varicella
Conditions
Interventions
Low Dose group:Injected with VZV-7D or positive control or placebo
Middle Dose group:Injected with VZV-7D
High Dose group:Injected with VZV-7D
Sponsors
Guangxi Center for Disease Prevention and Control
Eligibility
Sex/Gender
All
Age
1 Years to 49 Years
Inclusion criteria
Inclusion criteria: 1) Aged 1 to 49 years; 2) The legal guardian of the subject or/and the subject himself shall sign the informed consent; 3) The legal guardian of the subject or/and the subject himself can comply with the requirements of the clinical trial program and complete all studies program; 4) Men,women of Non-childbearing age or women of childbearing age have no plan for Pregnancy in nearly 42 days; 5) Subaxillary body temperature = 37.0?.
Exclusion criteria
Exclusion criteria: 1) Persons with severe allergic reaction,convulsion,epilepsy,encephalopathy and neurological diseases or family history; 2) Those who had been vaccinated with live attenuated varicella vaccine or had a history of varicella and herpes zoster virus infection; 3) Those who are allergic to any component of the vaccine (including dextran,sucrose,lactose,arginine,sodium glutamate,histidine,carbamide,human serum albumin,hydrochloric acid etc.) ; 4) Patients with immunodeficiency, malignant tumors, immunosuppressive therapy(oral steroids, etc.) which induced immunodeficiency; 5) Injection of immunoglobulin or any blood product within 3 months before admission, or planned to use during the trial (within 42 days after immunization); 6) Inoculating inactivated vaccines less than 14 days before admission,or inoculating attenuated vaccines less than 28 days before admission; 7)With acute febrile diseases or current infectious; 8) A history of clearly diagnosed thrombocytopenia or other coagulation disorders which may lead to contraindication of subcutaneous injection;A history of clearly diagnosed anemia; 9) Known or suspected to suffer from: severe respiratory diseases (including pneumonia, tuberculosis, severe asthma, chronic bronchitis, etc.), acute infections, severe chronic diseases or acute episodes of chronic diseases; 10) Suffering from serious hypertension,cardiovascular, liver and kidney diseases, and diabetes mellitus with complications; 11) Infectious, suppurative or allergic skin diseases; 12) Pregnant women(Sexually mature females whose urine pregnancy test is positive),lactating women; 13) Breastfeeding babies, premature babies or test tube babies; 14) Receiving antivirus treatment; 15) Living with babies(=28 days age),pregnant women or patients with congenital immune diseases; 16) Participating or plan to participate another clinical trial; 17) Before immunization, blood routine and blood biochemical laboratory collected abnormal indicators of which severity reached grade 2 or above; 18) The psychological situation can not comply with the research requirements, past or present psychosis and bi-level emotional psychosis have not been well controlled in the past two years. Psychosis needs to take drugs. In the past five years, people have suicidal tendencies. 19) Other medical, psychological, social or occupational factors that, according to the investigators' judgment, might affect the individual's ability to obey the protocol or sign the informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Antibody Level;Secretion of VZV through saliva; | — |
Countries
China
Contacts
Public ContactMo Zhaojun
Guangxi Center for Disease Prevention and Control
Outcome results
None listed