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 @ 4:14 PM
Ignite Modification Date:
2025-12-24 @ 4:14 PM
NCT ID:
NCT01782066
Eligibility Criteria:
Inclusion Criteria:
Meningococcal C naive subjects are required to fulfill all of the following criteria:
* Age ≥ 30 years
* Good health according to the investigator
* Willingness and ability to adhere to the study regimen
* Able to give informed consent
Meningococcal C experienced subjects are required to fulfill all of the following criteria:
* Age ≥ 18 years
* Good health according to the investigator
* Willingness and ability to adhere to the study regimen
* Able to give informed consent
Exclusion Criteria:
Meningococcal C naïve subjects should not have:
* Known previous invasive meningococcal infection
* Known or suspected previous vaccination against meningococcal disease
* Known or suspected allergy against any of the vaccine components
* Close contact in the last 60 days with a person known to be Neisseria positive
* History of unusual or severe reactions to any previous vaccination
* Family history of Guillain-Barré Syndrome
* Known or suspected immune deficiency, either congenital or acquired
* Administration of plasma or blood products less than three months prior to inclusion in the study
* Pregnancy (breastfeeding is allowed)
* Fertile female not conforming to prescribed contraceptive use (await first menstruation after vaccination before getting pregnant)
* Any infectious disease
* Bleeding disorders or use of anticoagulants
* Participation as a subject in another trial in the last 3 months
Meningococcal C experienced subjects should not have:
* Known or suspected allergy against any of the vaccine components
* Known previous vaccination with a quadrivalent meningococcal vaccine (either conjugate or polysaccharide)
* Close contact in the last 60 days with a person known to be Neisseria positive
* History of unusual or severe reactions to any previous vaccination
* Family history of Guillain-Barré Syndrome
* Known or suspected immune deficiency, either congenital or acquired
* Administration of plasma or blood products less than three months prior to inclusion in the study
* Pregnancy (breastfeeding is allowed)
* Fertile female not conforming to prescribed contraceptive use (await first menstruation after vaccination before getting pregnant)
* Any infectious disease
* Bleeding disorders or use of anticoagulants
* Participation as a subject in another trial in the last 3 months
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01782066
Study Brief:
Protocol Section:
NCT01782066