Chickenpox - disease caused by herpes zoster virus infection
Conditions
Interventions
Positive control group:Inject 1 dose into the deltoid muscle of the upper arm according to the immunization schedule of 0 and 2 months
Sponsors
Hubei Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
50 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. The age on the day of enrollment is 50-70 years old, and the gender is not limited. Legal identification can be provided; 2. Be able to understand the research procedures, voluntarily agree to participate in the research, and sign the informed consent form; 3. Female subjects are not pregnant or lactating; 4. Female subjects and male subjects should take effective contraceptive measures from the screening visit to 8 months after the first dose of vaccination; 5. Be able to participate in all planned follow-up visits and be able to comply with protocol requirements; 6. Underarm body temperature <= 37.0 degree C.
Exclusion criteria
Exclusion criteria: 1. Those with a history or family history of convulsions, epilepsy, encephalopathy and mental illness; 2. Those who received immunosuppressive therapy (such as long-term use of systemic glucocorticoids for >= 14 days, dose >= 2 mg/kg/day or >= 20 mg/day prednisone or equivalent to prednisone dose) within 3 months before vaccination ; 3. Those who have a history of severe allergy to any previous vaccination; those who are allergic to any component of the research vaccine, such as those who are allergic to polysorbate; 4. Impaired immune function or has been diagnosed with congenital or acquired immunodeficiency disease, human immunodeficiency virus (Human Immunodeficiency Virus, HIV) infection; 5. Those with a history of varicella or shingles vaccination; 6. Those who have suffered from herpes zoster in the past 10 years; 7. Received inactivated vaccine or recombinant vaccine within 14 days before vaccination, or received any live vaccine within 28 days; 8. Within 3 days before vaccination, those suffering from acute disease or in the acute exacerbation stage of chronic disease; 9. Those suffering from infectious skin diseases; 10. Those with a history of thrombocytopenia or other coagulation disorders, which may cause intramuscular injection contraindications; 11. Previous cardiovascular events, such as myocardial infarction (occurring within 6 months before signing the informed consent form), cardio-cerebral syndrome, severe arrhythmia, unstable angina pectoris or poorly controlled arrhythmia, uncontrolled hypertension, etc.; 12. Asplenia or functional asplenia, and asplenia or splenectomy caused by any circumstances; 13. Before the first dose of vaccination, laboratory test indicators are abnormal and clinically significant as determined by the clinician; 14. Participating in clinical studies of other investigational or unregistered products (drugs, vaccines or devices, etc.), or planning to participate in other clinical studies before the end of this clinical study; 15. Any condition that the investigator believes may affect the safety of the subject or affect the evaluation of the trial (disease factors such as extensive psoriasis, unexplained rash, eczema, chronic pain syndrome or social factors such as plans to move out before the end of the study. local, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vaccine-related and AEs at different time points (including 30-minute immediate adverse events (AEs), solicited local and systemic AEs 0-7 days, and non-solicited AEs 0-30 days) and different severities after each dose of vaccination incidence of unrelated AEs;;The incidence of all Serious Adverse Events (SAEs) during the study period;;The incidence of abnormal laboratory test indicators on the 3rd day (+1 day) after each dose of vaccination.; | — |
Countries
China
Contacts
Public ContactYeqing Tong
Hubei Provincial Center for Disease Control and Prevention
Outcome results
None listed