Japanese Encephalitis
Conditions
Interventions
0, 7-day immunization program: experimental group:Experimental vaccine
0, 7-day immunization program: control group:Control vaccine
0, 28-day immunization program:Experimental vaccine
Sponsors
Jiangsu Provincial Center for Disease Control and Prevention,
Eligibility
Sex/Gender
All
Age
6 Months to 11 Months
Inclusion criteria
Inclusion criteria: 1.Healthy infants aged 6 to 11 months. 2. Never received JE vaccine. 3. Subjects eligible for immunization with this product after medical history, physical examination and clinical judgment of health. 4. Obtain the informed consent of the subject's guardian and sign the informed consent. 5. Subject guardians can comply with the requirements of the clinical trial protocol according to the opinion of the investigator. 6. Armpit body temperature =37.0?.
Exclusion criteria
Exclusion criteria: 1. People with a history or family history of allergies, convulsions, epilepsy, encephalopathy and psychosis. 2. People who are allergic to any component of the investigational vaccine. 3. Known immune function impairment or low. 4. Patients who have suffered from JE disease. 5. Acute febrile diseases and infectious diseases. 6. Congenital malformations, developmental disorders or serious chronic diseases. 7. Patients with thrombocytopenia or other clotting disorders may cause contraindications of subcutaneous injection. 8. Had more severe allergic reactions in the past. 9. Others (such as blood collection difficulties), etc. 10. Immunosuppressive therapy, anti-allergy therapy, cytotoxic therapy, inhalation corticosteroids (excluding corticosteroid spray therapy for allergic rhinitis and surface corticosteroid therapy for acute non-concurrent dermatitis) in the past 6 months. 11. Received blood products within 3 months prior to receiving the experimental vaccine. 12. Received other investigational drugs within 30 days prior to receiving the experimental vaccine. 13. Immunoglobulin was injected within 30 days prior to receiving the trial vaccine. 14. Received live attenuated vaccine within 14 days prior to receiving the experimental vaccine. 15. Received subunit or inactivated vaccine within 7 days prior to receiving the experimental vaccine. 16. Infected persons who have had any acute illness in the past 7 days that requires systemic antibiotic or antiviral treatment. 17. Had fever (armpit temperature =38 ° C) in the past 3 days. 18. Medical, psychological, social, or other conditions that, in the investigator's judgment, are inconsistent with the protocol or affect the subject's guardian to sign the informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positive conversion rate of serum JE neutralizing antibody; | — |
Secondary
| Measure | Time frame |
|---|---|
| Positive conversion rate of serum JE neutralizing antibody;Positive conversion rate of serum JE neutralizing antibody; | — |
Countries
China
Contacts
Public ContactHong Tao
Jiangsu Provincial Center for Disease Control and Prevention
Outcome results
None listed