Immune Persistence After Inoculated With One-dose Freeze-Dried Live Attenuated Varicella Vaccine in Children Vaccine in Children

Study Overview
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Brief Summary
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The purpose of this study is to observe the persistence of protection, duration of protection, safety and breakthrough infection rates afforded by live attenuated varicella vaccine in children over a 5-year period.

Official Title
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A Study of Immune Persistence After Inoculated With One-dose Freeze-dried Live Attenuated Varicella Vaccine in Children Aged 1-6 Years

Conditions
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Chickenpox

Intervention / Treatment
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* Biological: Live Attenuated Varicella Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant are healthy children aged 1-6 years, who has inquired for medical history and physical examination, and met the requirement of the vaccine trial Parent/legal acceptable representative is willing and able to understand the protocol requirements and provide informed consent Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures Body temperature ≤37℃ Exclusion Criteria: Participant with previous history of chickenpox or zoster Receipt of varicella vaccine Reported the family history of allergies, convulsions, epilepsy and mental illness Known allergy to any constituent of the vaccine Known serve illness, in a fever, acute infection and chronic disease activity Receipt of steroid Reported the history of thrombocytopenia or other coagulation disorders, which may cause Known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth Known congenital malformation, developmental disorders and severe chronic disease (e.g. Down's syndrome, diabetes, sickle cell anemia and neurologic disorders) Known dermatopathy with allergy, herpes, fester, and fungal infection Receipt of whole blood, blood plasma or immunoglobulin in the 3 months preceding the trial vaccination Reported the history of acute illness had need systemic antibiotics or anti-viral treatment of infections in the 7 days preceding the trial vaccination Participant with fever(temperature≥ 38℃) in the days Any condition, which, in the opinion of the investigator, would pose a health risk to the subject

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Live Attenuated Varicella Vaccine<br>use the arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection | Biological: Live Attenuated Varicella Vaccine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immune protective effect and persistence after inoculated with live attenuated varicella vaccine | Clinical subjects are drawn 3ml's vein blood，respectively before vaccination, six weeks and every year in 5 years study period after inoculation of the live varicella vaccine. FAMA methods are used to test antibody rate of pox virus. | Before vaccination, six weeks and every year in 5 years study period after inoculation of the live varicella vaccine | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breakthrough rate, duration and severity of varicella in vaccinated children |  | 5 years period | 
| Occurrence of adverse events |  | Up to 4 weeks after vaccination |