RABV,Rabies virus
Conditions
Interventions
Four-dose group(Stage 2):Experimental vaccine
Four-dose group(Stage 2):Control vaccine
Five-dose group(Stage 2):Experimental vaccine
Five-dose group(Stage 2):Control vaccine
Four-dose group (Stage 1):Experimental vaccine
Five-dose group (Stage 1):Experimental vaccine
Sponsors
Hunan Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
10 Years to 60 Years
Inclusion criteria
Inclusion criteria: (1) The subjects and/or their guardians voluntarily agree to participate in the research and sign the adult informed consent form or the minor informed consent form (10 -17 years old and both themselves and their guardians are required to participate in informed consent and signature); (3) Subjects and/or their legal guardians have the ability to understand (non-literate) research procedures and participate in all planned follow-up visits; (4) Enrollment The axillary body temperature of people aged 14 and below on that day was <37.5 °C, and the axillary body temperature of people over 14 years old was <37.3 °C; (5) Female subjects of childbearing age were not breast-feeding or pregnant when they were enrolled (pre-inoculation (on the same day) urine pregnancy) Test negative), no pregnancy plan within 2 months after enrollment, agree to take effective contraceptive measures within 2 months after participating in the study.
Exclusion criteria
Exclusion criteria: (1) History of rabies vaccine immunization or use of rabies virus passive immunization preparations; (2) History of being bitten by mammals (such as dogs, cats, etc.) within 1 year before the first dose of vaccination (wound skin damage); (3) History of severe hypersensitivity to any vaccine component that requires medical intervention in previous vaccination (4) Acute febrile disease (armpit temperature>38.5?) or acute exacerbation of chronic disease within 3 days before vaccination, or taking antipyretic, analgesic, antiallergic drugs; (5) Before the first dose of vaccination Received blood/blood-related products or immune globulin within 3 months; or plan to use such products within 1 month after the last dose of vaccine; (6) Receive any vaccine within 14 days before the first dose of vaccine; ( 7) Asplenia or functional asplenia caused by any condition (such as splenectomy); (8) Has been diagnosed with congenital or acquired immunodeficiency (HIV), or received immunosuppressive therapy within 3 months (such as Long-term use of systemic glucocorticoids (=14 days, dose =20 mg/kg/day)); (9) Severe congenital malformations or autoimmune (hereditary) diseases, serious chronic diseases (including but not limited to: heart disease, kidney disease) , diabetes, hereditary allergy, Guillain-Barre syndrome, etc. with comorbidities), which may affect the research evaluation after evaluation by the investigator; (10) Those with a history or family history of convulsions, epilepsy, encephalopathy, and mental illness (including but not limited to Not limited to: congenital cerebral hypoplasia, traumatic brain injury, brain tumor, cerebral hemorrhage, cerebral nerve tissue damage caused by cerebral obstruction, infection, chemical poisoning, etc.); (11) There are contraindications to intramuscular injection (diagnosed as any coagulation disorder or receiving anticoagulant therapy); (12) participating in other research or unregistered product (drugs, vaccines or devices, etc.) clinical studies, or planning to participate in other clinical studies before the end of this clinical study; (13) ), in the opinion of the investigator, the subject has any condition that may interfere with the assessment of the purpose of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Antibody positive conversion rate;geometric mean concentration of antibodies;adverse event;Serious adverse event; | — |
Secondary
| Measure | Time frame |
|---|---|
| Antibody positive conversion rate;Geometric Mean Concentration ,GMC; | — |
Countries
China
Contacts
Public ContactFangjun Li
Hunan Provincial Center for Disease Control and Prevention
Outcome results
None listed