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 @ 3:26 AM
Ignite Modification Date:
2025-12-25 @ 3:26 AM
NCT ID:
NCT00825305
Eligibility Criteria:
Inclusion Criteria:
* Male and female subjects 18-50 years of age who:
* are in good health at the time of entry into the study as determined by medical history, physical examination and clinical judgment of the investigator;
* volunteer for the simulated post-exposure vaccination courses and blood draws;
* have given a written informed consent; informed consent must be obtained for all the subjects before enrolment in the study;
* are available for all the visits scheduled in the study.
Exclusion Criteria:
* Subjects with the below criteria were excluded:
* pregnancy or unwillingness to practice acceptable contraception during participation in the study;
* a history of rabies immunization;
* a significant acute or chronic infectious disease that may impact the subject's safety and /or immunogenicity in the Investigators opinion at the time of enrolment;
* fever ≥ 38.0°C (axillary) or/and significant acute or chronic infection requiring systemic antibiotic or antiviral therapy within the past 7 days before enrolment;
* treatment with corticosteroids, immunosuppressive or antimalaria drugs during the two month period before enrolment;
* administration of any vaccine within the past 14 days before enrolment;
* known/suspected immunodeficiency, or autoimmune disease, or any immunologic disorder;
* history of allergy to egg protein;
* known hypersensitivity to neomycin, tetracycline, amphotericin-B, or any other vaccine component;
* treatment with parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 3 months;
* mental condition rendering the subject unable to understand the nature, scope and consequences of the study;
* participation in any other investigational trial within the past 3 months before enrolment;
* planned surgery during the study period;
* intention to leave the area of the study site before the end of study period;
* any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objective.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT00825305
Study Brief:
Protocol Section:
NCT00825305