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 @ 9:31 PM
Ignite Modification Date:
2025-12-24 @ 9:31 PM
NCT ID:
NCT02569632
Eligibility Criteria:
Inclusion Criteria:
* Adults in the following risk groups: physicians, nurses, respiratory therapists, microbiology laboratory personnel working at UCSF Benioff Children's Hospital Oakland or the University of Massachusetts Medical School as well as medical students attending accredited U.S. medical schools
* Able to comprehend and follow all required study procedures
* In good health as determined by a brief medical history
* For females of child bearing age a negative urine pregnancy test will be required
Exclusion Criteria:
* Are not in the risk groups summarized above
* Have not given or are unable to give written informed consent to participate in the study
* Females of child bearing potential who are pregnant, or planning on becoming pregnant during the study period.
* Persons with a past history of having Guillain-Barré Syndrome (GBS), or a family history of GBS in a parent or sibling.
* Persons with presence or suspected presence of serious chronic disease including but not limited to: chronic cardiac disease, autoimmune disease, diabetes, hepatitis B/C, HIV, progressive neurological disease or seizure, leukemia, lymphomas, or neoplasm.
* Have participated in any other investigational drug or received any other vaccine within the last 30 days.
* Received a dose of a meningococcal serogroups A, C, Y, W conjugate vaccine within the previous 30 days or wish to receive a dose of this vaccine during the six month study period.
* Have a history of anaphylactic shock, asthma, urticaria or other allergic reaction after previous dose of Trumenba
* Have experienced fever (oral temperature above 38.0°C) within the past 3 days or are suffering from a present acute infectious disease
* Are planning to leave the area of the study site before the end of the study period
* Have obesity (BMI higher than 33); or 11.
* With any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02569632
Study Brief:
Protocol Section:
NCT02569632