Varicella
Conditions
Interventions
Treatment group:Vaccination
Placebo group:Vaccination
Sponsors
Jiangsu Provincial Center for Disease Control and Prevention (Public Health Research Institute of Jiangsu province)
Eligibility
Sex/Gender
All
Age
1 Years to 59 Years
Inclusion criteria
Inclusion criteria: The first stage: 1.On the day of joining the group, the age is 13-59 years old, regardless of gender, and can provide legal identification; 2.Subjects and/or guardians have the ability to understand the research requirements and process, agree to participate in clinical trials and sign informed consent forms; 3.Agree to take effective contraceptive measures and have no pregnancy and birth plan (applicable to fertile female subjects or their spouses) during the study period; 4.The underarm temperature was =37.0? on the day of enrollment. The second stage: 1.On the day of joining the group, the age is 1-12 years old, regardless of gender, and can provide legal identification; 2.Subjects and/or guardians have the ability to understand the research requirements and process, agree to participate in clinical trials and sign informed consent forms; 3.The underarm temperature was =37.0? on the day of enrollment.
Exclusion criteria
Exclusion criteria: The first stage: 1.At present, salicylate drugs (including salicylic acid, aspirin, diflunisal, sodium p-aminosalicylic acid, bisalicylate, benomyl ester, etc.) are being used, or are planned to be used for a long time during the research period; 2.3 days before vaccination, he had suffered from fever (underarm body temperature =38.5?) or used antipyretic, analgesic and antiallergic drugs (such as acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.); 3.Have a history of allergy to vaccine ingredients and accessories or severe drug allergy, such as anaphylactic shock, allergic laryngeal edema, anaphylactoid purpura, thrombocytopenic purpura, local anaphylactic necrosis reaction (Arthus reaction), severe urticaria, etc.; 4.Have a history of epilepsy, convulsion or convulsion, and a family history of severe nervous system diseases or psychosis; 5.Impaired immune function or has been diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease or other autoimmune diseases; 6.People suffering from severe congenital malformation, hereditary diseases, severe cardiovascular diseases, severe liver/kidney diseases, diabetes with complications, malignant tumors and severe malnutrition; 7.Receive immunosuppressant therapy within 3 months before vaccination or within 30 days after vaccination, such as long-term oral or injection of glucocorticoid therapy (=14 days, dose =2 mg/kg/ day or =20 mg/ day prednisone or its equivalent dose), but local medication is not restricted (such as ointment, eye drops, inhalant or nasal spray); 8.Have received blood/blood-related products or immunoglobulin 3 months before vaccination, or plan to use such products 30 days after vaccination; 9.Have been vaccinated with live attenuated vaccine within 30 days before vaccination of experimental vaccine, or have been vaccinated with any vaccine within 14 days before vaccination; 10.Any situation (such as splenectomy) causes no spleen or splenectomy; 11.Those who have a history of thrombocytopenia or other coagulation disorders, which may cause contraindication of subcutaneous injection; 12.Various infectious, suppurative or allergic skin diseases; 13.Participating in clinical trials of other research or unregistered products (drugs, vaccines or devices, etc.), or having plans to participate in other clinical trials before the end of this clinical trial; 14.According to the researcher's judgment, the subjects have any other factors that are not suitable for participating in clinical trials. The second stage: 1.Have been vaccinated with any chickenpox vaccine in the past (such as chickenpox vaccine, leprosy plus chickenpox vaccine); 2.Have a previous history of varicella or herpes zoster infection, or have been exposed to varicella/herpes zoster patients or suspected varicella/herpes zoster patients within 30 days of joining the group; 3.At present, salicylate drugs (including salicylic acid, aspirin, diflunisal, sodium p-aminosalicylic acid, bisalicylate, benomyl ester, etc.) are being used, or are planned to be used for a long time during the research period; 4.3 days before vaccination, he had suffered from fever (underarm body temperature =38.5?) or used antipyretic, analgesic and antiallergic drugs (such as acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.); 5.Have a history of allergy t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Protective efficacy;Neutralizing antibody ;Immune persistence;Local and systemic adverse effects/events;Serious adverse events; | — |
Countries
China
Contacts
Public ContactHongxing Pan
Jiangsu Provincial Center for Disease Control and Prevention (Public Health Research Institute of Jiangsu province)
Outcome results
None listed