rabies
Conditions
Interventions
Group 1 :rabies vaccine with 5 injections at day 0, 3, 7, 14, 28
Group 2:rabies vaccine with 4 injections at day 0 (twice a day), 7, 21
Group 3:rabies vaccine with 5 injections at day 0, 3, 7, 14, 28
Sponsors
Hubei Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
10 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Healthy permanent residents aged 10- 50 years; 2. Willing to participate in this trial and sign the informed consent form, adolescents aged 10-17 need to obtain the guardian's informed consent and sign the informed consent form in addition to themselves; 3. The subjects themselves and/or their guardians have the ability to understand the research procedures and participate in all planned follow-up visits; 4. Subjects has no history of rabies vaccine inoculation; 5. Females with fertility who are not pregnant or lactating; 6. Under arm body temperature before vaccination <= 37.0?; 7. Consent to take effective contraceptive measures, no pregnancy and childbearing plans (for women of childbearing potential) during the study period.
Exclusion criteria
Exclusion criteria: 1. Those with medical history of allergies, convulsions, epilepsy, mental and nervous system, or family history of epilepsy; 2. Those who are allergic to the main ingredients in the research vaccine; 3. Primary and secondary immunocompromised patients (history of thyroid, pancreas, liver, splenectomy, or treatment due to thyroid disease in the past 12 months); 4. Patients with armpit body temperature > 38.0°C due to acute febrile illness within three days; 5. Suffering from congenital malformations, developmental disorders or severe chronic diseases, severe cardiovascular diseases, diabetes, stable hypertension that cannot be controlled by drugs, liver and kidney diseases, malignant tumors, etc.; 6. Suffering from congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), juvenile rheumatoid arthritis (JRA), acute and chronic infectious diseases, Active infection, severe asthma, infectious skin disease, etc.; 7. History of abnormal coagulation function (such as coagulation factor deficiency, coagulation disease); 8. Inoculate other inactivated vaccines within 7 days before enrollment, and inoculate live attenuated vaccines within 14 days; 9. Long-term use of immunosuppressants or other immunomodulatory drugs (defined as continuous use for more than 14 days) within 3 months before enrollment, such as glucocorticoid dose >= 0.5 mg/kg/day (inhaled and topical glucocorticoids unrestricted); 10. Received blood or blood-related products 6 months before enrollment; 11. Are or plan to participate in other clinical research in the near future; 12. Any situation that the investigator believes may affect the evaluation of the trial. 13. Any serious adverse event causally related to vaccination; 14. Severe allergic reaction after vaccination; 15. Discovery of new cases that meet the "first dose exclusion criteria"; 16. Any situation that the investigator believes may affect the evaluation of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positive conversion of antibody;Geometric Mean Concentration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of serious adverse events;Incidence of solicited adverse events;Incidence of unsolicited adverse events; | — |
Countries
China
Contacts
Public ContactBeifang Yang
Hubei Provincial Center for Disease Control and Prevention
Outcome results
None listed