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 @ 2:40 AM
Ignite Modification Date:
2025-12-25 @ 2:40 AM
NCT ID:
NCT04295733
Eligibility Criteria:
Inclusion Criteria:
* Males and females 18 through 65 years of age at the time of enrollment who are high risk for IMD, including subjects with documented medical history of any of the following criteria:
1. Hematopoietic Stem Celi Transplantation (allogenic or autologous stem celi transplant)
2. HIV infection
3. candidate for / in treatment (ongoing) with biological drugs such as monoclonal antibodies anti CD- 20 (rituximab or ocrelizumab)
* Written informed consent obtained from the subject (or legal representative).
* Subjects (or legal representative) who are able to comprehend all procedures and to comply with the study requirements
Exclusion Criteria:
* Subjects not able to understand and to adhere to ali study procedures
* Subjects aged \<18 or \>65 years
* Known or suspected allergy/hypersensitivity to any vaccine component
* History of serious adverse reaction to any vaccine
* Administration of immunoglobulins and/or any blood products within 3 months prior to enrollment or planned administration during the entire study period
* History of any meningococcal group B vaccination or having been diagnosed with meningococcal disease ever before
* Stem celi transplantation within 6 months before the enrollment to the study
* HIV-infected patients with detectable viral load (\>50 copies/mL) and/or CD4 celi count \< 200 cells/mm3 in the last 6 months
* Receipt of any vaccine within 28 (for live vaccines) or 14 (for no-live vaccines) days prior to study vaccination
* Planned vaccination (other than the study vaccination) during the entire study period
* Fever or any acute disease or infection within 3 days prior to vaccination
* Receipt of any antibiotics within 3 days before enrollment
* Coagulation disorder contraindicating intramuscular vaccination Any condition that in the opinion of the investigator would pose a health risk to the subject if enrolled or could interfere with the study procedures
* Current participation to another investigational study or planned enrollment to an investigational during the entire study period
* Planned surgery or hospitalization during the entire study period
* Subjects who participated in Cohort 1, 2 or 3, cannot be included in other different cohorts
* Pregnancy or breastfeeding (asking the woman to sign a declaration that she is not pregnant or breastfeeding).
* Any contraindication to the study vaccine (Bexsero®) as specified in the Summary of Product Characteristics.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04295733
Study Brief:
Protocol Section:
NCT04295733