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 @ 5:37 PM
Ignite Modification Date:
2025-12-24 @ 5:37 PM
NCT ID:
NCT04852068
Eligibility Criteria:
Inclusion Criteria:
* Age 10-60 on the day of enrollment, able to provide legal identification
* Subjects and/or their guardians voluntarily agree to participate in the study and sign an adult informed consent form or a minor's informed consent form
* Subjects and/or their legal guardians have the ability to understand (non-illiterate) research procedures and participate in all planned follow-ups
* On the day of enrollment, the axillary body temperature of people aged 14 and under was \<37.5℃, and the axillary body temperature of people over 14 years of age was \<37.3℃
* Female subjects of childbearing age were not breast-feeding at the time of enrollment, were not pregnant (the urine pregnancy test was negative before vaccination (on the day)), had no pregnancy plan within 2 months after enrollment, and agreed to take effective measures within 2 months after enrolling in the study Contraceptive measures
Exclusion Criteria:
* Have a history of rabies vaccination or use of rabies virus passive immunization preparations
* A history of bites by mammals (such as dogs, cats, etc.) within 1 year before the first dose of vaccination (wound skin damage)
* Previous vaccination has a history of severe allergies to any vaccine component that requires medical intervention: such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis, severe urticaria, etc.
* Within 3 days before vaccination, acute febrile disease (body temperature under armpit\>38.5℃) or in the acute onset of chronic disease, or taking antipyretic, analgesic, and anti-allergic drugs
* Have received blood/blood-related products or immunoglobulins within 3 months before the first dose of vaccination; or plan to use such products within 1 month after the last dose of vaccination
* Get any vaccine within 14 days before the first dose of vaccination
* Any condition (such as splenectomy) caused asplenia or functional asplenia
* Has been diagnosed with congenital or acquired immunodeficiency (HIV), or received immunosuppressive therapy within 3 months
* Severe congenital malformations or autoimmune (hereditary) diseases, serious chronic diseases (including but not limited to: heart disease, kidney disease, diabetes with comorbidities, allergic constitution, Guillain-Barre syndrome, etc.), evaluated by the investigator that it may affect research evaluation
* People with a history or family history of convulsions, epilepsy, encephalopathy, and psychosis (including but not limited to: congenital brain hypoplasia, brain trauma, brain tumor, cerebral hemorrhage, cerebral obstruction, brain nerve tissue damage caused by infection, chemical drug poisoning, etc.)
* There are contraindications for intramuscular injection (diagnosed as any coagulation disorder or receiving anticoagulant treatment)
* Are participating in other research or unregistered products (drugs, vaccines or devices, etc.) clinical research, or plan to participate in other clinical research before the end of this clinical research
* The researcher believes that the subject has any conditions that may interfere with the evaluation of the research purpose
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
60 Years
Study:
NCT04852068
Study Brief:
Protocol Section:
NCT04852068