varicella
Conditions
Interventions
12 months-3 years old (experiment group 1):Injected with Varicella vaccine (Batch 1)
4-6 years old (experiment group 1):Injected with Varicella vaccine (Batch 1)
7-12 years old(Before 13th birthday) (experiment group 1):Injected with Varicella vaccine (Batch 1)
12 months-3 years old (experiment group 2):Injected with Varicella vaccine (Batch 2)
12 months-3 years old (experiment group 3):Injected with Varicella vaccine (Batch 3)
4-6 years old (experiment group 2):Injected with Varicella vaccine (Batch 2)
4-6 years old (experiment group 3):Injected with Varicella vaccine (Batch 3)
7-12 years old(Before 13th birthday) (experiment group 2):Injected with Varicella vaccine (Batch 2)
7-12 years old(Before 13th birthday) (experiment group 3):Injected with Varicella vaccine (Batch 3)
Sponsors
Hubei Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
1 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1.Aged from 12 months to 12 years old (before the 13th birthday), regular resident healthy people, and provide legal identification; 2.Obtain the informed consent of the volunteer and/or their legal guardian and sign the informed consent form (volunteers aged 8-12 need to sign the informed consent form in person and their legal guardian); 3.The volunteers and/or their legal guardians are able to comply with the requirements of the clinical trial protocol; 4.Armpit body temperature <= 37.0 ?.
Exclusion criteria
Exclusion criteria: 1.Previous vaccination with live attenuated varicella vaccine and history of varicella or shingles infection; 2.People with a history of asthma, allergy to known components of the vaccine, and history of any previous severe allergy to vaccination (such as urticaria, dyspnea, and angioedema); 3.A history of seizures, convulsions, or convulsions, or a family history of psychosis; 4.People with immune deficiency, immunosuppressant therapy (oral steroid hormones) or immunodeficiency due to HIV, or who have a congenital immune disease in their relatives; 5.Congenital malformations, developmental disorders or serious chronic conditions (e.g., Down syndrome, diabetes, sickle cell anemia or neurological disorders, Guillain-Barre syndrome); 6.Known or suspected co-existing illnesses include: respiratory diseases, acute infections or active periods of chronic disease, cardiovascular diseases, skin diseases, severe hypertension, and treatment of malignant tumors; 7.A doctor's diagnosis of coagulation dysfunction (such as coagulation factor deficiency, coagulation disorders, platelet abnormalities) or obvious bruising or coagulation disorder; 8.Have received blood products within the last 3 months; 9.Received live attenuated vaccine within the past 14 days or subunit or inactivated vaccine within the past 7 days; 10.Acute onset of various acute or chronic illnesses within the past 7 days; 11.High fever (armpit body temperature >=38.0 ° C) in the past 3 days; 12.Plan to use salicylic acid or products containing salicylic acid within 30 days after immunization with live attenuated varicella vaccine; 13.Researchers determine if the subjects have other factors that make them ineligible for the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| antibody geometric mean titer; | — |
Secondary
| Measure | Time frame |
|---|---|
| antibody positive conversion rate;antibody geometric mean fold increase;Incidence and severity of adverse reactions;Incidence and severity of solicited adverse events;Incidence and severity of unsolicited adverse events;The incidence and severity of adverse events leading to withdrawal;Incidence and severity of serious adverse events; | — |
Countries
China
Contacts
Public ContactXibao Huang
Hubei Provincial Center for Disease Control and Prevention
Outcome results
None listed