Varicella
Conditions
Interventions
Experimental group:A single dose of the investigational vaccine will be administered on Day 0
Placebo group:A single dose of placebo control vaccine will be administered on Day 0
Sponsors
Shandong Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
1 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male or female subjects who are at least 1 year old but less than 13 years of age at the time of enrollment. 2. The subject and/or legal guardian(s)/authorized representative(s) must be able to understand and comply with the requirements of the clinical trial protocol, complete all study procedures, voluntarily agree to participate, and sign the informed consent form. For subjects under 8 years of age, the informed consent form must be signed by legal guardian(s)/authorized representative(s); for subjects aged 8 to 12 years, both the subject and their parent(s)/legal guardian(s)/authorized representative(s) must sign the informed consent form. 3. No history of varicella vaccination, no history of varicella or herpes zoster, and no close contact with individuals with varicella or herpes zoster within 30 days prior to enrollment.
Exclusion criteria
Exclusion criteria: 1. Axillary temperature >37.0°C on the day of enrollment (prior to vaccination); 2. History of convulsion (excluding febrile seizures), epilepsy (excluding febrile-induced), encephalopathy, psychiatric disorders, or a family history of psychiatric illness; 3. Known hypersensitivity to any component of the investigational vaccine (including hydrochloric acid, dextran 40, sucrose, arginine, monosodium glutamate, histidine, urea, or human serum albumin), or a history of severe allergic reactions to any vaccines or medications (e.g., generalized urticaria, bronchospasm, dyspnea, angioedema, or anaphylactic shock); 4. History of asplenia or splenectomy, immunodeficiency (congenital or acquired), or diagnosis of lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease, or other autoimmune disorders; 5. Use of immunosuppressive agents or other immunomodulatory therapies (e.g., corticosteroids such as prednisone or equivalent at doses >=2 mg/kg/day or >=20 mg/day for >=14 consecutive days) within 6 months prior to vaccination. Topical medications (such as ointments, eye drops, inhalers, or nasal sprays) are allowed if not exceeding recommended dose in the instruction; 6. Receipt of immunoglobulin or any blood products within 3 months prior to vaccination, or planned use during the study period; 7. Those who have taken aspirin, drugs containing aspirin or salicylate within 14 days before vaccination or plan to use them within 42 days after vaccination, but topical medications (such as ointments, inhalers, or nasal sprays) is allowed. The topical medications must not exceed the recommended dose in the instruction or have any systemic exposure signs; 8. Receipt of an inactivated vaccine within 14 days before vaccination, or receipt of a live attenuated vaccine within 28 days before vaccination; 9. Presence of acute illness or an acute exacerbation of a chronic condition within 3 days before vaccination, or use of antipyretics, analgesics, or anti-allergic medications during that period; 10. Those who have a history of clearly diagnosed thrombocytopenia or other coagulation disorders which may lead to contraindication of subcutaneous injection; Those with a clear diagnosis of anemia, and the investigator evaluate that it affects the evaluation of the trial (e.g., blood collection, etc.); 11. Known or suspected to suffer from: respiratory diseases (including pneumonia, tuberculosis, severe asthma, etc.), acute infections or active stage of chronic diseases; 12. Those who are in the acute attack period of infectious, suppurative and allergic skin diseases on the day of inoculation; 13. Suffering from serious congenital malformations, genetic disorders, or other severe conditions that may interfere with the conduct or completion of the trial (including but not limited to: Down syndrome, thalassemia, severe cardiovascular disease, pulmonary edema, severe hepatic/renal disease, hereditary allergic diathesis, Henoch–Schönlein purpura, Guillain–Barré syndrome, severe developmental disorders); 14. Those who are receiving antiviral therapy ; 15. Planned participation in another clinical trial during the study period or current participation in another trial; 16. Children of the investigator(s), study staff, or any employee of the contract research organization (CRO) involved in the study; 17. The investigator judges that the clinical trial may be affected due to some other
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Laboratory-confirmed varicella cases occurring 42 days after administration of a single dose of the investigational vaccine; | — |
Secondary
| Measure | Time frame |
|---|---|
| Laboratory-confirmed moderate to severe and severe varicella cases occurring 42 days after administration of a single dose of the investigational vaccine;All adverse reactions/events occurring within 42 days after vaccination;All adverse reactions/events occurring at different time intervals after vaccination (including within 30 minutes, 0-14 days, and 15-42 days);All solicited and unsolicited adverse reactions/events after vaccination;Serious adverse events (SAEs) and adverse events of special interest (AESIs) throughout the study period;Seroconversion rate and GMT of anti-VZV-specific IgG antibodies on Day 42 after vaccination;GMI of anti-VZV-specific IgG antibodies on Day 42 after vaccination;Seroconversion rate and GMT of anti-VZV-specific IgG antibodies at 12 month after vaccination; | — |
Countries
China
Contacts
Public ContactLi Zhang
Shandong Center for Disease Control and Prevention
Outcome results
None listed