Chickenpox - disease caused by herpes zoster virus infection
Conditions
Interventions
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. The fertile subjects (including the subject's partner) should take effective contraceptive measures from the screening visit to 6 months after the full 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?.
Exclusion criteria
Exclusion criteria: 1. Have a medical history or family history of convulsion, epilepsy, encephalopathy and psychosis; 2. Those who received immunomodulator treatment within 3 months before vaccination (such as long-term use of systemic glucocorticoid = 14 days, dose = 2mg/kg/day or = 20mg/day of prednisone or equivalent dose of prednisone); 3. Have any history of severe allergy to vaccination in the past; People who are allergic to any component of the research vaccine, such as polysorbate; People with allergic constitution; 4. Impaired immune function or have been diagnosed with congenital or acquired immunodeficiency disease, human Immunodeficiency virus (HIV) infection; 5. Have a history of varicella or herpes zoster vaccination; 6. Persons suffering from herpes zoster in the past 10 years; 7. Have received non live vaccine within 14 days before vaccination, or have received any live vaccine within 28 days; 8. The user has used blood products or immunoglobulins within one month before the vaccination, or within one month after the planned full vaccination; 9. Those who suffer from acute disease or are in the acute attack period of chronic disease within 3 days before vaccination; 10. Patients with infectious skin diseases; 11. Have a history of thrombocytopenia or other blood coagulation dysfunction, which may cause contraindication of intramuscular injection; 12. Previous cardiovascular events, such as myocardial infarction (occurred within 6 months before signing the informed consent form), cardio cerebral syndrome, severe arrhythmia, unstable angina pectoris or arrhythmia poorly controlled, hypertension poorly controlled, etc; 13. Absence of spleen or functional absence of spleen, and absence of spleen or splenectomy caused by any condition; 14. Being involved in the clinical research of other investigational or unregistered products (drugs, vaccines or devices, etc.), or planning to participate in other clinical research before the end of this clinical research; 15. Any situation that the investigator thinks may affect the safety of the subject or affect the test evaluation (disease factors such as extensive psoriasis, unexplained rash, eczema, chronic pain syndrome or social factors such as the plan to move out of the local area before the end of the study).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anti-gE antibody geometric mean concentration (Geometric Mean Concentration, GMC), anti-VZV antibody geometric mean titer (Geometric Mean Titer, GMT) 30 days after full vaccination;;The positive conversion rate of anti-gE and anti-VZV antibodies 30 days after the whole inoculation.;The incidence of vaccine-related and unrelated AEs at different time points (including 30-minute immediate AEs, 0-7 days of solicitation AEs, 0-30 days of non-solicited AEs) and different severities after each dose of vaccination;;The incidence of SAE from the first dose to 6 months after the full vaccination;; | — |
Countries
China
Contacts
Public ContactYeqing Tong
Outcome results
None listed