preventing varicella
Conditions
Interventions
A1:The subjects aged from 18 to 59 years were vaccinated according to 0 and 42 days immunization program
A2:The subjects aged from 18 to 59 years were vaccinated with control vaccine 2 according to 0 and 42 days immunization program
B1:The subjects aged from 13 to 17 years were vaccinated according to 0 and 42 days immunization program
B2:The subjects aged from 13 to 17 years were vaccinated with control vaccine 2 according to 0 and 42 days immunization program
C1:The subjects aged 60 years and over were vaccinated according to 0 and 42 days immunization program
C2:The subjects aged from 60 years and over were vaccinated with control vaccine 2 according to 0 and 42 days immunization program
D1:The subjects aged from 4 to 12 years were vaccinated according to 0 and 3 months immunization program
D2:Subjects aged 4-12 years received 1 dose of control vaccine1
E1:The subjects aged from 1 to 3 years were vaccinated according to 0 and 3 months immunization program
E2:Subjects aged 1-3 years received 1 dose of control vaccine1
Sponsors
Disease Control Center, Hubei
Eligibility
Sex/Gender
All
Age
1 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Resident healthy subjects aged 1 years and older; 2. Able to provide valid identification; 3. The subject and/or his/her legal guardian and/or client are capable of understanding and agreeing to sign the informed consent form. The subject are able to receive blood, urine, and saliva samples before and after immunization as required by the protocol, and are able to participate in all scheduled follow-up visits. Subjects aged 8 to 17 years are required to sign the informed consent form by themselves and their legal guardian/client.
Exclusion criteria
Exclusion criteria: General Exclusion Criteria: 1. Axillary temperature = 37.3°C prior to vaccination; 2. Those who has received varicella vaccine or live attenuated measles-rubella-mumps-varicella vaccine or marketed/investigated products with varicella/zoster vaccine components, have an onset history of varicella or herpes zoster, or have had a close-contact history with varicella patients within the past half month. 3. Those who has a history of severe allergy or serious adverse reaction to any vaccine/drug, such as urticaria, dyspnea, angioneurotic edema, or abdominal pain, or are known to be allergic to any of the ingredients of investigational vaccines (including neomycin, excipients, such as: Sucrose, sodium glutamate, sodium chloride, potassium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate, trehalose, human blood albumin, glucose, urea, arginine, mannitol); 4. Medical diagnosis or history of convulsions, epilepsy, encephalopathy (e.g. congenital cerebral insufficiency, traumatic brain injury, brain tumor, cerebral hemorrhage, cerebral infarction, cerebral infections, brain's neural tissues injury caused by chemical poisoning, etc.), psychosis, or other neurological disorders, or has a family history of psychosis; 5. Those who was diagnosed with congenital or acquired immunodeficiencies or whose close contact family members were diagnosed with congenital immune diseases in close family members, such as HIV infection in the mother of a young child or in the child himself/herself, systemic lupus erythematosus (SLE), Guillain-Barré Syndrome, etc., or other autoimmune diseases; 6. Essential or secondary immunocompromised patients (thyroid, pancreas, liver, spleen excision history); 7. Those who diagnosed with immune deficiency or immunocompromised. Those who accepted immunosuppressive therapy (e.g. total lymphocyte counts less than 1200/mm3 or cellular immune deficiency), cytotoxic therapy, steroid therapy within 6 months (except: corticosteroid spray therapy for allergic rhinitis, surface corticosteroid therapy for acute non-concurrent dermatitis, Prednisone dosage < 20 mg/day or other equivalent drug). Whose co-occupants are infants aged =28 days or pregnant women; 8. Congenital malformations, genetic defects, developmental disorders, severe malnutrition, etc 9. Those who have diagnosed or suspected with serious illness (acute or chronic), such as diabetes mellitus with complications, various infectious, suppurative and allergic skin diseases, Down syndrome, sickle cell anemia, cardio-cerebrovascular diseases (coronary heart disease, pulmonary heart disease, pulmonary edema, medically uncontrollable hypertension [systolic blood pressure =140mmHg and/or diastolic blood pressure =90mmHg as reference for adults aged 18 years and older]), liver and kidney diseases, respiratory diseases (including pneumonia, tuberculosis, severe asthma, onset phase of chronic bronchitis, etc.), malignant tumors, etc.; 10. All kinds of acute illnesses, acute attacks of chronic diseases, infectious diseases, or the use of antipyretic, analgesic, or antiallergic drugs within the last 7 days; 11. Contraindications to intramuscular injection, e.g., physician-diagnosed coagulation abnormalities (e.g., coagulation factor deficiencies, thrombocytopenia, significant bruising caused by coagulation disorders, coagulation disorders or anticoagulants treatment); 12. Received blood or blood-related products (such as immunoglobulin) in the 5 months pri
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AE;AESI;SAE; | — |
Secondary
| Measure | Time frame |
|---|---|
| regularity of detoxification; | — |
Countries
China
Contacts
Public ContactYang Beifang
Disease Control Center, Hubei
Outcome results
None listed