preventing varicella
Conditions
Interventions
B1:The subjects aged from 17 to 50 years old were vaccinated according to the immunization program of 0 and 8 weeks
A1:The subjects aged from 17 to 50 years were vaccinated according to 0 and 4 weeks immunization program
A2:The subjects aged from 17 to 50 years old were vaccinated with control vaccine according to 0 and 4 weeks immunization program
B2:The subjects aged from 17 to 50 years old were vaccinated with control vaccine according to the immunization program of 0 and 8 weeks
C1:Subjects aged 13 ~ 16 years were vaccinated according to 0 and 4 weeks immunization program
C2:The subjects aged 13 ~ 16 years were vaccinated with control vaccine according to 0 and 4 weeks immunization program
D1:Subjects aged 13 ~ 16 years were vaccinated according to 0 and 8 weeks immunization program
D2:The subjects aged 13 ~ 16 years were vaccinated with control vaccine according to 0 and 8 weeks immunization program
Sponsors
Disease Control Center, Hubei Province
Eligibility
Sex/Gender
All
Age
13 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Healthy adolescents and adults aged 13 ~ 50 years (including boundary value), both male and female; 2. Can provide the legal identity certificate of the subject; 3. Subjects know the contents of the informed consent form and the vaccination situation, sign the informed consent form voluntarily, and have the ability to use thermometers, scales and fill in diary cards and contact cards as required. Subjects aged 13-17 need to sign the informed consent form with their guardians; 4. Be able to communicate well with researchers and understand and comply with the requirements of this study; 5. Female volunteers of childbearing age agreed to take effective contraceptive measures 6 months after the first dose of vaccination to full exemption.
Exclusion criteria
Exclusion criteria: 1. Having been vaccinated with varicella vaccine and having a history of varicella or herpes zoster infection; 2. Axillary body temperature before vaccination is = 37.5 ? (= 14 years old) and = 37.3 ? (> 14 years old); 3. Those who are allergic to any component of the study vaccine (including neomycin) and have a history of severe allergy to any vaccination in the past; 4. Have a history of epilepsy, convulsion or convulsion, or have a family history of mental illness, autoimmune disease or immunodeficiency; 5. Acute attack of various acute diseases or chronic diseases in recent 7 days; 6. Received blood products, immunosuppressive agent, hormones and other research drugs within 3 months before vaccination; 7. Received other live attenuated vaccine, subunit or inactivated vaccines within 4 weeks before vaccination; 8. Pregnant women (female subjects of childbearing age have positive urine pregnancy test) and lactating women; 9. Suffering from severe cardiovascular disesses (cor pulmonale, pulmonary edema and hypertension cannot be controlled to normal range by drugs), liver and kidney diseases and diabetes with complications; 10. According to the judgment of the researcher, the subject has any other factors that are not suitable for participating in clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| antibody positive conversion rate;antibody geometric mean titer; | — |
Secondary
| Measure | Time frame |
|---|---|
| geometric growth multiple of antibody;antibody positive rate; | — |
Countries
China
Contacts
Public ContactYang Beifang
Disease Control Center, Hubei Province
Outcome results
None listed