A Clinical Trial of Freeze-dried Human Rabies Vaccine (MRC-5 Cells)
Rabies Vaccine Adverse Reaction
About this trial
This is an interventional prevention trial for Rabies Vaccine Adverse Reaction focused on measuring Safety, Efficacy
Eligibility Criteria
Inclusion Criteria: Age range from 10 to 60 years old; Willing to participate in this experiment and sign an informed consent or notification form; The subjects themselves or/and their guardians promise to comply with the requirements of the clinical research protocol; Under the age of 14 (including 14 years old), the axillary body temperature is less than 37.5 ℃, and above the age of 14, the axillary body temperature is less than 37.3 ℃ Exclusion Criteria: Have a history of rabies vaccine immunization or use of rabies virus passive immunity preparations; Have a history of injury to dogs or other mammals within 12 months prior to the first vaccination; Have used blood products within 4 months before the first vaccination; Inoculate any vaccine within 14 days before the first vaccination; Have used other research or unregistered products (drugs or vaccines) within one month before the first vaccination, or have planned to participate in other clinical studies after enrollment in this clinical study; Suffering from congenital or acquired immune deficiency. Receiving immunosuppressive therapy, such as long-term (oral) systemic glucocorticoid therapy (continuous (oral) systemic glucocorticoid therapy for more than 2 weeks, such as prednisone or similar drugs); Have a history of convulsion, epilepsy, encephalopathy, psychosis or family history; Allergic to any component in the study vaccine (such as human albumin, disodium hydrogen phosphate, sodium dihydrogen phosphate, sodium chloride, sucrose, maltose, etc.); Have a history of severe allergies, such as allergic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, and local allergic necrosis reaction (Arthur reaction); Have any previous history of serious side effects from vaccines or drugs, such as urticaria, skin eczema, respiratory difficulties, vascular and neurological edema, etc; Individuals with acute febrile diseases (body temperature ≥ 38.5 ℃) and infectious diseases within 3 days before vaccination; Having congenital heart disease, developmental disorder or chronic disease, such as asthma, diabetes, thyroid disease; Suffering from urticaria within one year before receiving the experimental vaccine; Blood pressure: systolic blood pressure ≥ 160mmHg or diastolic blood pressure ≥ 100mmHg (regardless of medication); Suffering from thrombocytopenia or other coagulation disorders (which may cause contraindications for intramuscular injection); Women of childbearing age who have a positive urine pregnancy test, or have a fertility plan during pregnancy, lactation, or within 2 months; Any situation that the researcher believes may affect the evaluation of the experiment
Sites / Locations
- Hunan Provincial Center for Disease Control and Prevention
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Active Comparator
Active Comparator
Investigational Vaccine - 5-dose program
Investigational Vaccine - 4-dose program
Control vaccine - 5-dose program
Control vaccine - 4-dose program
Freeze-dried human rabies vaccine (MRC-5 cells), 1.0 ml after reconstitution, with a titer of not less than 5.24 IU, Anhui Zhifeilongkoma Biopharmaceutical Co., Ltd.
Freeze-dried human rabies vaccine (MRC-5 cells), 1.0 ml after reconstitution, with a titer of not less than 5.24 IU, Anhui Zhifeilongkoma Biopharmaceutical Co., Ltd.
Freeze-dried human rabies vaccine (MRC-5 cells), 1.0 ml after reconstitution, with a titer of not less than 4.57 IU, ,Chengdu Kanghua Biological Products Co., Ltd
Freeze-dried human rabies vaccine (MRC-5 cells), 1.0 ml after reconstitution, with a titer of not less than 4.57 IU, ,Chengdu Kanghua Biological Products Co., Ltd