Varicella
Conditions
Interventions
Low Dose group:2 doses of low-dose vaccine at 0 and 3rd month intervals
Medium Dose group:2 doses of medium-dose vaccine at 0 and 3rd month intervals
Low Dose group:2 doses of low-dose vaccine at 0 and 6th month intervals
Medium Dose group:2 doses of medium-dose vaccine at 0 and 6th month intervals
Low Dose group:2 doses of low-dose test vaccine at 0 and 15th month intervals
Medium Dose group:2 doses of medium-dose test vaccine at 0 and 15th month intervals
High Dose group:2 doses of high-dose test vaccine at 0 and 15th month intervals
Positive Control group:2 doses of positive control vaccine at 0 and 15th month intervals
Sponsors
Jiangsu provincial center for disease prevention and control (Public health research institute of Jiangsu province)
Eligibility
Sex/Gender
All
Age
1 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1) Be at least 1 year old and under 13 years old on the day of enrollment (only applicable to 0,3m and 0,6m immunization schedule groups) / have participated in the previous phase IIa study of this product (only applicable to 0,15m immunization schedule groups) ; 2) Individuals and their legal guardian shall attend the informed consent process and sign the informed consent form(=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 study protocol and complete all studies program.
Exclusion criteria
Exclusion criteria: Exclusion criteria for the first dose of vaccination: 1) Subaxillary body temperature > 37.0 ?; 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(except for vaccination in this study) 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, hydrochloric acid), had a history of severe allergies to any previous vaccinations; 5) Patients with immunodeficiency, during the treatment of malignant tumors, immunosuppressive therapy(oral steroids, etc.) which induced weakened immune system; 6) Injection of immunoglobulin or any blood product within 3 months before enrollment, or planned to use during the trial (within 42 days after immunization); 7) Have taken or plan to use aspirin or contain aspirin or salicylate drugs during the 14 days before the vaccination; 8) Inoculating inactivated vaccines less than 14 days before admission, or inoculating live vaccines less than 28 days before admission; 9)With acute febrile diseases or acute infectious diseases; 10)A history of clearly diagnosed thrombocytopenia or other coagulation disorders which may lead to contraindication of subcutaneous injection; A history of clearly diagnosed anemia; 11) Known or suspected to suffer from: respiratory diseases (including pneumonia, tuberculosis, severe asthma, chronic bronchitis episode, etc.), acute infections or active stage of chronic diseases; 12) Suffering from serious hypertension, cardiovascular, liver and kidney and other chronic diseases, and diabetes mellitus with complications; 13) Various infectious, suppurative or allergic skin diseases; 14) Congenital malformations or developmental disabilities; 15) Those who are receiving antiviral treatment; 16) Cohabitants with =28 days of babies, or pregnant women, or congenital immune diseases; 17) Plan to participate in another clinical study during the study or is participating in another clinical study; 18) 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; 19) According to the investigator's judgment, due to a variety of medical, psychological, social conditions, occupational factors or other conditions, it is contrary to the research protocol, or affects the subjects to sign the informed consent. Exclusion criteria for the second dose of vaccination: 1) Serious adverse reactions that are causally related to the previous vaccination, such as high fever (=39.5°C) and severe allergic reactions within 48 hours after vaccination; 2) Meet the first dose of vaccine exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positive conversion rate of varicella virus-specific IgG antibodies;GMT of varicella virus-specific IgG antibodies; | — |
Secondary
| Measure | Time frame |
|---|---|
| Local and systemic adverse reactions;All adverse reactions/events;Special events (varicella, varicella-like rash, shingles, etc.);Serious adverse event; | — |
Countries
China
Contacts
Public ContactFengcai Zhu
Jiangsu provincial center for disease prevention and control (Public health research institute of Jiangsu province)
Outcome results
None listed