Varicella
Conditions
Interventions
Low Dose group:Vaccination
Middle Dose group:Vaccination
High Dose group:Vaccination
Positive Control group:Vaccination
Sponsors
Jiangsu provincial centre for disease control and prevention (Public health research institute of Jiangsu province)
Eligibility
Sex/Gender
All
Age
3 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1) Aged 3 to 12 years old at screening; 2) Individuals and their legal guardian shall sign the informed consent(>=8 years old signed by the person and the guardian, < 8 years old signed by the guardian); 3) Individuals and their legal guardian are able to comply with the requirements of the clinical trial program and complete all studies program.
Exclusion criteria
Exclusion criteria: 1) Subaxillary body temperature > 37.0 degree C; 2) People with severe allergic reaction, convulsion, epilepsy, encephalopathy and neurological diseases or family history; 3) Those who have been vaccinated with live attenuated varicella vaccine or had a history of varicella and herpes zoster virus infection or close contact with varicella patients within the past half a month; 4) Those who are known to be allergic to any component of the research vaccine (including dextran, sucrose, lactose, arginine, sodium glutamate, histidine, urea, human blood albumin), have any previous severe allergy to vaccination Historian; 5) Patients with immunodeficiency, during the treatment of malignant tumors, immunosuppressive therapy(oral steroids, etc.) which induced immunodeficiency; 6) Injection of immunoglobulin or any blood product within 3 months before admission, or planned to use during the trial (within 42 days after immunization); 7) Have taken or plan to use aspirin or contain aspirin during the 14 days before the vaccine or salicylate drugs; 8) Those who have taken aspirin, drugs containing aspirin or salicylate within 14 days before vaccination or plan to use these drugs during the trial; 9) Inoculating inactivated vaccines less than 14 days before admission, or inoculating attenuated vaccines less than 28 days before admission; 10)With acute febrile diseases or current infectious; 11)A history of clearly diagnosed thrombocytopenia or other coagulation disorders which may lead to contraindication of subcutaneous injection;A history of clearly diagnosed anemia; 12) Known or suspected to suffer from: respiratory diseases (including pneumonia, tuberculosis, severe asthma, Chronic bronchitis episode, etc.), acute infections or acute episodes of chronic diseases; 13) Suffering from serious hypertension, cardiovascular, liver and kidney diseases, and diabetes mellitus with complications; 14) Infectious, suppurative or allergic skin diseases; 15) Congenital malformations or developmental disabilities; 16) Those who are receiving antiviral treatment; 17) Cohabitants with =28 days of babies, or pregnant women, or congenital immune diseases; 18) Plan to participate in another clinical study during the study or is participating in another clinical study; 19) Because of psychological problems, people who suffer from psychosis or Bipolar Disorder at this moment or before cannot comply with the requirements of the research, this condition has not been well controlled in the past two years, moreover, they have to take medicine for curing the psychosis, people with the suicidal tendency in the last five years cannot be in as well; 20) According to the investigator's judgment, due to some other diseases, medical, psychological, social conditions and occupational factors or other conditions, it is contrary to the research plan or not suitable for vaccination, or affects the subjects to sign the informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IgG;IFN-?;Adverse occurrence of local and systematic reactions or events;All the adverse occurrence of reactions or events;Special event(Chickenpox, varicella-like rash, shingles, etc.);Serious adverse event; | — |
Countries
China
Contacts
Public ContactYuemei Hu
Jiangsu provincial centre for disease control and prevention (Public health research institute of Jiangsu province)
Outcome results
None listed