Rabies
Conditions
Interventions
Group 1:5 doses of experimental vaccine, 0,3,7,14,28
Group 2:Four doses of experimental vaccine were administered, 0,7,21
Group 3:5 doses of control vaccine, 0,3,7,14,28
Group 4:5 doses of experimental vaccine, 0,3,7,14,28
Group 5:Four doses of experimental vaccine were administered, 0,7,21
Sponsors
Hu'nan Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
10 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. aged 10-60 years old; 2. willing to participate in the study and sign the informed consent or informed statement; 3. the subject himself/herself or his/her guardian undertakes to comply with the requirements of the clinical study protocol; 4. Under arm temperature <=37.0 degree C.
Exclusion criteria
Exclusion criteria: 1. rabies vaccine immunization history or rabies virus passive immune preparation use history; 2. a history of injury to dogs or other mammals within 12 months prior to the first inoculation; 3. blood products used within 4 months before the first inoculation; 4. receive any vaccine within 14 days before the first dose; 5. have used other investigational or unregistered products (drugs or vaccines) within 1 month prior to the first inoculation, or plan to participate in other clinical studies after enrollment in this clinical study; 6. congenital or acquired immune deficiency. Receiving immunosuppressant therapy, such as long-term use (oral) of systemic glucocorticoid therapy (continuous use (oral) of systemic glucocorticoid therapy, such as prednisone or similar drugs); 7. having a family history of convulsion, epilepsy, encephalopathy and psychosis; 8. allergic to any ingredients in the vaccine (such as human albumin, disodium hydrogen phosphate, sodium dihydrogen phosphate, sodium chloride, sucrose, maltose, etc.); Severe allergic history, such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, and local allergic necrosis reaction (Arthus reaction); 9. any previous history of serious adverse reactions to vaccines or drugs, such as hives, skin eczema, dyspnea, angioedema, etc.; 10. acute febrile diseases (body temperature >=38.5 degree C) and infectious diseases within 3 days before vaccination; 11. congenital heart disease, developmental disorder or chronic disease, such as asthma, diabetes or thyroid disease; 12. urticaria within one year before the experimental vaccine is administered; 13. systolic blood pressure =160mmHg or diastolic blood pressure >100mmHg (with or without medication); 14. thrombocytopenia or other clotting disorders (which may contraindicate intramuscular injection); 15. women of child-bearing age have positive urine pregnancy test, or have a birth plan during pregnancy or lactation, or within 2 months; 16. any circumstances that the investigator considers likely to affect the evaluation of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positive conversion of antibody;Geometric Mean Concentration; | — |
Countries
China
Contacts
Public ContactLi Fangjun
Hu'nan Provincial Center for Disease Control and Prevention
Outcome results
None listed