombocytopenia, coagulation disorder, or anticoagulant use in the 3 weeks preceding inclusion contraindicating intramuscular (IM) vaccination.
* Anticipated to receive oral or injected antibiotic therapy within the 72 hours prior to any of the trial blood draws.
* Personal or family history of Guillain-Barré Syndrome (GBS).
* Any condition which, in the opinion of the Investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
10 Years
Study:
NCT00700635
Study Brief:
Protocol Section:
NCT00700635